x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
Delaware
|
95-3698422
|
(State
or other jurisdiction
of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
14282
Franklin Avenue, Tustin,
California
|
92780-7017
|
(Address
of principal executive
offices)
|
(Zip
Code)
|
Large
Accelerated Filer o
|
Accelerated
Filer ý
|
Non-
Accelerated Filer o
|
Class
|
Shares
Outstanding at September 7, 2007
|
|
Common
Stock, $0.001 par value per share
|
226,210,617
shares
|
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Consolidated
Financial Statements (unaudited):
|
||
Condensed
Consolidated Balance Sheets
|
1
|
||
Condensed
Consolidated Statements of Operations
|
3
|
||
Condensed
Consolidated Statements of Cash Flows
|
4
|
||
Notes
to Condensed Consolidated Financial Statements
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
|
Company
Overview
|
14
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
22
|
|
Item
4.
|
Controls
and Procedures
|
22
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
22
|
|
Item
1A.
|
Risk
Factors
|
23
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
35
|
|
Item
3.
|
Defaults
upon Senior Securities
|
35
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
35
|
|
Item
5.
|
Other
Information
|
35
|
|
Item
6.
|
Exhibits
|
35
|
|
SIGNATURES
|
36
|
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
JULY
31,
2007
|
APRIL
30,
2007
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
30,635,000
|
$
|
16,044,000
|
|||
Trade
and other receivables
|
1,514,000
|
750,000
|
|||||
Inventories,
net
|
2,363,000
|
1,916,000
|
|||||
Prepaid
expenses and other current assets
|
1,172,000
|
1,188,000
|
|||||
Total
current assets
|
35,684,000
|
19,898,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
655,000
|
646,000
|
|||||
Laboratory
equipment
|
3,587,000
|
3,533,000
|
|||||
Furniture,
fixtures and office equipment
|
886,000
|
873,000
|
|||||
5,128,000
|
5,052,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,332,000
|
)
|
(3,212,000
|
)
|
|||
Property,
net
|
1,796,000
|
1,840,000
|
|||||
Other
assets
|
1,188,000
|
1,259,000
|
|||||
TOTAL
ASSETS
|
$
|
38,668,000
|
$
|
22,997,000
|
CONDENSED CONSOLIDATED BALANCE SHEETS (continued) | |||||||
JULY
31,
2007
|
APRIL
30,
2007
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,366,000
|
$
|
1,683,000
|
|||
Accrued
clinical trial site fees
|
113,000
|
228,000
|
|||||
Accrued
legal and accounting fees
|
281,000
|
392,000
|
|||||
Accrued
royalties and license fees
|
107,000
|
337,000
|
|||||
Accrued
payroll and related costs
|
664,000
|
874,000
|
|||||
Notes
payable, current portion
|
317,000
|
379,000
|
|||||
Capital
lease obligation, current portion
|
17,000
|
17,000
|
|||||
Deferred
revenue
|
1,820,000
|
1,060,000
|
|||||
Other
current liabilities
|
427,000
|
885,000
|
|||||
Total
current liabilities
|
5,112,000
|
5,855,000
|
|||||
Notes
payable, less current portion
|
69,000
|
119,000
|
|||||
Capital
lease obligation, less current portion
|
26,000
|
30,000
|
|||||
Deferred
license revenue
|
-
|
4,000
|
|||||
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 250,000,000 shares; outstanding
-
226,210,617 and 196,112,201, respectively
|
226,000
|
196,000
|
|||||
Additional
paid-in capital
|
245,551,000
|
224,453,000
|
|||||
Accumulated
deficit
|
(212,316,000
|
)
|
(207,660,000
|
)
|
|||
Total
stockholders' equity
|
33,461,000
|
16,989,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
38,668,000
|
$
|
22,997,000
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
THREE
MONTHS ENDED
|
|||||||
July
31, 2007
|
July
31, 2006
|
||||||
Unaudited
|
Unaudited
|
||||||
REVENUES:
|
|||||||
Contract
manufacturing revenue
|
$
|
1,621,000
|
$
|
398,000
|
|||
License
revenue
|
4,000
|
23,000
|
|||||
Total
revenues
|
1,625,000
|
421,000
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of contract manufacturing
|
1,181,000
|
530,000
|
|||||
Research
and development
|
3,624,000
|
4,041,000
|
|||||
Selling,
general and administrative
|
1,708,000
|
1,641,000
|
|||||
Total
costs and expenses
|
6,513,000
|
6,212,000
|
|||||
LOSS
FROM OPERATIONS
|
(4,888,000
|
)
|
(5,791,000
|
)
|
|||
OTHER
INCOME (EXPENSE):
|
|||||||
Interest
and other income
|
239,000
|
349,000
|
|||||
Interest
and other expense
|
(7,000
|
)
|
(15,000
|
)
|
|||
NET
LOSS
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
206,071,568
|
184,108,083
|
|||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
THREE
MONTHS ENDED JULY 31,
|
|||||||
2007
|
2006
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
119,000
|
115,000
|
|||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
197,000
|
373,000
|
|||||
Amortization
of expenses paid in shares of common stock
|
-
|
209,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(764,000
|
)
|
317,000
|
||||
Inventories
|
(447,000
|
)
|
(86,000
|
)
|
|||
Prepaid
expenses and other current assets
|
16,000
|
130,000
|
|||||
Accounts
payable
|
(317,000
|
)
|
(85,000
|
)
|
|||
Accrued
clinical trial site fees
|
(115,000
|
)
|
(19,000
|
)
|
|||
Deferred
revenue
|
756,000
|
(250,000
|
)
|
||||
Accrued
payroll and related costs
|
(210,000
|
)
|
(226,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
(799,000
|
)
|
4,000
|
||||
Net
cash used in operating activities
|
(6,220,000
|
)
|
(4,975,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(75,000
|
)
|
(46,000
|
)
|
|||
Decrease
in other assets
|
71,000
|
-
|
|||||
Net
cash used in investing activities
|
(4,000
|
)
|
(46,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of common stock, net of issuance costs of $1,641,000
and
$46,000, respectively
|
20,931,000
|
16,448,000
|
|||||
Principal
payments on notes payable and capital lease
|
(116,000
|
)
|
(109,000
|
)
|
|||
Net
cash provided by financing activities
|
20,815,000
|
16,339,000
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
14,591,000
|
11,318,000 | |||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
16,044,000
|
17,182,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$ | 30,635,000 | $ | 28,500,000 |
July
31,
2007
|
April
30,
2007
|
||||||
Raw
materials
|
$
|
892,000
|
$
|
810,000
|
|||
Work-in-process
|
1,471,000
|
1,106,000
|
|||||
Total
inventories, net
|
$
|
2,363,000
|
$
|
1,916,000
|
Three
Months Ended
July
31, 2007
|
Three
Months Ended
July
31, 2006
|
||||||
Research
and development
|
$
|
129,000
|
$
|
166,000
|
|||
Selling,
general and administrative
|
54,000
|
133,000
|
|||||
Total
|
$
|
183,000
|
$
|
299,000
|
Three
Months Ended
July
31,
|
|||||||||
2007
|
2006
|
||||||||
Risk-free
interest rate
|
4.56
|
%
|
|
5.00
|
%
|
|
|||
Expected
life (in years)
|
5.98
|
6.25
|
|||||||
Expected
volatility
|
87
|
%
|
|
101
|
%
|
|
|||
Expected
dividend yield
|
-
|
-
|
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
May 1, 2007
|
11,537,946
|
$
|
1.54
|
||||||||||
Granted
|
485,920
|
$
|
0.86
|
||||||||||
Exercised
|
(45,000
|
)
|
$
|
0.60
|
|||||||||
Canceled
or expired
|
(261,921
|
)
|
$
|
1.39
|
|||||||||
Outstanding,
July 31, 2007
|
11,716,945
|
$
|
1.51
|
5.68
|
$
|
512,000
|
|||||||
Exercisable
and expected to vest
|
11,498,740
|
$
|
1.52
|
5.63
|
$
|
511,000
|
|||||||
Exercisable,
July 31, 2007
|
9,338,556
|
$
|
1.60
|
4.98
|
$
|
507,000
|
Number
of
Shares
Reserved
|
||||
Shares
of common stock reserved for issuance under two registration
statements
|
5,030,634
|
|||
Shares
of common stock reserved for issuance upon exercise of outstanding
options
|
11,716,945
|
|||
Shares
of common stock reserved for future option grants under our Option
Plans
|
4,405,235
|
|||
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
360,000
|
|||
Total
shares of common stock reserved for issuance
|
21,512,814
|
Three
Months Ended July 31,
|
|||||||
2007
|
2006
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,621,000
|
$
|
398,000
|
|||
Products
in research and development
|
4,000
|
23,000
|
|||||
Total
revenues, net
|
$
|
1,625,000
|
$
|
421,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
440,000
|
$
|
(132,000
|
)
|
||
Products
in research and development
|
4,000
|
23,000
|
|||||
Total
gross profit (loss)
|
444,000
|
(109,000
|
)
|
||||
Research
and development expense
|
(3,624,000
|
)
|
(4,041,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,708,000
|
)
|
(1,641,000
|
)
|
|||
Other
income, net
|
232,000
|
334,000
|
|||||
Net
loss
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
Three
Months Ended July 31,
|
|||||||||
2007
|
2006
|
||||||||
Customer
revenues as a % of net revenues:
|
|||||||||
United
States (one customer)
|
79
|
%
|
|
1
|
%
|
|
|||
Australia
(one customer)
|
0
|
%
|
|
93
|
%
|
|
|||
Other
customers
|
21
|
%
|
|
6
|
%
|
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
|
100
|
%
|
|
July
31,
2007
|
April
30,
2007
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,490,000
|
$
|
1,527,000
|
|||
Products
in research and development
|
306,000
|
313,000
|
|||||
Total
long-lived assets, net
|
$
|
1,796,000
|
$
|
1,840,000
|
Product
|
Indication
|
Trial
Design
|
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I repeat dose monotherapy safety study to treat up to 28 patients.
|
Study
is open for enrollment in the U.S.
|
Bavituximab
plus chemotherapy agents carboplatin/paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II combination therapy study to treat up to 49 patients.
|
Submitted
clinical protocol with the regulatory authorities in India. Patient
enrollment is expected to initiate later this year.
|
Bavituximab
plus chemotherapy and/or radiation therapy
|
Solid
tumor cancers
|
Phase
I/II and Phase II studies.
|
Additional
clinical studies are currently being planned are expected to initiate
later this year.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme or GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Study
is open for enrollment in the U.S.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme or GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at 1st
relapse.
|
Study
is open for enrollment in India.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection (co-infected with HIV)
|
Phase
Ib repeat dose safety study in 24 patients.
|
Study
is open for enrollment in the U.S.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection
|
Phase
Ib safety and dosing study.
|
Study
is being planned.
|
Three
Months Ended July 31,
|
||||||||||
2007
|
2006
|
$
Change
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
1,621,000
|
$
|
398,000
|
$
|
1,223,000
|
||||
License
revenue
|
4,000
|
23,000
|
(19,000
|
)
|
||||||
Total
revenues
|
1,625,000
|
421,000
|
1,204,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
1,181,000
|
530,000
|
651,000
|
|||||||
Research
and development
|
3,624,000
|
4,041,000
|
(417,000
|
)
|
||||||
Selling,
general & administrative
|
1,708,000
|
1,641,000
|
67,000
|
|||||||
Total
costs and expenses
|
6,513,000
|
6,212,000
|
301,000
|
|||||||
LOSS
FROM OPERATIONS
|
(4,888,000
|
)
|
(5,791,000
|
)
|
903,000
|
|||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Interest
and other income
|
239,000
|
349,000
|
(110,000
|
)
|
||||||
Interest
and other expense
|
(7,000
|
)
|
(15,000
|
)
|
8,000
|
|||||
NET
LOSS
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
$
|
801,000
|
Technology
Platform
|
R&D
Expenses-Quarter Ended
July
31, 2007
|
R&D
Expenses-Quarter Ended
July
31, 2006
|
$
Change
|
|||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
2,294,000
|
$
|
2,558,000
|
$
|
(264,000
|
)
|
|||
TNT
(Cotara®)
|
709,000
|
832,000
|
(123,000
|
)
|
||||||
VTA
and Anti-Angiogenesis Agents
|
464,000
|
532,000
|
(68,000
|
)
|
||||||
VEA
|
157,000
|
119,000
|
38,000
|
|||||||
Total
R&D Expenses
|
$
|
3,624,000
|
$
|
4,041,000
|
$
|
(417,000
|
)
|
o |
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) -
The decrease in Anti-PS Immunotherapeutics program expenses of $264,000
during the three months ended July 31, 2007 compared to the same
period in
the prior year is primarily due to a decrease in clinical trial patient
fees and related expenses combined with a decrease in manufacturing
expenses. During the current quarter, we were primarily involved
in
designing and preparing the necessary protocols to study bavituximab
in
two additional clinical trials. In July 2007, we initiated a Phase
Ib
study using bavituximab for the treatment of hepatitis C virus infection
in patients co-infected with HIV. In addition, during the same month,
we
submitted a Phase II clinical protocol in India to treat patients
with
non-small cell lung cancer (“NSCLC”) using bavituximab in combination with
chemotherapy. During the prior year fiscal quarter ended July 31,
2006,
clinical trial patient fees and related expenses were greater than
the
current quarter as we were enrolling patents in three separate Phase
I
clinical trials, two of which completed enrollment in fiscal year
2007.
|
o |
Tumor Necrosis Therapy (“TNT”)
(Cotara®) - The
decrease in TNT program expenses of $123,000 during the three months
ended
July 31, 2007 compared to the same period in the prior year is primarily
due to a decrease in manufacturing and related expenses as more
manufacturing capacity was utilized by third-party customers. This
decrease was offset by a slight increase in clinical trial expenses
associated with the two Cotara® clinical trials for the treatment of brain
cancer.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents -
The decrease in VTA and Anti-Angiogenesis Agents program expenses
of
$68,000 during the three months ended July 31, 2007 compared to the
same
period in the prior year is primarily due to decreases in technology
license fees, sponsored research fees and payroll and related expenses
offset by an increase in manufacturing
expenses.
|
o |
Vasopermeation
Enhancement Agents (“VEAs”) -
The increase in VEA program expenses of $38,000 during the three
months
ended July 31, 2007 compared to the same period in the prior year
is
primarily due to increases in payroll and related expenses and laboratory
materials associated with increased efforts to advance the pre-clinical
development of our VEA program.
|
· |
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond fiscal year
2008;
|
· |
the
uncertainty of future clinical trial results;
|
· |
the
uncertainty of the ultimate number of patients to be treated in any
current or future clinical trial;
|
· |
the
uncertainty of the U.S. Food and Drug Administration allowing our
studies
to move forward from Phase I clinical studies to Phase II and Phase
III
clinical studies;
|
· |
the
uncertainty of the rate at which patients are enrolled into any current
or
future study. Any delays in clinical trials could significantly increase
the cost of the study and would extend the estimated completion
dates;
|
· |
the
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-Angiogenesis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are uncertain whether or
not these
product candidates will be successful and we are uncertain whether
or not
we will incur any additional costs beyond pre-clinical
development;
|
· |
the
uncertainty of terms related to potential future partnering or licensing
arrangements; and
|
· |
the
uncertainty of protocol changes and modifications in the design of
our
clinical trial studies, which may increase or decrease our future
costs.
|
THREE
MONTHS ENDED
|
|||||||
July
31,
2007
|
July
31,
2006
|
||||||
Net
loss, as reported
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
Less
non-cash expenses
and adjustments to net loss:
Depreciation
and amortization
Stock-based
compensation and common stock issued under stock bonus plan
Amortization
of expenses paid in shares of common stock
|
119,000
197,000
-
|
115,000
373,000
209,000
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(4,340,000
|
)
|
$
|
(4,760,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,880,000
|
)
|
$
|
(215,000
|
)
|
|
Net
cash used in operating activities
|
$
|
(6,220,000
|
)
|
$
|
(4,975,000
|
)
|
Net
Loss
|
||||
Three months ended July 31, 2007 (unaudited) | $ | 4,656,000 | ||
Fiscal Year 2007 | $ | 20,796,000 | ||
Fiscal Year 2006 | $ | 17,061,000 | ||
Fiscal Year 2005 | $ | 15,452,000 |
Number
of Shares
of
Common Stock Reserved For Issuance
|
||||
Shares
reserved for issuance under two effective shelf
registration statements
|
5,030,634
|
|||
Common
shares reserved for issuance upon exercise of outstanding options
or
reserved
for future option grants under our stock incentive plans
|
16,122,180
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
360,000
|
|||
Total
|
21,512,814
|
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Fiscal
Year 2008
|
|||||||||||||
Quarter
Ended July 31, 2007
|
$
|
1.40
|
$
|
0.72
|
21,653
|
237
|
|||||||
Fiscal
Year 2007
|
|||||||||||||
Quarter
Ended April 30, 2007
|
$
|
1.26
|
$
|
0.86
|
6,214
|
408
|
|||||||
Quarter
Ended January 31, 2007
|
$
|
1.39
|
$
|
1.09
|
4,299
|
203
|
|||||||
Quarter
Ended October 31, 2006
|
$
|
1.48
|
$
|
1.12
|
3,761
|
277
|
|||||||
Quarter
Ended July 31, 2006
|
$
|
1.99
|
$
|
1.30
|
23,790
|
429
|
|||||||
Fiscal
Year 2006
|
|||||||||||||
Quarter
Ended April 30, 2006
|
$
|
1.76
|
$
|
1.20
|
9,922
|
391
|
|||||||
Quarter
Ended January 31, 2006
|
$
|
1.40
|
$
|
0.88
|
12,152
|
251
|
|||||||
Quarter
Ended October 31, 2005
|
$
|
1.28
|
$
|
0.91
|
4,619
|
156
|
|||||||
Quarter
Ended July 31, 2005
|
$
|
1.31
|
$
|
0.92
|
7,715
|
178
|
|||||||
Fiscal
Year 2005
|
|||||||||||||
Quarter
Ended April 30, 2005
|
$
|
1.64
|
$
|
1.11
|
5,945
|
223
|
|||||||
Quarter
Ended January 31, 2005
|
$
|
1.45
|
$
|
0.99
|
6,128
|
160
|
|||||||
Quarter
Ended October 31, 2004
|
$
|
1.96
|
$
|
0.95
|
2,141
|
148
|
|||||||
Quarter
Ended July 31, 2004
|
$
|
1.92
|
$
|
0.88
|
1,749
|
131
|
· |
announcements
of technological innovations or new commercial products by us or
our
competitors;
|
· |
publicity
regarding actual or potential clinical trial results relating to
products
under development by us or our
competitors;
|
· |
our
financial results or that of our
competitors;
|
· |
the
offering and sale of shares of our common stock at a discount under
an
equity transaction;
|
· |
published
reports by securities analysts;
|
· |
announcements
of licensing agreements, joint ventures, strategic alliances, and
any
other transaction that involves the sale or use of our technologies
or
competitive technologies;
|
· |
developments
and/or disputes concerning our patent or proprietary
rights;
|
· |
regulatory
developments and product safety
concerns;
|
· |
general
stock trends in the biotechnology and pharmaceutical industry
sectors;
|
· |
public
concerns as to the safety and effectiveness of our
products;
|
· |
economic
trends and other external factors, including but not limited to,
interest
rate fluctuations, economic recession, inflation, foreign market
trends,
national crisis, and disasters; and
|
· |
healthcare
reimbursement reform and cost-containment measures implemented by
government agencies.
|
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of
at
least $35,000,000 or net income of at least $500,000 in either our
latest
fiscal year or in two of our last three fiscal
years;
|
2.
|
Public
float of at least 500,000 shares;
|
3.
|
Market
value of our public float of at least
$1,000,000;
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
5.
|
At
least two market makers; and
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
· |
delays
in product development, clinical testing or
manufacturing;
|
· |
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
· |
failure
in clinical trials or failure to receive regulatory
approvals;
|
· |
emergence
of superior or equivalent products;
|
· |
inability
to manufacture on our own, or through others, product candidates
on a
commercial scale;
|
· |
inability
to market products due to third party proprietary rights;
and
|
· |
failure
to achieve market acceptance.
|
· |
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
· |
the
inability of patients to meet FDA or other regulatory authorities
imposed
protocol requirements;
|
· |
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in
clinical
trials;
|
· |
the
need or desire to modify our manufacturing
processes;
|
· |
the
inability to adequately observe patients after
treatment;
|
· |
changes
in regulatory requirements for clinical
trials;
|
· |
the
lack of effectiveness during the clinical
trials;
|
· |
unforeseen
safety issues;
|
· |
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular
study
site; and
|
· |
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
· |
our
ability to provide acceptable evidence of safety and
efficacy;
|
· |
relative
convenience and ease of
administration;
|
· |
the
prevalence and severity of any adverse side
effects;
|
· |
availability
of alternative treatments;
|
· |
pricing
and cost effectiveness;
|
· |
effectiveness
of our or our collaborators’ sales and marketing strategy;
and
|
· |
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
|
· |
production
yields;
|
· |
quality
control and quality assurance;
|
· |
shortages
of qualified personnel;
|
· |
compliance
with FDA or other regulatory authorities regulations, including the
demonstration of purity and
potency;
|
· |
changes
in FDA or other regulatory authorities
requirements;
|
· |
production
costs; and/or
|
· |
development
of advanced manufacturing techniques and process
controls.
|
· |
the
pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we
expect
to result in issued patents;
|
· |
the
claims of any patents that issue may not provide meaningful
protection;
|
· |
we
may be unable to develop additional proprietary technologies that
are
patentable;
|
· |
the
patents licensed or issued to us may not provide a competitive
advantage;
|
· |
other
parties may challenge patents licensed or issued to
us;
|
· |
disputes
may arise regarding the invention and corresponding ownership rights
in
inventions and know-how resulting from the joint creation or use
of
intellectual property by us, our licensors, corporate partners and
other
scientific collaborators; and
|
· |
other
parties may design around our patented
technologies.
|
· |
no
stockholder action may be taken without a meeting, without prior
notice
and without a vote; solicitations by consent are thus
prohibited;
|
· |
special
meetings of stockholders may be called only by our Board of Directors;
and
|
· |
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares,
of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into
a large
number of shares of common stock could prevent a potential acquiror
from
gaining effective economic or voting
control.
|
(a) |
Exhibits:
|
|
31.1 |
Certification
of the Chief Executive Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
31.2 |
Certification
of the Chief Financial Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
|
32 |
Certification
of Chief Executive Officer and
Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
PEREGRINE PHARMACEUTICALS, INC. | ||
|
|
|
Date: September 7, 2007 | By: | /s/ STEVEN W. KING |
Steven
W. King
President
and Chief Executive Officer,
Director
|
Date: September 7, 2007 | By: | /s/ PAUL J. LYTLE |
Paul
J. Lytle
Chief
Financial Officer
(signed
both as an officer
duly authorized to sign on behalf
of the Registrant and principal financial
officer and chief accounting officer)
|
Date: September 7, 2007 | Signed: |
/s/
STEVEN W. KING
|
Steven
W. King
President
and Chief Executive Officer,
Director
|
Date: September 7, 2007 | Signed: | /s/ PAUL J. LYTLE |
Paul
J. Lytle
Chief
Financial Officer
|
By:
|
/s/
STEVEN W. KING
|
|
Name:
|
Steven
W. King
|
|
Title:
|
President
and Chief Executive Officer, Director
|
|
Date:
|
September
7, 2007
|
By:
|
/s/
PAUL J. LYTLE
|
|
Name:
|
Paul
J. Lytle
|
|
Title:
|
Chief
Financial Officer
|
|
Date:
|
September
7, 2007
|