As
filed
with the Securities and Exchange Commission on July 15, 2005.
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 14, 2005
(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.)
|
|
|
|
|
|
|
|
14272
Franklin Avenue, Suite 100, Tustin, California
92780
|
||||
|
(Address
of Principal Executive Offices)
|
||||
|
|
|
|
|
|
|
Registrant’s
telephone number, including area code: (714)
508-6000
|
||||
|
|
||||
|
Not
Applicable
|
||||
|
(Former
name or former address, if changed since last
report)
|
||||
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
o
Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
On
July
14, 2005, Peregrine Pharmaceuticals, Inc. issued a press release to report
the
Company’s financial results for the year ended April 30, 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.
(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 14, 2005
|
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: July 15, 2005 | By: | /s/ STEVEN W. KING |
|
Steven W. King, President and Chief Executive Officer |
||
| Title | ||
EXHIBIT
INDEX
|
Exhibit
Number
|
|
Description
|
|
|
99.1
|
|
Press
Release issued July 14, 2005
|
|
EXHIBIT
99.1
|
Investor
Inquiries
|
Media
Inquiries
|
|
Hawk
Associates, Inc.
|
Rachel
Martin
|
|
Frank
Hawkins and Ken AuYeung
|
Edelman
|
|
(800)
987-8256
|
(323)
202-1031/(323) 893-1047
|
|
info@hawkassociates.com
|
Rachel.Martin@edelman.com
|
PEREGRINE
PHARMACEUTICALS ANNOUNCES
FISCAL
YEAR 2005 FINANCIAL RESULTS
AND
OPERATIONAL HIGHLIGHTS
Tustin,
CA -- July 14, 2005
-
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced its
financial results for the year ended April 30, 2005 and its operational
highlights. Revenues generated by Avid Bioservices, Inc., the company's
wholly-owned subsidiary, increased $1,645,000 (or 54%) to $4,684,000 compared
to
$3,039,000 for the prior year. This increase in revenues helped offset the
company's consolidated net loss of $15,452,000, or $0.11 per basic and diluted
share, compared to a net loss of $14,345,000, or $0.11 per basic and diluted
share, for the prior year ended April 30, 2004.
Total
revenues for the year increased to $4,959,000 compared to $3,314,000 in fiscal
year 2004, an increase of 50%. The revenue improvement was due to an increase
in
contract manufacturing revenues from services provided by the company's
wholly-owned subsidiary, Avid Bioservices, Inc.
Total
costs and expenses increased $4,553,000 (or 28%) to $20,663,000 for the 2005
fiscal year from $16,110,000 for the year ended April 2004. The increase in
total costs and expenses was due to a current year increase in the cost of
contract manufacturing of $2,189,000 primarily related to the increase in
activities at Avid, an increase in research and development expenses of
$1,491,000 (or 15%), and an increase in selling, general and administrative
expenses of $873,000 (or 21%).
This
current year increase in research and development was primarily related to
the
advancement of Tarvacin™, for which the company received clearance from the FDA
to initiate two separate clinical trials for the treatment of solid cancers
and
hepatitis C virus, combined with an increase in Cotara® related expenses
associated with the collaboration with New Approaches to Brain Tumor Therapy
(NABTT) consortium, as we plan to initiate the first part of the Phase II/III
registration trial for the treatment of brain cancer. The current year increase
in selling,
general and administrative expenses was primarily due to an increase in expenses
associated with the expansion of the company’s operations combined with an
increase in fees associated with the implementation of section 404 of the
Sarbanes-Oxley Act of 2002.
At
April
30, 2005, the company had $9.8
million
in cash and cash equivalents. From
May
1, 2005 through the present, the company raised an additional $11.3 million
in
net proceeds from the sale of shares of its common stock and had a cash position
of $16.9 million as of July 6, 2005. The company believes it has sufficient
cash
on hand to meet its obligations through at least fiscal year 2006.
Peregrine
Pharmaceuticals’ president and CEO Steven W. King said, "We made significant
progress on a number of fronts during this fiscal year. In addition to receiving
FDA clearance to initiate our Tarvacin™ Phase 1 solid cancer and hepatitis C
clinical trials, we entered into a collaboration with New Approaches to Brain
Tumor Therapy to advance the Cotara® brain cancer clinical program. This should
make fiscal year 2006 even more exciting as we expect to enroll patients in
three separate clinical trials for the first time in the company’s
history.”
Highlights
of Fiscal Year 2005
Tarvacin™
for Solid Cancer Applications
During
the fiscal year, the company’s researchers generated a significant amount of
pre-clinical data supporting Tarvacin’s™ anti-cancer potential, showing
that
a
Tarvacin™ equivalent plus radiation therapy reduced tumor growth by up to 98%.
In January 2005, the company received
FDA clearance to commence a Phase I study for treatment of cancer using
Tarvacin™. The Phase I trial is currently open for enrollment.
Tarvacin™
for Viral Applications
Our
researchers generated a large body of pre-clinical evidence supporting
Tarvacin’s™ ability to treat viral infection. In April 2005, compelling data was
presented for the first time at the American Association of Immunologists (AAI)
Meeting showing Tarvacin’s™ significant anti-viral activity.
Peregrine
also added two prominent virologists to its Scientific Resource Board:
Dr.
Preston Marx, a
leading
AIDS researcher,
and Dr.
Stephen Smith, a
prominent physician and researcher in the treatment of viral and infectious
diseases. Concurrent with the AAI presentation, the
company and the National
Institute of Allergies and Infectious Diseases (NIAID) entered into a
collaboration to evaluate Tarvacin’s™ anti-viral potential against up to 32
different viruses, including herpes viruses, respiratory viruses, pox viruses,
hepatitis C virus, and viruses of biodefense concerns, including Pichinde (model
virus for Lassa fever), Yellow Fever, West Nile and Dengue. During April 2005,
we submitted the IND to treat patients with hepatitis C virus (HCV) and in
May
2005, the company received FDA clearance to initiate this trial in which the
company plans to enroll patients chronically infected with HCV in the near
term.
Cotara®
for Brain Cancer
In
January 2005, Peregrine and New Approaches to Brain Tumor Therapy (NABTT)
Consortium received approval for the Cotara® brain cancer
protocol. Peregrine
and NABTT are currently in the process of initiating the multi-center study
at
participating institutions. During
June of 2005, ‘Neurosurgery’
published clinical data showing Cotara’s® promise for treating brain
cancer.
About
Peregrine Pharmaceuticals, Inc.
Peregrine
Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio
of
products under development directed towards the treatment of cancer, viruses
and
other diseases. The company is in the process of initiating patient enrollment
in a Tarvacin™ clinical trial for the treatment of all solid cancers and in a
Cotara® clinical trial for the treatment of brain cancer. In addition, the
company has received clearance from the FDA to initiate a Tarvacin™ Phase I
clinical trial for the treatment of Hepatitis C virus infection, its first
viral
indication. Peregrine Pharmaceuticals is also developing Vascular Targeting
Agents (VTAs), Anti-Angiogenesis, and Vasopermeation Enhancement Agents (VEAs)
for the treatment of cancer and other diseases.
Peregrine
Pharmaceuticals also has in-house expertise to develop and manufacture
antibodies and recombinant proteins through its wholly-owned subsidiary, Avid
Bioservices, Inc., (http://www.avidbio.com). Avid is engaged in providing
contract manufacturing services and development of biologics for
biopharmaceutical and biotechnology companies, including Peregrine.
Copies
of
Peregrine Pharmaceuticals press releases, SEC filings, current price quotes
and
other valuable information for investors may be found at http://www.peregrineinc.com.
Statements
in this press release which are not purely historical including statements
regarding Peregrine Pharmaceutical’s intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. The forward-looking statements, 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 pre-clinical animal models, the timing of enrolling all 28 patients
under the Phase I study using Tarvacin™ for cancer, that pre-clinical binding
studies of Tarvacin™ against various enveloped viruses may prove to be
ineffective during clinical testing, the timing for initiating patient
enrollment in the Tarvacin™ study in the near term, the timing for initiating
the multi-center study with NABTT at participating institutions, continuing
to
receive assistance from scientists on our Scientific Resource Board in the
evaluation of potential ways to use Anti-Phospholipid Therapy agents clinically
to treat viral diseases and to move our 2C3 program toward clinical studies,
and
increased manufacturing activity at Avid Bioservices, Inc. due to the signing
of
a new contracts. It is important to note that the company’s actual results could
differ materially from those in any such forward-looking statements. Factors
that could cause actual results to differ materially include, but are not
limited to, uncertainties associated with completing and the outcomes of
pre-clinical and clinical trials for our technologies; slower than expected
rates of patient recruitment, unforeseen safety issues resulting from the
administration of antibody products in patients, the significant costs to
develop our products as all of our products are currently in development,
pre-clinical studies or clinical trials and no revenue has been generated from
commercial product sales; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory approval
for our technologies; complying with governmental regulations applicable to
our
business; consummating collaborative arrangements with corporate partners for
product development; and achieving milestones under collaborative arrangements
with corporate partners. Our business could be affected by all of the foregoing
and a number of other factors, including the risk factors listed from time
to
time in the Company’s SEC reports including, but not limited to, the annual
report on Form 10-K for the year ended April 30, 2005. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to
update or revise any forward-looking statements in this press release. There
can
be no assurance that such development efforts will succeed, that such products
will receive required regulatory clearance or that, even if such regulatory
clearance were received, such products would ultimately achieve commercial
success.
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
TWELVE
MONTHS ENDED
|
|||||||
|
April
30,
2005 |
April
30,
2004
|
||||||
|
REVENUES:
|
|||||||
|
Contract
manufacturing revenue
|
$
|
4,684,000
|
$
|
3,039,000
|
|||
|
License
revenue
|
275,000
|
275,000
|
|||||
|
Total
revenues
|
4,959,000
|
3,314,000
|
|||||
|
COSTS
AND EXPENSES:
|
|||||||
|
Cost
of contract manufacturing
|
4,401,000
|
2,212,000
|
|||||
|
Research
and development
|
11,164,000
|
9,673,000
|
|||||
|
Selling,
general and administrative
|
5,098,000
|
4,225,000
|
|||||
|
Total
costs and expenses
|
20,663,000
|
16,110,000
|
|||||
|
LOSS
FROM OPERATIONS
|
(15,704,000
|
)
|
(12,796,000
|
)
|
|||
|
OTHER
INCOME (EXPENSE):
|
|||||||
|
Interest
and other income
|
265,000
|
291,000
|
|||||
|
Interest
and other expense
|
(13,000
|
)
|
(1,840,000
|
)
|
|||
|
NET
LOSS
|
$
|
(15,452,000
|
)
|
$
|
(14,345,000
|
)
|
|
|
WEIGHTED
AVERAGE
SHARES
OUTSTANDING:
|
|||||||
|
Basic
and Diluted
|
144,812,001
|
134,299,407
|
|||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.11
|
)
|
$
|
(0.11
|
)
|
|
-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
APRIL
30,
2005
|
APRIL
30,
2004
|
||||||
|
ASSETS
|
|||||||
|
CURRENT
ASSETS:
|
|||||||
|
Cash
and cash equivalents
|
$
|
9,816,000
|
$
|
14,884,000
|
|||
|
Trade
and other receivables, net of allowance for doubtful accounts
of $69,000 and $64,000, respectively |
486,000
|
1,520,000
|
|||||
|
Inventories
|
627,000
|
1,240,000
|
|||||
|
Prepaid
expenses and other current assets
|
1,197,000
|
240,000
|
|||||
|
Total
current assets
|
12,126,000
|
17,884,000
|
|||||
|
PROPERTY:
|
|||||||
|
Leasehold
improvements
|
494,000
|
389,000
|
|||||
|
Laboratory
equipment
|
3,029,000
|
2,211,000
|
|||||
|
Furniture,
fixtures and computer equipment
|
647,000
|
646,000
|
|||||
|
4,170,000
|
3,246,000
|
||||||
|
Less
accumulated depreciation and amortization
|
(2,532,000
|
)
|
(2,373,000
|
)
|
|||
|
Property,
net
|
1,638,000
|
873,000
|
|||||
|
OTHER
ASSETS:
|
|||||||
|
Note
receivable, net of allowance of $1,512,000 and $1,581,000,
respectively
|
-
|
-
|
|||||
|
Other
|
481,000
|
380,000
|
|||||
|
Total
other assets
|
481,000
|
380,000
|
|||||
|
TOTAL
ASSETS
|
$
|
14,245,000
|
$
|
19,137,000
|
|||
-
more -
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
APRIL
30,
2005
|
APRIL
30, 2004
|
||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
CURRENT
LIABILITIES:
|
|||||||
|
Accounts
payable
|
$
|
1,325,000
|
$
|
1,331,000
|
|||
|
Accrued
clinical trial site fees
|
8,000
|
54,000
|
|||||
|
Accrued
legal and accounting fees
|
549,000
|
407,000
|
|||||
|
Accrued
royalties and license fees
|
149,000
|
149,000
|
|||||
|
Accrued
payroll and related costs
|
806,000
|
503,000
|
|||||
|
Notes
payable, current portion
|
234,000
|
-
|
|||||
|
Other
current liabilities
|
563,000
|
285,000
|
|||||
|
Deferred
revenue
|
517,000
|
1,524,000
|
|||||
|
Total
current liabilities
|
4,151,000
|
4,253,000
|
|||||
|
NOTES
PAYABLE
|
434,000
|
-
|
|||||
|
DEFERRED
LICENSE REVENUE
|
50,000
|
125,000
|
|||||
|
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 200,000,000 shares;
outstanding - 152,983,460 and 141,268,182, respectively |
153,000
|
141,000
|
|||||
|
Additional
paid-in capital
|
180,011,000
|
168,969,000
|
|||||
|
Deferred
stock compensation
|
(751,000
|
)
|
-
|
||||
|
Accumulated
deficit
|
(169,803,000
|
)
|
(154,351,000
|
)
|
|||
|
Total
stockholders' equity
|
9,610,000
|
14,759,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
14,245,000
|
$
|
19,137,000
|
|||
####