Peregrine Pharmaceuticals Reports Second Quarter 2012 Financial Results and Recent Developments
"The last quarter was truly remarkable for our clinical pipeline. During the quarter we completed patient enrollment in three randomized Phase II bavituximab trials setting the stage for numerous clinical data points from those trials, with most expected in the first half of next year. We have already seen the first promising data from these trials, a 50% improvement in overall response rates based on a preliminary analysis of data for front-line non-small cell lung cancer patients treated with bavituximab with chemotherapy versus chemotherapy alone," said
ONCOLOGY PROGRAM HIGHLIGHTS
Bavituximab Phase II NSCLC Trials
Peregrine has completed patient enrollment in two randomized Phase II clinical trials in non-small cell lung cancer (NSCLC). Preliminary results from the 86-patient front-line NSCLC trial show a 50% improvement in overall tumor response rates (ORR). Patients treated with bavituximab plus carboplatin and paclitaxel currently demonstrate an ORR of 39%, versus 26% in patients treated with carboplatin and paclitaxel alone. Peregrine expects to report the trial's secondary endpoints, median progression-free survival (PFS) and overall survival (OS), once these data are reached during 2012.
The second trial is a randomized, placebo-controlled, double-blinded trial in 121 second-line NSCLC patients evaluating bavituximab in combination with docetaxel versus placebo plus docetaxel. The study 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.
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. Patient enrollment is expected to be complete with interim data reported during 2012.
Bavituximab Phase II Breast Cancer Data
Peregrine recently reported median OS data of 23.2 months from a single-arm Phase II trial evaluating bavituximab plus carboplatin and paclitaxel in 46 patients. Previously Peregrine reported ORR of 74% and median PFS of 6.9 months. All three data points compare favorably to a separate published study (Loesch, D. et al, 2002,
Bavituximab Investigator-Sponsored Trials (IST)
Patient enrollment is progressing 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.
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. Peregrine has requested a meeting with the
ANTIVIRAL PROGRAM HIGHLIGHTS
Bavituximab Phase II HCV Program
In
PRECLINICAL DEVELOPMENT HIGHLIGHTS
Tumor Imaging
In
In
Infectious Disease
In
Intellectual Property
During the second quarter of FY 2012, Peregrine's phospholipid-targeting patent portfolio was further strengthened by antiviral patents granted in several countries, including
FINANCIAL RESULTS
Total revenues for the second quarter of FY 2012 were
Total costs and expenses in the second quarter of FY 2012 were
Peregrine's consolidated net loss was
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
Peregrine Pharmaceuticals call. A replay of the call will be available starting approximately two hours after the conclusion of the call throughDecember 26, 2011 by calling (855) 859-2056, or (404) 537-3406 and using passcode 28585204. - 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
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS THREE MONTHS ENDED SIX MONTHS ENDED OCTOBER 31, OCTOBER 31, 2011 2010 2011 2010 ------------ ------------ ------------ ------------ Unaudited Unaudited Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 4,154,000 $ 3,627,000 $ 9,593,000 $ 4,610,000 Government contract revenue - 966,000 - 3,077,000 License revenue 78,000 78,000 294,000 193,000 ------------ ------------ ------------ ------------ Total revenues 4,232,000 4,671,000 9,887,000 7,880,000 COSTS AND EXPENSES: Cost of contract manufacturing 3,718,000 3,003,000 6,735,000 4,159,000 Research and development 9,818,000 7,344,000 17,578,000 14,411,000 Selling, general and administrative 2,732,000 2,702,000 5,661,000 5,200,000 ------------ ------------ ------------ ------------ Total costs and expenses 16,268,000 13,049,000 29,974,000 23,770,000 ------------ ------------ ------------ ------------ LOSS FROM OPERATIONS (12,036,000) (8,378,000) (20,087,000) (15,890,000) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 9,000 996,000 22,000 1,014,000 Interest and other expense (28,000) (131,000) (82,000) (332,000) ------------ ------------ ------------ ------------ NET LOSS $(12,055,000) $ (7,513,000) $(20,147,000) $(15,208,000) ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 77,523,005 56,761,412 74,089,786 55,559,493 ============ ============ ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.16) $ (0.13) $ (0.27) $ (0.27) ============ ============ ============ ============PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS OCTOBER 31, APRIL 30, 2011 2011 ------------- ------------- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 18,055,000 $ 23,075,000 Trade and other receivables, net 1,191,000 1,389,000 Government contract receivables - 93,000 Inventories, net 3,178,000 5,284,000 Prepaid expenses and other current assets, net 1,125,000 974,000 ------------- ------------- Total current assets 23,549,000 30,815,000 Property, net 2,540,000 2,209,000 Other assets 1,187,000 1,742,000 ------------- ------------- TOTAL ASSETS $ 27,276,000 $ 34,766,000 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 4,425,000 $ 4,046,000 Accrued clinical trial and related fees 2,222,000 2,292,000 Accrued payroll and related costs 1,523,000 1,455,000 Notes payable, current portion and net of discount 333,000 1,321,000 Deferred revenue 2,012,000 5,617,000 Customer deposits 1,703,000 1,759,000 Other current liabilities 1,117,000 1,189,000 ------------- ------------- Total current liabilities 13,335,000 17,679,000 Deferred revenue 601,000 632,000 Other long-term liabilities 844,000 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 - 82,638,201 and 69,837,142, respectively 82,000 70,000 Additional paid-in capital 328,566,000 311,353,000 Accumulated deficit (316,152,000) (296,005,000) ------------- ------------- Total stockholders' equity 12,496,000 15,418,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 27,276,000 $ 34,766,000 ============= =============
Add to Digg Bookmark with del.icio.us Add to Newsvine
Contact:Amy Figueroa orJay Carlson Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com
Source:
News Provided by Acquire Media