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):
September 11, 2006
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
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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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Registrant’s
telephone number, including area code: (714)
508-6000
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Not
Applicable
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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
September 11, 2006, Peregrine Pharmaceuticals, Inc. issued a press release
to
report the Company’s financial results for the quarter ended July 31, 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 September 11, 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. | ||
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| Date: September 11, 2006 | By: | /s/ Steven W. King |
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Steven
W. King
President, Chief Executive Officer and
Director
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EXHIBIT
INDEX
Exhibit
Number Description
| 99.1 |
Press
Release issued September 11, 2006
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Exhibit
99.1
Contacts:
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GendeLLindheim
BioCom Partners
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Investors
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Media
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Barbara
Lindheim
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Stephen
Gendel
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(800)
987-8256
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(212)
918-4650
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info@peregrineinc.com
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PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS
FOR
FIRST QUARTER FY 2007
TUSTIN,
Calif., September 11, 2006
--
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM),
a
biopharmaceutical company with a portfolio of innovative, clinical-stage product
candidates for the treatment of hepatitis C infection (HCV) and cancer, today
announced financial results for the first quarter of fiscal year 2007 ended
July
31, 2006. The company reported a consolidated net loss of $5,457,000, or $0.03
per basic and diluted share, compared to a consolidated net loss of $4,339,000
or $0.03 per basic and diluted share for the same prior year period.
Total
revenues for the current quarter were $421,000 versus $208,000 for the
comparable quarter last year. Avid Bioservices, the company’s wholly owned
contract manufacturing subsidiary, contributed $398,000 in contract
manufacturing revenues versus $189,000 recorded in the similar prior year
period.
“The
first quarter was a strong start to the new fiscal year, as we made continued
positive progress in our key clinical programs,” said Steven W. King, president
and CEO of Peregrine. “We reported positive top-line safety data from our Phase
la trial of bavituximab in HCV patients, a key milestone for an innovative
first-in-class agent. Even more exciting was data from the study indicating
that
bavituximab showed promising signs of anti-viral activity, despite the fact
that
the drug was only administered as a single dose. The potential importance of
bavituximab as a new therapeutic approach for HCV was highlighted by the fact
that the full study results were selected for oral presentation at the plenary
session of a leading scientific liver disease meeting scheduled for late
October. The HCV Phase Ib repeat dose study is also proceeding well, and we
are
on track to complete patient enrollment by calendar year end. During the quarter
we also began planning combination therapy trials with current HCV treatments
which we plan to begin later this year.”
Mr.
King
continued, “Today we also announced a major development in the bavituximab
cancer program - we will soon be initiating a trial in India of bavituximab
in
combination with chemotherapy. We expect this study will enable us to accelerate
our overall development timelines for the program. Since bavituximab has shown
exceptional promise preclinically when used in combination with a number of
chemotherapy regimens, we are especially pleased to announce this development
in
the cancer clinical program. This new clinical trial is designed to complement
the ongoing U.S. Phase I trial in which bavituximab is administered as a single
agent. In addition to the bavituximab efforts, we are continuing our
collaboration with NABTT for the Cotara brain cancer program while making plans
to initiate a separate safety and efficacy trial by early next
year.”
Total
costs and expenses increased $1,599,000 to $6,212,000 for the 2007 first quarter
from $4,613,000 for the same quarter last year. The increase in total expenses
was due to an increase in research and development expenses associated with
the
positive advancement of the company’s clinical and preclinical product
candidates, as well as a small increase in selling, general and administrative
expenses.
Mr.
King
concluded, “We strengthened the company’s financial position during the quarter,
with the infusion of $13 million in new equity at favorable terms. These
resources will enable us to continue to generate data from our current three
independent clinical programs, which give us multiple opportunities for success
and which we anticipate should be a key value driver for the company during
fiscal year 2007. We also will use these resources to progress priority
preclinical candidates and to initiate additional clinical programs, further
strengthening and diversifying the value of our product portfolio.”
Interest
and other income increased $273,000 during the current quarter over the prior
year quarter. At July 31, 2006, the company had $28,500,000 in cash and cash
equivalents, compared to $17,182,000 at fiscal year end April 30, 2006.
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 candidates
bavituximab 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
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THREE
MONTHS ENDED
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July
31, 2006
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July
31, 2005
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Unaudited
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Unaudited
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REVENUES:
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Contract
manufacturing revenue
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$
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398,000
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$
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189,000
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License
revenue
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23,000
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19,000
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Total
revenues
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421,000
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208,000
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COSTS
AND EXPENSES:
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Cost
of contract manufacturing
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530,000
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304,000
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Research
and development
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4,041,000
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2,792,000
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Selling,
general and administrative
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1,641,000
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1,517,000
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Total
costs and expenses
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6,212,000
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4,613,000
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LOSS
FROM OPERATIONS
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(5,791,000
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)
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(4,405,000
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)
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OTHER
INCOME (EXPENSE):
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Interest
and other income
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349,000
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76,000
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Interest
and other expense
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(15,000
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)
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(10,000
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)
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NET
LOSS
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$
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(5,457,000
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)
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$
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(4,339,000
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)
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WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
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184,108,083
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160,035,717
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BASIC
AND DILUTED LOSS PER COMMON SHARE
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$
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(0.03
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)
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$
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(0.03
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)
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-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
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JULY
31,
2006
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APRIL
30,
2006
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Unaudited
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|||||||
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ASSETS
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CURRENT
ASSETS:
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Cash
and cash equivalents
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$
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28,500,000
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$
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17,182,000
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Trade
and other receivables, net of allowance for doubtful accounts of
$20,000
(July 2006)
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262,000
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579,000
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Inventories
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971,000
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885,000
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Prepaid
expenses and other current assets
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1,127,000
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1,466,000
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Total
current assets
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30,860,000
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20,112,000
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PROPERTY:
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Leasehold
improvements
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640,000
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618,000
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Laboratory
equipment
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3,468,000
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3,444,000
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Furniture,
fixtures and office equipment
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666,000
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666,000
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4,774,000
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4,728,000
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Less
accumulated depreciation and amortization
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(2,937,000
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)
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(2,822,000
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)
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Property,
net
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1,837,000
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1,906,000
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Other
assets
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658,000
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658,000
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TOTAL
ASSETS
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$
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33,355,000
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$
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22,676,000
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-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS (continued)
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JULY
31,
2006
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APRIL
30,
2006
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Unaudited
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LIABILITIES
AND STOCKHOLDERS' EQUITY
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CURRENT
LIABILITIES:
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Accounts
payable
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$
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1,148,000
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$
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1,233,000
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Accrued
clinical trial site fees
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151,000
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170,000
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Accrued
legal and accounting fees
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135,000
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250,000
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Accrued
royalties and license fees
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153,000
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138,000
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Accrued
payroll and related costs
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624,000
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850,000
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Notes
payable, current portion
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436,000
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429,000
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Capital
lease obligation, current portion
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15,000
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15,000
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Deferred
revenue
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317,000
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563,000
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Other
current liabilities
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940,000
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836,000
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|||||
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Total
current liabilities
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3,919,000
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4,484,000
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|||||
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Notes
payable, less current portion
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386,000
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498,000
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|||||
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Capital
lease obligation, less current portion
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43,000
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47,000
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|||||
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Deferred
license revenue
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17,000
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21,000
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|||||
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Commitments
and contingencies
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|||||||
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STOCKHOLDERS'
EQUITY:
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|||||||
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Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
-
|
-
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|||||
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Common
stock-$.001 par value; authorized 250,000,000 shares; outstanding
-
193,528,766 and 179,382,191, respectively
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193,000
|
179,000
|
|||||
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Additional
paid-in capital
|
221,118,000
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204,546,000
|
|||||
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Deferred
stock compensation
|
-
|
(235,000
|
)
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||||
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Accumulated
deficit
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(192,321,000
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)
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(186,864,000
|
)
|
|||
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Total
stockholders' equity
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28,990,000
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17,626,000
|
|||||
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TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
33,355,000
|
$
|
22,676,000
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####