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 8, 2006
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
December 8, 2006, Peregrine Pharmaceuticals, Inc. issued a press release to
report the Company’s financial results for the second quarter ended October 31,
2006. 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 8, 2006
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 8, 2006 |
By:
/s/
Steven W. King
|
Steven
W.
King
President,
Chief Executive Officer and
Director
EXHIBIT
INDEX
Exhibit
| Number |
Description
|
|
99.1
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Press
Release issued December 8, 2006
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Exhibit
99.1
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Contacts:
GendeLLindheim
BioCom Partners
Investors
info@peregrineinc.com
(800)
987-8256
|
Media
Barbara
Lindheim
(212)
918-4650
|
PEREGRINE
PHARMACEUTICALS REPORTS FINANCIAL RESULTS
FOR
SECOND QUARTER FISCAL YEAR 2007
TUSTIN,
Calif., December 8, 2006
--
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 second quarter of fiscal year 2007 ended October
31,
2006. The company reported a consolidated net loss of $5,070,000, or $0.03
per
basic and diluted share, compared to a consolidated net loss of
$4,571,000 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 $684,000 compared
to $556,000 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 $6,084,000 in
the
second quarter of 2007 versus $5,242,000 in
the
same quarter in the prior year. The increase in total expenses was primarily
due
to an increase in research and development expenses associated with the
advancement of the company’s clinical and preclinical product candidates.
Interest
and other income increased $211,000 during
the current quarter over the prior year quarter, primarily reflecting interest
earned on the company’s strengthened cash position. At October 31, 2006, the
company had $23,394,000 in
cash
and cash equivalents compared to $17,182,000 at fiscal year end April 30,
2006.
“The
second quarter of FY 2007 was marked by positive progress in all of our key
clinical programs that should set the stage for continued progress during the
remainder of the fiscal year,” said Steven W. King, president and CEO of
Peregrine. “During the last quarter, we received regulatory approvals to advance
two clinical trials in India for Cotara in brain cancer and bavituximab in
solid
tumors to complement ongoing U.S. clinical trials for the two programs. We
dosed
our first patients in the bavituximab combination therapy cancer trial several
weeks ago, and the Cotara brain cancer trial should commence in the near term.
We expect that enrollment in these trials will proceed rapidly compared to
the
pace more typical of trials conducted in the U.S.”
Mr.
King
continued, “In October we reported positive final data on safety and anti-viral
activity from our Phase la study of bavituximab in HCV patients in an oral
presentation at the prestigious American Association for the Study of Liver
Disease (AASLD) meeting in Boston, which drew a large audience of HCV opinion
leaders and analysts and generated significant positive interest in our drug.
We
completed patient dosing in the bavituximab HCV Phase lb repeat dose study
and
ramped up our planning for the next round of HCV combination therapy studies,
which we expect to initiate early in 2007.”
Mr.
King
concluded, “Peregrine also made progress in its preclinical programs during this
period, presenting encouraging preclinical data at scientific meetings on novel
targets and approaches related to our anti-phospholipid platform, as well as
receiving notification of the issuance of a broad patent covering vascular
targeting agents in combination therapy regimens, potentially boosting our
future intellectual property licensing efforts. During the quarter we also
were
very active in communicating with the investment community, including
presentations at a number of investor conferences and one-on-one meetings with
major institutional investors. We look forward to building on this momentum
with
what we expect to be an eventful and positive record of continued progress
in
the coming months from our five ongoing clinical trials.”
Conference
Call:
The
company will host a conference call today, December 8, 2006 at 11:00 a.m. EST/
8:00 a.m. PST to discuss its second 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 December
15,
2006 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 bavituximab's safety
profile in a repeat dose trial or in a combination therapy trial will not be
at
the same safety level as was found in the phase Ia trial, the risk that the
results of future trials will not correlate to the results from the phase Ia
trial, the risk that bavituximab will not be as well tolerated at ascending
doses or show promising results in other viral indications, the risk that
results of human studies using bavituximab plus radiation or chemotherapy will
not correlate to the results of the preclinical studies and the risk that the
commencement of planned clinical trials may be delayed. 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
|
OCTOBER
31,
2006
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APRIL
30,
2006
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Unaudited
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|||||||
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ASSETS
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CURRENT
ASSETS:
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Cash
and cash equivalents
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$
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23,394,000
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$
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17,182,000
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Trade
and other receivables
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801,000
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579,000
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Inventories
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1,899,000
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885,000
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Prepaid
expenses and other current assets
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1,323,000
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1,466,000
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Total
current assets
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27,417,000
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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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3,669,000
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3,444,000
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|||||
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Furniture,
fixtures and office equipment
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666,000
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666,000
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|||||
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4,975,000
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4,728,000
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||||||
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Less
accumulated depreciation and amortization
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(3,055,000
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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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1,920,000
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1,906,000
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|||||
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Other
assets
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468,000
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658,000
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|||||
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TOTAL
ASSETS
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$
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29,805,000
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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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OCTOBER
31,
2006
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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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1,093,000
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$
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1,233,000
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Accrued
clinical trial site fees
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315,000
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170,000
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Accrued
legal and accounting fees
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76,000
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250,000
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Accrued
royalties and license fees
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164,000
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138,000
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Accrued
payroll and related costs
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974,000
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850,000
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|||||
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Notes
payable, current portion
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443,000
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429,000
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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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1,388,000
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563,000
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|||||
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Other
current liabilities
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396,000
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836,000
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|||||
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Total
current liabilities
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4,865,000
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4,484,000
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|||||
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Notes
payable, less current portion
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273,000
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498,000
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|||||
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Capital
lease obligation, less current portion
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39,000
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47,000
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|||||
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Deferred
license revenue
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12,000
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21,000
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|||||
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Commitments
and contingencies
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|||||||
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STOCKHOLDERS'
EQUITY:
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|||||||
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Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
-
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-
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|||||
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Common
stock-$.001 par value; authorized 250,000,000 shares;
outstanding
- 193,920,390 and 179,382,191, respectively
|
194,000
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179,000
|
|||||
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Additional
paid-in capital
|
221,813,000
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204,546,000
|
|||||
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Deferred
stock compensation
|
-
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(235,000
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)
|
||||
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Accumulated
deficit
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(197,391,000
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)
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(186,864,000
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)
|
|||
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Total
stockholders' equity
|
24,616,000
|
17,626,000
|
|||||
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TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
29,805,000
|
$
|
22,676,000
|
|||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
||||||||||||
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October
31,
2006
|
October
31,
2005
|
October
31,
2006
|
October
31,
2005
|
||||||||||
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Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
|
REVENUES:
|
|||||||||||||
|
Contract
manufacturing revenue
|
$
|
636,000
|
$
|
533,000
|
$
|
1,034,000
|
$
|
722,000
|
|||||
|
License
revenue
|
48,000
|
23,000
|
71,000
|
42,000
|
|||||||||
|
Total
revenues
|
684,000
|
556,000
|
1,105,000
|
764,000
|
|||||||||
|
COSTS
AND EXPENSES:
|
|||||||||||||
|
Cost
of contract manufacturing
|
494,000
|
428,000
|
1,024,000
|
732,000
|
|||||||||
|
Research
and development
|
3,920,000
|
3,244,000
|
7,961,000
|
6,036,000
|
|||||||||
|
Selling,
general and administrative
|
1,670,000
|
1,570,000
|
3,311,000
|
3,087,000
|
|||||||||
|
Total
costs and expenses
|
6,084,000
|
5,242,000
|
12,296,000
|
9,855,000
|
|||||||||
|
LOSS
FROM OPERATIONS
|
(5,400,000
|
)
|
(4,686,000
|
)
|
(11,191,000
|
)
|
(9,091,000
|
)
|
|||||
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OTHER
INCOME (EXPENSE):
|
|||||||||||||
|
Interest
and other income
|
339,000
|
128,000
|
688,000
|
204,000
|
|||||||||
|
Interest
and other expense
|
(9,000
|
)
|
(13,000
|
)
|
(24,000
|
)
|
(23,000
|
)
|
|||||
|
NET
LOSS
|
$
|
(5,070,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(10,527,000
|
)
|
$
|
(8,910,000
|
)
|
|
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
|||||||||||||
|
Basic
and Diluted
|
193,793,766
|
165,925,879
|
188,950,924
|
162,980,798
|
|||||||||
|
BASIC
AND DILUTED LOSS
PER
COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
|
####