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)
|
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))
|
ITEM
2.02
|
RESULTS
OF OPERATIONS AND FINANCIAL
CONDITION
|
ITEM
7.01
|
REGULATION
FD DISCLOSURE
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS
|
(d)
|
Exhibits.
The following material is filed as an exhibit to this Current Report on
Form 8-K:
|
99.1
|
Press
Release issued December 10, 2009
|
PEREGRINE PHARMACEUTICALS, INC. | |||
Date:
December 10, 2009
|
By:
|
/s/ Paul J. Lytle | |
Paul
J. Lytle
|
|||
Chief
Financial Officer
|
Exhibit
Number
|
Description
|
99.1
|
Press
Release issued December 10,
2009
|
Contacts: | |
GendeLLindheim BioCom Partners | |
Investors | Media |
info@peregrineinc.com | Barbara Lindheim |
(800) 987-8256 | (212) 918-4650 |
§
|
Reported
61% objective response rate in 46-patient Phase II trial evaluating
bavituximab in combination with docetaxel in advanced breast cancer
patients, exceeding the 41% tumor response data for docetaxel as
monotherapy that was used as the benchmark for the design of this
study. With these positive initial data in hand, Peregrine
reported that it is assessing possible trial designs for future
studies.
|
§
|
Reported
that enrollment was completed in a 49-patient 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. Analysis from the initial 21-patient cohort in this
trial showed that the median progression-free-survival (PFS) was 6.5
months, which is superior to the PFS range of 4.2 to 4.5 months reported
in a similar patient population receiving carboplatin and paclitaxel as a
single agent in the NSCLC trials that were the basis for the design of
this trial.
|
§
|
Completed
enrollment of the planned 46 patients in a Phase II trial evaluating
bavituximab in combination with carboplatin and paclitaxel in advanced
breast cancer patients. Peregrine previously reported that nine
of 14, or 64% of evaluable patients in the initial cohort of this trial
achieved 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 results with
chemotherapy alone. Patient dosing and follow-up in this trial
are continuing.
|
§
|
Announced
issuance of a new U.S. patent with claims covering the use of bavituximab
in combination with a broad range of cancer therapeutic agents. The
combinations of bavituximab with docetaxel or carboplatin and paclitaxel,
which have shown promising initial results in Peregrine’s Phase II trials,
are all covered under the claims of this patent. The additional protection
it provides further strengthens Peregrine’s intellectual property
leadership in the field of phosphatidylserine (PS)-targeting
therapeutics
|
§
|
Published
a new study in Clinical
Cancer Research showing the therapeutic promise of bavituximab with
radiation in a lethal brain cancer model. A PS-targeting
antibody similar to bavituximab demonstrated potent anti-tumor activity
when combined with radiation in a model of aggressive brain cancer,
doubling the survival time of test animals and producing long-term cures.
The study also provided additional evidence that PS-targeting antibodies
employ multiple novel mechanisms to mobilize the immune system to combat
cancer and that these mechanisms are enhanced by concurrent radiation
therapy.
|
§
|
Announced
that noted cancer researcher Bruce Chabner, M.D., will serve as a clinical
advisor on the design of clinical trials for the bavituximab and Cotara
cancer programs. Dr. Chabner is currently the clinical director
of Massachusetts General Hospital (MGH) Cancer Center, chief of hematology
and oncology at MGH and a professor of medicine at Harvard Medical
School. Previously, Dr. Chabner had a distinguished 25-year
career at the National Cancer
Institute.
|
§
|
Presented
promising interim data at the 2009 Chemical and Biological Defense Science
and Technology Conference from Peregrine's program to assess the company's
PS-targeting antibodies as broad-spectrum agents for the treatment of
viral hemorrhagic fevers (VHF), a potential biodefense threat. Researchers
confirmed broad spectrum PS-targeting antibody binding to VHF viral
particles and also to mammalian cells infected with hemorrhagic fever
viruses. Initial anti-viral efficacy studies were encouraging,
showing that a single dose of a PS-targeting antibody increased the
survival of hamsters infected with lethal doses of viruses from two
different VHF families. Based on these findings, additional efficacy
studies are now underway.
|
§
|
Formed
anti-viral research group to oversee the company’s anti-PS infectious
disease collaborations. The new group has responsibility for coordinating,
expanding and leveraging the company's multiple external collaborations to
assess the potential utility of Peregrine's PS-targeting antibody platform
for the prevention and treatment of serious infectious diseases, including
viral hemorrhagic fevers and other biodefense threats, HIV, influenza,
cytomegalovirus, leishmaniasis and malaria. Peregrine's
broad-spectrum PS-targeting antibodies are being assessed in
anti-infective applications by more than a dozen leading research
institutions.
|
§
|
Was
awarded a second broad U.S. patent for anti-viral applications of
Peregrine’s phospholipid-targeting antibodies that includes broad claims
covering anti-viral uses of PS-targeting antibodies including bavituximab.
The new patent covers compositions and methods of treating virus
infections using bavituximab and similar antibodies, either alone or as
immunoconjugates attached to anti-viral agents, as well as in combination
with other anti-viral agents. The broad claims include methods for
treating all viruses in humans and
animals.
|
§
|
Announced
that research colleagues at the University of Texas Southwestern Medical
Center received a two-year $763,000 grant from the U.S. National Institute
of Allergy and Infectious Diseases (NIAID) for research expanding studies
of anti-PS antibodies as potential treatments for viral hemorrhagic fever
infections.
|
§
|
Completed
patient enrollment in the Cotara dose confirmation and dosimetry trial at
U.S. brain cancer centers, meeting all of the dosimetry data-gathering
objectives of the study. Patients in the initial two cohorts of
this study have all either met or exceeded the expected median survival
time of six months for recurrent glioblastoma multiforme (GBM) patients.
Peregrine also reported that the ongoing Phase II Cotara brain cancer
trial would be expanded to clinical sites that had participated in the
dosimetry trial.
|
§
|
Presented
interim Phase II data at the XIV World Congress of Neurological Surgery
Annual Meeting showing that Cotara appeared well tolerated and
demonstrated encouraging signs of efficacy in patients with
GBM. Researchers presented interim data on 10 recurrent GBM
patients at first relapse. Using the clinical site’s
institutional definitions, the interim median recurrence-free survival of
these patients was 33 weeks and the interim median overall survival was
40.6 weeks. This compares favorably with historical data on
expected survival for patients with GBM, which is approximately 24 weeks
from time of disease recurrence. Based on this data, the study
authors conclude that Cotara appears to be feasible, tolerable and has
encouraging signs of efficacy in recurrent GBM
patients.
|
§
|
Was
selected as U.S. West Coast partner of Boehringer Ingelheim’s Global
Production Alliance Network for Biologic Contract Manufacturing services,
with the two companies entering into a global strategic production
alliance agreement. The Production Alliance Network program combines
access to Boehringer Ingelheim’s high expression manufacturing technology,
Avid's proven competence and flexibility in process development and cGMP
manufacturing for earlier-stage projects, along with preferred access to
Boehringer Ingelheim's large-scale commercial manufacturing
facilities.
|
§
|
Expanded
the Avid executive team to prepare for continued growth, appointing
operations and quality expert Truc Le as chief operating officer and
Christopher Eso as vice president of business
operations.
|
§
|
Appointed
former Genentech senior vice president Dr. Robert Garnick as head of
regulatory affairs. Dr. Garnick oversaw 17 new drug approvals
in his 24 years at Genentech, including approvals for the major cancer
drugs Herceptin®
and Avastin®. He
is expected to play an important strategic and operational role in
designing Peregrine’s clinical and regulatory strategies for its clinical
stage products bavituximab and
Cotara.
|
§
|
Achieved
full compliance with NASDAQ listing requirements after implementation of a
stockholder-approved 1:5 reverse stock
split.
|
OCTOBER
31,
2009
|
APRIL
30,
2009
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 13,599,000 | $ | 10,018,000 | ||||
Trade
and other receivables, net
|
2,487,000 | 1,770,000 | ||||||
Government
contract receivables
|
1,595,000 | 1,944,000 | ||||||
Inventories,
net
|
5,850,000 | 4,707,000 | ||||||
Debt
issuance costs, current portion
|
175,000 | 229,000 | ||||||
Prepaid
expenses and other current assets
|
1,049,000 | 1,466,000 | ||||||
Total current
assets
|
24,755,000 | 20,134,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
|
675,000 | 675,000 | ||||||
Laboratory
equipment
|
4,100,000 | 4,180,000 | ||||||
Furniture,
fixtures and office equipment
|
901,000 | 902,000 | ||||||
5,676,000 | 5,757,000 | |||||||
Less
accumulated depreciation and amortization
|
(4,245,000 | ) | (4,076,000 | ) | ||||
Property, net
|
1,431,000 | 1,681,000 | ||||||
OTHER
ASSETS:
|
||||||||
Debt
issuance costs, less current portion
|
68,000 | 142,000 | ||||||
Other
assets
|
1,275,000 | 1,170,000 | ||||||
Total other
assets
|
1,343,000 | 1,312,000 | ||||||
TOTAL
ASSETS
|
$ | 27,529,000 | $ | 23,127,000 |
OCTOBER
31,
2009
|
APRIL
30,
2009
|
|||||||
Unaudited
|
||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 3,659,000 | $ | 3,518,000 | ||||
Accrued
clinical trial site fees
|
416,000 | 955,000 | ||||||
Accrued
legal and accounting fees
|
284,000 | 667,000 | ||||||
Accrued
royalties and license fees
|
145,000 | 182,000 | ||||||
Accrued
payroll and related costs
|
1,363,000 | 1,580,000 | ||||||
Notes
payable, current portion and net of discount
|
1,846,000 | 1,465,000 | ||||||
Deferred
revenue
|
4,260,000 | 3,776,000 | ||||||
Deferred
government contract revenue
|
3,989,000 | 3,871,000 | ||||||
Customer
deposits
|
790,000 | 2,287,000 | ||||||
Other
current liabilities
|
550,000 | 563,000 | ||||||
Total current
liabilities
|
17,302,000 | 18,864,000 | ||||||
Notes
payable, less current portion and net of discount
|
2,157,000 | 3,208,000 | ||||||
Other
long-term liabilities
|
152,000 | 154,000 | ||||||
Commitments
and contingencies
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock-$0.001 par value; authorized 5,000,000 shares; non-voting;
none
issued
|
- | - | ||||||
Common
stock-$0.001 par value; authorized 325,000,000 shares;
outstanding – 48,869,563 and 45,537,711,
respectively
|
48,000 | 227,000 | ||||||
Additional
paid-in capital
|
260,445,000 | 248,034,000 | ||||||
Accumulated
deficit
|
(252,575,000 | ) | (247,360,000 | ) | ||||
Total stockholders'
equity
|
7,918,000 | 901,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 27,529,000 | $ | 23,127,000 |
Three
Months Ended
October
31,
|
Six
Months Ended
October
31,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Contract
manufacturing revenue
|
$ | 5,308,000 | $ | 983,000 | $ | 7,378,000 | $ | 2,176,000 | ||||||||
Government
contract revenue
|
1,510,000 | 958,000 | 6,181,000 | 1,282,000 | ||||||||||||
License
revenue
|
78,000 | - | 87,000 | - | ||||||||||||
Total
revenues
|
6,896,000 | 1,941,000 | 13,646,000 | 3,458,000 | ||||||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Cost
of contract manufacturing
|
3,540,000 | 663,000 | 4,613,000 | 1,566,000 | ||||||||||||
Research
and development
|
4,132,000 | 4,301,000 | 10,206,000 | 8,369,000 | ||||||||||||
Selling,
general and administrative
|
1,761,000 | 1,527,000 | 3,554,000 | 3,233,000 | ||||||||||||
Total
costs and expenses
|
9,433,000 | 6,491,000 | 18,373,000 | 13,168,000 | ||||||||||||
LOSS
FROM OPERATIONS
|
(2,537,000 | ) | (4,550,000 | ) | (4,727,000 | ) | (9,710,000 | ) | ||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
and other income
|
34,000 | 53,000 | 74,000 | 128,000 | ||||||||||||
Interest
and other expense
|
(284,000 | ) | - | (562,000 | ) | (1,000 | ) | |||||||||
NET
LOSS
|
$ | (2,787,000 | ) | $ | (4,497,000 | ) | $ | (5,215,000 | ) | $ | (9,583,000 | ) | ||||
WEIGHTED
AVERAGE COMMON
SHARES OUTSTANDING:
|
||||||||||||||||
Basic
and Diluted
|
48,147,702 | 45,242,124 | 47,478,247 | 45,242,124 | ||||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.06 | ) | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.21 | ) |