Delaware
(State or other jurisdiction of
incorporation or organization)
|
95-3698422
(I.R.S. Employer
Identification No.)
|
|||
14282 Franklin Avenue
Tustin, California 92780-7017
(714) 508-6000
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
|
||||
Paul J. Lytle, Chief Financial Officer
Peregrine Pharmaceuticals, Inc.
14282 Franklin Avenue
Tustin, California 92780-7017
(714) 508-6000
(Name, address, including zip code, and telephone number, including area code, of agent for service)
|
Large accelerated filer o | Accelerated filer þ |
Non-accelerated filer (do not check if a smaller reporting company) o | Smaller reporting company o |
·
|
a basic prospectus which covers the offering, issuance and sale of $75,000,000 of common stock and warrants of Peregrine Pharmaceuticals, Inc. by the registrant; and
|
·
|
a sales agreement prospectus covering the offering, issuance and sale of our common stock that may be issued and sold under a sales agreement that we have entered into with McNicoll, Lewis & Vlak LLC.
|
ABOUT THIS PROSPECTUS | 1 |
OUR BUSINESS | 1 |
RISK FACTORS | 4 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS | 19 |
USE OF PROCEEDS | 19 |
DESCRIPTION OF COMMON STOCK | 19 |
DESCRIPTION OF WARRANTS | 20 |
PLAN OF DISTRIBUTION | 22 |
LEGAL MATTERS | 23 |
EXPERTS | 23 |
WHERE TO LEARN MORE ABOUT US | 23 |
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE | 24 |
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES | 25 |
Common stock and/or warrants offered by us in this prospectus |
$75,000,000 aggregate gross sales proceeds
|
Common stock outstanding before this offering
|
64,404,097 (1) |
Use of proceeds | See “Use of Proceeds” |
Nasdaq Capital Market symbol | PPHM |
(1)
|
The number set forth above does not include approximately 14,255,257 shares of our common stock that, as of December 15, 2010, are reserved for issuance under our stock incentive plans, employee stock purchase plan, and for outstanding warrants, calculated as follows:
|
Number of Shares
of Common Stock
Reserved For
Issuance
|
||||
Common shares reserved for issuance under outstanding option and restricted stock award grants and available for issuance under our stock incentive plans
|
9,035,290 | |||
Common shares reserved for and available for issuance under our employee stock purchase plan
|
5,000,000 | |||
Common shares issuable upon exercise of outstanding warrants
|
219,967 | |||
Total shares of common stock reserved for issuance
|
14,255,257 |
·
|
incur additional indebtedness, except for certain permitted indebtedness. Permitted indebtedness is defined to include accounts payable incurred in the ordinary course of business and leases of equipment or property incurred in the ordinary course of business not to exceed in the aggregate $500,000 outstanding at any one time;
|
·
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incur additional liens on any of our assets except for certain permitted liens including but not limited to non-exclusive licenses of our intellectual property in the ordinary course of business and exclusive licenses of intellectual property provided they are approved by our board of directors and do not involve bavituximab or Cotara;
|
·
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make any payment of subordinated debt, except as permitted under the applicable subordination or intercreditor agreement;
|
·
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merge with or acquire any other entity, or sell all or substantially all of our assets, except as permitted under the Loan Agreement;
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·
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pay dividends (other than stock dividends) to our shareholders;
|
·
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redeem any outstanding shares of our common stock or any outstanding options or warrants to purchase shares of our common stock except in connection with the repurchase of stock from former employees and consultants pursuant to share repurchase agreements provided such repurchases do not exceed $50,000 in the aggregate during any twelve-month period;
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·
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enter into transactions with affiliates other than on arms-length terms; and
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·
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make any change in any of our business objectives, purposes and operations which has or could be reasonably expected to have a material adverse effect on our business.
|
Net Loss | ||||
Six months ended October 31, 2010 (unaudited) | $ | 15,208,000 | ||
Fiscal Year 2010 | $ | 14,494,000 | ||
Fiscal Year 2009 | $ | 16,524,000 | ||
Fiscal Year 2008 | $ | 23,176,000 |
Number of Shares
Reserved
|
||||
Common shares reserved for issuance under outstanding option and restricted stock award grants and available for issuance under our stock incentive plans
|
9,035,290 | |||
Common shares reserved for and available for issuance under our employee stock purchase plan
|
5,000,000 | |||
Common shares issuable upon exercise of outstanding warrants
|
219,967 | |||
Total shares of common stock reserved for issuance
|
14,255,257 |
Common Stock
Sales Price
|
Common Stock Daily
Trading Volume
(000’s omitted)
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|||||||||||||||
High
|
Low
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High
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Low
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|||||||||||||
Quarter Ended October 31, 2010
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$ | 2.08 | $ | 1.25 | 4,997 | 118 | ||||||||||
Quarter Ended July 31, 2010
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$ | 4.14 | $ | 1.51 | 9,520 | 140 | ||||||||||
Quarter Ended April 30, 2010
|
$ | 4.30 | $ | 2.86 | 1,278 | 66 | ||||||||||
Quarter Ended January 31, 2010
|
$ | 3.46 | $ | 2.51 | 1,384 | 49 | ||||||||||
Quarter Ended October 31, 2009
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$ | 4.74 | $ | 2.74 | 2,243 | 64 | ||||||||||
Quarter Ended July 31, 2009
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$ | 5.65 | $ | 1.85 | 7,345 | 39 | ||||||||||
Quarter Ended April 30, 2009
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$ | 2.60 | $ | 1.52 | 702 | 14 | ||||||||||
Quarter Ended January 31, 2009
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$ | 2.35 | $ | 1.10 | 260 | 19 | ||||||||||
Quarter Ended October 31, 2008
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$ | 2.00 | $ | 1.15 | 263 | 15 | ||||||||||
Quarter Ended July 31, 2008
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$ | 2.65 | $ | 1.54 | 599 | 21 | ||||||||||
Quarter Ended April 30, 2008
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$ | 3.63 | $ | 1.75 | 769 | 26 | ||||||||||
Quarter Ended January 31, 2008
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$ | 3.25 | $ | 1.75 | 622 | 28 | ||||||||||
Quarter Ended October 31, 2007
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$ | 3.95 | $ | 2.70 | 526 | 34 | ||||||||||
Quarter Ended July 31, 2007
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$ | 7.00 | $ | 3.60 | 4,331 | 47 |
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announcements of technological innovations or new commercial products by us or our competitors;
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publicity regarding actual or potential clinical trial results relating to products under development by us or our competitors;
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our financial results or that of our competitors, including our abilities to continue as a going concern;
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the offering and sale of shares of our common stock at a discount under an equity transaction;
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changes in our capital structure;
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published reports by securities analysts;
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announcements of licensing agreements, joint ventures, strategic alliances, and any other transaction that involves the sale or use of our technologies or competitive technologies;
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developments and/or disputes concerning our patent or proprietary rights;
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regulatory developments and product safety concerns;
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general stock trends in the biotechnology and pharmaceutical industry sectors;
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public concerns as to the safety and effectiveness of our products;
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economic trends and other external factors, including but not limited to, interest rate fluctuations, economic recession, inflation, foreign market trends, national crisis, and disasters; and
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healthcare reimbursement reform and cost-containment measures implemented by government agencies.
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1.
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Net tangible assets of at least $2,500,000 or market capitalization of at least $35,000,000 or net income of at least $500,000 in either our latest fiscal year or in two of our last three fiscal years;
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2.
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Public float of at least 500,000 shares;
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3.
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Market value of our public float of at least $1,000,000;
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4.
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A minimum closing bid price of $1.00 per share of common stock, without falling below this minimum bid price for a period of thirty consecutive trading days;
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5.
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At least two market makers; and
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6.
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At least 300 stockholders, each holding at least 100 shares of common stock.
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●
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delays in product development, clinical testing or manufacturing;
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unplanned expenditures in product development, clinical testing or manufacturing;
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failure in clinical trials or failure to receive regulatory approvals;
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emergence of superior or equivalent products;
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inability to manufacture on our own, or through others, product candidates on a commercial scale;
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inability to market products due to third party proprietary rights; and
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failure to achieve market acceptance.
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obtaining regulatory approval to commence a clinical trial;
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reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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slower than expected rates of patient recruitment due to narrow screening requirements;
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the inability of patients to meet FDA or other regulatory authorities imposed protocol requirements;
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the inability to retain patients who have initiated a clinical trial but may be prone to withdraw due to various clinical or personal reasons, or who are lost to further follow-up;
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the inability to manufacture sufficient quantities of qualified materials under current good manufacturing practices, or cGMPs, for use in clinical trials;
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the need or desire to modify our manufacturing processes;
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the inability to adequately observe patients after treatment;
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changes in regulatory requirements for clinical trials;
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the lack of effectiveness during the clinical trials;
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unforeseen safety issues;
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delays, suspension, or termination of the clinical trials due to the institutional review board responsible for overseeing the study at a particular study site; and
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government or regulatory delays or “clinical holds” requiring suspension or termination of the trials.
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the patient eligibility criteria defined in the protocol;
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the size of the patient population required for analysis of the trial’s primary endpoints;
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the proximity of patients to study sites;
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the design of the trial;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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our ability to obtain and maintain patient consents;
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the risk that patients enrolled in clinical trials will drop out of the trials before completion; and
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competition for patients by clinical trial programs for other treatments.
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difficulty in establishing or managing relationships with clinical research organizations and physicians;
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different standards for the conduct of clinical trials and/or health care reimbursement;
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our inability to locate qualified local consultants, physicians, and partners;
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the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical products and treatment; and
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general geopolitical risks, such as political and economic instability, and changes in diplomatic and trade relations.
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our ability to provide acceptable evidence of safety and efficacy;
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relative convenience and ease of administration;
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the prevalence and severity of any adverse side effects;
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availability of alternative treatments;
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pricing and cost effectiveness;
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effectiveness of our or our collaborators’ sales and marketing strategy; and
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our ability to obtain sufficient third-party insurance coverage or reimbursement.
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production yields;
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quality control and quality assurance;
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shortages of qualified personnel;
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compliance with FDA or other regulatory authorities regulations, including the demonstration of purity and potency;
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changes in FDA or other regulatory authorities requirements;
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production costs; and/or
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development of advanced manufacturing techniques and process controls.
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Reduce, cancel, or otherwise modify our contracts or related subcontract agreements;
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Decline to exercise an option to renew a multi-year contract;
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Claim rights in products and systems produced by us;
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Prohibit future procurement awards with a particular agency as a result of a finding of an organizational conflict of interest based upon prior related work performed for the agency that would give a contractor an unfair advantage over competing contractors;
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Subject the award of contracts to protest by competitors, which may require the contracting federal agency or department to suspend our performance pending the outcome of the protest;
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Suspend or debar us from doing business with the federal government or with a governmental agency; and
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Control or prohibit the export of our products and services.
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the pending patent applications we have filed or to which we have exclusive rights may not result in issued patents or may take longer than we expect to result in issued patents;
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the claims of any patents that issue may not provide meaningful protection;
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·
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we may be unable to develop additional proprietary technologies that are patentable;
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·
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the patents licensed or issued to us may not provide a competitive advantage;
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other parties may challenge patents licensed or issued to us;
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disputes may arise regarding the invention and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by us, our licensors, corporate partners and other scientific collaborators; and
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other parties may design around our patented technologies.
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no stockholder action may be taken without a meeting, without prior notice and without a vote; solicitations by consent are thus prohibited;
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special meetings of stockholders may be called only by our Board of Directors; and
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our Board of Directors has the authority, without further action by the stockholders, to fix the rights and preferences, and issue shares, of preferred stock. An issuance of preferred stock with dividend and liquidation rights senior to the common stock and convertible into a large number of shares of common stock could prevent a potential acquiror from gaining effective economic or voting control.
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·
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the offering price and aggregate number of warrants offered;
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the currency for which the warrants may be purchased;
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if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security;
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if applicable, the date on and after which the warrants and the related securities will be separately transferable;
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·
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in the case of warrants to purchase common stock, the number of shares of common stock purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise;
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the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the terms of any rights to redeem or call the warrants;
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any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the dates on which the right to exercise the warrants will commence and expire;
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the manner in which the warrant agreements and warrants may be modified;
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the anti-dilutive protections given to the holder of such warrant;
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a discussion of any material or special U.S. federal income tax consequences of holding or exercising the warrants;
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the terms of the securities issuable upon exercise of the warrants; and
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any other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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a fixed price or prices, which may be changed;
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market prices prevailing at the time of sale;
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·
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prices related to the prevailing market prices; or
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·
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negotiated prices.
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1.
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our Annual Report on Form 10-K for the fiscal year ended April 30, 2010, as filed with the Commission on July 14, 2010, under Section 13(a) of the Securities Exchange Act of 1934;
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2.
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our Definitive Proxy Statement with respect to the Annual Meeting of Stockholders held on October 21, 2010, as filed with the Commission on August 27, 2010;
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3.
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our Quarterly Report on Form 10-Q for the quarterly periods ended July 31, 2010 and October 31, 2010, as filed with the SEC on September 9, 2010 and December 9, 2010, respectively.
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4.
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our Current Reports on Form 8-K filed on July 14, 2010, September 9, 2010, September 20, 2010, October 22, 2010, December 9, 2010 and December 29, 2010;
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5.
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the description of our common stock contained in our Registration Statement on Form 8-A and Form 8-B (Registration of Successor Issuers) filed under the Securities Exchange Act of 1934, including any amendment or report filed for the purpose of updating such description;
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6.
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the description of our preferred stock purchase rights contained in our Form 8-A filed under the Securities Exchange Act of 1934 on March 17, 2006, including any amendment or report filed for the purpose of updating such descriptions; and
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7.
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all other reports filed by us under Section 13(a) of 15(d) of the Securities Exchange Act of 1934 since the end of our fiscal year ended April 30, 2010.
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You should rely only on the information contained in this document or to which we have referred you. We have not authorized anyone to provide you with information that is different. This document may only be used where it is legal to sell these securities. The information in this document may only be accurate on the date of this document.
|
$75,000,000
Common Stock and Warrants
|
TABLE OF CONTENTS
|
|||
|
|||
ABOUT THIS PROSPECTUS
|
1 | ||
OUR BUSINESS
|
1 | ||
RISK FACTORS
|
4 | ||
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
|
19 |
_______________________
|
|
USE OF PROCEEDS
|
19 | PROSPECTUS | |
DESCRIPTION OF COMMON STOCK
|
19 | _______________________ | |
DESCRIPTION OF WARRANTS
|
20 | ||
PLAN OF DISTRIBUTION
|
22 | ||
LEGAL MATTERS
|
23 | ||
EXPERTS
|
23 | ||
WHERE TO LEARN MORE ABOUT US
|
23 | ||
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
|
24 | ||
DISCLOSURE OF COMMISSION
POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
|
25 | ||
|
Dated: December 29, 2010
|
ABOUT THIS PROSPECTUS
|
A-1
|
OUR BUSINESS
|
A-1
|
RISK FACTORS
|
A-4
|
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
A-18
|
USE OF PROCEEDS
|
A-18
|
DESCRIPTION OF COMMON STOCK
|
A-18
|
PLAN OF DISTRIBUTION
|
A-19
|
LEGAL MATTERS
|
A-20
|
EXPERTS
|
A-20
|
WHERE TO LEARN MORE ABOUT US
|
A-20
|
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
|
A-20
|
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
|
A-21
|
Common stock and/or warrants offered
|
||
by us in this prospectus
|
$75,000,000 aggregate gross sales proceeds
|
|
Common stock outstanding before this offering
|
64,404,097 (1)
|
|
Use of proceeds
|
See “Use of Proceeds”
|
|
Nasdaq Capital Market symbol
|
PPHM
|
(1)
|
The number set forth above does not include approximately 14,255,257 shares of our common stock that, as of December 15, 2010, are reserved for issuance under our stock incentive plans, employee stock purchase plan, and for outstanding warrants, calculated as follows:
|
Number of Shares
of Common Stock Reserved For Issuance
|
||||
Common shares reserved for issuance under outstanding option and restricted stock award grants and available for issuance under our stock incentive plans
|
9,035,290 | |||
Common shares reserved for and available for issuance under our employee stock purchase plan
|
5,000,000 | |||
Common shares issuable upon exercise of outstanding warrants
|
219,967 | |||
Total shares of common stock reserved for issuance
|
14,255,257 |
·
|
incur additional indebtedness, except for certain permitted indebtedness. Permitted indebtedness is defined to include accounts payable incurred in the ordinary course of business and leases of equipment or property incurred in the ordinary course of business not to exceed in the aggregate $500,000 outstanding at any one time;
|
·
|
incur additional liens on any of our assets except for certain permitted liens including but not limited to non-exclusive licenses of our intellectual property in the ordinary course of business and exclusive licenses of intellectual property provided they are approved by our board of directors and do not involve bavituximab or Cotara;
|
·
|
make any payment of subordinated debt, except as permitted under the applicable subordination or intercreditor agreement;
|
·
|
merge with or acquire any other entity, or sell all or substantially all of our assets, except as permitted under the Loan Agreement;
|
·
|
pay dividends (other than stock dividends) to our shareholders;
|
·
|
redeem any outstanding shares of our common stock or any outstanding options or warrants to purchase shares of our common stock except in connection with the repurchase of stock from former employees and consultants pursuant to share repurchase agreements provided such repurchases do not exceed $50,000 in the aggregate during any twelve-month period;
|
·
|
enter into transactions with affiliates other than on arms-length terms; and
|
·
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make any change in any of our business objectives, purposes and operations which has or could be reasonably expected to have a material adverse effect on our business.
|
Net Loss
|
||
Six months ended October 31, 2010 (unaudited)
|
$15,208,000
|
|
Fiscal Year 2010
|
$14,494,000
|
|
Fiscal Year 2009
|
$16,524,000
|
|
Fiscal Year 2008
|
$23,176,000
|
Number of Shares Reserved
|
||||
Common shares reserved for issuance under outstanding option and restricted stock award grants and available for issuance under our stock incentive plans
|
9,035,290 | |||
Common shares reserved for and available for issuance under our employee stock purchase plan
|
5,000,000 | |||
Common shares issuable upon exercise of outstanding warrants
|
219,967 | |||
Total shares of common stock reserved for issuance
|
14,255,257 |
Common Stock
Sales Price
|
Common Stock Daily Trading Volume
(000’s omitted)
|
|||||||||
High
|
Low
|
High
|
Low
|
|||||||
Quarter Ended October 31, 2010
|
$2.08
|
$1.25
|
4,997
|
118
|
||||||
Quarter Ended July 31, 2010
|
$4.14
|
$1.51
|
9,520
|
140
|
||||||
Quarter Ended April 30, 2010
|
$4.30
|
$2.86
|
1,278
|
66
|
||||||
Quarter Ended January 31, 2010
|
$3.46
|
$2.51
|
1,384
|
49
|
||||||
Quarter Ended October 31, 2009
|
$4.74
|
$2.74
|
2,243
|
64
|
||||||
Quarter Ended July 31, 2009
|
$5.65
|
$1.85
|
7,345
|
39
|
||||||
Quarter Ended April 30, 2009
|
$2.60
|
$1.52
|
702
|
14
|
||||||
Quarter Ended January 31, 2009
|
$2.35
|
$1.10
|
260
|
19
|
||||||
Quarter Ended October 31, 2008
|
$2.00
|
$1.15
|
263
|
15
|
||||||
Quarter Ended July 31, 2008
|
$2.65
|
$1.54
|
599
|
21
|
||||||
Quarter Ended April 30, 2008
|
$3.63
|
$1.75
|
769
|
26
|
||||||
Quarter Ended January 31, 2008
|
$3.25
|
$1.75
|
622
|
28
|
||||||
Quarter Ended October 31, 2007
|
$3.95
|
$2.70
|
526
|
34
|
||||||
Quarter Ended July 31, 2007
|
$7.00
|
$3.60
|
4,331
|
47
|
·
|
announcements of technological innovations or new commercial products by us or our competitors;
|
·
|
publicity regarding actual or potential clinical trial results relating to products under development by us or our competitors;
|
·
|
our financial results or that of our competitors, including our abilities to continue as a going concern;
|
·
|
the offering and sale of shares of our common stock at a discount under an equity transaction;
|
·
|
changes in our capital structure;
|
·
|
published reports by securities analysts;
|
·
|
announcements of licensing agreements, joint ventures, strategic alliances, and any other transaction that involves the sale or use of our technologies or competitive technologies;
|
·
|
developments and/or disputes concerning our patent or proprietary rights;
|
·
|
regulatory developments and product safety concerns;
|
·
|
general stock trends in the biotechnology and pharmaceutical industry sectors;
|
·
|
public concerns as to the safety and effectiveness of our products;
|
·
|
economic trends and other external factors, including but not limited to, interest rate fluctuations, economic recession, inflation, foreign market trends, national crisis, and disasters; and
|
·
|
healthcare reimbursement reform and cost-containment measures implemented by government agencies.
|
|
1.
|
Net tangible assets of at least $2,500,000 or market capitalization of at least $35,000,000 or net income of at least $500,000 in either our latest fiscal year or in two of our last three fiscal years;
|
|
2.
|
Public float of at least 500,000 shares;
|
|
3.
|
Market value of our public float of at least $1,000,000;
|
|
4.
|
A minimum closing bid price of $1.00 per share of common stock, without falling below this minimum bid price for a period of thirty consecutive trading days;
|
|
5.
|
At least two market makers; and
|
|
6.
|
At least 300 stockholders, each holding at least 100 shares of common stock.
|
·
|
delays in product development, clinical testing or manufacturing;
|
·
|
unplanned expenditures in product development, clinical testing or manufacturing;
|
·
|
failure in clinical trials or failure to receive regulatory approvals;
|
·
|
emergence of superior or equivalent products;
|
·
|
inability to manufacture on our own, or through others, product candidates on a commercial scale;
|
·
|
inability to market products due to third party proprietary rights; and
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·
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failure to achieve market acceptance.
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·
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obtaining regulatory approval to commence a clinical trial;
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·
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reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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·
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slower than expected rates of patient recruitment due to narrow screening requirements;
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·
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the inability of patients to meet FDA or other regulatory authorities imposed protocol requirements;
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·
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the inability to retain patients who have initiated a clinical trial but may be prone to withdraw due to various clinical or personal reasons, or who are lost to further follow-up;
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·
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the inability to manufacture sufficient quantities of qualified materials under current good manufacturing practices, or cGMPs, for use in clinical trials;
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·
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the need or desire to modify our manufacturing processes;
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·
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the inability to adequately observe patients after treatment;
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·
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changes in regulatory requirements for clinical trials;
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·
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the lack of effectiveness during the clinical trials;
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·
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unforeseen safety issues;
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·
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delays, suspension, or termination of the clinical trials due to the institutional review board responsible for overseeing the study at a particular study site; and
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·
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government or regulatory delays or “clinical holds” requiring suspension or termination of the trials.
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·
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the patient eligibility criteria defined in the protocol;
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·
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the size of the patient population required for analysis of the trial’s primary endpoints;
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·
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the proximity of patients to study sites;
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·
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the design of the trial;
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·
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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·
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our ability to obtain and maintain patient consents;
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·
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the risk that patients enrolled in clinical trials will drop out of the trials before completion; and
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·
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competition for patients by clinical trial programs for other treatments.
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·
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difficulty in establishing or managing relationships with clinical research organizations and physicians;
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·
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different standards for the conduct of clinical trials and/or health care reimbursement;
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·
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our inability to locate qualified local consultants, physicians, and partners;
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·
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the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical products and treatment; and
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·
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general geopolitical risks, such as political and economic instability, and changes in diplomatic and trade relations.
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·
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our ability to provide acceptable evidence of safety and efficacy;
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·
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relative convenience and ease of administration;
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·
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the prevalence and severity of any adverse side effects;
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·
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availability of alternative treatments;
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·
|
pricing and cost effectiveness;
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·
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effectiveness of our or our collaborators’ sales and marketing strategy; and
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·
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our ability to obtain sufficient third-party insurance coverage or reimbursement.
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·
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production yields;
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·
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quality control and quality assurance;
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·
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shortages of qualified personnel;
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·
|
compliance with FDA or other regulatory authorities regulations, including the demonstration of purity and potency;
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·
|
changes in FDA or other regulatory authorities requirements;
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·
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production costs; and/or
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·
|
development of advanced manufacturing techniques and process controls.
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·
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Reduce, cancel, or otherwise modify our contracts or related subcontract agreements;
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·
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Decline to exercise an option to renew a multi-year contract;
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·
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Claim rights in products and systems produced by us;
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·
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Prohibit future procurement awards with a particular agency as a result of a finding of an organizational conflict of interest based upon prior related work performed for the agency that would give a contractor an unfair advantage over competing contractors;
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·
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Subject the award of contracts to protest by competitors, which may require the contracting federal agency or department to suspend our performance pending the outcome of the protest;
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·
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Suspend or debar us from doing business with the federal government or with a governmental agency; and
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·
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Control or prohibit the export of our products and services.
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·
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the pending patent applications we have filed or to which we have exclusive rights may not result in issued patents or may take longer than we expect to result in issued patents;
|
·
|
the claims of any patents that issue may not provide meaningful protection;
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·
|
we may be unable to develop additional proprietary technologies that are patentable;
|
·
|
the patents licensed or issued to us may not provide a competitive advantage;
|
·
|
other parties may challenge patents licensed or issued to us;
|
·
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disputes may arise regarding the invention and corresponding ownership rights in inventions and know-how resulting from the joint creation or use of intellectual property by us, our licensors, corporate partners and other scientific collaborators; and
|
·
|
other parties may design around our patented technologies.
|
·
|
no stockholder action may be taken without a meeting, without prior notice and without a vote; solicitations by consent are thus prohibited;
|
·
|
special meetings of stockholders may be called only by our Board of Directors; and
|
·
|
our Board of Directors has the authority, without further action by the stockholders, to fix the rights and preferences, and issue shares, of preferred stock. An issuance of preferred stock with dividend and liquidation rights senior to the common stock and convertible into a large number of shares of common stock could prevent a potential acquiror from gaining effective economic or voting control.
|
|
1.
|
our Annual Report on Form 10-K for the fiscal year ended April 30, 2010, as filed with the Commission on July 14, 2010, under Section 13(a) of the Securities Exchange Act of 1934;
|
|
2.
|
our Definitive Proxy Statement with respect to the Annual Meeting of Stockholders held on October 21, 2010, as filed with the Commission on August 27, 2010;
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|
3.
|
our Quarterly Report on Form 10-Q for the quarterly periods ended July 31, 2010 and October 31, 2010, as filed with the SEC on September 9, 2010 and December 9, 2010, respectively.
|
|
4.
|
our Current Reports on Form 8-K filed on July 14, 2010, September 9, 2010, September 20, 2010, October 22, 2010, December 9, 2010, and December 29, 2010;
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|
5.
|
the description of our common stock contained in our Registration Statement on Form 8-A and Form 8-B (Registration of Successor Issuers) filed under the Securities Exchange Act of 1934, including any amendment or report filed for the purpose of updating such description;
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|
6.
|
the description of our preferred stock purchase rights contained in our Form 8-A filed under the Securities Exchange Act of 1934 on March 17, 2006, including any amendment or report filed for the purpose of updating such descriptions; and
|
|
7.
|
all other reports filed by us under Section 13(a) of 15(d) of the Securities Exchange Act of 1934 since the end of our fiscal year ended April 30, 2010.
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You should rely only on the information contained in this document or to which we have referred you. We have not authorized anyone to provide you with information that is different. This document may only be used where it is legal to sell these securities. The information in this document may only be accurate on the date of this document.
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Common Stock
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TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
|
A-1 | ||
OUR BUSINESS
|
A-1 | ||
RISK FACTORS
|
A-4 | ||
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
|
A-18 |
_______________________
|
|
USE OF PROCEEDS
|
A-18 | PROSPECTUS | |
DESCRIPTION OF COMMON STOCK
|
A-18 | _______________________ | |
PLAN OF DISTRIBUTION
|
A-19 | ||
LEGAL MATTERS
|
A-20 | ||
EXPERTS
|
A-20 | ||
WHERE TO LEARN MORE ABOUT US
|
A-20 | ||
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE
|
A-20 | ||
DISCLOSURE OF COMMISSION
POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
|
A-21 | ||
|
Dated: December 29, 2010
|
SEC registration fee
|
$ | 5,348 | ||
Printing and engraving expenses
|
2,500 | * | ||
Legal fees and expenses
|
12,500 | * | ||
Accounting fees and expenses
|
10,000 | * | ||
Miscellaneous
|
3,000 | * | ||
Total
|
$ | 33,348 |
PEREGRINE PHARMACEUTICALS, INC.
|
||
By:
|
/s/ Steven W. King | |
Steven W. King, | ||
President and Chief Executive Officer,
Director
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||
EXHIBIT
NUMBER
|
DESCRIPTION
|
3.1
|
Certificate of Incorporation of Techniclone Corporation, a Delaware corporation (Incorporated by reference to Exhibit B to the Company’s 1996 Proxy Statement as filed with the Commission on or about August 20, 1996).
|
3.2
|
Amended and Restated Bylaws of Peregrine Pharmaceuticals, Inc. (formerly Techniclone Corporation), a Delaware corporation (Incorporated by reference to Exhibit 3.1 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended October 31, 2003).
|
3.3
|
Certificate of Designation of 5% Adjustable Convertible Class C Preferred Stock as filed with the Delaware Secretary of State on April 23, 1997. (Incorporated by reference to Exhibit 3.1 contained in Registrant’s Current Report on Form 8-K as filed with the Commission on or about May 12, 1997).
|
3.4
|
Certificate of Amendment to Certificate of Incorporation of Techniclone Corporation to effect the name change to Peregrine Pharmaceuticals, Inc., a Delaware corporation. (Incorporated by reference to Exhibit 3.4 contained in Registrant’s Annual Report on Form 10-K for the year ended April 30, 2001).
|
3.5
|
Certificate of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals, Inc. to increase the number of authorized shares of the Company’s common stock to two hundred million shares (Incorporated by reference to Exhibit 3.5 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended October 31, 2003).
|
3.6
|
Certificate of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals, Inc. to increase the number of authorized shares of the Company’s common stock to two hundred fifty million shares (Incorporated by reference to Exhibit 3.6 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended October 31, 2005).
|
3.7
|
Certificate of Designation of Rights, Preferences and Privileges of Series D Participating Preferred Stock of the Registrant, as filed with the Secretary of State of the State of Delaware on March 16, 2006. (Incorporated by reference to Exhibit 3.7 to Registrant’s Current Report on Form 8-K as filed with the Commission on March 17, 2006).
|
3.8
|
Certificate of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals, Inc. to increase the number of authorized shares of the Company’s common stock to three hundred twenty five million shares (Incorporated by reference to Exhibit 3.8 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended October 31, 2007).
|
3.9
|
Amended and Restated Bylaws of Peregrine Pharmaceuticals, Inc., a Delaware corporation (Incorporated by reference to Exhibit 3.9 to Registrant’s Current Report on Form 8-K as filed with the Commission on December 21, 2007).
|
3.10
|
Certificate of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals, in order to effect a 1-for-5 reverse stock split of the Company common stock effective as of the close of business on October 16, 2009 (Incorporated by reference to Exhibit 3.10 to Registrant’s Current Report on Form 8-K as filed with the Commission on October 19, 2009).
|
4.0
|
Form of Certificate for Common Stock (Incorporated by reference to the exhibit of the same number contained in Registrant’s Annual Report on Form 10-K for the year end April 30, 1988).
|
4.1
|
Form of Non-qualified Stock Option Agreement by and between Registrant, Director and certain consultants dated December 22, 1999 (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement on Form S-3 (File No. 333-40716)).*
|
4.2
|
Peregrine Pharmaceuticals, Inc. 2002 Non-Qualified Stock Option Plan (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement in Form S-8 (File No. 333-106385)).*
|
EXHIBIT
NUMBER
|
DESCRIPTION
|
4.3
|
Form of 2002 Non-Qualified Stock Option Agreement (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement in Form S-8 (File No. 333-106385)).*
|
4.4
|
Preferred Stock Rights Agreement, dated as of March 16, 2006, between the Company and Integrity Stock Transfer, Inc., including the Certificate of Designation, the form of Rights Certificate and the Summary of Rights attached thereto as Exhibits A, B and C, respectively (Incorporated by reference to Exhibit 4.19 to Registrant’s Current Report on Form 8-K as filed with the Commission on March 17, 2006).
|
4.5
|
1996 Stock Incentive Plan (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement in form S-8 (File No. 333-17513)).*
|
4.6
|
Stock Exchange Agreement dated as of January 15, 1997 among the stockholders of Peregrine Pharmaceuticals, Inc. and Registrant (Incorporated by reference to Exhibit 2.1 to Registrant’s Quarterly Report on Form 10-Q for the quarter ended January 31, 1997).
|
4.7
|
First Amendment to Stock Exchange Agreement among the Stockholders of Peregrine Pharmaceuticals, Inc. and Registrant (Incorporated by reference to Exhibit 2.1 contained in Registrant’s Current Report on Form 8-K as filed with the Commission on or about May 12, 1997).
|
4.8
|
2003 Stock Incentive Plan Non-qualified Stock Option Agreement (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement in form S-8 (File No. 333-121334).*
|
4.9
|
2003 Stock Incentive Plan Incentive Stock Option Agreement (Incorporated by reference to the exhibit contained in Registrant’s Registration Statement in form S-8 (File No. 333-121334)).*
|
4.10
|
Form of Incentive Stock Option Agreement for 2005 Stock Incentive Plan (Incorporated by reference to Exhibit 10.98 to Registrant’s Current Report on Form 8-K as filed with the Commission on October 28, 2005).*
|
4.11
|
Form of Non-Qualified Stock Option Agreement for 2005 Stock Incentive Plan (Incorporated by reference to Exhibit 10.99 to Registrant’s Current Report on Form 8-K as filed with the Commission on October 28, 2005).*
|
4.12
|
Peregrine Pharmaceuticals, Inc. 2005 Stock Incentive Plan (Incorporated by reference to Exhibit B to Registrant’s Definitive Proxy Statement filed with the Commission on August 29, 2005).*
|
4.13
|
Form of Incentive Stock Option Agreement for 2009 Stock Incentive Plan (Incorporated by reference to Exhibit 4.14 to Registrant’s Current Report on Form 8-K as filed with the Commission on October 27, 2009).*
|
4.14
|
Form of Non-Qualified Stock Option Agreement for 2009 Stock Incentive Plan (Incorporated by reference to Exhibit 4.15 to Registrant’s Current Report on Form 8-K as filed with the Commission on October 27, 2009).*
|
4.15
|
Form of Restricted Stock Issuance Agreement dated February 1, 2010. (*)(**)
|
4.16
|
2010 Stock Incentive Plan (Incorporated by reference to Exhibit A to Registrant’s Definitive Proxy Statement filed with the Commission on August 27, 2010). *
|
4.17
|
Form of Stock Option Award Agreement under 2010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.17 to Registrant’s Registration Statement in Form S-8 (File No. 333-171067)). *
|
EXHIBIT
NUMBER
|
DESCRIPTION
|
4.18
|
2010 Employee Stock Purchase Plan (Incorporated by reference to Exhibit B to Registrant’s Definitive Proxy Statement filed with the Commission on August 27, 2010). *
|
5.1
|
Opinion of Snell & Wilmer L.L.P. ***
|
10.1
|
Placement Agent Agreement dated June 27, 2007, between Registrant and Rodman & Renshaw, LLC (Incorporated by reference to Exhibit 1.1 to Registrant’s Current Report on Form 8-K as filed with the Commission on June 28, 2007).
|
10.2
|
Form of Securities Purchase Agreement dated June 28, 2007 (Incorporated by reference to Exhibit 4.1 to Registrant’s Current Report on Form 8-K as filed with the Commission on June 28, 2007).
|
10.3
|
Government contract by and between Peregrine Pharmaceuticals, Inc. and the Defense Threat Reduction Agency dated June 30, 2008 (Incorporated by reference to Exhibit 10.110 to Registrant’s Current Report on Form 10-Q as filed with the Commission on September 9, 2008).
|
10.4
|
Loan and Security Agreement dated December 9, 2008 between Registrant and BlueCrest Capital Finance, L.P. (Incorporated by reference to Exhibit 10.111 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009). **
|
10.5
|
Secured Term Promissory Note dated December 19, 2008 between Registrant and BlueCrest Capital Finance, L.P. (Incorporated by reference to Exhibit 10.112 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.6
|
Secured Term Promissory Note dated December 19, 2008 between Registrant and MidCap Funding I, LLC. (Incorporated by reference to Exhibit 10.113 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.7
|
Intellectual Property Security Agreement dated December 19, 2008 between Avid Bioservices, Inc. and MidCap Funding I, LLC. (Incorporated by reference to Exhibit 10.114 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.8
|
Intellectual Property Security Agreement dated December 19, 2008 between Registrant and MidCap Funding I, LLC. (Incorporated by reference to Exhibit 10.115 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.9
|
Warrant to purchase 507,614 shares of Common Stock of Registrant issued to BlueCrest Capital Finance, L.P. dated December 9, 2008. (Incorporated by reference to Exhibit 10.116 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.10
|
Warrant to purchase 1,184,433 shares of Common Stock of Registrant issued to MidCap Funding I, LLC dated December 9, 2008. (Incorporated by reference to Exhibit 10.117 to Registrant’s Current Report on Form 10-Q as filed with the Commission on March 12, 2009).
|
10.11
|
At Market Issuance Sales Agreement, dated March 26, 2009, by and between Peregrine Pharmaceuticals, Inc. and Wm. Smith & Co. (Incorporated by reference to Exhibit 10.118 to Registrant’s Current Report on Form 8-K as filed with the Commission on March 27, 2009).
|
10.12
|
Employment Agreement by and between Peregrine Pharmaceuticals, Inc. and Steven W. King, dated March 18, 2009. *
|
10.13
|
Employment Agreement by and between Peregrine Pharmaceuticals, Inc. and Paul J. Lytle, dated March 18, 2009. *
|
10.14
|
Employment Agreement by and between Peregrine Pharmaceuticals, Inc. and Joseph S. Shan, dated March 18, 2009. *
|
EXHIBIT
NUMBER
|
DESCRIPTION
|
10.15
|
Employment Agreement by and between Peregrine Pharmaceuticals, Inc. and Shelley P.M. Fussey, Ph.D., dated March 18, 2009. *
|
10.16
|
At Market Issuance Sales Agreement, dated July 14, 2009, by and between Peregrine Pharmaceuticals, Inc., and Wm. Smith & Co. (Incorporated by reference to Exhibit 10.16 to Registrant’s Current Report on Form 8-K as filed with the Commission on July 14, 2009).
|
10.17
|
Exclusive Patent License Agreement between The University of Texas System and Peregrine Pharmaceuticals, Inc., effective as of August 18, 2005 (Incorporated by reference to Exhibit 10.17 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.18
|
Amendment No. 1 to Exclusive Patent License Agreement between The University of Texas System and Peregrine Pharmaceuticals, Inc., dated June 1, 2009 (Incorporated by reference to Exhibit 10.18 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.19
|
Exclusive Patent License Agreement between The University of Texas System and Peregrine Pharmaceuticals, Inc., effective as of August 1, 2001 (Incorporated by reference to Exhibit 10.19 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.20
|
Amendment No. 1 to Exclusive Patent License agreement between The University of Texas System and Peregrine Pharmaceuticals, Inc., dated June 1, 2009 (Incorporated by reference to Exhibit 10.20 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.21
|
Non-Exclusive Cabilly Patent License Agreement between Genentech, Inc., and Peregrine Pharmaceuticals, Inc., effective as of November 5, 2003 (Incorporated by reference to Exhibit 10.21 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.22
|
Commercial License Agreement between Avanir Pharmaceuticals, Inc., and Peregrine Pharmaceuticals, Inc., dated December 1, 2003 (Incorporated by reference to Exhibit 10.22 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.23
|
License Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc., dated July 1, 1998 (Incorporated by reference to Exhibit 10.23 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.24
|
License Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc., dated March 1, 2005 (Incorporated by reference to Exhibit 10.24 to Registrant’s Current Report on Form 8-K as filed with the Commission on April 14, 2010). **
|
10.25
|
At Market Issuance Sales Agreement, dated June 22, 2010, by and between Peregrine Pharmaceuticals, Inc., and McNicoll, Lewis & Vlak LLC (Incorporated by reference to Exhibit 10.25 to Registrant’s Current Report on Form 8-K as filed with the Commission on June 22, 2010).
|
10.26
|
License Agreement between Stason Pharmaceuticals, Inc. and Peregrine Pharmaceuticals, Inc., dated May 3, 2010 (Incorporated by reference to Exhibit 10.26 to Registrant’s Current Report on Form 10-Q as filed with the Commission on September 9, 2010). **
|
10.27
|
Assignment Agreement between Stason Pharmaceuticals, Inc. and Peregrine Pharmaceuticals, Inc., dated May 3, 2010 (Incorporated by reference to Exhibit 10.27 to Registrant’s Current Report on Form 10-Q as filed with the Commission on September 9, 2010). **
|
10.28 | At Market Issuance Sales Agreement, dated December 29, 2010, by and between Peregrine Pharmaceuticals, Inc., and McNicoll, Lewis & Vlak LLC (Incorporated by reference to Exhibit 10.28 to Registrant's Current Report on Form 8-K as filed with the Commission on December 29, 2010). |
23.1 | Consent of Independent Registered Public Accounting Firm. *** |
23.2 | Consent of Snell & Wilmer L.L.P. (included in Exhibit 5.1). *** |
24.1 | Powers of Attorney (included in signature page). *** |
*
**
***
|
This Exhibit is a management contract or a compensation plan or arrangement.
Portions omitted pursuant to a request of confidentiality filed separately with the Commission.
Previously filed.
|