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Peregrine Pharmaceuticals Reports Second Quarter Fiscal Year

Peregrine Pharmaceuticals Reports Second Quarter Fiscal Year 2013
Financial Results and Recent Developments 
Contract Manufacturing Revenue Expected to Exceed $18 Million for
Fiscal Year 2013; Company Reaches Agreement With FDA on Pivotal Phase
III Clinical Trial Design for Cotara; Multiple Bavituximab Clinical
Milestones Anticipated in the Coming Months 
TUSTIN, CA -- (Marketwire) -- 12/10/12 --  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 second
quarter ended October 31, 2012 of fiscal year (FY) 2013 and provided
an update on its advancing clinical pipeline and other corporate
developments.  
"Certainly the recent highlight for Peregrine is the agreement
reached with the FDA that provides a clear pathway for advancing our
Cotara program into a pivotal registration trial in patients with
brain cancer. This milestone is the result of a significant amount of
work and collaboration with the FDA of which we are particularly
proud given the potential for this novel treatment in this difficult
to treat disease," said Steven W. King, president and chief executive
officer of Peregrine. "This was also a very strong quarter for our
manufacturing subsidiary, Avid Bioservices, as we are on track for
another record year of manufacturing revenues. We are also making
steady progress in advancing the bavituximab program on multiple
clinical fronts with important clinical milestones anticipated to
occur over the coming months. Upcoming clinical milestones for the
program include key median overall survival endpoints in pancreatic
and front-line non-small cell lung cancer and final results from our
second-line non-small cell lung cancer study in which we discovered
discrepancies and have subsequently been intensely reviewing. The
goal of this review is to be able to generate a final data set that
we believe could be used to support advancing the program into a
pivotal trial." 
COTARA PROGRAM HIGHLIGHTS
 Peregrine announced that it has reached
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) following an end-of-Phase II
meeting. The FDA has agreed with the company's proposed randomized
trial design evaluating two dose levels of Cotara in up to 300
patients. The trial design allows for multiple interim data analyses
with the potential to stop patient accrual early based on predicted
success or futility. The company plans to seek partners both in the
U.S. and internationally to support the development of Cotara for
this deadly form of brain cancer. Cotara has been granted orphan drug
status and Fast Track designation for the treatment of GBM and
anaplastic astrocytoma by the FDA and orphan drug designation by the
European Medicines Agency (EMA). 
BAVITUXIMAB CLINICAL TRIALS
 Peregrine currently has eight ongoing
clinical trials as follows:  


 
--  Peregrine continues to conduct a detailed internal review into the
    discrepancies tied to the randomized, double-blind placebo-controlled
    Phase II trial of bavituximab in second-line non-small cell lung
    cancer (NSCLC), that were discovered as part of the routine collection
    of data in advance of the company's end-of-Phase II meeting with
    regulatory authorities. The goal of this review is to gain a thorough
    understanding of the events leading up to, including and following the
    patient treatment group assignments and investigational drug coding
    and distribution. This review includes the testing of investigational
    product, patient samples, reviewing the operations of multiple
    vendors, among other activities. Investors are reminded not to rely on
    clinical data that the company disclosed on or before September 7,
    2012 regarding this trial.
    
    
--  Randomized Phase II clinical trial evaluating bavituximab plus
    carboplatin and paclitaxel versus carboplatin and paclitaxel alone in
    83 evaluable patients with previously untreated Stage IIIb or Stage IV
    NSCLC. Patient enrollment was completed in September of 2011. A
    secondary endpoint in the trial, median overall survival (OS), is an
    event-driven endpoint and will be reported once mature.
    
    
--  Randomized Phase II clinical trial evaluating bavituximab plus
    gemcitabine versus gemcitabine alone in 70 patients with previously
    untreated Stage IV pancreatic cancer. Patient enrollment was completed
    in June 2012. The primary endpoint in the trial, median OS, is an
    event-driven endpoint and will be reported once mature.
    
    
--  Phase I/II Investigator Sponsored Trial (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.
    
    
--  Phase I/II IST evaluating bavituximab in combination with cabazitaxel
    in up to 31 patients with second-line castration-resistant prostate
    cancer.
    
    
--  Phase Ib IST evaluating bavituximab in combination with carboplatin
    and pemetrexed in up to 25 patients with previously untreated Stage IV
    NSCLC.
    
    
--  Phase I IST evaluating bavituximab in combination with paclitaxel in
    up to 14 patients with HER2-negative metastatic breast cancer.
    
    
--  Phase I IST evaluating bavituximab in combination with capecitabine
    and radiation therapy in up to 18 patients with Stage II or III rectal
    adenocarcinoma.

  
PS-TARGETING MOLECULAR IMAGING PROGRAM HIGHLIGHTS
 Peregrine continues
to enroll and dose up to 12 patients in an open-label, single-center
trial of its experimental phosphatidylserine (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. 
PRECLINICAL DEVELOPMENT HIGHLIGHTS
 In October, at the 27th Annual
Meeting of the Society for Immunotherapy of Cancer, data were
presented demonstrating the ability of the company's PS-targeting
antibodies to stimulate cancer fighting immune responses.
Additionally, data were published in the peer-reviewed journal
Nuclear Medicine and Biology highlighting results from a study
investigating the company's fully human phosphatidylserine
(PS)-targeting antibody PGN635 utilized as a radiolabeled tumor
imaging probe. The results demonstrate the potential breadth of
applicability of the company's PS-targeting antibodies to clearly
image solid tumors regardless of cancer type, and provide a potential
method to rapidly assess the anti-tumor efficacy of chemotherapies
and other approved and experimental cancer treatments 
FINANCIAL RESULTS
 Total revenues for the second quarter of FY 2013
were $6,139,000 compared to $4,232,000, for the same quarter of the
prior fiscal year. This increase was primarily attributable to
contract manufacturing revenue generated by Peregrine's
biomanufacturing subsidiary Avid Bioservices, which generated
contract manufacturing revenue of $6,061,000 for the second quarter
of FY 2013, compared to $4,154,000 for the same quarter of the prior
fiscal year. The increase in contract manufacturing revenue was 
primarily due to a greater number of completed manufacturing runs
being released and shipped during the current quarter. Based on
current manufacturing commitments from Avid's third-party clients for
services to be provided during the remainder of FY 2013, we expect
contract manufacturing revenue to be at least $18 million for FY
2013. In addition, 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, while also seeking to grow its services from third-party
clients.  
Total costs and expenses decreased $3,072,000 to $13,196,000 in the
second quarter of FY 2013 from $16,268,000 in the second quarter of
FY 2012. This decrease was primarily attributable to lower research
and development expenses associated with a decrease in clinical trial
costs. For the second quarter of FY 2013, cost of contract
manufacturing and research and development expenses were $3,703,000
and $6,053,000, respectively, compared to $3,718,000 and $9,818,000,
respectively, for the second quarter of FY 2012. Selling, general and
administrative expenses for the second quarter of FY 2013 were
$3,440,000 compared to $2,732,000 in the second quarter of FY 2012.  
Peregrine's consolidated net loss was $8,753,000, or $0.08 per basic
and diluted share, for the second quarter of FY 2013, compared to a
net loss of $12,055,000, or $0.16 per basic and diluted share, for
the same quarter of the prior year.  
Peregrine reported $24,443,000 in cash and cash equivalents at
October 31, 2012, compared to $18,991,000 at July 31, 2012. From the
period of September 27, 2012 through October 31, 2012, the company
raised $16.2 million in net proceeds in order to replace the initial
funding it repaid on September 25, 2012 under a loan facility dated
August 30, 2012. The funds were raised under an At Market Sales
Issuance Agreement with McNicoll, Lewis & Vlak LLC at an average
price per share of $0.90. The company issued no warrants in
connection with the At Market Sales Issuance Agreement. 
More detailed financial information and analysis may be found in
Peregrine's Quarterly 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, December 10, 2012, at 4:30 PM EST (1:30 PM PST).  
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 December 24, 2012 by calling
(855) 859-2056, or (404) 537-3406 and using passcode 75630640.  
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 product 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 outside 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 data from a Cotara pivotal trial may not support
BLA submission or registration, the risk that the company does not
have, or is unable to raise, sufficient capital to fund a pivotal
trial and the risk that the company is unable to find a suitable
partner to advance the Cotara program, the risk that final data from
the randomized, double-blind, placebo-controlled Phase IIb may never
support future development in second-line NSCLC, the risks associated
with the recently filed class action lawsuits or potential regulatory
investigations due to the uncertainty created by the above referenced
discrepancies, the risk that results from the other randomized Phase
II trial will not be consistent with results experienced in the
earlier single-arm Phase II trial or support registration filings
with the FDA, 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, including those with committed manufacturing
or representing its backlog, 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 the our SEC reports including, but not
limited to, the annual report on Form 10-K for the fiscal year ended
April 30, 2012 and quarterly report on Form 10-Q for the quarter
ended October 31, 2012. 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           Six Months Ended      
                             October 31,                 October 31,        
                         2012          2011          2012          2011     
                     ------------  ------------  ------------  ------------ 
                       Unaudited     Unaudited     Unaudited     Unaudited  
REVENUES:                                      
                             
Contract                                                                    
 manufacturing                                                              
 revenue             $  6,061,000  $  4,154,000  $ 10,196,000  $  9,593,000 
License revenue            78,000        78,000       194,000       294,000 
                     ------------  ------------  ------------  ------------ 
  Total revenues        6,139,000     4,232,000    10,390,000     9,887,000 
                                                                            
COSTS AND EXPENSES:                                                         
Cost of contract                                                            
 manufacturing          3,703,000     3,718,000     5,727,000     6,735,000 
Research and                                                                
 development            6,053,000     9,818,000    13,034,000    17,578,000 
Selling, general and                                                        
 administrative         3,440,000     2,732,000     6,357,000     5,661,000 
                     ------------  ------------  ------------  ------------ 
  Total costs and                                                           
   expenses            13,196,000    16,268,000    25,118,000    29,974,000 
                     ------------  ------------  ------------  ------------ 
                                                                            
LOSS FROM OPERATIONS   (7,057,000)  (12,036,000)  (14,728,000)  (20,087,000)
                     ------------  ------------  ------------  ------------ 
                                                                            
OTHER INCOME                                                                
 (EXPENSE):                                                                 
Interest and other                                                          
 income                    44,000         9,000        52,000        22,000 
Interest and other                                                          
 expense                  (44,000)      (28,000)      (45,000)      (82,000)
Loss on early                                                               
 extinguishment of                                                          
 debt                  (1,696,000)            -    (1,696,000)            - 
                     ------------  ------------  ------------  ------------ 
                                                                            
NET LOSS             $ (8,753,000) $(12,055,000) $(16,417,000) $(20,147,000)
                     ============  ============  ============  ============ 
                                                                            
WEIGHTED AVERAGE                                                            
 COMMON SHARES                                                              
 OUTSTANDING:                                                               
  Basic and Diluted   109,405,778    77,523,005   106,344,857    74,089,786 
                     ============  ============  ============  ============ 
                                                                            
BASIC AND DILUTED                                                           
 LOSS PER COMMON                                                            
 SHARE               $      (0.08) $      (0.16) $      (0.15) $      (0.27)
                     ============  ============  ============  ============ 
                                                                            
COMPREHENSIVE LOSS   $ (8,753,000) $(12,055,000) $(16,417,000) $(20,147,000)
                     ============  ============  ============  ============ 
                                                                            
                                                                            
PEREGRINE PHARMACEUTICALS, INC.                                             
CONDENSED CONSOLIDATED BALANCE SHEETS                                       
                                                                            
                                                OCTOBER 31,     APRIL 30,   
                                                    2012           2012     
                                               -------------  ------------- 
                                                 Unaudited                  
ASSETS                                                                      
CURRENT ASSETS:                                                             
  Cash and cash equivalents                    $  24,443,000  $  18,033,000 
  Trade and other receivables, net                 2,320,000      2,353,000 
  Inventories, net                                 5,426,000      3,611,000 
  Prepaid expenses and other current assets,                                
   net                                               885,000        795,000 
                                               -------------  ------------- 
    Total current assets                          33,074,000     24,792,000 
Property, net                                      2,683,000      2,900,000 
Other assets                                         771,000        570,000 
                                               -------------  ------------- 
TOTAL ASSETS                                   $  36,528,000  $  28,262,000 
                                               =============  ============= 
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
CURRENT LIABILITIES:                                                        
Accounts payable                               $   3,176,000  $   3,492,000 
Accrued clinical trial and related fees            1,558,000      2,111,000 
Accrued payroll and related costs                  2,394,000      2,468,000 
Deferred revenue                                   6,221,000      3,651,000 
Customer deposits                                  8,500,000      4,865,000 
Other current liabilities                          1,083,000      1,052,000 
                                               -------------  ------------- 
    Total current liabilities                     22,932,000     17,639,000 
Deferred revenue                                     205,000        361,000 
Other long-term liabilities                          721,000        779,000 
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 - 123,
310,188                              
 and 101,421,365, respectively                       123,000        101,000 
Additional paid-in capital                       367,088,000    347,506,000 
Accumulated deficit                             (354,541,000)  (338,124,000)
                                               -------------  ------------- 
    Total stockholders' equity                    12,670,000      9,483,000 
                                               -------------  ------------- 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $  36,528,000  $  28,262,000 
                                               =============  ============= 

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