Peregrine Pharmaceuticals Reports Third Quarter Fiscal Year 2013 Financial Results and Recent Developments
"A key development this quarter was reporting updated data from our second-line non-small cell lung cancer trial that showed a meaningful improvement in median overall survival in the high dose bavituximab arm that we believe clearly supports advancing the program into Phase III. We are now actively preparing for a meeting with the
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
- Recently announced updated results from its Phase II randomized, double-blind, placebo-controlled trial of bavituximab in second-line non-small cell lung cancer (NSCLC).
- Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab plus docetaxel arm compared to the control arm and that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
- Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
- Planning for a meeting with the
U.S. Food and Drug Administration (FDA) in the first half of calendar year 2013 with the goal of initiating the Phase III trial by calendar year-end.
Front-Line Pancreatic Cancer:
- Recently announced data from its open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in 70 patients with previously untreated, advanced Stage IV pancreatic cancer.
- Enrollment included patients with poor prognosis including advanced metastatic disease with significant liver involvement and poor performance status associated with rapid disease progression.
- Results showed a more than a doubling of overall response rate (ORR) in the bavituximab-containing arm, a positive safety profile and a modest improvement in median OS.
- Additional data from the trial, including subgroup analysis and safety data, to be presented at an upcoming scientific meeting.
- Encouraging signs of activity from the trial support advancing this program, potentially in combination with new treatment options.
Other Oncology Indications:
The company is exploring the potential of bavituximab through a number of other ongoing company-sponsored and investigator-sponsored trials (IST) including:
- A randomized, open-label, Phase II clinical trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 86 patients with previously untreated Stage IIIb or Stage IV NSCLC. Peregrine expects to report median OS from this trial, an event driven endpoint, in the first half of calendar year 2013.
- A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
- A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
- A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer.
- A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma.
In addition, Peregrine is continually evaluating its IST program based on a number of factors, including changes in the standard of care of patients and trial enrollment. Following a recent review of the ongoing IST studies, a Phase I/II IST evaluating bavituximab combined with cabazitaxel in patients with second-line castration resistant prostate cancer was discontinued due to slow enrollment and the approvals of two new oral drugs for the same indication which are changing the standard of care treatment for these patients. Peregrine will continue to evaluate proposals for ISTs as part of its overall program to assess new indications and combinations based on the broad potential of bavituximab.
COTARA PROGRAM HIGHLIGHTS
During the quarter, Peregrine announced that it reached agreement with the
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental phosphatidylserine (PS)-targeting molecular imaging candidate, 124I-PGN650, in patients with various 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.
FINANCIAL RESULTS
"Avid, our wholly-owned manufacturing subsidiary, continues to demonstrate its importance as a non-dilutive source of capital for the company under our hybrid business model," said
Total revenues for the third quarter of FY 2013 were
Total costs and expenses decreased
Peregrine's consolidated net loss decreased 56% to
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 this afternoon,
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.
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Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended Nine Months Ended
January 31, January 31,
2013 2012 2013 2012
------------ ------------ ------------ ------------
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract
manufacturing
revenue $ 6,961,000 $ 3,203,000 $ 17,157,000 $ 12,796,000
License revenue 78,000 78,000 272,000 372,000
------------ ------------ ------------ ------------
Total revenues 7,039,000 3,281,000 17,429,000 13,168,000
COSTS AND EXPENSES:
Cost of contract
manufacturing 3,651,000 2,484,000 9,378,000 9,219,000
Research and
development 5,437,000 9,180,000 18,471,000 26,758,000
Selling, general and
administrative 3,112,000 2,710,000 9,469,000 8,371,000
------------ ------------ ------------ ------------
Total costs and
expenses 12,200,000 14,374,000 37,318,000 44,348,000
------------ ------------ ------------ ------------
LOSS FROM OPERATIONS (5,161,000) (11,093,000) (19,889,000) (31,180,000)
------------ ------------ ------------ ------------
OTHER INCOME
(EXPENSE):
Interest and other
income 255,000 9,000 307,000 31,000
Interest and other
expense (8,000) (6,000) (53,000) (88,000)
Loss on early
extinguishment of
debt - - (1,696,000) -
------------ ------------ ------------ ------------
NET LOSS $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)
============ ============ ============ ============
WEIGHTED AVERAGE
COMMON SHARES
OUTSTANDING:
Basic and Diluted 131,489,994 87,149,770 114,726,569 78,443,114
============ ============ ============ ============
BASIC AND DILUTED
LOSS PER COMMON
SHARE $ (0.04) $ (0.13) $ (0.19) $ (0.40)
============ ============ ============ ============
COMPREHENSIVE LOSS $ (4,914,000) $(11,090,000) $(21,331,000) $(31,237,000)
============ ============ ============ ============
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, APRIL 30,
2013 2012
------------- -------------
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 26,255,000 $ 18,033,000
Trade and other receivables, net 1,983,000 2,353,000
Inventories, net 4,635,000 3,611,000
Prepaid expenses and other current assets,
net 878,000 795,000
------------- -------------
Total current assets 33,751,000 24,792,000
Property, net 2,783,000 2,900,000
Other assets 623,000 570,000
------------- -------------
TOTAL ASSETS $ 37,157,000 $ 28,262,000
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 1,620,000 $ 3,492,000
Accrued clinical trial and related fees 1,478,000 2,111,000
Accrued payroll and related costs 2,949,000 2,468,000
Deferred revenue 5,061,000 3,651,000
Customer deposits 6,729,000 4,865,000
Other current liabilities 930,000 1,052,000
------------- -------------
Total current liabilities 18,767,000 17,639,000
Deferred revenue 292,000 361,000
Other long-term liabilities 699,000 779,000
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 - 133,770,614
and 101,421,365, respectively 134,000 101,000
Additional paid-in capital 376,720,000 347,506,000
Accumulated deficit (359,455,000) (338,124,000)
------------- -------------
Total stockholders' equity 17,399,000 9,483,000
------------- -------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 37,157,000 $ 28,262,000
============= =============
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Contact:Christopher Keenan orJay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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