Peregrine Pharmaceuticals Inc. (PPHM)

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Peregrine Pharmaceuticals (PPHM)

Q2 2012 Earnings Call

December 12, 2011 4:30 pm ET


Steven W. King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc

Paul J. Lytle - Chief Financial Officer, Principal Accounting Officer, Corporate Secretary, Chief Financial Officer of Avid Bioservices and Corporate Secretary of Avid Bioservices

Jay Carlson -

Joseph S. Shan - Vice President of Clinical & Regulatory Affairs


Gena Huidong Wang - JMP Securities LLC, Research Division

Boris Peaker - Oppenheimer & Co. Inc., Research Division

Stephen M. Dunn - LifeTech Capital, Research Division

George B. Zavoico - McNicoll, Lewis & Vlak LLC, Research Division

Joseph Pantginis - Roth Capital Partners, LLC, Research Division



Good day, ladies and gentlemen, and thank you for standing by. And welcome to the Peregrine Pharmaceuticals Second Quarter 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 Jay Carlson of Peregrine's investor relations group. Please go ahead.

Jay Carlson

Thanks, Huey. 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; and Joe Shan, Vice President of Clinical and Regulatory Affairs. Steve will begin by providing an overview of our significant clinical progress over the last quarter and highlight our multiple near-term clinical data milestones. Joe will discuss our clinical and regulatory plans as we advance our 3 Phase II clinical programs for bavituximab and Cotara. And Paul will wrap up with a review of our financial results for the second quarter and our increased contract manufacturing revenue guidance for fiscal year 2012 and will discuss 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'll 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 2011 ended April 30, 2011, and quarterly report on Form 10-Q for the second quarter ended October 31, 2011, 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 result of new information, future events or otherwise.

I'll now turn the call over to Steve.

Steven W. King

Thanks, Jay, and thank you to all of you who are participating in today's quarterly conference call. In the second quarter, we've seen unprecedented momentum in advancing our clinical programs. We completed patient enrollment in 3 randomized Phase II trials, positioning us for multiple data milestones starting early in 2012.

We reported median overall survival data from 2 prior single-arm Phase II trials, showing remarkably consistent, promising data across our bavituximab oncology trials. And perhaps most importantly, we recently reported our first randomized Phase II data, a 50% increase in overall response rates for patients treated with bavituximab in combination with chemotherapy in a preliminary analysis from our front-line non-small cell lung cancer trial.

We believe this first randomized data point, the first of multiple clinical data points expected from our 7 ongoing bavituximab oncology trials over the coming year, is a potentially game-changing early validation of the anti-tumor activity of our PS-targeting antibody platform. This is the type of data that we, institutional investors and potential pharmaceutical partners have been waiting to see. In a minute, I'll turn the call over to Joe to discuss our clinical programs in further detail, but I do want to share my thoughts about what these recent developments mean for Peregrine and touch base on our upcoming milestones.

At Peregrine and Avid, we have a vision, which is to develop, manufacture and commercialize our novel monoclonal antibodies to significantly improve the lives of patients with cancer and HCV. And we have several assets in play that are helping us to achieve these goals. The backbone of Peregrine is our first-in-class technology platforms, which have a broad intellectual property estate and remain mostly unencumbered for partnering.

Over the past year, we have focused on building the value into our bavituximab and Cotara programs, executing on randomized clinical trials and securing clear development and regulatory paths for these products, enhancing the value of these programs for Peregrine, as well as for potential partners.

While we have been in close contact with the potential partners in the past, many have been waiting to see randomized data. With our initial randomized clinical data in hand, further validating promising early clinical results, we are now in a position to advance and accelerate these discussions.

Our goal is to secure regional partners for our bavituximab oncology program, and we look forward to seeing additional data points from our randomized trials as we advance these discussions. In addition to the exciting results from our bavituximab oncology program, we have opened a dialogue with the FDA to negotiate a pivotal trial design for Cotara, our novel single-administration approach to treating deadly recurrent GBM.

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