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

Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2013 Financial 
Results and Recent Developments 
Positive Phase IIb Data in Second-Line NSCLC and FDA Agreement on
Pivotal Phase III Trial Design Position Start of Phase III Trial by
Calendar Year-End; Bavituximab's Immunotherapeutic Mechanism of
Action Data Presented at AACR Creates Expanded Drug Development
Opportunities; Avid's Contract Manufacturing Revenue Topped $21
Million for FY 2013 and Starts FY 2014 With Over $27 Million in
Revenue Backlog From Contract Manufacturing Business 
TUSTIN, CA -- (Marketwired) -- 07/11/13 --  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 fourth quarter and fiscal year (FY) ended April 30, 2013 and
provided an update on its advancing clinical pipeline and other
corporate developments.  
"The combination of preclinical data supporting bavituximab's
immunotherapeutic mechanism of action presented at AACR, compelling
second-line NSCLC data presented at ASCO and reaching the recent
agreement with the FDA on a pivotal Phase III design have helped
transform our bavituximab clinical program. We are now focused on
initiating this Phase III trial in second-line NSCLC by the end of
the year while simultaneously evaluating new areas of opportunity
based on the enhanced understanding we now have of bavituximab's
mechanism of action," said Steven W. King, president and chief
executive officer of Peregrine. "This increased knowledge further
supports the combination with docetaxel that we are pursuing in Phase
III while opening the door to multiple new potential combinations
that were not previously explored. These developments have initiated
new partnering opportunities as well as increased interest amongst
current partnership discussions surrounding the bavituximab program
which continue while we execute this supplemental development
strategy." 
Data from a series of preclinical studies exploring the mechanism of
action for phosphatidylserine (PS)-targeting antibodies, such as
bavituximab, were presented at the Annual Meeting of the American
Association for Cancer Research (AACR). Results from these studies
demonstrated that PS-targeting antibodies mediate immune-stimulatory
changes in tumors by acting on upstream immune checkpoints and
transforming those immune cells that are inhibiting immune
recognition (MDSC's) into tumor-fighting (M1) macrophages and
activated dendritic cells that lead to the formation of tumor
fighting T-cells. Based on these findings, Peregrine is collecting
immune correlative data from three of the its ongoing
investigator-sponsored clinical trials in breast, rectal and liver
cancers while also exploring the potential to combine bavituximab
with other immunotherapies such as PD-1 antibodies and CTLA-4
targeted approaches.  
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
 Lead Indication in
Second-Line Non-Small Cell Lung Cancer: 


 
--  Reached agreement with the U.S. Food and Drug Administration (FDA) on
    a Phase III registration trial design of bavituximab in second-line
    non-small cell lung cancer (NSCLC).
--  Recently announced final results from its 121 patient Phase IIb
    randomized, double-blind, placebo-controlled trial of bavituximab in
    second-line NSCLC at the 2013 American Society of Clinical Oncology
    (ASCO) Annual Meeting.
    --  Promising 60% improvement in median overall survival (OS) in the
        3mg/kg bavituximab plus docetaxel arm compared to the control arm
        and bavituximab was well-tolerated with no significant differences
        in adverse events between the trial arms.
    --  Subgroup analyses of OS by key patient characteristics including
        age, gender, ECOG status, ethnicity and prior treatment favored
        the bavituximab 3 mg/kg arm.
--  Planning for the initiation of a pivotal Phase III trial by calendar
    year-end.

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


 
--  A Phase II randomized, open-label, clinical trial evaluating
    bavituximab plus gemcitabine in 70 patients with previously untreated,
    advanced Stage IV pancreatic cancer. Data presented at the 2013 ASCO
    Annual Meeting 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. As enrollment included patients
    with poor prognosis including advanced metastatic disease with
    significant liver involvement and poor performance status associated
    with rapid disease progression, a subgroup analysis was conducted.
    Results from this subgroup analysis showed that the effect of
    bavituximab plus gemcitabine was more pronounced in patients with ECOG
    ≤ 1 and those without hepatic metastases. While the final data
    combined with the results from subgroup analyses warrant future
    consideration, given the fast progression of pancreatic cancer and the
    need for longer treatment periods associated with immunotherapies such
    as bavituximab, there are no plans to initiate a follow-on trial in
    pancreatic cancer at this time.
    
    
--  A Phase II randomized, open-label clinical trial evaluating
    bavituximab plus carboplatin and paclitaxel versus carboplatin and
    paclitaxel (C/P) alone in up to 86 patients with previously untreated
    Stage IIIb or Stage IV NSCLC. Data recently announced, with less than
    60% of survival events reached, that while the bavituximab-containing
    treatment arm demonstrated a median OS of over 14 months, there was
    not a meaningful enough difference in survival between the two arms of
    the trial to support another study using this combination and timing
    of therapy. An independent study with another immunotherapy agent
    showed that when C/P are given together with an immunotherapy, as was
    done in this bavituximab trial, the results were similar to the
    control arm however when C/P are administered in advance of the
    immunotherapy much more favorable results are achieved. We are
    currently evaluating options for moving bavituximab forward in
    front-line NSCLC. Full results from this trial will be presented at a
    future scientific meeting or through publication.
    
    
--  A Phase I IST evaluating bavituximab in combination with paclitaxel in
    up to 14 patients with HER2-negative metastatic breast cancer. Interim
    data on 13 evaluable patients were presented at the 2013 ASCO Annual
    Meeting showed that 85% of patients achieved an objective tumor
    response, including 15% of patients achieving a complete response (CR)
    measured in accordance with RECIST criteria. All patients have been
    enrolled in this trial.
    
    
--  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 evalu
ating 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.

  
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. Recently, data were
presented from imaging studies demonstrating that the
chemotherapeutic drug docetaxel, a commonly prescribed second-line
treatment for patients with advanced NSCLC, increases the exposure of
bavituximab's target molecule, PS, on tumor blood vessel cells and
tumor cells. Results also showed that PS exposure in tumors is
correlated with tumor burden and response to docetaxel treatment,
supporting exposed PS as a promising biomarker of cancer and response
to therapy. In the June 2013 issue of the journal Molecular Imaging,
scientists from Peregrine published results from a study showing that
PGN650 could be useful in imaging tumors and detect enhanced PS
exposure in response to chemotherapy.  
FINANCIAL RESULTS
 "This quarter capped off a record year for our
wholly-owned manufacturing subsidiary, Avid Bioservices, which
generated over $21 million in non-dilutive contract manufacturing
revenue and has started FY 2014 with more than $27 million in
committed services from existing third-party clients," said Paul
Lytle, chief financial officer of Peregrine. "We have also
strengthened our cash position that gives us the needed flexibility
to initiate the upcoming Phase III trial in second-line NSCLC while
we continue to evaluate our future opportunities."  
Total revenues for the fourth quarter of FY 2013 were $4,254,000,
compared to $2,065,000 for the same quarter of the prior fiscal year.
For FY 2013, total revenues were $21,683,000, compared to $15,233,000
for the prior year. The FY 2013 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
increased 44% to $21,333,000 for FY 2013, which were the highest
reported amount in Avid's history and were within Peregrine's
previous guidance range, compared to $14,783,000 for FY 2012. FY 2014
started with manufacturing commitments from Avid's third-party
customers in excess of $27 million, covering services to be provided
during FY 2014 and into FY 2015. Of this amount, 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 fourth quarter of FY 2013 were
$12,717,000, compared to $12,955,000 in the fourth quarter of FY
2012. For FY 2013, total costs and expenses were $50,035,000 compared
to $57,303,000 for FY 2012. This decrease primarily was attributable
to lower research and development expenses due to the decrease in
clinical trial expenses. For the fourth quarter FY 2013, research and
development expenses were $5,835,000, compared to $8,930,000 for the
fourth quarter of FY 2012, and for FY 2013 were $24,306,000, compared
to $35,688,000 for FY 2012. Selling, general and administrative
expenses for FY 2013 were $13,134,000 compared to $11,462,000 for FY
2012.  
Peregrine's consolidated net loss was $8,449,000, or $0.06 per share,
for the fourth quarter of FY 2013, compared to a net loss of
$10,882,000 or $0.10 per share, for the same quarter of the prior
year. For FY 2013, net loss was $29,780,000, or $0.25 per share,
compared to $42,119,000, or $0.50 per share, for FY 2012.  
Peregrine reported $35,204,000 in cash and cash equivalents as of
April 30, 2013, compared to $18,033,000 at fiscal year ended April
30, 2012. As of June 30, 2013, the company had $42,563,000 in cash
and cash equivalents.  
More detailed financial information and analysis may be found in
Peregrine's Annual Report on Form 10-K, which will be filed with the
Securities and Exchange Commission today.  
Conference Call
 Peregrine will host a conference call and webcast
this afternoon, July 11, 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 July 18, 2013 by calling
(855) 859-2056, or (404) 537-3406 and using passcode 10642041. 
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 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 associ
ated 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.
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.                                             
                                                                            
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS                
                                                                            
                         Three Months Ended          Twelve Months Ended    
                              April 30,                   April 30,         
                         2013          2012          2013          2012     
                     ------------  ------------  ------------  ------------ 
                       Unaudited     Unaudited                              
REVENUES:                                                                   
Contract                                                                    
 manufacturing                                                              
 revenue             $  4,176,000  $  1,987,000  $ 21,333,000  $ 14,783,000 
License revenue            78,000        78,000       350,000       450,000 
                     ------------  ------------  ------------  ------------ 
  Total revenues        4,254,000     2,065,000    21,683,000    15,233,000 
                                                                            
COSTS AND EXPENSES:                                                         
Cost of contract                                                            
 manufacturing          3,217,000       934,000    12,595,000    10,153,000 
Research and                                                                
 development            5,835,000     8,930,000    24,306,000    35,688,000 
Selling, general and                                                        
 administrative         3,665,000     3,091,000    13,134,000    11,462,000 
                     ------------  ------------  ------------  ------------ 
  Total costs and                                                           
   expenses            12,717,000    12,955,000    50,035,000    57,303,000 
                     ------------  ------------  ------------  ------------ 
                                                                            
LOSS FROM OPERATIONS   (8,463,000)  (10,890,000)  (28,352,000)  (42,070,000)
                     ------------  ------------  ------------  ------------ 
                                                                            
OTHER INCOME                                                                
 (EXPENSE):                                                                 
Interest and other                                                          
 income                    15,000        10,000       322,000        41,000 
Interest and other                                                          
 expense                   (1,000)       (2,000)      (54,000)      (90,000)
Loss on early                                                               
 extinguishment of                                                          
 debt                           -             -    (1,696,000)            - 
                     ------------  ------------  ------------  ------------ 
                                                                            
NET LOSS             $ (8,449,000) $(10,882,000) $(29,780,000) $(42,119,000)
                     ============  ============  ============  ============ 
                                                                            
COMPREHENSIVE LOSS   $ (8,449,000) $(10,882,000) $(29,780,000) $(42,119,000)
                     ============  ============  ============  ============ 
                                                                            
WEIGHTED AVERAGE                                                            
 COMMON SHARES                                                              
 OUTSTANDING:                                                               
Basic and Diluted     137,872,343    99,303,678   120,370,333    83,572,761 
                     ============  ============  ============  ============ 
                                                                            
BASIC AND DILUTED                                                           
 LOSS PER COMMON                                                            
 SHARE               $      (0.06) $      (0.10) $      (0.25) $      (0.50)
                     ============  ============  ============  ============ 
                                                                            
                                                                            
                                                                            
PEREGRINE PHARMACEUTICALS, INC.                                             
CONSOLIDATED BALANCE SHEETS                                                 
AS OF APRIL 30, 2013 AND 2012                                               
                                                                            
                                                    2013           2012     
                                               -------------  ------------- 
ASSETS                                                                      
                                                                            
CURRENT ASSETS:                                                             
Cash and cash equivalents                      $  35,204,000  $  18,033,000 
Trade and other receivables, net                   1,662,000      2,353,000 
Inventories                                        4,339,000      3,611,000 
Prepaid expenses and other current assets, net       709,000        795,000 
                                               -------------  ------------- 
                                                                            
  Total current assets                            41,914,000     24,792,000 
                                                                            
PROPERTY:                                                                   
Leasehold improvements                             1,383,000      1,383,000 
Laboratory equipment                               5,441,000      4,967,000 
Furniture, fixtures, office equipment and                                   
 software                                          2,627,000      2,287,000 
                                               -------------  ------------- 
                                                                            
                                                   9,451,000      8,637,000 
Less accumulated depreciation and amortization    (6,773,000)    (5,737,000)
             
                                  -------------  ------------- 
                                                                            
  Property, net                                    2,678,000      2,900,000 
                                                                            
Other assets                                         466,000        570,000 
                                               -------------  ------------- 
                                                                            
TOTAL ASSETS                                   $  45,058,000  $  28,262,000 
                                               =============  ============= 
                                                                            
                                                                            
                                                                            
PEREGRINE PHARMACEUTICALS, INC.                                             
CONSOLIDATED BALANCE SHEETS                                                 
AS OF APRIL 30, 2013 AND 2012 (continued)                                   
                                                                            
                                                    2013           2012     
                                               -------------  ------------- 
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
                                                                            
CURRENT LIABILITIES:                                                        
Accounts payable                               $   2,821,000  $   3,492,000 
Accrued clinical trial and related fees              930,000      2,111,000 
Accrued payroll and related costs                  3,582,000      2,468,000 
Deferred revenue, current portion                  4,171,000      3,651,000 
Customer deposits                                  8,059,000      4,865,000 
Other current liabilities                            998,000      1,052,000 
                                               -------------  ------------- 
                                                                            
  Total current liabilities                       20,561,000     17,639,000 
                                                                            
Deferred revenue, less current portion               292,000        361,000 
Other long-term liabilities                          445,000        779,000 
Commitments and contingencies                                               
                                                                            
STOCKHOLDERS' EQUITY:                                                       
Preferred stock - $.001 par value; authorized                               
 5,000,000 shares; non-voting; none issued                 -              - 
Common stock - $.001 par value; authorized                                  
 325,000,000 shares; outstanding - 143,768,946                              
 and 101,421,365, respectively                       143,000        101,000 
Additional paid-in-capital                       391,521,000    347,506,000 
Accumulated deficit                             (367,904,000)  (338,124,000)
                                               -------------  ------------- 
                                                                            
  Total stockholders' equity                      23,760,000      9,483,000 
                                               -------------  ------------- 
                                                                            
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY     $  45,058,000  $  28,262,000 
                                               =============  ============= 

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