Peregrine Pharmaceuticals Inc – 10Q


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 10-Q



(Mark One)
ý
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
       
For the quarterly period ended October 31, 2005

OR
o
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
   
For the transition period from _______________ to _______________
 
Commission file number: 0-17085
 
PEREGRINE PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
   
Delaware
95-3698422
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
   
14272 Franklin Avenue, Tustin, California
92780-7017
(Address of principal executive offices)
(Zip Code)
 
Registrant's telephone number, including area code: (714) 508-6000
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes ý    No o.

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes ý    No o.

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

Class
 
Number of Shares Outstanding
Common Stock, $0.001 par value
 
174,044,349 shares of common stock as of December 5, 2005
 
 



PEREGRINE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
     
 
Page No.
       
   
   
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29
       
 
30
       
 
30
       
 
30
       
 
31
       
 
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32
       
The terms “we,” “us,” “our,” “the Company,” and “Peregrine,” as used in this Report on Form 10-Q refers to Peregrine Pharmaceuticals, Inc. and its wholly-owned subsidiary, Avid Bioservices, Inc.



PART I - FINANCIAL INFORMATION


ITEM 1.
FINANCIAL STATEMENTS


PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

           
   
OCTOBER 31,
2005
 
APRIL 30,
2005
 
   
Unaudited
     
         
           
CURRENT ASSETS:
         
Cash and cash equivalents
 
$
11,902,000
 
$
9,816,000
 
Trade and other receivables, net of allowance for doubtful accounts of $72,000 (October) and $69,000 (April)
   
491,000
   
486,000
 
Inventories
   
1,487,000
   
627,000
 
Prepaid expenses and other current assets
   
877,000
   
1,197,000
 
Total current assets
   
14,757,000
   
12,126,000
 
               
PROPERTY:
             
Leasehold improvements
   
494,000
   
494,000
 
Laboratory equipment
   
3,209,000
   
3,029,000
 
Furniture, fixtures and computer equipment
   
684,000
   
647,000
 
     
4,387,000
   
4,170,000
 
Less accumulated depreciation and amortization
   
(2,732,000
)
 
(2,532,000
)
Property, net
   
1,655,000
   
1,638,000
 
               
OTHER ASSETS:
             
Note receivable, net of allowance of $1,475,000 (October) and $1,512,000 (April)
   
   
 
Other
   
554,000
   
481,000
 
Total other assets
   
554,000
   
481,000
 
TOTAL ASSETS
 
$
16,966,000
 
$
14,245,000
 

 

PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued)

           
   
OCTOBER 31,
2005
 
APRIL 30,
2005
 
   
Unaudited
     
LIABILITIES AND STOCKHOLDERS' EQUITY
         
           
CURRENT LIABILITIES:
         
Accounts payable
 
$
1,161,000
 
$
1,325,000
 
Accrued clinical trial site fees
   
61,000
   
8,000
 
Accrued legal and accounting fees
   
176,000
   
549,000
 
Accrued royalties and license fees
   
152,000
   
149,000
 
Accrued payroll and related costs
   
572,000
   
806,000
 
Notes payable, current portion
   
325,000
   
234,000
 
Other current liabilities
   
470,000
   
563,000
 
Deferred revenue
   
1,060,000
   
517,000
 
Total current liabilities
   
3,977,000
   
4,151,000
 
               
NOTES PAYABLE
   
474,000
   
434,000
 
DEFERRED LICENSE REVENUE
   
41,000
   
50,000
 
COMMITMENTS AND CONTINGENCIES
             
               
STOCKHOLDERS' EQUITY:
             
Preferred stock-$.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding
   
   
 
Common stock-$.001 par value; authorized 250,000,000 shares; outstanding - 166,032,599 (October); 152,983,460 (April)
   
166,000
   
153,000
 
Additional paid-in capital
   
191,611,000
   
180,011,000
 
Deferred stock compensation
   
(590,000
)
 
(751,000
)
Accumulated deficit
   
(178,713,000
)
 
(169,803,000
)
Total stockholders' equity
   
12,474,000
   
9,610,000
 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
 
$
16,966,000
 
$
14,245,000
 
               
               
See accompanying notes to condensed consolidated financial statements
 
 
 
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

           
   
THREE MONTHS ENDED
 
SIX MONTHS ENDED
 
   
October 31,
2005
 
October 31,
2004
 
October 31,
2005
 
October 31,
2004
 
   
Unaudited
 
Unaudited
 
Unaudited
 
Unaudited
 
REVENUES:
                 
Contract manufacturing revenue
 
$
533,000
 
$
2,164,000
 
$
722,000
 
$
2,649,000
 
License revenue
   
23,000
   
19,000
   
42,000
   
38,000
 
Total revenues
   
556,000
   
2,183,000
   
764,000
   
2,687,000
 
                           
COSTS AND EXPENSES:
                         
Cost of contract manufacturing
   
428,000
   
1,544,000
   
732,000
   
1,992,000
 
Research and development
   
3,244,000
   
3,004,000
   
6,036,000
   
5,574,000
 
Selling, general and administrative
   
1,570,000
   
1,337,000
   
3,087,000
   
2,304,000
 
Total costs and expenses
   
5,242,000
   
5,885,000
   
9,855,000
   
9,870,000
 
LOSS FROM OPERATIONS
   
(4,686,000
)
 
(3,702,000
)
 
(9,091,000
)
 
(7,183,000
)
                           
OTHER INCOME (EXPENSE):
                         
Interest and other income
   
128,000
   
64,000
   
204,000
   
132,000
 
Interest and other expense
   
(13,000
)
 
   
(23,000
)
 
 
NET LOSS
 
$
(4,571,000
)
$
(3,638,000
)
$
(8,910,000
)
$
(7,051,000
)
                           
WEIGHTED AVERAGE SHARES OUTSTANDING:
                         
Basic and Diluted
   
165,925,879
   
141,545,829
   
162,980,798
   
141,429,201
 
BASIC AND DILUTED LOSS PER COMMON SHARE
 
$
(0.03
)
$
(0.03
)
$
(0.05
)
$
(0.05
)
                           
                           
See accompanying notes to condensed consolidated financial statements
 


PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

       
   
SIX MONTHS ENDED
OCTOBER 31,
 
   
2005
 
2004
 
   
Unaudited
 
Unaudited
 
CASH FLOWS FROM OPERATING ACTIVITIES:
         
Net loss
 
$
(8,910,000
)
$
(7,051,000
)
Adjustments to reconcile net loss to net cash used in operating activities:
             
Depreciation and amortization
   
200,000
   
155,000
 
Stock-based compensation
   
161,000
   
114,000
 
Stock issued for research services
   
678,000
   
307,000
 
Changes in operating assets and liabilities:
             
Trade and other receivables
   
(5,000
)
 
739,000
 
Inventories
   
(860,000
)
 
(617,000
)
Prepaid expenses and other current assets
   
(37,000
)
 
106,000
 
Accounts payable
   
(164,000
)
 
353,000
 
Accrued clinical trial site fees
   
53,000
   
(33,000
)
Deferred revenue
   
534,000
   
126,000
 
Accrued payroll and related costs
   
(234,000
)
 
83,000
 
Other accrued expenses and current liabilities
   
(463,000
)
 
265,000
 
Net cash used in operating activities
   
(9,047,000
)
 
(5,453,000
)
               
CASH FLOWS FROM INVESTING ACTIVITIES:
             
Property acquisitions
   
(217,000
)
 
(203,000
)
Increase in other assets
   
(73,000
)
 
(199,000
)
Net cash used in investing activities
   
(290,000
)
 
(402,000
)
               
CASH FLOWS FROM FINANCING ACTIVITIES:
             
Proceeds from issuance of notes payable
   
267,000
   
 
Principal payments on notes payable
   
(136,000
)
 
 
Proceeds from issuance of common stock, net of issuance costs of $46,000 (October 2005) and $15,000 (October 2004)
   
11,292,000
   
1,296,000
 
Net cash provided by financing activities
   
11,423,000
   
1,296,000
 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
2,086,000
   
(4,559,000
)
               
CASH AND CASH EQUIVALENTS, beginning of period
   
9,816,000
   
14,884,000
 
CASH AND CASH EQUIVALENTS, end of period
 
$
11,902,000
 
$
10,325,000
 
               
NON-CASH FINANCING ACTIVITIES:
             
Common stock issued for research fees and prepayments for future research services
 
$
321,000
 
$
 
               
               
See accompanying notes to condensed consolidated financial statements
 
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited)


1.
BASIS OF PRESENTATION
 
The accompanying interim condensed consolidated financial statements include the accounts of Peregrine Pharmaceuticals, Inc. (“Peregrine”), a biopharmaceutical company with a broad portfolio of products under development, and its wholly-owned subsidiary, Avid Bioservices, Inc. (“Avid”), which performs contract manufacturing of biologics and related services (collectively, the “Company”). All intercompany balances and transactions have been eliminated.

In addition, the accompanying interim condensed consolidated financial statements are unaudited; however they contain all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the condensed consolidated financial position of the Company at October 31, 2005, and the condensed consolidated results of our operations and our condensed consolidated cash flows for the three and six month periods ended October 31, 2005 and 2004. We prepared the condensed consolidated financial statements following the requirements of the Securities and Exchange Commission (or SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (or GAAP) can be condensed or omitted. Although we believe that the disclosures in the financial statements are adequate to make the information presented herein not misleading, the information included in this quarterly report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended April 30, 2005. Results of operations for interim periods covered by this quarterly report on Form 10-Q may not necessarily be indicative of results of operations for the full fiscal year.

As of October 31, 2005, we had $11,902,000 in cash and cash equivalents on hand. In addition, we received an additional $6,720,000 in net proceeds from the sale of shares of our common stock under a Common Stock Purchase Agreement dated November 23, 2005 (Note 6). As of November 30, 2005, including the $6,720,00 in proceeds from the Common Stock Purchase Agreement dated November 23, 2005, we had $17,011,000 in cash and cash equivalents. We have expended substantial funds on the development of our product candidates and we have incurred negative cash flows from operations for the majority of our years since inception. Since inception, we have generally financed our operations primarily through the sale of our common stock and issuance of convertible debt, which has been supplemented with payments received from various licensing collaborations and through the revenues generated by Avid. We expect negative cash flows from operations to continue until we are able to generate sufficient revenue from the contract manufacturing services provided by Avid and/or from the sale and/or licensing of our products under development.

Revenues earned by Avid during the six months ended October 31, 2005 and 2004 amounted to $722,000 and $2,649,000, respectively. We expect that Avid will continue to generate revenues which should lower consolidated cash flows used in operations, although we expect those near term revenues will be insufficient to fully cover anticipated cash flows used in operations. In addition, revenues from the sale and/or licensing of our products under development are always uncertain. Therefore, we expect we will continue to need to raise additional capital to continue the development of our product candidates, including the anticipated development and clinical costs of Tarvacin™ and Cotara®, the anticipated research and development costs associated with our other technology platforms and the potential expansion of our manufacturing capabilities.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)


We plan to raise additional capital primarily through the registered offer and sale of shares of our common stock from our shelf registration statements on Form S-3, which as of December 5, 2005, we had an aggregate of approximately 4,576,000 shares available for possible future registered transactions. However, given uncertain market conditions and the volatility of our stock price and trading volume, we may not be able to sell our securities at prices or on terms that are favorable to us, if at all.

In addition to equity financing, we explore various other sources of funding, including possible debt financing and leveraging our many assets, including our intellectual property portfolio. Our broad intellectual property portfolio allows us to develop products internally while at the same time we are able to out-license certain areas of the technology which would not interfere with our internal product development efforts.

There can be no assurances that we will be successful in raising sufficient capital on terms acceptable to us, or at all (from either debt, equity or the licensing, partnering or sale of technology assets and/or the sale of all or a portion of Avid), or that sufficient additional revenues will be generated from Avid or under potential licensing agreements to complete the research, development, and clinical testing of our product candidates beyond our quarter ending October 31, 2006.

2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash and Cash Equivalents - We consider all highly liquid, short-term investments with an initial maturity of three months or less to be cash equivalents.

Allowance for Doubtful Receivables - We continually monitor our allowance for all receivables. A considerable amount of judgment is required in assessing the ultimate realization of these receivables and we estimate an allowance for doubtful accounts based on factors that appear reasonable under the circumstances.

Prepaid Expenses - Our prepaid expenses primarily represent pre-payments made to secure the receipt of services at a future date. During fiscal years 2005 and 2006, we prepaid various research and development related services through the issuance of our shares of common stock with unrelated entities, which are expensed once the services have been provided under the terms of the arrangement. As of October 31, 2005, prepaid expenses and other current assets include $650,000 in research and development services prepaid in shares of our common stock.
 
Inventories - Inventories are stated at the lower of cost or market and primarily include raw materials, direct labor and overhead costs associated with our wholly-owned subsidiary, Avid. Inventories consist of the following at October 31, 2005 and April 30, 2005:
 
   
October 31,
2005
 
April 30,
2005
 
Raw materials
 
$
547,000
 
$
445,000
 
Work-in-process
   
940,000
   
182,000
 
Total inventories
 
$
1,487,000
 
$
627,000
 
 
 
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)


Concentrations of Credit Risk - The majority of trade and other receivables are from customers in the United States. Most contracts require up-front payments and installment payments as the project progresses. We perform periodic evaluations of our ongoing customers and generally do not require collateral, although we can terminate any contract if a material default occurs. Reserves are maintained for potential credit losses, and such losses have been minimal and within our estimates.

Comprehensive Loss - Comprehensive loss is equal to net loss for all periods presented.
 
Deferred Revenue - Deferred revenue primarily consists of up-front contract fees and installment payments received prior to the recognition of revenues under contract manufacturing and development agreements and up-front license fees received under technology licensing agreements. Deferred revenue is generally recognized once the service has been provided, all obligations have been met, and/or upon shipment of the product to the customer.
 
Revenue Recognition - We currently derive revenues primarily from licensing agreements associated with Peregrine’s technologies under development and from contract manufacturing services provided by Avid.
 
We recognize revenues pursuant to Staff Accounting Bulletin No. 101 (“SAB No. 101”), Revenue Recognition in Financial Statements and Staff Accounting Bulletin No. 104 (“SAB No. 104”), Revenue Recognition. These bulletins draw on existing accounting rules and provide specific guidance on how those accounting rules should be applied. Revenue is generally realized or realizable and earned when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectibility is reasonably assured.

In addition, we comply with Financial Accounting Standards Board’s Emerging Issues Task Force No. 00-21 (“EITF 00-21”), Revenue Arrangements with Multiple Deliverables. In accordance with EITF 00-21, we recognize revenue for delivered elements only when the delivered element has stand-alone value and we have objective and reliable evidence of fair value for each undelivered element. If the fair value of any undelivered element included in a multiple element arrangement cannot be objectively determined, revenue is deferred until all elements are delivered and services have been performed, or until fair value can objectively be determined for any remaining undelivered elements.

Revenues associated with licensing agreements primarily consist of nonrefundable up-front license fees and milestone payments. Revenues under licensing agreements are recognized based on the performance requirements of the agreement. Nonrefundable up-front license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant licensed technology, are generally recognized as revenue upon delivery of the technology. Nonrefundable up-front license fees, whereby ongoing involvement or performance obligations exist, are generally recorded as deferred revenue and generally recognized as revenue over the term of the performance obligation or relevant agreement.
 
Contract manufacturing revenues are generally recognized once the service has been provided and/or upon shipment of the product to the customer. We also record a provision for estimated contract losses, if any, in the period in which they are determined. 
 
 
PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
 
In July 2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF 99-19”), Reporting Revenue Gross as a Principal versus Net as an Agent. EITF 99-19 summarized the EITF’s views on when revenue should be recorded at the gross amount billed to a customer because it has earned revenue from the sale of goods or services, or the net amount retained (the amount billed to the customer less the amount paid to a supplier) because it has earned a fee or commission. In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting for Shipping and Handling Fees and Costs, and Issue 01-14 (“EITF 01-14”), Income Statement Characterization of Reimbursements Received for “Out-of-Pocket” Expenses Incurred. EITF 00-10 summarized the EITF’s views on how the seller of goods should classify in the income statement amounts billed to a customer for shipping and handling, and the costs associated with shipping and handling. EITF 01-14 summarized the EITF’s views on when the reimbursement of out-of-pocket expenses should be characterized as revenue or as a reduction of expenses incurred. Our revenue recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF 01-14 whereby we recorded revenue for the gross amount billed to customers (the cost of raw materials, supplies, and shipping, plus the related handling mark-up fee) and we recorded the cost of the amounts billed as cost of sales as we act as a principal in these transactions.
 
Research and Development - Research and development costs are charged to expense when incurred in accordance with Statement of Financial Accounting Standards No. 2, Accounting for Research and Development Costs. Research and development expenses primarily include (i) payroll and related costs associated with research and development personnel, (ii) costs related to clinical trials and pre-clinical testing of technologies under development, (iii) the costs to manufacture the product candidates, including raw materials and supplies, (iv) technology access and maintenance fees, including amounts incurred under licensing agreements and intellectual property access fees, (v) expenses for research and services rendered under outside contracts, including sponsored research funding paid to universities, and (vi) facility and other research and development expenses.

Reclassification - Certain amounts in fiscal year 2005 condensed consolidated financial statements have been reclassified to conform to the current year presentation.
 
Basic and Dilutive Net Loss Per Common Share - Basic and dilutive net loss per common share is calculated in accordance with Statement of Financial Accounting Standards No. 128, Earnings per Share. Basic net loss per common share is computed by dividing our net loss by the weighted average number of common shares outstanding during the period excluding the dilutive effects of options and warrants. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the potential dilutive effects of options and warrants outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive.

The calculation of weighted average diluted shares outstanding excludes the dilutive effect of options and warrants to purchase up to 3,140,081 and 3,205,261 shares of common stock for the three and six months ended October 31, 2005, respectively, and 7,645,598 and 7,886,527 shares of common stock for the three and six months ended October 31, 2004, respectively, as the impact of options and warrants are anti-dilutive during periods of net loss. 

The calculation of weighted average diluted shares outstanding also excludes options and warrants to purchase up to 14,516,913 and 14,621,138 shares of common stock for the three and six months ended October 31, 2005, respectively, and 12,084,093 and 11,427,939 shares of common stock for the three and six months ended October 31, 2004, respectively, as the exercise price of those options was greater than the average market price of our common stock during the respective periods, resulting in an anti-dilutive effect.
 
 
 
PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
 
On November 23, 2005, we entered into a Common Stock Purchase Agreement with one institutional investor whereby we sold 8,000,000 shares of our common stock for gross proceeds of $6,720,000 (Note 6), which additional shares have been excluded from basic and dilutive net loss per common share for the three and six months ended October 31, 2005.

Stock-Based Compensation - In December 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards No. 148 (“SFAS No. 148”), Accounting for Stock-Based Compensation-Transition and Disclosure.  SFAS No. 148 amends SFAS No. 123 (“SFAS No. 123”), Accounting for Stock-Based Compensation, and provides alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation.  In addition, SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation, and the effect of the method used on reported results.
 
We have not adopted a method under SFAS No. 148 to expense stock options, but rather we continue to apply the provisions of SFAS No. 123; however, we have adopted the additional disclosure provisions of the statement. As SFAS No. 123 permits, we elected to continue accounting for our employee stock options in accordance with Accounting Principles Board Opinion No. 25 (“APB No. 25”), Accounting for Stock Issued to Employees and Related Interpretations. APB No. 25 requires compensation expense to be recognized for stock options when the market price of the underlying stock exceeds the exercise price of the stock option on the date of the grant.
 
We utilize the guidelines in APB No. 25 for measurement of stock-based transactions for employees and, accordingly, no compensation expense has been recognized for the options in the accompanying condensed consolidated financial statements for the three and six months ended October 31, 2005 and October 31, 2004.

Had we used a fair value model for measurement of stock-based transactions for employees under SFAS No. 123 and amortized the expense over the vesting period, pro forma information would be as follows:

   
THREE MONTHS ENDED
 
SIX MONTHS ENDED
 
   
October 31,
2005
 
October 31,
2004
 
October 31,
2005
 
October 31,
2004
 
Net loss, as reported
 
$
(4,571,000
)
$
(3,638,000
)
$
(8,910,000
)
$
(7,051,000
)
Stock-based employee compensation cost that would have been included in the determination of net loss if the fair value based method had been applied to all awards
   
(570,000
)
 
(718,000
)
 
(1,213,000
)
 
(1,508,000
)
Pro forma net loss as if the fair value based method had been applied to all awards
 
$
(5,141,000
)
$
(4,356,000
)
$
(10,123,000
)
$
(8,559,000
)
Basic and diluted net loss per share, as reported
 
$
(0.03
)
$
(0.03
)
$
(0.05
)
$
(0.05
)
Basic and diluted net loss per share, pro forma
 
$
(0.03
)
$
(0.03
)
$
(0.06
)
$
(0.06
)
 
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
Stock-based compensation expense recorded during the three and six months ended October 31, 2005 and October 31, 2004 relate to stock option grants issued to non-employee consultants. The fair value of these options are measured utilizing the Black-Scholes option valuation model and are being amortized over the estimated period of service or related vesting period in accordance with the provisions of SFAS No. 123 and EITF 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Stock-based compensation expense recorded during the three and six months ended October 31, 2005 amounted to $57,000 and $161,000, respectively. Stock-based compensation expense recorded during the three and six months ended October 31, 2004 amounted to $19,000 and $114,000, respectively.
 
In December 2004, the FASB issued Statement of Financial Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised 2004), which requires companies to recognize in the income statement the fair value of all employee share-based payments, including grants of employee stock options as well as compensatory employee stock purchase plans, for interim periods beginning after June 15, 2005. In April 2005, the Securities and Exchange Commission adopted a rule amendment that delayed the compliance dates of SFAS No. 123R such that we are now allowed to adopt the new standard no later than May 1, 2006. SFAS No. 123R eliminates the ability to account for share-based compensation using APB No. 25, and the pro forma disclosures previously permitted under SFAS No. 123 no longer will be an alternative to financial statement recognition. Although we have not yet determined whether the adoption of SFAS No. 123R will result in amounts that are similar to the current pro forma disclosures under SFAS No. 123 (as shown above), we are evaluating the requirements under SFAS No. 123R including the valuation methods and support for the assumptions that underlie the valuation of the awards, as well as the transition methods (modified prospective transition method or the modified retrospective transition method) and expect the adoption to have a significant impact on our consolidated statements of operations and net loss per share and minimal impact on our consolidated statement of financial position.
 
In addition, during August 2003, a member of our Board of Directors voluntarily cancelled an option to purchase shares of our common stock due to an insufficient number of stock options available in our stock option plans for new employee grants. During October 2003, we received stockholder approval for our 2003 Stock Incentive Plan (“2003 Plan”) and the director was re-granted options to purchase shares under the 2003 Plan. In accordance with FASB Interpretation No. 44 (“FIN No. 44”), Accounting for Certain Transactions Involving Stock Compensation, the option granted to the director under the 2003 Plan is subject to variable accounting, which could result in an increase in compensation expense in subsequent periods if the market price of our common stock exceeds the original exercise price of the option until the date the option is exercised, forfeited, or expires unexercised. If the market price of our common stock decreases, then decreases in compensation expense would be recognized, limited to the net expense previously reported. During the three and six months ended October 31, 2005 and October 31, 2004, we did not record compensation expense with respect to such option in accordance with FIN No. 44 since the market price of our stock was less than the exercise price of the option at the end of the respective periods.

Recent Accounting Pronouncement - In December 2004, the FASB issued Statement of Financial Accounting Standards No. 153 (“SFAS No. 153”), Exchanges of Nonmonetary Assets - An Amendment of APB Opinion No. 29, Accounting for Nonmonetary Transactions. SFAS No. 153 eliminates the exception from fair value measurement for nonmonetary exchanges of similar productive assets in paragraph 21(b) of APB Opinion No. 29, Accounting for Nonmonetary Transactions, and replaces it with an exception for exchanges that do not have commercial substance. SFAS No. 153 specifies that a nonmonetary exchange has commercial substance if the future cash flows of the entity are expected to change significantly as a result of the exchange. SFAS No. 153 is effective for the fiscal periods beginning after June 15, 2005 and we would be required to adopt this standard no later than May 1, 2006. The adoption of SFAS No. 153 is not expected to have a material impact on our consolidated financial position and results of operations.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
3.
NOTE RECEIVABLE

During December 1998, we completed the sale and subsequent leaseback of our two facilities and recorded an initial note receivable from the buyer of $1,925,000. The note receivable bears interest at 7.5% per annum and payments are due monthly based on a 20-year amortization period. The note receivable is due on the earlier to occur of (i) December 1, 2010 or (ii) upon the sale of the facility and the transfer of title. In addition, if we default under the lease agreement, including but not limited to, filing a petition for bankruptcy or failure to pay the basic rent, the note receivable shall be deemed to be immediately satisfied in full and the buyer shall have no further obligation to us for such note receivable, as defined in the note agreement. Although we have made all payments under the lease agreement and we have not filed for protection under the laws of bankruptcy, during the quarter ended October 31, 1999, we did not have sufficient cash on hand to meet our obligations on a timely basis and we were operating at significantly reduced levels. In addition, at that time, if we could not raise additional cash by December 31, 1999, we may have had to file for protection under the laws of bankruptcy. Due to the uncertainty of our ability to pay our lease obligations on a timely basis, we established a 100% reserve for the note receivable in the amount of $1,887,000 as of October 31, 1999. We reduce the reserve as payments are received and we record the reduction as interest and other income in the accompanying condensed consolidated statements of operations. Due to the uncertainty of our ability to fund our operations beyond our quarter ending October 31, 2006, the carrying value of the note receivable approximates its fair value at October 31, 2005. We have received all payments to date under the note receivable.  
 
The following represents a rollforward of the allowance of the note receivable for the six months ended October 31, 2005:
       
Allowance balance, April 30, 2005
 
$
1,581,000
 
Principal payments received
   
(34,000
)
Allowance balance, October 31, 2005
 
$
1,547,000
 

4.
NOTES PAYABLE

During November 2004, we entered into a note agreement with General Electric Capital Corporation (“GE”) in the amount of $350,000 collateralized by certain laboratory equipment. The note bears interest at a rate of 5.78% per annum with payments due monthly in the amount of approximately $11,000 over 36 months commencing January 1, 2005. Under the terms of the agreement, we paid to GE a security deposit of 25%, or approximately $88,000, which is due and payable to us at the end of the note term. The deposit is included in other long-term assets in the accompanying consolidated financial statements.

During December 2004, we entered into a second note agreement with GE in the amount of $383,000 collateralized by certain laboratory equipment. The note bears interest at a rate of 5.85% per annum with payments due monthly in the amount of approximately $12,000 over 36 months commencing February 1, 2005. Under the terms of the agreement, we paid to GE a security deposit of 25%, or approximately $96,000, which is due and payable to us at the end of the note term. The deposit is included in other long-term assets in the accompanying consolidated financial statements.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
During June 2005, we entered into a third note agreement with GE in the amount of $267,000 collateralized by certain laboratory equipment. The note bears interest at a rate of 6.39% per annum with payments due monthly in the amount of approximately $8,000 over 36 months which commenced in August 2005. Under the terms of the agreement, we paid to GE a security deposit of 25%, or approximately $67,000, which is due and payable to us at the end of the note term. The deposit is included in other long-term assets in the accompanying consolidated financial statements.

As of October 31, 2005, we owed GE an aggregate amount of $799,000 under all note payable agreements. Minimum future principal payments on notes payable as of October 31, 2005 are as follows:

       
Year ending April 30:
     
2006
 
$
160,000
 
2007
   
336,000
 
2008
   
279,000
 
2009
   
24,000
 
Total
 
$
799,000
 


5.
LITIGATION

In the ordinary course of business, we are at times subject to various legal proceedings, including licensing and contract disputes and other matters, which are further discussed below:

On December 16, 2004, we filed a lawsuit against the University of Southern California (“USC”) and Alan Epstein, M.D. The lawsuit was filed in the Superior Court of the State of California for the County of Los Angeles, Central District. The lawsuit alleges that USC has breached various agreements with the Company by (i) failing to protect the Company’s patent rights in Japan with respect to certain technology exclusively licensed from USC due to non-payment of annuities, (ii) failing to provide accounting documentation for research expenditures, and (iii) misusing certain antibodies the Company provided to USC and Dr. Epstein for research. The claims against Dr. Epstein, who was a scientific advisor and former consultant to the Company, involve breach of contract for misusing certain antibodies and breach of fiduciary duties. The Company is seeking unspecified damages, declaratory relief with respect to its rights under the option and license agreement pursuant to which it acquired the rights to the technology, and an accounting of research expenditures. Because the lawsuit is ongoing, the final outcome of this matter cannot be determined at this time. However, a tentative settlement of most and potentially all of these claims are currently being negotiated following non-binding mediation held on October 21, 2005.
 
On August 3, 2005, USC filed a cross-complaint against the Company relating to the above-mentioned lawsuit. The cross-complaint alleges that the Company has breached various agreements with USC by (i) breaching reporting and diligence provisions of the option and license agreements, (ii) failing to make payments under a sponsored research agreement, and (iii) failing to exercise its rights under the product and option license agreement for hybridoma clones. USC is seeking unspecified punitive damages with respect to its rights under the option and license agreements and the sponsored research agreement. The Company believes that the cross-complaint is erroneous and without merit and intends to contest it vigorously. The Company does not believe any such claim, proceeding, or litigation, either alone or in the aggregate, will have a material adverse effect on the Company's consolidated financial statements taken as a whole. The claims asserted by USC against the Company are included in the mediation discussions described above and will be dismissed by USC with prejudice at such time as a settlement agreement is finalized.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
On September 30, 2004, we filed a lawsuit against Knobbe, Martens, Olson & Bear, LLP and Joseph Reisman, of the law firm Knobbe, Martens, Olson & Bear, LLP, in San Diego Superior Court. This suit is related to USC’s above-mentioned failure to protect patent rights in Japan. Accordingly, the case against the Knobbe firm was dismissed in connection with receiving a tolling agreement extending the statute of limitations on our claims against the firm while USC pursues those claims. Our pending discussions with USC include a negotiation and potential resolution of the claims that were asserted in this action.

In addition, we have been investigating whether certain technologies developed at USC and subsequently licensed to a private company, Pivotal BioSciences, Inc., an entity we believe is partially owned by the principal investigator and others at USC, were developed using resources under our sponsored research agreement with USC and/or funding provided from another source for which we have geographic technology rights. We have determined that we do not have any specific rights to technology licensed by USC to Pivotal, although a part of our dispute with USC is whether the Principal Investigator applied our funds paid to his laboratory under our Sponsored Research Agreement with USC in order to develop technology that is benefiting Pivotal Biosciences. Resolution of that dispute with USC is a part of the negotiations of the litigation with USC described above. In addition, we initiated discussions with Pivotal Biosciences, Inc. to verify whether our rights to materials loaned to the Principal Investigator but being utilized by him in connection with technology licensed by Pivotal from USC, was impacted. Pivotal has provided us written assurances that it does not have any of our materials and would not attempt to make use of our materials commercially without our consent or that of our licensee.

6.
STOCKHOLDERS’ EQUITY

During the six months ended October 31, 2005, we entered into various financing transactions as summarized below:

Description of Financing Transaction
 
Number of Common Stock Shares Issued
 
Net Issuance Value
 
Common stock purchase agreement dated January 31, 2005
   
1,582,217
 
$
1,576,000
 
Common stock purchase agreement dated May 11, 2005
   
3,125,000
 
$
2,989,000
 
Common stock purchase agreement dated June 22, 2005
   
8,000,000
 
$
6,691,000
 
Common stock issued to an unrelated entity for research services
   
299,422
 
$
321,000
 
     
13,006,639
 
$
11,577,000
 
 
In addition, we filed a registration statement on Form S-3, File Number 333-128322 during September 2005, which was declared effective by the Securities and Exchange Commission, allowing us to issue, from time to time, in one or more offerings, up to 12,000,000 shares of our common stock (“September 2005 Shelf”). As of October 31, 2005, all 12,000,000 shares of common stock were available for issuance under the September 2005 Shelf.

On November 23, 2005, we entered into a Common Stock Purchase Agreement with one institutional investor whereby we agreed to sell 8,000,000 shares of our common stock under the September 2005 Shelf at the per share price of $0.84 (“November 23, 2005 Financing”) in exchange for net proceeds of $6,720,000. We paid no commissions nor issued any warrants in connection with the November 23, 2005 Financing.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
As of December 5, 2005, we had an aggregate of 4,575,578 shares of common stock available for future issuance under two shelf registration statements on Form S-3, as filed with the Securities and Exchange Commission.
 
Shares of Common Stock Authorized and Reserved For Future Issuance

In accordance with our shares reserved for issuance under our shelf registration statements, stock option plans and warrant agreements, we have reserved 34,911,753 shares of our common stock at October 31, 2005 for possible future issuance, calculated as follows:

   
Number of Shares of Common Stock Reserved For Issuance
 
Shares reserved under shelf registration statements
   
4,575,578
 
Options issued and outstanding
   
11,114,831
 
Options available for future grant
   
5,679,548
 
Warrants issued and outstanding
   
13,541,796
 
Total shares reserved
   
34,911,753
 

On December 1, 2005, warrants to purchase 3,825,000 and 1,000,000 shares of our common stock at the exercise price of $3.00 and $5.00, respectively, expired unexercised.

7.
STOCK OPTIONS

As of October 31, 2005, options to purchase up to 11,114,831 shares of our common stock were issued and outstanding and exercisable under all of our option plans at prices ranging between $0.34 and $5.28 per share with an average exercise price of $1.58 per share and expire at various dates through October 24, 2015.

During October 2005, our stockholders approved the 2005 Stock Incentive Plan (“2005 Plan”) for the granting of options to purchase up to 5,000,000 shares of our common stock. The 2005 Plan provides for the granting of options to purchase shares of our common stock at prices not less than its fair market value at the date of grant and which generally expire ten years after the date of grant. As of October 31, 2005, options to purchase up to 5,679,548 shares of common stock were available for future grant under all stock option plans. 

8.
WARRANTS

As of October 31, 2005, warrants to purchase up to 13,541,796 shares of our common stock were issued and outstanding and exercisable at prices ranging between $0.71 and $5.00 per share with an average exercise price of $1.81 per share and expire at various dates through March 31, 2008. On December 1, 2005, warrants to purchase 3,825,000 and 1,000,000 shares of our common stock at the exercise price of $3.00 and $5.00, respectively, expired unexercised.
 

PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)


9.
SEGMENT REPORTING

Our business is organized into two reportable operating segments. Peregrine is engaged in the research and development of targeted therapeutics for the treatment of viruses and cancer. Avid is engaged in providing contract manufacturing of biologics and related services to biopharmaceutical and biotechnology businesses.
 
The accounting policies of the operating segments are the same as those described in Note 2. We primarily evaluate the performance of our segments based on net revenues, gross profit or loss (exclusive of research and development expenses, selling, general and administrative expenses, and interest and other income/expense) and long-lived assets. Our segment net revenues shown below are derived from transactions with external customers. Our segment gross profit or loss represents net revenues less the cost of sales. Our long-lived assets consist of leasehold improvements, laboratory equipment, and furniture, fixtures and computer equipment and are net of accumulated depreciation.

Segment information for three months ended October 31, 2005 and October 31, 2004 is summarized as follows:

   
Three Months Ended October 31,
 
   
2005
 
2004
 
Net Revenues:
         
Contract manufacturing and development of biologics
 
$
533,000
 
$
2,164,000
 
Research and development of biotherapeutics
   
23,000
   
19,000
 
Total net revenues
 
$
556,000
 
$
2,183,000
 
               
Gross Profit:
             
Contract manufacturing and development of biologics
 
$
105,000
 
$
620,000
 
Research and development of biotherapeutics
   
23,000
   
19,000
 
Total gross profit
   
128,000
   
639,000
 
               
Research and development expense of biotherapeutics
   
(3,244,000
)
 
(3,004,000
)
Selling, general and administrative expense
   
(1,570,000
)
 
(1,337,000
)
Other income, net
   
115,000
   
64,000
 
Net loss
 
$
(4,571,000
)
$
(3,638,000
)
               

Net revenues generated from Avid during the three months ended October 31, 2005 and October 31, 2004 were primarily from two customers located in the U.S and one customer headquartered in Israel as follows:

   
Three Months Ended October 31,
 
   
2005
 
2004
 
Customer revenues as a % of net revenues:
         
United States (customer A)
   
97%
 
 
46%
 
United States (customer B)
   
2%
 
 
16%
 
Israel (one customer)
   
1%
 
 
38%
 
Total customer revenues as a % of net revenues
   
100%
 
 
100%
 
 
 
PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
Segment information for six months ended October 31, 2005 and October 31, 2004 is summarized as follows:

   
Six Months Ended October 31,
 
   
2005
 
2004
 
Net Revenues:
         
Contract manufacturing and development of biologics
 
$
722,000
 
$
2,649,000
 
Research and development of biotherapeutics
   
42,000
   
38,000
 
Total net revenues
 
$
764,000
 
$
2,687,000
 
               
Gross Profit (Loss):
             
Contract manufacturing and development of biologics
 
$
(10,000
)
$
657,000
 
Research and development of biotherapeutics
   
42,000
   
38,000
 
Total gross profit
   
32,000
   
695,000
 
               
Research and development expense of biotherapeutics
   
(6,036,000
)
 
(5,574,000
)
Selling, general and administrative expense
   
(3,087,000
)
 
(2,304,000
)
Other income, net
   
181,000
   
132,000
 
Net loss
 
$
(8,910,000
)
$
(7,051,000
)
               
Net revenues generated from Avid during the six months ended October 31, 2005 and October 31, 2004 were primarily from three customers located in the U.S and one customer headquartered in Israel as follows:

   
Six Months Ended October 31,
 
   
2005
 
2004
 
Customer revenues as a % of net revenues:
         
United States (customer A)
   
82%
 
 
45%
 
United States (customer B)
   
6%
 
 
13%
 
United States (customer C)
   
10%
 
 
0%
 
Israel (one customer)
   
2%
 
 
41%
 
Other customers
   
0%
 
 
1%
 
Total customer revenues as a % of net revenues
   
100%
 
 
100%
 

Long-lived assets consist of the following at October 31, 2005 and April 30, 2005:

   
October 31,
2005
 
April 30,
2005
 
Long-lived Assets, net:
         
Contract manufacturing and development of biologics
 
$
1,336,000
 
$
1,291,000
 
Research and development of biotherapeutics
   
319,000
   
347,000
 
Total long-lived assets, net
 
$
1,655,000
 
$
1,638,000
 
               
Net revenues generated from Peregrine during the three and six months ended October 31, 2005 and October 31, 2004 were primarily from the amortized portion of the up-front license fees under the December 2002 license agreement with Schering A.G.
 
 
PEREGRINE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND SIX MONTHS ENDED OCTOBER 31, 2005 (unaudited) (continued)

 
10.
SUBSEQUENT EVENTS

On November 18, 2005, we entered into a fourth note payable agreement with GE in the amount of approximately $103,000 collateralized by certain laboratory equipment. The note bears interest at a rate of 6.63% per annum with payments due monthly in the amount of approximately $3,000 over 36 months commencing January 1, 2006. Under the terms of the agreement, we paid to GE a security deposit of 25%, or approximately $26,000, which is due and payable to us at the end of the note term.

On November 23, 2005, we entered into a Common Stock Purchase Agreement with one institutional investor whereby we sold 8,000,000 shares of our common stock at the per share price of $0.84 in exchange for net proceeds of $6,720,000 (Note 6).
 

ITEM2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent our projections, estimates, expectations or beliefs concerning among other things, financial items that relate to management’s future plans or objectives or to our future economic and financial performance.  In some cases, you can identify these statements by terminology such as “may”, “should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect”, or “intend”, including their opposites or similar phrases or expressions. You should be aware that these statements are projections or estimates as to future events and are subject to a number of factors that may tend to influence the accuracy of the statements. These forward-looking statements should not be regarded as a representation by the Company or any other person that the events or plans of the Company will be achieved. You should not unduly rely on these forward-looking statements, which speak only as of the date of this Quarterly Report. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports we file from time to time with the Securities and Exchange Commission (“SEC”) after the date of this Quarterly Report. Actual results may differ materially from any forward looking statement.
 
To gain a better understanding of the risk factors that may tend to influence the accuracy of our forward looking statements, we recommend that you read the risk factors identified in the Company's Annual Report on Form 10-K for the year ended April 30, 2005 and all other reports we file from time to time with the SEC after the date of this Quarterly Report. Although we believe that the risks described in the 10-K and other reports filed with the SEC represent all material risks currently applicable to us, additional risks and uncertainties not presently known to us or that are currently not believed to be important to us may also affect our actual future results and could harm our business, financial condition, and results of operations.

Company Overview

We are a biopharmaceutical company primarily developing targeted therapeutics directed towards the treatment of viruses and cancer using monoclonal antibodies. We are organized into two reportable operating segments: (i) Peregrine Pharmaceuticals, Inc. (“Peregrine”), the parent company, is engaged in the research and development of targeted therapeutics and (ii) Avid Bioservices, Inc. (“Avid”), our wholly owned subsidiary, is engaged in providing manufacturing expertise of biologics for biopharmaceutical and biotechnology companies, including Peregrine.
 

Recent Developments

The following table provides you with an overview of our products in clinical trials and the current clinical status of each trial:

Products in Clinical Trials
Technology
Platform
Product Name
Disease
Stage of Development
Development Status Overview
Tumor Necrosis Therapy (“TNT”)
 
Cotara®
 
Brain Cancer
 
Phase II/III registration trial
 
Peregrine, in collaboration with New Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor consortium, have initiated the first part of the Phase II/III product registration study to evaluate Cotara® for the treatment of brain cancer. This study is partially funded by the National Cancer Institute ("NCI”) and will treat up to 28 patients. The study is being conducted at the following four NABTT institutions: Wake Forest University, Emory University, University of Alabama at Birmingham and University of Pennsylvania.
Anti-Phospholipid Therapy
 
Tarvacin™
 
Advanced Solid Cancers
 
Phase I
 
This phase I clinical study is a single and repeat dose escalation study designed to enroll up to 28 patients with advanced solid tumors that no longer respond to standard cancer treatments. Patient enrollment is open at the following clinical sites: MD Anderson Cancer Center in Houston, Texas; Arizona Cancer Center in Tucson, Arizona; Premiere Oncology in Scottsdale, Arizona;  Premiere Oncology in Santa Monica, California and; Scott & White Hospital & Clinic in Temple, Texas.
Anti-Phospholipid Therapy
 
Tarvacin™
 
Hepatitis C Virus
 
Phase I
 
This phase I clinical study is a single dose-escalation study in up to 32 adult patients with chronic hepatitis C virus (HCV) infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy. Patient enrollment is open at Bach and Godofsky Infectious Diseases located in Bradenton, FL.


Results of Operations
 
The following table compares the unaudited condensed consolidated statements of operations for the three and six-month periods ended October 31, 2005 and October 31, 2004. This table provides you with an overview of the changes in the condensed consolidated statements of operations for the comparative periods, which changes are further discussed below.

   
Three Months Ended
October 31,
 
Six Months Ended
October 31,
 
   
2005
 
2004
 
$ Change
 
2005
 
2004
 
$ Change
 
   
(in thousands)
 
(in thousands)
 
REVENUES:
                         
Contract manufacturing revenue
 
$
533
 
$
2,164
 
$
(1,631
)
$
722
 
$
2,649
 
$
(1,927
)
License revenue
   
23
   
19
   
4
   
42
   
38
   
4
 
Total revenues
   
556
   
2,183
   
(1,627
)
 
764
   
2,687
   
(1,923
)
                                       
COST AND EXPENSES:
                                     
Cost of contract manufacturing
   
428
   
1,544
   
(1,116
)
 
732
   
1,992
   
(1,260
)
Research and development
   
3,244
   
3,004
   
240
   
6,036
   
5,574
   
462
 
Selling, general and administrative
   
1,570
   
1,337
   
233
   
3,087
   
2,304
   
783
 
Total cost and expenses
   
5,242
   
5,885
   
(643
)
 
9,855
   
9,870
   
(15
)
                                       
LOSS FROM OPERATIONS
   
(4,686
)
 
(3,702
)
 
(984
)
 
(9,091
)
 
(7,183
)
 
(1,908
)
                                       
OTHER INCOME (EXPENSE):
                                     
Interest and other income
   
128
   
64
   
64
   
204
   
132
   
72
 
Interest and other expense
   
(13
)
 
-
   
(13
)
 
(23
)
 
-
   
(23
)
NET LOSS
 
$
(4,571
)
$
(3,638
)
$
(933
)
$
(8,910
)
$
(7,051
)
$
(1,859
)
                                       
Results of operations for interim periods covered by this quarterly report on Form 10-Q may not necessarily be indicative of results of operations for the full fiscal year.

Total Revenues. 

Three and Six Months: The decrease in total revenues of $1,627,000 and $1,923,000 during the three and six months ended October 31, 2005, respectively, compared to the same periods in the prior year was primarily due to a decrease in contract manufacturing revenue of $1,631,000 and $1,927,000, respectively. The decrease in contract manufacturing revenue was primarily due to a decrease in the number of completed manufacturing runs associated with unrelated entities compared to the same three and six-month periods in the prior year. In addition, during the three and six months ended October 31, 2005, we significantly increased our utilization of our manufacturing facility to manufacture clinical grade materials to support Peregrine’s three active clinical trials and other products under development.

We expect to continue to generate contract manufacturing revenue during the remainder of the current fiscal year based on the anticipated completion of in-process customer related projects and the anticipated demand for Avid’s services under outstanding proposals. Although Avid is presently working on several active projects for unrelated entities and has submitted project proposals with various potential customers, we cannot estimate nor can we determine the likelihood that we will be successful in completed these ongoing projects or converting any of these outstanding project proposals into definitive agreements during the remainder of fiscal year 2006.
 
 
Cost of Contract Manufacturing.

Three and Six Months: The decrease in cost of contract manufacturing of $1,116,000 and $1,260,000 during the three and six months ended October 31, 2005, respectively, compared to the same periods in the prior year was primarily related to the current year three and six-month period decreases in contract manufacturing revenue. However, the six month decrease in cost of contract manufacturing was offset by additional costs incurred during the first quarter of the current year to provide additional data to support required studies for current customers. We expect contract manufacturing costs to increase during the remainder of the current fiscal year based on the anticipated completion of customer projects under our current contract manufacturing agreements.

Research and Development Expenses. 

Three Months: The increase in research and development expenses of $240,000 during the three months ended October 31, 2005 compared to the same period in the prior year was primarily due to a net increase in expenses associated with the following platform technologies under development:

Anti-Phospholipid Therapy (Tarvacin™) - During the three months ended October 31, 2005, Anti-Phospholipid Therapy (Tarvacin™) program expenses increased $1,240,000 from $1,274,000 in fiscal year 2005 to $2,514,000 in fiscal year 2006. The increase in Anti-Phospholipid Therapy (Tarvacin™) program expenses of $1,240,000 is primarily due to an increase in manufacturing expenses and various clinical trial expenses to support two separate Phase I clinical studies using Tarvacin™ for the treatment of advanced solid cancers and chronic hepatitis C virus infection combined with an increase in technology access fees associated with Tarvacin™ Phase I clinical trial milestones achieved during the current quarter in accordance with third party licensing agreements. These increases were supplemented with an increase in sponsored research fees and payroll and related expenses associated with Anti-Phospholipid Therapy development. These increases were offset by a decrease in pre-clinical toxicology study expenses incurred in the prior year quarter to support the Investigational New Drug (“IND”) applications that were filed for Tarvacin™ in the prior fiscal year with the U.S. Food & Drug Administration combined with a decrease in antibody development fees regarding an up-front technology access fee incurred in the prior year quarter under an antibody research collaboration for the generation of a human antibody under our Anti-Phospholipid Therapy technology platform.

Tumor Necrosis Therapy (“TNT”) (Cotara®) - During the three months ended October 31, 2005, TNT (Cotara®) program expenses decreased $433,000 from $734,000 in fiscal year 2005 to $301,000 in fiscal year 2006. The decrease in TNT (Cotara®) program expenses of $433,000 is primarily due to a decrease in payroll and related expenses and radiolabeling process development expenses incurred in the prior year to support the initiation of the first part of the Cotara® Phase II/III registration trial for the treatment of brain cancer in collaboration with the New Approaches to Brain Tumor Therapy consortium, and to support other development programs associated with our TNT technology platform. These decreases were further supplemented by a decrease in technology access fees incurred in the same prior year quarter supporting the production of monoclonal antibodies for the Cotara® antibody.

Vascular Targeting Agents (“VTAs”) and Anti-Angiogenesis - During the three months ended October 31, 2005, VTA and Anti-Angiogenesis program expenses decreased $535,000 from $880,000 in fiscal year 2005 to $345,000 in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program expenses of $535,000 is primarily due to a decrease in intellectual property access fees, sponsored research fees, and technology access fees associated with VTA development.

Vasopermeation Enhancements Agents (“VEAs”) - During the three months ended October 31, 2005, VEA program expenses decreased $28,000 from $112,000 in fiscal year 2005 to $84,000 in fiscal year 2006. The decrease in VEA program expenses of $28,000 is primarily due to a decrease in manufacturing development expenses. In January 2005, we entered into an agreement with Merck KGaA of Darmstadt, Germany, that will give us access to Merck's technology and expertise in protein expression to advance the development of our VEA technology and other platform technologies. Merck KGaA is presently working on a clinical candidate under the VEA technology platform.
 

Six Months: The increase in research and development expenses of $462,000 during the six months ended October 31, 2005 compared to the same period in the prior year was primarily due to a net increase in expenses associated with the following platform technologies under development:

Anti-Phospholipid Therapy (Tarvacin™) - During the six months ended October 31, 2005, Anti-Phospholipid Therapy (Tarvacin™) program expenses increased $1,539,000 from $2,545,000 in fiscal year 2005 to $4,084,000 in fiscal year 2006. The increase in Anti-Phospholipid Therapy (Tarvacin™) program expenses of $1,539,000 is primarily due to an increase in manufacturing expenses and various clinical trial expenses to support two separate Phase I clinical studies using Tarvacin™ for the treatment of advanced solid cancers and chronic hepatitis C virus infection combined with an increase in technology access fees associated with Tarvacin™ Phase I clinical trial milestones achieved during the current year in accordance with third party licensing agreements. These increases were supplemented with an increase in sponsored research fees and payroll and related expenses associated with Anti-Phospholipid Therapy development. These increases were primarily offset by a decrease in pre-clinical toxicology study expenses incurred in the prior year to support the Tarvacin™ Investigational New Drug (“IND”) applications that were filed in the prior fiscal year with the U.S. Food & Drug Administration combined with a decrease in antibody development fees regarding an up-front technology access fee incurred in the prior year under an antibody research collaboration for the generation of a human antibody under our Anti-Phospholipid Therapy technology platform.

Vascular Targeting Agents (“VTAs”) and Anti-Angiogenesis - During the six months ended October 31, 2005, VTA and Anti-Angiogenesis program expenses decreased $788,000 from $1,484,000 in fiscal year 2005 to $696,000 in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program expenses of $788,000 is primarily due to a decrease in intellectual property access fees, sponsored research fees, and technology access fees associated with VTA development.

Vasopermeation Enhancements Agents (“VEAs”) - During the six months ended October 31, 2005, VEA program expenses decreased $222,000 from $408,000 in fiscal year 2005 to $186,000 in fiscal year 2006. The decrease in VEA program expenses of $222,000 is primarily due to a decrease in sponsored research fees paid to University of Southern California combined with a decrease in antibody development fees regarding expenses incurred in the prior year associated with a research study that was completed in the prior year. In January 2005, we entered into an agreement with Merck KGaA of Darmstadt, Germany, that will give us access to Merck's technology and expertise in protein expression to advance the development of our VEA technology and other platform technologies. Merck KGaA is presently working on a clinical candidate under the VEA technology platform.

Tumor Necrosis Therapy (“TNT”) (Cotara®) - During the six months ended October 31, 2005, TNT (Cotara®) program expenses decreased $55,000 from $1,124,000 in fiscal year 2005 to $1,069,000 in fiscal year 2006. The decrease in TNT (Cotara®) program expenses of $55,000 is primarily due to a decrease in payroll and related expenses and radiolabeling process development expenses incurred in the same prior year period to support the initiation of the first part of the Cotara® Phase II/III registration trial for the treatment of brain cancer in collaboration with the New Approaches to Brain Tumor Therapy consortium, and to support other development programs associated with our TNT technology platform. These decreases were further supplemented by a decrease in technology access fees incurred in the same prior year period supporting the production of monoclonal antibodies for the Cotara®. These decreases in expenses were offset by an increase in manufacturing expenses incurred to support the TNT development program.
 

We expect research and development expenses to increase over the near term primarily under the following ongoing research and development programs:

1.      
Clinical programs associated with the commencement of two separate Phase I clinical trials to evaluate Tarvacin™ for the treatment of solid tumors and chronic hepatitis C virus infection;
2.      
Cotara® clinical study for the treatment of brain cancer in collaboration with New Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor treatment consortium, representing the first part of our Phase II/III registration trial;
3.      
Anti-Phospholipid Therapy research and development program;
4.      
2C3 (anti-angiogenesis antibody) research and development program;
5.      
Vascular Targeting Agent research and development program; and
6.      
Vasopermeation Enhancement Agent research and development program.

The following represents the research and development expenses (“R&D Expenses”) we have incurred by each major technology platform under development:
               
Technology Platform
 
R&D Expenses-Quarter Ended
October 31, 2004
 
R&D Expenses-Quarter Ended
October 31, 2005
 
R&D Expenses-
May 1, 1998 to
October 31, 2005
 
TNT (Cotara®)
 
$
734,000
 
$
301,000
 
$
29,885,000
 
Anti-Phospholipid Therapy (Tarvacin™)
   
1,274,000
   
2,514,000
   
11,967,000
 
VTA and Anti-Angiogenesis
   
880,000
   
345,000
   
11,451,000
 
VEA
   
112,000
   
84,000
   
5,554,000
 
Other research programs
   
4,000
   
-
   
13,441,000
 
Total R&D Expenses
 
$
3,004,000
 
$
3,244,000
 
$
72,298,000
 

From inception to April 30, 1998, we expensed $20,898,000 on research and development of our product candidates, with the costs primarily being closely split between the TNT and prior developed technologies. In addition to the above costs, we expensed an aggregate of $32,004,000 for the acquisition of our TNT and VTA technologies, which were acquired during fiscal years 1995 and 1997, respectively.

Looking beyond the current fiscal year, it is extremely difficult for us to reasonably estimate all future research and development costs associated with each of our technologies due to the number of unknowns and uncertainties associated with pre-clinical and clinical trial development. These unknown variables and uncertainties include, but are not limited to:

§  
The uncertainty of our capital resources to fund research, development and clinical studies beyond our quarter ending October 31, 2006;
§  
The uncertainty of future costs associated with our pre-clinical candidates, including Vascular Targeting Agents, Anti-Angiogensis Agents, and Vasopermeation Enhancement Agents, which costs are dependent on the success of pre-clinical development. We are uncertain whether or not these product candidates will be successful and we are uncertain whether or not we will incur any additional costs beyond pre-clinical development;
§  
The uncertainty of future clinical trial results;
§  
The uncertainty of the ultimate number of patients to be treated in any clinical trial;
§  
The uncertainty of the Food and Drug Administration allowing our studies to move into and forward from Phase I clinical studies to Phase II and Phase III clinical studies;
§  
The uncertainty of the rate at which patients are enrolled into any current or future study. Any delays in clinical trials could significantly increase the cost of the study and would extend the estimated completion dates;
§  
The uncertainty of terms related to potential future partnering or licensing arrangements; and
§  
The uncertainty of protocol changes and modifications in the design of our clinical trial studies, which may increase or decrease our future costs.
 
 
 
We or our potential partners will need to do additional development and clinical testing prior to seeking any regulatory approval for commercialization of our product candidates as all of our products are in discovery, pre-clinical or clinical development. Testing, manufacturing, commercialization, advertising, promotion, exporting, and marketing, among other things, of our proposed products are subject to extensive regulation by governmental authorities in the United States and other countries. The testing and approval process requires substantial time, effort, and financial resources, and we cannot guarantee that any approval will be granted on a timely basis, if at all. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in conducting advanced human clinical trials, even after obtaining promising results in earlier trials. Furthermore, the United States Food and Drug Administration may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Even if regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which it may be marketed. Accordingly, we or our potential partners may experience difficulties and delays in obtaining necessary governmental clearances and approvals to market our products, and we or our potential partners may not be able to obtain all necessary governmental clearances and approvals to market our products.

Selling, General and Administrative Expenses. Selling, general and administrative expenses consist primarily of payroll and related expenses, director fees, legal and accounting fees, investor and public relation fees, insurance, and other expenses relating to our general management, administration, and business development activities of the Company.

Three Months: The increase in selling, general and administrative expenses of $233,000 during the three months ended October 31, 2005 compared to the same period in the prior year is primarily due to an increase in (i) legal fees of $92,000 from $86,000 in fiscal year 2005 to $178,000 in fiscal year 2006 primarily pertaining to the general corporate matters and lawsuits described in the Quarterly Report on Form 10-Q under Part II, Item 1, Legal Proceedings, (ii) investor and public relation fees increased $79,000 from $73,000 in fiscal year 2005 to $152,000 in fiscal year 2006 primarily due to services provided by public relation firms assisting the Company with its investor and public relations activities, whose services were not utilized in the same prior year period, and (iii) stock-based compensation expense of $41,000 from zero expense in fiscal year 2005 to $41,000 in fiscal year 2006 due to the amortization expenses associated with the fair value of stock options granted to non-employee consultants performing business development activities.

Six Months: The increase in selling, general and administrative expenses of $783,000 during the six months ended October 31, 2005 compared to the same period in the prior year is primarily due to an increase in (i) legal fees of $211,000 from $159,000 in fiscal year 2005 to $370,000 in fiscal year 2006 primarily pertaining to the general corporate matters and litigation matters described in the Quarterly Report on Form 10-Q under Part II, Item 1, Legal Proceedings, (ii) payroll and related expenses of $176,000 from $1,133,000 in fiscal year 2005 to $1,309,000 in fiscal year 2006 primarily due to an increase in headcount across most corporate functions to support the increased operations primarily pertaining to Avid and the expansion of our pre-clinical and clinical development plans, (iii) investor and public relation fees increased $128,000 from $99,000 in fiscal year 2005 to $227,000 in fiscal year 2006 primarily due to services provided by public relation firms assisting the Company with its investor and public relations activities, whose services were not utilized in the same prior year period, (iv) travel and related expenses of $99,000 from $104,000 in fiscal year 2005 to $203,000 in fiscal year 2006 related primarily to Peregrine’s increased business development activities, (v) director fees of $85,000 from $124,000 in fiscal year 2005 to $209,000 in fiscal year 2006 primarily due to an increase in the number of non-employee directors combined with an increase in the number of Company Board meetings, and (vi) audit and accounting fees of $65,000 from $111,000 in fiscal year 2005 to $176,000 in fiscal year 2006 primarily related to the implementation of Section 404 of the Sarbanes-Oxley Act of 2002.


Interest and Other Income. 

Three and Six Months: The increase in interest and other income of $64,000 and $72,000 during the three and six months ended October 31, 2005, respectively, compared to the same periods in the prior year was primarily due to an increase in interest income as a result of a higher average cash balance on hand and higher prevailing interest rates during the current year compared to the same prior year period.
 
Critical Accounting Policies

The methods, estimates, and judgments we use in applying our most critical accounting policies have a significant impact on the results we report in our condensed consolidated financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances. Our experience and assumptions form the basis for our judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may vary from what we anticipate and different assumptions or estimates about the future could change our reported results. We believe the following accounting policies are the most critical to us, in that they are important to the portrayal of our financial statements and they require our most difficult, subjective, or complex judgments in the preparation of our condensed consolidated financial statements:

Revenue Recognition. We currently derive revenues primarily from licensing agreements associated with Peregrine’s technologies under development and from contract manufacturing services provided by Avid. We recognize revenues pursuant to Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, as well as the recently issued Staff Accounting Bulletin No. 104, Revenue Recognition. These bulletins draw on existing accounting rules and provide specific guidance on how those accounting rules should be applied. Revenue is generally realized or realizable and earned when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the seller's price to the buyer is fixed or determinable, and (iv) collectibility is reasonably assured.

In addition, we comply with Financial Accounting Standards Board’s Emerging Issues Task Force No. 00-21 (“EITF 00-21”), Revenue Arrangements with Multiple Deliverables. In accordance with EITF 00-21, we recognize revenue for delivered elements only when the delivered element has stand-alone value and we have objective and reliable evidence of fair value for each undelivered element. If the fair value of any undelivered element included in a multiple element arrangement cannot be objectively determined, revenue is deferred until all elements are delivered and services have been performed, or until fair value can objectively be determined for any remaining undelivered elements.

Revenues associated with licensing agreements primarily consist of nonrefundable up-front license fees and milestone payments. Revenues under licensing agreements are recognized based on the performance requirements of the agreement. Nonrefundable up-front license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant licensed technology, are generally recognized as revenue upon delivery of the technology. Milestone payments are generally recognized as revenue upon completion of the milestone assuming there are no other continuing obligations. Nonrefundable up-front license fees, whereby we have an ongoing involvement or performance obligation, are generally recorded as deferred revenue and generally recognized as revenue over the term of the performance obligation or relevant agreement. Under some license agreements, the obligation period may not be contractually defined. Under these circumstances, we must exercise judgment in estimating the period of time over which certain deliverables will be provided to enable the licensee to practice the license.

Contract manufacturing revenues are generally recognized once the service has been provided and/or upon shipment of the product to the customer. We also record a provision for estimated contract losses, if any, in the period in which they are determined.
 
 
In July 2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF 99-19”), Reporting Revenue Gross as a Principal versus Net as an Agent. EITF 99-19 summarized the EITF’s views on when revenue should be recorded at the gross amount billed to a customer because it has earned revenue from the sale of goods or services, or the net amount retained (the amount billed to the customer less the amount paid to a supplier) because it has earned a fee or commission. In addition, the EITF released Issue 00-10 (“EITF 00-10”), Accounting for Shipping and Handling Fees and Costs, and Issue 01-14 (“EITF 01-14”), Income Statement Characterization of Reimbursements Received for “Out-of-Pocket” Expenses Incurred. EITF 00-10 summarized the EITF’s views on how the seller of goods should classify in the income statement amounts billed to a customer for shipping and handling and the costs associated with shipping and handling. EITF 01-14 summarized the EITF’s views on when the reimbursement of out-of-pocket expenses should be characterized as revenue or as a reduction of expenses incurred. Our revenue recognition policies are in compliance with EITF 99-19, EITF 00-10 and EITF 01-14 whereby we record revenue for the gross amount billed to customers (the cost of raw materials, supplies, and shipping, plus the related handling mark-up fee) and record the cost of the amounts billed as cost of sales as we act as a principal in these transactions.
 
Allowance for Doubtful Receivables. We continually monitor our allowance for all receivables. A considerable amount of judgment is required in assessing the ultimate realization of these receivables and we estimate an allowance for doubtful accounts based on factors that appear reasonable under the circumstances.
 
Liquidity and Capital Resources

As of October 31, 2005, we had $11,902,000 in cash and cash equivalents on hand. In addition, we received an additional $6,720,000 in net proceeds from the sale of shares of our common stock under a Common Stock Purchase Agreement dated November 23, 2005. As of November 30, 2005, including the $6,720,00 in proceeds from the Common Stock Purchase Agreement dated November 23, 2005, we had $17,011,000 in cash and cash equivalents. Although we have sufficient cash on hand to meet our current planned obligations through our quarter ending October 31, 2006, our development efforts are dependent on our ability to raise additional capital to support our future operations.

We have expended substantial funds on the development of our product candidates and we have incurred negative cash flows from operations for the majority of our years since inception. Since inception, we have generally financed our operations primarily through the sale of our common stock and issuance of convertible debt, which has been supplemented with payments received from various licensing collaborations and through the revenues generated by Avid. We expect negative cash flows from operations to continue until we are able to generate sufficient revenue from the contract manufacturing services provided by Avid and/or from the sale and/or licensing of our products under development.

Revenues earned by Avid during the six months ended October 31, 2005 and 2004 amounted to $722,000 and $2,649,000, respectively. We expect that Avid will continue to generate revenues which should lower consolidated cash flows used in operations, although we expect those near term revenues will be insufficient to cover anticipated cash flows used in operations. In addition, revenues from the sale and/or licensing of our products under development are always uncertain. Therefore, we expect we will continue to need to raise additional capital to continue the development of our product candidates, including the anticipated development and clinical trial costs of Tarvacin™ and Cotara®, the anticipated research and development costs associated with our other technology platforms and the potential expansion of our manufacturing capabilities.

We plan to raise additional capital primarily through the registered offer and sale of shares of our common stock from our shelf registration statements on Form S-3, which as of December 5, 2005, we had an aggregate of approximately 4,576,000 shares available for possible future registered transactions. However, given uncertain market conditions and the volatility of our stock price and trading volume, we may not be able to sell our securities at prices or on terms that are favorable to us, if at all.
 

In addition to equity financing, we actively explore various other sources of funding, including possible debt financing and leveraging our many assets, including our intellectual property portfolio. Our broad intellectual property portfolio allows us to develop products internally while at the same time we are able to out-license certain areas of the technology which would not interfere with our internal product development efforts.

There can be no assurances that we will be successful in raising sufficient capital on terms acceptable to us, or at all (from either debt, equity or the licensing, partnering or sale of technology assets and/or the sale of all or a portion of Avid), or that sufficient additional revenues will be generated from Avid or under potential licensing agreements to complete the research, development, and clinical testing of our product candidates for our quarter ending October 31, 2006.

Significant components of the changes in cash flows from operating, investing, and financing activities for the six months ended October 31, 2005 compared to the same prior year period are as follows:

Cash Used In Operating Activities. Cash used in operating activities is primarily driven by changes in our net loss. However, cash used in operating activities generally differs from our reported net loss as a result of non-cash operating expenses or differences in the timing of cash flows as reflected in the changes in operating assets and liabilities. During the six months ended October 31, 2005, cash used in operating activities increased $3,594,000 to $9,047,000 compared to $5,453,000 for the six months ended October 31, 2004. The increase in cash used in operating activities was primarily related to the timing of cash flows as reflected in the changes in operating assets and payment or reduction of liabilities in the aggregate amount of $2,198,000, the amount of which was further supplemented by an increase of $1,396,000 in net cash used in operating activities after deducting non-cash operating expenses and before considering the changes in operating assets and liabilities. This increase was primarily due to a decrease in contract manufacturing revenue combined with an increase in research and development expenses and general and administrative expenses.

The changes in operating activities as a result of non-cash operating expenses or differences in the timing of cash flows as reflected in the changes in operating assets and liabilities are as follows:
 
   
SIX MONTHS ENDED
 
   
October 31,
2005
 
October 31,
2004
 
Net loss, as reported
 
$
(8,910,000
)
$
(7,051,000
)
Less non-cash operating expenses:
             
Depreciation and amortization
   
200,000
   
155,000
 
Stock-based compensation
   
161,000
   
114,000
 
Common stock issued for services
   
678,000
   
307,000
 
Net cash used in operating activities before changes in operating assets and liabilities
 
$
(7,871,000
)
$
(6,475,000
)
Net change in operating assets and liabilities
 
$
(1,176,000
)
$
1,022,000
 
Net cash used in operating activities
 
$
(9,047,000
)
$
(5,453,000
)

Cash Used In Investing Activities. Net cash used in investing activities decreased $112,000 to $290,000 for the six months ended October 31, 2005 compared to $402,000 for the six months ended October 31, 2004. Cash used in investing activities during the six months ended October 31, 2005 was primarily due to the purchase of laboratory equipment to support the continued research and development efforts of Peregrine and the expanded manufacturing services of Avid combined with an increase in security deposits paid to GE Capital Corporation on notes payable to finance the purchase of laboratory equipment. Cash used in investing activities during the six months ended October 31, 2004 was primarily due to the purchase of laboratory equipment combined with installment payments made on a 1,000-liter bioreactor.
 
 
Cash Provided By Financing Activities.  Net cash provided by financing activities increased $10,127,000 to $11,423,000 for the six months ended October 31, 2005 compared to net cash provided of $1,296,000 for the six months ended October 31, 2004. Cash provided by financing activities during the six months ended October 31, 2005, was primarily due to proceeds received under three separate security purchase agreements whereby we sold and issued 12,707,217 shares of our common stock in exchange for aggregate net proceeds of $11,256,000. This was supplemented by a current six-month increase in proceeds received from notes payable in the amount of $267,000, the amount of which was offset by $136,000 in principal payments made on notes payable during the current six-month period. Cash provided by financing activities during the six months ended October 31, 2004, was primarily due to proceeds received under a security purchase agreement whereby we sold and issued 1,000,000 shares of our common stock in exchange for aggregate net proceeds of $1,238,000.

Commitments

At October 31, 2005, we had no material capital commitments, other than the commitments for laboratory equipment in the amount of approximately $100,000.

Risk Factors of Our Company

The biotechnology industry includes many risks and challenges. Our challenges may include, but are not limited to: uncertainties associated with completing pre-clinical and clinical trials for our technologies; the significant costs to develop our products as all of our products are currently in development, pre-clinical studies or clinical trials and no revenue has been generated from commercial product sales; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; complying with governmental regulations applicable to our business; obtaining the raw materials necessary in the development of such compounds; consummating collaborative arrangements with corporate partners for product development; achieving milestones under collaborative arrangements with corporate partners; developing the capacity to manufacture, market, and sell our products, either directly or indirectly with collaborative partners; developing market demand for and acceptance of such products; competing effectively with other pharmaceutical and biotechnological products; attracting and retaining key personnel; protecting intellectual property rights; and accurately forecasting operating and capital expenditures, other capital commitments, or clinical trial costs, and general economic conditions. A more detailed discussion regarding our industry and business risk factors can be found in our Annual Report on Form 10-K for the year ended April 30, 2005, as filed with the Securities and Exchange Commission on July 14, 2005.

ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Changes in United States interest rates would affect the interest earned on our cash and cash equivalents. Based on our overall interest rate exposure at October 31, 2005, a near-term change in interest rates, based on historical movements, would not materially affect the fair value of interest rate sensitive instruments. Our debt instruments have fixed interest rates and terms and, therefore, a significant change in interest rates would not have a material adverse effect on our financial position or results of operations.
 
CONTROLS AND PROCEDURES

The Company maintains disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed in its reports filed under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
 

The Company carried out an evaluation, under the supervision and with the participation of management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of its disclosure controls and procedures as of October 31, 2005, the end of the period covered by this Quarterly Report. Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that its disclosure controls and procedures were effective at the reasonable assurance level as of October 31, 2005.
     
There were no significant changes in the Company’s internal controls over financial reporting, during the quarter ended October 31, 2005, that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting.

PART II OTHER INFORMATION


ITEM 1.
LEGAL PROCEEDINGS.

In the ordinary course of business, we are at times subject to various legal proceedings, including licensing and contract disputes and other matters, which are further discussed below:

On December 16, 2004, we filed a lawsuit against the University of Southern California (“USC”) and Alan Epstein, M.D. The lawsuit was filed in the Superior Court of the State of California for the County of Los Angeles, Central District. The lawsuit alleges that USC has breached various agreements with the Company by (i) failing to protect the Company’s patent rights in Japan with respect to certain technology exclusively licensed from USC due to non-payment of annuities, (ii) failing to provide accounting documentation for research expenditures, and (iii) misusing certain antibodies the Company provided to USC and Dr. Epstein for research. The claims against Dr. Epstein, who was a scientific advisor and former consultant to the Company, involve breach of contract for misusing certain antibodies and breach of fiduciary duties. The Company is seeking unspecified damages, declaratory relief with respect to its rights under the option and license agreement pursuant to which it acquired the rights to the technology, and an accounting of research expenditures. Because the lawsuit is ongoing, the final outcome of this matter cannot be determined at this time. However, a tentative settlement of most and potentially all of these claims are currently being negotiated following non-binding mediation held on October 21, 2005.
 
On August 3, 2005, USC filed a cross-complaint against the Company relating to the above-mentioned lawsuit. The cross-complaint alleges that the Company has breached various agreements with USC by (i) breaching reporting and diligence provisions of the option and license agreements, (ii) failing to make payments under a sponsored research agreement, and (iii) failing to exercise its rights under the product and option license agreement for hybridoma clones. USC is seeking unspecified punitive damages with respect to its rights under the option and license agreements and the sponsored research agreement. The Company believes that the cross-complaint is erroneous and without merit and intends to contest it vigorously. The Company does not believe any such claim, proceeding, or litigation, either alone or in the aggregate, will have a material adverse effect on the Company's consolidated financial statements taken as a whole. The claims asserted by USC against the Company are included in the mediation discussions described above and will be dismissed by USC with prejudice, provided a settlement agreement is finalized.

On September 30, 2004, we filed a lawsuit against Knobbe, Martens, Olson & Bear, LLP and Joseph Reisman, of the law firm Knobbe, Martens, Olson & Bear, LLP, in San Diego Superior Court. This suit is related to USC’s above-mentioned failure to protect patent rights in Japan. Accordingly, the case against the Knobbe firm was dismissed in connection with receiving a tolling agreement extending the statute of limitations on our claims against the firm while USC pursues those claims. Our pending discussions with USC include a negotiation and potential resolution of the claims that were asserted in this action.
 

In addition, we have been investigating whether certain technologies developed at USC and subsequently licensed to a private company, Pivotal BioSciences, Inc., an entity we believe is partially owned by the principal investigator and others at USC, were developed using resources under our sponsored research agreement with USC and/or funding provided from another source for which we have geographic technology rights. We have determined that we do not have any specific rights to technology licensed by USC to Pivotal, although a part of our dispute with USC is whether the Principal Investigator applied our funds paid to his laboratory under our Sponsored Research Agreement with USC in order to develop technology that is benefiting Pivotal Biosciences. Resolution of that dispute with USC is a part of the negotiations of the litigation with USC described above. In addition, we initiated discussions with Pivotal Biosciences, Inc. to verify whether our rights to materials loaned to the Principal Investigator but being utilized by him in connection with technology licensed by Pivotal from USC, was impacted. Pivotal has provided us written assurances that it does not have any of our materials and would not attempt to make use of our materials commercially without our consent or that of our licensee.

CHANGES IN SECURITIES AND USE OF PROCEEDS.   None.
 
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES.   None.

ITEM 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. 

We held our annual meeting of stockholders’ on October 24, 2005. The following represents the matters voted upon and the results of the voting:
             
    
Routine Matters
 
For
 
Against or Withheld
 
             
1)
Election of Directors:
         
 
Carlton M. Johnson
   
138,710,144
   
4,979,764
 
 
Steven W. King
   
139,864,463
   
3,825,445
 
 
David Pohl
   
139,366,179
   
4,323,729
 
 
Eric Swartz
   
139,382,032
   
4,307,876
 
 
Dr. Thomas Waltz
   
140,021,781
   
3,668,127
 
                 
2)
To ratify the appointment of Ernst & Young LLP as independent auditors of the Company for the fiscal year ending April 30, 2006.
   
145,126,370
   
1,363,457
 
                 
3)
To approve an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock from 200 million to 250 million.
   
138,592,173
   
7,897,654
 
                 
4)
To approve the adoption of the Company’s 2005 Stock Incentive Plan
   
20,228,710
   
11,321,265
 
                 
5)
To require the nomination of two individuals for each open seat on the board of directors.
   
11,282,794
   
20,267,182
 
                 
6)
To require stockholder approval of all option and warrant grants to members of the board of directors and officers of the Company.
   
12,235,968
   
19,314,008
 
 
 
 
ITEM 5.
OTHER INFORMATION. None.

ITEM 6.
EXHIBITS.

(a)
Exhibits:
 
3.6

31.1

31.2

32
 



SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
     
  PEREGRINE PHARMACEUTICALS, INC.
 
 
 
 
 
 
  By:   /s/ STEVEN W. KING
 
 
Steven W. King
President and Chief Executive Officer, Director
     
     
  By:   /s/ PAUL J. LYTLE
 
 
Paul J. Lytle
Chief Financial Officer
(signed both as an officer duly authorized to sign on behalf of the
Registrant and principal financial officer and Chief accounting officer)
   
   
-32-

Certificate of Amendment
EXHIBIT 3.6

 
CERTIFICATE OF AMENDMENT
OF
CERTIFICATE OF INCORPORATION
OF
PEREGRINE PHARMACEUTICALS, INC.,
A DELAWARE CORPORATION

PEREGRINE PHARMACEUTICALS, INC., a Delaware corporation organized and existing under and by virtue of the Delaware General Corporation Law (hereinafter referred to as the "Corporation"), hereby certifies as follows:

1. That at a meeting of the Board of Directors of the Corporation resolutions were duly adopted setting forth a proposed amendment of the Certificate of Incorporation of the Corporation, declaring said amendment to be advisable and directing said amendment to be submitted to the stockholders of the Corporation at a special meeting. The resolutions setting forth the proposed amendment is as follows:

“RESOLVED, that the Certificate of Incorporation be amended by changing the first sentence of ARTICLE 4 so that it shall read as follows:

 
“The total number of shares of all classes of stock which the Corporation shall have authority to issue is 255,000,000, of which (i) 250,000,000 shares shall be designated “Common Stock” and shall have a par value of $0.001 per share; and (ii) 5,000,000 shares shall be designated “Preferred Stock” and shall have a par value of $0.001 per share.”

2. That thereafter, pursuant to resolution of the Board of Directors, an Annual Meeting of the stockholders of the Corporation was duly called and held, upon notice in accordance with Section 222 of the Delaware General Corporation Law, at which Annual Meeting the necessary number of shares as required by statute were voted in favor of the amendment.

3. That said amendment was duly adopted in accordance with the provisions of Section 242 of the Delaware General Corporation Law of the State of Delaware.

IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be executed by Steven W. King, its President & CEO, and attested to by Paul J. Lytle, its Secretary, this 24th day of October, 2005.
 
     
  PEREGRINE PHARMACEUTICALS, INC.
a Delaware corporation
 
 
 
 
 
 
  By:   /s/ STEVEN W. KING
 
  Steven W. King, President & CEO

ATTEST:

/s/ PAUL J. LYTLE    
Paul J. Lytle, Secretary
Exhibit 31.1
EXHIBIT 31.1
 
Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Steven W. King, certify that:
 
1.    I have reviewed this quarterly report on Form 10-Q of Peregrine Pharmaceuticals, Inc.;
 
2.    Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
3.    Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
4.    The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a)    designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 b)    designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)    evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this quarterly report based on such evaluation; and
 
d)    disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.    The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
a)    all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b)    any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
     
     
Dated: December 9, 2005 Signed:   /s/ STEVEN W. KING
 
 
Steven W. King
President and Chief Executive Officer, Director
   
   

Exhibit 31.2
EXHIBIT 31.2
 
Certification of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Paul J. Lytle, certify that:
 
1.    I have reviewed this quarterly report on Form 10-Q of Peregrine Pharmaceuticals, Inc.;
 
2.    Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
3.    Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
4.    The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a)    designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 b)    designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)    evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by this quarterly report based on such evaluation; and
 
d)    disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.    The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
a)    all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b)    any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
     
     
Dated:  December 9, 2005 Signed:   /s/ PAUL J. LYTLE
 
 
Paul J. Lytle
Chief Financial Officer
   
   

Exhibit 32
EXHIBIT 32

 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
 
Each of the undersigned hereby certifies, in his capacity as an officer of Peregrine Pharmaceuticals, Inc. (the “Company”), for purposes of 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
 
(1)    the Quarterly Report of the Company on Form 10-Q for the period ended October 31, 2005 fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(2)    the information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: December 9, 2005    


/s/ STEVEN W. KING

Steven W. King
President and Chief Executive Officer, Director


/s/ PAUL J. LYTLE

Paul J. Lytle
Chief Financial Officer
 

A signed original of this written statement required by Section 906 has been provided to Peregrine Pharmaceuticals, Inc. and will be retained by Peregrine Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

This Certification is being furnished pursuant to Rule 15(d) and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act (15 U.S.C. 78r), or otherwise subject to the liability of that section. This Certification shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.