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):
December 9, 2005
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).
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| o |
Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
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| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
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| o |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
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| ITEM 2.02. |
RESULTS
OF OPERATIONS AND FINANCIAL
CONDITION
|
On
December 9, 2005, Peregrine Pharmaceuticals, Inc. issued a press release to
report the Company’s financial results for the second quarter ended October 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 |
FINANCIAL
STATEMENTS AND EXHIBITS
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| (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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SIGNATURE
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: December 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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EXHIBIT
99.1
Investors
Brod
& Schaffer
(800)
987-8256
ir@peregrineinc.com
PEREGRINE
PHARMACEUTICALS REPORTS FISCAL YEAR 2006
SECOND
QUARTER RESULTS
TUSTIN,
Calif., December 9
--
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM),
a
biopharmaceutical company with a portfolio of innovative, clinical stage product
candidates for viral diseases and cancer, today announced financial results
for
the second quarter of fiscal year 2006 ended October 31, 2005. The company
reported a consolidated net loss of $4,571,000, or $0.03 per basic and diluted
share, compared to $3,638,000, or $0.03 per basic and diluted share, for the
prior year period.
Total
revenues for the current quarter were $556,000, of which $533,000 were
attributable to Avid Bioservices, the company’s wholly owned contract
manufacturing subsidiary. This compared to total revenues of $2,183,000 for
the
comparable quarter last year.
“During
the quarter, we made significant progress in advancing our Tarvacin™
Anti-Cancer
and
Tarvacin Anti-Viral
programs,” said Steven King, president and CEO of Peregrine. “We expect to build
upon this momentum and accelerate our activities to further these key clinical
programs in 2006.”
Total
costs and expenses decreased $643,000 to $5,242,000 for the 2006 second quarter
from $5,885,000 for the same quarter last year, primarily reflecting a decrease
in cost of sales associated with Avid Bioservices. This decrease was offset
by
an increase in research and development expenses of $240,000 to $3,244,000
combined with an increase in selling, general and administrative expenses of
$233,000 to $1,570,000 in the second quarter.
At
October 31, 2005, the company had $11,902,000 in cash and cash equivalents,
compared to $9,816,000 at fiscal year end April 30, 2005. Subsequent to the
second quarter, the company raised $6,720,000 in November with the completion
of
a private placement of 8.0 million shares of common stock.
“As
part
of our plans to expedite our development activities, Avid focused much of
its
efforts this quarter on the scale-up and manufacturing of Peregrine’s lead
products that were scheduled in the production queue,” said Steven King,
president and CEO of Peregrine. “Going forward, our long-term operating results
are expected to benefit from two recently announced customer contract wins.”
--more--
Update
on Tarvacin™ Program
Tarvacin
Anti-Viral
The
Tarvacin Anti-Viral
Phase I
hepatitis C virus (HCV) trial is proceeding according to plan, with initial
safety data results expected in the first quarter of calendar year 2006. Overall
results from the trial are expected in the third quarter of 2006. The company
also plans to conduct two additional HCV trials in 2006: a repeat dose trial
and
a combination therapy trial with a standard of care drug, such as ribavirin.
Peregrine is also evaluating the potential of Tarvacin in preclinical models
for
the treatment of several viral infections including seasonal and pandemic
influenza, cytomegalovirus and HIV and plans to initiate trials in one to two
additional anti-viral indications during 2006 pending positive results from
preclinical studies. To advance these preclinical and clinical programs, the
company has established collaborations with private contract laboratories as
well as a number of federal government agencies, including the National
Institute of Allergy and Infectious Diseases and the Department of Defense.
The
Tarvacin Anti-Viral
program
will also benefit from the addition of three new members to the company’s
Scientific Resource Board who are leading experts in their fields and will
help
advance additional indications for Tarvacin Anti-Viral.
Tarvacin
Anti-Cancer
Patient
enrollment is now ongoing for the Phase I trial of Tarvacin Anti-Cancer
at five
clinical sites, including the M.D. Anderson Cancer Center. Peregrine expects
this trial to be completed by the end of calendar year 2006. The company is
evaluating options to expand the Tarvacin Anti-Cancer
studies
to additional sites to facilitate enrollment. As part of this effort to
accelerate clinical development, Peregrine is exploring initiating studies
outside the U.S. in 2006. Safety data from these studies will be used to support
rapid transition into efficacy trials for both monotherapy as well as
combination therapy with chemotherapeutic agents and/or radiation.
In
November, the University of Texas Southwestern Medical Center at Dallas secured
financing from the U.S. Department of Defense to conduct preclinical studies
of
Tarvacin Anti-Cancer
in
combination with chemotherapy agents for the treatment of prostate cancer.
Results from these studies are expected to contribute to the design of
additional clinical trials.
Update
on Cotara® Program
The
company is continuing the Cotara study in patients with recurrent brain cancer
through its collaboration with the New Approaches to Brain Tumor Therapy (NABTT)
Consortium. The company expects to complete patient treatment in 2006 and has
begun planning for a follow-on study to treat additional patients.
--more--
Conference
Call:
The
company will host a conference call on Friday, December 9, 2005 at 11:00 a.m.
ET/ 8:00 a.m. PT to discuss its second quarter results. Interested parties
may
listen to the live teleconference by dialing 1-800-860-2442. A telephonic replay
of the conference call will also be available through December 16, 2005, by
calling 1-877-344-7529 and entering passcode 382933#.
To
listen
to a live broadcast of the call over the Internet, please visit: http://www.peregrineinc.com.
The
broadcast will be archived on Peregrine’s website for 30 days.
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 is pursuing three separate clinical trials in cancer
and anti-viral indications with its lead product candidates 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 biomanufacturing 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 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,
including, but not limited to, the following uncertainties: that safety and
efficacy studies in the Phase I clinical cancer study may not correlate to
safety and efficacy data from the preclinical animal models, the timing of
enrolling all patients In any clinical trial, that preclinical binding studies
of Tarvacin™ against various enveloped viruses may prove to be ineffective
during clinical testing, the timing for initiating any new studies, and
increased manufacturing activity at Avid Bioservices, Inc. due to the signing
of
a new contracts and the profitability of such 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 preclinical 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, preclinical 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.
--tables
to follow--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
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SIX
MONTHS ENDED
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October
31,
2005
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October
31,
2004
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October
31,
2005
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October
31,
2004
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Unaudited
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Unaudited
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Unaudited
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Unaudited
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||||||||||
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REVENUES:
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Contract
manufacturing revenue
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$
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533,000
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$
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2,164,000
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$
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722,000
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$
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2,649,000
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|||||
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License
revenue
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23,000
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19,000
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42,000
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38,000
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Total
revenues
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556,000
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2,183,000
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764,000
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2,687,000
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COSTS
AND EXPENSES:
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Cost
of contract manufacturing
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428,000
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1,544,000
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732,000
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1,992,000
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Research
and development
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3,244,000
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3,004,000
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6,036,000
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5,574,000
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Selling,
general and administrative
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1,570,000
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1,337,000
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3,087,000
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2,304,000
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Total
costs and expenses
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5,242,000
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5,885,000
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9,855,000
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9,870,000
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LOSS
FROM OPERATIONS
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(4,686,000
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)
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(3,702,000
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)
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(9,091,000
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)
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(7,183,000
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)
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OTHER
INCOME (EXPENSE):
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Interest
and other income
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128,000
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64,000
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204,000
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132,000
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Interest
and other expense
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(13,000
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)
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–
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(23,000
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)
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–
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NET
LOSS
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$
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(4,571,000
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)
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$
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(3,638,000
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)
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$
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(8,910,000
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)
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$
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(7,051,000
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)
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WEIGHTED
AVERAGE SHARES
OUTSTANDING:
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Basic
and Diluted
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165,925,879
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141,545,829
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162,980,798
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141,429,201
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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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$
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(0.05
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)
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$
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(0.05
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)
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--more--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
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OCTOBER
31,
2005
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APRIL
30,
2005
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|||||
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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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11,902,000
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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
$72,000
(October) and $69,000 (April)
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491,000
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486,000
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|||||
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Inventories
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1,487,000
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627,000
|
|||||
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Prepaid
expenses and other current assets
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877,000
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1,197,000
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|||||
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Total
current assets
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14,757,000
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12,126,000
|
|||||
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PROPERTY:
|
|||||||
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Leasehold
improvements
|
494,000
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494,000
|
|||||
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Laboratory
equipment
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3,209,000
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3,029,000
|
|||||
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Furniture,
fixtures and computer equipment
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684,000
|
647,000
|
|||||
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4,387,000
|
4,170,000
|
||||||
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Less
accumulated depreciation and amortization
|
(2,732,000
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)
|
(2,532,000
|
)
|
|||
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Property,
net
|
1,655,000
|
1,638,000
|
|||||
|
OTHER
ASSETS:
|
|||||||
|
Note
receivable, net of allowance of $1,475,000 (October) and $1,512,000
(April)
|
–
|
–
|
|||||
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Other
|
554,000
|
481,000
|
|||||
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Total
other assets
|
554,000
|
481,000
|
|||||
|
TOTAL
ASSETS
|
$
|
16,966,000
|
$
|
14,245,000
|
|||
--more--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
OCTOBER
31,
2005
|
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
|
$
|
1,161,000
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$
|
1,325,000
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|||
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Accrued
clinical trial site fees
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61,000
|
8,000
|
|||||
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Accrued
legal and accounting fees
|
176,000
|
549,000
|
|||||
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Accrued
royalties and license fees
|
152,000
|
149,000
|
|||||
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Accrued
payroll and related costs
|
572,000
|
806,000
|
|||||
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Notes
payable, current portion
|
325,000
|
234,000
|
|||||
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Other
current liabilities
|
470,000
|
563,000
|
|||||
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Deferred
revenue
|
1,060,000
|
517,000
|
|||||
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Total
current liabilities
|
3,977,000
|
4,151,000
|
|||||
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NOTES
PAYABLE
|
474,000
|
434,000
|
|||||
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DEFERRED
LICENSE REVENUE
|
41,000
|
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
-
166,032,599 (October); 152,983,460 (April)
|
166,000
|
153,000
|
|||||
|
Additional
paid-in capital
|
191,611,000
|
180,011,000
|
|||||
|
Deferred
stock compensation
|
(590,000
|
)
|
(751,000
|
)
|
|||
|
Accumulated
deficit
|
(178,713,000
|
)
|
(169,803,000
|
)
|
|||
|
Total
stockholders' equity
|
12,474,000
|
9,610,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
16,966,000
|
$
|
14,245,000
|
|||
####