Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2011 Financial Results and Recent Developments
"During this fiscal year, we advanced our clinical pipeline significantly
by reporting promising clinical data from five trials and launching four
new randomized Phase II trials and four investigator-sponsored trials for
our lead clinical product bavituximab, building for what we expect to be an
exciting fiscal year 2012," said
Clinical Program Update
Bavituximab Clinical Trials
In four ongoing randomized Phase II trials, Peregrine is evaluating bavituximab's broad therapeutic potential in non-small cell lung cancer, pancreatic cancer, and hepatitis C virus (HCV) infections. Bavituximab is a first-in-class monoclonal antibody that targets the highly immunosuppressive molecule phosphatidylserine (PS), enabling the immune system to recognize and fight cancer and viral infections.
-- Phase II front-line NSCLC trial evaluating bavituximab with carboplatin
and paclitaxel versus carboplatin and paclitaxel. Enrollment of up to
86 patients is expected to be completed over the next few weeks with
interim data expected by the end of this year. Last month, Peregrine
reported promising 12.4 months median overall survival (OS) from a
prior single-arm Phase II trial using this same therapeutic regimen in
49 front-line NSCLC patients. The OS was consistent with encouraging
earlier data, including 43% objective response rate (ORR) and 6.1
months median progression-free survival (PFS). These data exceed the
10.3 month OS, 15% ORR, and 4.5 months PFS reported from a separate
historic control trial evaluating carboplatin and paclitaxel alone in a
similar patient population.
-- Phase II second-line non-small cell lung cancer (NSCLC) trial
evaluating bavituximab with docetaxel versus docetaxel plus placebo.
Peregrine has modified patient enrollment criteria and has 37 sites
open in the U.S. and internationally and expects to complete enrollment
of up to 120 patients early in the fourth quarter of this year. The
primary endpoint for this study is overall response rate and these data
are expected to be unblinded in the first half of 2012. Secondary
endpoints include median OS and median PFS.
-- Phase II pancreatic cancer trial evaluating bavituximab with
gemcitabine versus gemcitabine is currently enrolling up to 70 patients
with previously untreated stage IV pancreatic cancer.
-- Phase II trial in patients with previously untreated genotype-1
hepatitis C virus (HCV) infection, Peregrine is measuring the early
virologic response (EVR) rate after 12 weeks of therapy with
bavituximab in combination with ribavirin versus standard of care,
pegylated interferon alpha 2a and ribavirin.
To further evaluate bavituximab's broad potential in additional oncology indications and therapeutic combinations, Peregrine's investigator-sponsored trials (IST) program has four currently enrolling clinical trials.
-- Phase I/II trial evaluating bavituximab combined with sorafenib in
approximately 50 patients with advanced liver cancer. This IST is
being conducted at University of Texas Southwestern Medical Center .
-- Phase I/II trial evaluating bavituximab combined with cabazitaxel in 31
patients with second-line castration resistant prostate cancer (CRPC).
This IST is being conducted at the University of California, Irvine .
-- Phase Ib trial evaluating bavituximab combined with pemetrexed and
carboplatin in up to 25 front-line NSCLC patients. This IST is being
conducted at the University of North Carolina at Chapel Hill .
-- Phase I trial evaluating bavituximab combined with paclitaxel in
patients with HER2-negative metastatic breast cancer. This IST is
being conducted at the Arizona Cancer Center at UMC North.
Cotara® Phase II Brain Cancer Program
At the Annual Meeting of the
For more information on Peregrine's clinical trials, please visit http://www.peregrinetrials.com.
At a keynote address at the
At the Annual meeting of the
Financial Results
Total revenues for the fourth quarter of FY 2011 were
Contract manufacturing revenues from Avid's clinical and commercial
biomanufacturing services provided to its third-party clients were
Total costs and expenses in the fourth quarter of FY 2011 were
Peregrine's consolidated net loss was
Peregrine reported
More detailed financial information and analysis may be found in
Peregrine's Annual Report on Form 10-K, which was filed with the
Conference Call
Peregrine will host a conference call and webcast today,
-- To listen to the live webcast or access the archived webcast available
for 30 days, please visit: http://ir.peregrineinc.com/events.cfm.
-- 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 July 28, 2011 by calling
(800) 642-1687 or (706) 645-9291 and using passcode 79032398.
About
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding
PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended Twelve Months Ended April 30, April 30, 2011 2010 2011 2010 ------------ ----------- ------------ ------------ unaudited unaudited REVENUES: Contract manufacturing revenue $ 1,970,000 $ 2,881,000 $ 8,502,000 $ 13,204,000 Government contract revenue 681,000 1,461,000 4,640,000 14,496,000 License revenue 78,000 78,000 350,000 243,000 ------------ ----------- ------------ ------------ Total revenues 2,729,000 4,420,000 13,492,000 27,943,000 COSTS AND EXPENSES: Cost of contract manufacturing 1,411,000 2,229,000 7,296,000 8,716,000 Research and development 7,998,000 7,130,000 29,462,000 24,658,000 Selling, general and administrative 3,274,000 2,630,000 11,421,000 8,182,000 ------------ ----------- ------------ ------------ Total costs and expenses 12,683,000 11,989,000 48,179,000 41,556,000 ------------ ----------- ------------ ------------ LOSS FROM OPERATIONS (9,954,000) (7,569,000) (34,687,000) (13,613,000) ------------ ----------- ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 18,000 20,000 1,052,000 116,000 Interest and other expense (78,000) (192,000) (516,000) (997,000) ------------ ----------- ------------ ------------ NET LOSS $(10,014,000) $(7,741,000) $(34,151,000) $(14,494,000) ============ =========== ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 68,293,847 51,863,157 60,886,392 49,065,322 ============ =========== ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.15) $ (0.16) $ (0.56) $ (0.30) ============ =========== ============ ============PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS AS OFAPRIL 30, 2011 AND 2010 2011 2010 ----------- ----------- ASSETS CURRENT ASSETS: Cash and cash equivalents $23,075,000 $19,681,000 Trade and other receivables, net 1,389,000 1,481,000 Government contract receivables 93,000 367,000 Inventories, net 5,284,000 3,123,000 Debt issuance costs, current portion 21,000 122,000 Prepaid expenses and other current assets, net 953,000 2,004,000 ----------- ----------- Total current assets 30,815,000 26,778,000 PROPERTY: Leasehold improvements 932,000 697,000 Laboratory equipment 4,391,000 4,221,000 Furniture, fixtures, office equipment and software 1,814,000 917,000 ----------- ----------- 7,137,000 5,835,000 Less accumulated depreciation and amortization (4,928,000) (4,366,000) ----------- ----------- Property, net 2,209,000 1,469,000 Debt issuance costs, less current portion - 21,000 Other assets 1,742,000 1,067,000 ----------- ----------- TOTAL ASSETS $34,766,000 $29,335,000 =========== ===========PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS AS OFAPRIL 30, 2011 AND 2010 (continued) 2011 2010 ------------ ------------ LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 4,046,000 $ 3,434,000 Accrued clinical trial and related fees 2,292,000 1,308,000 Accrued payroll and related costs 1,455,000 1,623,000 Notes payable, current portion and net of discount 1,321,000 1,893,000 Deferred revenue, current portion 5,617,000 2,406,000 Deferred government contract revenue - 78,000 Customer deposits 1,759,000 2,618,000 Other current liabilities 1,189,000 685,000 ------------ ------------ Total current liabilities 17,679,000 14,045,000 Notes payable, less current portion and net of discount - 1,315,000 Deferred revenue, less current portion 632,000 - Other long-term liabilities 1,037,000 568,000 Commitments and contingencies STOCKHOLDERS' EQUITY: Preferred stock -$.001 par value; authorized 5,000,000 shares; non-voting; none issued - - Common stock -$.001 par value; authorized 325,000,000 shares; outstanding - 69,837,142 and 53,094,896, respectively 70,000 53,000 Additional paid-in-capital 311,353,000 275,208,000 Accumulated deficit (296,005,000) (261,854,000) ------------ ------------ Total stockholders' equity 15,418,000 13,407,000 ------------ ------------ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 34,766,000 $ 29,335,000 ============ ============
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Contact:Amy Figueroa Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com
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