Peregrine Pharmaceuticals (PPHM)
Q4 2011 Earnings Call
July 14, 2011 4:30 pm ET
Unknown Speaker -
Robert Garnick - Head of Regulatory Affairs
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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Jeffrey Masten - Vice President of Quality
Amy Figueroa - IR, BioCom Partners
Christopher Eso - Vice President of Business Operations
Joseph Pantginis - Roth Capital Partners, LLC
George Zavoico - McNicoll, Lewis & Vlak LLC
Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals Fourth Quarter and Fiscal Year 2011 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. Please go ahead.
Thanks, Huey [ph]. 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; Rob Garnick, Head of Regulatory Affairs; Jeff Masten, Vice President of Quality; and Chris Eso, Vice President of Business Operations.
Steve will begin by providing an overview of our clinical progress over the last year and highlight upcoming milestones. Joe, Rob and Jeff will discuss our clinical, regulatory and manufacturing plans as we advance our 3 Phase II clinical programs.
Chris will provide an update on Avid, our strategically integrated biomanufacturing subsidiary. And then Paul will wrap up with a review of our financial results for the fourth quarter and fiscal year 2011 and our financing strategy.
After our prepared remarks, we welcome your questions, and Steve is staying up late tonight from Europe on business so we can answer them.
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 the fiscal year ended April 30, 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'll now turn the call over to Steve.
Thanks, Amy. Fiscal year 2011 was a building year and a very important year for Peregrine. Over the last year, we have completely transformed our pipeline, reporting promising data from 5 clinical trials, launching 4 new randomized Phase II trials and kicking off 4 investigator-sponsored trials or IST.
We've made significant progress in advancing our clinical programs to build for what we expect to be an even more exciting fiscal year 2012.
Over the coming year, we'll continue to advance our 3 Phase II clinical programs. And we are looking forward to clinical data reports and regulatory meetings, which have the potential to be important value-driving events for our company.
And as we advance our programs, we have our strategic asset, Avid Bioservices, to support our later-stage clinical trials and prepare for potential commercial launch of bavituximab and Cotara.
Avid's revenues from services for its third-party clients and cost-effective manufacturing of our products both help reduce our overall burn.
But beyond the financial benefits, Avid is an important strategic asset. Not many biotech companies have an integrated cGMP, commercial biomanufacturing unit, with the potential to commercially manufacture their own products, representing a significant advantage as we move our products closer to our potential launch.
And to drive our programs forward into these later-stage trials to potential launch, we have expanded our teams at Peregrine and Avid, bringing on board critical expertise in clinical developments, regulatory affairs, quality assurance and manufacturing.
We have some of the industry's best experts developing our strategy and executing our plans to reach our overarching goal to develop, manufacture and commercialize antibodies to treat patients with cancer and viral infections.
Since our last quarterly conference call, we have continued making significant progress with our 3 Phase II clinical programs, advancing toward key clinical and regulatory milestones, while carefully managing our resources to reach these milestones.
We presented data at ASCO, EASL, AACR and a leading European antibody conference. And Joe will talk more about the data presented next.
Before handing the call over to Joe, I'd like to highlight some of our key upcoming clinical milestones, starting with bavituximab.
As we explained in our last quarterly call, patient enrollment in clinical trials is becoming increasingly challenging on an industry-wide basis. We responded to the challenges by making amendments to our protocols and expanding the number of sites involved in our trials. And Joe will describe our efforts in greater detail next.
Amending protocols takes time for investigator and regulatory agency review. But taking these steps now will help expand the potential product label for bavituximab should it become an approved product. And since amending the protocols, we've seen a noticeable uptick in patient enrollment, further supporting the importance of addressing these patient enrollment criteria during Phase II development.