UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report (Date of earliest event reported):
July 14, 2006
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
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0-17085
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95-3698422
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(State
of other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
|
|
|
|
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14272
Franklin Avenue, Tustin, California 92780
|
||||
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(Address
of Principal Executive Offices)
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||||
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Registrant’s
telephone number, including area code: (714)
508-6000
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||||
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Not
Applicable
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||||
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(Former
name or former address, if changed since last
report)
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||||
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
o
Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
2.02 RESULTS OF OPERATIONS AND FINANCIAL
CONDITION
On
July
14, 2006, Peregrine Pharmaceuticals, Inc. issued a press release to report
the
Company’s financial results for the year ended April 30, 2006. A copy of the
press release is attached to this current report on Form 8-K as Exhibit 99.1.
No
additional information is included in this Current Report on Form
8-K.
The
information included in this Current Report on Form 8-K, including the exhibit
hereto, shall not be deemed “filed” for purposes of, nor shall it be deemed
incorporated by reference in, any filing under the Securities Act of 1933 or
the
Securities Exchange Act of 1934, except as expressly set forth by specific
reference in such a filing.
ITEM
9.01 FINANCIAL STATEMENTS AND
EXHIBITS
(c)
Exhibits. The following material is filed as an exhibit to this Current Report
on Form 8-K:
Exhibit
Number
99.1 Press
Release issued July 14, 2006
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| PEREGRINE PHARMACEUTICALS, INC. | ||
| |
|
|
| Date: July 14, 2006 | By: | /s/ Steven W. King |
|
Steven
W. King
President
and Chief Executive Officer,
Director
|
||
EXHIBIT
INDEX
| Exhibit
Number
|
Description |
|
99.1
|
Press
Release issued July 14, 2006
|
EXHIBIT
99.1
|
Investors
|
Media
|
|
The
Brod Group
|
Barbara
Lindheim and
Stephen Gendel
|
|
(800)
987-8256
|
GendeLLindheim
BioCom Partners
|
|
ir@peregrineinc.com
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(212)
918-4650
|
PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS
FOR
FISCAL YEAR 2006
--Fiscal
Year Marked by Initiation of Three Clinical Programs for First-in-Class
Anti-Viral and
Anti-Cancer
Agent Bavituximab and TNT Agent Cotara®--
TUSTIN,
Calif., July 14, 2006
--
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM),
a
biopharmaceutical company with a portfolio of innovative, clinical stage
products for the treatment of hepatitis C virus (HCV) infections and cancer,
today announced financial results for the year ended April 30, 2006. The
company
reported a consolidated net loss of $17,061,000, or $0.10 per basic and diluted
share, compared to a consolidated net loss of $15,452,000, or $0.11 per basic
and diluted share for fiscal 2005. Total revenues for fiscal 2006 were
$3,193,000 versus $4,959,000 in the prior year. Avid Bioservices, the company’s
wholly owned contract manufacturing subsidiary contributed $3,005,000 in
contract manufacturing revenues versus $4,684,000 recorded in the year ago
period. During the current fiscal year, the company significantly increased
its
utilization of this facility to manufacture clinical grade materials to support
Peregrine’s three active clinical trials and other products in
development.
Total
costs and expenses in FY 2006 increased to $22,276,000 from $20,663,000 for
the
year ended April 2005. The increase in total expenses was due to an increase
in
research and development expenses associated with the advancement of the
company’s clinical and preclinical product candidates as well as an increase in
selling, general and administrative expenses, partially offset by a decrease
in
cost of sales associated with Avid Bioservices’ revenues.
This
current year increase in research and development was primarily related to
the
advancement of bavituximab as the company increased expenses directed towards
manufacturing, scale-up, preclinical studies and clinical trials to support
two
separate clinical programs using bavituximab for the treatment of advanced
solid
cancers and HCV infections and preclinical studies that could possibly support
expansion of clinical trials in other anti-viral indications. The current
year
increase in selling, general and administrative expenses was primarily due
to
development of infrastructure across key corporate functions to support the
company’s expanded operations.
"This
past fiscal year has been one of substantial progress for the company on
every
front,” commented Steven W. King, president and CEO of Peregrine. “At the
beginning of the fiscal year, we had no active clinical trials. We now have
three sets of clinical trials ongoing for multiple indications, with positive
preliminary results already reported from one of the programs. Our focus
has
been to initiate and expand our clinical programs while continuing preclinical
studies that support our current clinical programs and should also help to
create future clinical development opportunities.”
“During
the past year we initiated two separate clinical programs with bavituximab,
the
first product from our new class of drugs we refer to as anti-phosphatidylserine
(anti-PS) immunotherapeutic agents. These trials are for the treatment of
chronic hepatitis C infections and all types of solid tumors. We have already
completed patient dosing in the first HCV clinical trial and have initiated
a
second trial. We recently reported top-line data from the first trial that
indicated bavituximab was safe, well tolerated and showed promising signs
of
anti-viral activity at all dose levels administered. These results were
particularly encouraging given the fact that this was a first-in-human study
for
an entirely new class of drugs. We are currently treating patients in a Phase
lb
HCV study that is designed to evaluate repeat doses of bavituximab for safety
and to assess changes in HCV viral levels. Combination therapy clinical trials
to evaluate bavituximab with current standard HCV infection therapies are
being
planned for later this year, and Phase ll HCV trials are slated for next
calendar year.”
Mr.
King
added, “In addition to the current clinical studies, during the year we
continued to evaluate bavituximab for the treatment of other viral infections
including HIV, influenza, cytomegalovirus and other life threatening diseases.
These studies are being conducted through collaborations with top academic
and
private research centers and we expect they could support expanded anti-viral
indications for bavituximab.”
Mr.
King
continued, “During the year, we also made significant progress in the
bavituximab anti-cancer program. We opened patient enrollment in the Phase
l
cancer trial at a total of five sites, including the renowned MD Anderson
Cancer
Center. In addition, researchers associated with Peregrine published and
presented peer-reviewed data from animal cancer models highlighting the exciting
promise of the bavituximab as a treatment for breast, prostate, pancreatic
and
brain cancer, both as monotherapy and in combination with radiation and
chemotherapy. The anti-cancer potential of bavituximab was further validated
when researchers working with Peregrine received substantial new grants from
the
federal government to support further preclinical cancer studies, which should
help us design clinical trials for specific cancer indications that could
follow
successful completion of the ongoing Phase l clinical trial.”
“During
the year, we also initiated a dose confirmation and dosimetry clinical trial
for
our lead Tumor Necrosis Therapy (TNT) agent Cotara in collaboration with
the
NABTT clinical research consortium. This study will provide important data
using
single doses of Cotara administered directly into the tumor by an optimized
delivery method. By using these optimized methods, we believe it may be possible
to improve on the promising results seen in earlier clinical studies while
increasing the clinical and commercial potential of the drug. Data published
last spring suggested that Cotara may have unusual promise in this particularly
deadly disease, and we are committed to ensuring that its potential is fully
evaluated.”
Mr.
King
concluded, “In fiscal 2006, we significantly expanded our research efforts,
highlighted by initiation of three promising clinical trials, while effectively
raising capital to support these efforts. This has been a very productive
year
for Peregrine and we intend to build upon this momentum during the upcoming
fiscal year.”
At
April
30, 2006, the company had $17.2 million in cash and cash equivalents. Since
the
start of the new fiscal year on May 1, 2006, the company raised an additional
$13.0 million in net proceeds from the sale of shares of its common stock
and
had a cash position of $26.3 million as of June 30, 2006.
The
company believes it has sufficient cash on hand to progress its current clinical
programs through fiscal year 2007.
Corporate
Highlights Since the Start of Fiscal Year 2006
|
§
|
In
June 2006, Peregrine
announced that bavituximab showed promising anti-viral activity
and signs
of prolonged anti-viral effect in a single dose Phase la trial
as
monotherapy in patients with HCV
infections. These results were especially noteworthy since HCV
drugs
typically show little anti-viral effect when given only as a single
dose.
These results built on Phase la data presented at a February 2006
scientific meeting reporting that bavituximab appeared to be well
tolerated, with no dose limiting adverse events. The company also
announced that it has extended enrollment to an additional cohort
of
patients at a higher dose in the Phase 1a trial and also that patient
dosing in its Phase lb repeat dose HCV study was underway.
|
|
§
|
In
May 2006, at the American Society of Microbiology annual meeting,
Peregrine announced the results of an early stage study of bavituximab
for
the treatment of influenza. The company reported that bavituximab
completely inhibited replication of a laboratory strain of the
H5N1 virus,
commonly known as avian flu, in fertilized chicken eggs, an in
vivo
model for influenza anti-viral activity. Peregrine indicated that
it is
collaborating with a number of independent institutions to further
test
the potential of bavituximab as a treatment for seasonal and avian
influenza, focusing on optimizing potential dosing regimens and
modes of
delivery.
|
|
§
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Peregrine
researchers have published and presented data on the bavituximab
and
Cotara programs in a number of peer-reviewed settings. In April
2006,
researchers associated with Peregrine presented preclinical studies
at
the AACR cancer research meeting showing the potential of a bavituximab
equivalent plus radiation or chemotherapy to increase survival
in
resistant breast and brain cancer, a very positive result in these
models
of advanced disease. In
January 2006, a study published in the International
Journal of Cancer
showed that a bavituximab equivalent showed encouraging efficacy
in animal
models of pancreatic cancer, including reductions in the metastatic
disease that actually kills most victims. Earlier, an article in
Cancer
Research
in
May 2005 reported that a bavituximab equivalent plus chemotherapy
inhibited tumor growth by 93% in a model of advanced breast cancer.
And in
June 2005, a study published in the journal Neurosurgery
highlighted
the clinical potential of Cotara in treating lethal brain
cancers.
|
|
§
|
During
fiscal 2006, researchers associated with Peregrine at the University
of
Texas Southwestern Medical Center at Dallas received three major
competitive awards for bavituximab studies from the U.S. Defense
Department for additional preclinical studies of the bavituximab
approach
in breast and prostate cancer models. The results are expected
to help
guide design of human clinical studies for these indications. These
new
awards bring the total grants awarded to Peregrine researchers
at UT
Southwestern to $3.6 million.
|
|
§
|
In
late 2005, Peregrine added a number of leading antiviral experts
to its
Scientific Resource Board, including highly regarded opinion leaders
in
the fields of hepatitis C virus infection, influenza and avian
flu and
cytomegalovirus infection. These new members are providing valuable
assistance to Peregrine’s preclinical and clinical anti-viral
programs.
|
Conference
Call:
The
company will host a conference call on Friday, July 14, 2006 at 11:00 a.m.
EDT
to discuss its year-end quarter results.
To
listen
to a live broadcast of the call over the Internet, please visit: www.peregrineinc.com.
The
broadcast will be archived on Peregrine’s website for approximately 30 days.
To
listen
to the live teleconference by telephone, please dial 1-800-860-2442. A
telephonic replay of the conference call will also be available through July
21,
2006, by calling 1-877-344-7529 and entering passcode 382933#.
About
Peregrine Pharmaceuticals
Peregrine
Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of
innovative product candidates in clinical trials for the treatment of cancer
and
hepatitis C virus (HCV) infection. The company is pursuing three separate
clinical trials in cancer and HCV infection with its lead product candidate
bavituximab (formerly Tarvacin) and Cotara®. Peregrine also has in-house
manufacturing capabilities through its wholly owned subsidiary Avid Bioservices,
Inc. (www.avidbio.com),
which
provides development and bio-manufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be found at
www.peregrineinc.com.
Safe
Harbor Statement: Statements in this press release which are not purely
historical, including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations, projections, plans
or
predictions of the future are forward-looking statements within the meaning
of
the Private Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties including, but not limited to,
the
risk that bavituximab's safety profile in a repeat dose trial or in a
combination therapy trial will not be at the same safety level as was found
in
the phase Ia trial, the risk that the results of future trials will not
correlate to the results from the phase Ia trial, the risk that bavituximab
will
not be as well tolerated at ascending doses or show promising results in
other
viral indications and the risk that results of human studies using bavituximab
plus radiation or chemotherapy will not correlate to the results of the
preclinical studies. It is important to note that the company's actual results
could differ materially from those in any such forward-looking statements.
Factors that could cause actual results to differ materially include, but
are
not limited to, uncertainties associated with completing preclinical and
clinical trials for our technologies; the early stage of product development;
the significant costs to develop our products as all of our products are
currently in development, preclinical studies or clinical trials; obtaining
additional financing to support our operations and the development of our
products; obtaining regulatory approval for our technologies; anticipated
timing
of regulatory filings and the potential success in gaining regulatory approval
and complying with governmental regulations applicable to our business. Our
business could be affected by a number of other factors, including the risk
factors listed from time to time in the Company's SEC reports including,
but not
limited to, the annual report on Form 10-K for the year ended April 30, 2006.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to
update
or revise any forward-looking statements in this press
release.
--tables
to follow--
PEREGRINE
PHARMACEUTICALS, INC.
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
|
FISCAL
YEAR ENDED
|
|||||||
|
April
30, 2006
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April
30, 2005
|
||||||
|
REVENUES:
|
|||||||
|
Contract
manufacturing revenue
|
$
|
3,005,000
|
$
|
4,684,000
|
|||
|
License
revenue
|
188,000
|
275,000
|
|||||
|
Total
revenues
|
3,193,000
|
4,959,000
|
|||||
|
COSTS
AND EXPENSES:
|
|||||||
|
Cost
of contract manufacturing
|
3,297,000
|
4,401,000
|
|||||
|
Research
and development
|
12,415,000
|
11,164,000
|
|||||
|
Selling,
general and administrative
|
6,564,000
|
5,098,000
|
|||||
|
Total
costs and expenses
|
22,276,000
|
20,663,000
|
|||||
|
LOSS
FROM OPERATIONS
|
(19,083,000
|
)
|
(15,704,000
|
)
|
|||
|
OTHER
INCOME (EXPENSE):
|
|||||||
|
Recovery
of note receivable
|
1,229,000
|
-
|
|||||
|
Interest
and other income
|
846,000
|
265,000
|
|||||
|
Interest
and other expense
|
(53,000
|
)
|
(13,000
|
)
|
|||
|
NET
LOSS
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
|
WEIGHTED
AVERAGE COMMON
SHARES
OUTSTANDING:
|
168,294,782
|
144,812,001
|
|||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
|
-
more -
PEREGRINE
PHARMACEUTICALS, INC.
| CONSOLIDATED BALANCE SHEETS | |||||||
|
APRIL
30,
2006
|
APRIL
30,
2005
|
||||||
|
ASSETS
|
|||||||
|
CURRENT
ASSETS:
|
|||||||
|
Cash
and cash equivalents
|
$
|
17,182,000
|
$
|
9,816,000
|
|||
|
Trade
and other receivables, net of allowance for doubtful accounts of
nil and
$69,000, respectively
|
579,000
|
486,000
|
|||||
|
Inventories
|
885,000
|
627,000
|
|||||
|
Prepaid
expenses and other current assets
|
1,466,000
|
1,197,000
|
|||||
|
Total
current assets
|
20,112,000
|
12,126,000
|
|||||
|
PROPERTY:
|
|||||||
|
Leasehold
improvements
|
618,000
|
494,000
|
|||||
|
Laboratory
equipment
|
3,444,000
|
3,029,000
|
|||||
|
Furniture,
fixtures and computer equipment
|
666,000
|
647,000
|
|||||
|
4,728,000
|
4,170,000
|
||||||
|
Less
accumulated depreciation and amortization
|
(2,822,000
|
)
|
(2,532,000
|
)
|
|||
|
Property,
net
|
1,906,000
|
1,638,000
|
|||||
|
OTHER
ASSETS:
|
|||||||
|
Note
receivable, net of allowance of nil and $1,512,000,
respectively
|
-
|
-
|
|||||
|
Other
|
658,000
|
481,000
|
|||||
|
Total
other assets
|
658,000
|
481,000
|
|||||
|
TOTAL
ASSETS
|
$
|
22,676,000
|
$
|
14,245,000
|
|||
-
more -
PEREGRINE
PHARMACEUTICALS, INC.
| CONSOLIDATED BALANCE SHEETS (continued) | |||||||
|
APRIL
30,
2006
|
APRIL
30,
2005
|
||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
CURRENT
LIABILITIES:
|
|||||||
|
Accounts
payable
|
$
|
1,233,000
|
$
|
1,325,000
|
|||
|
Accrued
clinical trial site fees
|
170,000
|
8,000
|
|||||
|
Accrued
legal and accounting fees
|
250,000
|
549,000
|
|||||
|
Accrued
royalties and license fees
|
138,000
|
149,000
|
|||||
|
Accrued
payroll and related costs
|
850,000
|
806,000
|
|||||
|
Notes
payable, current portion
|
429,000
|
234,000
|
|||||
|
Capital
lease obligation, current portion
|
15,000
|
-
|
|||||
|
Deferred
revenue
|
563,000
|
517,000
|
|||||
|
Other
current liabilities
|
836,000
|
563,000
|
|||||
|
Total
current liabilities
|
4,484,000
|
4,151,000
|
|||||
|
Notes
payable, less current portion
|
498,000
|
434,000
|
|||||
|
Capital
lease obligation, less current portion
|
47,000
|
-
|
|||||
|
Deferred
license revenue
|
21,000
|
50,000
|
|||||
|
Commitments
and contingencies
|
|||||||
|
STOCKHOLDERS'
EQUITY:
|
|||||||
|
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
-
|
-
|
|||||
|
Common
stock-$.001 par value; authorized 250,000,000 shares; outstanding
-
179,382,191 and 152,983,460, respectively
|
179,000
|
153,000
|
|||||
|
Additional
paid-in capital
|
204,546,000
|
180,011,000
|
|||||
|
Deferred
stock compensation
|
(235,000
|
)
|
(751,000
|
)
|
|||
|
Accumulated
deficit
|
(186,864,000
|
)
|
(169,803,000
|
)
|
|||
|
Total
stockholders' equity
|
17,626,000
|
9,610,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
22,676,000
|
$
|
14,245,000
|
|||
####