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 10,
2007
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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14282
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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||||
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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):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425).
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o
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Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
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o
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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 10, 2007, Peregrine Pharmaceuticals, Inc. issued a press release to
report the Company’s financial results for the second quarter ended
October 31, 2007. 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 December 10, 2007
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:
December 10,
2007
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By:
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/s/ Steven W. King | |
| Steven W. King | |||
| President, Chief Executive Officer and Director | |||
EXHIBIT
INDEX
Exhibit
Number Description
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99.1
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Press
Release issued December 10, 2007
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Exhibit
99.1
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Contacts:
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GendeLLindheim
BioCom Partners
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Investors
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Media
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info@peregrineinc.com
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Barbara
Lindheim
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(800)
987-8256
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(212)
918-4650
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PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS
FOR
THE SECOND QUARTER OF FISCAL YEAR 2008
TUSTIN,
Calif., December 10, 2007 -- Peregrine Pharmaceuticals, Inc. (Nasdaq:
PPHM), a clinical stage biopharmaceutical company developing monoclonal
antibodies for the treatment of cancer and hepatitis C virus (HCV) infection,
today announced financial results for the second quarter of fiscal year 2008
ended October 31, 2007. The company reported a consolidated net loss
of $6,207,000, or $0.03 per basic and diluted share, compared to a consolidated
net loss of $5,070,000 or $0.03 per basic and diluted share for the same prior
year period. The increased net loss primarily reflects increased
investments in research and development as the company advanced its clinical
programs for bavituximab and Cotara®.
Total
revenues for the current quarter increased to $1,892,000 compared to $684,000
for the comparable quarter last year, and were primarily generated from services
provided by Avid Bioservices, the company's wholly owned contract manufacturing
subsidiary.
Total
costs and expenses increased to $8,445,000 in the second quarter of fiscal
year
2008 from $6,084,000 in the same prior year quarter. The increase was
primarily related to the increase in the cost of contract manufacturing during
the quarter resulting from higher reported revenues from external customers
in
addition to an increase in research and development expenses associated with
the
advancement of the company's clinical and preclinical product
candidates.
At
October 31, 2007, the company had $26,138,000 in cash and cash equivalents
compared to $16,044,000 at fiscal year end April 30, 2007.
"We
are
very optimistic about the future prospects of the company as we move into the
new year. With several Phase II clinical studies either underway or
in the process of starting, with Defense Department contract negotiations
proceeding nicely and with our research collaborations providing exciting new
data on a number of our programs, 2008 is shaping up to be an exciting year
for
Peregrine,” said Steven W. King, president and CEO of Peregrine. “In
addition, we believe there are multiple opportunities for turning some of these
developments into partnering opportunities that could create significant value
for the company. We intend to continue working closely with our
bankers and analyst team to promote our story to institutional investors and
are
optimistic that the combination of delivering on our product development
milestones, executing our business development initiatives and continuing to
ramp up our investor outreach efforts should result in significant value
creation for our stockholders going forward.”
Recent
Highlights
Bavituximab
Anti-Cancer Program: The company achieved a number of
clinical and preclinical advancements in the bavituximab cancer
program.
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§
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Received
regulatory approval to begin a new Phase II combination therapy trial
of
bavituximab and docetaxel in patients with metastatic breast
cancer: Preparations for patient enrollment are
underway.
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§
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Filed
protocols for two separate Phase II bavituximab combination therapy
trials
in patients with metastatic breast
cancer.
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§
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A
study published in Clinical Cancer Research demonstrated the
anti-cancer potential of Peregrine's bavituximab combined with radiation
in animal models of lung cancer, and researchers presented data at
the
Innovative Minds in Prostate Cancer Today (IMPaCT) Conference further
confirming bavituximab’s potential to shrink tumors in animal models of
resistant prostate tumors.
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Bavituximab
Anti-Viral Program: The company continued to advance its
bavituximab HCV program and presented positive data at a key liver disease
meeting
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§
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Dosed
first patient in a clinical trial of bavituximab in HCV patients
co-infected with HIV.
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§
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Added
The Johns Hopkins Hospital and a private AIDS clinic in Orange County,
California as additional clinical study sites for the HCV/HIV co-infection
study.
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§
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Presented
final results from the Phase I multiple dose HCV trial at the prestigious
Annual Meeting of the American Association for the Study of Liver
Disease
that showed bavituximab was well tolerated and demonstrated encouraging
signs of anti-viral activity.
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Cotara®
Glioblastoma Program: The company made significant
advancements in moving its Cotara brain cancer program forward.
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§
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Initiated
patient dosing in a 40-patient Cotara Phase II study in patients
with
glioblastoma multiforme, one of the most deadly forms of brain
cancer.
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§
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Regained
operational responsibility for the ongoing Cotara dosimetry and dose
confirmation clinical study and made progress in advancing the
trial.
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Preclinical
Anti-Cancer Programs: Researchers affiliated with Peregrine
presented data at scientific conferences highlighting the clinical potential
of
the company’s preclinical pipeline.
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§
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Researchers
presented data at IBC’s 5th
Annual
International Anti-Angiogenesis Conference confirming that a selective,
fully human anti-VEGF antibody being developed by Peregrine is as
effective as Avastin® in preclinical cancer
models.
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§
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Researchers
presented data at the International Conference on Vascular Targeted
Therapies in Oncology supporting the anti-cancer potential of Peregrine’s
immunocytokine fusion proteins and the broad anti-cancer potential
of its
anti-PS technology platform.
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Avid
Bioservices
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§
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Wholly
owned manufacturing subsidiary Avid Bioservices signed an agreement
with
ARIUS Research to produce clinical supplies of their lead cancer
stem cell
anti-CD44 antibody.
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§
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Avid
continued to demonstrate strong revenue performance in through the
second
quarter of fiscal year 2008.
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Conference
Call:
The
company will host a conference call today, December 10, 2007 at 11:30 a.m.
EST/
8:30 a.m. PST to discuss its second quarter FY 2008 financial
results.
To
listen
to a live broadcast of the call over the Internet or to review the archived
call, please visit: www.peregrineinc.com. The webcast will be
archived on Peregrine's website for approximately 30 days.
To
listen
to the conference call via telephone, please call the following number
approximately 10 minutes prior to the scheduled start time and request to join
the Peregrine Pharmaceuticals call: 1 (800)
860-2442. A telephonic replay of the conference call will be
available starting approximately one hour after the conclusion of the call
through December 17, 2007 by calling (877)
344-7529, 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 programs 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 the company may experience delays in clinical trial patient
enrollment, the risk that Avid’s revenue growth may slow or decline, the risk
that future protocol submissions may not be approved, the risk that the company
may not be able to monetize any of its assets, and the uncertainty as to whether
the company will successfully consummate a contract with the Defense Threat
Reduction Agency. 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, 2007
and
the quarterly report on Form 10-Q for the second fiscal quarter ended October
31, 2007. 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.
-financial
tables to follow-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
OCTOBER
31,
2007
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APRIL
30,
2007
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|||||||
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Unaudited
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||||||||
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ASSETS
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||||||||
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CURRENT
ASSETS:
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||||||||
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Cash
and cash equivalents
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$ |
26,138,000
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$ |
16,044,000
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Trade
and other receivables
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1,029,000
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750,000
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Inventories,
net
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2,500,000
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1,916,000
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Prepaid
expenses and other current assets
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1,484,000
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1,188,000
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Total
current
assets
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31,151,000
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19,898,000
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PROPERTY:
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||||||||
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Leasehold
improvements
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656,000
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646,000
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Laboratory
equipment
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3,687,000
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3,533,000
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Furniture,
fixtures and office equipment
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905,000
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873,000
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5,248,000
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5,052,000
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Less
accumulated depreciation and amortization
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(3,447,000 | ) | (3,212,000 | ) | ||||
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Property,
net
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1,801,000
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1,840,000
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||||||
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Other
assets
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1,493,000
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1,259,000
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||||||
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TOTAL
ASSETS
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$ |
34,445,000
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$ |
22,997,000
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||||
--continued--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
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OCTOBER
31,
2007
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APRIL
30, 2007
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|||||||
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Unaudited
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||||||||
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LIABILITIES
AND STOCKHOLDERS' EQUITY
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||||||||
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CURRENT
LIABILITIES:
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||||||||
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Accounts
payable
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$ |
2,455,000
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$ |
1,683,000
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||||
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Accrued
clinical trial site fees
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242,000
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228,000
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||||||
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Accrued
legal and accounting fees
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277,000
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392,000
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||||||
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Accrued
royalties and license fees
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189,000
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337,000
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||||||
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Accrued
payroll and related costs
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972,000
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874,000
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||||||
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Notes
payable, current portion
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231,000
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379,000
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||||||
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Capital
lease obligation, current portion
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17,000
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17,000
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||||||
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Deferred
revenue
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1,338,000
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1,060,000
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||||||
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Other
current liabilities
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1,207,000
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885,000
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||||||
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Total
current
liabilities
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6,928,000
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5,855,000
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||||||
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Notes
payable, less current portion
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42,000
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119,000
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||||||
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Capital
lease obligation, less current portion
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22,000
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30,000
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||||||
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Deferred
license revenue
|
-
|
4,000
|
||||||
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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 325,000,000 shares;
outstanding – 226,210,617 and 196,112,201,
respectively
|
226,000
|
196,000
|
||||||
|
Additional
paid-in capital
|
245,750,000
|
224,453,000
|
||||||
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Accumulated
deficit
|
(218,523,000 | ) | (207,660,000 | ) | ||||
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Total
stockholders'
equity
|
27,453,000
|
16,989,000
|
||||||
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TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ |
34,445,000
|
$ |
22,997,000
|
||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
|||||||||||||||
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October
31,
2007
|
October
31,
2006
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October
31, 2007
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October
31,
2006
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|||||||||||||
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Unaudited
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Unaudited
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Unaudited
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Unaudited
|
|||||||||||||
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REVENUES:
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||||||||||||||||
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Contract
manufacturing revenue
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$ |
1,863,000
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$ |
636,000
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$ |
3,484,000
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$ |
1,034,000
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||||||||
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License
revenue
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29,000
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48,000
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33,000
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71,000
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||||||||||||
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Total
revenues
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1,892,000
|
684,000
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3,517,000
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1,105,000
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||||||||||||
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COSTS
AND EXPENSES:
|
||||||||||||||||
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Cost
of contract manufacturing
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1,402,000
|
494,000
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2,583,000
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1,024,000
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||||||||||||
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Research
and development
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5,100,000
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3,920,000
|
8,724,000
|
7,961,000
|
||||||||||||
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Selling,
general and administrative
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1,943,000
|
1,670,000
|
3,651,000
|
3,311,000
|
||||||||||||
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Total
costs and expenses
|
8,445,000
|
6,084,000
|
14,958,000
|
12,296,000
|
||||||||||||
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LOSS
FROM OPERATIONS
|
(6,553,000 | ) | (5,400,000 | ) | (11,441,000 | ) | (11,191,000 | ) | ||||||||
|
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
|
Interest
and other income
|
353,000
|
339,000
|
592,000
|
688,000
|
||||||||||||
|
Interest
and other expense
|
(7,000 | ) | (9,000 | ) | (14,000 | ) | (24,000 | ) | ||||||||
|
NET
LOSS
|
$ | (6,207,000 | ) | $ | (5,070,000 | ) | $ | (10,863,000 | ) | $ | (10,527,000 | ) | ||||
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
|
Basic
and Diluted
|
226,210,617
|
193,793,766
|
216,141,092
|
188,950,924
|
||||||||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.03 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.06 | ) | ||||
###