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): March 11,
2008
____________________________
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-17085
|
95-3698422
|
||
|
(State
of other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
||
|
14282
Franklin Avenue, Tustin, California 92780
|
||||
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(Address
of Principal Executive Offices)
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||||
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Registrant’s
telephone number, including area code: (714)
508-6000
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||||
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Not
Applicable
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||||
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(Former
name or former address, if changed since last
report)
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||||
____________________________
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
o Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM 2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITION
On March
11, 2008, Peregrine Pharmaceuticals, Inc. issued a press release to report the
Company’s financial results for the third quarter ended January 31,
2008. 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 March 11, 2008
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.
| Date: March 11, 2008 |
PEREGRINE
PHARMACEUTICALS, INC.
By: /s/ Steven W.
King
|
|
Steven
W. King
President,
Chief Executive Officer and Director
|
EXHIBIT
INDEX
Exhibit
Number Description
0;
|
99.1
|
Press
Release issued March 11,
2008
|
Exhibit
99.1
|
Contacts:
|
|
|
GendeLLindheim
BioCom Partners
|
|
|
Investors
|
Media
|
|
info@peregrineinc.com
|
Barbara
Lindheim
|
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(800)
987-8256
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(212)
918-4650
|
PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS
FOR
THE THIRD QUARTER OF FISCAL YEAR 2008
--Advances Reported in All Three
Clinical Programs, Including Launch of Key Bavituximab Phase II Cancer
Program--
TUSTIN, Calif., March 11, 2008
- -- 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 third quarter of fiscal year (FY) 2008 ended January 31,
2008. The company reported a consolidated net loss of $6,154,000, or
$0.03 per basic and diluted share, compared to a consolidated net loss of
$5,025,000 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 $1,675,000 compared to $363,000
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 $8,077,000 in the third quarter of FY 2008 from
$5,643,000 in the same prior year quarter. The increase was primarily
related to the increase in the cost of contract manufacturing of $1,066,000
during the quarter resulting from higher reported revenues from external
customers, in addition to the increase in research and development expenses of
$1,034,000 associated with the advancement of the company's clinical and
preclinical product candidates. Research and development expenses
were $4,941,000 in the third quarter of FY 2008, compared to $3,907,000 in the
third quarter of FY 2007. At January 31, 2008, the company had
$20,063,000 in cash and cash equivalents compared to $16,044,000 at fiscal year
end April 30, 2007.
“The past
quarter was highlighted by a major milestone in our oncology program, as we
dosed the first patients in a Phase II trial evaluating bavituximab in
combination with chemotherapy in patients with breast cancer,” said Steven W.
King, president and CEO of Peregrine. “We also received regulatory
approval to initiate two additional bavituximab Phase II cancer trials—a second
breast cancer study and a trial in patients with non-small cell lung cancer, a
leading cause of cancer deaths worldwide. Planning for these trials
is well underway and we anticipate initiating both studies next
month. We also made progress in our Cotara clinical program in
patients with glioblastoma multiforme (GBM), today announcing promising data
from the ongoing dosimetry and Phase II trials showing that several patients are
already surviving longer than the expected six-month median survival time for
this patient population, with the longest surviving patient now at 15 months
post-treatment. Patients who are continuing in the trials are
being monitored for safety and overall survival, and we look forward to
providing further updates on these trials going forward. We have also
recently expanded the number of clinical sites in the Phase Il study to eight
and also added a distinguished brain cancer center and experienced Cotara
clinical study site—the Barrow Neurological Institute—to our dosimetry study in
the U.S.”
Mr. King
added, “Our initiative to raise awareness for the bavituximab and Cotara
programs in the scientific and medical communities scored gains, including an
oral presentation covering the clinical experience to date in the bavituximab
Phase I cancer program at Angio 2008, an oral presentation of clinical data from
our Phase I bavituximab trial in hepatitis C patients at the prestigious 2007
Liver Meeting®, a recent publication in Clinical Cancer Research
highlighting bavituximab’s ability to target tumor blood vessels with excellent
specificity, and the acceptance last week of an abstract discussing patient data
from the Cotara dosimetry trial for presentation at the 2008 ASCO Annual
Meeting. We anticipate additional high profile scientific
publications and presentations in the coming months while we continue making
good progress in advancing our trio of Phase II bavituximab cancer trials, the
two ongoing Cotara clinical trials and the trial of bavituximab in HCV patients
co-infected with HIV. We look forward to a steady flow of news from
these multiple activities in the coming months.”
Recent
Highlights
Bavituximab Anti-Cancer
Program: The company launched the Phase II cancer clinical program for
bavituximab during the quarter and achieved a number of other clinical and
preclinical advancements.
|
§
|
Initiated
patient dosing in a Phase II combination therapy trial of bavituximab and
docetaxel in patients with advanced breast cancer within 14 days of study
initiation.
|
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§
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Received
regulatory approval to begin two additional Phase II bavituximab
combination therapy trials—one in combination with carboplatin and
paclitaxel in patients with advanced breast cancer and another in
combination with carboplatin plus paclitaxel in patients with non-small
cell lung cancer (NSCLC). Both trials are preparing to begin
enrolling patients shortly.
|
|
§
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A
bavituximab cancer investigator presented data at a leading scientific
meeting on anti-angiogenic agents--the 10th Annual International Symposium
on Anti-Angiogenic Agents (Angio 2008)--highlighting the positive clinical
experience to date with
bavituximab.
|
|
§
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A
preclinical study published in Clinical Cancer
Research confirmed bavituximab’s ability to target tumor blood
vessels with excellent specificity. The high degree of
selective targeting seen in the study provides additional evidence of
bavituximab’s therapeutic
potential.
|
Bavituximab Anti-Viral
Program: During the third quarter, 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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Added
The Johns Hopkins Hospital and a private 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: Peregrine continued to advance the Cotara brain
cancer program.
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§
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Added
additional study sites and continued patient dosing and follow-up in the
Cotara Phase II study in patients with glioblastoma multiforme, the most
deadly form of brain cancer. Eight sites are now open for
patient enrollment.
|
|
§
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Added
an additional site, the Barrow Neurological Institute (BNI) in Phoenix,
Arizona, to the ongoing Cotara dosimetry and dose confirmation clinical
study. BNI also participated in a previous Cotara Phase II
clinical trial.
|
|
§
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Announced
positive results from the first cohort of patients treated in the Cotara
dosimetry trial and from the initial patients treated in the Cotara Phase
II trial. Cotara appeared safe and well tolerated with no
dose-limiting adverse events, with continuing patients being monitored for
overall survival. Several patients in these studies have lived
longer than the six-month expected median survival time for this patient
population.
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Other
Preclinical Programs:
|
§
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Preclinical
data presented at the 5th Annual International Anti-Angiogenesis
Conference confirmed that Peregrine’s fully human, selective anti-VEGF
antibody R84 was as effective as Avastin® in
inhibiting tumor growth in a model of human breast
cancer. Selective anti-VEGF agents may have potential
advantages over non-selective
approaches.
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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 during the third
quarter of fiscal year 2008.
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Conference
Call
The
company will host a conference call today, March 11, 2008 at 11:30 a.m. EDT/8:30
a.m. PDT to discuss its third 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 March 18, 2008
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 future
clinical trial results may not correlate with the results of prior clinical
trials and preclinical studies, 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, the risk that
the company will not regain compliance with the Nasdaq Stock Market minimum bid
price requirement by July 21, 2008, and the risk that the company will not have
additional high profile scientific publications and presentations. 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 third fiscal quarter ended January 31, 2008. 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
|
JANUARY
31,
2008
|
APRIL
30,
2007
|
|||||||
|
Unaudited
|
||||||||
|
ASSETS
|
||||||||
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CURRENT
ASSETS:
|
||||||||
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Cash
and cash equivalents
|
$ | 20,063,000 | $ | 16,044,000 | ||||
|
Trade
and other receivables
|
1,316,000 | 750,000 | ||||||
|
Inventories,
net
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2,394,000 | 1,916,000 | ||||||
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Prepaid
expenses and other current assets
|
1,140,000 | 1,188,000 | ||||||
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Total current
assets
|
24,913,000 | 19,898,000 | ||||||
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PROPERTY:
|
||||||||
|
Leasehold
improvements
|
669,000 | 646,000 | ||||||
|
Laboratory
equipment
|
3,756,000 | 3,533,000 | ||||||
|
Furniture,
fixtures and office equipment
|
913,000 | 873,000 | ||||||
| 5,338,000 | 5,052,000 | |||||||
|
Less
accumulated depreciation and amortization
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(3,537,000 | ) | (3,212,000 | ) | ||||
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Property, net
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1,801,000 | 1,840,000 | ||||||
|
Other
assets
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1,527,000 | 1,259,000 | ||||||
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TOTAL
ASSETS
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$ | 28,241,000 | $ | 22,997,000 | ||||
--continued--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
JANUARY
31,
2008
|
APRIL
30,
2007
|
|||||||
|
Unaudited
|
||||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
|
CURRENT
LIABILITIES:
|
||||||||
|
Accounts
payable
|
$ | 2,387,000 | $ | 1,683,000 | ||||
|
Accrued
clinical trial site fees
|
244,000 | 228,000 | ||||||
|
Accrued
legal and accounting fees
|
390,000 | 392,000 | ||||||
|
Accrued
royalties and license fees
|
124,000 | 337,000 | ||||||
|
Accrued
payroll and related costs
|
858,000 | 874,000 | ||||||
|
Notes
payable, current portion
|
- | 379,000 | ||||||
|
Capital
lease obligation, current portion
|
17,000 | 17,000 | ||||||
|
Deferred
revenue
|
1,434,000 | 1,060,000 | ||||||
|
Other
current liabilities
|
1,239,000 | 885,000 | ||||||
|
Total current
liabilities
|
6,693,000 | 5,855,000 | ||||||
|
Notes
payable, less current portion
|
- | 119,000 | ||||||
|
Capital
lease obligation, less current portion
|
17,000 | 30,000 | ||||||
|
Deferred
license revenue
|
- | 4,000 | ||||||
|
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 325,000,000 shares;
outstanding – 226,210,617 and 196,112,201,
respectively
|
226,000 | 196,000 | ||||||
|
Additional
paid-in capital
|
245,982,000 | 224,453,000 | ||||||
|
Accumulated
deficit
|
(224,677,000 | ) | (207,660,000 | ) | ||||
|
Total stockholders'
equity
|
21,531,000 | 16,989,000 | ||||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 28,241,000 | $ | 22,997,000 | ||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
|||||||||||||||
|
January
31,
2008
|
January
31,
2007
|
January
31,
2008
|
January
31,
2007
|
|||||||||||||
|
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
|
REVENUES:
|
||||||||||||||||
|
Contract
manufacturing revenue
|
$ | 1,662,000 | $ | 347,000 | $ | 5,146,000 | $ | 1,381,000 | ||||||||
|
License
revenue
|
13,000 | 16,000 | 46,000 | 87,000 | ||||||||||||
|
Total
revenues
|
1,675,000 | 363,000 | 5,192,000 | 1,468,000 | ||||||||||||
|
COSTS
AND EXPENSES:
|
||||||||||||||||
|
Cost
of contract manufacturing
|
1,289,000 | 223,000 | 3,872,000 | 1,247,000 | ||||||||||||
|
Research
and development
|
4,941,000 | 3,907,000 | 13,665,000 | 11,868,000 | ||||||||||||
|
Selling,
general and administrative
|
1,847,000 | 1,513,000 | 5,498,000 | 4,824,000 | ||||||||||||
|
Total
costs and expenses
|
8,077,000 | 5,643,000 | 23,035,000 | 17,939,000 | ||||||||||||
|
LOSS
FROM OPERATIONS
|
(6,402,000 | ) | (5,280,000 | ) | (17,843,000 | ) | (16,471,000 | ) | ||||||||
|
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
|
Interest
and other income
|
259,000 | 267,000 | 851,000 | 955,000 | ||||||||||||
|
Interest
and other expense
|
(11,000 | ) | (12,000 | ) | (25,000 | ) | (36,000 | ) | ||||||||
|
NET
LOSS
|
$ | (6,154,000 | ) | $ | (5,025,000 | ) | $ | (17,017,000 | ) | $ | (15,552,000 | ) | ||||
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
|
Basic
and Diluted
|
226,210,617 | 195,299,586 | 219,497,601 | 191,067,145 | ||||||||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.03 | ) | $ | (0.03 | ) | $ | (0.08 | ) | $ | (0.08 | ) | ||||
###