Peregrine Pharaceuticals, Inc.
Filed
Pursuant to 424(b)(2)
Registration Statement No. 333-121450
PROSPECTUS
SUPPLEMENT TO PROSPECTUS DATED DECEMBER 20, 2004
12,000,000
Shares of Common Stock
Unless
the context otherwise requires, all references to “we,” “us,” or “our” in this
prospectus supplement refer to Peregrine Pharmaceuticals, Inc., a Delaware
corporation.
This
Prospectus Supplement and the attached Prospectus relate to the offering
and
sale of 396,398 shares of our common stock issued to the University of Texas
Southwestern Medical Center at Dallas as payment for certain amounts due
under
our two sponsored research agreements (the “Agreements”) to support the
continued research and development of our products. The shares issued were
priced at $1.32 per share, which per share price was determined based on
the
average closing price of our common stock for the five trading days immediately
preceding the date the shares are issued pursuant to the Agreement. After
this
offering, we have 179,180 shares of common stock available for issuance under
Registration Statement No. 333-121450.
Our
common stock is listed on The Nasdaq Capital Market under the symbol
“PPHM”. On February 2, 2006, the last reported sale price of our common stock on
the Nasdaq Capital Market was $1.54 per share. As of February 2, 2006,
after giving effect to this offering, there are approximately 174,506,000
shares
of our common stock outstanding. The common stock sold under this prospectus
supplement will be listed on The Nasdaq Capital Market after we notify The
Nasdaq Capital Market that the shares have been issued.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION
HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS
SUPPLEMENT IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS
A
CRIMINAL OFFENSE.
THIS
PROSPECTUS SUPPLEMENT IS NOT COMPLETE WITHOUT THE PROSPECTUS DATED DECEMBER
20,
2004, AND WE HAVE NOT AUTHORIZED ANYONE TO DELIVER OR USE THIS PROSPECTUS
SUPPLEMENT WITHOUT THE PROSPECTUS. You should read this Prospectus Supplement
and the accompanying Prospectus carefully before you invest. Both documents
contain information you should consider when making your investment
decision.
The
date
of this prospectus supplement is February 3, 2006.
S-1
PROSPECTUS
12,000,000
Shares of Common Stock
This
prospectus will allow us to issue, from time to time in one or more offerings,
up to 12,000,000 shares of our common stock. In this prospectus, we sometimes
refer to our common stock as the “securities.” Each time we sell
securities:
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• |
we
will provide a prospectus supplement; and |
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the
prospectus supplement will inform you about the specific terms
of that offering and may also add, update or change information contained
in this document. |
You
should read this document and any prospectus supplement carefully
before you invest.
Our
common stock is
registered under Section 12(g) of the Securities Exchange Act of 1934 and is
listed on The Nasdaq SmallCap Market under the symbol “PPHM”. On December 16,
2004, the last reported sale price of our common stock on The Nasdaq SmallCap
Market was $1.23 per share.
THIS
PROSPECTUS MAY NOT BE USED TO OFFER OR SELL ANY SECURITIES UNLESS ACCOMPANIED
BY
A PROSPECTUS SUPPLEMENT.
The
securities may be sold directly by us to investors, through agents designated
from time to time or to or through underwriters or dealers. For additional
information on the methods of sale, you should refer to the section entitled
“Plan of Distribution.” If any underwriters are involved in the sale of any
securities with respect to which this prospectus is being delivered, the names
of such underwriters and any applicable commissions or discounts will be set
forth in a prospectus supplement. The net proceeds we expect to receive from
such sale will also be set forth in a prospectus supplement.
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.
INVESTING
IN
OUR SECURITIES INVOLVES SIGNIFICANT RISKS. SEE “RISK FACTORS” BEGINNING ON PAGE
3 FOR A DESCRIPTION OF CERTAIN FACTORS THAT YOU SHOULD CONSIDER BEFORE
PURCHASING THE SECURITIES OFFERED BY THIS PROSPECTUS.
The
date of this Prospectus is December 20, 2004
TABLE
OF CONTENTS
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.
i
The
following summary
is qualified in its entirety by reference to the more detailed information
and
consolidated financial statements appearing elsewhere or incorporated by
reference in this prospectus. As used in this prospectus, the terms “we”, “us”,
“our”, “Company” and “Peregrine” refers to Peregrine Pharmaceuticals, Inc., and
its wholly-owned subsidiaries, Avid Bioservices, Inc., and Vascular Targeting
Technologies, Inc.
About
Peregrine Pharmaceuticals, Inc.
About
Us. Peregrine Pharmaceuticals, Inc., located in Tustin,
California, is a biopharmaceutical company primarily engaged in the research,
development, manufacture and commercialization of products for cancer
therapeutics, cancer diagnostics, and other diseases, through a series of
proprietary platform technologies using monoclonal antibodies. We are organized
into two reportable operating segments: (i) Peregrine, the parent company,
is
engaged in the research and development of novel therapeutics and (ii) Avid
Bioservices, Inc., (“Avid”) our wholly-owned subsidiary, is engaged in providing
contract manufacturing and development of biologics for biopharmaceutical and
biotechnology companies.
Our
Development Focus. We are primarily focused on
developing therapeutic agents that affect blood vessels and blood flow in cancer
and other diseases. Our vascular research programs fall under several different
proprietary platforms including Anti-Phospholipid Therapy (“APT”), Vascular
Targeting Agents (“VTAs”), anti-Angiogenesis and Vasopermeation Enhancement
Agents (“VEAs”). Our most clinically advanced therapeutic program is based on a
targeting platform outside vascular biology. This technology platform is known
as Tumor Necrosis Therapy (“TNT”) and targets dead or dying tumor cells that are
common to the majority of different tumor types and deliver therapeutic agents
that kill nearby living tumor cells.
For
a more detailed discussion of our proprietary platforms, please refer to our
Form 10-K for the fiscal year ended April 30, 2004, filed with the Securities
and Exchange Commission on July 14, 2004.
1
About the Offering
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Common
stock offered in this |
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prospectus
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12,000,000
shares |
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Common
stock outstanding after |
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this
offering |
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156,558,472
shares (1) |
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Use
of proceeds |
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See
“Use
of Proceeds” |
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Nasdaq
Small Cap Market symbol |
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PPHM
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(1) |
Based
on 144,558,472 shares outstanding as of December 16, 2004,
and assumes the issuance of common stock offered in this prospectus.
The
number set forth above does not include approximately 27,838,892 shares
of
our common stock that, as of December 16, 2004, are issuable upon the
exercise of outstanding options and warrants. These options and warrants
are exercisable at prices ranging from $0.24 to $5.28 per share, with
an
average exercise price of $1.61 per share.
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2
An
investment in our securities being offered in this prospectus is very risky.
You
should carefully consider the risk factors described below, together with all
other information in this prospectus or incorporated herein by reference before
making an investment decision. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial may also impair our business
operations. If any of the following risks actually occurs, our business,
financial conditions or operating results could be materially adversely
affected. In such case, the trading price of our common stock could decline,
and
you may lose all or part of your investment.
If
We Cannot Obtain Additional Funding, Our Product
Development and Commercialization Efforts May Be Reduced or
Discontinued.
At
October 31, 2004,
we had $10,325,000 in cash and cash equivalents. We have expended substantial
funds on (i) the research, development and clinical trials of our product
candidates, and (ii) funding the initial operations of our wholly-owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically experienced
negative cash flows from operations since our inception and we expect the
negative cash flows from operations to continue for the foreseeable future,
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. While we expect Avid to generate revenues in the
foreseeable future, we expect our monthly negative cash flow to continue for
the
foreseeable future, due to our anticipated clinical trial activities using
Tarvacin™ and Cotara®, our anticipated development costs associated with
Anti-Phospholipid Therapy (“APT”), Vasopermeation Enhancement Agents (“VEAs”)
and Vascular Targeting Agents (“VTAs”), and expansion of our manufacturing
capabilities. We believe we have sufficient cash on hand to meet our obligations
on a timely basis through at least the first quarter of our fiscal year 2006.
We
plan to obtain any
necessary financing through one or more methods including either equity or
debt
financing and/or negotiating additional licensing or collaboration agreements
for our platform technologies. Under equity transactions, we plan to raise
additional capital through the offer and sale of shares of our common stock
off
our current shelf registration statement on Form S-3, File No. 333-109982.
As of
December 3, 2004, we had approximately 7,003,000 shares available for possible
future transactions under that shelf registration statement. However, given
uncertain market conditions and the volatility of our stock price and trading
volume, we may not be able to sell our securities at prices and on terms that
are favorable to us, if at all.
We
Have Had Significant Losses And We Anticipate Future
Losses.
All
of our products
are currently in development, pre-clinical studies or clinical trials, and
no
revenues have been generated from commercial product sales. We have incurred
net
losses in most fiscal years since we began operations in 1981. The following
table represents net losses incurred during the past three fiscal
years:
|
Net
Loss
|
|
Fiscal
Year
2004 |
$ |
14,345,000 |
|
Fiscal
Year 2003 |
$ |
11,559,000 |
|
Fiscal
Year 2002 |
$ |
11,718,000 |
|
As
of October 31,
2004, we had an accumulated deficit of $161,402,000. While we expect to generate
revenues from Avid’s contract manufacturing services, we expect those near term
revenues will be insufficient to fully cover anticipated cash flows used in
operations. In addition, revenues from the sale and/or licensing of our products
under development are always uncertain and the costs associated with clinical
trials and product manufacturing are 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 2 years,
and we may never generate product revenues sufficient to become profitable
or to
ever sustain profitability.
3
Our
Product Development Efforts May Not Be
Successful.
Since
inception, we
have been engaged in the development of compounds for the treatment and
diagnosis of people with cancer. Our product candidates have not received
regulatory approval and are generally in research, pre-clinical and clinical
stages of development. The development of safe and effective therapies for
treating people with cancer and other diseases is highly uncertain and subject
to numerous risks. Product candidates that may appear to be promising at early
stages of development may not reach the market for a number of reasons. Product
candidates may be found ineffective or cause harmful side effects during
clinical trials, may fail to receive necessary regulatory approvals, may prove
impracticable to manufacture in commercial quantities at reasonable cost and
with acceptable quality or may fail to achieve market acceptance.
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, the
eligibility criteria for the study, and the availability of insurance coverage.
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 participate in our clinical study(ies).
Our
Product Development Efforts Are Subject to Government
Regulation That Is Time-Consuming and Uncertain.
Any
products that we
develop are subject to regulation by federal, state and local governmental
authorities in the United States, including the U.S. Food and Drug
Administration (“FDA”), and by similar agencies in other countries. Any product
that we develop must receive all relevant regulatory approvals or clearances
before clinical trials commence all the way through the date it is approved
for
commercial distribution by the FDA or similar agency and marketed in a
particular country.
The
approval process,
which includes extensive pre-clinical studies and clinical trials of each
product candidate in order to study its safety and efficacy, is uncertain,
can
take many years and requires the expenditure of substantial resources. Clinical
trials of our product candidates may not demonstrate safety and efficacy to
the
extent necessary to obtain regulatory approvals for the indications being
studied, if at all. Companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in advanced clinical trials, even after
obtaining promising results in earlier trials. The failure to demonstrate
adequately the safety and efficacy of any of our product candidates could delay
or prevent regulatory approval of the product candidate.
We
may also encounter
significant delays in initiating clinical trials or continuing clinical trials
due to regulatory questions or concerns pertaining to pre-clinical data
submitted to the FDA, or the FDA may reject our product candidates if our
product candidates are found to be ineffective or cause harmful side effects
during clinical trials. In addition, data submitted to the FDA from pre-clinical
and clinical activities are susceptible to varying interpretations, which could
delay, limit or prevent clinical development and regulatory approval, which
factors are beyond our control.
In
September 2004, we
filed an Investigational New Drug Application (“IND”) with the FDA to initiate
our first clinical trial under our APT program using Tarvacin™. In response to
requests from the FDA following the IND submission, we will provide additional
information and may alter some aspects of the planned clinical study. We are
currently working with the FDA and our clinical advisors and scientists to
submit a revised clinical protocol to the FDA in the near term. The Phase I
study can begin following the FDA’s review and approval of the additional
information and the final clinical protocol. These efforts to work with the
FDA
to initiate the Tarvacin™ clinical trial could be unsuccessful which would
prevent clinical development of Tarvacin™.
Delays
in advancing our product candidates may adversely affect our ability to raise
additional capital, which will affect our ability to continue full-scale
research and development for our antibody technologies.
4
If
We Cannot License Or Sell Our Cotara® Product, This Product
May Be Delayed or Never Be Further Developed.
We
recently concluded enrollment of our Phase I study with Cotara® for colorectal
cancer, and are evaluating potential indications for further studies with
Cotara®. In addition, we recently entered into a collaboration with New
Approaches to Brain Tumor Therapy (“NABTT”) Consortium to initiate the first
stage of our FDA approved registration trial with Cotara® for brain cancer.
After the first stage of the FDA approved registration trial, we will require
substantial financial resources, which we do not presently have, to complete
the
remainder of the registration trial in order to potentially file a biologics
license application for product approval. We have been seeking a licensing
or
funding partner for our Cotara® brain cancer project since February 2003 when we
obtained protocol acceptance from the FDA. While we are hopeful that our new
collaboration with NABTT will give us the opportunity to commence the
registration trial, there is no certainty that the clinical data that will
be
generated from this clinical trial will be sufficient to attract a licensing
partner to continue clinical development. The collaboration with NABTT alone
will not provide us with the resources necessary to complete the registration
trial.
If
a licensing partner is not found for this technology, we may not be able to
further advance this project beyond the first part of the FDA approved
registration trial. In addition, 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 anti-cancer drug, we may not find a suitable
partnering candidate for the technology.
Our
Dependency On One Radiolabeling Supplier May Negatively
Impact Our Ability To Complete Clinical Trials And Market Our
Products.
We
have procured our
antibody radioactive isotope combination services (“radiolabeling”) with Iso-tex
Diagnostics, Inc. for all clinical trials using Cotara®. If this supplier is
unable to continue to qualify its facility or label and supply our antibody
in a
timely manner, our clinical trial activities could be adversely affected and
delayed. While there are other suppliers for radioactive isotope combination
services, our clinical trial would be delayed for up to 12 to 18 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. 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.
We
May Not be Able to Manufacture Our Products in Commercial
Quantities, Which Would Prevent Us From Marketing Our Products, if
Approved.
During
the clinical trial process, drug candidates are generally manufactured in small
quantities. If the FDA approves one of our product candidates for commercial
sale, we may need to manufacture these products in larger quantities to support
commercial quantities. We cannot assure you that we will be able to successfully
increase the manufacturing capacity, whether on our own or in collaboration
with
third party manufacturers, for any of our product candidates in a timely or
economic manner, or at all. Significant scale-up of manufacturing may require
certain additional validation studies, which the FDA must review and approve.
Currently, we manufacture all pre-clinical and clinical material through Avid
Bioservices, our wholly-owned subsidiary. Although Avid has recently acquired
a
1,000 liter bioreactor, that may not be enough additional capacity to meet
our
anticipated commercial needs.
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 $5,000,000 per occurrence or $5,000,000
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.
5
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
successful partially or completely uninsured claim against Avid would have
a
material adverse effect on our consolidated operations.
The
Liquidity Of Our Common Stock Will Be Adversely Affected
If Our Common Stock Is Delisted from The Nasdaq SmallCap
Market.
Our
common stock is
presently traded on The Nasdaq SmallCap Market. To maintain inclusion on The
Nasdaq SmallCap Market, we must continue to meet the following six listing
requirements:
|
1. |
Net
tangible assets of at least $2,000,000 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. |
Public
float of at least 500,000 shares; |
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3. |
Market
value of our public float of at least
$1,000,000; |
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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 30
consecutive trading days; |
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5. |
At
least two market makers; and |
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6. |
At
least 300 stockholders, each holding at least 100 shares of
common stock. |
We
cannot guarantee
that we will be able to maintain the minimum bid price requirement or maintain
any of the other requirements in the future. The market price of our common
stock has generally been highly volatile. During the past twelve months, the
trading price of our common stock on the Nasdaq SmallCap Market ranged from
$0.88 per share to $3.14 per share. If we fail to meet any of the Nasdaq
SmallCap 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 being delisted, however, our common stock will
become subject to the regulations of the Securities and Exchange Commission
relating to the market for penny stocks. Penny stock, as defined by the Penny
Stock Reform Act, is any equity security not traded on a national securities
exchange or quoted on the NASDAQ National or SmallCap Market, 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.
6
The
Sale Of Substantial Shares Of Our Common Stock May Depress
Our Stock Price.
As
of December 16, 2004, we had 144,558,472 shares of common stock outstanding,
and
the last reported sales price of our common stock was $1.23 per share on
December 16, 2004. We could also issue up to 27,838,892 additional shares
of common stock upon the exercise of outstanding options and warrants as further
described in the following table:
Description
of
instrument |
|
Number
of
Shares Outstanding |
|
Weighted
Average
Per Share Exercise Price |
|
Common
shares
issuable upon exercise of |
|
|
|
|
|
|
|
outstanding
stock options |
|
|
12,526,044 |
|
|
$1.55
|
|
Common
shares
issuable upon exercise of |
|
|
|
|
|
|
|
outstanding
warrants |
|
|
15,312,848 |
|
|
$1.65
|
|
|
|
|
|
|
|
Total |
|
|
27,838,892 |
|
|
$1.61
|
|
|
|
|
|
|
|
Of
the total warrants and
options outstanding as of December 16, 2004, approximately 13,563,570 option
and
warrants would be considered dilutive to shareholders because we would receive
an amount per share which is less than the market price of our common stock
at
December 16, 2004.
In
addition, we plan to raise additional capital through the offer and sale of
shares of our common stock off our current shelf registration statement on
Form
S-3, File No. 333-109982 which will cause future dilution and may depress our
stock price. As of December 16, 2004, we had approximately 7,003,000 shares
available for possible future transactions under the shelf registration
statement.
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 of the ten fiscal quarters ended October 31, 2004:
|
Common
Stock Sales Price |
|
Common
Stock
Daily Trading Volume (000’s omitted) |
|
|
High |
|
Low |
|
High |
|
Low |
|
First
Two
Quarters of Fiscal Year 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended
October 31, 2004 |
$ |
1.96 |
|
$ |
0.95 |
|
|
2,141 |
|
|
148 |
|
Quarter
Ended
July 31, 2004 |
$ |
1.92 |
|
$ |
0.88 |
|
|
1,749 |
|
|
131 |
|
Fiscal
Year 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2004 |
$ |
2.85 |
|
$ |
1.56 |
|
|
3,550 |
|
|
320 |
|
Quarter
Ended January 31, 2004 |
$ |
3.14 |
|
$ |
2.01 |
|
|
6,062 |
|
|
201 |
|
Quarter
Ended October 31, 2003 |
$ |
2.44 |
|
$ |
1.25 |
|
|
18,060 |
|
|
314 |
|
Quarter
Ended July 31, 2003 |
$ |
2.19 |
|
$ |
0.60 |
|
|
12,249 |
|
|
255 |
|
Fiscal
Year 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2003 |
$ |
0.85 |
|
$ |
0.44 |
|
|
3,239 |
|
|
94 |
|
Quarter
Ended January 31, 2003 |
$ |
1.20 |
|
$ |
0.50 |
|
|
3,619 |
|
|
59 |
|
Quarter
Ended October 31, 2002 |
$ |
0.93 |
|
$ |
0.35 |
|
|
1,696 |
|
|
104 |
|
Quarter
Ended July 31, 2002 |
$ |
2.29 |
|
$ |
0.66 |
|
|
1,686 |
|
|
113 |
|
Fiscal
Year 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
Ended April 30, 2002 |
$ |
2.90 |
|
$ |
1.50 |
|
|
751 |
|
|
135 |
|
Quarter
Ended January 31, 2002 |
$ |
4.00 |
|
$ |
1.32 |
|
|
3,525 |
|
|
73 |
|
Quarter
Ended October 31, 2001 |
$ |
2.23 |
|
$ |
0.81 |
|
|
4,265 |
|
|
117 |
|
Quarter
Ended July 31, 2001 |
$ |
3.50 |
|
$ |
1.21 |
|
|
2,127 |
|
|
127 |
|
7
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; |
|
• |
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; |
|
• |
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 |
|
• |
Health
care 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.
We
May Become Involved in Lawsuits, Interference or Opposition
Proceedings to Enforce or Protect Our Patents and Intellectual Property Position
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 of inventions or the validity of claims in a granted patent. 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 patent
application at risk of not issuing, cause us to revise the claims in our
application, or render our granted patent invalid.
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 materially adversely affect our business and 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
biotechnology industry is intensely competitive. We face competition from
pharmaceutical companies, pharmaceutical divisions of chemical companies, and
biotechnology companies of various sizes. 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 which are
comparable or superior to our technologies and products. The FDA has approved
our Cotara® registration protocol for the treatment of brain cancer. We recently
entered into a collaboration with New Approaches to Brain Tumor Therapy
(“NABTT”) Consortium to initiate the first stage of the registration trial.
Companies conducting late stage clinical trials in brain cancer that may
complete with us include, among others, Xenova Group plc, Allos Therapeutics,
Inc. and NeoPharm, Inc. Xenova Group plc has initiated a phase III clinical
trial of TransMID™ for the treatment of progressive or recurrent non-operable
glioblastoma multiforme. Allos Therapeutics, Inc. is developing RSR13
(efaproxiral) for the treatment of patients with brain metastases originating
from breast cancer in a phase III study. NeoPharm is developing IL13-PE38QQR
for
the treatment of recurrent glioblastoma multiforme in a Phase III study. Most
of
our other products are in earlier stages of development or clinical trials,
including Tarvacin™. As for Tarvacin™, there are a number of possible
competitors with approved products or targeted agents under development for
the
treatment of cancer, including but not limited to, Avastin™ by Genentech
Inc., Iressa® by AstraZeneca PLC, Gleevec® by Novartis AG, Tarceva™ by OSI
Pharmaceuticals, Inc. and Genentech, Inc., Erbitux™ by ImClone Systems, Inc.,
and ABX-EGF by Abgenix, Inc. Due to the significant number of companies
attempting to develop cancer therapeutics combined with the fact that our other
products are generally in early stages of development, we cannot provide an
accurate listing of all possible competitors at this stage of
development.
8
New
and Potential New Accounting Pronouncements May Impact Our
Future Financial Position and Results of Operations.
There
may be potential new accounting pronouncements or regulatory rulings, which
may
have an impact on our future financial position and results of operations.
In
particular, there are a number of rule changes and proposed legislative
initiatives following the recent corporate bankruptcies and failures which
could
result in changes in accounting rules, including the accounting for employee
stock options as an expense. These and other potential changes could materially
impact our assets and liabilities, and the expenses we report under generally
accepted accounting principles, and could adversely affect our operating results
or financial condition.
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 our scientific researchers.
For example, because of his extensive understanding of our technologies and
product development programs, the loss of Mr. Steven King, our President and
Chief Executive Officer, would adversely affect our development efforts and
clinical trial programs during the 6 to 12 month period 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.
The
Manufacture of Our Products and the Products of Avid’s
Customers is Subject to Government Regulation.
Avid
is generally required to maintain compliance with current Good Manufacturing
Practice, or cGMP, and is subject to inspections by the FDA or comparable
agencies in other jurisdictions to confirm this compliance. Any changes of
suppliers or modifications of methods of manufacturing require amending our
application to the FDA. Our inability to demonstrate ongoing cGMP compliance
could require us to suspend or terminate the manufacture of our products or
those of Avid’s third party customers. Any delay, interruption or other issues
that arise in the manufacture, fill-finish, packaging, or storage of our
products or those of Avid’s third party customers as a result of a failure of
our facilities to pass any regulatory agency inspection could significantly
impair (i) our ability to advance our products through clinical trials, and
(ii)
Avid’s ability to generate revenue. This could increase our costs, cause us to
lose revenue or market share and damage our reputation.
Except
for historical
information, the information contained in this prospectus and in our reports
filed with the Securities and Exchange Commission (“Commission”) are “forward
looking” statements about our expected future business and financial
performance. 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.
9
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, 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.
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.
As
of the date of the
prospectus, we are authorized to issue up to 200,000,000 shares of common stock,
$.001 par value per share. As of December 16, 2004, 144,558,472 shares of our
common stock were outstanding, and an additional 27,838,892 shares are reserved
for issuance upon the exercise of outstanding stock options and
warrants.
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.
10
We
may 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.
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 we 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.
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
SmallCap 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.
11
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 SmallCap Market under the symbol “PPHM.”
The
validity of the
securities offered by this prospectus has been passed upon for us by Snell
&
Wilmer LLP, Irvine, 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.
Ernst
& Young LLP, independent registered public accounting firm, have audited our
consolidated financial statements and schedule included in our Annual Report
on
Form 10-K for the year ended April 30, 2004, as set forth in their report,
which
is incorporated by reference in this prospectus and elsewhere in the
registration statement. Our consolidated financial statements and schedule
are
incorporated by reference in reliance on Ernst & Young LLP’s report, given
on their authority as experts in accounting and auditing.
We
have filed with the
Commission a registration statement on Form S-3 under the Securities Act of
1933, relating to the securities being offered by this prospectus. For
further information pertaining to our securities being offering by this
prospectus, reference is made to such registration statement. This prospectus
constitutes the prospectus we filed as a part of the registration statement
and
it does not contain all information in the registration statement, certain
portions of which have been omitted in accordance with the rules and regulations
of the Commission. In addition, we are subject to the informational requirements
of the Securities Exchange Act of 1934, and, in accordance with such
requirements, files reports, proxy statements and other information with the
Commission relating to its business, financial statements and other matters.
Reports and proxy and information statements filed under Section 14(a) and
14(c)
of the Securities Exchange Act of 1934 and other information filed with the
Commission as well as copies of the registration statement can be inspected
and
copied at the public reference facilities maintained by the Commission at Room
1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549, and
at
the Commission’s Midwest Regional Offices at 500 West Madison Street, Chicago,
Illinois 60606. Copies of such material can also be obtained at prescribed
rates
from the Public Reference Section of the Commission at its principal office
at
Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549. Such material
may also be obtained electronically by visiting the Commission’s web site on the
Internet at http://www.sec.gov. Our common stock is traded on The Nasdaq
SmallCap Market under the symbol “PPHM.” Reports, proxy statements and other
information concerning our Company may be inspected at the National Association
of Securities Dealers, Inc., at 1735 K Street, N.W., Washington D.C.
20006.
The
Commission 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 incorporate by reference into this prospectus
the documents listed below:
|
1. |
Annual
Report on Form 10-K for the fiscal year ended April 30,
2004, as filed with the Commission on July 14, 2004, under Section
13(a)
of the Securities Exchange Act of 1934; |
|
|
|
|
2. |
Quarterly
Reports on Form 10-Q for the quarters ended July 31, 2004
and October 31, 2004, filed with the Commission on September 9, 2004
and
December 10, 2004, respectively. |
|
|
|
|
3.
|
Definitive
Proxy Statement with respect to the Annual Meeting of
Stockholders to be held on October 25, 2004, as filed with the Commission
on September 13, 2004; |
|
|
|
|
4. |
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;
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, 2004. |
12
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 Attention: Paul J. Lytle, Chief Financial
Officer, 14272 Franklin Avenue, Suite 100, Tustin, California 92780-7017,
telephone number (714) 508-6000. See also “Where to Learn More About
Us.”
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.
13
|
|
|
Common
Stock
|
|
|
|
PROSPECTUS |
|
|
|
Dated
December 20, 2004 |
|
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. |
|
|
|
TABLE
OF CONTENTS |
|
|
|
|
PROSPECTUS
SUMMARY |
|
1 |
|
RISK
FACTORS |
|
3 |
|
FORWARD-LOOKING
STATEMENTS |
|
9 |
|
USE
OF PROCEEDS |
|
10 |
|
DESCRIPTION
OF
COMMON STOCK |
|
10 |
|
PLAN
OF DISTRIBUTION |
|
11 |
|
LEGAL
MATTERS |
|
12 |
|
EXPERTS |
|
12 |
|
WHERE
TO LEARN
MORE ABOUT US |
|
12 |
|
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE |
|
12 |
|
DISCLOSURE
OF
COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES |
|
13 |
|