Delaware
|
0-17085
|
95-3698422
|
||
(State
of other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
||
14282
Franklin Avenue, Tustin, California 92780
|
||||
(Address
of Principal Executive Offices)
|
||||
Registrant’s
telephone number, including area code: (714)
508-6000
|
||||
Not
Applicable
|
||||
(Former
name or former address, if changed since last
report)
|
ITEM 2.02 | RESULTS OF OPERATIONS AND FINANCIAL CONDITION |
ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
Exhibit
Number
|
|
99.1 | Press Release issued July 14, 2009 |
PEREGRINE
PHARMACEUTICALS, INC.
|
|||
Date:
July 14, 2009
|
By:
|
/s/ Paul J. Lytle | |
Paul J. Lytle | |||
Chief Financial Officer | |||
Exhibit
Number
|
Description | |
99.1 | Press Release issued July 14, 2009 |
Contacts: | |
GendeLLindheim BioCom Partners | |
Investors | Media |
info@peregrineinc.com | Jennifer Anderson |
(800) 987-8256 | (212) 918-4642 |
§
|
Completed
enrollment of the planned 46 patients in a Phase II trial evaluating
bavituximab in combination with docetaxel in advanced breast cancer
patients. As reported in an oral presentation at the 2009 ASCO
Annual Meeting, 10 of 14, or 71% of evaluable patients in the initial
cohort demonstrated an objective tumor response according to RECIST
criteria. These data exceeded the pre-specified endpoint needed
to expand the trial and compare favorably with historical data with
chemotherapy alone. Recent analysis shows the median
progression free survival of patients enrolled in the first part of the
study was 7.4 months, a promising early result. Patient dosing
and follow-up in this trial are
continuing.
|
§
|
Reported
that in a Phase II trial evaluating bavituximab in combination with
carboplatin and paclitaxel in advanced breast cancer patients, nine of 14,
or 64% of evaluable patients in the initial cohort achieved an objective
tumor response according to RECIST criteria. These data
exceeded the pre-specified endpoint needed to expand the
trial. Patient enrollment and dosing are underway in the
expansion stage of the trial, which will enroll a total of 46 advanced
breast cancer patients overall.
|
§
|
Reported
that in a Phase II trial evaluating bavituximab in combination with
carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) patients
with locally advanced or metastatic disease, 11 of 17, or almost 65% of
evaluable patients in the initial cohort, achieved an objective tumor
response according to RECIST criteria. These early results,
which exceeded the pre-specified endpoint needed to expand the trial,
compare very favorably with historical data with chemotherapy alone and
are especially encouraging in this hard-to-treat
cancer. Patient enrollment and dosing are continuing in the
expansion stage of the trial, which will enroll a total of 49 NSCLC
patients overall.
|
§
|
Completed
patient enrollment in a Phase I trial evaluating bavituximab as
monotherapy in patients with advanced refractory cancers. At
the 2009 ASCO Annual Meeting, study researchers reported that bavituximab
had demonstrated a predictable pharmacokinetic profile and acceptable
safety, and that a maximum tolerated dose was not reached, even at the
highest planned dose level.
|
§
|
Announced
that the ASCO Research Foundation awarded one of its 2009 Career
Development Awards to a researcher at the University of Texas Southwestern
Medical Center for a study of the biologic effects of bavituximab and
chemotherapy in patients with advanced lung
cancer.
|
§
|
Presented
data from two studies at the AACR 2009 Annual Meeting providing further
confirmation of the unique immunomodulatory mechanisms contributing to the
anti-tumor activity of Peregrine’s anti-PS antibody
platform.
|
§
|
Received
major validation of the broad anti-viral potential of the company’s
anti-PS antibody platform with the publication of data in Nature Medicine showing
that its PS-targeting drug bavituximab can cure lethal virus infections in
animal disease models.
|
§
|
Entered
into a five-year contract potentially worth up to $44.4 million with the
Department of Defense’s Defense Threat Reduction Agency (DTRA), and ramped
up activities under this contract to assess bavituximab and other anti-PS
antibodies for biodefense applications against viral hemorrhagic
fevers.
|
§
|
Continued
to enroll and dose patients in an ongoing Phase I clinical trial of
bavituximab in hepatitis C virus infected patients co-infected with
HIV.
|
§
|
Was
awarded a U.S. patent that includes broad claims covering anti-viral
applications of antibodies that directly bind to aminophospholipids,
including PS.
|
§
|
Reported
that the company's anti-PS technology was positively highlighted in
scientific sessions at the AIDS Vaccine 2008 conference in Cape Town,
South Africa.
|
§
|
Reported
that patient enrollment in the Cotara dosing and dosimetry trial at U.S.
brain cancer centers was nearing completion, and that patients in the
initial two cohorts of the study have all either met or exceeded the
expected median survival time of six months for recurrent glioblastoma
multiforme (GBM) patients.
|
§
|
Presented
data at the Society of Nuclear Medicine 2009 Annual Meeting showing that
Cotara specifically localizes to brain tumors at high concentrations with
minimal radiation exposure to other organs. This data confirms
a key safety attribute of Cotara—its ability to precisely target
tumors. Data showed that the concentration of Cotara in brain
tumors was on average more than 300-fold higher than in normal
organs.
|
§
|
Reported
that patient enrollment has exceeded the halfway mark in the Cotara Phase
II trial in patients with relapsed
GBM.
|
§
|
Avid
management gave scientific presentations at a number of industry meetings,
including the 2009 BIO International Convention, highlighting the
company’s distinctive capabilities and
experience.
|
§
|
Avid
expanded its biomanufacturing capabilities with the installation of two
Thermo Scientific HyClone Single-Use Bioreactors, which further enhance
Avid’s ability to meet the growing demand for its cell culture production
services.
|
§
|
Signed
a manufacturing supply agreement with Catalyst Biosciences to produce
clinical-grade material for their candidate for the treatment of acute
bleeding in hemophilia patients.
|
§
|
Peregrine
settled a lawsuit with Cancer Therapeutics Laboratories
(CTL). Under the terms of the agreement, CTL is transferring
shares in Medibiotech Co., Inc. to Peregrine, giving Peregrine close to a
5% ownership stake in Medibiotech. Medibiotech is a Chinese
company that has the exclusive rights in the People’s Republic of China to
develop and market a version of Peregrine’s radiolabeled tumor necrosis
therapy (TNT) technology for the treatment of cancer. Peregrine
will also make certain cash payments to
CTL.
|
§
|
In
March 2009, Peregrine announced an agreement with Wm Smith & Co. to
raise a target of $7.5 million from its existing shelf registration by
selling new equity in an “At the Market” offering as defined in Rule 415
of the Securities Act. The stock was sold at market prices
between April and early June by Wm Smith & Co. to reach the targeted
$7.5 million in new capital.
|
§
|
Entered
into a loan agreement for up to $10 million to finance ongoing clinical
development efforts. Peregrine received an initial $5 million
tranche and later declined an option for a second $5 million
tranche.
|
§
|
Received
a letter from NASDAQ providing Peregrine with additional time to regain
compliance with NASDAQ's $1.00 minimum bid price
rule. Peregrine now has at least until October 26, 2009 to
regain compliance.
|
§
|
Received
shareholder approval at the Annual Meeting of Stockholders held on October
21, 2008, for a proposal that provides the company's Board of Directors
with discretionary authority to implement a reverse split of the issued
and outstanding shares of Peregrine's common stock before the 2009 Annual
Meeting.
|
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 10,018,000 | $ | 15,130,000 | ||||
Trade
and other receivables
|
1,770,000 | 605,000 | ||||||
Government
contract receivables
|
1,944,000 | - | ||||||
Inventories,
net
|
4,707,000 | 2,900,000 | ||||||
Debt
issuance costs, current portion
|
229,000 | - | ||||||
Prepaid
expenses and other current assets, net
|
1,466,000 | 1,208,000 | ||||||
Total
current assets
|
20,134,000 | 19,843,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
675,000 | 669,000 | ||||||
Laboratory
equipment
|
4,180,000 | 4,140,000 | ||||||
Furniture,
fixtures and computer equipment
|
902,000 | 919,000 | ||||||
5,757,000 | 5,728,000 | |||||||
Less
accumulated depreciation and amortization
|
(4,076,000 | ) | (3,670,000 | ) | ||||
Property,
net
|
1,681,000 | 2,058,000 | ||||||
Debt
issuance costs, less current portion
|
142,000 | - | ||||||
Other
assets
|
1,170,000 | 1,156,000 | ||||||
TOTAL
ASSETS
|
$ | 23,127,000 | $ | 23,057,000 |
2009
|
2008
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 3,518,000 | $ | 2,060,000 | ||||
Accrued
clinical trial site fees
|
955,000 | 237,000 | ||||||
Accrued
legal and accounting fees
|
667,000 | 450,000 | ||||||
Accrued
royalties and license fees
|
182,000 | 222,000 | ||||||
Accrued
payroll and related costs
|
1,580,000 | 1,084,000 | ||||||
Capital
lease obligation, current portion
|
17,000 | 22,000 | ||||||
Notes
payable, current portion and net of discount
|
1,465,000 | - | ||||||
Deferred
revenue
|
3,776,000 | 2,196,000 | ||||||
Deferred
government contract revenue
|
3,871,000 | - | ||||||
Customer
deposits
|
2,287,000 | 838,000 | ||||||
Other
current liabilities
|
546,000 | 331,000 | ||||||
Total
current liabilities
|
18,864,000 | 7,440,000 | ||||||
Capital
lease obligation, less current portion
|
4,000 | 22,000 | ||||||
Notes
payable, less current portion and net of discount
|
3,208,000 | - | ||||||
Other
long-term liabilities
|
150,000 | - | ||||||
Commitments
and contingencies
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock - $.001 par value; authorized 5,000,000 shares; non-voting; nil
shares outstanding
|
- | - | ||||||
Common
stock - $.001 par value; authorized 325,000,000 shares; outstanding -
227,688,555 and 226,210,617, respectively
|
227,000 | 226,000 | ||||||
Additional
paid-in-capital
|
248,034,000 | 246,205,000 | ||||||
Accumulated
deficit
|
(247,360,000 | ) | (230,836,000 | ) | ||||
Total
stockholders' equity
|
901,000 | 15,595,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 23,127,000 | $ | 23,057,000 |
2009
|
2008
|
2007
|
||||||||||
REVENUES:
|
||||||||||||
Contract
manufacturing revenue
|
$ | 12,963,000 | $ | 5,897,000 | $ | 3,492,000 | ||||||
Government
contract revenue
|
5,013,000 | - | - | |||||||||
License
revenue
|
175,000 | 196,000 | 216,000 | |||||||||
Total
revenues
|
18,151,000 | 6,093,000 | 3,708,000 | |||||||||
COSTS
AND EXPENSES:
|
||||||||||||
Cost
of contract manufacturing
|
9,064,000 | 4,804,000 | 3,296,000 | |||||||||
Research
and development
|
18,424,000 | 18,279,000 | 15,876,000 | |||||||||
Selling,
general and administrative
|
6,979,000 | 7,150,000 | 6,446,000 | |||||||||
Total
costs and expenses
|
34,467,000 | 30,233,000 | 25,618,000 | |||||||||
LOSS
FROM OPERATIONS
|
(16,316,000 | ) | (24,140,000 | ) | (21,910,000 | ) | ||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||
Interest
and other income
|
200,000 | 989,000 | 1,160,000 | |||||||||
Interest
and other expense
|
(408,000 | ) | (25,000 | ) | (46,000 | ) | ||||||
NET
LOSS
|
$ | (16,524,000 | ) | $ | (23,176,000 | ) | $ | (20,796,000 | ) | |||
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
226,231,464 | 221,148,342 | 192,297,309 | |||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.07 | ) | $ | (0.10 | ) | $ | (0.11 | ) |