TUSTIN, CA -- (MARKET WIRE) -- 12/09/10 --
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM),
a clinical-stage biopharmaceutical company developing first-in-class
monoclonal antibodies for the treatment of cancer and viral infections,
today announced financial results for the second quarter ended October 31,
2010 for its fiscal year (FY) 2011 and provided an update on the progress
of its clinical development programs.
"Our Phase II oncology programs for our broad-spectrum antibody bavituximab
and novel brain cancer therapy Cotara® are building value for Peregrine as
we execute our clinical and regulatory strategies," said Steven W. King,
president and chief executive officer of Peregrine. "We are managing our
resources to support advancing and expanding our clinical trials in
multiple oncology and viral infection indications, providing the
opportunity for a robust flow of clinical data with potential value
inflection points as we progress into 2011."
Oncology Program Highlights
Bavituximab Phase IIb NSCLC Trials
Peregrine is conducting two randomized Phase IIb clinical trials in
non-small cell lung cancer (NSCLC).
The first trial is enrolling up to 120 second-line NSCLC patients in this
randomized, placebo-controlled, double-blinded trial. Enrollment is
expected to be complete by
mid-year 2011 with data unblinded from the second-line trial by year-end
2011.
The second trial is enrolling up to 86 front-line NSCLC patients in this
randomized open-label trial. Enrollment is expected to be complete by
mid-year 2011 and interim data is expected to be available by mid-year
2011.
Bavituximab Phase I/II HCC IST
On December 1, 2010, Peregrine announced the initiation of its first
investigator-sponsored trial (IST) for patients with advanced
hepatocellular carcinoma (HCC), or liver cancer. This open-label Phase
I/II trial will treat up to 50 patients with bavituximab in combination
with sorafenib and is being conducted by the University of Texas
Southwestern Medical Center at Dallas.
Cotara® Phase II Brain Cancer Trial
In October 2010, Peregrine reported Phase II interim data on 14 patients
with glioblastoma multiforme (GBM) treated at a single medical with its
novel brain cancer therapy Cotara. Interim median overall survival was 86
weeks for patients treated at first relapse with a single infusion of
Cotara. Previously, interim median overall survival for patients treated
with Cotara has ranged from 38 to 41 weeks which compares very favorably to
published historical data of 24 weeks in this patient population.
Peregrine expects to complete enrollment of the 40 patient Phase II trial
shortly and plans to report data by mid-year 2011. Once this trial is
completed and data are analyzed, Peregrine plans to meet with the FDA to
determine the optimal registration pathway for Cotara.
Antiviral Program Highlights
Bavituximab Phase Ib HCV/HIV Trial
Peregrine expects to complete enrollment shortly in its Phase Ib safety and
efficacy trial of bavituximab monotherapy in up to 24 patients coinfected
with hepatitis C virus (HCV) and HIV. The company expects to initiate its
next HCV study in the near term.
For more information on Peregrine's clinical trials, please visit
http://www.peregrinetrials.com.
Government-Sponsored Research
In November 2010, Peregrine presented preclinical data at the 2010 Chemical
and Biological Defense Science and Technology Conference demonstrating
bavituximab's ability to bind to virus particles and virus-infected cells
of five viruses that cause viral hemorrhagic fever (VHF), including the
highly lethal Ebola virus. Additionally, bavituximab in combination with
the antiviral drug ribavirin improved survival by up to 50% compared to
either drug used as a monotherapy in several models of VHF.
This research is being conducted under Peregrine's government contract to
evaluate its phosphatidylserine (PS)-targeting antibodies for VHF. This
contract provides for up to $24.7 million in funding for the base period
ending March 2011 for a total of up to $36.3 million in funding during the
five-year potential duration of the contract.
In October 2010, Peregrine was award of $977,917 under Section 48D of the
Internal Revenue Code for Qualifying Therapeutic Discovery Projects to
support the following projects:
-- Bavituximab for the treatment of patients with second-line NSCLC
-- Bavituximab for the treatment of patients with front-line NSCLC
-- Bavituximab for the treatment of patients coinfected with HCV/HIV
-- Cotara for the treatment of patients with GBM
Biomanufacturing Subsidiary Avid Bioservices
On December 8, 2010, Peregrine's biomanufacturing subsidiary Avid
Bioservices announced an agreement to provide services for a privately held
U.S. and China-based biopharmaceutical company focused on developing
biosimilars for global commercialization. Under the terms of this
contract, Avid Bioservices will provide fully-integrated process
development and analytical services for a complex biosimilar product to
support planned clinical development.
In September 2010, Avid announced it has secured a biomanufacturing
contract to supply clinical material of AT001/r84, a fully human antibody,
to Affitech A/S. The initial one-year contract for committed services
provides for several large-scale cGMP manufacturing runs as well as other
cGMP-related services.
Financial Results
Total revenues for the second quarter of FY 2011 were $4,671,000, compared
to $6,896,000 for the same quarter of the prior fiscal year. This decrease
was attributed to a reduction in contract manufacturing revenue from
Peregrine's subsidiary Avid Bioservices, due to the level and timing of
services provided to its third-party clients, and in government contract
revenue. Expected to generate between $8 million and $12 million in
contract manufacturing revenue from third-party clients during fiscal year
2011, Avid will continue to utilize available capacity and resources to
begin preparing for the future clinical development and potential
commercialization of bavituximab and Cotara, while also seeking to grow its
base of third-party clients.
Total costs and expenses in the second quarter of FY 2011 were $13,049,000,
compared to $9,433,000 in the second quarter of FY 2010. The increase was
attributable to higher research and development and selling, general
administrative expenses, primarily to support Peregrine's two randomized
Phase IIb bavituximab NSCLC trials. For the second quarter FY 2011,
research and development expenses were $7,344,000, compared to $4,132,000
for the second quarter of FY 2010.
Peregrine's consolidated net loss was $7,513,000, or $0.13 per share, for
the second quarter of FY 2011, compared to a net loss of $2,787,000 or
$0.06 per share, for the same quarter of the prior year.
Peregrine reported $17,268,000 in cash and cash equivalents at October 31,
2010, compared to $17,983,000 at July 31, 2010. Cash and cash equivalents
as of November 30, 2010 increased to $22,618,000.
More detailed financial information and analysis may be found in
Peregrine's Quarterly Report on Form 10-Q, which was filed with the
Securities and Exchange Commission today.
Conference Call
Peregrine will host a conference call and webcast today, December 9, 2010,
at 4:30 p.m. ET (1:30 p.m. PT).
-- To listen to the live webcast or access the archived webcast available
for 30 days, please visit: www.peregrineinc.com.
-- To listen to the conference call, please call (877) 312-5443 or (253)
237-1126 and request the Peregrine Pharmaceuticals call. A replay of
the call will be available starting approximately two hours after the
conclusion of the call through December 23, 2010 by calling (800)
642-1687 or (706) 645-9291 and using passcode 25993873.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative monoclonal antibodies in clinical trials for the
treatment of cancer and serious viral infections. The company is pursuing
multiple clinical programs in cancer and hepatitis C virus infection with
its lead product candidate bavituximab and novel brain cancer agent
Cotara®. Peregrine also has in-house cGMP manufacturing capabilities
through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing 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 the company may experience delays
in clinical trial patient enrollment, the risk that the results of the
Phase IIb clinical trials may not correlate with the results from prior
clinical and preclinical studies, the risk that the company may not have or
be able to raise sufficient financial resources to complete the Phase IIb
trials, 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, and the risk that the government contract may
not be further extended or provide any additional funding. 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 fiscal year ended April 30, 2010 and quarterly report on
Form 10-Q for the quarter ended October 31, 2010. 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.
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED SIX MONTHS ENDED
OCTOBER 31, OCTOBER 31,
2010 2009 2010 2009
----------- ----------- ------------ -----------
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract manufacturing
revenue $ 3,627,000 $ 5,308,000 $ 4,610,000 $ 7,378,000
Government contract
revenue 966,000 1,510,000 3,077,000 6,181,000
License revenue 78,000 78,000 193,000 87,000
----------- ----------- ------------ -----------
Total revenues 4,671,000 6,896,000 7,880,000 13,646,000
COSTS AND EXPENSES:
Cost of contract
manufacturing 3,003,000 3,540,000 4,159,000 4,613,000
Research and
development 7,344,000 4,132,000 14,411,000 10,206,000
Selling, general and
administrative 2,702,000 1,761,000 5,200,000 3,554,000
----------- ----------- ------------ -----------
Total costs and
expenses 13,049,000 9,433,000 23,770,000 18,373,000
----------- ----------- ------------ -----------
LOSS FROM OPERATIONS (8,378,000) (2,537,000) (15,890,000) (4,727,000)
----------- ----------- ------------ -----------
OTHER INCOME (EXPENSE):
Interest and other
income 996,000 34,000 1,014,000 74,000
Interest and other
expense (131,000) (284,000) (332,000) (562,000)
----------- ----------- ------------ -----------
NET LOSS $(7,513,000) $(2,787,000) $(15,208,000) $(5,215,000)
=========== =========== ============ ===========
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING:
Basic and Diluted 56,761,412 48,147,702 55,559,493 47,478,247
=========== =========== ============ ===========
BASIC AND DILUTED LOSS
PER COMMON SHARE $ (0.13) $ (0.06) $ (0.27) $ (0.11)
=========== =========== ============ ===========
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31, APRIL 30,
2010 2010
------------ ------------
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 17,268,000 $ 19,681,000
Trade and other receivables, net 2,522,000 1,481,000
Government contract receivables 425,000 367,000
Inventories, net 3,555,000 3,123,000
Debt issuance costs, current portion 67,000 122,000
Prepaid expenses and other current assets, net 1,524,000 2,004,000
------------ ------------
Total current assets 25,361,000 26,778,000
PROPERTY:
Leasehold improvements 891,000 697,000
Laboratory equipment 4,285,000 4,221,000
Furniture, fixtures, office equipment and
software 1,714,000 917,000
------------ ------------
6,890,000 5,835,000
Less accumulated depreciation and amortization (4,661,000) (4,366,000)
------------ ------------
Property, net 2,229,000 1,469,000
OTHER ASSETS:
Debt issuance costs, less current portion 1,000 21,000
Other assets 1,178,000 1,067,000
------------ ------------
Total other assets 1,179,000 1,088,000
TOTAL ASSETS $ 28,769,000 $ 29,335,000
============ ============
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
OCTOBER 31, APRIL 30,
2010 2010
------------ ------------
Unaudited
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 3,027,000 $ 2,259,000
Accrued clinical trial and related fees 2,699,000 2,666,000
Accrued payroll and related costs 1,081,000 1,623,000
Notes payable, current portion and net of
discount 1,961,000 1,893,000
Deferred revenue 2,447,000 2,406,000
Deferred government contract revenue 35,000 78,000
Customer deposits 3,325,000 2,618,000
Other current liabilities 1,123,000 860,000
------------ ------------
Total current liabilities 15,698,000 14,403,000
Notes payable, less current portion and net of
discount 333,000 1,315,000
Deferred revenue 663,000 -
Other long-term liabilities 450,000 210,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized
5,000,000 shares; non-voting; none issued - -
Common stock-$0.001 par value; authorized
325,000,000 shares;
outstanding - 59,220,742
and 53,094,896, respectively 59,000 53,000
Additional paid-in capital 288,628,000 275,208,000
Accumulated deficit (277,062,000) (261,854,000)
------------ ------------
Total stockholders' equity 11,625,000 13,407,000
------------ ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 28,769,000 $ 29,335,000
============ ============
Contact:
Amy FigueroaPeregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
Source: Peregrine Pharmaceuticals
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