Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2012 Financial Results and Recent Developments
"Since our last quarterly update, we reported transformational data from a robust double-blinded, placebo-controlled Phase II proof-of-principle trial evaluating the potential of bavituximab in treating second-line non-small cell lung cancer patients. The doubling of tumor response rates, a 50% increase in median progression free survival, and trends toward significant improvement in median overall survival strongly support advancing the program toward Phase III development," said
ONCOLOGY PROGRAM HIGHLIGHTS
Bavituximab Lead Indication: Second-Line Non-Small Cell Lung Cancer
In May, Peregrine announced positive top-line results from its randomized, double-blind, placebo-controlled Phase IIb trial evaluating two dose levels of bavituximab plus docetaxel versus docetaxel plus placebo (control arm) in second-line Stage IIIb/IV non-small cell lung cancer (NSCLC). Top-line data in 117 evaluable patients demonstrated a doubling of overall response rates (ORR), the primary endpoint, from 7.9% in the control arm to 15.0% and 17.9% in the 1.0 mg/kg and 3.0 mg/kg bavituximab containing arms, respectively. Progression-free survival (PFS), a secondary endpoint, was also improved in the bavituximab arms as compared to the control arm, with the control arm PFS of 3.0 months and the bavituximab arms of 4.2 and 4.5 months in the 1.0 mg/kg and 3.0 mg/kg bavituximab containing arms, respectively. Another secondary endpoint, median overall survival (OS), has already been
determined in the control arm at less than 6 months, while the median has not been reached in either bavituximab-containing arm. Median OS from this trial is an event-driven secondary endpoint with results anticipated in 2012.
Additional Bavituximab Clinical Studies:
Based on bavituximab's broad therapeutic potential, six additional clinical studies including investigator-sponsored trials (IST) are ongoing evaluating new indications and treatment combinations in patients with various cancers.
Front-Line Non-Small Cell Lung Cancer
There are currently two trials evaluating bavituximab in front-line NSCLC. A randomized Phase II trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 83 evaluable patients with previously untreated Stage IIIb and Stage IV non-small cell lung cancer. The trial completed enrollment in September of 2011 and median OS from this trial is event-driven and anticipated in the fourth quarter of 2012. In addition, an IST Phase Ib trial evaluating bavituximab with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC is ongoing.
Other Bavituximab Indications
In June, Peregrine announced completion of patient enrollment in a randomized Phase II trial in 70 previously untreated Stage IV pancreatic cancer patients evaluating bavituximab plus gemcitabine versus gemcitabine alone. Interim median overall survival data from the trial is event-driven and data may be available by the end of 2012.
Preliminary data presented at the Annual Meeting of the
Preliminary data from a Phase I/II IST investigating bavituximab with sorafenib in nine patients with advanced hepatocellular carcinoma (liver cancer) was presented at AACR demonstrating no dose-limiting toxicities or serious adverse events. The trial is now enrolling patients in the Phase II portion of the trial.
This morning, Peregrine announced the initiation of a Phase I single-arm, open-label dose-escalation IST investigating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma.
A Phase I/II IST in patients with castration-resistant prostate cancer is also ongoing in combination with cabazitaxel.
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 and the
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Recently, Peregrine launched its experimental phosphatidylserine (PS)-targeting molecular imaging candidate, 124I-PGN650, for the imaging of multiple solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety.
CORPORATE
In May, at a symposium hosted by
Last month, Peregrine named
FINANCIAL RESULTS
Total revenues for the fourth quarter of fiscal year (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 fourth 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 Annual Report on Form 10-K, 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
PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended Twelve Months Ended April 30, April 30, 2012 2011 2012 2011 ------------ ------------ ------------ ------------ Unaudited Unaudited REVENUES: Contract manufacturing revenue $ 1,987,000 $ 1,970,000 $ 14,783,000 $ 8,502,000 Government contract revenue - 681,000 - 4,640,000 License revenue 78,000 78,000 450,000 350,000 ------------ ------------ ------------ ------------ Total revenues 2,065,000 2,729,000 15,233,000 13,492,000 COSTS AND EXPENSES: Cost of contract manufacturing 934,000 1,411,000 10,153,000 7,296,000 Research and development 8,930,000 7,998,000 35,688,000 29,462,000 Selling, general and administrative 3,091,000 3,274,000 11,462,000 11,421,000 ------------ ------------ ------------ ------------ Total costs and expenses 12,955,000 12,683,000 57,303,000 48,179,000 ------------ ------------ ------------ ------------ LOSS FROM OPERATIONS (10,890,000) (9,954,000) (42,070,000) (34,687,000) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSE): Interest and other income 10,000 18,000 41,000 1,052,000 Interest and other expense (2,000) (78,000) (90,000) (516,000) ------------ ------------ ------------ ------------ NET LOSS $(10,882,000) $(10,014,000) $(42,119,000) $(34,151,000) ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic and Diluted 99,303,678 68,293,847 83,572,761 60,886,392 ============ ============ ============ ============ BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.10) $ (0.15) $ (0.50) $ (0.56) ============ ============ ============ ============PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS AS OFAPRIL 30, 2012 AND 2011 2012 2011 ------------- ------------- ASSETS CURRENT ASSETS: Cash and cash equivalents $ 18,033,000 $ 23,075,000 Trade and other receivables, net 2,353,000 1,389,000 Government contract receivables - 93,000 Inventories, net 3,611,000 5,284,000 Prepaid expenses and other current assets, net 795,000 974,000 ------------- ------------- Total current assets 24,792,000 30,815,000 PROPERTY: Leasehold improvements 1,383,000 932,000 Laboratory equipment 4,967,000 4,391,000 Furniture, fixtures, office equipment and software 2,287,000 1,814,000 ------------- ------------- 8,637,000 7,137,000 Less accumulated depreciation and amortization (5,737,000) (4,928,000) ------------- ------------- Property, net 2,900,000 2,209,000 Other assets 570,000 1,742,000 ------------- ------------- TOTAL ASSETS $ 28,262,000 $ 34,766,000 ============= =============PEREGRINE PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS AS OFAPRIL 30, 2012 AND 2011 (continued) 2012 2011 ------------- ------------- LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 3,492,000 $ 4,046,000 Accrued clinical trial and related fees 2,111,000 2,292,000 Accrued payroll and related costs 2,468,000 1,455,000 Notes payable, current portion and net of discount - 1,321,000 Deferred revenue, current portion 3,651,000 5,617,000 Customer deposits 4,865,000 1,759,000 Other current liabilities 1,052,000 1,189,000 ------------- ------------- Total current liabilities 17,639,000 17,679,000 Deferred revenue, less current portion 361,000 632,000 Other long-term liabilities 779,000 1,037,000 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 - 101,421,365 and 69,837,142, respectively 101,000 70,000 Additional paid-in-capital 347,506,000 311,353,000 Accumulated deficit (338,124,000) (296,005,000) ------------- ------------- Total stockholders' equity 9,483,000 15,418,000 ------------- ------------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 28,262,000 $ 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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