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 10,
2008
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
|
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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||||
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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
December 10, 2008, Peregrine Pharmaceuticals, Inc. issued a press release to
report the Company’s financial results for the second quarter ended October 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.
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ITEM
7.01
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REGULATION
FD DISCLOSURE
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On December 10, 2008, at 11:30 a.m.
EST/8:30 a.m. PST, the Company hosted a conference call to discuss its Second
Quarter Fiscal Year 2009 financial results. The webcast of the
conference call will be archived on the Company’s website for approximately 30
days.
ITEM
9.01 FINANCIAL
STATEMENTS AND EXHIBITS
(d) 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 10, 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.
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PEREGRINE
PHARMACEUTICALS, INC.
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|
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Date:
December 10, 2008
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By: /s/ Paul J.
Lytle
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Paul
J. Lytle
Chief
Financial Officer
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EXHIBIT
INDEX
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Exhibit
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|
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Number
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Description
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99.1
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Press
Release issued December 10, 2008
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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 THE
SECOND
QUARTER OF FISCAL YEAR 2009
—Three
Bavituximab Phase II Cancer Trials and the Company’s Other Clinical
Programs
All Advanced During the Quarter—
—Significant
Validation Achieved for Bavituximab and Peregrine’s Anti-PS
Anti-Viral Platform in Nature
Medicine
Publication—
—Company
Enters into Loan Agreement for Up to $10 Million in Funding—
TUSTIN, Calif., December 10,
2008 -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced
financial results for the second quarter of fiscal year (FY) 2009 ended October
31, 2008. Separately, the company also announced today that it has entered into
a loan agreement for up to $10 million in funding to help finance its ongoing
clinical development programs for the treatment of cancer and serious viral
infections.
Peregrine
reported a consolidated net loss of $4,497,000, or $0.02 per basic and diluted
share, compared to a consolidated net loss of $6,207,000, or $0.03 per basic and
diluted share for the same prior year period, a decrease of 28%. The
net loss decline of $1,710,000 reflects decreased costs in many areas of
Peregrine’s business, including research and development and selling, general
and administrative expenses.
Total
revenues for the current quarter were $1,941,000 compared to $1,892,000 for the
comparable quarter last year. Revenues were generated from contract
manufacturing services provided by Avid Bioservices and from Peregrine’s
contract with the U.S. Defense Threat Reduction Agency (DTRA) to evaluate
bavituximab for the treatment of viral hemorrhagic fever
infections. Contract manufacturing revenues generated by Avid were
$983,000 for the current quarter compared to $1,863,000 for the comparable prior
year quarter. This decrease in Avid revenues is primarily due to the
timing of product shipments to customers, since several batches of product that
were manufactured during the latter part of the second quarter were not shipped
until the third quarter, when these revenues will be recorded.
Total
costs and expenses decreased $1,954,000 to $6,491,000 in the second quarter of
FY 2009 from $8,445,000 in the same prior year quarter, a decrease of
23%. The decrease was primarily related to planned reductions in
R&D costs associated with Peregrine’s preclinical programs. These
reductions were implemented to maximize the R&D resources available to
advance the company’s priority clinical product candidates bavituximab and
Cotara®. R&D expenses were $4,301,000 in the second quarter of FY
2009, compared to $5,100,000 in the second quarter of FY 2008. The
decrease in R&D expense was achieved despite an increase in clinical
activity during the quarter. SG&A expenses were down
$416,000 to $1,527,000 for the second quarter of FY 2009 compared to
$1,943,000 for the comparable period in FY 2008, a decrease of
21%. This decrease reflects a reduction in SG&A expenses across
the board, reflecting the company’s focus on stringent management of all
discretionary expense categories.
At
October 31, 2008, the company had $8,210,000 in cash and cash
equivalents. After the close of the quarter, on December 9, 2008,
Peregrine entered into an agreement for a non-convertible term loan with an
initial tranche of $5 million that will be funded upon closing, with an option
to acquire a second $5 million tranche in the future, upon Peregrine’s
satisfaction of certain additional conditions.
"This
past quarter was highlighted by significant milestones for both our bavituximab
cancer and anti-viral programs,” said Steven W. King, president and CEO of
Peregrine. “For the first time, we reported patient enrollment
underway in three bavituximab Phase II cancer trials, along with encouraging
updated results from our Phase II trial testing bavituximab and docetaxel in
advanced breast cancer patients. Our anti-viral program received
global attention with a publication in the leading journal Nature Medicine highlighting
the broad anti-viral potential of bavituximab and other anti-PS antibodies, and
we were also awarded a broad U.S. patent covering anti-viral applications of
antibodies that directly target PS. These developments, following a
major government contract award last quarter to study bavituximab in viral
hemorrhagic fever infections, have established our PS-targeting anti-viral
platform as an approach that could represent a completely new class of drugs for
the treatment of life-threatening viral infections. We look forward to reporting
continued progress in our anti-PS programs in the coming months, as well as
providing an update on progress in our Cotara® clinical program.”
Mr. King
continued, "Our Avid manufacturing subsidiary continued to expand its client
base during the quarter and increased its manufacturing capacity with the
addition of an innovative single-use bioreactor system, which should allow Avid
to meet the growing demand for its cell culture production services using
state-of-the-art, cost-effective technology. Avid revenues recorded
this quarter were lower than last year’s as a result of the timing of shipments
of finished product to customers, but based on product now being readied for
shipping and our backlog of orders in hand, we expect robust revenue growth from
Avid over the remainder of the fiscal year, with revenues in the third quarter
of FY 2009 estimated at upwards of $5 million.”
Mr. King
concluded, “Despite the turmoil in the global financial markets, we have never
been more optimistic about the potential of our lead drug
candidates. The encouraging progress in our clinical programs to date
and increasing scientific recognition of the promise of our innovative
technology have already made this fiscal year one of significant achievement,
and we look forward to reporting on additional progress in the coming
months.”
Recent
Operating Highlights
Bavituximab
Anti-Cancer Program
Peregrine
reported progress in all three Phase II trials in the bavituximab cancer
program.
|
§
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Reported
updated early results from the first cohort of patients (Stage A) enrolled
in a Phase II trial of bavituximab in combination with docetaxel in
advanced breast cancer patients. Bavituximab achieved the pre-specified
primary endpoint, with 10 of 14 (71%) evaluable patients achieving an
objective tumor response according to RECIST
criteria.
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§
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Initiated
patient dosing in Stage B of the Phase II trial of bavituximab in
combination with docetaxel in advanced breast cancer
patients.
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§
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Completed
patient enrollment in Stage A of the Phase II trial of bavituximab in
combination with carboplatin and paclitaxel in patients with advanced
breast cancer.
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§
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Completed
patient enrollment in Stage A of the Phase II trial of bavituximab in
combination with carboplatin and paclitaxel in patients with non-small
cell lung cancer.
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Bavituximab
Anti-Viral Program
The
company continued to advance its bavituximab anti-viral program and received
major validation for its anti-PS anti-viral platform.
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§
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Reported
publication of data in Nature Medicine that
supports the broad anti-viral potential of Peregrine’s anti-PS antibody
platform, showing that its PS-targeting drug bavituximab can cure lethal
virus infections in animal disease
models.
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§
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Was
awarded a U.S. patent that includes broad claims covering anti-viral
applications of antibodies that directly bind to aminophospholipids,
including PS, which represent a novel target for anti-viral
therapies.
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§
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Reported
that the company's anti-PS technology was positively highlighted in
scientific sessions at the AIDS Vaccine 2008 conference in Cape Town,
South Africa.
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Other
Developments
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§
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Entered
into a loan agreement for up to $10 million in funding to finance ongoing
development efforts.
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§
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Avid
Bioservices signed a manufacturing supply agreement with Catalyst
Biosciences, Inc. to produce clinical-grade material in support of their
candidate to treat acute bleeding in hemophilia
patients.
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§
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Avid
Bioservices expanded its biomanufacturing capabilities with the
installation of two Thermo Scientific HyClone Single-Use Bioreactors,
which further enhance Avid's ability to meet the growing demand for its
cell culture production services.
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§
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Received
a letter from NASDAQ that provides Peregrine with additional time to
regain compliance with NASDAQ's $1.00 minimum bid price rule. Peregrine
now has until April 27, 2009 to regain
compliance.
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§
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Received
shareholder approval at the Annual Meeting of Stockholders held on October
21, 2008, for a proposal that provides the company's Board of Directors
with discretionary authority over the course of the next year to implement
a reverse split of the issued and outstanding shares of Peregrine's common
stock.
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Conference
Call
The
company will host a conference call today, December 10, 2008 at 11:30 a.m.
EST/8:30 a.m. PST to discuss its Second Quarter FY 2009 financial
results.
To listen
to a live broadcast of the call over the Internet or to review the archived
call, please visit: http://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: (800) 860-2442. A telephonic replay of the
conference call will be available starting approximately one hour after the
conclusion of the call through December 17, 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 results of future
clinical trials may not correlate with the results from prior clinical and
preclinical studies, the risk that Avid’s revenue growth may slow or
decline, the risk that Avid may experience technical difficulties in processing
customer orders which could delay delivery of products to customers and receipt
of payment, the risk that one or more existing Avid customers terminates its
contract prior to completion, the risk that the company does not receive all of
its funding under the DTRA contract, the risk that future protocol submissions
may not be approved, the risk that the company does not satisfy the conditions
under its loan agreement necessary to receive the initial $5 million funding or
the second $5 million tranche, the risk that the company does not generate cash
flow sufficient to service the debt or repay the principal amount and
the risk that the company may not be able to monetize any of its assets. 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, 2008 or our quarterly report on Form 10-Q
for the period ended October 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
|
OCTOBER
31,
2008
|
APRIL
30,
2008
|
|||||||
|
Unaudited
|
||||||||
|
ASSETS
|
||||||||
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CURRENT
ASSETS:
|
||||||||
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Cash
and cash equivalents
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$ | 8,210,000 | $ | 15,130,000 | ||||
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Trade
and other receivables
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1,747,000 | 605,000 | ||||||
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Government
contract receivables
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837,000 | - | ||||||
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Inventories,
net
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6,700,000 | 2,900,000 | ||||||
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Prepaid
expenses and other current assets
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1,142,000 | 1,208,000 | ||||||
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Total current
assets
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18,636,000 | 19,843,000 | ||||||
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PROPERTY:
|
||||||||
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Leasehold
improvements
|
675,000 | 669,000 | ||||||
|
Laboratory
equipment
|
4,247,000 | 4,140,000 | ||||||
|
Furniture,
fixtures and office equipment
|
919,000 | 919,000 | ||||||
| 5,841,000 | 5,728,000 | |||||||
|
Less
accumulated depreciation and amortization
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(3,931,000 | ) | (3,670,000 | ) | ||||
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Property, net
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1,910,000 | 2,058,000 | ||||||
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Other
assets
|
1,201,000 | 1,156,000 | ||||||
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TOTAL
ASSETS
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$ | 21,747,000 | $ | 23,057,000 | ||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
OCTOBER
31,
2008
|
APRIL
30,
2008
|
|||||||
|
Unaudited
|
||||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
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CURRENT
LIABILITIES:
|
||||||||
|
Accounts
payable
|
$ | 3,419,000 | $ | 2,060,000 | ||||
|
Accrued
clinical trial site fees
|
550,000 | 237,000 | ||||||
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Accrued
legal and accounting fees
|
225,000 | 450,000 | ||||||
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Accrued
royalties and license fees
|
113,000 | 222,000 | ||||||
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Accrued
payroll and related costs
|
782,000 | 1,084,000 | ||||||
|
Capital
lease obligation, current portion
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23,000 | 22,000 | ||||||
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Deferred
revenue
|
6,472,000 | 2,196,000 | ||||||
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Deferred
government contract revenue
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1,701,000 | - | ||||||
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Customer
deposits
|
1,575,000 | 838,000 | ||||||
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Other
current liabilities
|
372,000 | 331,000 | ||||||
|
Total current
liabilities
|
15,232,000 | 7,440,000 | ||||||
|
Capital
lease obligation, less current portion
|
10,000 | 22,000 | ||||||
|
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 226,210,617,
respectively
|
226,000 | 226,000 | ||||||
|
Additional
paid-in capital
|
246,698,000 | 246,205,000 | ||||||
|
Accumulated
deficit
|
(240,419,000 | ) | (230,836,000 | ) | ||||
|
Total stockholders'
equity
|
6,505,000 | 15,595,000 | ||||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 21,747,000 | $ | 23,057,000 | ||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
|||||||||||||||
|
October
31,
2008
|
October
31,
2007
|
October
31,
2008
|
October
31,
2007
|
|||||||||||||
|
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
|
REVENUES:
|
||||||||||||||||
|
Contract
manufacturing revenue
|
$ | 983,000 | $ | 1,863,000 | $ | 2,176,000 | $ | 3,484,000 | ||||||||
|
Government
contract revenue
|
958,000 | - | 1,282,000 | - | ||||||||||||
|
License
revenue
|
- | 29,000 | - | 33,000 | ||||||||||||
|
Total
revenues
|
1,941,000 | 1,892,000 | 3,458,000 | 3,517,000 | ||||||||||||
|
COSTS
AND EXPENSES:
|
||||||||||||||||
|
Cost
of contract manufacturing
|
663,000 | 1,402,000 | 1,566,000 | 2,583,000 | ||||||||||||
|
Research
and development
|
4,301,000 | 5,100,000 | 8,369,000 | 8,724,000 | ||||||||||||
|
Selling,
general and administrative
|
1,527,000 | 1,943,000 | 3,233,000 | 3,651,000 | ||||||||||||
|
Total
costs and expenses
|
6,491,000 | 8,445,000 | 13,168,000 | 14,958,000 | ||||||||||||
|
LOSS
FROM OPERATIONS
|
(4,550,000 | ) | (6,553,000 | ) | (9,710,000 | ) | (11,441,000 | ) | ||||||||
|
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
|
Interest
and other income
|
53,000 | 353,000 | 128,000 | 592,000 | ||||||||||||
|
Interest
and other expense
|
- | (7,000 | ) | (1,000 | ) | (14,000 | ) | |||||||||
|
NET
LOSS
|
$ | (4,497,000 | ) | $ | (6,207,000 | ) | $ | (9,583,000 | ) | $ | (10,863,000 | ) | ||||
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
|
Basic
and Diluted
|
226,210,617 | 226,210,617 | 226,210,617 | 216,141,092 | ||||||||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.05 | ) | ||||
####