Leader in First-in-Class Monoclonal Antibodies Focussed on the Treatment and Diagnosis of Cancer

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. We are pursuing multiple clinical programs in cancer with our lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers.

For oncology indications,our lead PS-targeting candidate bavituximab in combination with chemotherapy has demonstrated promising signs of anti-tumor activity and survival trends in patients with non-small cell lung cancer (NSCLC) and advanced breast cancer.

Agreement with FDA on Phase III Bavituximab Clinical Trial Design

In May, 2013, we announced that we had reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase III registration trial design of our lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer (NSCLC). The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel.

The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 600 patients at sites worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint of the trial will be overall survival (OS). We anticipate initiating the trial by year-end 2013.

Bavituximab Clinical Data

• Second-line NSCLC trial evaluating bavituximab combined with docetaxel in 121 patients. In February, 2013, we reported data from this randomized, double-blind placebo-controlled Phase II trial. Data from the trial has been updated based on completion of an earlier review of discrepancies in the trial and the most current survival data from the trial. Updated results from this Phase II trial indicate a meaningful improvement in median overall survival of 11.7 months in the 3mg/kg bavituximab + docetaxel arm compared to 7.3 months in the control arm (HR=0.73; p value=0.217). Persistent separation in the survival curves was observed with response rates and progression free survival also favoring the 3mg/kg bavituximab + docetaxel arm in this difficult to treat second-line NSCLC. The results also demonstrated that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms. Peregrine plans to report additional data from the trial, including updated subgroup analysis and safety data, at an upcoming scientific meeting. Investors are reminded not to rely on clinical data that the company disclosed on or before September 7, 2012 regarding this trial.
• Front-line NSCLC trial evaluating bavituximab plus paclitaxel and carboplatin in 86 NSCLC patients. Patient enrollment in this trial was completed in September 2011. In March 2012 we announced top-line data from this trial showing promising progression-free survival from site assessments. Overall survival data from the trial, which is an event driven endpoint, is expected during the 1st half of calendar year 2013.
• Front-line pancreatic cancer trial evaluating bavituximab with gemcitabine in 70 patients with previously untreated stage IV pancreatic cancer. Patient enrollment in this trial was completed in June 2012. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. In February, 2013, we announced results showing that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75). Further analysis of the data including subgroups show potentially promising trends and we look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting.

In addition to the trials we are conducting, bavituximab's broad-spectrum therapeutic potential is being explored through several cost-effective investigator-sponsored trials (IST).

Cotara, our lead Tumor Necrosis Therapy (TNT) agent, demonstrated promising results in a Phase II clinical trial in glioblastoma multiform (GBM) patients at first relapse. Patient treatment in this trial was completed and top-line data was presented in a poster session at the ASCO 2011 annual meeting. A novel approach to treating brain cancer, Cotara targets necrotic cells at the core of solid tumors. It transports and binds radioactive iodine to the center of the tumor, allowing the radiation to destroy the tumor from the inside out.

In December 2012, we announced that we had made significant progress in advancing the Cotara program into late-stage development through an agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM).  The FDA agreed with our proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. Our next steps include the engagement of other regulatory agencies, where we plan to run the trial as part of a global registration study.

Unique for a biopharmaceutical company, we have an integrated asset Avid Bioservices, which provides biomanufacturing services for its clients as well as products for our clinical trials.