Delaware
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0-17085
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95-3698422
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(State of other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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14282 Franklin Avenue, Tustin, California 92780
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(Address of Principal Executive Offices)
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Registrant’s telephone number, including area code: (714) 508-6000
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Not Applicable
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(Former name or former address, if changed since last report)
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o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
o | Soliciting material pursuant to Rule 14A-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
PEREGRINE PHARMACEUTICALS, INC.
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Date: July 14, 2011
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By:
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/s/ Paul J. Lytle | |
Paul J. Lytle
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Chief Financial Officer
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Exhibit
Number
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Description | ||
99.1 | Press Release issued July 14, 2011 |
·
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Phase II front-line NSCLC trial evaluating bavituximab with carboplatin and paclitaxel versus carboplatin and paclitaxel. Enrollment of up to 86 patients is expected to be completed over the next few weeks with interim data expected by the end of this year. Last month, Peregrine reported promising 12.4 months median overall survival (OS) from a prior single-arm Phase II trial using this same therapeutic regimen in 49 front-line NSCLC patients. The OS was consistent with encouraging earlier data, including 43% objective response rate (ORR) and 6.1 months median progression-free survival (PFS). These data exceed the 10.3 month OS, 15% ORR, and 4.5 months PFS reported from a separate historic control trial evaluating carboplatin and paclitaxel alone in a similar patient population.
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·
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Phase II second-line non-small cell lung cancer (NSCLC) trial evaluating bavituximab with docetaxel versus docetaxel plus placebo. Peregrine has modified patient enrollment criteria and has 37 sites open in the U.S. and internationally and 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 OS and median PFS.
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·
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Phase II pancreatic cancer trial evaluating bavituximab with gemcitabine versus gemcitabine is currently enrolling up to 70 patients with previously untreated stage IV pancreatic cancer.
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Phase II trial in 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.
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·
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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.
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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.
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·
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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.
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·
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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.
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To listen to the live webcast or access the archived webcast available for 30 days, please visit: http://ir.peregrineinc.com/events.cfm.
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·
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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 through July 28, 2011 by calling (800) 642-1687 or (706) 645-9291 and using passcode 79032398.
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Three Months Ended
April 30,
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Twelve Months Ended
April 30,
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2011
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2010
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2011
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2010
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|||||||||||||
unaudited
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unaudited
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REVENUES:
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||||||||||||||||
Contract manufacturing revenue
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$ | 1,970,000 | $ | 2,881,000 | $ | 8,502,000 | $ | 13,204,000 | ||||||||
Government contract revenue
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681,000 | 1,461,000 | 4,640,000 | 14,496,000 | ||||||||||||
License revenue
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78,000 | 78,000 | 350,000 | 243,000 | ||||||||||||
Total revenues
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2,729,000 | 4,420,000 | 13,492,000 | 27,943,000 | ||||||||||||
COSTS AND EXPENSES:
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Cost of contract manufacturing
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1,411,000 | 2,229,000 | 7,296,000 | 8,716,000 | ||||||||||||
Research and development
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7,998,000 | 7,130,000 | 29,462,000 | 24,658,000 | ||||||||||||
Selling, general and administrative
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3,274,000 | 2,630,000 | 11,421,000 | 8,182,000 | ||||||||||||
Total costs and expenses
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12,683,000 | 11,989,000 | 48,179,000 | 41,556,000 | ||||||||||||
LOSS FROM OPERATIONS
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(9,954,000 | ) | (7,569,000 | ) | (34,687,000 | ) | (13,613,000 | ) | ||||||||
OTHER INCOME (EXPENSE):
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||||||||||||||||
Interest and other income
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18,000 | 20,000 | 1,052,000 | 116,000 | ||||||||||||
Interest and other expense
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(78,000 | ) | (192,000 | ) | (516,000 | ) | (997,000 | ) | ||||||||
NET LOSS
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$ | (10,014,000 | ) | $ | (7,741,000 | ) | $ | (34,151,000 | ) | $ | (14,494,000 | ) | ||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
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||||||||||||||||
Basic and Diluted
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68,293,847 | 51,863,157 | 60,886,392 | 49,065,322 | ||||||||||||
BASIC AND DILUTED LOSS PER COMMON SHARE
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$ | (0.15 | ) | $ | (0.16 | ) | $ | (0.56 | ) | $ | (0.30 | ) |
2011
|
2010
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ASSETS
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CURRENT ASSETS:
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Cash and cash equivalents
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$ | 23,075,000 | $ | 19,681,000 | ||||
Trade and other receivables, net
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1,389,000 | 1,481,000 | ||||||
Government contract receivables
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93,000 | 367,000 | ||||||
Inventories, net
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5,284,000 | 3,123,000 | ||||||
Debt issuance costs, current portion
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21,000 | 122,000 | ||||||
Prepaid expenses and other current assets, net
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953,000 | 2,004,000 | ||||||
Total current assets
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30,815,000 | 26,778,000 | ||||||
PROPERTY:
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Leasehold improvements
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932,000 | 697,000 | ||||||
Laboratory equipment
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4,391,000 | 4,221,000 | ||||||
Furniture, fixtures, office equipment and software
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1,814,000 | 917,000 | ||||||
7,137,000 | 5,835,000 | |||||||
Less accumulated depreciation and amortization
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(4,928,000 | ) | (4,366,000 | ) | ||||
Property, net
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2,209,000 | 1,469,000 | ||||||
Debt issuance costs, less current portion
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- | 21,000 | ||||||
Other assets
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1,742,000 | 1,067,000 | ||||||
TOTAL ASSETS
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$ | 34,766,000 | $ | 29,335,000 |
2011
|
2010
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|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY
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||||||||
CURRENT LIABILITIES:
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Accounts payable
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$ | 4,046,000 | $ | 3,434,000 | ||||
Accrued clinical trial and related fees
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2,292,000 | 1,308,000 | ||||||
Accrued payroll and related costs
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1,455,000 | 1,623,000 | ||||||
Notes payable, current portion and net of discount
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1,321,000 | 1,893,000 | ||||||
Deferred revenue, current portion
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5,617,000 | 2,406,000 | ||||||
Deferred government contract revenue
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- | 78,000 | ||||||
Customer deposits
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1,759,000 | 2,618,000 | ||||||
Other current liabilities
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1,189,000 | 685,000 | ||||||
Total current liabilities
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17,679,000 | 14,045,000 | ||||||
Notes payable, less current portion and net of discount
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- | 1,315,000 | ||||||
Deferred revenue, less current portion
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632,000 | - | ||||||
Other long-term liabilities
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1,037,000 | 568,000 | ||||||
Commitments and contingencies
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STOCKHOLDERS' EQUITY:
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Preferred stock - $.001 par value; authorized 5,000,000 shares; non-voting; none issued
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- | - | ||||||
Common stock - $.001 par value; authorized 325,000,000 shares; outstanding - 69,837,142 and 53,094,896, respectively
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70,000 | 53,000 | ||||||
Additional paid-in-capital
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311,353,000 | 275,208,000 | ||||||
Accumulated deficit
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(296,005,000 | ) | (261,854,000 | ) | ||||
Total stockholders' equity
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15,418,000 | 13,407,000 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
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$ | 34,766,000 | $ | 29,335,000 |