peregrine_s3-071409.htm
As
filed with the Securities and Exchange Commission on July 14, 2009
Registration
No. 333- ___________
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
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95-3698422
(I.R.S.
Employer
Identification
No.)
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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)
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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)
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with
copies to:
Mark
R. Ziebell, Esq.
Snell
& Wilmer LLP
600
Anton Boulevard
Suite
1400
Costa
Mesa, California 92626
Approximate
date of commencement of proposed sale to the public:
From
time to time after the effective date of this Registration
Statement.
If
the only securities being registered on this form are being offered pursuant to
dividend or interest reinvestment plans, please check the following
box. ¨
If
any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. ý
If
this form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, please check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. ¨
If
this form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. o
If this
form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. o
If this
form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large accelerated
filer o |
Accelerated
filer þ |
Non-accelerated
filer (do not check if a smaller reporting company) o |
Smaller reporting
company o |
CALCULATION
OF REGISTRATION FEE
Title
of Each Class of Securities to be Registered
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Amount
to be Registered
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Proposed
Maximum
Offering
Price per Unit
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Proposed
Maximum
Aggregate
Offering Price
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Amount
of Registration Fee
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Common
Stock, $0.001 par value per share
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Warrants
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Total
for sale by registrant
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(1)
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(2)
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$50,000,000
(3)
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$
2,790 (4)
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Secondary
Offering: Common Stock, $0.001 par value per share
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Total
for sale by selling security holders
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1,873,711
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$0.755 (5)
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$
1,414,652 (5)
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$ 79
(6)
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(1)
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There
are being registered hereunder for sale by the registrant such
indeterminate number of shares of common stock and such indeterminate
number of warrants as shall have an aggregate initial offering price not
to exceed $50,000,000. The securities registered also include
such indeterminate number of shares of common stock as may be issued upon
exercise of warrants or pursuant to the anti-dilution provisions of any
such securities. An aggregate of 1,873,711 shares of common stock are
being registered hereunder for sale by the selling security
holders.
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(2)
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The
proposed maximum offering price with respect to shares for sale by the
registrant will be determined from time to time by the registrant in
connection with the issuance by the registrant of the securities
registered hereunder.
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(3)
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Estimated
solely for the purpose of determining the registration fee. The aggregate
public offering price of all securities for sale by the registrant
registered hereby will not exceed $50,000,000.
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(4)
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Calculated
pursuant to Rule 457(o) based on an estimate of the proposed maximum
aggregate offering price.
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(5)
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Estimated
solely for the purpose of computing the registration fee pursuant to Rule
457(c) under the Securities Act of 1933, as amended, based on the average
of the high ($0.77) and low ($0.74) prices of our common stock as reported
on The Nasdaq Capital Market on July 10, 2009.
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(6)
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Calculated
pursuant to Rule 457(c) under the Securities
Act.
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The
registrant hereby amends this registration statement on such date or dates as
may be necessary to delay its effective date until the registrant shall
file a further amendment which specifically states that this registration
statement shall thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the registration statement shall become
effective on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
EXPLANATORY
NOTE
This
registration statement contains two prospectuses:
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●
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a
basic prospectus which covers both (i) the offering, issuance and
sale of $50,000,000 of common stock and warrants of Peregrine
Pharmaceuticals, Inc. by the registrant and (ii) sales of common
stock by certain selling security holders; and
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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 Wm Smith &
Co.
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The basic
prospectus immediately follows this explanatory note. The sales agreement
prospectus immediately follows the basic prospectus. The common stock that
may be offered, issued and sold under the sales agreement prospectus is included
in the $50,000,000 of securities that may be offered, issued and sold by the
registrant under the basic prospectus.
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and is not soliciting offers to buy these securities in any
state where such offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED JULY 14, 2009
PROSPECTUS
$50,000,000
Common
Stock and Warrants
1,873,711
Shares
of Common Stock
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission using a “shelf” registration process. We may offer and
sell our common stock and warrants described in this prospectus in one or
more offerings from time to time and at prices and on terms to be determined at
or prior to the time of the applicable offering. The aggregate initial offering
price of all securities sold under this prospectus by us will not exceed
$50,000,000. We may offer and sell these securities to or through one or more
underwriters, dealers, and agents, or directly to purchasers, on a continuous or
delayed basis. If any agents or underwriters are involved in the sale of any of
these securities, the applicable prospectus supplement will provide the names of
the agents or underwriters and any applicable fees, commissions or
discounts.
This
prospectus describes the general terms of these securities. The specific terms
of the securities and the specific manner in which we will offer and sell them
will be contained in a prospectus supplement. The prospectus supplement may also
add, update, or change information contained in this prospectus.
In
addition, certain selling security holders may sell up to 1,873,711 shares of
our common stock from time to time under this prospectus.
We
encourage you to carefully review and consider this prospectus and any
prospectus supplement before investing in our securities. We also encourage you
to read the documents to which we have referred you in the “Where You Can Find
More Information” section of this prospectus for information on us and for our
financial statements. This prospectus may not be used to consummate sales of our
securities by us unless accompanied by a prospectus supplement. However, the
selling security holders may use this prospectus to sell shares of our common
stock, from time to time, without a prospectus supplement.
Our
common stock is registered under Section 12(b) of the Securities Exchange Act of
1934 and is listed on The Nasdaq Capital Market under the symbol
“PPHM”. On July 10, 2009, the last reported sale price of our common
stock on The Nasdaq Capital Market was $0.76 per share. You are urged to obtain
current market quotations for our common stock.
__________________________________
Investing
in our securities involves risks. Please carefully review the information under
the heading “Risk Factors” on page 5. In addition, risks associated with any
investment in our securities will be described in the applicable prospectus
supplement and certain of our filings with the Securities and Exchange
Commission, as described in “Risk Factors” on page 5.
_________________________________
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is July __, 2009
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
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1
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OUR
BUSINESS
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1
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RISK
FACTORS
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5
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CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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20
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USE
OF PROCEEDS
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20
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DESCRIPTION
OF COMMON STOCK
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21
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DESCRIPTION
OF WARRANTS
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21
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PLAN
OF DISTRIBUTION
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23
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SELLING
SECURITY HOLDERS
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24
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LEGAL
MATTERS
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25
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EXPERTS
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26
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WHERE
TO LEARN MORE ABOUT US
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26
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INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
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27
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DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
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28
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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. However,
in the event of a material change, this prospectus will be amended or
supplemented accordingly.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with
the SEC utilizing a “shelf” registration process. Under this shelf
registration process, we may from time to time offer and sell any combination of
the securities described in this prospectus in one or more offerings for total
gross proceeds of up to $50,000,000. This prospectus provides you
with a general description of the securities we may offer
hereunder. Each time we sell securities hereunder, we will provide a
prospectus supplement that will contain specific information about the terms of
that offering. The prospectus supplement may also add, update or change
information contained in this prospectus. You should read both this prospectus
and any prospectus supplement together with additional information described
below under the heading “Where You Can Find More Information.”
In addition, this prospectus may be
used by the selling security holders to sell up to 1,873,711 shares of our
common stock as described under the heading “Selling Security
Holders.”
We have not authorized any dealer,
salesman or other person to give any information or to make any representation
other than those contained or incorporated by reference in this prospectus and
any related supplement to this prospectus. You must not rely upon any
information or representation not contained or incorporated by reference in this
prospectus or any related prospectus supplement. This prospectus and any related
supplement to this prospectus do not constitute an offer to sell or the
solicitation of an offer to buy any securities other than the registered
securities to which they relate, nor do this prospectus or any related
supplement to this prospectus constitute an offer to sell or the solicitation of
an offer to buy securities in any jurisdiction to any person to whom it is
unlawful to make such offer or solicitation in such jurisdiction. You should not
assume that the information contained in this prospectus and any related
prospectus supplement is accurate on any date subsequent to the date set forth
on the front of the document or that any information we have incorporated by
reference is correct on any date subsequent to the date of the document
incorporated by reference, even though this prospectus and any related
prospectus supplement is delivered or securities are sold on a later
date.
As used
in this prospectus, the terms “we”, “us”, “our”, “Company” and “Peregrine” refer
to Peregrine Pharmaceuticals, Inc., and its wholly-owned subsidiary, Avid
Bioservices, Inc.
OUR
BUSINESS
This
is only a summary and does not contain all of the information that you should
consider before investing in our Common Stock. You should read the entire
prospectus carefully, including the “Risk Factors” section as well as the
information incorporated by reference into this prospectus under “Where You Can
Find More Information.”
Overview
We are a
clinical stage biopharmaceutical company that manufactures and develops
monoclonal antibodies for the treatment of cancer and serious viral
infections. We are advancing three separate clinical programs with
our novel compounds bavituximab and Cotara® that are the first clinical
candidates under our Anti-Phosphatidylserine (“Anti-PS”) therapeutics and Tumor
Necrosis Therapy (“TNT”) platforms.
In
addition to our clinical programs, we are performing pre-clinical research on
bavituximab and an equivalent fully human antibody as a potential broad-spectrum
treatment for viral hemorrhagic fever infections under a contract awarded
through the Transformational Medical Technologies Initiative (“TMTI”) of the
U.S. Department of Defense's Defense Threat Reduction Agency
(“DTRA”). This federal contract is expected to provide us with up to
$22.3 million in funding over an initial 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year ending
September 30, 2009.
In
addition to our research and development efforts, we operate a wholly owned cGMP
(current Good Manufacturing Practices) contract manufacturing subsidiary, Avid
Bioservices, Inc. (“Avid”). Avid provides contract manufacturing
services for biotechnology and biopharmaceutical companies on a fee-for-service
basis, from pre-clinical drug supplies up through commercial-scale drug
manufacture. In addition to these activities, Avid provides critical
services in support of Peregrine’s product pipeline including manufacture and
scale-up of pre-clinical and clinical drug supplies.
Products
in Clinical Stage Development
Our
products in clinical trials are focused on the treatment of cancer and HCV
infection. The below table is a summary of our clinical trials
and the current status of each clinical trial. Additional information pertaining
to each clinical trial is further discussed below.
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Product
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Indication
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Trial
Design
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Trial
Status
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Bavituximab
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Solid
tumor cancers
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Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
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In
June 2009, we completed planned patient enrollment in this
study. Patient treatments and follow-up are
continuing. Initial top-line data is expected to be available
in calendar year 2009
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Bavituximab
plus docetaxel
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Advanced
breast cancer
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Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
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The
trial was fully enrolled in May 2009. Patient treatment and
follow-up are continuing. Initial top-line data is expected to
be available in calendar year 2009.
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Bavituximab
plus carboplatin and paclitaxel
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Advanced
breast cancer
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Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
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Patient
enrollment was initiated in April 2009 in the final 31-patient second
stage of the trial. The study is actively enrolling
patients.
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Bavituximab
plus carboplatin and paclitaxel
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Non-small
cell lung cancer (“NSCLC”)
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Phase
II study designed to treat up to 21 patients initially. Study was expanded
to treat up to a total of 49 patients based on early promising results
observed in the initial 21 patients.
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Patient
enrollment was initiated in April 2009 in the final 28-patient second
stage of the trial. The study is actively enrolling
patients.
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Cotara
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Glioblastoma
multiforme (“GBM”)
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Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
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This
trial is nearing completion of planned patient enrollment.
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Cotara
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Glioblastoma
multiforme (“GBM”)
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Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
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This
study is actively enrolling patients and enrollment is over halfway
completed
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Bavituximab
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Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
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Phase
Ib repeat dose safety study designed to treat up to 24
patients.
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This
study is actively enrolling patients.
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For a more detailed discussion of our
proprietary platforms, please refer to our Form 10-K for the fiscal year ended
April 30, 2009, filed with the SEC on July 14, 2009.
Company
Information
We are a
Delaware corporation. Our principal offices are located at 14282
Franklin Avenue, Tustin, California 92780. The telephone number of
our principal offices is 714-508-6000. Our internet addresses are
www.peregrineinc.com and www.avidbio.com. The information contained
on our websites is not incorporated by reference and should not be considered a
part of this prospectus. Our website address is included in this
prospectus as an inactive textual reference only.
About
the Offering
Common
stock and/or warrants offered by us in this
prospectus
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$50,000,000
aggregate gross sales proceeds
|
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Common
stock offered by the selling security
holders |
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1,873,711
shares |
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Common stock
outstanding before this
offering |
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236,964,414 shares
(1) |
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Use of
proceeds |
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See “Use of
Proceeds” |
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Nasdaq Capital
Market symbol |
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PPHM |
(1) The
number set forth above does not include approximately 16,806,892 shares of our
common stock that, as of July 10, 2009, are reserved for issuance under our
outstanding stock option plans and warrant agreements, calculated as
follows:
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Number
of Shares
of
Common Stock Reserved For Issuance
|
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Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
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15,114,845 |
|
Common
shares issuable upon exercise of outstanding warrants
|
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1,692,047 |
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Total
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16,806,892 |
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RISK
FACTORS
You should consider carefully the risk
factors described below, and all other information contained in or incorporated
by reference in this prospectus, before deciding to invest in our Common Stock
and/or Warrants. If any of the following risks actually occur, they
may materially harm our business, financial condition, operating results or cash
flow. As a result, the market price of our Common Stock could
decline, and you could lose all or part of your investment. Additional risks and
uncertainties that are not yet identified or that we think are immaterial may
also materially harm our business, operating results or financial condition and
could result in a complete loss of your investment.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be Able
To Continue Operations.
At April
30, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2009, 2008, and 2007 amounted
to $16,524,000, $23,176,000, and $20,796,000, respectively. Unless
and until we are able to generate sufficient revenues from Avid’s contract
manufacturing services and/or from the sale and/or licensing of our products
under development, we expect such losses to continue for the foreseeable
future.
Therefore, our ability to continue our
clinical trials and development efforts and to continue as a going concern is
highly dependent on the amount of cash and cash equivalents on hand combined
with our ability to raise additional capital to support our future
operations. As discussed in Note 1 to the consolidated financial
statements on Form
10-K for the fiscal year ended April 30, 2009, there exists substantial
doubt regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With
respect to financing our operations through the issuance of equity, on
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our shelf registration statement on Form S-3, File Number 333-139975, for
aggregate gross proceeds of up to $7,500,000. Shares of common stock
sold under this arrangement were to be sold at market prices. As of
April 30, 2009, we had sold 1,477,938 shares of common stock under the AMI
Agreement for aggregate net proceeds of $550,000. Subsequent to April
30, 2009, we raised net proceeds of $6,685,000 after deducting commissions of 3%
paid to Wm Smith & Co. under the AMI Agreement in exchange for 9,275,859
shares of common stock.
With respect to financing our
operations through the issuance of debt, on December 9, 2008, we entered into a
loan and security agreement pursuant to which we had the ability to borrow up to
$10,000,000 (“Loan Agreement”). On December 19, 2008, we received
initial funding of $5,000,000, in which principal and interest are payable over
a thirty (30) month period commencing after the initial six month interest only
period. The amount payable under the Loan Agreement is secured by
generally all assets of the Company as further explained in Note 5 to the
consolidated financial statements. Under the Loan Agreement, we had
an option, which expired June 30, 2009, to borrow a second tranche in the amount
of $5,000,000 upon the satisfaction of certain clinical and financial conditions
as set forth in the Loan Agreement. Although we had satisfied the
required clinical and financial conditions by June 30, 2009, we determined that
exercising the option to borrow the second tranche, and issuing the additional
warrants to the Lenders, was not in the best interests of the Company or our
stockholders.
In
addition to the above, we may also raise additional capital through additional
equity offerings or licensing our products or technology platforms or entering
into similar collaborative arrangements. In order to raise capital
through the issuance of equity, we have filed a new shelf registration statement
on Form S-3 to register up to $50 million gross in proceeds from the sale of our
common stock. Although we are not required to issue any shares of
common stock under this registration statement, we plan to register the
underlying shares of common stock as a potential method of raising additional
capital to support our drug development efforts.
While we
will continue to consider and explore these potential opportunities, there can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all, or that sufficient additional revenues will
be generated from Avid or under potential licensing or partnering agreements to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections and assumptions, which
include projected revenues under signed contracts with existing customers of
Avid, combined with the projected revenues from our government contract, we
believe we have sufficient cash on hand combined with amounts expected to be
received from Avid customers and from our government contract to meet our
obligations as they become due through at least fiscal year
2010. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of third party
or government contracts, technical challenges, or possible reductions in funding
under our government contract, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the event our
contract with the Defense Threat Reduction Agency is terminated or canceled for
any reason, including reasons pertaining to budget cuts by the government or
reduction in government funding for the program, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessible by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
Our Outstanding
Indebtedness To MidCap Financial LLC and BlueCrest Capital Finance, L.P. Imposes
Certain Restrictions On How We Conduct Our Business. In Addition, All
Of Our Assets, Including Our Intellectual Property, Are Pledged To Secure This
Indebtedness. If We Fail To Meet Our Obligations To The Lenders, Our
Payment Obligations May Be Accelerated And The Collateral Securing The Debt May
Be Sold To Satisfy These Obligations.
Pursuant
to a Loan and Security Agreement dated December 9, 2008 (the “Loan
Agreement”), MidCap Financial LLC and BlueCrest Capital Finance, L.P. (the
“Lenders”) have provided us a three-year, $5,000,000 working capital loan, which
funded on December 19, 2008. As collateral to secure our repayment
obligations to the Lenders, we and our wholly-owned subsidiary, Avid
Bioservices, Inc., have granted the Lenders a first priority security interest
in generally all of our respective assets, including our intellectual
property.
The
Loan Agreement also contains various covenants that restrict our operating
flexibility. Pursuant to the Loan Agreement, we may not, among other
things:
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●
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incur
additional indebtedness, except for certain permitted indebtedness.
Permitted indebtedness is defined to include accounts payable incurred in
the ordinary course of business, leases of equipment or property incurred
in the ordinary course of business not to exceed in the aggregate $100,000
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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●
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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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enter
into transactions with affiliates other than on arms-length terms;
and
|
|
●
|
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.
|
These
provisions could have important consequences for us, including (i) making
it more difficult for us to obtain additional debt financing from another
lender, or obtain new debt financing on terms favorable to us, because a new
lender will have to be willing to be subordinate to the lenders,
(ii) causing us to use a portion of our available cash for debt repayment
and service rather than other perceived needs and/or (iii) impacting our
ability to take advantage of significant, perceived business
opportunities. Our failure to timely repay our obligations under the
Loan Agreement or meet the covenants set forth in the Loan Agreement could give
rise to a default under the agreement. In the event of an uncured
default, the Loan Agreement provides that all amounts owed to the Lender may be
declared immediately due and payable and the Lenders have the right to enforce
their security interest in the assets securing the Loan Agreement. In
such event, the Lenders could take possession of any or all of our assets in
which they hold a security interest, and dispose of those assets to the extent
necessary to pay off our debts, which would materially harm our
business.
In
The Event Our Contract With The DTRA Is Terminated, Our Loan Requires Us To
Place A Significant Amount Of Our Cash In A Restricted Bank
Account.
Under the terms of the Loan Agreement,
if our contract with the Defense Threat Reduction Agency is terminated while any
principal balance of the loan is outstanding, we will be required to at all
times thereafter maintain cash and cash equivalents in an amount of at least
eighty percent (80%) of the then outstanding principal balance of the loan in a
restricted account over which we will not be permitted to make withdrawals or
otherwise exercise control.
We
Have Had Significant Losses And We Anticipate Future Losses.
We have incurred net losses in most
fiscal years since we began operations in 1981. The following table
represents net losses incurred for each of the past three fiscal
years:
|
|
Net
Loss
|
Fiscal
Year 2009
|
|
$16,524,000
|
Fiscal
Year 2008
|
|
$23,176,000
|
Fiscal
Year 2007
|
|
$20,796,000
|
As of
April 30, 2009, we had an accumulated deficit of $247,360,000. While
we expect to continue to generate revenues from Avid’s contract manufacturing
services, in order to achieve and sustain profitable operations, we must
successfully develop and obtain regulatory approval for our products, either
alone or with others, and must also manufacture, introduce, market and sell our
products. The costs associated with clinical trials and product
manufacturing is very expensive and the time frame necessary to achieve market
success for our products is long and uncertain. We do not expect to
generate product or royalty revenues for at least the next three years, and we
may never generate product and/or royalty revenues sufficient to become
profitable or to sustain profitability.
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of
July 10, 2009, there were 236,964,414 shares of our common stock
outstanding. Substantially all of these shares are eligible for
trading in the public market, subject in some cases to volume and other
limitations. The market price of our common stock may decline if our
common stockholders sell a large number of shares of our common stock in the
public market, or the market perceives that such sales may
occur.
We could also issue up to 16,806,892
additional shares of our common stock that are reserved for future issuance
under our stock option plans and for outstanding warrants, as further described
in the following table:
|
|
Number
of Shares
of
Common Stock Reserved For Issuance
|
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
|
|
15,114,845 |
|
Common
shares issuable upon exercise of outstanding warrants
|
|
|
1,692,047 |
|
Total
|
|
|
16,806,892 |
|
Of the total options and warrants
outstanding as of July 10, 2009, 5,095,641 would be considered dilutive to
stockholders because we would receive an amount per share which is less than the
market price of our common stock at July 10, 2009.
In
addition, we will need to raise substantial additional capital in the future to
fund our operations. If we raise additional funds by issuing equity
securities, the market price of our securities may decline and our existing
stockholders may experience significant dilution.
Current
Economic Conditions And Capital Markets Are In A Period Of Disruption And
Instability Which Could Adversely Affect Our Ability To Access The Capital
Markets, And Thus Adversely Affect Our Business And Liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of
liquidity and credit combined with recent substantial losses in worldwide equity
markets could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including our
pre-clinical studies and clinical trial schedules and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future disruptions or how long the current conditions
may continue.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The market price of our common stock
and the market prices of securities of companies in the biotechnology sector
have generally been highly volatile and are likely to continue to be highly
volatile.
The following table shows the high and
low sales price and trading volume of our common stock for each quarter in the
three fiscal years ended April 30, 2009:
|
Common
Stock
Sales
Price
|
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|
High
|
|
Low
|
|
High
|
|
Low
|
Fiscal
Year 2009
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2009
|
$0.52
|
|
$0.30
|
|
3,509
|
|
|
68 |
|
Quarter
Ended January 31, 2009
|
$0.47
|
|
$0.22
|
|
1,298 |
|
|
93 |
|
Quarter
Ended October 31, 2008
|
$0.40
|
|
$0.23
|
|
1,318
|
|
|
77 |
|
Quarter
Ended July 31, 2008
|
$0.53
|
|
$0.31
|
|
2,997 |
|
|
103 |
|
Fiscal
Year 2008
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2008
|
$0.73
|
|
$0.35
|
|
3,846 |
|
|
130 |
|
Quarter
Ended January 31, 2008
|
$0.65
|
|
$0.35
|
|
3,111 |
|
|
140 |
|
Quarter
Ended October 31, 2007
|
$0.79
|
|
$0.54
|
|
2,631 |
|
|
169 |
|
Quarter
Ended July 31, 2007
|
$1.40
|
|
$0.72
|
|
21,653 |
|
|
237 |
|
Fiscal
Year 2007
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2007
|
$1.26
|
|
$0.86
|
|
6,214 |
|
|
408 |
|
Quarter
Ended January 31, 2007
|
$1.39
|
|
$1.09
|
|
4,299 |
|
|
203 |
|
Quarter
Ended October 31, 2006
|
$1.48
|
|
$1.12
|
|
3,761 |
|
|
277 |
|
Quarter
Ended July 31, 2006
|
$1.99
|
|
$1.30
|
|
23,790 |
|
|
429 |
|
The market price of our common stock
may be significantly impacted by many factors, including, but not limited
to:
|
·
|
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, including but not limited to any potential
reverse stock split;
|
|
·
|
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.
|
These and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock Is
Delisted From The NASDAQ Capital Market.
Our common stock is presently traded on
The NASDAQ Capital Market. To maintain inclusion on The NASDAQ
Capital Market, we must continue to meet the following six listing
requirements:
|
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.
|
On July 25, 2007, we received a
deficiency notice from The NASDAQ Stock Market notifying us that we had not met
the $1.00 minimum closing bid price requirement for thirty consecutive trading
days as required under NASDAQ listing rules. According to the NASDAQ
notice, we were automatically afforded an initial “compliance period” of 180
calendar days, or until January 22, 2008, to regain compliance with this
requirement. After the initial 180 calendar day period, we remained
noncompliant with the minimum closing bid price requirement but because we were
in compliance with all other initial listing requirements, we were afforded an
additional “compliance period” of 180 calendar days, or until July 21,
2008. Because we did not regain compliance, i.e., the closing bid
price of the Company’s common stock did not meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days prior to July 21, 2008, on July
22, 2008 we received a notice from The NASDAQ Stock Market indicating that we
were not in compliance with the minimum bid price requirement for continued
listing, and as a result our common stock is subject to delisting. On
July 28, 2008, we requested a hearing with the NASDAQ Listing Qualifications
Panel (“Panel”) to review the delisting determination. Our request
for a hearing stayed the delisting pending a decision by the
Panel. The oral hearing took place September 4, 2008 at which we
presented to the Panel our definitive plan to achieve and sustain long-term
compliance with the listing requirements of the NASDAQ Capital
Market. On September 16, 2008, we received a letter from the NASDAQ
Stock Market informing us that the Panel had determined to grant our request to
remain listed, subject to the condition that on or before January 20, 2009, we
must evidence a closing bid price for our common stock of $1.00 or more for a
minimum of ten prior consecutive trading days.
On
October 21, 2008, we conducted our 2008 annual meeting of stockholders at which
our stockholders approved an amendment to our certificate of incorporation to
effect a reverse stock split of the outstanding shares of our common stock at a
ratio to be determined by our Board of Directors within a range of three-for-one
and ten-for-one. Subsequent to our annual meeting of stockholders,
the NASDAQ Stock Market suspended the bid price and market value of publicly
held shares continued listing requirements through April 17, 2009. As
a result of this suspension, the exception granted to us by the Panel, which
required us to demonstrate compliance with the closing minimum bid price
requirement by January 20, 2009, has now been extended to no later than November
11, 2009. On July 14, 2009, we received a letter from The NASDAQ
Stock Market informing us that NASDAQ does not anticipate that it will further
extend its suspension of the bid price requirement.
We intend
to pursue all available options to ensure our continued listing on the NASDAQ
Stock Market, including, if necessary, effecting the reverse stock split of our
outstanding common stock previously approved by our
stockholders. Although we currently meet all other NASDAQ listing
requirements, the market price of our common stock has generally been highly
volatile and we cannot guarantee that we will be able to regain compliance with
the minimum closing bid price requirement within the required compliance
period. If we fail to regain compliance with the minimum closing bid
price requirement or fail to comply with any other of The NASDAQ Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
If our
common stock is delisted, we would apply to have our common stock quoted on the
over-the-counter electronic bulletin board. Upon any such delisting,
our common stock would become subject to the regulations of the Securities and
Exchange Commission relating to the market for penny stocks. A penny
stock, as defined by the Penny Stock Reform Act, is any equity security not
traded on a national securities exchange that has a market price of less than
$5.00 per share. The penny stock regulations generally require that a
disclosure schedule explaining the penny stock market and the risks associated
therewith be delivered to purchasers of penny stocks and impose various sales
practice requirements on broker-dealers who sell penny stocks to persons other
than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In
addition, the broker-dealer must make certain mandated disclosures, including
the actual sale or purchase price and actual bid offer quotations, as well as
the compensation to be received by the broker-dealer and certain associated
persons. The regulations applicable to penny stocks may severely
affect the market liquidity for our common stock and could limit your ability to
sell your securities in the secondary market.
If
We Effect A Reverse Stock Split, The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have
Been Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
|
·
|
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
|
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant
portions of these development efforts are not successfully completed, required
regulatory approvals are not obtained, or any approved products are not
commercially successful, our business, financial condition and results of
operations may be materially harmed.
Because
we have not begun the commercial sale of any of our products, our revenue and
profit potential is unproven and our limited operating history makes it
difficult for an investor to evaluate our business and prospects. Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of
our products, and our products may not generate revenues in the
future. Our business and prospects should be considered in light of
the heightened risks and unexpected expenses and problems we may face as a
company in an early stage of development in a new and rapidly evolving
industry.
We
Are Primarily Focusing Our Activities And Resources On The Development Of
Bavituximab And Depend On Its Success.
We are
focusing most of our near-term research and development activities and resources
on bavituximab, and we believe a significant portion of the value of our Company
relates to our ability to develop this drug candidate. The
development of bavituximab is subject to many risks, including the risks
discussed in other risk factors. If the results of clinical trials of
bavituximab, the regulatory decisions affecting bavituximab, the anticipated or
actual timing and plan for commercializing bavituximab, or, ultimately, the
market acceptance of bavituximab do not meet our, your, analysts’ or others’
expectations, the market price of our common stock could be adversely
affected.
Our
Product Development Efforts May Not Be Successful.
Our product candidates have not
received regulatory approval and are generally in research, pre-clinical and
various clinical stages of development. If the results from any of
the clinical trials are poor, those results may adversely affect our ability to
raise additional capital or obtain regulatory approval to conduct additional
clinical trials, which will affect our ability to continue full-scale research
and development for our antibody technologies. In addition, our
product candidates may take longer than anticipated to progress through clinical
trials, or patient enrollment in the clinical trials may be delayed or prolonged
significantly, thus delaying the clinical trials. Patient enrollment
is a function of many factors, including the size of the patient population, the
nature of the protocol, the proximity of patients to the clinical sites, and the
eligibility criteria for the study. In addition, because our Cotara®
product currently in clinical trials represents a departure from more commonly
used methods for cancer treatment, potential patients and their doctors may be
inclined to use conventional therapies, such as chemotherapy, rather than enroll
patients in our clinical study.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming, And
Their Outcome Is Uncertain.
In order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct
extensive pre-clinical testing and “adequate and well-controlled” clinical
trials. Conducting clinical trials is a lengthy, time-consuming and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty and intended use of the product
candidate, and often can be several years or more per trial. Delays
associated with products for which we are directly conducting pre-clinical or
clinical trials may cause us to incur additional operating
expenses. Moreover, we may continue to be affected by delays
associated with the pre-clinical testing and clinical trials of certain product
candidates conducted by our partners over which we have no
control. The commencement and rate of completion of clinical trials
may be delayed by many factors, including, for example:
|
·
|
obtaining
regulatory approval to commence a clinical
trial;
|
|
·
|
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;
|
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
|
·
|
the
inability of patients to meet FDA or other regulatory authorities imposed
protocol requirements;
|
|
●
|
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;
|
|
●
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in clinical
trials;
|
|
·
|
the
need or desire to modify our manufacturing
processes;
|
|
·
|
the
inability to adequately observe patients after
treatment;
|
|
·
|
changes
in regulatory requirements for clinical
trials;
|
|
·
|
the
lack of effectiveness during the clinical
trials;
|
|
·
|
unforeseen
safety issues;
|
|
●
|
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
|
|
·
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
Even if
we obtain positive results from pre-clinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may
not demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence
new clinical trials from time to time in the course of our business as our
product development work continues. The failure of clinical trials to
demonstrate safety and effectiveness for our desired indications could harm the
development of that product candidate as well as other product
candidates. Any change in, or termination of, our clinical trials
could materially harm our business, financial condition and results of
operations.
We
Rely On Third Parties To Conduct Our Clinical Trials And Many Of Our Preclinical
Studies. If Those Parties Do Not Successfully Carry Out Their
Contractual Duties Or Meet Expected Deadlines, Our Drug Candidates May Not
Advance In A Timely Manner Or At All.
In the
course of our discovery, preclinical testing and clinical trials, we rely on
third parties, including universities, investigators and clinical research
organizations, to perform critical services for us. For example, we rely on
third parties to conduct our clinical trials and many of our preclinical
studies. Clinical research organizations and investigators are responsible for
many aspects of the trials, including finding and enrolling patients for testing
and administering the trials. Although we rely on these third parties
to conduct our clinical trials, we are responsible for ensuring that each of our
clinical trials is conducted in accordance with its investigational plan and
protocol. Moreover, the FDA and foreign regulatory authorities
require us to comply with regulations and standards, commonly referred to as
good clinical practices, or GCPs, for conducting, monitoring, recording and
reporting the results of clinical trials to ensure that the data and results are
scientifically credible and accurate and that the trial subjects are adequately
informed of the potential risks of participating in clinical
trials. Our reliance on third parties does not relieve us of these
responsibilities and requirements. These third parties may not be
available when we need them or, if they are available, may not comply with all
regulatory and contractual requirements or may not otherwise perform their
services in a timely or acceptable manner, and we may need to enter into new
arrangements with alternative third parties and our clinical trials may be
extended, delayed or terminated. These independent third parties may
also have relationships with other commercial entities, some of which may
compete with us. In addition, if such third parties fail to perform
their obligations in compliance with our clinical trial protocols, our clinical
trials may not meet regulatory requirements or may need to be
repeated. As a result of our dependence on third parties, we may face
delays or failures outside of our direct control. These risks also
apply to the development activities of our collaborators, and we do not control
our collaborators’ research and development, clinical trials or regulatory
activities. We do not expect any drugs resulting from our
collaborators’ research and development efforts to be commercially available for
many years, if ever.
We
Do Not Have Experience As a Company Conducting Large-Scale Clinical Trials, Or
In Other Areas Required For The Successful Commercialization And Marketing Of
Our Product Candidates.
Preliminary results from clinical
trials of bavituximab may not be indicative of successful outcomes in later
stage trials. Negative or limited results from any current or future
clinical trial could delay or prevent further development of our product
candidates which would adversely affect our business.
We have no experience as a Company in
conducting large-scale, late stage clinical trials, and our experience with
early-stage clinical trials with small numbers of patients is
limited. In part because of this limited experience, we cannot be
certain that planned clinical trials will begin or be completed on time, if at
all. Large-scale trials would require either additional financial and
management resources, or reliance on third-party clinical investigators,
clinical research organizations (“CROs”) or consultants. Relying on third-party
clinical investigators or CROs may force us to encounter delays that are outside
of our control. Any such delays could have a material adverse effect
on our business.
We
also do not currently have marketing and distribution capabilities for our
product candidates. Developing an internal sales and distribution capability
would be an expensive and time-consuming process. We may enter into
agreements with third parties that would be responsible for marketing and
distribution. However, these third parties may not be capable of
successfully selling any of our product candidates. The inability to
commercialize and market our product candidates could materially affect our
business.
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely Impacted By
Social, Political And Economic Factors Affecting The Particular Foreign
Country.
We are
presently conducting clinical trials in India and the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
|
·
|
difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
|
|
·
|
different
standards for the conduct of clinical trials and/or health care
reimbursement;
|
|
·
|
our
inability to locate qualified local consultants, physicians, and
partners;
|
|
·
|
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
|
|
● |
general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
|
Because
we will be conducting a number of our Phase II clinical trials in India and the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from
pre-clinical and clinical activities are subject to varying interpretations,
which may delay, limit or prevent regulatory approval.
Positive
results from our pre-clinical studies, Phase I and the first stage of our Phase
II clinical trials should not be relied upon as evidence that later or
larger-scale clinical trials will succeed. The Phase I studies we
have completed to date have been designed to primarily assess safety in a small
number of patients. In addition, while we have completed the first
stage of all three of our Phase II studies, and obtained positive results with
respect to our primary endpoints, our Phase II trials are open-label, Simon
two-stage design trials to evaluate the safety and efficacy on bavituximab in
combination with chemotherapy drugs in a limited number of
patients. The limited results we have obtained, and will obtain in
the Phase II trials, may not predict results for any future studies and also may
not predict future therapeutic benefit of our drug candidates. We
will be required to demonstrate through larger-scale clinical trials that
bavituximab and Cotara® are safe and effective for use in a diverse population
before we can seek regulatory approval for their commercial
sale. There is typically an extremely high rate of attrition from the
failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be Profitable.
Even if bavituximab, Cotara®, or any
future product candidate is approved for commercial sale by the FDA or other
regulatory authorities, the degree of market acceptance of any approved product
candidate by physicians, healthcare professionals and third-party payors and our
profitability and growth will depend on a number of factors,
including:
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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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In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the
market. If any products we may develop do not achieve market
acceptance, then we may not generate sufficient revenue to achieve or maintain
profitability.
In addition, even if our products
achieve market acceptance, we may not be able to maintain that market acceptance
over time if new products or technologies are introduced that are more favorably
received than our products, are more cost effective or render our products
obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We have
completed Phase I and Phase I/II studies with Cotara® for the treatment of brain
cancer. In addition, we are currently conducting a dose confirmation
and dosimetry clinical trial in patients with recurrent glioblastoma multiforme
(“GBM”). We are also currently conducting a Phase II safety and
efficacy study using a single administration of the drug through an optimized
delivery method. Taken together, the
current U.S. study along with data collected from the Phase II safety and
efficacy study should provide the safety, dosimetry and efficacy data that will
support the final design of the larger Phase III study. Once we
complete these two Cotara® studies for the treatment of GBM, substantial
financial resources will be needed to complete the final part of the trial and
any additional supportive clinical studies necessary for potential product
approval. We do not presently have the financial resources internally
to complete the larger Phase III study. We therefore intend to
continue to seek a licensing or funding partner for Cotara®, and hope that the
data from our clinical studies will enhance our opportunities of finding such
partner. If a partner is not found for this technology, we may not be
able to advance the project past its current state of
development. Because there are a limited number of companies which
have the financial resources, the internal infrastructure, the technical
capability and the marketing infrastructure to develop and market a
radiopharmaceutical based oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
Our
Dependency On Our Radiolabeling Suppliers May Negatively Impact Our Ability To
Complete Clinical Trials And Market Our Products.
We have
procured our antibody radioactive isotope combination services (“radiolabeling”)
for Cotara® with Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with
the Board of Radiation & Isotope Technology (“BRIT”) for our Phase II study
in India. If either of these suppliers is unable to continue to
qualify its respective facility or radiolabel and supply our antibody in a
timely manner, our current clinical trials using radiolabeling technology could
be adversely affected and significantly delayed. While there are
other suppliers for radioactive isotope combination services in the U.S., our
clinical trial would be delayed for up to twelve to eighteen months because it
may take that amount of time to certify a new facility under current Good
Manufacturing Practices and qualify the product, plus we would incur significant
costs to transfer our technology to another vendor. In addition, the
number of facilities that can perform these radiolabeling services is very
limited. Prior to commercial distribution of any of our products, if
approved, we will be required to identify and contract with a company for
commercial antibody manufacturing and radioactive isotope combination
services. An antibody that has been combined with a radioactive
isotope, such as Iodine-131, cannot be stored for long periods of time, as it
must be used within one week of being radiolabeled to be
effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our
therapeutic products must be manufactured for development and, following
approval, in commercial quantities, in compliance with regulatory requirements
and at acceptable costs. Currently, we manufacture all pre-clinical
and clinical material through Avid Bioservices, our wholly owned
subsidiary. While we believe our current facilities are adequate for
the manufacturing of product candidates for clinical trials, our facilities may
not be adequate to produce sufficient quantities of any products for commercial
sale.
If we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially
harmed.
We may
also encounter problems with the following:
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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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In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities, provided
it had not already registered. The facilities will be subject to
inspections confirming compliance with cGMP or other regulations. If
any of our third-party manufacturers or we fail to maintain regulatory
compliance, the FDA can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a new drug product or
biologic product, or revocation of a pre-existing approval. As a
result, our business, financial condition and results of operations may be
materially harmed.
We
Currently Depend On A Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded up to a five-year contract potentially worth up to
$44.4 million to test and develop bavituximab and an equivalent fully human
antibody as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (“TMTI”) of the U.S. Department
of Defense's Defense Threat Reduction Agency “DTRA”). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. The remainder
of the $22.3 million in funding is expected to be appropriated over the
remainder of the two-year base period ending June 29, 2010. Subject
to the progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period. Work under this contract
commenced on June 30, 2008. If we do not receive the expected funding
under this contract, we may not be able to develop therapeutics to treat
hemorrhagic fever virus infection nor otherwise receive the other indirect
benefits that may be derived from receipt of the full funding under this
contract.
Federal
Government Contracts Contain Provisions Giving Government Customers A Variety Of
Rights That Are Unfavorable To Us, Including The Ability To Terminate A Contract
At Any Time For Convenience.
Federal
government contracts, such as our contract with the DTRA, contain provisions,
and are subject to laws and regulations, that give the government rights and
remedies not typically found in commercial contracts. These provisions may allow
the government to:
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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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If the
government terminates our contract for convenience, we may recover only our
incurred or committed costs, settlement expenses and profit on work completed
prior to the termination. If the government terminates our contract for default,
we may not recover even those amounts, and instead may be liable for excess
costs incurred by the government in procuring undelivered items and services
from another source. If the DTRA were to unexpectedly terminate or cancel, or
decline to exercise the option to extend our contract beyond the base period,
our revenues, product development efforts and operating results would be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain
product liability insurance for clinical studies in the amount of $3,000,000 per
occurrence or $3,000,000 in the aggregate on a claims-made basis, this coverage
may not be adequate. Product liability insurance is expensive,
difficult to obtain and may not be available in the future on acceptable terms,
if at all. Our inability to obtain sufficient insurance coverage on
reasonable terms or to otherwise protect against potential product liability
claims in excess of our insurance coverage, if any, or a product recall, could
negatively impact our financial position and results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We
obtain agreements from our customers indemnifying and defending us from any
potential liability arising from such risk. There can be no assurance
that such indemnification agreements will adequately protect us against
potential claims relating to such contract manufacturing services or protect us
from being named in a possible lawsuit. Although Avid has procured
insurance coverage, there is no guarantee that we will be able to maintain our
existing coverage or obtain additional coverage on commercially reasonable
terms, or at all, or that such insurance will provide adequate coverage against
all potential claims to which we might be exposed. A partially
successful or completely uninsured claim against Avid would have a material
adverse effect on our consolidated operations.
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary
positions by filing United States and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to
developing our business. However, if we fail to obtain and maintain
patent protection for our proprietary technology, inventions and improvements,
our competitors could develop and commercialize products that would otherwise
infringe upon our patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of
claims in the biotechnology and biopharmaceutical fields are still
evolving. Accordingly, the degree of future protection for our patent
rights is uncertain. The risks and uncertainties that we face with
respect to our patents include the following:
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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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we
may be unable to develop additional proprietary technologies that are
patentable;
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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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We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would Be
Expensive And Time Consuming.
In order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to
interference or opposition proceedings conducted in patent and trademark offices
to determine the priority and patentability of inventions. The
defense of intellectual property rights, including patent rights through
lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings, would be costly and divert our technical and
management personnel from their normal responsibilities. An adverse
determination of any litigation or defense proceedings could put our pending
patent applications at risk of not being issued.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of
litigation. For example, during the course of this kind of
litigation, confidential information may be inadvertently disclosed in the form
of documents or testimony in connection with discovery requests, depositions or
trial testimony. This disclosure could have a material adverse effect
on our business and our financial results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The pharmaceutical and biotechnology
industry is intensely competitive and subject to rapid and significant
technological change. Many of the drugs that we are attempting to
discover or develop will be competing with existing therapies. In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater
financial resources, larger technical staffs, and larger research budgets than
we have, as well as greater experience in developing products and running
clinical trials. We expect to continue to experience significant and
increasing levels of competition in the future. In addition, there
may be other companies which are currently developing competitive technologies
and products or which may in the future develop technologies and products that
are comparable or superior to our technologies and products.
We are conducting the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of recurrent
glioblastoma multiforme (“GBM”), the most aggressive form of brain
cancer. Approved treatments for brain cancer include the Gliadel®
Wafer (polifeprosan 20 with carmustine implant) from Eisai, Inc., Temodar®
(temozolomide) from Schering-Plough Corporation and Avastin®
(bevacizumab). Gliadel® is inserted in the tumor cavity following
surgery and releases a chemotherapeutic agent over time. Temodar® is
administered orally to patients with brain cancer. Avastin® is a
monoclonal antibody that targets vascular endothelial growth factor to prevent
the formation of new tumor blood vessels.
Because Cotara® targets brain tumors
from the inside out, it is a novel treatment dissimilar from other drugs in
development for this disease. Some products in development may
compete with Cotara® should they become approved for marketing. These
products include, but are not limited to: 131I-TM601, a radiolabeled
chlorotoxin peptide being developed by TransMolecular, Inc., CDX-110, a peptide
vaccine under development by Celldex, cilengitide, an integrin-targeting peptide
being evaluated by Merk KGaA, and cediranib, a VEGFR tyrosine kinase inibitor
being developed by AstraZeneca. In addition, oncology products
marketed for other indications such as Gleevec® (Novartis), Tarceva®
(Genentech/OSI), and Nexavar® (Bayer), are being tested in clinical trials for
the treatment of brain cancer.
Bavituximab is currently in clinical
trials for the treatment of advanced solid cancers. There are a
number of possible competitors with approved or developmental targeted agents
used in combination with standard chemotherapy for the treatment of
cancer, including but not limited to, Avastin® by Genentech, Inc., Gleevec®
by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and Genentech, Inc., Erbitux®
by ImClone Systems Incorporated and Bristol-Myers Squibb Company, Rituxan® and
Herceptin® by Genentech, Inc., and Vectibix™ by Amgen. There are a
significant number of companies developing cancer therapeutics using a variety
of targeted and non-targeted approaches. A direct comparison of these
potential competitors will not be possible until bavituximab advances to
later-stage clinical trials.
In addition, we are evaluating
bavituximab for the treatment of HCV. Bavituximab is a first-in-class
approach for the treatment of HCV. We are aware of no other products
in development targeting phosphatidylserine as a potential therapy for
HCV. There are a number of companies that have products approved and
on the market for the treatment of HCV, including but not limited
to: Peg-Intron® (pegylated interferon-alpha-2b), Rebetol®
(ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys® (pegylated interferon-alpha-2a),
Copegus® (ribavirin USP) and Roferon-A® (interferon-alpha-2a), which are
marketed by Roche Pharmaceuticals, and Infergen® (interferon alfacon-1) now
marketed by Three Rivers Pharmaceuticals, LLC. First line treatment
for HCV has changed little since alpha interferon was first introduced in
1991. The current standard of care for HCV includes a combination of
an alpha interferon (pegylated or non-pegylated) with ribavirin. This
combination therapy is generally associated with considerable toxicity including
flu-like symptoms, hematologic changes and central nervous system side effects
including depression. It is not uncommon for patients to discontinue
alpha interferon therapy because they are unable to tolerate the side effects of
the treatment.
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in
development. Later-stage developmental treatments include
improvements to existing therapies, such as Albuferon™ (albumin interferon) from
Human Genome Sciences, Inc. Other developmental approaches include,
but are not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated and boceprevir from Schering-Plough
Corporation.
Avid
Bioservices, Our subsidiary, Is Exposed To Risks Resulting From Its Small
Customer Base.
A significant portion of Avid
Bioservices’ revenues have historically been derived from a small customer
base. These customers typically do not enter into long-term contracts
because their need for drug supply depends on a variety of factors, including
the drug’s stage of development, their financial resources, and, with respect to
commercial drugs, demand for the drug in the market. Our results of
operations could be adversely affected if revenue from any one of our primary
customers is significantly reduced or eliminated
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our Products.
Our success is dependent, in part, upon
a limited number of key executive officers, each of whom is an at-will employee,
and also upon our scientific researchers. For example, because of his
extensive understanding of our technologies and product development programs,
the loss of Mr. Steven W. King, our President & Chief Executive Officer and
Director, would adversely affect our development efforts and clinical trial
programs during the six to twelve month period that we estimate it would take to
find and train a qualified replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
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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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Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents we incorporate by reference herein contain
forward-looking statements within the meaning of Sections 27A of the
Securities Act of 1933, as amended, which we refer to as the Securities Act, and
21E of the Exchange Act. Some of the statements under “About Peregrine
Pharmaceuticals, Inc.”, “Risk Factors” and elsewhere in this prospectus
constitute “forward-looking” statements. These statements involve
known and unknown risks, including, among others, risks resulting from economic
and market conditions, the regulatory environment in which we operate, pricing
pressures, accurately forecasting operating and capital expenditures and
clinical trial costs, competitive activities, uncertainties of litigation and
other business conditions, and are subject to uncertainties and assumptions
contained elsewhere in this prospectus. We base our forward-looking
statements on information currently available to us, and, in accordance with the
requirements of federal securities laws, we will disclose to you material
developments affecting such statements. Our actual operating results
and financial performance may prove to be very different from what we have
predicted as of the date of this prospectus due to certain risks and
uncertainties. The risks described above in the section entitled
“Risk Factors” specifically address some of the factors that may affect our
future operating results and financial performance.
USE
OF PROCEEDS
Except as
otherwise provided in the applicable prospectus supplement, we will use the net
proceeds from the sale of the securities for general corporate purposes, which
may include research and development expenses, clinical trial expenses,
repayment of debt, expansion of our contract manufacturing capabilities and
increasing our working capital. Pending the application of the net
proceeds, we expect to invest the proceeds in investment grade, interest bearing
securities. We will not receive any proceeds from the sale of common stock by
the selling security holders.
The
principal purposes of this offering are to increase our operating and financial
flexibility. As of the date of this prospectus, we cannot specify
with certainty all of the particular uses for the net proceeds we will have upon
completion of this offering. Accordingly, our management will have
broad discretion in the application of net proceeds, if any.
DESCRIPTION
OF COMMON STOCK
As of the
date of the prospectus, we are authorized to issue up to 325,000,000 shares of
common stock, $.001 par value per share. As of July 10, 2009,
236,964,414 shares of our common stock were outstanding. In addition,
we reserved an additional 16,806,892 shares of common stock for issuance under
our stock option plans and warrant agreements that were issued and outstanding
or reserved for issuance as of July 10, 2009.
Dividends
Our Board
of Directors may, out of funds legally available, at any regular or special
meeting, declare dividends to the holders of shares of our common stock as and
when they deem expedient, subject to the rights of holders of the preferred
stock, if any.
Voting
Each
share of common stock entitles the holders to one vote per share on all matters
requiring a vote of the stockholders, including the election of
directors. No holders of shares of common stock shall have the right
to vote such
shares cumulatively in any election for the Board of Directors.
Rights
Upon Liquidation
In the
event of our voluntary or involuntary liquidation, dissolution, or winding up,
the holders of our common stock will be entitled to share equally in our assets
available for distribution after payment in full of all debts and after the
holders of preferred stock, if any, have received their liquidation preferences
in full.
Miscellaneous
No
holders of shares of our common stock shall have any preemptive rights to
subscribe for, purchase or receive any shares of any class, whether now or
hereafter authorized, or any options or warrants to purchase any such shares, or
any securities convertible into or exchanged for any such shares, which may at
any time be issued, sold or offered for sale by us.
We may
issue warrants for the purchase of our common stock. We may issue warrants
independently or together with shares of our common stock, and the warrants may
be attached to or separate from our shares of common stock. While the terms
summarized below will apply generally to any warrants that we may offer, we will
describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered under a
prospectus supplement may differ from the terms described
below.
A copy of the form of warrant
agreement, including the form of warrant certificate representing a series of
warrants, will be filed with the SEC in connection with the offering of a
particular series of warrants. The following summaries of material provisions of
the warrants and the warrant agreements are subject to, and qualified in their
entirety by reference to, all the provisions of the warrant agreement and
warrant certificate applicable to the particular series of warrants that we may
offer under this prospectus. We urge you to read the applicable prospectus
supplements related to the particular series of warrants that we may offer under
this prospectus, as well as any prospectus supplement, and the complete warrant
agreements and warrant certificates that contain the terms of the
warrants.
We will describe in the applicable
prospectus supplement the terms of the series of warrants being offered,
including:
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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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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;
|
|
●
|
the
terms of any rights to redeem or call the
warrants;
|
|
●
|
any
provisions for changes to or adjustments in the exercise price or number
of securities issuable upon exercise of the
warrants;
|
|
●
|
the
dates on which the right to exercise the warrants will commence and
expire;
|
|
●
|
the
manner in which the warrant agreements and warrants may be
modified;
|
|
●
|
the
anti-dilutive protections given to the holder of such
warrant;
|
|
●
|
a
discussion of any material or special U.S. federal income tax
consequences of holding or exercising the
warrants;
|
|
●
|
the
terms of the securities issuable upon exercise of the
warrants; and
|
|
●
|
any
other specific terms, preferences, rights or limitations of or
restrictions on the warrants.
|
Before exercising their warrants,
holders of warrants will not have any of the rights of holders of the securities
purchasable upon such exercise, including the right to receive dividends, if
any, or payments upon our liquidation, dissolution or winding up or to exercise
voting rights, if any.
Each
warrant will entitle the holder to purchase the securities that we specify in
the applicable prospectus supplement at the exercise price that we describe in
the applicable prospectus supplement. Holders of the warrants may exercise the
warrants at any time up to the specified time on the expiration date that we set
forth in the applicable prospectus supplement. After the close of business on
the expiration date, unexercised warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information,
and paying the required amount to the warrant agent in immediately available
funds, as provided in the applicable prospectus supplement. We will set forth on
the reverse side of the warrant certificate and in the applicable prospectus
supplement the information that the holder of the warrant will be required to
deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed
and duly executed at the corporate trust office of the warrant agent or any
other office indicated in the applicable prospectus supplement, we will issue
and deliver the securities purchasable upon such exercise. If fewer than all of
the warrants represented by the warrant certificate are exercised, then we will
issue a new warrant certificate for the remaining amount of warrants. If we so
indicate in the applicable prospectus supplement, holders of the warrants may
surrender securities as all or part of the exercise price for
warrants.
Unless we provide otherwise in the
applicable prospectus supplement, the warrants and warrant agreements will be
governed by and construed in accordance with the laws of the State of
California.
Enforceability of Rights by Holders
of Warrants
Each
warrant agent will act solely as our agent under the applicable warrant
agreement and will not assume any obligation or relationship of agency or trust
with any holder of any warrant. A single bank or trust company may act as
warrant agent for more than one issue of warrants. A warrant agent will have no
duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a
warrant may, without the consent of the related warrant agent or the holder of
any other warrant, enforce by appropriate legal action its right to exercise,
and receive the securities purchasable upon exercise of, its
warrants.
As of
July 10, 2009, there were outstanding warrants to purchase 1,692,047 shares of
common stock at an exercise price of $0.2955 per share.
PLAN
OF DISTRIBUTION
We may use this prospectus and any
related prospectus supplement to sell the securities from time to time pursuant
to underwritten public offerings, negotiated transactions, block trades or a
combination of these methods. We may sell the securities
(1) through underwriters or dealers, (2) through agents, and/or
(3) directly to one or more purchasers. We may distribute the securities
from time to time in one or more transactions at:
● a
fixed price or prices, which may be changed;
● market
prices prevailing at the time of sale;
● prices
related to the prevailing market prices; or
● negotiated
prices.
We may
solicit directly offers to purchase the securities being offered by this
prospectus. We may also designate agents to solicit offers to
purchase the securities from time to time. We will name in a
prospectus supplement any agent involved in the offer or sale of our
securities.
We, or
agents designated by us, may directly solicit, from time to time, offers to
purchase our securities. Any such agent may be deemed to be an underwriter as
that term is defined in the Securities Act. We will name the agents involved in
the offer or sale of our securities and describe any commissions payable by us
to these agents in the applicable prospectus supplement. Unless otherwise
indicated in the applicable prospectus supplement, these agents will be acting
on a best efforts basis for the period of their appointment. The agents may be
entitled under agreements, which may be entered into with us, to indemnification
by us against specific civil liabilities, including liabilities under the
Securities Act. The agents may also be our customers or may engage in
transactions with or perform services for us in the ordinary course of
business.
If we
utilize a dealer in the sale of the securities being offered by this prospectus,
we will sell the securities to the dealer, as principal. The dealer
may then resell the securities to the public at varying prices to be determined
by the dealer at the time of resale.
If we
utilize an underwriter in the sale of the securities being offered by this
prospectus, we will execute an underwriting agreement with the underwriter at
the time of sale and will provide the name of any underwriter in the prospectus
supplement which the underwriter will use to make resales of the securities to
the public. In connection with the sale of the securities, we, or the purchasers
of securities for whom the underwriter may act as agent, may compensate the
underwriter in the form of underwriting discounts or commissions. The
underwriter may sell the securities to or through dealers, and the underwriter
may compensate those dealers in the form of discounts, concessions or
commissions.
With
respect to underwritten public offerings, negotiated transactions and block
trades, we will provide in the applicable prospectus supplement any compensation
we pay to underwriters, dealers or agents in connection with the offering of the
securities, and any discounts, concessions or commissions allowed by
underwriters to participating dealers. Underwriters, dealers and
agents participating in the distribution of the securities may be deemed to be
underwriters within the meaning of the Securities Act of 1933, as amended, and
any discounts and commissions received by them and any profit realized by them
on resale of the securities may be deemed to be underwriting discounts and
commissions. We may enter into agreements to indemnify underwriters,
dealers and agents against civil liabilities, including liabilities under the
Securities Act, or to contribute to payments they may be required to make in
respect thereof.
To the
extent that we make sales through one or more underwriters or agents in
at-the-market offerings, we will do so pursuant to the terms of a sales agency
financing agreement or other at-the-market offering arrangement between us and
the underwriters or agents. If we engage in at-the-market sales pursuant to any
such agreement, we will issue and sell our securities through one or more
underwriters or agents, which may act on an agency basis or on a principal
basis. During the term of any such agreement, we may sell securities on a daily
basis in exchange transactions or otherwise as we agree with the underwriters or
agents. The agreement will provide that any securities sold will be sold at
prices related to the then prevailing market prices for our securities.
Therefore, exact figures regarding proceeds that will be raised or commissions
to be paid cannot be determined at this time. Pursuant to the terms of the
agreement, we also may agree to sell, and the relevant underwriters or agents
may agree to solicit offers to purchase, blocks of our common stock or other
securities. The terms of each such agreement will be set forth in more detail in
the applicable prospectus supplement. In the event that any underwriter or agent
acts as principal, or broker-dealer acts as underwriter, it may engage in
certain transactions that stabilize, maintain, or otherwise affect the price of
our securities. We will describe any such activities in the prospectus
supplement relating to the transaction.
Shares of
common stock sold pursuant to the registration statement of which this
prospectus is a part will be authorized for quotation and trading on the Nasdaq
Capital Market. To facilitate the offering of securities, certain
persons participating in the offering may engage in transactions that stabilize,
maintain or otherwise affect the price of the securities. This may
include over-allotments or short sales of the securities, which involve the sale
by persons participating in the offering of more securities than we sold to
them. In these circumstances, these persons would cover such
over-allotments or short positions by making purchases in the open market or by
exercising their over-allotment option. In addition, these persons
may stabilize or maintain the price of the securities by bidding for or
purchasing securities in the open market or by imposing penalty bids, whereby
selling concessions allowed to dealers participating in the offering may be
reclaimed if securities sold by them are repurchased in connection with
stabilization transactions. The effect of these transactions may be
to stabilize or maintain the market price of the securities at a level above
that which might otherwise prevail in the open market. These
transactions may be discontinued at any time.
The
underwriters, dealers and agents may engage in other transactions with us, or
perform other services for us, in the ordinary course of their
business.
In order
to comply with the securities laws of certain states, if applicable, the
securities offered by this prospectus may be sold in these jurisdictions only
through registered or licensed brokers or dealers. In addition, in
certain states the securities offered by this prospectus may not be sold unless
such securities have been registered or qualified for sale in these states or an
exemption from registration or qualification is available and complied
with.
Our
common stock is currently traded on the Nasdaq Capital Market under the symbol
“PPHM.”
SELLING
SECURITY HOLDERS
In
addition to covering the offering of securities by us, this prospectus covers
the offering for resale of common stock by the security holders listed
below.
The
shares of common stock being registered for the account of Midcap Funding I, LLC
and BlueCrest Venture Finance Master Fund Limited (as assignee of the warrant
we originally issued to BlueCrest Capital Finance, L.P.) (collectively, the
“Lenders”), are shares underlying certain warrants we issued in connection with
a loan and security agreement that closed on December 19, 2008 (the “Loan
Agreement”). We are registering the shares underlying the aforementioned
warrants in order to permit the Lenders to offer the shares for resale from time
to time. Except for ownership of the warrants and the making of the loan under
the Loan Agreement, neither Lender has had any material relationship with us
within the past three years. The shares of common stock being
registered for the account of the remaining selling security holder, Dr. Philip
E. Thorpe, are shares underlying a non-qualified stock option which was granted
to Dr. Thorpe on December 22, 1999. Dr. Thorpe is a member of the
Company’s Scientific Resource Board and an inventor of certain technologies that
the Company has in-licensed from the University of Texas Southwestern Medical
Center at Dallas.
The
following table presents information regarding the selling security holders and
the shares that they may offer and sell from time to time under this
prospectus. This table is prepared based on information supplied to
us by the selling security holders, and reflects holdings as of July 10,
2009. As used in this prospectus, the term “selling security holders”
includes the entities and person listed below and any donees, pledges,
transferees or other successors-in-interest selling shares received after the
date of this prospectus from any of the selling security holders as a gift,
pledge or other transfer. Except as set forth in the footnotes below,
beneficial ownership is determined in accordance with Rule 13d-3(d)
promulgated by the SEC under the Exchange Act.
|
Shares
of Common Stock Beneficially Owned
Prior
to Offering
|
Number
of
Shares
Being
Offered
|
Shares
of Common Stock Beneficially Owned
After
Offering
|
Name
of Selling Security Holder
|
Number(1)
|
Percent(2)
|
Number(3)
|
Percent(3)
|
Midcap Funding I, LLC
(4)
|
1,184,433
|
*
|
1,184,433
|
0
|
*
|
BlueCrest Venture Finance Master
Fund Limited (5)
|
507,614
|
*
|
507,614
|
0
|
*
|
Dr.
Philip E. Thorpe (6)
|
710,914
|
*
|
181,664
|
529,250
|
*
|
(1)
|
Represents
all of the shares beneficially owned by the selling stockholder as of July
10, 2009, including those issuable upon the exercise of any warrants
and/or stock options owned by the selling security holder. The
number of shares beneficially owned by the selling security holder may
increase as a result of anti-dilution adjustments.
|
(2)
|
The
percentage of shares beneficially owned prior to the offering is based on
236,964,414 shares of our common stock outstanding as of July 10,
2009. Shares of common stock subject to options or warrants
currently exercisable or exercisable within 60 days of the date of this
prospectus are deemed outstanding for computing the percentage of the
person holding such options or warrants, but are not deemed outstanding
for computing the percentage for any other selling security
holder.
|
(3)
|
The
number of shares and percentage of ownership in these columns assumes that
the selling security holders will offer and sell all of the shares of
common stock registered under this prospectus. The selling
stockholders may elect to sell some, all or none of their
shares. We do not know how long the selling stockholders will
hold the shares before selling them, and we currently have no agreements,
arrangements or understandings with the selling stockholders regarding the
sale of any of the shares. Shares of common stock subject to
options or warrants currently exercisable or exercisable within 60 days of
the date of this prospectus are deemed outstanding for computing the
percentage of the person holding such options or warrants, but are not
deemed outstanding for computing the percentage for any other selling
stockholder.
|
(4)
|
Mr.
William Gould, President, Asset Based Lending and Life Sciences of Midcap
Financial, LLC, has voting and dispositive power with respect to the
shares of this selling stockholder that are registered under this
prospectus. Mr. Gould disclaims beneficial ownership of any
such shares. The address for the selling security holder is : 7735 Old
Georgetown Road, Suite 400, Bethesda, Maryland 20814.
|
(5)
|
Mr.
Paul Dehadray, General Counsel of BlueCrest Capital
Management LLP, the agent and investment manager to the selling
stockholder has voting and dispositive power with respect to the shares of
this selling stockholder that are registered under this
prospectus. Both Mr. Dehadray and
BlueCrest Capital Management LLP disclaim beneficial ownership
of any such shares. The address for the selling security holder
is: c/o BlueCrest Capital Finance LP, 225 West Washington, Suite 200,
Chicago, Illinois 60606,
|
(6)
|
Includes
11,250 shares of common stock and options to purchase 699,664 shares of
common stock. The address for the selling security holder is:
Dr. Thorpe, c/o Peregrine Pharmaceuticals, Inc., 14282 Franklin Avenue,
Tustin, California, 92780.
|
LEGAL
MATTERS
The
validity of the securities offered by this prospectus has been passed upon for
us by Snell & Wilmer LLP, Costa Mesa, California, counsel to Peregrine
Pharmaceuticals, Inc. Certain legal matters will be passed upon for
any agents or underwriters by counsel for such agents or underwriters identified
in the applicable prospectus supplement.
EXPERTS
Ernst
& Young LLP, independent registered public accounting firm, has audited our
consolidated financial statements and schedule included in our Annual Report on
Form 10-K for the year ended April 30, 2009 (which contains an explanatory
paragraph describing conditions that raise substantial doubt about the Company's
ability to continue as a going concern as described in Note 1 to the
consolidated financial statements) and the effectiveness of our internal control
over financial reporting as of April 30, 2009, as set forth in their reports,
which are incorporated by reference in this prospectus and elsewhere in the
registration statement. Our financial statements and schedule are incorporated
by reference in reliance on Ernst & Young LLP's reports, given on their
authority as experts in accounting and auditing.
WHERE
TO LEARN MORE ABOUT US
We have
filed with the SEC a registration statement on Form S-3 under the
Securities Act with respect to the securities being offered under this
prospectus. This prospectus, which forms part of the registration statement,
does not contain all of the information in the registration statement. We have
omitted certain parts of the registration statement, as permitted by the rules
and regulations of the SEC. For further information regarding the Company and
our securities, please see the registration statement and our other filings with
the SEC, including our annual, quarterly, and current reports and any proxy
statements, which you may read and copy at the Public Reference Room maintained
by the SEC at 100 F Street, N.E., Washington, D.C. 20549. You may
obtain information about the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our public filings with the SEC are also available to the public
on the SEC’s Internet website at www.sec.gov. Our Internet website address is
www.peregrineinc.com.
We
furnish holders of our common stock with annual reports containing audited
financial statements prepared in accordance with accounting principles generally
accepted in the United States following the end of each fiscal year. We file
reports and other information with the SEC pursuant to the reporting
requirements of the Exchange Act.
Descriptions
in this prospectus of documents are intended to be summaries of the material,
relevant portions of those documents, but may not be complete descriptions of
those documents. For complete copies of those documents, please refer to the
exhibits to the registration statement and other documents filed by us with the
SEC.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC
allows us to “incorporate by reference” into this prospectus the documents we
file with them, which means that we can disclose important information to you by
referring you to these documents. The information that we incorporate by
reference into this prospectus is considered to be part of this prospectus, and
information that we file later with the Commission automatically updates and
supersedes any information in this prospectus. We have filed the
following documents with the Commission. These documents are
incorporated by reference as of their respective dates of filing:
|
1.
|
our
Annual Report on Form 10-K for the fiscal year ended April 30, 2009, as
filed with the Commission on July 14, 2009, 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, 2008, as filed with the Commission on
August 28, 2008;
|
|
3.
|
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;
|
|
4.
|
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
|
|
5.
|
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,
2009.
|
All
documents we have filed with the Commission under Sections 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934 after the date of the initial
registration statement and prior to the effective date of the registration
statement or subsequent to the date of this prospectus and prior to the filing
of a post-effective amendment indicating that all securities offered have been
sold (or which re-registers all securities then remaining unsold), are deemed to
be incorporated in this prospectus by this reference and to be made a part of
this prospectus from the date of filing of such documents.
We will
provide, without charge, upon written or oral request of any person to whom a
copy of this prospectus is delivered, a copy of any or all of the foregoing
documents and information that has been or may be incorporated in this
prospectus by reference, other than exhibits to such documents. Requests for
such documents and information should be directed to:
Peregrine
Pharmaceuticals, Inc.
Attn:
Paul J. Lytle, Chief Financial Officer
14282
Franklin Avenue
Tustin,
California 92780-7017
(714)
508-6000
See also
“Where to Learn More About Us.”
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
Our
Bylaws provide that we will indemnify our directors and officers and may
indemnify our employees and other agents to the fullest extent permitted by
law. We believe that indemnification under our Bylaws covers at least
negligence and gross negligence by indemnified parties, and permits us to
advance litigation expenses in the case of stockholder derivative actions or
other actions, against an undertaking by the indemnified party to repay such
advances if it is ultimately determined that the indemnified party is not
entitled to indemnification. We have liability insurance for our
directors and officers.
In
addition, our Certificate of Incorporation provides that, under Delaware law,
our directors shall not be liable for monetary damages for breach of the
directors’ fiduciary duty as a director to us and our
stockholders. This provision in the Certificate of Incorporation does
not eliminate the directors’ fiduciary duty, and in appropriate circumstances
equitable remedies such as injunctive or other forms of non-monetary relief will
remain available under Delaware law. In addition, each director will
continue to be subject to liability for breach of the director’s duty of loyalty
to our Company for acts or omissions not in good faith or involving intentional
misconduct, for knowing violations of law, for actions leading to improper
personal benefit to the director, and for payment of dividends or approval of
stock repurchases or redemptions that are unlawful under Delaware
law. The provision also does not affect a director’s responsibilities
under any other law, such as the federal securities laws or state or federal
environmental laws.
Provisions
of our Bylaws require us, among other things, to indemnify them against certain
liabilities that may arise by reason of their status or service as directors or
officers (other than liabilities arising from actions not taken in good faith or
in a manner the indemnitee believed to be opposed to our best interests) to
advance their expenses incurred as a result of any proceeding against them as to
which they could be indemnified and to obtain directors’ insurance if available
on reasonable terms. To the extent that indemnification for
liabilities arising under the Securities Act of 1933 may be permitted to
directors, officers or persons controlling our Company as discussed in the
foregoing provisions, we have been informed that in the opinion of the
Commission, such indemnification is against public policy as expressed in the
Securities Act of 1933, and is therefore unenforceable. We believe
that our Certificate of Incorporation and Bylaw provisions are necessary to
attract and retain qualified persons as directors and officers.
We have
in place a directors’ and officers’ liability insurance policy that, subject to
the terms and conditions of the policy, insures our directors and officers
against losses arising from any wrongful act (as defined by the policy) in his
or her capacity as a director or officer. The policy reimburses us for amounts,
which we lawfully indemnifies or is required or permitted by law to indemnify
its directors and officers.
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.
|
|
$50,000,000
Common
Stock and Warrants
1,873,711
Shares
of Common Stock
|
TABLE OF CONTENTS
|
|
|
ABOUT
THIS PROSPECTUS |
1
|
|
|
OUR
BUSINESS |
1
|
|
|
RISK
FACTORS |
5
|
|
|
CAUTIONARY
NOTE REGARDING
FORWARD-LOOKING
STATEMENTS
|
20
|
|
|
USE
OF PROCEEDS |
20
|
|
|
DESCRIPTION
OF COMMON STOCK |
21
|
|
|
DESCRIPTION
OF WARRANTS |
21
|
|
PROSPECTUS
|
PLAN
OF DISTRIBUTION |
23
|
|
|
SELLING
SECURITY HOLDERS |
24
|
|
|
LEGAL
MATTERS |
25
|
|
|
EXPERTS
|
26
|
|
|
WHERE
TO LEARN MORE ABOUT US |
26
|
|
|
INCORPORATION
OF CERTAIN
DOCUMENTS
BY REFERENCE
|
27
|
|
|
DISCLOSURE
OF COMMISSION
POSITION
ON INDEMNIFICATION
FOR
SECURITIES ACT LIABILITIES
|
28
|
|
|
|
|
|
Dated:
July __, 2009
|
The
information in this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and is not soliciting offers to buy these securities in any
state where such offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED JULY 14, 2009
PROSPECTUS
$25,000,000
Common
Stock
This
prospectus relates to the issuance and sale of shares of our common stock for
aggregate proceeds of up to $25,000,000 from time to time through Wm
Smith & Co., as our exclusive sales manager. These sales, if any, will
be made in accordance with the terms of a sales agreement between Wm
Smith & Co. and us. A form of such sales agreement has been filed as an
exhibit to the registration statement of which this prospectus is a part. You
should read this prospectus, particularly the “Risk Factors” beginning on
page A-4, and any supplement carefully before you invest. We also encourage
you to read the documents to which we have referred you in the “Where You Can
Find More Information” section of this prospectus for information on us and for
our financial statements.
Our common stock is registered under
Section 12(b) of the Securities Exchange Act of 1934 and is listed on The Nasdaq
Capital Market under the symbol “PPHM”. Sales of shares of our common
stock, if any, by Wm Smith & Co. will be made in privately negotiated
transactions or in any method permitted by law deemed to be an “at the market”
offering as defined in Rule 415 promulgated under the Securities Act of
1933, as amended, at negotiated prices, at prices prevailing at the time of sale
or at prices related to such prevailing market prices, including sales made
directly on The Nasdaq Capital Market or sales made through a market maker other
than on an exchange. Wm Smith & Co. will make all sales using
commercially reasonable efforts consistent with its normal sales and trading
practices on mutually agreed upon terms between Wm Smith & Co. and us.
On July 10, 2009, the last reported sales price of our common stock on The
Nasdaq Capital Market was $0.76 per share. You are urged to obtain
current market quotations for our common stock.
The compensation to Wm
Smith & Co. for sales of common stock will be 3% of the first
$15,000,000 in gross proceeds from the sale of shares of our common stock and 2%
of the next $10,000,000 in gross proceeds from the sale of shares of our common
stock. The net proceeds from any sales under this prospectus will be used
as described under “Use of Proceeds” in this prospectus. In connection with the
sale of common stock on our behalf, Wm Smith & Co. is an “underwriter”
within the meaning of the Securities Act, and the compensation of the sales
manger constitutes underwriting commissions. We have agreed to provide
indemnification and contribution to Wm Smith & Co. against certain
liabilities, including liabilities under the Securities Act.
__________________________________
Investing
in our securities involves risks. Please carefully review the information under
the heading “Risk Factors” on page A-4. In addition, risks associated with any
investment in our securities will be described in the applicable prospectus
supplement and certain of our filings with the Securities and Exchange
Commission, as described in “Risk Factors” on page A-4.
_________________________________
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus is July __, 2009
ABOUT
THIS PROSPECTUS
|
A-1
|
OUR
BUSINESS
|
A-1
|
RISK
FACTORS
|
A-4
|
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
A-19
|
USE
OF PROCEEDS
|
A-19
|
DESCRIPTION
OF COMMON STOCK
|
A-20
|
PLAN
OF DISTRIBUTION
|
A-20
|
LEGAL
MATTERS
|
A-21
|
EXPERTS
|
A-21
|
WHERE
TO LEARN MORE ABOUT US
|
A-21
|
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
|
A-23
|
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
A-24
|
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. However,
in the event of a material change, this prospectus will be amended or
supplemented accordingly.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with
the SEC utilizing a “shelf” registration process. This prospectus
provides you with a general description of the shares we may offer
hereunder. You should read this prospectus together with
additional information described below under the heading “Where You Can Find
More Information.”
We have
not authorized any dealer, salesman or other person to give any information or
to make any representation other than those contained or incorporated by
reference in this prospectus. You must not rely upon any information or
representation not contained or incorporated by reference in this prospectus.
This prospectus does not constitute an offer to sell or the solicitation of an
offer to buy any securities other than the registered securities to which it
relates, nor does this prospectus constitute an offer to sell or the
solicitation of an offer to buy securities in any jurisdiction to any person to
whom it is unlawful to make such offer or solicitation in such jurisdiction. You
should not assume that the information contained in this prospectus is accurate
on any date subsequent to the date set forth on the front of the document or
that any information we have incorporated by reference is correct on any date
subsequent to the date of the document incorporated by reference, even though
this prospectus is delivered or securities are sold on a later
date.
As used
in this prospectus, the terms “we”, “us”, “our”, “Company” and “Peregrine” refer
to Peregrine Pharmaceuticals, Inc., and its wholly-owned subsidiary, Avid
Bioservices, Inc.
OUR
BUSINESS
This
is only a summary and does not contain all of the information that you should
consider before investing in our Common Stock. You should read the entire
prospectus carefully, including the “Risk Factors” section as well as the
information incorporated by reference into this prospectus under “Where You Can
Find More Information.”
Overview
We are a
clinical stage biopharmaceutical company that manufactures and develops
monoclonal antibodies for the treatment of cancer and serious viral
infections. We are advancing three separate clinical programs with
our novel compounds bavituximab and Cotara® that are the first clinical
candidates under our Anti-Phosphatidylserine (“Anti-PS”) therapeutics and Tumor
Necrosis Therapy (“TNT”) platforms.
In
addition to our clinical programs, we are performing pre-clinical research on
bavituximab and an equivalent fully human antibody as a potential broad-spectrum
treatment for viral hemorrhagic fever infections under a contract awarded
through the Transformational Medical Technologies Initiative (“TMTI”) of the
U.S. Department of Defense's Defense Threat Reduction Agency
(“DTRA”). This federal contract is expected to provide us with up to
$22.3 million in funding over an initial 24-month base period, with $14.3
million having been appropriated through the current federal fiscal year ending
September 30, 2009.
In
addition to our research and development efforts, we operate a wholly owned cGMP
(current Good Manufacturing Practices) contract manufacturing subsidiary, Avid
Bioservices, Inc. (“Avid”). Avid provides contract manufacturing
services for biotechnology and biopharmaceutical companies on a fee-for-service
basis, from pre-clinical drug supplies up through commercial-scale drug
manufacture. In addition to these activities, Avid provides critical
services in support of Peregrine’s product pipeline including manufacture and
scale-up of pre-clinical and clinical drug supplies.
Products
in Clinical Stage Development
Our
products in clinical trials are focused on the treatment of cancer and HCV
infection. The below table is a summary of our clinical trials
and the current status of each clinical trial. Additional information pertaining
to each clinical trial is further discussed below.
|
Product
|
|
|
Indication
|
|
|
Trial
Design
|
|
|
Trial
Status
|
|
|
Bavituximab
|
|
|
Solid
tumor cancers
|
|
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
|
|
In
June 2009, we completed planned patient enrollment in this
study. Patient treatments and follow-up are
continuing. Initial top-line data is expected to be available
in calendar year 2009
|
|
|
Bavituximab
plus docetaxel
|
|
|
Advanced
breast cancer
|
|
|
Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
|
|
|
The
trial was fully enrolled in May 2009. Patient treatment and
follow-up are continuing. Initial top-line data is expected to
be available in calendar year 2009.
|
|
|
Bavituximab
plus carboplatin and paclitaxel
|
|
|
Advanced
breast cancer
|
|
|
Phase
II study designed to treat up to 15 patients initially. Study was expanded
to treat up to a total of 46 patients based on early promising results
observed in the initial 15 patients.
|
|
|
Patient
enrollment was initiated in April 2009 in the final 31-patient second
stage of the trial. The study is actively enrolling
patients.
|
|
|
Bavituximab
plus carboplatin and paclitaxel
|
|
|
Non-small
cell lung cancer (“NSCLC”)
|
|
|
Phase
II study designed to treat up to 21 patients initially. Study was expanded
to treat up to a total of 49 patients based on early promising results
observed in the initial 21 patients.
|
|
|
Patient
enrollment was initiated in April 2009 in the final 28-patient second
stage of the trial. The study is actively enrolling
patients.
|
|
|
Cotara
|
|
|
Glioblastoma
multiforme (“GBM”)
|
|
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
|
|
This
trial is nearing completion of planned patient enrollment.
|
|
|
Cotara
|
|
|
Glioblastoma
multiforme (“GBM”)
|
|
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
|
|
This
study is actively enrolling patients and enrollment is over halfway
completed
|
|
|
Bavituximab
|
|
|
Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
|
|
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
|
|
This
study is actively enrolling patients.
|
|
For a more detailed discussion of our
proprietary platforms, please refer to our Form 10-K for the fiscal year ended
April 30, 2009, filed with the SEC on July 14, 2009.
Company
Information
We are a
Delaware corporation. Our principal offices are located at 14282
Franklin Avenue, Tustin, California 92780. The telephone number of
our principal offices is 714-508-6000. Our internet addresses are
www.peregrineinc.com and www.avidbio.com. The information contained
on our websites is not incorporated by reference and should not be considered a
part of this prospectus. Our website address is included in this
prospectus as an inactive textual reference only.
About
the Offering
Common
stock offered by us in this prospectus
|
|
$25,000,000
aggregate gross sales proceeds
|
|
|
|
Common stock
outstanding before this
offering |
|
236,964,414 shares
(1) |
|
|
|
Use of
proceeds |
|
See “Use of
Proceeds” |
|
|
|
Nasdaq Capital
Market symbol |
|
PPHM |
(1) The
number set forth above does not include approximately 16,806,892shares of our
common stock that, as of July 10, 2009, are reserved for issuance under our
outstanding stock option plans and warrant agreements, calculated as
follows:
|
|
Number
of Shares
of
Common Stock Reserved For Issuance
|
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
|
|
15,114,845 |
|
Common
shares issuable upon exercise of outstanding warrants
|
|
|
1,692,047 |
|
Total
|
|
|
16,806,892 |
|
RISK
FACTORS
You
should consider carefully the risk factors described below, and all other
information contained in or incorporated by reference in this prospectus, before
deciding to invest in our Common Stock. If any of the following risks
actually occur, they may materially harm our business, financial condition,
operating results or cash flow. As a result, the market price of our
Common Stock could decline, and you could lose all or part of your investment.
Additional risks and uncertainties that are not yet identified or that we think
are immaterial may also materially harm our business, operating results or
financial condition and could result in a complete loss of your
investment.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be Able
To Continue Operations.
At April
30, 2009, we had $10,018,000 in cash and cash equivalents. We have
expended substantial funds on the research, development and clinical trials of
our product candidates, and funding the operations of Avid. As a
result, we have historically experienced negative cash flows from operations
since our inception and we expect to continue to experience negative cash flows
from operations for the foreseeable future. Our net losses incurred
during the past three fiscal years ended April 30, 2009, 2008, and 2007 amounted
to $16,524,000, $23,176,000, and $20,796,000, respectively. Unless
and until we are able to generate sufficient revenues from Avid’s contract
manufacturing services and/or from the sale and/or licensing of our products
under development, we expect such losses to continue for the foreseeable
future.
Therefore,
our ability to continue our clinical trials and development efforts and to
continue as a going concern is highly dependent on the amount of cash and cash
equivalents on hand combined with our ability to raise additional capital to
support our future operations. As discussed in Note 1 to the
consolidated financial statements on Form
10-K for the fiscal year ended April 30, 2009, there exists substantial
doubt regarding our ability to continue as a going concern.
We will need to raise additional
capital through one or more methods, including but not limited to, issuing
additional equity or debt, in order to support the costs of our research and
development programs.
With
respect to financing our operations through the issuance of equity, on
March 26, 2009, we entered into an At Market Issuance Sales Agreement (“AMI
Agreement”) with Wm Smith & Co., pursuant to which we may sell shares of our
common stock through Wm Smith & Co., as agent, in registered transactions
from our shelf registration statement on Form S-3, File Number 333-139975, for
aggregate gross proceeds of up to $7,500,000. Shares of common stock
sold under this arrangement were to be sold at market prices. As of
April 30, 2009, we had sold 1,477,938 shares of common stock under the AMI
Agreement for aggregate net proceeds of $550,000. Subsequent to April
30, 2009, we raised net proceeds of $6,685,000 after deducting commissions of 3%
paid to Wm Smith & Co. under the AMI Agreement in exchange for 9,275,859
shares of common stock.
With
respect to financing our operations through the issuance of debt, on December 9,
2008, we entered into a loan and security agreement pursuant to which we had the
ability to borrow up to $10,000,000 (“Loan Agreement”). On December
19, 2008, we received initial funding of $5,000,000, in which principal and
interest are payable over a thirty (30) month period commencing after the
initial six month interest only period. The amount payable under the
Loan Agreement is secured by generally all assets of the Company as further
explained in Note 5 to the consolidated financial statements. Under
the Loan Agreement, we had an option, which expired June 30, 2009, to borrow a
second tranche in the amount of $5,000,000 upon the satisfaction of certain
clinical and financial conditions as set forth in the Loan
Agreement. Although we had satisfied the required clinical and
financial conditions by June 30, 2009, we determined that exercising the option
to borrow the second tranche, and issuing the additional warrants to the
Lenders, was not in the best interests of the Company or our
stockholders.
In
addition to the above, we may also raise additional capital through additional
equity offerings or licensing our products or technology platforms or entering
into similar collaborative arrangements. In order to raise capital
through the issuance of equity, we have filed a new shelf registration statement
on Form S-3 to register up to $50 million gross in proceeds from the sale of our
common stock. Although we are not required to issue any shares of
common stock under this registration statement, we plan to register the
underlying shares of common stock as a potential method of raising additional
capital to support our drug development efforts.
While we
will continue to consider and explore these potential opportunities, there can
be no assurances that we will be successful in raising sufficient capital on
terms acceptable to us, or at all, or that sufficient additional revenues will
be generated from Avid or under potential licensing or partnering agreements to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections and assumptions, which
include projected revenues under signed contracts with existing customers of
Avid, combined with the projected revenues from our government contract, we
believe we have sufficient cash on hand combined with amounts expected to be
received from Avid customers and from our government contract to meet our
obligations as they become due through at least fiscal year
2010. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of third party
or government contracts, technical challenges, or possible reductions in funding
under our government contract, which could reduce or delay our future projected
cash-inflows. In addition, under the Loan Agreement, in the event our
contract with the Defense Threat Reduction Agency is terminated or canceled for
any reason, including reasons pertaining to budget cuts by the government or
reduction in government funding for the program, we would be required to set
aside cash and cash equivalents in an amount equal to 80% of the outstanding
loan balance in a restricted collateral account non-accessible by
us. In the event our projected cash-inflows are reduced or delayed or
if we default on a loan covenant that limits our access to our available cash on
hand, we might not have sufficient capital to operate our business through the
fiscal year 2010 unless we raise additional capital. The
uncertainties surrounding our future cash inflows have raised substantial doubt
regarding our ability to continue as a going concern.
Our Outstanding
Indebtedness To MidCap Financial LLC and BlueCrest Capital Finance, L.P. Imposes
Certain Restrictions On How We Conduct Our Business. In Addition, All
Of Our Assets, Including Our Intellectual Property, Are Pledged To Secure This
Indebtedness. If We Fail To Meet Our Obligations To The Lenders, Our
Payment Obligations May Be Accelerated And The Collateral Securing The Debt May
Be Sold To Satisfy These Obligations.
Pursuant
to a Loan and Security Agreement dated December 9, 2008 (the “Loan
Agreement”), MidCap Financial LLC and BlueCrest Capital Finance, L.P. (the
“Lenders”) have provided us a three-year, $5,000,000 working capital loan, which
funded on December 19, 2008. As collateral to secure our repayment
obligations to the Lenders, we and our wholly-owned subsidiary, Avid
Bioservices, Inc., have granted the Lenders a first priority security interest
in generally all of our respective assets, including our intellectual
property.
The
Loan Agreement also contains various covenants that restrict our operating
flexibility. Pursuant to the Loan Agreement, we may not, among other
things:
|
●
|
incur
additional indebtedness, except for certain permitted indebtedness.
Permitted indebtedness is defined to include accounts payable incurred in
the ordinary course of business, leases of equipment or property incurred
in the ordinary course of business not to exceed in the aggregate $100,000
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
|
|
●
|
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.
|
These
provisions could have important consequences for us, including (i) making
it more difficult for us to obtain additional debt financing from another
lender, or obtain new debt financing on terms favorable to us, because a new
lender will have to be willing to be subordinate to the lenders,
(ii) causing us to use a portion of our available cash for debt repayment
and service rather than other perceived needs and/or (iii) impacting our
ability to take advantage of significant, perceived business
opportunities. Our failure to timely repay our obligations under the
Loan Agreement or meet the covenants set forth in the Loan Agreement could give
rise to a default under the agreement. In the event of an uncured
default, the Loan Agreement provides that all amounts owed to the Lender may be
declared immediately due and payable and the Lenders have the right to enforce
their security interest in the assets securing the Loan Agreement. In
such event, the Lenders could take possession of any or all of our assets in
which they hold a security interest, and dispose of those assets to the extent
necessary to pay off our debts, which would materially harm our
business.
In
The Event Our Contract With The DTRA Is Terminated, Our Loan Requires Us To
Place A Significant Amount Of Our Cash In A Restricted Bank
Account.
Under the
terms of the Loan Agreement, if our contract with the Defense Threat Reduction
Agency is terminated while any principal balance of the loan is outstanding, we
will be required to at all times thereafter maintain cash and cash equivalents
in an amount of at least eighty percent (80%) of the then outstanding principal
balance of the loan in a restricted account over which we will not be permitted
to make withdrawals or otherwise exercise control.
We
Have Had Significant Losses And We Anticipate Future Losses.
We have incurred net losses in most
fiscal years since we began operations in 1981. The following table
represents net losses incurred for each of the past three fiscal
years:
|
Net
Loss
|
Fiscal
Year 2009
|
$16,524,000
|
Fiscal Year
2008 |
$23,176,000
|
Fiscal
Year 2007
|
$20,796,000
|
As of
April 30, 2009, we had an accumulated deficit of $247,360,000. While
we expect to continue to generate revenues from Avid’s contract manufacturing
services, in order to achieve and sustain profitable operations, we must
successfully develop and obtain regulatory approval for our products, either
alone or with others, and must also manufacture, introduce, market and sell our
products. The costs associated with clinical trials and product
manufacturing is very expensive and the time frame necessary to achieve market
success for our products is long and uncertain. We do not expect to
generate product or royalty revenues for at least the next three years, and we
may never generate product and/or royalty revenues sufficient to become
profitable or to sustain profitability.
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of
July 10, 2009, there were 236,964,414 shares of our common stock
outstanding. Substantially all of these shares are eligible for
trading in the public market, subject in some cases to volume and other
limitations. The market price of our common stock may decline if our
common stockholders sell a large number of shares of our common stock in the
public market, or the market perceives that such sales may occur.
We could also issue up to 16,806,892
additional shares of our common stock that are reserved for future issuance
under our stock option plans and for outstanding warrants, as further described
in the following table:
|
|
Number
of Shares
of
Common Stock Reserved For Issuance
|
|
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
|
|
15,114,845 |
|
Common
shares issuable upon exercise of outstanding warrants
|
|
|
1,692,047 |
|
Total
|
|
|
16,806,892 |
|
Of the total options and warrants
outstanding as of July 10, 2009, 5,095,641 would be considered dilutive to
stockholders because we would receive an amount per share which is less than the
market price of our common stock at July 10, 2009.
In
addition, we will need to raise substantial additional capital in the future to
fund our operations. If we raise additional funds by issuing equity
securities, the market price of our securities may decline and our existing
stockholders may experience significant dilution.
Current
Economic Conditions And Capital Markets Are In A Period Of Disruption And
Instability Which Could Adversely Affect Our Ability To Access The Capital
Markets, And Thus Adversely Affect Our Business And Liquidity.
The
current economic conditions and financial crisis have had, and will continue to
have, a negative impact on our ability to access the capital markets, and thus
have a negative impact on our business and liquidity. The shortage of
liquidity and credit combined with recent substantial losses in worldwide equity
markets could lead to an extended worldwide recession. We may face
significant challenges if conditions in the capital markets do not
improve. Our ability to access the capital markets has been and
continues to be severely restricted at a time when we need to access such
markets, which could have a negative impact on our business plans, including our
pre-clinical studies and clinical trial schedules and other research and
development activities. Even if we are able to raise capital, it may
not be at a price or on terms that are favorable to us. We cannot
predict the occurrence of future disruptions or how long the current conditions
may continue.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The market price of our common stock
and the market prices of securities of companies in the biotechnology sector
have generally been highly volatile and are likely to continue to be highly
volatile.
The following table shows the high and
low sales price and trading volume of our common stock for each quarter in the
three fiscal years ended April 30, 2009:
|
|
Common
Stock
Sales
Price
|
|
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
Fiscal
Year 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2009
|
|
$0.52
|
|
|
$0.30
|
|
|
|
3,509 |
|
|
|
|
68 |
|
|
Quarter
Ended January 31, 2009
|
|
$0.47
|
|
|
$0.22
|
|
|
|
1,298 |
|
|
|
|
93 |
|
|
Quarter
Ended October 31, 2008
|
|
$0.40
|
|
|
$0.23
|
|
|
|
1,318 |
|
|
|
|
77 |
|
|
Quarter
Ended July 31, 2008
|
|
$0.53
|
|
|
$0.31
|
|
|
|
2,997 |
|
|
|
|
103 |
|
|
Fiscal
Year 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2008
|
|
$0.73
|
|
|
$0.35
|
|
|
|
3,846 |
|
|
|
|
130 |
|
|
Quarter
Ended January 31, 2008
|
|
$0.65
|
|
|
$0.35
|
|
|
|
3,111 |
|
|
|
|
140 |
|
|
Quarter
Ended October 31, 2007
|
|
$0.79
|
|
|
$0.54
|
|
|
|
2,631 |
|
|
|
|
169 |
|
|
Quarter
Ended July 31, 2007
|
|
$1.40
|
|
|
$0.72
|
|
|
|
21,653 |
|
|
|
|
237 |
|
|
Fiscal
Year 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2007
|
|
$1.26
|
|
|
$0.86
|
|
|
|
6,214 |
|
|
|
|
408 |
|
|
Quarter
Ended January 31, 2007
|
|
$1.39
|
|
|
$1.09
|
|
|
|
4,299 |
|
|
|
|
203 |
|
|
Quarter
Ended October 31, 2006
|
|
$1.48
|
|
|
$1.12
|
|
|
|
3,761 |
|
|
|
|
277 |
|
|
Quarter
Ended July 31, 2006
|
|
$1.99
|
|
|
$1.30
|
|
|
|
23,790 |
|
|
|
|
429 |
|
|
The market price of our common stock
may be significantly impacted by many factors, including, but not limited
to:
|
·
|
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, including but not limited to any potential
reverse stock split;
|
|
·
|
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.
|
These and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock Is
Delisted From The NASDAQ Capital Market.
Our common stock is presently traded on
The NASDAQ Capital Market. To maintain inclusion on The NASDAQ
Capital Market, we must continue to meet the following six listing
requirements:
|
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;
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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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On July 25, 2007, we received a
deficiency notice from The NASDAQ Stock Market notifying us that we had not met
the $1.00 minimum closing bid price requirement for thirty consecutive trading
days as required under NASDAQ listing rules. According to the NASDAQ
notice, we were automatically afforded an initial “compliance period” of 180
calendar days, or until January 22, 2008, to regain compliance with this
requirement. After the initial 180 calendar day period, we remained
noncompliant with the minimum closing bid price requirement but because we were
in compliance with all other initial listing requirements, we were afforded an
additional “compliance period” of 180 calendar days, or until July 21,
2008. Because we did not regain compliance, i.e., the closing bid
price of the Company’s common stock did not meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days prior to July 21, 2008, on July
22, 2008 we received a notice from The NASDAQ Stock Market indicating that we
were not in compliance with the minimum bid price requirement for continued
listing, and as a result our common stock is subject to delisting. On
July 28, 2008, we requested a hearing with the NASDAQ Listing Qualifications
Panel (“Panel”) to review the delisting determination. Our request
for a hearing stayed the delisting pending a decision by the
Panel. The oral hearing took place September 4, 2008 at which we
presented to the Panel our definitive plan to achieve and sustain long-term
compliance with the listing requirements of the NASDAQ Capital
Market. On September 16, 2008, we received a letter from the NASDAQ
Stock Market informing us that the Panel had determined to grant our request to
remain listed, subject to the condition that on or before January 20, 2009, we
must evidence a closing bid price for our common stock of $1.00 or more for a
minimum of ten prior consecutive trading days.
On
October 21, 2008, we conducted our 2008 annual meeting of stockholders at which
our stockholders approved an amendment to our certificate of incorporation to
effect a reverse stock split of the outstanding shares of our common stock at a
ratio to be determined by our Board of Directors within a range of three-for-one
and ten-for-one. Subsequent to our annual meeting of stockholders,
the NASDAQ Stock Market suspended the bid price and market value of publicly
held shares continued listing requirements through April 17, 2009. As
a result of this suspension, the exception granted to us by the Panel, which
required us to demonstrate compliance with the closing minimum bid price
requirement by January 20, 2009, has now been extended to no later than November
11, 2009. On July 14, 2009, we received a letter from The NASDAQ
Stock Market informing us that NASDAQ does not anticipate that it will further
extend its suspension of the bid price requirement.
We intend
to pursue all available options to ensure our continued listing on the NASDAQ
Stock Market, including, if necessary, effecting the reverse stock split of our
outstanding common stock previously approved by our
stockholders. Although we currently meet all other NASDAQ listing
requirements, the market price of our common stock has generally been highly
volatile and we cannot guarantee that we will be able to regain compliance with
the minimum closing bid price requirement within the required compliance
period. If we fail to regain compliance with the minimum closing bid
price requirement or fail to comply with any other of The NASDAQ Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
If our
common stock is delisted, we would apply to have our common stock quoted on the
over-the-counter electronic bulletin board. Upon any such delisting,
our common stock would become subject to the regulations of the Securities and
Exchange Commission relating to the market for penny stocks. A penny
stock, as defined by the Penny Stock Reform Act, is any equity security not
traded on a national securities exchange that has a market price of less than
$5.00 per share. The penny stock regulations generally require that a
disclosure schedule explaining the penny stock market and the risks associated
therewith be delivered to purchasers of penny stocks and impose various sales
practice requirements on broker-dealers who sell penny stocks to persons other
than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In
addition, the broker-dealer must make certain mandated disclosures, including
the actual sale or purchase price and actual bid offer quotations, as well as
the compensation to be received by the broker-dealer and certain associated
persons. The regulations applicable to penny stocks may severely
affect the market liquidity for our common stock and could limit your ability to
sell your securities in the secondary market.
If
We Effect A Reverse Stock Split, The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have
Been Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
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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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Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant
portions of these development efforts are not successfully completed, required
regulatory approvals are not obtained, or any approved products are not
commercially successful, our business, financial condition and results of
operations may be materially harmed.
Because
we have not begun the commercial sale of any of our products, our revenue and
profit potential is unproven and our limited operating history makes it
difficult for an investor to evaluate our business and prospects. Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of
our products, and our products may not generate revenues in the
future. Our business and prospects should be considered in light of
the heightened risks and unexpected expenses and problems we may face as a
company in an early stage of development in a new and rapidly evolving
industry.
We
Are Primarily Focusing Our Activities And Resources On The Development Of
Bavituximab And Depend On Its Success.
We are
focusing most of our near-term research and development activities and resources
on bavituximab, and we believe a significant portion of the value of our Company
relates to our ability to develop this drug candidate. The
development of bavituximab is subject to many risks, including the risks
discussed in other risk factors. If the results of clinical trials of
bavituximab, the regulatory decisions affecting bavituximab, the anticipated or
actual timing and plan for commercializing bavituximab, or, ultimately, the
market acceptance of bavituximab do not meet our, your, analysts’ or others’
expectations, the market price of our common stock could be adversely
affected.
Our
Product Development Efforts May Not Be Successful.
Our product candidates have not
received regulatory approval and are generally in research, pre-clinical and
various clinical stages of development. If the results from any of
the clinical trials are poor, those results may adversely affect our ability to
raise additional capital or obtain regulatory approval to conduct additional
clinical trials, which will affect our ability to continue full-scale research
and development for our antibody technologies. In addition, our
product candidates may take longer than anticipated to progress through clinical
trials, or patient enrollment in the clinical trials may be delayed or prolonged
significantly, thus delaying the clinical trials. Patient enrollment
is a function of many factors, including the size of the patient population, the
nature of the protocol, the proximity of patients to the clinical sites, and the
eligibility criteria for the study. In addition, because our Cotara®
product currently in clinical trials represents a departure from more commonly
used methods for cancer treatment, potential patients and their doctors may be
inclined to use conventional therapies, such as chemotherapy, rather than enroll
patients in our clinical study.
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming, And
Their Outcome Is Uncertain.
In order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct
extensive pre-clinical testing and “adequate and well-controlled” clinical
trials. Conducting clinical trials is a lengthy, time-consuming and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty and intended use of the product
candidate, and often can be several years or more per trial. Delays
associated with products for which we are directly conducting pre-clinical or
clinical trials may cause us to incur additional operating
expenses. Moreover, we may continue to be affected by delays
associated with the pre-clinical testing and clinical trials of certain product
candidates conducted by our partners over which we have no
control. The commencement and rate of completion of clinical trials
may be delayed by many factors, including, for example:
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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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Even if
we obtain positive results from pre-clinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may
not demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence
new clinical trials from time to time in the course of our business as our
product development work continues. The failure of clinical trials to
demonstrate safety and effectiveness for our desired indications could harm the
development of that product candidate as well as other product
candidates. Any change in, or termination of, our clinical trials
could materially harm our business, financial condition and results of
operations.
We
Rely On Third Parties To Conduct Our Clinical Trials And Many Of Our Preclinical
Studies. If Those Parties Do Not Successfully Carry Out Their
Contractual Duties Or Meet Expected Deadlines, Our Drug Candidates May Not
Advance In A Timely Manner Or At All.
In the
course of our discovery, preclinical testing and clinical trials, we rely on
third parties, including universities, investigators and clinical research
organizations, to perform critical services for us. For example, we rely on
third parties to conduct our clinical trials and many of our preclinical
studies. Clinical research organizations and investigators are responsible for
many aspects of the trials, including finding and enrolling patients for testing
and administering the trials. Although we rely on these third parties
to conduct our clinical trials, we are responsible for ensuring that each of our
clinical trials is conducted in accordance with its investigational plan and
protocol. Moreover, the FDA and foreign regulatory authorities
require us to comply with regulations and standards, commonly referred to as
good clinical practices, or GCPs, for conducting, monitoring, recording and
reporting the results of clinical trials to ensure that the data and results are
scientifically credible and accurate and that the trial subjects are adequately
informed of the potential risks of participating in clinical
trials. Our reliance on third parties does not relieve us of these
responsibilities and requirements. These third parties may not be
available when we need them or, if they are available, may not comply with all
regulatory and contractual requirements or may not otherwise perform their
services in a timely or acceptable manner, and we may need to enter into new
arrangements with alternative third parties and our clinical trials may be
extended, delayed or terminated. These independent third parties may
also have relationships with other commercial entities, some of which may
compete with us. In addition, if such third parties fail to perform
their obligations in compliance with our clinical trial protocols, our clinical
trials may not meet regulatory requirements or may need to be
repeated. As a result of our dependence on third parties, we may face
delays or failures outside of our direct control. These risks also
apply to the development activities of our collaborators, and we do not control
our collaborators’ research and development, clinical trials or regulatory
activities. We do not expect any drugs resulting from our
collaborators’ research and development efforts to be commercially available for
many years, if ever.
We
Do Not Have Experience As a Company Conducting Large-Scale Clinical Trials, Or
In Other Areas Required For The Successful Commercialization And Marketing Of
Our Product Candidates.
Preliminary results from clinical
trials of bavituximab may not be indicative of successful outcomes in later
stage trials. Negative or limited results from any current or future
clinical trial could delay or prevent further development of our product
candidates which would adversely affect our business.
We have no experience as a Company in
conducting large-scale, late stage clinical trials, and our experience with
early-stage clinical trials with small numbers of patients is
limited. In part because of this limited experience, we cannot be
certain that planned clinical trials will begin or be completed on time, if at
all. Large-scale trials would require either additional financial and
management resources, or reliance on third-party clinical investigators,
clinical research organizations (“CROs”) or consultants. Relying on third-party
clinical investigators or CROs may force us to encounter delays that are outside
of our control. Any such delays could have a material adverse effect
on our business.
We
also do not currently have marketing and distribution capabilities for our
product candidates. Developing an internal sales and distribution capability
would be an expensive and time-consuming process. We may enter into
agreements with third parties that would be responsible for marketing and
distribution. However, these third parties may not be capable of
successfully selling any of our product candidates. The inability to
commercialize and market our product candidates could materially affect our
business.
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely Impacted By
Social, Political And Economic Factors Affecting The Particular Foreign
Country.
We are
presently conducting clinical trials in India and the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
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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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Because
we will be conducting a number of our Phase II clinical trials in India and the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from
pre-clinical and clinical activities are subject to varying interpretations,
which may delay, limit or prevent regulatory approval.
Positive
results from our pre-clinical studies, Phase I and the first stage of our Phase
II clinical trials should not be relied upon as evidence that later or
larger-scale clinical trials will succeed. The Phase I studies we
have completed to date have been designed to primarily assess safety in a small
number of patients. In addition, while we have completed the first
stage of all three of our Phase II studies, and obtained positive results with
respect to our primary endpoints, our Phase II trials are open-label, Simon
two-stage design trials to evaluate the safety and efficacy on bavituximab in
combination with chemotherapy drugs in a limited number of
patients. The limited results we have obtained, and will obtain in
the Phase II trials, may not predict results for any future studies and also may
not predict future therapeutic benefit of our drug candidates. We
will be required to demonstrate through larger-scale clinical trials that
bavituximab and Cotara® are safe and effective for use in a diverse population
before we can seek regulatory approval for their commercial
sale. There is typically an extremely high rate of attrition from the
failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be Profitable.
Even if bavituximab, Cotara®, or any
future product candidate is approved for commercial sale by the FDA or other
regulatory authorities, the degree of market acceptance of any approved product
candidate by physicians, healthcare professionals and third-party payors and our
profitability and growth will depend on a number of factors,
including:
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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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In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the
market. If any products we may develop do not achieve market
acceptance, then we may not generate sufficient revenue to achieve or maintain
profitability.
In
addition, even if our products achieve market acceptance, we may not be able to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective or render our products obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We have
completed Phase I and Phase I/II studies with Cotara® for the treatment of brain
cancer. In addition, we are currently conducting a dose confirmation
and dosimetry clinical trial in patients with recurrent glioblastoma multiforme
(“GBM”). We are also currently conducting a Phase II safety and
efficacy study using a single administration of the drug through an optimized
delivery method. Taken together, the
current U.S. study along with data collected from the Phase II safety and
efficacy study should provide the safety, dosimetry and efficacy data that will
support the final design of the larger Phase III study. Once we
complete these two Cotara® studies for the treatment of GBM, substantial
financial resources will be needed to complete the final part of the trial and
any additional supportive clinical studies necessary for potential product
approval. We do not presently have the financial resources internally
to complete the larger Phase III study. We therefore intend to
continue to seek a licensing or funding partner for Cotara®, and hope that the
data from our clinical studies will enhance our opportunities of finding such
partner. If a partner is not found for this technology, we may not be
able to advance the project past its current state of
development. Because there are a limited number of companies which
have the financial resources, the internal infrastructure, the technical
capability and the marketing infrastructure to develop and market a
radiopharmaceutical based oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
Our
Dependency On Our Radiolabeling Suppliers May Negatively Impact Our Ability To
Complete Clinical Trials And Market Our Products.
We have
procured our antibody radioactive isotope combination services (“radiolabeling”)
for Cotara® with Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with
the Board of Radiation & Isotope Technology (“BRIT”) for our Phase II study
in India. If either of these suppliers is unable to continue to
qualify its respective facility or radiolabel and supply our antibody in a
timely manner, our current clinical trials using radiolabeling technology could
be adversely affected and significantly delayed. While there are
other suppliers for radioactive isotope combination services in the U.S., our
clinical trial would be delayed for up to twelve to eighteen months because it
may take that amount of time to certify a new facility under current Good
Manufacturing Practices and qualify the product, plus we would incur significant
costs to transfer our technology to another vendor. In addition, the
number of facilities that can perform these radiolabeling services is very
limited. Prior to commercial distribution of any of our products, if
approved, we will be required to identify and contract with a company for
commercial antibody manufacturing and radioactive isotope combination
services. An antibody that has been combined with a radioactive
isotope, such as Iodine-131, cannot be stored for long periods of time, as it
must be used within one week of being radiolabeled to be
effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our
therapeutic products must be manufactured for development and, following
approval, in commercial quantities, in compliance with regulatory requirements
and at acceptable costs. Currently, we manufacture all pre-clinical
and clinical material through Avid Bioservices, our wholly owned
subsidiary. While we believe our current facilities are adequate for
the manufacturing of product candidates for clinical trials, our facilities may
not be adequate to produce sufficient quantities of any products for commercial
sale.
If we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially
harmed.
We may
also encounter problems with the following:
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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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In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities, provided
it had not already registered. The facilities will be subject to
inspections confirming compliance with cGMP or other regulations. If
any of our third-party manufacturers or we fail to maintain regulatory
compliance, the FDA can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a new drug product or
biologic product, or revocation of a pre-existing approval. As a
result, our business, financial condition and results of operations may be
materially harmed.
We
Currently Depend On A Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded up to a five-year contract potentially worth up to
$44.4 million to test and develop bavituximab and an equivalent fully human
antibody as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (“TMTI”) of the U.S. Department
of Defense's Defense Threat Reduction Agency “DTRA”). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $14.3 million having been appropriated through the
current federal fiscal year ending September 30, 2009. The remainder
of the $22.3 million in funding is expected to be appropriated over the
remainder of the two-year base period ending June 29, 2010. Subject
to the progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period. Work under this contract
commenced on June 30, 2008. If we do not receive the expected funding
under this contract, we may not be able to develop therapeutics to treat
hemorrhagic fever virus infection nor otherwise receive the other indirect
benefits that may be derived from receipt of the full funding under this
contract.
Federal
Government Contracts Contain Provisions Giving Government Customers A Variety Of
Rights That Are Unfavorable To Us, Including The Ability To Terminate A Contract
At Any Time For Convenience.
Federal
government contracts, such as our contract with the DTRA, contain provisions,
and are subject to laws and regulations, that give the government rights and
remedies not typically found in commercial contracts. These provisions may allow
the government to:
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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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If the
government terminates our contract for convenience, we may recover only our
incurred or committed costs, settlement expenses and profit on work completed
prior to the termination. If the government terminates our contract for default,
we may not recover even those amounts, and instead may be liable for excess
costs incurred by the government in procuring undelivered items and services
from another source. If the DTRA were to unexpectedly terminate or cancel, or
decline to exercise the option to extend our contract beyond the base period,
our revenues, product development efforts and operating results would be
materially harmed.
We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We face
an inherent business risk of exposure to product liability claims in the event
that the administration of one of our drugs during a clinical trial adversely
affects or causes the death of a patient. Although we maintain
product liability insurance for clinical studies in the amount of $3,000,000 per
occurrence or $3,000,000 in the aggregate on a claims-made basis, this coverage
may not be adequate. Product liability insurance is expensive,
difficult to obtain and may not be available in the future on acceptable terms,
if at all. Our inability to obtain sufficient insurance coverage on
reasonable terms or to otherwise protect against potential product liability
claims in excess of our insurance coverage, if any, or a product recall, could
negatively impact our financial position and results of operations.
In
addition, the contract manufacturing services that we offer through Avid expose
us to an inherent risk of liability as the antibodies or other substances
manufactured by Avid, at the request and to the specifications of our customers,
could possibly cause adverse effects or have product defects. We
obtain agreements from our customers indemnifying and defending us from any
potential liability arising from such risk. There can be no assurance
that such indemnification agreements will adequately protect us against
potential claims relating to such contract manufacturing services or protect us
from being named in a possible lawsuit. Although Avid has procured
insurance coverage, there is no guarantee that we will be able to maintain our
existing coverage or obtain additional coverage on commercially reasonable
terms, or at all, or that such insurance will provide adequate coverage against
all potential claims to which we might be exposed. A partially
successful or completely uninsured claim against Avid would have a material
adverse effect on our consolidated operations.
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary
positions by filing United States and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to
developing our business. However, if we fail to obtain and maintain
patent protection for our proprietary technology, inventions and improvements,
our competitors could develop and commercialize products that would otherwise
infringe upon our patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of
claims in the biotechnology and biopharmaceutical fields are still
evolving. Accordingly, the degree of future protection for our patent
rights is uncertain. The risks and uncertainties that we face with
respect to our patents include the following:
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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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we
may be unable to develop additional proprietary technologies that are
patentable;
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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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We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would Be
Expensive And Time Consuming.
In order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to
interference or opposition proceedings conducted in patent and trademark offices
to determine the priority and patentability of inventions. The
defense of intellectual property rights, including patent rights through
lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings, would be costly and divert our technical and
management personnel from their normal responsibilities. An adverse
determination of any litigation or defense proceedings could put our pending
patent applications at risk of not being issued.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of
litigation. For example, during the course of this kind of
litigation, confidential information may be inadvertently disclosed in the form
of documents or testimony in connection with discovery requests, depositions or
trial testimony. This disclosure could have a material adverse effect
on our business and our financial results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The pharmaceutical and biotechnology
industry is intensely competitive and subject to rapid and significant
technological change. Many of the drugs that we are attempting to
discover or develop will be competing with existing therapies. In
addition, we are aware of several pharmaceutical and biotechnology companies
actively engaged in research and development of antibody-based products that
have commenced clinical trials with, or have successfully commercialized,
antibody products. Some or all of these companies may have greater
financial resources, larger technical staffs, and larger research budgets than
we have, as well as greater experience in developing products and running
clinical trials. We expect to continue to experience significant and
increasing levels of competition in the future. In addition, there
may be other companies which are currently developing competitive technologies
and products or which may in the future develop technologies and products that
are comparable or superior to our technologies and products.
We are conducting the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of recurrent
glioblastoma multiforme (“GBM”), the most aggressive form of brain
cancer. Approved treatments for brain cancer include the Gliadel®
Wafer (polifeprosan 20 with carmustine implant) from Eisai, Inc., Temodar®
(temozolomide) from Schering-Plough Corporation and Avastin®
(bevacizumab). Gliadel® is inserted in the tumor cavity following
surgery and releases a chemotherapeutic agent over time. Temodar® is
administered orally to patients with brain cancer. Avastin® is a
monoclonal antibody that targets vascular endothelial growth factor to prevent
the formation of new tumor blood vessels.
Because Cotara® targets brain tumors
from the inside out, it is a novel treatment dissimilar from other drugs in
development for this disease. Some products in development may
compete with Cotara® should they become approved for marketing. These
products include, but are not limited to: 131I-TM601, a radiolabeled
chlorotoxin peptide being developed by TransMolecular, Inc., CDX-110, a peptide
vaccine under development by Celldex, cilengitide, an integrin-targeting peptide
being evaluated by Merk KGaA, and cediranib, a VEGFR tyrosine kinase inibitor
being developed by AstraZeneca. In addition, oncology products
marketed for other indications such as Gleevec® (Novartis), Tarceva®
(Genentech/OSI), and Nexavar® (Bayer), are being tested in clinical trials for
the treatment of brain cancer.
Bavituximab is currently in clinical
trials for the treatment of advanced solid cancers. There are a
number of possible competitors with approved or developmental targeted agents
used in combination with standard chemotherapy for the treatment of
cancer, including but not limited to, Avastin® by Genentech, Inc., Gleevec®
by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and Genentech, Inc., Erbitux®
by ImClone Systems Incorporated and Bristol-Myers Squibb Company, Rituxan® and
Herceptin® by Genentech, Inc., and Vectibix™ by Amgen. There are a
significant number of companies developing cancer therapeutics using a variety
of targeted and non-targeted approaches. A direct comparison of these
potential competitors will not be possible until bavituximab advances to
later-stage clinical trials.
In addition, we are evaluating
bavituximab for the treatment of HCV. Bavituximab is a first-in-class
approach for the treatment of HCV. We are aware of no other products
in development targeting phosphatidylserine as a potential therapy for
HCV. There are a number of companies that have products approved and
on the market for the treatment of HCV, including but not limited
to: Peg-Intron® (pegylated interferon-alpha-2b), Rebetol®
(ribavirin), and Intron-A (interferon-alpha-2a), which are marketed by
Schering-Plough Corporation, and Pegasys® (pegylated interferon-alpha-2a),
Copegus® (ribavirin USP) and Roferon-A® (interferon-alpha-2a), which are
marketed by Roche Pharmaceuticals, and Infergen® (interferon alfacon-1) now
marketed by Three Rivers Pharmaceuticals, LLC. First line treatment
for HCV has changed little since alpha interferon was first introduced in
1991. The current standard of care for HCV includes a combination of
an alpha interferon (pegylated or non-pegylated) with ribavirin. This
combination therapy is generally associated with considerable toxicity including
flu-like symptoms, hematologic changes and central nervous system side effects
including depression. It is not uncommon for patients to discontinue
alpha interferon therapy because they are unable to tolerate the side effects of
the treatment.
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in
development. Later-stage developmental treatments include
improvements to existing therapies, such as Albuferon™ (albumin interferon) from
Human Genome Sciences, Inc. Other developmental approaches include,
but are not limited to, protease inhibitors such as telaprevir from Vertex
Pharmaceuticals Incorporated and boceprevir from Schering-Plough
Corporation.
Avid
Bioservices, Our subsidiary, Is Exposed To Risks Resulting From Its Small
Customer Base.
A significant portion of Avid
Bioservices’ revenues have historically been derived from a small customer
base. These customers typically do not enter into long-term contracts
because their need for drug supply depends on a variety of factors, including
the drug’s stage of development, their financial resources, and, with respect to
commercial drugs, demand for the drug in the market. Our results of
operations could be adversely affected if revenue from any one of our primary
customers is significantly reduced or eliminated
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our Products.
Our
success is dependent, in part, upon a limited number of key executive officers,
each of whom is an at-will employee, and also upon our scientific
researchers. For example, because of his extensive understanding of
our technologies and product development programs, the loss of Mr. Steven W.
King, our President & Chief Executive Officer and Director, would adversely
affect our development efforts and clinical trial programs during the six to
twelve month period that we estimate it would take to find and train a qualified
replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
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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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Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although
we believe these provisions and our rights plan collectively provide for an
opportunity to receive higher bids by requiring potential acquirers to negotiate
with our Board of Directors, they would apply even if the offer may be
considered beneficial by some stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace
or remove our current management by making it more difficult for stockholders to
replace members of our Board of Directors, which is responsible for appointing
the members of our management.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents we incorporate by reference herein contain
forward-looking statements within the meaning of Sections 27A of the
Securities Act of 1933, as amended, which we refer to as the Securities Act, and
21E of the Exchange Act. Some of the statements under “About Peregrine
Pharmaceuticals, Inc.”, “Risk Factors” and elsewhere in this prospectus
constitute “forward-looking” statements. These statements involve
known and unknown risks, including, among others, risks resulting from economic
and market conditions, the regulatory environment in which we operate, pricing
pressures, accurately forecasting operating and capital expenditures and
clinical trial costs, competitive activities, uncertainties of litigation and
other business conditions, and are subject to uncertainties and assumptions
contained elsewhere in this prospectus. We base our forward-looking
statements on information currently available to us, and, in accordance with the
requirements of federal securities laws, we will disclose to you material
developments affecting such statements. Our actual operating results
and financial performance may prove to be very different from what we have
predicted as of the date of this prospectus due to certain risks and
uncertainties. The risks described above in the section entitled “Risk Factors”
specifically address some of the factors that may affect our future operating
results and financial performance.
USE
OF PROCEEDS
Except as
otherwise provided in an applicable prospectus supplement, we will use the net
proceeds from the sale of the securities for general corporate purposes, which
may include research and development expenses, clinical trial expenses,
repayment of debt, expansion of our contract manufacturing capabilities and
increasing our working capital. Pending the application of the net
proceeds, we expect to invest the proceeds in investment grade, interest bearing
securities. We will not receive any proceeds from the sale of common stock by
the selling security holders.
The
principal purposes of this offering are to increase our operating and financial
flexibility. As of the date of this prospectus, we cannot specify
with certainty all of the particular uses for the net proceeds we will have upon
completion of this offering. Accordingly, our management will have
broad discretion in the application of net proceeds, if any.
DESCRIPTION
OF COMMON STOCK
As of the
date of the prospectus, we are authorized to issue up to 325,000,000 shares of
common stock, $.001 par value per share. As of July 10, 2009,
236,964,414 shares of our common stock were outstanding. In addition, we
reserved an additional 16,806,892 shares of common stock for issuance under our
stock option plans and warrant agreements that were issued and outstanding or
reserved for issuance as of July 10, 2009.
Dividends
Our Board
of Directors may, out of funds legally available, at any regular or special
meeting, declare dividends to the holders of shares of our common stock as and
when they deem expedient, subject to the rights of holders of the preferred
stock, if any.
Voting
Each
share of common stock entitles the holders to one vote per share on all matters
requiring a vote of the stockholders, including the election of
directors. No holders of shares of common stock shall have the right
to vote such
shares cumulatively in any election for the Board of Directors.
Rights
Upon Liquidation
In the
event of our voluntary or involuntary liquidation, dissolution, or winding up,
the holders of our common stock will be entitled to share equally in our assets
available for distribution after payment in full of all debts and after the
holders of preferred stock, if any, have received their liquidation preferences
in full.
Miscellaneous
No
holders of shares of our common stock shall have any preemptive rights to
subscribe for, purchase or receive any shares of any class, whether now or
hereafter authorized, or any options or warrants to purchase any such shares, or
any securities convertible into or exchanged for any such shares, which may at
any time be issued, sold or offered for sale by us.
Sales Agreement with Wm
Smith & Co.
We have
entered into a sales agreement with Wm Smith & Co. pursuant to which we
may issue and sell shares of our common stock for aggregate gross proceeds of up
to $25,000,000 from time to time through Wm Smith & Co, as our
exclusive sales manager. The form of the sales agreement is an exhibit to the
registration statement of which this prospectus is a part and is incorporated by
reference into this prospectus. The sales, if any, of common stock made under
the sales agreement will be made in privately negotiated transactions or in any
method permitted by law deemed to be an “at the market” offering as defined in
Rule 415 promulgated under the Securities Act of 1933, as amended, at
negotiated prices, at prices prevailing at the time of sale or at prices related
to such prevailing market prices, including sales made directly on The Nasdaq
Capital Market, or sales made through a market maker other than on an exchange.
Wm Smith & Co will make all sales using commercially reasonable efforts
consistent with its normal sales and trading practices on mutually agreed upon
terms between Wm Smith & Co. and us.
Wm Smith
& Co. will sell the shares of common stock subject to the sales agreement
from time to time as agreed upon by us and Wm Smith & Co. Each time we
wish to issue and sell shares of common stock, we will notify Wm
Smith & Co. of the proposed terms of the placement. Subject to the
terms and conditions of the sales agreement, including agreement by Wm
Smith & Co. of the terms of the placement, Wm Smith & Co. will
use its commercially reasonable efforts, consistent with its normal trading and
sales practices, to try to sell all of the designated shares of common stock. We
may instruct Wm Smith & Co. not to sell shares of common stock if the
sales cannot be effected at or above the price designated by us in any such
instruction. Wm Smith & Co. will not be obligated to attempt to sell
shares if the market price is below the designated price. We or Wm
Smith & Co. may suspend the offering of shares of common stock upon
proper notice and subject to other conditions.
The
compensation to Wm Smith & Co. for sales of common stock will equal a
fixed commission rate of 3% of the first $15,000,000 in gross proceeds from the
sale of shares of our common stock and 2% of the next $10,000,000 in gross
proceeds from the sale of shares of our common stock. The remaining sales
proceeds, after deducting offering expenses and any transaction fees imposed by
any governmental or self-regulatory organization in connection with the sales,
will equal our net proceeds for the sale of the shares.
Settlement
for sales of common stock will occur on the third business day following the
date on which any sales are made in return for payment of the net proceeds to
us. There is no arrangement for funds to be received in an escrow, trust or
similar arrangement.
In
connection with the sale of common stock on our behalf, Wm Smith & Co.
is an “underwriter” within the meaning of the Securities Act, and compensation
to Wm Smith & Co. constitutes underwriting commissions. We have agreed
to provide indemnification and contribution to Wm Smith & Co. against
certain civil liabilities, including liabilities under the Securities Act. Wm
Smith & Co. may engage in transactions with, or perform services for,
us in the ordinary course of business.
The
offering of our common stock in accordance with the sales agreement will
terminate upon the earlier of:
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the
sale of shares of common stock for aggregate gross proceeds of
$25,000,000; or
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the
termination of the sales
agreement.
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Wm Smith
may terminate the sales agreement at any time in certain circumstances,
including the occurrence of a material adverse change that, in Wm Smith’s
reasonable judgment, may impair its ability to sell the common stock, the
Company’s failure to satisfy any condition under of the Agreement or a
suspension or limitation of trading of the Company’s common stock on
NASDAQ. The Company may terminate the sales agreement at any time
upon 30 days prior notice while Wm Smith may terminate the Agreement at any
time upon 90 days prior notice.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus has been passed upon for
us by Snell & Wilmer LLP, Costa Mesa, California, counsel to Peregrine
Pharmaceuticals, Inc. Certain legal matters will be passed upon for
any agents or underwriters by counsel for such agents or underwriters identified
in the applicable prospectus supplement.
EXPERTS
Ernst
& Young LLP, independent registered public accounting firm, has audited our
consolidated financial statements and schedule included in our Annual Report on
Form 10-K for the year ended April 30, 2009 (which contains an explanatory
paragraph describing conditions that raise substantial doubt about the Company's
ability to continue as a going concern as described in Note 1 to the
consolidated financial statements) and the effectiveness of our internal control
over financial reporting as of April 30, 2009, as set forth in their reports,
which are incorporated by reference in this prospectus and elsewhere in the
registration statement. Our financial statements and schedule are incorporated
by reference in reliance on Ernst & Young LLP's reports, given on their
authority as experts in accounting and auditing.
WHERE
TO LEARN MORE ABOUT US
We have
filed with the SEC a registration statement on Form S-3 under the
Securities Act with respect to the securities being offered under this
prospectus. This prospectus, which forms part of the registration statement,
does not contain all of the information in the registration statement. We have
omitted certain parts of the registration statement, as permitted by the rules
and regulations of the SEC. For further information regarding the Company and
our securities, please see the registration statement and our other filings with
the SEC, including our annual, quarterly, and current reports and any proxy
statements, which you may read and copy at the Public Reference Room maintained
by the SEC at 100 F Street, N.E., Washington, D.C. 20549. You may
obtain information about the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our public filings with the SEC are also available to the public
on the SEC’s Internet website at www.sec.gov. Our Internet website address is
www.peregrineinc.com.
We
furnish holders of our common stock with annual reports containing audited
financial statements prepared in accordance with accounting principles generally
accepted in the United States following the end of each fiscal year. We file
reports and other information with the SEC pursuant to the reporting
requirements of the Exchange Act.
Descriptions
in this prospectus of documents are intended to be summaries of the material,
relevant portions of those documents, but may not be complete descriptions of
those documents. For complete copies of those documents, please refer to the
exhibits to the registration statement and other documents filed by us with the
SEC.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC
allows us to “incorporate by reference” into this prospectus the documents we
file with them, which means that we can disclose important information to you by
referring you to these documents. The information that we incorporate by
reference into this prospectus is considered to be part of this prospectus, and
information that we file later with the Commission automatically updates and
supersedes any information in this prospectus. We have filed the
following documents with the Commission. These documents are
incorporated by reference as of their respective dates of filing:
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1.
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our
Annual Report on Form 10-K for the fiscal year ended April 30, 2009, as
filed with the Commission on July 14, 2009, 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, 2008, as filed with the Commission on
August 28, 2008;
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3.
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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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4.
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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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5.
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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,
2009.
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All
documents we have filed with the Commission under Sections 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934 after the date of the initial
registration statement and prior to the effective date of the registration
statement or subsequent to the date of this prospectus and prior to the filing
of a post-effective amendment indicating that all securities offered have been
sold (or which re-registers all securities then remaining unsold), are deemed to
be incorporated in this prospectus by this reference and to be made a part of
this prospectus from the date of filing of such documents.
We will
provide, without charge, upon written or oral request of any person to whom a
copy of this prospectus is delivered, a copy of any or all of the foregoing
documents and information that has been or may be incorporated in this
prospectus by reference, other than exhibits to such documents. Requests for
such documents and information should be directed to:
Peregrine
Pharmaceuticals, Inc.
Attn:
Paul J. Lytle, Chief Financial Officer
14282
Franklin Avenue
Tustin,
California 92780-7017
(714)
508-6000
See also
“Where to Learn More About Us.”
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
Our
Bylaws provide that we will indemnify our directors and officers and may
indemnify our employees and other agents to the fullest extent permitted by
law. We believe that indemnification under our Bylaws covers at least
negligence and gross negligence by indemnified parties, and permits us to
advance litigation expenses in the case of stockholder derivative actions or
other actions, against an undertaking by the indemnified party to repay such
advances if it is ultimately determined that the indemnified party is not
entitled to indemnification. We have liability insurance for our
directors and officers.
In
addition, our Certificate of Incorporation provides that, under Delaware law,
our directors shall not be liable for monetary damages for breach of the
directors’ fiduciary duty as a director to us and our
stockholders. This provision in the Certificate of Incorporation does
not eliminate the directors’ fiduciary duty, and in appropriate circumstances
equitable remedies such as injunctive or other forms of non-monetary relief will
remain available under Delaware law. In addition, each director will
continue to be subject to liability for breach of the director’s duty of loyalty
to our Company for acts or omissions not in good faith or involving intentional
misconduct, for knowing violations of law, for actions leading to improper
personal benefit to the director, and for payment of dividends or approval of
stock repurchases or redemptions that are unlawful under Delaware
law. The provision also does not affect a director’s responsibilities
under any other law, such as the federal securities laws or state or federal
environmental laws.
Provisions
of our Bylaws require us, among other things, to indemnify them against certain
liabilities that may arise by reason of their status or service as directors or
officers (other than liabilities arising from actions not taken in good faith or
in a manner the indemnitee believed to be opposed to our best interests) to
advance their expenses incurred as a result of any proceeding against them as to
which they could be indemnified and to obtain directors’ insurance if available
on reasonable terms. To the extent that indemnification for
liabilities arising under the Securities Act of 1933 may be permitted to
directors, officers or persons controlling our Company as discussed in the
foregoing provisions, we have been informed that in the opinion of the
Commission, such indemnification is against public policy as expressed in the
Securities Act of 1933, and is therefore unenforceable. We believe
that our Certificate of Incorporation and Bylaw provisions are necessary to
attract and retain qualified persons as directors and officers.
We have
in place a directors’ and officers’ liability insurance policy that, subject to
the terms and conditions of the policy, insures our directors and officers
against losses arising from any wrongful act (as defined by the policy) in his
or her capacity as a director or officer. The policy reimburses us for amounts,
which we lawfully indemnifies or is required or permitted by law to indemnify
its directors and officers.
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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$25,000,000
Common
Stock
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TABLE OF CONTENTS
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ABOUT
THIS PROSPECTUS
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A-1
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OUR
BUSINESS |
A-1
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RISK
FACTORS |
A-4
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CAUTIONARY
NOTE REGARDING
FORWARD-LOOKING
STATEMENTS
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A-19
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PROSPECTUS
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USE
OF PROCEEDS |
A-19
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DESCRIPTION
OF COMMON STOCK |
A-20
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PLAN
OF DISTRIBUTION |
A-20
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LEGAL
MATTERS |
A-21
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EXPERTS |
A-21
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WHERE
TO LEARN MORE ABOUT US |
A-21
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INCORPORATION
OF CERTAIN
DOCUMENTS BY
REFERENCE
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A-23
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DISCLOSURE
OF COMMISSION
POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT
LIABILITIES
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A-24
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|
|
|
Dated:
July __, 2009
|
PART
II. INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM
14. OTHER EXPENSES OF ISSUANCES AND DISTRIBUTION
The
following table sets forth the estimated expenses in connection with the
offering described in this registration statement:
SEC
registration fee
|
|
$ |
2,869 |
|
Printing
and engraving expenses
|
|
|
2,500
|
* |
Legal
fees and expenses
|
|
|
10,000
|
* |
Accounting
fees and expenses
|
|
|
15,000
|
* |
Miscellaneous
|
|
|
3,000
|
* |
|
|
|
|
|
Total
|
|
$ |
33,369 |
|
* Estimated
ITEM
15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our
Certificate of Incorporation (the “Certificate”) and Bylaws include provisions
that eliminate the directors personal liability for monetary damages to the
fullest extent possible under Delaware Law or other applicable law (the
“Director Liability Provision”). The Director Liability Provision
eliminates the liability of directors to us and our stockholders for monetary
damages arising out of any violation by a director of his fiduciary duty of due
care. However, the Director Liability Provision does not eliminate
the personal liability of a director for (i) breach of the director’s duty of
loyalty, (ii) acts or omissions not in good faith or involving intentional
misconduct or knowing violation of law, (iii) payment of dividends or
repurchases or redemption of stock other than from lawfully available funds, or
(iv) any transactions from which the director derived an improper
benefit. The Director Liability Provision also does not affect a
director’s liability under the federal securities laws or the recovery of
damages by third parties. Furthermore, under Delaware Law, the
limitation liability afforded by the Director Liability Provision does not
eliminate a director’s personal liability for breach of the director’s duty of
due care. Although the directors would not be liable for monetary damages to us
or our stockholders for negligent acts or omissions in exercising their duty of
due care, the directors remain subject to equitable remedies, such as actions
for injunction or rescission, although these remedies, whether as a result of
timeliness or otherwise, may not be effective in all situations. With
regard to directors who also are officers of our company, these persons would be
insulated from liability only with respect to their conduct as directors and
would not be insulated from liability for acts or omissions in their capacity as
officers. These provisions may cover actions undertaken by the Board
of Directors, which may serve as the basis for a claim against us under the
federal and state securities laws. We have been advised that it is
the position of the Commission that insofar as the foregoing provisions may be
involved to disclaim liability for damages arising under the Securities Act of
1933, as amended (the “Securities Act”), such provisions are against public
policy as expressed in the Securities Act and are therefore
unenforceable.
Delaware
law provides a detailed statutory framework covering indemnification of our
directors, officers, employees or agents against liabilities and expenses
arising out of legal proceedings brought against them by reason of their status
or service as directors, officers, employees or agents. Section 145 of the
Delaware General Corporation Law (“Section 145”) provides that a director,
officer, employee or agent of a corporation (i) shall be indemnified by the
corporation for expenses actually and reasonably incurred in defense of any
action or proceeding if such person is sued by reason of his service to the
corporation, to the extent that such person has been successful in defense of
such action or proceeding, or in defense of any claim, issue or matter raised in
such litigation, (ii) may, in actions other than actions by or in the right of
the corporation (such as derivative actions), be indemnified for expenses
actually and reasonably incurred, judgments, fines and amounts paid in
settlement of such litigation, even if he is not successful on the merits, if he
acted in good faith and in a manner he reasonably believed to be in or not
opposed to the best interests of the corporation (and in a criminal proceeding,
if he did not have reasonable cause to believe his conduct was unlawful), and
(iii) may be indemnified by the corporation for expenses actually and reasonably
incurred (but not judgments or settlements) in any action by the corporation or
of a derivative action (such as a suit by a stockholder alleging a breach by the
director or officer of a duty owed to the corporation), even if he is not
successful, provided that he acted in good faith and in a manner reasonably
believed to be in or not opposed to the best interests of the corporation,
provided that no indemnification is permitted without court approval if the
director has been adjudged liable to the corporation.
Delaware
Law also permits a corporation to elect to indemnify its officers, directors,
employees and agents under a broader range of circumstances than that provided
under Section 145. The Certificate contains a provision that takes full
advantage of the permissive Delaware indemnification laws (the “Indemnification
Provision”) and provides that we are required to indemnify our officers,
directors, employees and agents to the fullest extent permitted by law,
including those circumstances in which indemnification would otherwise be
discretionary, provided, however, that prior to making such discretionary
indemnification, we must determine that the person acted in good faith and in a
manner he or she believed to be in the best interests of the corporation and, in
the case of any criminal action or proceeding, the person had no reason to
believe his or her conduct was unlawful.
In
furtherance of the objectives of the Indemnification Provision, we have also
entered into agreements to indemnify our directors and executive officers, in
addition to the indemnification provided for in our Certificate and Bylaws (the
“Indemnification Agreements”). We believe that the Indemnification Agreements
are necessary to attract and retain qualified directors and executive officers.
Pursuant to the Indemnification Agreements, an indemnitee will be entitled to
indemnification to the extent permitted by Section 145 or other applicable law.
In addition, to the maximum extent permitted by applicable law, an indemnitee
will be entitled to indemnification for any amount or expense which the
indemnitee actually and reasonably incurs as a result of or in connection with
prosecuting, defending, preparing to prosecute or defend, investigating,
preparing to be a witness, or otherwise participating in any threatened, pending
or completed claim, suit, arbitration, inquiry or other proceeding (a
“Proceeding”) in which the indemnitee is threatened to be made or is made a
party or participant as a result of his or her position with our company,
provided that the indemnitee acted in good faith and in a manner he or she
reasonably believed to be in or not opposed to our best interests and had no
reasonable cause to believe his or her conduct was unlawful. If the Proceeding
is brought by or in the right of our company and applicable law so provides, the
Indemnification Agreement provides that no indemnification against expenses
shall be made in respect of any claim, issue or matter in the Proceeding as to
which the indemnitee shall have been adjudged liable to us.
Insofar
as indemnification for liabilities arising under the Securities Act, may be
permitted to our directors, officers or controlling persons pursuant to the
foregoing provisions, we have been advised that in the opinion of the Securities
and Exchange Commission, such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable.
ITEM
16. EXHIBITS
The Exhibits to this Registration
Statement are listed in the Exhibit Index commencing on page EX-1
hereof.
ITEM
17. UNDERTAKINGS
(a) The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To
include any prospectus required by Section 10(a)(3) of the Securities Act of
1933, as amended (the “Securities Act”):
(ii) To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective
registration statement; and
(iii) To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement; provided, however, that
subparagraphs (i), (ii) and (iii) above do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission by
the Registrant pursuant to section 13 or section 15(d) of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), that are
incorporated by reference in the registration statement, or is contained in a
form of prospectus filed pursuant to Rule 424(b) (§ 230.424(b) of
this chapter) that is part of the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act, each such
post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4) That,
for the purpose of determining liability of the registrant under the Securities
Act of 1933 to any purchaser in the initial distribution of the securities, the
undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser:
(i) any
preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424 (§ 230.424 of this
chapter);
(ii) any
free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned
registrant;
(iii) the
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
The
registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act, each filing of the registrant’s annual report pursuant
to Sections 13(a) or 15(d) of the Exchange Act (and, where
applicable, each filing of an employee benefit plan’s annual report pursuant to
section 15(d) of the Exchange Act) that is incorporated by reference
in this registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of the registrant
pursuant to the indemnification provisions described herein, or otherwise, the
registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by
the registrant of expenses incurred or paid by a director, officer or
controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such
issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement on Form S-3
to be signed on its behalf by the undersigned, thereunto duly authorized, in the
City of Tustin, State of California, on July 14, 2009.
PEREGRINE
PHARMACEUTICALS, INC.
By: /s/ Steven W.
King
Steven
W. King,
President
and Chief Executive Officer,
Director
POWER
OF ATTORNEY
KNOW ALL
PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby
constitutes and appoints, Steven W. King and Paul J. Lytle, and each of them, as
his attorney-in-fact, each with full power of substitution, for him in any and
all capacities, to sign any and all amendments to this Registration Statement
(including post-effective amendments), and any and all Registration Statements
filed pursuant to Rule 462 under the Securities Act of 1933, as amended, in
connection with or related to the Offering contemplated by this Registration
Statement and its amendments, if any, and to file the same, with exhibits
thereto and other documents in connection therewith, with the Securities and
Exchange Commission, hereby ratifying and confirming our signatures as they may
be signed by our said attorney to any and all amendments to said Registration
Statement.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the dates
indicated.
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
|
|
|
|
/s/ Steven W.
King
Steven
W. King
|
|
President
and Chief Executive Officer, Director
|
|
July
14, 2009
|
|
|
|
|
|
|
|
|
|
|
/s/ Paul J.
Lytle
Paul
J. Lytle
|
|
Chief Financial Officer (signed both as an
officer duly authorized to sign
on behalf of the Registrant as
Principal Financial Officer and Principal
Accounting Officer)
|
|
July
14, 2009
|
|
|
|
|
|
|
|
|
|
|
/s/ Carlton M.
Johnson
|
|
Director
|
|
July
14, 2009
|
|
|
|
|
|
|
|
|
|
|
/s/ David H.
Pohl
|
|
Director
|
|
July
14, 2009
|
|
|
|
|
|
|
|
|
|
|
/s/ Eric S.
Swartz
|
|
Director
|
|
July
14, 2009
|
|
|
|
|
|
|
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).
|
|
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)).*
|
|
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).*
|
|
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 Shan,
dated March 18, 2009. *
|
|
10.15
|
Employment
Agreement by and between Peregrine Pharmaceuticals, Inc. and Shelley P.M.
Fussey, Ph.D., dated March 18, 2009. *
|
|
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.
Filed
herewith.
|
peregrine_s3-ex0501.htm
EXHIBIT
5.1
OPINION
OF COUNSEL
Snell
& Wilmer LLP
600 Anton
Boulevard
Suite
1400
Costa
Mesa, California 92626-7689
TELEPHONE:
(714) 427-7000
FACSIMILE:
(714) 427-7799
July 14,
2009
Peregrine
Pharmaceuticals, Inc.
14272
Franklin Avenue, Suite 100
Tustin,
California 92780-7017
Re: Registration
Statement on Form S-3
|
Peregrine
Pharmaceuticals, Inc., Common Stock, par value $.001 per share and
Warrants
|
Ladies
and Gentlemen:
We have
acted as counsel to Peregrine Pharmaceuticals, Inc., a Delaware corporation (the
“Company”), with respect to certain legal matters in connection with the
registration under the Securities Act of 1933, as amended (the “Securities
Act”), of the offer and sale by the Company from time to time pursuant to
Rule 415 under the Securities Act of: (i) common stock, $0.001 par
value per share, of the Company (the “Common Stock”) and warrants to purchase
Common Stock (the “Warrants”). The “Securities” refers to the Company Stock and
Warrants, collectively. This opinion is being furnished in accordance
with the requirements of Item 601(b)(5) of Regulation S-K under the
Act.
In
addition, we have acted as counsel to the Company in connection with the
registration on behalf of certain of its security holders (the “Selling Security
Holders”) of an aggregate of 1,873,711 shares of Common Stock consisting of (i)
1,692,047 shares of Common Stock underlying warrants dated as of December 19,
2008 (the “2008 Warrants”); and (ii) 181,664 shares of Common Stock
underlying a stock option dated December 22, 1999 (the “1999
Option”).
We also
have participated in the preparation of the prospectus and “at the market”
prospectus (together, the “Prospectus”) contained in the Registration Statement
on Form S-3 (the “Registration Statement”) to which this opinion is an
exhibit. The Securities will be offered (i) in amounts, at prices, and on
terms to be determined in light of market conditions at the time of sale or (ii)
“at the market” in accordance with Rule 415(a)(4) under the Securities Act.
Supplements to the Prospectus (each a “Prospectus Supplement”) contained in the
Registration Statement will contain such amounts, prices and terms for
securities offered other than “at the market.”
In
rendering the opinions below, we have examined and relied upon: (i) the
Registration Statement, including the Prospectus; (ii) the Company’s
Certificate of Incorporation and Bylaws, as currently in effect; and
(iii) such certificates, statutes, documents, and other instruments as we
considered appropriate for purposes of the opinions expressed below. We also
reviewed the questions of law that we considered appropriate. In arriving at the
opinions expressed below, we have assumed: (a) the authenticity of original
documents and the genuineness of all signatures; (b) the conformity to the
originals of all documents submitted to us as copies; and (c) the truth,
accuracy and completeness of the information, representations and warranties
contained in the records, documents, instruments, and certificates we have
reviewed. In addition, we have assumed and have not verified the
accuracy as to factual matters of each document we have reviewed.
In
rendering the opinions below, we have assumed that: (i) the Registration
Statement, and any amendments to it (including post-effective amendments), will
have become and will remain effective when any Securities or any Common Stock
requested on behalf of the Selling Security Holders (collectively, the
“Registered Securities”) are issued thereunder; (ii) a Prospectus
Supplement describing each class of Securities offered under the Registration
Statement, to the extent required by applicable law and relevant rules and
regulations of the Securities and Exchange Commission (the “Commission”), will
be timely filed with the Commission; (iii) the definitive terms of each
class of Securities will have been established pursuant to the authorizing
resolutions duly adopted by the Company’s board of directors (or its duly
authorized committee), the Company’s Certificate of Incorporation, and
applicable law; (iv) the Company will issue and deliver the Registered
Securities in the manner contemplated by the Registration Statement;
(v) the resolutions authorizing the Company to issue, offer, and sell the
Registered Securities will have been duly adopted by the Company’s board of
directors and will be in full force and effect at all times at which the
Registered Securities are offered or sold by the Company; and (vi) all
Registered Securities will be issued in compliance with federal and state
securities laws.
With
respect to any Warrants, we have assumed further that: (i) the warrant
agreement, which the Company will have approved (the “Warrant Agreement”), to be
entered into between the Company and the Purchaser thereof (the "Purchaser") or
an entity selected by the Company to act as the warrant agent (the “Warrant
Agent”) will have been duly authorized, executed, and delivered by the Company
and the Purchaser or the Warrant Agent; and (ii) the Warrants will be duly
authorized, executed, and delivered by the Company and the Purchaser or the
Warrant Agent in accordance with the provisions of the Warrant
Agreement.
Based
on the foregoing, and subject to the assumptions, qualifications, limitations,
and exceptions set forth herein, we are of the opinion that:
1. With
respect to the Common Stock (other than the Common Stock to be offered by the
Selling Security Holders or by the Company in an “at the market” offering
pursuant to Rule 415(a)(4) under the Securities Act), when
(i) the Company has taken all necessary action to approve the issuance of
the Common Stock, the terms of the offering, and related matters, and
(ii) the Common Stock has been issued and delivered pursuant to the terms
of the applicable definitive purchase, underwriting, or similar agreement
approved by the Company, then, upon payment of the relevant consideration, the
Common Stock will be duly authorized, validly issued, fully paid, and
nonassessable. The Common Stock to be sold in an “at the market” offering
pursuant to Rule 415(a)(4) under the Securities Act, when sold in
accordance with the Registration Statement, the Prospectus, and Prospectus
Supplement and such rule for the consideration provided therein, will be duly
authorized, validly issued, fully paid, and nonassessable.
July 14,
2009
Page
3
2. The
Warrants included in the Securities will, when (i) the Company has taken
all necessary action to approve the creation and issuance and terms of the
Warrants, the terms of the offering, and related matters; (ii) a Warrant
Agreement and any other agreements relating to the Warrants have been duly
authorized and validly executed and delivered by the Company and the Purchaser
or Warrant Agent appointed by the Company; and (iii) the Warrants or
certificates representing the Warrants have been duly executed, countersigned,
and delivered in accordance with the appropriate Warrant Agreement, any other
agreements relating to the Warrants, and the applicable definitive purchase,
underwriting, or similar agreement approved by the Company; then, upon payment
of the relevant consideration, will be duly authorized and validly
issued.
3. The
1,692,047 shares and 181,664 shares of Common Stock to be sold by the Selling
Security Holders are duly authorized and, when issued in accordance with the
2008 Warrants and the 1999 Option and for the consideration respectively
provided therein, will be validly issued, fully paid, and nonassessable.
We
express no opinions concerning the enforceability of indemnification provisions,
to the extent they purport to relate to liabilities resulting from or based upon
negligence, or any violation of federal or state securities laws, or blue sky
laws.
The
foregoing opinions are limited to the Delaware General Corporation Law (including the statutory provisions,
all applicable provisions of the Delaware Constitution and reported judicial
decisions interpreting the foregoing) and we express no opinion as to the effect
on matters covered by this letter of the laws of any other
jurisdiction.
We hereby
consent to the references to this firm under the caption “Legal Matters” in the
Prospectus and to the filing of this opinion as an exhibit to the Registration
Statement. By giving such consent, we do not admit that we are within the
category of persons whose consent is required under Section 7 of the
Securities Act or the rules and regulations thereunder.
The
foregoing opinions are rendered as of the date hereof, and we assume no
obligation to update such opinions to reflect any facts or circumstances which
may hereafter come to our attention or any changes in the law which may
hereafter occur.
Very
truly yours,
/s/ SNELL
& WILMER L.L.P.
SNELL
& WILMER L.L.P.
peregrine_s3-ex2301.htm
EXHIBIT
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the reference to our firm under the caption "Experts" in this Registration Statement (Form S-3) to be filed
on or about July 14, 2009 and related Prospectus of Peregrine Pharmaceuticals,
Inc. for the registration of common stock and warrants for an aggregate initial
offering price not to exceed $50,000,000 and an aggregate of 1,873,711 shares of
common stock and to the incorporation by reference therein of our reports dated
July 10, 2009, with respect to the consolidated financial statements and
schedule of Peregrine Pharmaceuticals, Inc., and the effectiveness of internal
control over financial reporting of Peregrine Pharmaceuticals, Inc., included in
its Annual Report (Form 10-K) for the year ended April 30, 2009, filed with the
Securities and Exchange Commission.
/s/ ERNST & YOUNG
LLP
Orange
County, California
July 10,
2009