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Peregrine Pharmaceuticals (PPHM)
Q3 2013 Earnings Call
March 12, 2013 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
Joseph S. Shan - Vice President of Clinical & Regulatory Affairs
Robert Garnick - Head of Regulatory Affairs
Previous Statements by PPHM
» Peregrine Pharmaceuticals' CEO Discusses F2Q 2013 Results - Earnings Call Transcript
» Peregrine Pharmaceuticals Management Discusses Q1 2013 Results - Earnings Call Transcript
» Peregrine Pharmaceuticals Management Discusses Q4 2012 Results - Earnings Call Transcript
Joseph Pantginis - Roth Capital Partners, LLC, Research Division
Charles C. Duncan - Piper Jaffray Companies, Research Division
George B. Zavoico - MLV & Co LLC, Research Division
Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals, Inc. Third Quarter Fiscal Year 2013 Financial Results Conference Call. [Operator Instructions] Today's conference is being recorded. I would now like to turn the call over to Jay Carlson.
Thanks, Jamie. 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; and Rob Garnick; Head of Regulatory Affairs.
Steve will begin by providing a brief overview of the company's progress over the last quarter, including the company-sponsored trials, as well as the investigator-sponsored trials or ISTs, and how these events set the stage for numerous near-term clinical data milestones. Joe will then review the clinical developments of the quarter, with Rob then discussing our regulatory plans as we advance our bavituximab and Cotara programs. Paul will then finish with a summary of our financial results for the third quarter fiscal year 2013. 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 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 2012 ended April 30, 2012, and quarterly report on Form 10-Q for the third quarter ended January 31, 2013.
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 will now turn the call over to Steve.
Steven W. King
Thanks, Jay, and thanks to all of you for participating in today's quarterly call.
Since last quarterly conference call, we've made significant advancements in our drug development programs and have seen continued solid performance from our manufacturing business as part of our hybrid business model. We have successfully executed toward our stated goals for advancing our lead clinical programs, bavituximab and Cotara, and have already surpassed last year's manufacturing revenue total with still one quarter to go before fiscal year end. Perhaps at the forefront of these advancements was completing and announcing the results of our internal review of data from our Phase II clinical trial of bavituximab in second-line non-small cell lung cancer. The review was prompted by the discovery of bio-coding discrepancies in 2 arms of the study and was very comprehensive. It involved testing thousands of product vials, patient samples and a thorough review of data from the study.
Results from the review did not indicate any evidence of discrepancies in coding assignments at the high dose or 3-milligram per kilogram bavituximab arm of the trial. While there was ample evidence of coding discrepancies between the placebo and the low dose or 1-milligram per kilogram bavituximab arm.
Based on the thorough review, we chose to move forward with the conservative, and in the end, the least subjective approach to the updating of the data from the trial, combining the 1-milligram per kilogram and placebo arms into a single control arm and comparing those results with the 3-milligram per kilogram arm of the study.
As Joe will discuss in a moment, the data from this updated analysis shows a compelling improvement in median overall survival for patients receiving 3 milligram per kilogram bavituximab and we are confident that the overall data from the trial provides a strong rationale for advancing this dose combination in the later-stage clinical development. Rob will provide additional insight during his upcoming section.
We also continued to make progress in the rest of our bavituximab clinical program. In addition to the second-line non-small cell lung cancer data, during the quarter we also announced encouraging data from our randomized Phase II front-line pancreatic cancer study. Joe will cover the data in greater detail, but I can tell you that we are encouraged by the early signs of activity we saw in this very sick patient population with advanced disease, and that we look forward to presenting additional data from the study in an upcoming medical conference and to working closely with our clinical advisors to establish the next step toward advancing the program.
In addition, we and our clinical collaborators are continuing the study of bavituximab in different indications and combinations, and we look forward to presenting data from these studies as it becomes available.