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, 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)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
||
|
14282
Franklin Avenue, Tustin, California 92780
|
||||
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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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(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
14, 2008, Peregrine Pharmaceuticals, Inc. issued a press release to report the
Company’s financial results for the fiscal year ended April 30,
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.
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 14, 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.
| PEREGRINE PHARMACEUTICALS, INC. | |||
|
|
By:
|
/s/ Paul J. Lytle | |
| Paul J. Lytle | |||
| Chief Financial Officer | |||
Date: July 15, 2008
EXHIBIT
INDEX
Exhibit
Number Description
0;
|
99.1
|
Press
Release issued July 14, 2008
|
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
FISCAL YEAR 2008
--Achieves
Record Revenues While Advancing Three Major Clinical Programs and Securing
5-Year Contract With U.S. Defense Threat Reduction Agency Worth Up to $44.4
Million--
TUSTIN, Calif., July 14, 2008
- -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), today announced financial
results for fiscal year (FY) 2008 ended April 30, 2008. Total
revenues for FY 2008 increased 64% to $6,093,000, primarily reflecting increased
sales by Avid Bioservices, the company's wholly owned contract manufacturing
subsidiary.
Total
costs and expenses in FY 2008 increased to $30,233,000 from $25,618,000 in FY
2007. Increased costs of contract manufacturing directly related to
the increase in Avid’s revenues accounted for almost one-third of the increase
in total expenses. Most of the remainder of the increase was due to
the company’s increased investment in research and development associated with
the advancement of its three clinical programs for bavituximab and Cotara® for
the treatment of solid tumors and hepatitis C virus (HCV)
infection. These programs include seven clinical trials: Three
bavituximab Phase II studies in combination with chemotherapy for the treatment
of advanced breast cancer and non-small cell lung cancer (NSCLC), a bavituximab
Phase I cancer study, a bavituximab Phase I study in HCV patients co-infected
with HIV, and two Cotara studies for the treatment of glioblastoma multiforme
(GBM), a deadly form of brain cancer.
The
company reported a consolidated net loss of $23,176,000, or $0.10 per basic and
diluted share in FY 2008, compared to a consolidated net loss of $20,796,000, or
$0.11 per basic and diluted share for FY 2007.
"This
past year has been marked by major progress in all areas of our business,” said
Steven W. King, president and CEO of Peregrine. “The most significant
developments included initiating, completing enrollment in and reporting
positive data for the first set of patients in our first bavituximab Phase II
oncology study, entering into a five-year contract potentially worth up to $44.4
million with the Defense Threat Reduction Agency (DTRA) to expedite evaluation
of bavituximab for the prevention or treatment of viral hemorrhagic fever
infections and achieving significantly increased revenues and an expanded client
base at our manufacturing subsidiary Avid. We expect to continue
building on these accomplishments during FY 2009 and we are optimistic that the
company will achieve even more significant advances during the coming
year.”
Mr. King
continued, “Our most significant product advancements this year were in the
bavituximab clinical program. In the anti-cancer program, we were
able to start and complete patient enrollment in the planned first set of 15
patients in a Phase II breast cancer trial combining bavituximab and the
chemotherapy drug docetaxel. The trial has already met the
pre-established primary endpoint with none of the patients having any tumor
growth to date and half of the patients achieving an objective tumor response by
the first eight-week evaluation point. These are encouraging results
and open the door to expanding the trial to an additional planned 31
patients. We also initiated patient enrollment in a second Phase II
study combining bavituximab with carboplatin and paclitaxel in patients with
advanced lung cancer. A third Phase II study is set to begin shortly
testing this same combination in advanced breast cancer patients. In
addition, the bavituximab cancer program received significant attention when
positive data from an earlier Phase l study was presented at the 2008 ASCO
Annual Meeting. These developments have set the stage for what we
expect to be additional significant clinical advancements during the coming
year. In the bavituximab anti-viral program, we recently received a
significant external validation of this program when the DTRA awarded Peregrine
a multi-year contract worth up to $44.4 million to develop bavituximab for the
treatment and prevention of viral hemorrhagic fevers. We expect this
contract will help advance all of our bavituximab anti-viral
programs.”
Mr. King
added, "Similarly, we strengthened the foundation for progress in the Cotara
clinical program by initiating additional sites in two ongoing trials of Cotara
in patients with GBM. Data was presented at the 2008 ASCO Annual
Meeting reinforcing Cotara’s safety and its ability to target radiation
precisely to the brain tumor while avoiding healthy tissue, further reinforcing
its potential as a possible new treatment for GBM. We look forward to
generating more data on Cotara’s impact on tumor status and patient survival
over the course of this fiscal year.”
Mr. King
concluded, “We believe that the company’s future has never looked
brighter. With multiple Phase II trials underway or soon to begin, we
expect a consistent flow of clinical data throughout the upcoming
year. The expected new clinical trial data we are in the process of
generating along with anticipated increased contract manufacturing revenues and
continued progress in our preclinical anti-viral programs are setting the stage
for what we believe will be a positive and productive FY 2009."
At April
30 2008, Peregrine had $15.1 in cash and cash equivalents compared to $16.0
million at April 30, 2007. The company’s FY 2008 Annual Report on
Form 10-K to be filed today will include an audit opinion with a "going concern"
qualification. The qualification is a statement in the audit opinion
of Ernst & Young LLP, the company’s independent registered public accounting
firm, expressing substantial doubt, based upon Peregrine’s current financial
resources, as to whether it can continue to meet its financial obligations
beyond fiscal year 2009 without access to additional cash and cash
equivalents. Nasdaq Marketplace Rule 4350(b)(1)(B) requires
Nasdaq-listed companies to publicly announce through the news media the receipt
of an audit opinion containing a "going concern" qualification. The
company’s Annual Report on Form 10-K will be filed later today and will be
available at the SEC’s website at www.sec.org, or
through the investor portion of Peregrine’s website at www.peregrineince.com.
Paul
Lytle, chief financial officer of Peregrine, noted, “Based on a combination of
projected cash-inflows from the anticipated funding from the government DTRA
contract and our projected FY 2009 revenues from Avid, which we project to be in
excess of $10 million based on current signed contracts from third-party
customers, we believe the company has sufficient financial resources to meet its
obligations through at least FY 2009. While we feel confident about
our likely cash in-flows from these contracts over the next 12 months, there are
potential uncertainties associated with these financial projections that
required the company’s independent registered public accounting firm to include
a going concern qualification in its audit opinion. We remain
confident that should we need to raise additional funds, these funds could be
raised through a debt financing or equity offering, with the possibility that
future market conditions could be significantly better. We therefore
expect this qualified opinion that was required from our auditors will have
minimal effect on the company as we advance our programs and continue to service
our Avid customers.”
Corporate
Highlights Since the Start of Fiscal Year 2008
|
·
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In
July 2008, Peregrine reported positive early results from the first cohort
of patients enrolled in its Phase II trial of bavituximab in combination
with docetaxel in advanced breast cancer patients. The results
showed that bavituximab achieved the pre-specified stage 1 primary
endpoint in this trial. Of 14 evaluable patients, seven achieved partial
tumor responses and seven had stable disease at week eight according to
RECIST criteria. None showed tumor progression during this
period.
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·
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In
July 2008, Peregrine announced that it entered into a five-year contract
worth up to $44.4 million to test and develop bavituximab and an
equivalent fully human antibody as potential broad spectrum treatments for
viral hemorrhagic fever infections. The initial contract was
awarded through the Transformational Medical Technologies Initiative of
the U.S. Department of Defense's Defense Threat Reduction
Agency.
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·
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In
June 2008, Peregrine announced that patient screening and dosing had begun
in a Phase II trial designed to evaluate the safety and efficacy of
bavituximab in combination with carboplatin and paclitaxel in patients
with the form of lung cancer know as NSCLC, which is the most commonly
occurring cancer in both men and women and lacks effective
treatment.
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·
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In
March 2008, Peregrine announced a clinical update on its Cotara program
for the treatment of glioblastoma multiforme (GBM), covering the first
cohort of patients in its dosimetry trial as well as experience to date in
an ongoing Phase II safety and efficacy trial. Cotara appeared
to be safe and well tolerated in these brain cancer
patients. Several patients who are continuing in the trials
have already surpassed the expected median survival time for relapsed GBM
patients.
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·
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In
February 2008, Peregrine announced that patient dosing had begun in its
first Phase II bavituximab trial. This clinical trial is
designed to evaluate the safety and efficacy of bavituximab in combination
with chemotherapy in patients with advanced breast
cancer.
|
|
·
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In
November 2007 at the prestigious AASLD meeting, Peregrine reported final
results from its Phase Ib study of bavituximab in patients with chronic
HCV infection. Bavituximab appeared generally safe and well tolerated and
there were signs of anti-viral activity at all dose levels
tested.
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|
·
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In
October 2007, Peregrine announced that the first patient had been dosed in
a clinical trial designed to evaluate the safety and pharmacokinetics of
bavituximab in patients co-infected with HCV and HIV. Patient
cohorts are receiving ascending doses of bavituximab. HCV and HIV viral
titers and other biomarkers are being
evaluated.
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·
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In
August 2007, Peregrine announced that the first GBM brain cancer patient
had been administered Cotara in a Phase II clinical trial designed to
evaluate its safety and efficacy. The study's primary objective
is to confirm the maximum tolerated dose of Cotara and secondary
objectives include estimates of overall patient survival, progression free
survival and the proportion of patients alive at six
months.
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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.
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Conference
Call
The
company will host a conference call today, July 14, 2008 at 11:30 a.m. EDT/8:30
a.m. PDT to discuss its fiscal year 2008 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 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 July 21, 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 a 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 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.
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
BALANCE SHEETS
AS
OF APRIL 30, 2008 AND 2007
|
2008
|
2007
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|||||||
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ASSETS
|
||||||||
|
CURRENT
ASSETS:
|
||||||||
|
Cash
and cash equivalents
|
$ | 15,130,000 | $ | 16,044,000 | ||||
|
Trade
and other receivables
|
605,000 | 750,000 | ||||||
|
Inventories,
net
|
2,900,000 | 1,916,000 | ||||||
|
Prepaid
expenses and other current assets
|
1,208,000 | 1,188,000 | ||||||
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Total
current assets
|
19,843,000 | 19,898,000 | ||||||
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PROPERTY:
|
||||||||
|
Leasehold
improvements
|
669,000 | 646,000 | ||||||
|
Laboratory
equipment
|
4,140,000 | 3,533,000 | ||||||
|
Furniture,
fixtures and computer equipment
|
919,000 | 873,000 | ||||||
| 5,728,000 | 5,052,000 | |||||||
|
Less
accumulated depreciation and amortization
|
(3,670,000 | ) | (3,212,000 | ) | ||||
|
Property,
net
|
2,058,000 | 1,840,000 | ||||||
|
Other
assets
|
1,156,000 | 1,259,000 | ||||||
|
TOTAL
ASSETS
|
$ | 23,057,000 | $ | 22,997,000 | ||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF APRIL 30, 2008 AND 2007 (continued)
|
2008
|
2007
|
|||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
|
CURRENT
LIABILITIES:
|
||||||||
|
Accounts
payable
|
$ | 2,060,000 | $ | 1,683,000 | ||||
|
Accrued
clinical trial site fees
|
237,000 | 228,000 | ||||||
|
Accrued
legal and accounting fees
|
450,000 | 392,000 | ||||||
|
Accrued
royalties and license fees
|
222,000 | 337,000 | ||||||
|
Accrued
payroll and related costs
|
1,084,000 | 874,000 | ||||||
|
Notes
payable, current portion
|
- | 379,000 | ||||||
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Capital
lease obligation, current portion
|
22,000 | 17,000 | ||||||
|
Deferred
revenue
|
2,196,000 | 1,060,000 | ||||||
|
Customer
deposits
|
838,000 | 585,000 | ||||||
|
Other
current liabilities
|
331,000 | 300,000 | ||||||
|
Total
current liabilities
|
7,440,000 | 5,855,000 | ||||||
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Notes
payable, less current portion
|
- | 119,000 | ||||||
|
Capital
lease obligation, less current portion
|
22,000 | 30,000 | ||||||
|
Deferred
license revenue
|
- | 4,000 | ||||||
|
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 196,112,201, respectively
|
226,000 | 196,000 | ||||||
|
Additional
paid-in-capital
|
246,205,000 | 224,453,000 | ||||||
|
Accumulated
deficit
|
(230,836,000 | ) | (207,660,000 | ) | ||||
|
Total
stockholders' equity
|
15,595,000 | 16,989,000 | ||||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 23,057,000 | $ | 22,997,000 | ||||
-continued-
PEREGRINE
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2008
|
2008
|
2007
|
2006
|
||||||||||
|
REVENUES:
|
||||||||||||
|
Contract
manufacturing revenue
|
$ | 5,897,000 | $ | 3,492,000 | $ | 3,005,000 | ||||||
|
License
revenue
|
196,000 | 216,000 | 188,000 | |||||||||
|
Total
revenues
|
6,093,000 | 3,708,000 | 3,193,000 | |||||||||
|
COSTS
AND EXPENSES:
|
||||||||||||
|
Cost
of contract manufacturing
|
4,804,000 | 3,296,000 | 3,297,000 | |||||||||
|
Research
and development
|
18,279,000 | 15,876,000 | 12,415,000 | |||||||||
|
Selling,
general and administrative
|
7,150,000 | 6,446,000 | 6,564,000 | |||||||||
|
Total
costs and expenses
|
30,233,000 | 25,618,000 | 22,276,000 | |||||||||
|
LOSS
FROM OPERATIONS
|
(24,140,000 | ) | (21,910,000 | ) | (19,083,000 | ) | ||||||
|
OTHER
INCOME (EXPENSE):
|
||||||||||||
|
Recovery
of note receivable
|
- | - | 1,229,000 | |||||||||
|
Interest
and other income
|
989,000 | 1,160,000 | 846,000 | |||||||||
|
Interest
and other expense
|
(25,000 | ) | (46,000 | ) | (53,000 | ) | ||||||
|
NET
LOSS
|
$ | (23,176,000 | ) | $ | (20,796,000 | ) | $ | (17,061,000 | ) | |||
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
221,148,342 | 192,297,309 | 168,294,782 | |||||||||
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.10 | ) | $ | (0.11 | ) | $ | (0.10 | ) | |||
###