Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2011 Financial Results and Recent Developments
"We are continuing to advance our later-stage clinical programs for
bavituximab and Cotara® by completing clinical studies and initiating new
studies which can provide meaningful clinical data over the coming year,"
said
Clinical Program Update
Bavituximab Oncology Trials
Peregrine is conducting three randomized Phase II trials in non-small cell lung cancer (NSCLC) and pancreatic cancer.
-- Phase IIb second-line NSCLC trial evaluating bavituximab with docetaxel versus docetaxel plus placebo. Enrollment of up to 120 patients is expected to be complete by mid-year 2011 with data unblinded by year-end 2011. -- Phase IIb front-line NSCLC trial evaluating bavituximab with paclitaxel and carboplatin versus paclitaxel and carboplatin. Enrollment of up to 86 patients is expected to be complete by mid-year 2011 with interim data from this open-label trial expected in the second half of 2011. -- Phase II pancreatic cancer trial evaluating bavituximab with gemcitabine versus gemcitabine. This new trial was initiated inJanuary 2011 and seeks to enroll up to 70 patients with previously untreated stage IV pancreatic cancer.
In addition to its company-sponsored trials, Peregrine has launched an investigator-sponsored trials (IST) program to evaluate further bavituximab's broad potential in different oncology indications and therapeutic combinations.
-- Phase I/II trial evaluating bavituximab combined with sorafenib in approximately 50 patients with advanced liver cancer. This IST is being conducted atUniversity of Texas Southwestern Medical Center . -- Phase Ib trial evaluating bavituximab combined with pemetrexed and carboplatin in up to 25 front-line NSCLC patients. This IST is being conducted at theUniversity 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 theArizona Cancer Center at UMC North.
Cotara® Phase II Brain Cancer Trial
In
Bavituximab HCV Trials
In
In addition, Peregrine completed enrollment in a Phase I trial to evaluate
the safety and pharmacokinetics of bavituximab in patients coinfected with
chronic HCV and HIV and expects to report data at the 46th Annual Meeting
of the
For more information on Peregrine's clinical trials, please visit http://www.peregrinetrials.com.
Preclinical data from four studies investigating bavituximab and other
phosphatidylserine (PS)-targeting antibodies have been accepted for poster
presentation at the 102nd Annual Meeting of the
Peregrine has conducted preclinical research to evaluate its PS-targeting
antibodies for viral hemorrhagic fever (VHF) infections under a government
contract. This contract, which will expire on
Intellectual Property
On
Financial Results
Total revenues for the third quarter of FY 2011 were
Total costs and expenses in the third 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 Quarterly Report on Form 10-Q, 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 thePeregrine Pharmaceuticals call. A replay of the call will be available starting approximately two hours after the conclusion of the call throughMarch 25, 2011 by calling (800) 642-1687 or (706) 645-9291 and using passcode 42778420.
About
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS THREE MONTHS ENDED NINE MONTHS ENDED JANUARY 31, JANUARY 31, 2011 2010 2011 2010 ------------ ------------ ------------ ------------ Unaudited Unaudited Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 1,922,000 $ 2,945,000 $ 6,532,000 $ 10,323,000 Government contract revenue 882,000 6,854,000 3,959,000 13,035,000 License revenue 79,000 78,000 272,000 165,000 ------------ ------------ ------------ ------------ Total revenues 2,883,000 9,877,000 10,763,000 23,523,000 COSTS AND EXPENSES: Cost of contract manufacturing 1,726,000 1,874,000 5,885,000 6,487,000 Research and development 7,053,000 7,322,000 21,464,000 17,528,000 Selling, general and administrative 2,947,000 1,998,000 8,147,000 5,552,000 ------------ ------------ ------------ ------------ Total costs and expenses 11,726,000 11,194,000 35,496,000 29,567,000 ------------ ------------ ------------ ------------ LOSS FROM OPERATIONS (8,843,000) (1,317,000) (24,733,000) (6,044,000) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 20,000 22,000 1,034,000 96,000 Interest and other expense (106,000) (243,000) (438,000) (805,000) ------------ ------------ ------------ ------------ NET LOSS $ (8,929,000) $ (1,538,000) $(24,137,000) $ (6,753,000) ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 64,374,282 49,532,869 58,497,756 48,163,121 ============ ============ ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.14) $ (0.03) $ (0.41) $ (0.14) ============ ============ ============ ============PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS JANUARY 31, APRIL 30, 2011 2010 ------------- ------------- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 24,068,000 $ 19,681,000 Trade and other receivables, net 2,075,000 1,481,000 Government contract receivables 381,000 367,000 Inventories, net 3,916,000 3,123,000 Debt issuance costs, current portion 41,000 122,000 Prepaid expenses and other current assets, net 1,318,000 2,004,000 ------------- ------------- Total current assets 31,799,000 26,778,000 PROPERTY: Leasehold improvements 932,000 697,000 Laboratory equipment 4,320,000 4,221,000 Furniture, fixtures, office equipment and software 1,725,000 917,000 ------------- ------------- 6,977,000 5,835,000 Less accumulated depreciation and amortization (4,745,000) (4,366,000) ------------- ------------- Property, net 2,232,000 1,469,000 OTHER ASSETS: Debt issuance costs, less current portion - 21,000 Other assets 1,379,000 1,067,000 ------------- ------------- Total other assets 1,379,000 1,088,000 TOTAL ASSETS $ 35,410,000 $ 29,335,000 ============= =============PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (continued) JANUARY 31, APRIL 30, 2011 2010 ------------- ------------- Unaudited LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 2,712,000 $ 2,259,000 Accrued clinical trial and related fees 2,388,000 2,666,000 Accrued payroll and related costs 1,514,000 1,623,000 Notes payable, current portion and net of discount 1,810,000 1,893,000 Deferred revenue 4,300,000 2,406,000 Deferred government contract revenue 40,000 78,000 Customer deposits 2,651,000 2,618,000 Other current liabilities 1,246,000 860,000 ------------- ------------- Total current liabilities 16,661,000 14,403,000 Notes payable, less current portion and net of discount - 1,315,000 Deferred revenue 710,000 - Other long-term liabilities 281,000 210,000 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 - 66,813,419 and 53,094,896, respectively 67,000 53,000 Additional paid-in capital 303,682,000 275,208,000 Accumulated deficit (285,991,000) (261,854,000) ------------- ------------- Total stockholders' equity 17,758,000 13,407,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 35,410,000 $ 29,335,000 ============= =============
Contact:Amy Figueroa Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com
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