Peregrine Pharmaceuticals Reports First Quarter Fiscal Year 2012 Financial Results and Recent Developments
"Over the last quarter we have reported promising median overall survival from two prior Phase II oncology trials and completed patient enrollment in the first of our four ongoing randomized Phase II trials for bavituximab. While we build toward multiple data reports over the coming year, we are encouraged by the consistency of each positive data point from our earlier Phase II clinical studies, reinforcing our optimism in bavituximab's potential in multiple oncology settings and for Cotara in GBM to make a real difference in the lives of our patients. We look forward to additional data points ahead as we continue to advance these two programs," 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 second-line non-small cell lung cancer (NSCLC) trial evaluating bavituximab plus docetaxel versus docetaxel plus placebo. Peregrine 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 overall survival (OS) and median progression-free survival (PFS).
- Phase II front-line NSCLC trial evaluating bavituximab with carboplatin and paclitaxel versus carboplatin and paclitaxel. Peregrine has completed enrollment of up to 86 patients and expects to report interim data by the end of this year.
- Phase II pancreatic cancer trial evaluating bavituximab with gemcitabine versus gemcitabine alone is currently enrolling up to 70 patients with previously untreated stage IV pancreatic cancer.
- Phase II trial in 66 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. Peregrine expects to complete patient enrollment by the end of the third quarter and report primary endpoint, EVR, data in late 2011 or early 2012.
Peregrine recently reported encouraging 20.7 month median overall survival (OS) from a prior single-arm Phase II trial evaluating bavituximab in combination with docetaxel in patients with locally advanced or metastatic breast cancer. In a separate published study included in the docetaxel package insert, median OS was 11.4 months for metastatic breast cancer patients treated with docetaxel alone.
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
Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion treatment directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue. Peregrine plans to meet with the
For more information on Peregrine's clinical trials, please visit http://www.peregrinetrials.com.
Financial Results
Total revenues for the first quarter of FY 2012 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 first 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 live webcast or access the archived webcast, 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 throughSeptember 23, 2011 by calling (855) 859-2056 or (404) 537-3406 and using passcode 93521214.
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 ---------------------------- July 31, 2011 July 31, 2010 ------------- ------------- Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 5,439,000 $ 983,000 Government contract revenue - 2,111,000 License revenue 216,000 115,000 ------------- ------------- Total revenues 5,655,000 3,209,000 COSTS AND EXPENSES: Cost of contract manufacturing 3,017,000 1,156,000 Research and development 7,760,000 7,067,000 Selling, general and administrative 2,929,000 2,498,000 ------------- ------------- Total costs and expenses 13,706,000 10,721,000 ------------- ------------- LOSS FROM OPERATIONS (8,051,000) (7,512,000) ------------- ------------- OTHER INCOME (EXPENSE): Interest and other income 13,000 18,000 Interest and other expense (54,000) (201,000) ------------- ------------- NET LOSS $ (8,092,000) $ (7,695,000) ============= ============= WEIGHTED AVERAGE COMMON SHARES OUTSTANDING Basic and diluted 70,656,568 54,357,574 ============= ============= BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.11) $ (0.14) ============= =============PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS --------------------------------------------------------------------------- JULY 31, APRIL 30, 2011 2011 ------------- ------------- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 16,540,000 $ 23,075,000 Trade and other receivables, net 1,087,000 1,389,000 Government contract receivables - 93,000 Inventories, net 4,481,000 5,284,000 Prepaid expenses and other current assets, net 853,000 974,000 ------------- ------------- Total current assets 22,961,000 30,815,000 Property, net 2,441,000 2,209,000 Other assets 1,613,000 1,742,000 ------------- ------------- TOTAL ASSETS $ 27,015,000 $ 34,766,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 2,959,000 $ 4,046,000 Accrued clinical trial and related fees 2,786,000 2,292,000 Accrued payroll and related costs 1,532,000 1,455,000 Notes payable, current portion and net of discount 829,000 1,321,000 Deferred revenue 4,145,000 5,617,000 Customer deposits 289,000 1,759,000 Other current liabilities 1,253,000 1,189,000 ------------- ------------- Total current liabilities 13,793,000 17,679,000 Deferred revenue 554,000 632,000 Other long-term liabilities 871,000 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 - 71,749,718 and 69,837,142, respectively 72,000 70,000 Additional paid-in capital 315,822,000 311,353,000 Accumulated deficit (304,097,000) (296,005,000) ------------- ------------- Total stockholders' equity 11,797,000 15,418,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 27,015,000 $ 34,766,000 ============= =============
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Contact:Amy Figueroa orJay Carlson Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com
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