Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2012 Financial Results and Recent Developments
"This quarter we continued to advance our clinical programs toward a number of significant milestones with the potential to build considerable value in our bavituximab clinical programs, our Cotara clinical program and at our contract manufacturing subsidiary Avid Bioservices," said
ONCOLOGY PROGRAM HIGHLIGHTS
Bavituximab Phase II NSCLC Trials
This morning, Peregrine announced top-line overall response rate (ORR) and current median progression free survival (PFS) estimates from its phase II trial comparing bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in patients with front-line Stage IIIb and Stage IV non-small cell lung cancer (NSCLC). Based on these reported data, the next important data points that will allow us to plan the next steps in our clinical development strategy of bavituximab for NSCLC include, but are not limited to median overall survival ("OS") data from the front-line NSCLC study which is expected in the second half of calendar year 2012, data from our second-line NSCLC study which is expected in the first half of calendar year 2012 and data from an ongoing investigator sponsored trial (IST) evaluating bavituximab in combination with pemetrexed and carboplatin in
front-line NSCLC which is expected during calendar year 2012.
Peregrine is also conducting a randomized, placebo-controlled, double-blinded trial in 121 second-line NSCLC patients evaluating bavituximab in combination with docetaxel versus placebo plus docetaxel. The trial is expected to be unblinded in the first half of 2012 to assess the trial's primary endpoint, overall response rates, according to RECIST criteria. Secondary endpoints, including PFS and OS will be reported once these data-driven events are reached.
Bavituximab Phase II Pancreatic Cancer Trial
Patient enrollment is progressing in a randomized Phase II trial in up to 70 advanced pancreatic cancer patients evaluating bavituximab plus gemcitabine versus gemcitabine alone. Patient enrollment is expected to be completed this year and interim data reported during 2012.
Bavituximab Investigator-Sponsored Trials (IST)
Patient enrollment is continuing in four ISTs evaluating bavituximab plus standard therapies in patients with HER-2 negative advanced metastatic breast cancer, advanced NSCLC, advanced liver cancer, and castration resistant advanced prostate cancer. These trials are designed to explore bavituximab's broad potential in additional treatment combinations and oncology indications. Peregrine is scheduled to present initial data from the breast cancer, NSCLC and liver cancer trials at the Annual Meeting of the
Cotara® Clinical Program
Peregrine's single-administration approach to treating recurrent glioblastoma multiforme (GBM) has shown encouraging 9.3 month median overall survival data from a Phase II trial in 41 patients. Discussions between Peregrine and the
ANTIVIRAL PROGRAM HIGHLIGHTS
Bavituximab Phase II HCV Program
In December, Peregrine announced preliminary data from a randomized Phase II trial evaluating bavituximab plus ribavirin versus pegylated interferon alpha-2A, plus ribavirin in patients infected with genotype-1 chronic hepatitis C virus (HCV). Analysis of data from the 12-week trial indicated that the combination of bavituximab and ribavirin appeared safe and well tolerated, with patients reporting fewer side effects than in the interferon-containing arm. The trial also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, with a higher early viral response (EVR) rate in patients receiving the 0.3 mg/kg dosing level. While the EVR rate was greatest in the interferon-containing group by the end of the study, based on the nature of late EVR development in the bavituximab containing arms, a longer-term evaluation is needed to adequately compare
the effectiveness of bavituximab versus interferon. Peregrine is seeking a partner to further advance the program.
CORPORATE
Last week, Peregrine announced that seven posters were accepted for presentation at the AACR Annual Meeting being held
FINANCIAL RESULTS
Total revenues for the third quarter of FY 2012 were
Total costs and expenses in the third quarter of FY 2012 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 will be filed with the
Conference Call
Peregrine will host a conference call and webcast today,
-- To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the
-- To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm
About
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED NINE MONTHS ENDED JANUARY 31, JANUARY 31, 2012 2011 2012 2011 ------------ ------------ ------------ ------------ Unaudited Unaudited Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 3,203,000 $ 1,922,000 $ 12,796,000 $ 6,532,000 Government contract revenue - 882,000 - 3,959,000 License revenue 78,000 79,000 372,000 272,000 ------------ ------------ ------------ ------------ Total revenues 3,281,000 2,883,000 13,168,000 10,763,000 COSTS AND EXPENSES: Cost of contract manufacturing 2,484,000 1,726,000 9,219,000 5,885,000 Research and development 9,180,000 7,053,000 26,758,000 21,464,000 Selling, general and administrative 2,710,000 2,947,000 8,371,000 8,147,000 ------------ ------------ ------------ ------------ Total costs and expenses 14,374,000 11,726,000 44,348,000 35,496,000 ------------ ------------ ------------ ------------ LOSS FROM OPERATIONS (11,093,000) (8,843,000) (31,180,000) (24,733,000) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 9,000 20,000 31,000 1,034,000 Interest and other expense (6,000) (106,000) (88,000) (438,000) ------------ ------------ ------------ ------------ NET LOSS $(11,090,000) $ (8,929,000) $(31,237,000) $(24,137,000) ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 87,149,770 64,374,282 78,443,114 58,497,756 ============ ============ ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.13) $ (0.14) $ (0.40) $ (0.41) ============ ============ ============ ============
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, APRIL 30, 2012 2011 ------------- ------------- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 19,761,000 $ 23,075,000 Trade and other receivables, net 2,078,000 1,389,000 Government contract receivables - 93,000 Inventories, net 2,744,000 5,284,000 Prepaid expenses and other current assets, net 1,238,000 974,000 ------------- ------------- Total current assets 25,821,000 30,815,000 Property, net 2,659,000 2,209,000 Other assets 960,000 1,742,000 ------------- ------------- TOTAL ASSETS $ 29,440,000 $ 34,766,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 3,940,000 $ 4,046,000 Accrued clinical trial and related fees 3,042,000 2,292,000 Accrued payroll and related costs 2,098,000 1,455,000 Notes payable, current portion and net of discount - 1,321,000 Deferred revenue 2,552,000 5,617,000 Customer deposits 2,463,000 1,759,000 Other current liabilities 1,104,000 1,189,000 ------------- ------------- Total current liabilities 15,199,000 17,679,000 Deferred revenue 523,000 632,000 Other long-term liabilities 813,000 1,037,000 Commitments and contingencies STOCKHOLDERS' EQUITY: Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding - - Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 93,146,226 and 69,837,142, respectively 93,000 70,000 Additional paid-in capital 340,054,000 311,353,000 Accumulated deficit (327,242,000) (296,005,000) ------------- ------------- Total stockholders' equity 12,905,000 15,418,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 29,440,000 $ 34,766,000 ============= =============
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Contact:Christopher Keenan orJay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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