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 9, 2005
(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, Suite 100, 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))
On
September 9, 2005, Peregrine Pharmaceuticals, Inc. issued a press release to
report the Company’s financial results for the quarter ended July 31, 2005. 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 |
| (c) |
Exhibits.
The following material is filed as an exhibit to this Current Report
on
Form 8-K:
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Exhibit
Number
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99.1
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Press
Release issued September 9, 2005
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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 9, 2005 | By: | /s/ STEVEN W. KING |
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| Steven
W. King,
President
and Chief Executive
Officer
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EXHIBIT
INDEX
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Exhibit
Number
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Description
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99.1
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Press
Release issued September 9, 2005
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EXHIBIT
99.1
| Investors
Krista
Mallory
Director
of Investor Relations
(714)
508-6046
info@peregrineinc.com
|
Media
Stephen
Gendel
GendeLLindheim
BioCom Partners
(212)
918-4650
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FOR
IMMEDIATE RELEASE
PEREGRINE
PHARMACEUTICALS ANNOUNCES
FIRST
QUARTER 2006 FINANCIAL RESULTS
Tustin,
CA -- September 9, 2005
-
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a
biopharmaceutical company with a portfolio of innovative product candidates
in
clinical trials for the treatment of cancer and viral diseases, today
announced financial results for the first quarter of fiscal year 2006. The
company reported a net loss of $4,339,000 or $0.03 per basic and diluted share
for the quarter ended July 31, 2005. This compares to a net loss of $3,413,000
or $0.02 per basic and diluted share for the same period last year. The
increased net loss for the first quarter of fiscal year 2006 resulted primarily
from decreased contract manufacturing revenues, as well as increased staffing,
infrastructure development and R&D expense, reflecting in part Peregrine’s
continued success in advancing the clinical development of Tarvacin™ and Cotara®
and its preclinical pipeline.
“Peregrine
has already achieved important milestones in the new fiscal year that reinforce
the momentum of our clinical programs and underscore the major potential of
our
lead product candidates,” said Steven King, president and chief executive
officer of Peregrine.
Mr.
King
continued, “We received FDA clearance to initiate Phase l studies of
Tarvacin™Anti-Viral and
initiated patient enrollment in this hepatitis C trial, opened patient
enrollment for a Phase l study of Tarvacin™Cancer
at three
centers, launched a study of Cotara® in brain cancer patients in collaboration
with a leading consortium, concluded an agreement with a U.S. government agency
to assess the broad anti-viral utility of Tarvacin™Anti-Viral
and
released scientific data that highlights the clinical promise of our lead
products. We also strengthened the company’s cash reserves and laid the
groundwork for increased contract manufacturing revenues. We look forward to
a
highly productive fiscal year where we will continue to focus on advancing
our
clinical programs while optimizing the value of our rich asset
base.”
Total
revenues for the current quarter decreased to $208,000 compared to revenues
of
$504,000 for the comparable quarter last year. This decrease reflects a drop
in
contract manufacturing revenues that was primarily due to a decrease in the
number of external manufacturing projects being conducted during the first
quarter. During the quarter, Peregrine’s manufacturing facility was primarily
utilized to support the scale-up and manufacturing of Tarvacin™ and other
antibodies in development by Peregrine.
Selling,
general and administrative expenses increased $550,000 to $1,517,000 in the
current quarter compared to $967,000 in the same prior year quarter. This
increase is primarily attributable to an increase in general corporate
activities, including increased staffing, legal fees, and costs associated
with
the implementation of section 404 of the Sarbanes-Oxley Act of 2002.
At
July
31, 2005, the company had $16,495,000 in cash and cash equivalents, compared
to
$9,816,000 at fiscal year end April 30, 2005.
Recent
Highlights
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·
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Submitted
an Investigational New Drug (IND) Application for Tarvacin™Anti-Viral
and received FDA clearance to initiate clinical
trials
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-
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Enrollment
now underway in a Phase l trial for patients chronically infected
with
hepatitis C virus (HCV)
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·
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Opened
patient enrollment for Tarvacin™ Cancer
Phase 1 trial
in
patients with solid tumor cancers
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-
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Enrollment
in multi-center study is
underway
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·
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Presented
data at BIO 2005 supporting the broad spectrum potential of
Tarvacin™ Anti-Viral
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·
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Signed
an agreement with the United States Army Medical Research Institute
of
Infectious Diseases (USAMRIID) for broad anti-viral testing of
Tarvacin™ Anti-Viral
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·
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Data
were published in Cancer
Research
showing that a Tarvacin equivalent plus docetaxel inhibited breast
tumor
growth by 93% and also inhibited tumor
colonies in the lung by 93%, without added
toxicity
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·
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Clinical
data were published in Neurosurgery
confirmed the potential of Peregrine’s Cotara® for treating brain
cancer
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·
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Presented
at the Rodman and Renshaw Techvest 2nd Annual Security & Connectivity
Investor Conference
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§
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Announced
a $6.7 million investment from an institutional
investor
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§
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Entered
into a licensing agreement with Medarex to develop vascular targeting
agents, Peregrine’s third collaboration for its Vascular Targeting Agent
platform technology
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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
viral diseases. The company has opened patient enrollment in three separate
clinical trials with its lead product candidates, Tarvacin™ and Cotara®. The
company also has in-house manufacturing capabilities through its wholly-owned
subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com),
which
provides development and manufacturing services for the company and outside
customers.
Copies
of
Peregrine Pharmaceuticals press releases, SEC filings, current price quotes
and
other valuable information for investors may be found at
http://www.peregrineinc.com.
Statements
in this press release which are not purely historical, including statements
regarding Peregrine Pharmaceutical's 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, include, but
are
not limited to, the following uncertainties: that safety and efficacy studies
in
the Tarvacin Phase I clinical cancer studies may not correlate to safety and
efficacy data from the pre-clinical animal models, the timing of enrolling
patients under the Phase I studies using Tarvacin™ for the treatment of cancer
and HCV, that pre-clinical binding studies of Tarvacin™ against various
enveloped viruses may prove to be ineffective during clinical testing, and
increased manufacturing activity at Avid Bioservices, Inc. due to the signing
of
new contracts. 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 and the outcomes of
pre-clinical and clinical trials for our technologies; slower than expected
rates of patient recruitment, unforeseen safety issues resulting from the
administration of antibody products in patients, the significant costs to
develop our products as all of our products are currently in development,
pre-clinical studies or clinical trials and no revenue has been generated from
commercial product sales; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory approval
for our technologies; complying with governmental regulations applicable to
our
business; consummating collaborative arrangements with corporate partners for
product development; and achieving milestones under collaborative arrangements
with corporate partners. Our business could be affected by all of the foregoing
and 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, 2005. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to
update or revise any forward-looking statements in this press release.
-more-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
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THREE
MONTHS ENDED
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July
31, 2005
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July
31, 2004
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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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189,000
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$
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485,000
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License
revenue
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19,000
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19,000
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Total
revenues
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208,000
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504,000
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COSTS
AND EXPENSES:
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Cost
of contract manufacturing
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304,000
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448,000
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Research
and development
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2,792,000
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2,570,000
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Selling,
general and administrative
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1,517,000
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967,000
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Total
costs and expenses
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4,613,000
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3,985,000
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LOSS
FROM OPERATIONS
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(4,405,000
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)
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(3,481,000
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)
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OTHER
INCOME (EXPENSE):
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Interest
and other income
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76,000
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68,000
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Interest
and other expense
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(10,000
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)
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-
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NET
LOSS
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$
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(4,339,000
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)
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$
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(3,413,000
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)
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WEIGHTED
AVERAGE SHARES
OUTSTANDING:
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Basic
and Diluted
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160,035,717
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141,312,572
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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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(0.02
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)
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-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
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JULY
31,
2005
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APRIL
30,
2005
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Unaudited
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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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16,495,000
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$
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9,816,000
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Trade
and other receivables, net of allowance for doubtful accounts of
$70,000
(July) and $69,000 (April)
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405,000
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486,000
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Inventories
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811,000
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627,000
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Prepaid
expenses and other current assets
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938,000
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1,197,000
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Total
current assets
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18,649,000
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12,126,000
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PROPERTY:
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Leasehold
improvements
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494,000
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494,000
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Laboratory
equipment
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3,201,000
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3,029,000
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Furniture,
fixtures and computer equipment
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683,000
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647,000
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4,378,000
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4,170,000
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Less
accumulated depreciation and amortization
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(2,633,000
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)
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(2,532,000
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)
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Property,
net
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1,745,000
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1,638,000
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OTHER
ASSETS:
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Note
receivable, net of allowance of $1,494,000 (July) and $1,512,000
(April)
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-
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-
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Other
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492,000
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481,000
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|||||
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Total
other assets
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492,000
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481,000
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|||||
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TOTAL
ASSETS
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$
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20,886,000
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$
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14,245,000
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-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
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JULY
31,
2005
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APRIL
30,
2005
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||||||
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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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1,078,000
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$
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1,325,000
|
|||
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Accrued
clinical trial site fees
|
17,000
|
8,000
|
|||||
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Accrued
legal and accounting fees
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458,000
|
549,000
|
|||||
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Accrued
royalties and license fees
|
184,000
|
149,000
|
|||||
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Accrued
payroll and related costs
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466,000
|
806,000
|
|||||
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Notes
payable, current portion
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321,000
|
234,000
|
|||||
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Other
current liabilities
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418,000
|
563,000
|
|||||
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Deferred
revenue
|
725,000
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517,000
|
|||||
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Total
current liabilities
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3,667,000
|
4,151,000
|
|||||
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NOTES
PAYABLE
|
557,000
|
434,000
|
|||||
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DEFERRED
LICENSE REVENUE
|
31,000
|
50,000
|
|||||
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COMMITMENTS
AND CONTINGENCIES
|
|||||||
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STOCKHOLDERS'
EQUITY:
|
|||||||
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Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting; nil
shares
outstanding
|
-
|
-
|
|||||
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Common
stock-$.001 par value; authorized 200,000,000 shares;
outstanding
- 165,690,677 (July); 152,983,460 (April)
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166,000
|
153,000
|
|||||
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Additional
paid-in capital
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191,254,000
|
180,011,000
|
|||||
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Deferred
stock compensation
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(647,000
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)
|
(751,000
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)
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Accumulated
deficit
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(174,142,000
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)
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(169,803,000
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)
|
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Total
stockholders' equity
|
16,631,000
|
9,610,000
|
|||||
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TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,886,000
|
$
|
14,245,000
|
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####