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 12, 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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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).
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
12, 2007, Peregrine Pharmaceuticals, Inc. issued a press release to report
the
Company’s financial results for the third quarter ended January 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 March 12, 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: March 12, 2007 | By: | /s/ Steven W. King |
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Steven
W. King
President,
Chief Executive Officer and
Director
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EXHIBIT
INDEX
Exhibit
| Number |
Description
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99.1
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Press
Release issued March 12, 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
THIRD QUARTER FISCAL YEAR 2007
TUSTIN,
Calif., March 12, 2007
--
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM),
a
clinical stage biopharmaceutical company developing targeted therapeutics for
the treatment of cancer and hepatitis C virus (HCV) infection, today announced
financial results for the third quarter of fiscal year 2007 ended January 31,
2007. The company reported a consolidated net loss of $5,025,000 or $0.03 per
basic and diluted share, compared to a consolidated net loss of $3,113,000
or
$0.02 per basic and diluted share for the same prior year period. The increased
net loss primarily reflects a decrease in revenues during the current quarter
combined with a decrease in interest and other income that resulted from a
large
one-time payment received by Peregrine in the third quarter of fiscal year
2006.
“Avid
built up a significant work-in-process inventory over the past quarter and
was
also engaged in providing manufacturing services for Peregrine’s clinical stage
products,” noted Paul Lytle, chief financial officer of Peregrine. “As a result,
we saw a temporary decrease in Avid revenues reported in the third quarter,
but
some of this decrease represents Avid revenue that has shifted into the current
fourth quarter ending April 30, 2007. Based on production we have already
completed, as well the anticipated near-term completion of in-process
manufacturing services now underway, we believe our fourth quarter Avid revenues
will be strong. We expect that total Avid revenues for this 2007 fiscal year
will surpass the total we achieved in fiscal year 2006, and our current Avid
revenue projections for fiscal 2008 look better yet.”
Total
revenues for the current quarter were $363,000 compared
to $1,528,000 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 were $5,643,000 in the third quarter of 2007 versus
$6,010,000 in
the
same quarter in the prior year. The decrease in total expenses was primarily
due
to a decrease in the cost of goods expense reflecting lower contract
manufacturing revenues at Avid, combined with a decrease of about 7% in SG&A
expenses. These amounts were partly offset by a $613,000 increase in research
and development expenses associated with the advancement of the company’s
clinical and preclinical product candidates.
Interest
and other income was $267,000 during
the current quarter, compared to $1,381,000 in the prior year quarter In the
third quarter of fiscal year 2006, the company received a one-time payment
of
approximately $1.2 million related to the collection of a note that had
previously been deemed uncollectible. This payment was included in interest
and
other income in the third quarter of fiscal 2006. Excluding the collection
of
this note receivable, interest and other income increased in the current quarter
compared to the prior year quarter, primarily reflecting interest earned on
the
company’s strengthened cash position combined with higher prevailing interest
rates. At January 31, 2007, the company had $20,114,000 in
cash
and cash equivalents compared to $17,182,000 at fiscal year end April 30,
2006.
“We
have
made tremendous progress in our clinical programs during the first three
quarters of fiscal year 2007, and the fourth quarter is shaping up to be a
period of significant progress as well“ said Steven W. King, president and CEO
of Peregrine. “In the third quarter we initiated and nearly completed, with 11
of the anticipated 12 evaluable patients enrolled, the first clinical trial
of
bavituximab in combination with major chemotherapy drugs to treat solid cancers.
We expect enrollment to be fully completed in the coming weeks and we will
provide an update on the trial at that time.”
“While
moving bavituximab forward, we also advanced preparations to launch a Cotara®
Phase ll clinical trial in glioblastoma patients in India. We have now completed
necessary manufacturing and regulatory filings related to producing the final
drug product in India and expect that we will be able to initiate the trial
shortly. While the process required to obtain approval for Cotara manufacturing
in India has been extensive, we believe these efforts will help us advance
the
Cotara program much faster than would otherwise have been possible. Our clinical
investigators are eager to initiate the trial and have already begun to identify
potential subjects. We believe enrollment in this trial should proceed at a
good
pace. In a complementary development, our U.S. Cotara trial sponsored by NABTT
is now starting to benefit from a patient outreach campaign Peregrine initiated
this quarter, and we have already seen an increased activity level in the
trial.”
Mr.
King
continued, “Most importantly, last month we released positive initial results
from our bavituximab Phase lb repeat dose trial in patients with HCV infection.
Bavituximab appeared safe and well tolerated and showed encouraging signs of
antiviral activity that appeared to be dose dependent. These were the two key
objectives of the study and they were successfully achieved. We and our clinical
investigators are pleased with these results, which lay the foundation for
advancing bavituximab into the next set of HCV trials that we currently are
finalizing. We intend to make more information about these plans public in
the
coming weeks.”
Mr.
King
concluded, “We are entering the home stretch of our fiscal year with excellent
momentum in all our clinical programs. In addition, Peregrine has reported
a
number of other significant events since our last quarterly report. A product
based on our targeted TNT technology was launched for lung cancer in China.
Our
European pharmaceutical partner initiated clinical trials with a novel TNT
anti-cancer product licensed from Peregrine. We established our own subsidiary
in China to increase our ability to leverage opportunities in this important
new
market and researchers affiliated with our company reported on a number of
exciting preclinical developments that further strengthen our new drug pipeline.
We believe this is an exciting time for the company and that our advancements
should drive shareholder value as we move forward.”
Conference
Call:
The
company will host a conference call today, March 12, 2007 at 11:00am EDT/ 8:00am
PDT to discuss its third quarter FY 2007 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 call via telephone, please call the following number approximately 10
minutes prior to the scheduled time of the conference call: 1-800-860-2442.
A
telephonic replay of the conference call will be available through March 19,
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 five separate
clinical trials 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 uncertainty
of
Avid achieving its anticipated revenues for the remainder of fiscal year 2007
and beyond, the risk that the company will encounter delays in one or more
of
its ongoing clinical trials, the risk that results from current or future
clinical trials will not correlate to prior pre-clinical or clinical results
.
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, 2006 and the quarterly report on Form
10-Q for the second fiscal quarter ended October 31, 2006. 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,
2007
|
APRIL
30,
2006
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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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$
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20,114,000
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$
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17,182,000
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Trade
and other receivables
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957,000
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579,000
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Inventories
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2,871,000
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885,000
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Prepaid
expenses and other current assets
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1,325,000
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1,466,000
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Total
current assets
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25,267,000
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20,112,000
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PROPERTY:
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Leasehold
improvements
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640,000
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618,000
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Laboratory
equipment
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3,488,000
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3,444,000
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|||||
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Furniture,
fixtures and office equipment
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808,000
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666,000
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|||||
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4,936,000
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4,728,000
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||||||
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Less
accumulated depreciation and amortization
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(3,091,000
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)
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(2,822,000
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)
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Property,
net
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1,845,000
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1,906,000
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|||||
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Other
assets
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1,259,000
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658,000
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|||||
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TOTAL
ASSETS
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$
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28,371,000
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$
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22,676,000
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-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
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JANUARY
31,
2007
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APRIL
30,
2006
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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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CURRENT
LIABILITIES:
|
|||||||
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Accounts
payable
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$
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1,439,000
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$
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1,233,000
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|||
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Accrued
clinical trial site fees
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319,000
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170,000
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|||||
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Accrued
legal and accounting fees
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185,000
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250,000
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|||||
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Accrued
royalties and license fees
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249,000
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138,000
|
|||||
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Accrued
payroll and related costs
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724,000
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850,000
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|||||
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Notes
payable, current portion
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440,000
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429,000
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|||||
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Capital
lease obligation, current portion
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16,000
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15,000
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|||||
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Deferred
revenue
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2,202,000
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563,000
|
|||||
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Other
current liabilities
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480,000
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836,000
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|||||
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Total
current liabilities
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6,054,000
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4,484,000
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|||||
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Notes
payable, less current portion
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168,000
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498,000
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|||||
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Capital
lease obligation, less current portion
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35,000
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47,000
|
|||||
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Deferred
license revenue
|
8,000
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21,000
|
|||||
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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 250,000,000 shares; outstanding
-
196,112,201 and 179,382,191, respectively
|
196,000
|
179,000
|
|||||
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Additional
paid-in capital
|
224,326,000
|
204,546,000
|
|||||
|
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
|
Accumulated
deficit
|
(202,416,000
|
)
|
(186,864,000
|
)
|
|||
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Total
stockholders' equity
|
22,106,000
|
17,626,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
28,371,000
|
$
|
22,676,000
|
|||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
||||||||||||
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January
31,
2007
|
January
31,
2006
|
January
31,
2007
|
January
31,
2006
|
||||||||||
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Unaudited
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Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
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REVENUES:
|
|||||||||||||
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Contract
manufacturing revenue
|
$
|
347,000
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$
|
1,505,000
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$
|
1,381,000
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$
|
2,227,000
|
|||||
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License
revenue
|
16,000
|
23,000
|
87,000
|
65,000
|
|||||||||
|
Total
revenues
|
363,000
|
1,528,000
|
1,468,000
|
2,292,000
|
|||||||||
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COSTS
AND EXPENSES:
|
|||||||||||||
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Cost
of contract manufacturing
|
223,000
|
1,088,000
|
1,247,000
|
1,820,000
|
|||||||||
|
Research
and development
|
3,907,000
|
3,294,000
|
11,868,000
|
9,330,000
|
|||||||||
|
Selling,
general and administrative
|
1,513,000
|
1,628,000
|
4,824,000
|
4,715,000
|
|||||||||
|
Total
costs and expenses
|
5,643,000
|
6,010,000
|
17,939,000
|
15,865,000
|
|||||||||
|
LOSS
FROM OPERATIONS
|
(5,280,000
|
)
|
(4,482,000
|
)
|
(16,471,000
|
)
|
(13,573,000
|
)
|
|||||
|
OTHER
INCOME (EXPENSE):
|
|||||||||||||
|
Interest
and other income
|
267,000
|
1,381,000
|
955,000
|
1,585,000
|
|||||||||
|
Interest
and other expense
|
(12,000
|
)
|
(12,000
|
)
|
(36,000
|
)
|
(35,000
|
)
|
|||||
|
NET
LOSS
|
$
|
(5,025,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(15,552,000
|
)
|
$
|
(12,023,000
|
)
|
|
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
|||||||||||||
|
Basic
and Diluted
|
195,299,586
|
171,355,523
|
191,067,145
|
165,772,373
|
|||||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
|
xxxx