Peregrine Pharmaceuticals (PPHM)
Q1 2012 Earnings Call
September 09, 2011 11:30 am ET
Amy Figueroa - IR, BioCom Partners
Steven King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc
Robert Garnick - Head of Regulatory Affairs
Joseph Shan - Vice President, Clinical and Regulatory Affairs
Previous Statements by PPHM
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Jason Butler - JMP Securities LLC
George Zavoico - McNicoll, Lewis & Vlak LLC
Welcome to the Peregrine Pharmaceuticals First Quarter of Fiscal Year 2012 Conference Call. I would like to remind you that today's call is being recorded. [Operator Instructions] I would now like to turn the call over to Amy Figueroa.
Thanks, Jerome. Good morning, and thank you for joining us. On today's call, we have Steve King, President and CEO; Paul Lytle, CFO; Joe Shan, Vice President of Clinical and Regulatory Affairs; and Rob Garnick, Head of Regulatory Affairs.
Steve will begin by providing an overview of our clinical progress over the last quarter and highlight our upcoming clinical data and regulatory meeting milestones. Joe and Rob will discuss our clinical and regulatory plan as we advance our 3 Phase II clinical programs and Paul will wrap up with a review of our financial results for the first quarter of fiscal year 2012 and our financing strategy. 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 they 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 quarterly report on Form 10-Q for the first quarter ended July 31, 2011, which will be filed later today, and our annual report on Form 10-K for the fiscal year ended April 30, 2010, which was filed July 14, 2011.
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.
Thanks, Amy. I thank all of you for participating in today's quarterly conference call.
This quarter, we've had continued progress in advancing our clinical programs, building from important clinical data and regulatory meeting milestones later this year and throughout 2012. One of the key highlights this quarter was clinical data from our Phase II trial treating cancer patients with bavituximab and Cotara. What's particularly encouraging to the team here at Peregrine is that each data point continues to provide positive signs of safety and activity, not only for each trial, but for the programs as a whole. Positive tumor response rates, progression-free survival, and most recently, median overall survival. Taken together, these results are further convincing us that these are active developable drugs which have the potential to make a real difference in the lives of the patients we are treating.
Beginning with bavituximab, we have recently reported very promising median overall survival data from our single-arm Phase IIa trials, one in front-line non-small cell lung cancer and one in locally advanced or metastatic breast cancer. Joe will be reviewing specific details of these later in the call, but let me say that we are all excited to see that the promising early data from these trials have correlated nicely with the most recent survival data for our patients.
It's worth noting that we continue to monitor survival from a third Phase IIa single-arm trial in which we treated advanced breast cancer patients with bavituximab in combination with carboplatin and paclitaxel. Earlier data from this trial were promising and we are pleased that the patients from this trial, which was completed around the time of our other breast cancer study, haven't yet reached median overall survival. While breast cancer is a very large yet fragmented clinical indication, these compelling data motivate us to look at ways to move forward with future bavituximab trials for these patients. One of these trials is already underway as an IST. So far, 8 of the 9 data points from these 3 prior trials have been very encouraging with one data point still yet to be reported, encouraging to say the least. Our focus is now to advance our 4 ongoing randomized Phase II trials for bavituximab in cancer and HCV, while continuing to find ways to advance the multitude of potential indications for bavituximab. Joe will discuss these important clinical developments later on our call.
It's important to remember that PS-targeting technology platform has many potential uses and that researchers continue to explore bavituximab and our other PS-targeting antibodies therapeutic and diagnostic potential. And we look forward to pursuing the full potential of the technology, both internally and with our development partners.
Before turning the call over to Rob, I'd like to quickly review our upcoming clinical data and regulatory milestones. We recently completed patient enrollment in our randomized Phase II trial for bavituximab in front-line non-small cell lung cancer, keeping us on track to report interim data by the end of this year and top line response data from all patients in the first quarter of next year. Our second line non-small cell lung cancer trial is expected to complete enrollment of 120 patients early in the fourth quarter, putting us on track for primary endpoint tumor response data unblinded in the first half of next year.