Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2013 Financial Results and Recent Developments

Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2013 Financial 
Results and Recent Developments 
Meaningful Improvement in Median Overall Survival in Patients With
Second-Line NSCLC Supports Advancing Bavituximab Into Phase III
Development; Contract Manufacturing Revenue Tops $17 Million for Nine
Months Ended January 2013 
TUSTIN, CA -- (Marketwire) -- 03/12/13 --  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 third
quarter ended January 31, 2013 of fiscal year (FY) 2013 and provided
an update on its advancing clinical pipeline and other corporate
developments.  
"A key development this quarter was reporting updated data from our
second-line non-small cell lung cancer trial that showed a meaningful
improvement in median overall survival in the high dose bavituximab
arm that we believe clearly supports advancing the program into Phase
III. We are now actively preparing for a meeting with the FDA as part
of our plans to initiate the Phase III trial by year-end," said
Steven W. King, president and chief executive officer of Peregrine.
"These results, along with the promising signs of anti-tumor activity
we reported from our Phase II trial in front-line pancreatic cancer,
are helping further guide the upcoming development of bavituximab
with its broad potential in oncology. We are continuing to update
potential partners on the new data as well as our plans for advancing
the program."  
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
 Lead Indication in
Second-Line Non-Small Cell Lung Cancer: 


 
--  Recently announced updated results from its Phase II randomized,
    double-blind, placebo-controlled trial of bavituximab in second-line
    non-small cell lung cancer (NSCLC).
--  Promising 60% improvement in median overall survival (OS) in the
    3mg/kg bavituximab plus docetaxel arm compared to the control arm and
    that bavituximab was well-tolerated with no significant differences in
    adverse events between the trial arms.
--  Additional data from the trial, including subgroup analysis and safety
    data, to be presented at an upcoming scientific meeting.
--  Planning for a meeting with the U.S. Food and Drug Administration
    (FDA) in the first half of calendar year 2013 with the goal of
    initiating the Phase III trial by calendar year-end.

  
Front-Line Pancreatic Cancer: 


 
--  Recently announced data from its open-label, randomized Phase II
    clinical trial of bavituximab used in combination with gemcitabine in
    70 patients with previously untreated, advanced Stage IV pancreatic
    cancer.
--  Enrollment included patients with poor prognosis including advanced
    metastatic disease with significant liver involvement and poor
    performance status associated with rapid disease progression.
--  Results showed a more than a doubling of overall response rate (ORR)
    in the bavituximab-containing arm, a positive safety profile and a
    modest improvement in median OS.
--  Additional data from the trial, including subgroup analysis and safety
    data, to be presented at an upcoming scientific meeting.
--  Encouraging signs of activity from the trial support advancing this
    program, potentially in combination with new treatment options.

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


 
--  A randomized, open-label, Phase II clinical trial evaluating
    bavituximab plus carboplatin and paclitaxel versus carboplatin and
    paclitaxel alone in 86 patients with previously untreated Stage IIIb
    or Stage IV NSCLC. Peregrine expects to report median OS from this
    trial, an event driven endpoint, in the first half of calendar year
    2013.
    
    
--  A Phase Ib IST evaluating bavituximab in combination with carboplatin
    and pemetrexed in up to 25 patients with previously untreated Stage IV
    NSCLC.
    
    
--  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 I IST evaluating bavituximab in combination with paclitaxel in
    up to 14 patients with HER2-negative metastatic breast cancer.
    
    
--  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.

  
In addition, Peregrine is continually evaluating its IST program based
on a number of factors, including changes in the standard of care of
patients and trial enrollment. Following a recent review of the
ongoing IST studies, a Phase I/II IST evaluating bavituximab combined
with cabazitaxel in patients with second-line castration resistant
prostate cancer was discontinued due to slow enrollment and the
approvals of two new oral drugs for the same indication which are
changing the standard of care treatment for these patients. Peregrine
will continue to evaluate proposals for ISTs as part of its overall
program to assess new indications and combinations based on the broad
potential of bavituximab. 
COTARA PROGRAM HIGHLIGHTS
 During the quarter, Peregrine announced
that it reached agreement with the 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 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).  
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 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. 
FINANCIAL RESULTS
 "Avid, our wholly-owned manufacturing subsidiary,
continues to demonstrate its importance as a non-dilutive source of
capital for the company under our hybrid business model," said Paul
Lytle, chief financial officer of Peregrine. "Avid generated more
than $17 million in contract manufacturing revenue during the recent
nine-month period, already exceeding total revenue reported in FY
2012, and we expect third-party contract manufacturing revenue for
the full FY 2013 to exceed $20 million. In addition, Avid has
commitments for future manufacturing services in excess of $25
million, covering services to be delivered during the fourth quarter
of FY 2013 and through FY 2014." 
Total revenues for the third quarter of FY 2013 were $7,039,000
compared to $3,281,000, for the same quarter of the prior fiscal
year. This increase was primarily attributable to greater contract
manufacturing revenue generated by Avid Bioservices, Peregrine's
wholly-owned contract manufacturing subsidiary, which generated
contract manufacturing revenue of $6,961,000 for the third quarter of
FY 2013, compared to $3,203,000 for the same quarter of the prior
fiscal year. The increase in contract manufacturing revenue was
primarily due to an increase in the number of completed manufacturing
runs 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, Peregrine
expects contract manufacturing revenue to be at least $20 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 $2,174,000 to $12,200,000 in the
third quarter of FY 2013 from $14,374,000 in the third 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 third quarter of FY 2013, cost of contract
manufacturing and research and development expenses were $3,651,000
and $5,437,000, respectively, compared to $2,484,000 and $9,180,000,
respectively, for the third quarter of FY 2012. Selling, general and
administrative expenses for the third quarter of FY 2013 were
$3,112,000 compared to $2,710,000 in the third quarter of FY 2012.  
Peregrine's consolidated net loss decreased 56% to $4,914,000, or
$0.04 per basic and diluted share, for the third quarter of FY 2013,
compared to a net loss of $11,090,000, or $0.13 per basic and diluted
share, for the same quarter of the prior year.  
Peregrine reported $26,255,000 in cash and cash equivalents at
January 31, 2013, compared to $24,443,000 at October 31, 2012.  
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, March 12, 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 March 19, 2013 by calling
(855) 859-2056, or (404) 537-3406 and using passcode 18046320. 
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 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 major discrepancies discovered with respect to
our randomized, double-blind placebo-controlled Phase II trial of
bavituximab in patients with refractory NSCLC may cause regulatory
authorities to require further clinical trials to support a
registration package, the risks that partnering discussions may not
result in a partnering transaction or that such discussions could be
hindered or delayed as a result of the potential impact on the
regulatory pathway for bavituximab caused by the major discrepancies
discovered with respect to the Phase II NSCLC trial or the existing
class action lawsuits, the risk that results from the front-line
NSCLC trial will not be consistent with results experienced in
earlier trials and may not support advancing this indication into
later stage trials, 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 Cotara trial, the risk that the company is unable to
find a suitable partner to advance the Cotara program, the risk that
Peregrine may not have or raise adequate financial resources to
complete its other planned clinical programs, 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 com
pletion. 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, 2012
and our quarterly report on Form 10-Q for the quarter ended January
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-loo
king statements in
this press release.  


 
                                                                            
                      PEREGRINE PHARMACEUTICALS, INC.                       
                                                                            
   CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS   
                                                                            
                         Three Months Ended           Nine Months Ended     
                             January 31,                 January 31,        
                         2013          2012          2013          2012     
                     ------------  ------------  ------------  ------------ 
                       Unaudited     Unaudited     Unaudited     Unaudited  
REVENUES:                                                                   
Contract                                                                    
 manufacturing                                                              
 revenue             $  6,961,000  $  3,203,000  $ 17,157,000  $ 12,796,000 
License revenue            78,000        78,000       272,000       372,000 
                     ------------  ------------  ------------  ------------ 
  Total revenues        7,039,000     3,281,000    17,429,000    13,168,000 
                                                                            
COSTS AND EXPENSES:                                                         
Cost of contract                                                            
 manufacturing          3,651,000     2,484,000     9,378,000     9,219,000 
Research and                                                                
 development            5,437,000     9,180,000    18,471,000    26,758,000 
Selling, general and                                                        
 administrative         3,112,000     2,710,000     9,469,000     8,371,000 
                     ------------  ------------  ------------  ------------ 
  Total costs and                                                           
   expenses            12,200,000    14,374,000    37,318,000    44,348,000 
                     ------------  ------------  ------------  ------------ 
                                                                            
LOSS FROM OPERATIONS   (5,161,000)  (11,093,000)  (19,889,000)  (31,180,000)
                     ------------  ------------  ------------  ------------ 
                                                                            
OTHER INCOME                                                                
 (EXPENSE):                                                                 
Interest and other                                                          
 income                   255,000         9,000       307,000        31,000 
Interest and other                                                          
 expense                   (8,000)       (6,000)      (53,000)      (88,000)
Loss on early                                                               
 extinguishment of                                                          
 debt                           -             -    (1,696,000)            - 
                     ------------  ------------  ------------  ------------ 
                                                                            
NET LOSS             $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)
                     ============  ============  ============  ============ 
                                                                            
WEIGHTED AVERAGE                                                            
 COMMON SHARES                                                              
 OUTSTANDING:                                                               
  Basic and Diluted   131,489,994    87,149,770   114,726,569    78,443,114 
                     ============  ============  ============  ============ 
                                                                            
BASIC AND DILUTED                                                           
 LOSS PER COMMON                                                            
 SHARE               $      (0.04) $      (0.13) $      (0.19) $      (0.40)
                     ============  ============  ============  ============ 
                                                                            
COMPREHENSIVE LOSS   $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)
                     ============  ============  ============  ============ 
                                                                            
                                                                            
                      PEREGRINE PHARMACEUTICALS, INC.                       
                   CONDENSED CONSOLIDATED BALANCE SHEETS                    
                                                                            
                                                JANUARY 31,     APRIL 30,   
                                                    2013           2012     
                                               -------------  ------------- 
                                                 Unaudited                  
ASSETS                                                                      
CURRENT ASSETS:                                                             
  Cash and cash equivalents                    $  26,255,000  $  18,033,000 
  Trade and other receivables, net                 1,983,000      2,353,000 
  Inventories, net                                 4,635,000      3,611,000 
  Prepaid expenses and other current assets,                                
   net                                               878,000        795,000 
                                               -------------  ------------- 
    Total current assets                          33,751,000     24,792,000 
Property, net                                      2,783,000      2,900,000 
Other assets                                         623,000        570,000 
                                               -------------  ------------- 
TOTAL ASSETS                                   $  37,157,000  $  28,262,000 
                                               =============  ============= 
                                                                            
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
CURRENT LIABILITIES:                                                        
Accounts payable                               $   1,620,000  $   3,492,000 
Accrued clinical trial and related fees            1,478,000      2,111,000 
Accrued payroll and related costs                  2,949,000      2,468,000 
Deferred revenue                                   5,061,000      3,651,000 
Customer deposits                                  6,729,000      4,865,000 
Other current liabilities                            930,000      1,052,000 
                                               -------------  ------------- 
    Total current liabilities                     18,767,000     17,639,000 
Deferred revenue                                     292,000        361,000 
Other long-term liabilities                          699,000        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 - 133,770,614                              
 and 101,421,365, respectively                       134,000        101,000 
Additional paid-in capital                       376,720,000    347,506,000 
Accumulated deficit                             (359,455,000)  (338,124,000)
                                               -------------  ------------- 
    Total stockholders' equity                    17,399,000      9,483,000 
                                               -------------  ------------- 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $  37,157,0
00  $  28,262,000 
                                               =============  ============= 

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