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):
July 11, 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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Not
Applicable
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(Former
name or former address, if changed since last
report)
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__________________________
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
o
Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
2.02 RESULTS OF OPERATIONS
AND FINANCIAL CONDITION
On
July
11, 2007, Peregrine Pharmaceuticals, Inc. issued a press release to report
the
Company’s financial results for the year ended April 30, 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 July 11, 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. | ||
| |
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| Date: July 11, 2007 | By: | /s/ Steven W. King |
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Steven
W. King
President and Chief Executive Officer,
Director
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EXHIBIT
INDEX
Exhibit
Number Description
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99.1
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Press
Release issued July 11, 2007
|
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
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PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR FISCAL YEAR
2007
TUSTIN,
Calif., July 11, 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 fiscal year ended April 30, 2007. The company reported a consolidated
net loss of $20,796,000, or $0.11 per basic and diluted share, compared to
a
consolidated net loss of $17,061,000, or $0.10 per basic and diluted share
for
fiscal year 2006. Total revenues for fiscal year 2007 were up 16% to $3,708,000
versus $3,193,000 in the prior year, primarily generated from Avid Bioservices,
the company's wholly owned contract manufacturing subsidiary.
Total
costs and expenses in fiscal year 2007 increased to $25,618,000 from $22,276,000
for the fiscal year ended April 2006. The increase in total expenses was
entirely due to an increase in research and development expenses associated
with
the advancement of the company's clinical and preclinical product candidates.
Cost of sales related to Avid Bioservices’ revenues were flat despite an
increase in manufacturing revenues, and overall selling, general and
administrative expenses slightly decreased from the prior fiscal
year.
This
current year increase in research and development expenses was primarily
related
to the advancement of bavituximab and Cotara® for the treatment of solid tumors
and hepatitis C virus (HCV) infection. Over the past fiscal year, the company
increased its expenditures in support of five separate clinical trials,
including a Phase I bavituximab study for the treatment of advanced solid
tumors, a Phase Ib bavituximab study in combination with chemotherapy for
the
treatment of advanced solid tumors, a Phase Ib bavituximab repeat dose study
in
patients with chronic HCV infection, and two Cotara® clinical trials for the
treatment of glioblastoma multiforme, a deadly form of brain cancer. In
addition, the company supported the advancement of its preclinical programs,
including studies that were presented at the Annual Meeting of the American
Association for Cancer Research (AACR) in April 2007.
"This
past fiscal year has been marked by significant progress in the three clinical
programs that we expect to be key value drivers for Peregrine during fiscal
year
2008," commented Steven W. King, president and CEO of Peregrine. "Most
importantly, we successfully completed Phase lb clinical trials for our
first-in-class anti-PS monoclonal antibody bavituximab for the treatment
of both
cancer and hepatitis C viral infection. These studies represent major milestones
for the bavituximab program, with positive results in both indications showing
that bavituximab appeared well-tolerated and that it demonstrated encouraging
signs of anti-viral and anti-tumor activity. Successful completion of these
studies has set the stage for Phase ll clinical trials.”
Mr.
King
added, “Similarly, we laid the foundation for substantial progress in the
clinical program for lead tumor necrosis therapy (TNT) agent Cotara by preparing
to conduct a new trial in patients with malignant brain cancer. Our Indian
clinical centers are well equipped to conduct this trial and have access
to
large numbers of patients with brain cancer who are eager to participate
in
clinical studies. We expect that positive results in this Phase ll trial
would
set the stage for product registration trials and eventual commercialization.”
Mr.
King
added, "While our focus during the past fiscal year was on advancing our
clinical programs, we also reported important progress in our preclinical
programs. In September 2006, we reported new research showing that a fusion
protein approach combining our Vascular Targeting Agent (VTA) and anti-PS
technology platforms demonstrated significant potential, reducing tumor growth
in animal cancer models by more than 90%. At the AACR meeting in April 2007,
Peregrine’s collaborators reported positive results from a number of our
preclinical programs, including data indicating that bavituximab-type compounds
may have potential as powerful vaccine-like agents against malignant brain
cancer and also as part of immunocytokine fusion protein therapies targeted
to
lymphoma and other cancers. We also reported on progress in our anti-VEGF
program, presenting data showing that our unique selective inhibitor was
as
effective as Avastin® in preclinical cancer models while having potential
advantages as a result of its selectivity. Earlier in the year, a peer-reviewed
publication reported that microbubbles constructed using our VTA technology
can
be used with widely available ultrasound systems to monitor patient response
to
Avastin®, identifying at an early stage which cancer patients are actually
benefiting from this treatment. These developments and others highlight the
depth and diversity of our preclinical programs. We currently are pursuing
some
of these programs on our own and are actively seeking partners to collaborate
with us on others.”
Mr.
King
concluded, "Since the start of the last fiscal year, we believe that Peregrine
has made exceptional progress in advancing its three lead clinical programs
towards Phase II trials and reporting progress in a number of high potential
earlier stage programs. As a result of our recent financing, we now have
the
resources to pursue these programs aggressively in the year ahead. We believe
the company has set the stage for what could be a very successful 2008 fiscal
year.”
At
April
30 2007, the company had $16,044,000 in cash and cash equivalents. The company
has strengthened its cash position to about $32,500,000 as of June 30, 2007,
after taking into consideration the net proceeds received from a recent
financing announced on June 28, 2007. The company believes it has sufficient
cash on hand to progress its current clinical programs through at least fiscal
year 2008 based on its current projections.
Corporate
Highlights Since the Start of Fiscal Year 2007
|
§
|
In
July 2007, Peregrine announced that it had submitted a clinical
protocol
with the Drug Controller General of India for a Phase ll trial
of
bavituximab in combination with chemotherapy in patients with non-small
cell lung cancer (NSCLC). Up to 21 NSCLC patients will be enrolled
initially and the study may be expanded up to a total of 49 patients
if
positive results are observed in the first cohort. The primary
objective
of the study is to assess overall response to the combination of
bavituximab and chemotherapy; secondary objectives include time
to tumor
progression, duration of response, overall patient survival and
safety
parameters. This trial is expected to begin enrolling patients
later this
year.
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|
§
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In
June 2007, Peregrine announced commitments to purchase $22.5 million
in
shares of its common stock in a registered direct offering, for
net
proceeds of approximately $20.9 million. The financing did not
include
warrants. Rodman & Renshaw acted as the exclusive placement
agent.
|
|
§
|
In
June 2007, Peregrine announced initiation of a new clinical trial
designed
to evaluate the safety and efficacy of its TNT agent Cotara in
patients
with glioblastoma multiforme, a deadly form of brain cancer. Peregrine
believes that combined positive data from this new study in India
and
ongoing U.S. glioblastoma trials would provide a foundation for
advancing
Cotara into Phase III product registration
trials.
|
|
§
|
In
May 2007, the company reported positive results in its Phase lb
open label
cancer trial of bavituximab in combination with chemotherapy. This
trial
was designed to assess the safety and tolerability of bavituximab
in
combination with common chemotherapy agents in advanced cancer
patients
with metastatic disease. In the trial, the safety profile of bavituximab
in combination with chemotherapy appeared similar to that seen
in advanced
cancer patients undergoing chemotherapy alone. The combination
of
bavituximab and chemotherapy showed positive signs of clinical
activity,
achieving objective tumor response or stable disease in 50% of
the
patients who were evaluable for tumor response. Data from this
study are
being further analyzed to support the initiation of Phase II cancer
trials.
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§
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In
May 2007, Peregrine announced it had filed a new clinical trial
protocol
with the FDA to study bavituximab in patients co-infected with
HCV and
HIV, and this study was initiated in early July 2007. The multi-center
open-label study designed to assess the safety and pharmacokinetics
of
bavituximab in approximately 24 patients will initially be conducted
at
Saint Michael's Medical Center under the direction of Dr. Stephen
Smith.
An estimated 30% of HIV patients are co-infected with HCV and these
patients often do not respond well to current HCV
therapies.
|
|
§
|
At
the April 2007 AACR meeting, data from multiple studies reinforced
the
versatility and broad anti-cancer potential of bavituximab, provided
new
preclinical data confirming the potential anti-tumor efficacy of
the
company's selective VEGF inhibitors, provided validating data for
its
immunocytokine fusion proteins developed using the company's VTA
technology, and highlighted the clinical potential of Peregrine's
earlier
stage Vasopermeation
Enhancement Agent (VEA)
cancer platforms.
|
|
§
|
In
February 2007, Peregrine reported results from a Phase lb study
of
bavituximab in patients with chronic HCV infection. The study was
designed
to assess the safety, distribution and pharmacokinetic properties
of four
ascending dose levels of bavituximab administered as twice-weekly
monotherapy. Bavituximab was generally safe and well-tolerated,
with no
dose limiting toxicities or serious adverse events reported. The
preliminary results also indicate that bavituximab showed positive
signs
of dose dependent anti-viral activity, setting the stage for HCV
combination therapy trials and further dosing
studies.
|
|
§
|
In
October 2006 at the prestigious AASLD meeting, Peregrine reported
final
results from its Phase Ia study of bavituximab in HCV patients
who had
failed or relapsed after standard therapy. Bavituximab appeared
generally
safe and well-tolerated and there were signs of anti-viral activity
at all
dose levels tested.
|
|
§
|
In
June 2006, Peregrine announced that had signed a definitive agreement
for
the sale of 9,285,714 shares of common stock to one institutional
investor
in exchange for net proceeds of $13 million. This financing involved
no
warrants and no placement fees.
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§
|
In
June 2006, Peregrine reported top-line results on the effect of
bavituximab on viral RNA serum titers when administered as single
dose
monotherapy in a Phase Ia study in patients with chronic HCV infection.
Bavituximab showed signs of anti-viral activity at all four dose
levels
studied and it also showed evidence of a prolonged anti-viral
effect.
|
Conference
Call:
The
company will host a live conference call and webcast on Wednesday, July 11,
2007
at 11:00 a.m. EDT/8:00 a.m. PDT to discuss its year-end 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
broadcast will be archived on Peregrine's website for approximately 30
days.
To
listen
to the call via telephone, please call the following number approximately
10
minutes prior to the scheduled time of the conference call: (800)
860-2442.
A
telephonic replay of the conference call will be available through July 18,
2007
by calling (877)
344-7529
and
entering 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 in the U.S. and India 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 will not receive regulatory approval to commence one
or
more of its planned Phase II clinical trials, the risk that enrollment in
current and planned clinical trials will be slower than anticipated, the
risk
that results from current or planned clinical trials will not correlate to
the
earlier preclinical or clinical results, and the risk that the Company will
experience difficulties in complying with foreign regulations applicable
to
current and planned clinical trials in India . 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. 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.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2007
|
2007
|
2006
|
2005
|
||||||||
|
REVENUES:
|
||||||||||
|
Contract
manufacturing revenue
|
$
|
3,492,000
|
$
|
3,005,000
|
$
|
4,684,000
|
||||
|
License
revenue
|
216,000
|
188,000
|
275,000
|
|||||||
|
Total
revenues
|
3,708,000
|
3,193,000
|
4,959,000
|
|||||||
|
COSTS
AND EXPENSES:
|
||||||||||
|
Cost
of contract manufacturing
|
3,296,000
|
3,297,000
|
4,401,000
|
|||||||
|
Research
and development
|
15,876,000
|
12,415,000
|
11,164,000
|
|||||||
|
Selling,
general and administrative
|
6,446,000
|
6,564,000
|
5,098,000
|
|||||||
|
|
|
|
||||||||
|
Total
costs and expenses
|
25,618,000
|
22,276,000
|
20,663,000
|
|||||||
|
LOSS
FROM OPERATIONS
|
(21,910,000
|
)
|
(19,083,000
|
)
|
(15,704,000
|
)
|
||||
|
OTHER
INCOME (EXPENSE):
|
||||||||||
|
Recovery
of note receivable
|
-
|
1,229,000
|
-
|
|||||||
|
Interest
and other income
|
1,160,000
|
846,000
|
265,000
|
|||||||
|
Interest
and other expense
|
(46,000
|
)
|
(53,000
|
)
|
(13,000
|
)
|
||||
|
NET
LOSS
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
192,297,309
|
168,294,782
|
144,812,001
|
|||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.11
|
)
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
|
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2007 AND 2006
|
2007
|
2006
|
||||||
|
ASSETS
|
|||||||
|
CURRENT
ASSETS:
|
|||||||
|
Cash
and cash equivalents
|
$
|
16,044,000
|
$
|
17,182,000
|
|||
|
Trade
and other receivables
|
750,000
|
579,000
|
|||||
|
Inventories,
net
|
1,916,000
|
885,000
|
|||||
|
Prepaid
expenses and other current assets
|
1,188,000
|
1,466,000
|
|||||
|
Total
current assets
|
19,898,000
|
20,112,000
|
|||||
|
PROPERTY:
|
|||||||
|
Leasehold
improvements
|
646,000
|
618,000
|
|||||
|
Laboratory
equipment
|
3,533,000
|
3,444,000
|
|||||
|
Furniture,
fixtures and computer equipment
|
873,000
|
666,000
|
|||||
|
5,052,000
|
4,728,000
|
||||||
|
Less
accumulated depreciation and amortization
|
(3,212,000
|
)
|
(2,822,000
|
)
|
|||
|
Property,
net
|
1,840,000
|
1,906,000
|
|||||
|
Other
assets
|
1,259,000
|
658,000
|
|||||
|
TOTAL
ASSETS
|
$
|
22,997,000
|
$
|
22,676,000
|
|||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2007 AND 2006 (continued)
|
2007
|
2006
|
||||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
CURRENT
LIABILITIES:
|
|||||||
|
Accounts
payable
|
$
|
1,683,000
|
$
|
1,233,000
|
|||
|
Accrued
clinical trial site fees
|
228,000
|
170,000
|
|||||
|
Accrued
legal and accounting fees
|
392,000
|
250,000
|
|||||
|
Accrued
royalties and license fees
|
337,000
|
138,000
|
|||||
|
Accrued
payroll and related costs
|
874,000
|
850,000
|
|||||
|
Notes
payable, current portion
|
379,000
|
429,000
|
|||||
|
Capital
lease obligation, current portion
|
17,000
|
15,000
|
|||||
|
Deferred
revenue
|
1,060,000
|
563,000
|
|||||
|
Other
current liabilities
|
885,000
|
836,000
|
|||||
|
Total
current liabilities
|
5,855,000
|
4,484,000
|
|||||
|
Notes
payable, less current portion
|
119,000
|
498,000
|
|||||
|
Capital
lease obligation, less current portion
|
30,000
|
47,000
|
|||||
|
Deferred
license revenue
|
4,000
|
21,000
|
|||||
|
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
-
196,112,201 and 179,382,191, respectively
|
196,000
|
179,000
|
|||||
|
Additional
paid-in-capital
|
224,453,000
|
204,546,000
|
|||||
|
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
|
Accumulated
deficit
|
(207,660,000
|
)
|
(186,864,000
|
)
|
|||
|
Total
stockholders’ equity
|
16,989,000
|
17,626,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
22,997,000
|
$
|
22,676,000
|
|||
####