Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2014 Financial Results and Recent Developments

Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2014 Financial 
Results and Recent Developments 
Bavituximab Pivotal Phase III Lung Cancer Trial Named "SUNRISE" on
Track for Initiation by Calendar Year-End; Bavituximab Pre-Clinical
Proof-Of Concept Studies Underway to Support Potential Immunotherapy
Combination Trial; Avid Bioservices Quarterly Revenue Tops $4.5
Million 
TUSTIN, CA -- (Marketwired) -- 09/09/13 --  Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company
developing first-in-class monoclonal antibodies focused on the
treatment and diagnosis of cancer, today announced financial results
for the first quarter of fiscal year (FY) 2014 ended July 31, 2013
and provided an update on its advancing clinical pipeline and other
corporate developments.  
"We continue to steadily progress the bavituximab clinical program as
we prepare to initiate a global Phase III trial by year-end in
second-line non-small cell lung cancer. In addition to Phase III
preparations, our researchers and external collaborators have
undertaken a flurry of preclinical experimentation that will help
guide exciting new combinations and therapeutic areas for
bavituximab. This activity was spurred on by recent data showing that
bavituximab works by harnessing the body's natural immune system to
fight cancer," said Steven W. King, president and chief executive
officer of Peregrine. "Our preclinical development plan is designed
to simultaneously look at new indications and therapeutic regimens
including new combinations with other immunotherapy agents. Because
bavituximab acts on a primary immune system checkpoint, there are an
abundance of possible immunotherapy combinations with agents working
on further downstream targets. We expect results from these studies
over the coming months as we move toward advancing new combinations
into the clinic. We look forward to a number of updates on the
program as we move through the rest of the year." 
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS 
Lead Indication in Second-Line Non-Small Cell Lung Cancer: 


 
--  Continued to plan for the initiation of the SUNRISE Trial (Stimulating
    ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study).
    --  SUNRISE is a Phase III, global, randomized, double-bli
nd,
        placebo-controlled clinical trial designed to evaluate the safety,
        tolerability and efficacy of bavituximab in patients with
        second-line non-small cell lung cancer (NSCLC). Specifically, the
        trial will evaluate bavituximab plus docetaxel versus docetaxel
        plus placebo in approximately 600 patients at clinical sites
        worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who
        have progressed after standard front-line treatment are eligible
        for enrollment. Patients will be randomized into 1 of 2 treatment
        arms. All patients will receive up to six 21-day cycles of
        docetaxel at 75 milligrams per meter squared plus weekly infusions
        of either bavituximab (3mg/kg) or placebo until progression of
        toxicity. The primary endpoint of the trial will be overall
        survival. The company anticipates initiating the SUNRISE trial by
        the end of this calendar year.

  
Other Oncology Indications:  
The company is exploring the potential of bavituximab through a
number of investigator-sponsored trials (IST) including: 


 
--  A Phase I IST evaluating bavituximab in combination with paclitaxel in
    up to 14 patients with HER2-negative metastatic breast cancer. All
    patients have been enrolled in this trial with interim data on 13
    evaluable patients presented at the 2013 American Society of Clinical
    Oncology (ASCO) Annual Meeting showing that 85% of patients achieved
    an objective tumor response, including 15% of patients achieving a
    complete response measured in accordance with RECIST criteria.
    
    
--  A Phase I/II IST evaluating bavituximab in combination with sorafenib
    in up to 48 patients with advanced hepatocellular carcinoma (liver
    cancer). The Phase I portion of the trial has completed patient
    enrollment with enrollment in the Phase II portion of the trial
    ongoing.
    
    
--  A Phase Ib IST evaluating bavituximab in combination with carboplatin
    and pemetrexed in up to 25 patients with previously untreated Stage IV
    NSCLC. This trial continues to enroll and dose patients.
    
    
--  A Phase I IST evaluating bavituximab in combination with capecitabine
    and radiation therapy in up to 18 patients with Stage II or III rectal
    adenocarcinoma. This trial continues to enroll and dose patients.

  
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM  
This morning, Peregrine announced the publication of a data
supporting the immune-stimulatory mechanism of action of
phosphatidylserine (PS)-targeting antibodies, such as the company's
lead drug candidate bavituximab in the American Association for
Cancer Research (AACR) peer-reviewed journal, Cancer Immunology
Research. In the manuscript titled: "Phosphatidylserine-targeting
antibody induces M1 macrophage polarization and promotes myeloid
derived suppressor cell differentiation," researchers demonstrated
that exposed PS plays a major role in the inhibition of
pro-inflammatory cellular and cytokine responses in tumors and that
PS-targeting antibodies override this primary upstream immune
checkpoint, activating multiple downstream immunostimulatory effects,
including the conversion of myeloid derived suppressor cells into
tumor immunity promoting M1 macrophages and the generation of tumor
killing cytotoxic T-cells. 
Peregrine is exploring the potential to combine bavituximab with
other immunotherapies such as anti-CTLA-4, anti-PD-1, and anti-PD-L1
antibodies and has initiated several ongoing pre-clinical
proof-of-concept studies to support an immunotherapy combination
trial with bavituximab.  
IMAGING PROGRAM HIGHLIGHTS 
PS-Targeting Molecular Imaging Program  
Peregrine continues to enroll and dose patients in an open-label,
single-center trial of its experimental PS-targeting molecular
imaging candidate, 124I-PGN650, in patients with various solid tumor
types. The primary goal of the trial is to estimate radiation
dosimetry in critical and non-critical organs. Secondary objectives
of the trial are tumor imaging and safety.  
FINANCIAL RESULTS 
"Our wholly-owned contract manufacturing subsidiary, Avid
Bioservices, continue to perform well, generating over $4.5 million
in contract manufacturing revenue in the first quarter of FY 2014, a
non-dilutive source of capital. With our current backlog for
services, we expect contract manufacturing revenue for the entire FY
2014 to be between $18 and $22 million," said Paul Lytle, chief
financial officer of Peregrine. "We also remained focused on seeking
potential partners for our bavituximab program while successfully
maintaining a balanced financial approach that provides us much
flexibility in our ongoing partnering discussions."  
Total revenues for the first quarter of FY 2014 were $4,688,000,
compared to $4,251,000 for the same quarter of the prior fiscal year.
The increase was primarily attributed to an increase in contract
manufacturing revenue generated from Avid Bioservices due to an
increase in the number of completed manufacturing runs.  
Contract manufacturing revenues from Avid's clinical and commercial
biomanufacturing services provided to its third-party clients for the
first quarter
 FY 2014 were $4,581,000, compared to $4,135,000 for the
same quarter of the prior fiscal year. Peregrine expects contract
manufacturing revenues for FY 2014 to be between $18 million and $22
million. In addition to providing biomanufacturing services to its
third-party clients, Avid will continue to utilize available capacity
and resources to continue its preparation for later stage clinical
development and potential commercialization of bavituximab and
Cotara.  
Total costs and expenses in the first quarter of FY 2014 were
$12,308,000, compared to $11,922,000 in the first quarter of FY 2013.
This increase was attributable to the current year three-month period
increase in the cost of contract manufacturing associated with higher
revenues in the current quarter combined with an increase in selling,
general and administrative expenses. The increase in selling, general
and administrative expenses for the first quarter FY 2014 compared to
the first quarter of FY 2013 was primarily attributable to increases
in share-based compensation expense, payroll and related expenses,
and corporate legal fees.  
Peregrine's consolidated net loss was $7,600,000, or $0.05 per share,
for the first quarter of FY 2014, compared to a net loss of
$7,664,000, or $0.07 per share, for the same quarter of the prior
year.  
Peregrine reported $41,600,000 in cash and cash equivalents as of
July 31, 2013, compared to $35,204,000 at fiscal year ended April 30,
2013. 
More detailed financial information and analysis may be found in
Peregrine's Annual Report on Form 10-Q, which will be filed with the
Securities and Exchange Commission today.  
Conference Call
 Peregrine will host a conference call and webcast
this afternoon, September 9, 2013, at 4:30 PM EDT (1:30 PM PDT).  
To listen to the conference call, please dial (877) 312-5443 or (253)
237-1126 and request the Peregrine Pharmaceuticals conference call. A
replay of the call will be available starting approximately two hours
after the conclusion of the call through September 16, 2013 by
calling (855) 859-2056, or (404) 537-3406 and using passcode
37006614. 
To listen to the live webcast, or access the archived webcast, please
visit: http://ir.peregrineinc.com/events.cfm.  
About Peregrine Pharmaceuticals, Inc.
 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. The company is pursuing multiple clinical
programs in cancer with its lead immunotherapy candidate bavituximab
and novel brain cancer agent Cotara(R). 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 third-party
customers. Additional information about Peregrine can be found at
www.peregrineinc.com.  
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties including, but not limited
to, the risk that the company may not be able to initiate the Phase
III trial within its anticipated timeline, the risk that the results
from the Phase III trial may not support a future Biologics License
Application (BLA) submission, the risk that the company may not have
or raise adequate financial resources to complete the Phase III
trial, the risk that the company may not find a suitable partner for
the Phase III trial or the PS program, the risk that the results from
ongoing proof-of-concept studies may not support combining
bavituximab with other antibodies that enhance tumor immunity, such
as an anti-PD1, anti-PD-L1, or anti-CTLA-4, the risk that such
combination studies may not result in any additional benefit, the
risk that Avid's revenue growth may slow or decline, the risk that
Avid may experience technical difficulties in processing customer
orders which could delay delivery of products to customers and
receipt of payment, and the risk that one or more existing Avid
customers terminates its contract prior to completion. It is
important to note that the company's actual results could differ
materially from those in any such forward-looking statements. Factors
that could cause actual results to differ materially include, but are
not limited to, uncertainties associated with completing preclinical
and clinical trials for our technologies; the early stage of product
development; the significant costs to develop our products as all of
our products are currently in development, preclinical studies or
clinical trials; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory
approval for our technologies; anticipated timing of regulatory
filings and the potential success in gaining regulatory approval and
complying with governmental regulations applicable to our business.
Our business could be affected by a number of other factors,
including the risk factors listed from time to time in our reports
filed with the Securities and Exchange Commission including, but not
limited to, our annual report on Form 10-K for the fiscal year ended
April 30, 2013 and our quarterly report on Form 10-Q for the quarter
ended July 31, 2013. The company cautions investors not to place
undue reliance on the forward-looking statements contained in this
press release. Peregrine Pharmaceuticals, Inc. disclaims any
obligation, and does not undertake to update or revise any
forward-looking statements in this press release. 


 
PEREGRINE PHARMACEUTICALS, INC.                                             
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS      
                                                                            
                                                    THREE MONTHS ENDED      
                                               July 31, 2013  July 31, 2012 
                                               -------------  ------------- 
                                                 Unaudited      Unaudited   
REVENUES:                                                                   
Contract manufacturing revenue                 $   4,581,000  $   4,135,000 
License revenue                                      107,000        116,000 
                                               -------------  ------------- 
  Total revenues                                   4,688,000      4,251,000 
                                                                            
COSTS AND EXPENSES:                                                         
Cost of contract manufacturing                     2,670,000      2,024,000 
Research and development                           5,304,000      6,981,000 
Selling, general and administrative                4,334,000      2,917,000 
                                               -------------  ------------- 
  Total costs and expenses                        12,308,000     11,922,000 
                                        
       -------------  ------------- 
LOSS FROM OPERATIONS                              (7,620,000)    (7,671,000)
                                               -------------  ------------- 
                                                                            
OTHER INCOME (EXPENSE):                                                     
Interest and other income                             21,000          8,000 
Interest and other expense                            (1,000)        (1,000)
                                               -------------  ------------- 
                                                                            
NET LOSS                                       $  (7,600,000) $  (7,664,000)
                                               =============  ============= 
                                                                            
COMPREHENSIVE LOSS                             $  (7,600,000) $  (7,664,000)
                                               =============  ============= 
                                                                            
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING                                  
  Basic and diluted                              149,393,630    103,283,937 
                                               =============  ============= 
                                                                            
BASIC AND DILUTED LOSS PER COMMON SHARE        $       (0.05) $       (0.07)
                                               =============  ============= 
                                                                            
                                                                            
PEREGRINE PHARMACEUTICALS, INC.                                             
CONDENSED CONSOLIDATED BALANCE SHEETS                                       
                                                  JULY 31,      APRIL 30,   
                                                    2013           2013     
                                               -------------  ------------- 
                                                 Unaudited                  
ASSETS                                                                      
CURRENT ASSETS:                                                             
Cash and cash equivalents                      $  41,600,000  $  35,204,000 
Trade and other receivables, net                   2,272,000      1,662,000 
Inventories                                        5,679,000      4,339,000 
Prepaid expenses and other current assets, net       635,000        709,000 
                                               -------------  ------------- 
  Total current assets                            50,186,000     41,914,000 
Property and equipment, net                        2,448,000      2,678,000 
Other assets                                         689,000        466,000 
                                               -------------  ------------- 
TOTAL ASSETS                                   $  53,323,000  $  45,058,000 
                                               =============  ============= 
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
CURRENT LIABILITIES:                                                        
Accounts payable                               $   2,160,000  $   2,821,000 
Accrued clinical trial and related fees              608,000        930,000 
Accrued payroll and related costs                  3,271,000      3,582,000 
Deferred revenue, current portion                  4,164,000      4,171,000 
Customer deposits                                  8,528,000      8,059,000 
Other current liabilities                          1,335,000        998,000 
                                               -------------  ------------- 
  Total current liabilities                       20,066,000     20,561,000 
Deferred revenue, less current portion               292,000        292,000 
Other long-term liabilities                          422,000        445,000 
Commitments and contingencies                                               
                                                                            
STOCKHOLDERS' EQUITY:                                                       
Preferred stock-$0.001 par value; authorized                                
 5,000,000 shares; non-voting; nil shares                                   
 outstanding                                               -              - 
Common stock-$0.001 par value; authorized                                   
 325,000,000 shares; outstanding - 153,506,811                              
 and 143,768,946, respectively                       153,000        143,000 
Additional paid-in capital                       407,894,000    391,521,000 
Accumulated deficit                             (375,504,000)  (367,904,000)
                                               -------------  ------------- 
  Total stockholders' equity                      32,543,000     23,760,000 
                                               -------------  ------------- 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $  53,323,000  $  45,058,000 
                                               =============  ============= 

  
Contact:  
Christopher Keenan or Jay Carlson 
Peregrine Pharmaceuticals 
(800) 987-8256 
info@peregrineinc.com 
 
 
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