ý
|
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.)
|
|
14272
Franklin Avenue, Tustin, California
|
92780-7017
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Class
|
Shares
Outstanding at December 5, 2006
|
|
Common
Stock, $0.001 par value per share
|
195,120,390
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
|
15
|
|
Company
Overview
|
15
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
24
|
|
Item
4.
|
Controls
and Procedures
|
24
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
24
|
|
Item
1A.
|
Risk
Factors
|
24
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
36
|
|
Item
3.
|
Defaults
upon Senior Securities
|
36
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
36
|
|
Item
5.
|
Other
Information
|
36
|
|
Item
6.
|
Exhibits
|
36
|
|
SIGNATURES
|
37
|
OCTOBER
31,
2006
|
APRIL
30,
2006
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
23,394,000
|
$
|
17,182,000
|
|||
Trade
and other receivables
|
801,000
|
579,000
|
|||||
Inventories
|
1,899,000
|
885,000
|
|||||
Prepaid
expenses and other current assets
|
1,323,000
|
1,466,000
|
|||||
Total
current assets
|
27,417,000
|
20,112,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
640,000
|
618,000
|
|||||
Laboratory
equipment
|
3,669,000
|
3,444,000
|
|||||
Furniture,
fixtures and office equipment
|
666,000
|
666,000
|
|||||
4,975,000
|
4,728,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,055,000
|
)
|
(2,822,000
|
)
|
|||
Property,
net
|
1,920,000
|
1,906,000
|
|||||
Other
assets
|
468,000
|
658,000
|
|||||
TOTAL
ASSETS
|
$
|
29,805,000
|
$
|
22,676,000
|
OCTOBER
31,
2006
|
APRIL
30,
2006
|
||||||
|
Unaudited
|
||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,093,000
|
$
|
1,233,000
|
|||
Accrued
clinical trial site fees
|
315,000
|
170,000
|
|||||
Accrued
legal and accounting fees
|
76,000
|
250,000
|
|||||
Accrued
royalties and license fees
|
164,000
|
138,000
|
|||||
Accrued
payroll and related costs
|
974,000
|
850,000
|
|||||
Notes
payable, current portion
|
443,000
|
429,000
|
|||||
Capital
lease obligation, current portion
|
16,000
|
15,000
|
|||||
Deferred
revenue
|
1,388,000
|
563,000
|
|||||
Other
current liabilities
|
396,000
|
836,000
|
|||||
Total
current liabilities
|
4,865,000
|
4,484,000
|
|||||
Notes
payable, less current portion
|
273,000
|
498,000
|
|||||
Capital
lease obligation, less current portion
|
39,000
|
47,000
|
|||||
Deferred
license revenue
|
12,000
|
21,000
|
|||||
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
-
193,920,390 and 179,382,191, respectively
|
194,000
|
179,000
|
|||||
Additional
paid-in capital
|
221,813,000
|
204,546,000
|
|||||
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
Accumulated
deficit
|
(197,391,000
|
)
|
(186,864,000
|
)
|
|||
Total
stockholders' equity
|
24,616,000
|
17,626,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
29,805,000
|
$
|
22,676,000
|
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
||||||||||||
October
31,
2006
|
October
31,
2005
|
October
31,
2006
|
October
31,
2005
|
||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
REVENUES:
|
|||||||||||||
Contract
manufacturing revenue
|
$
|
636,000
|
$
|
533,000
|
$
|
1,034,000
|
$
|
722,000
|
|||||
License
revenue
|
48,000
|
23,000
|
71,000
|
42,000
|
|||||||||
Total
revenues
|
684,000
|
556,000
|
1,105,000
|
764,000
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of contract manufacturing
|
494,000
|
428,000
|
1,024,000
|
732,000
|
|||||||||
Research
and development
|
3,920,000
|
3,244,000
|
7,961,000
|
6,036,000
|
|||||||||
Selling,
general and administrative
|
1,670,000
|
1,570,000
|
3,311,000
|
3,087,000
|
|||||||||
Total
costs and expenses
|
6,084,000
|
5,242,000
|
12,296,000
|
9,855,000
|
|||||||||
LOSS
FROM OPERATIONS
|
(5,400,000
|
)
|
(4,686,000
|
)
|
(11,191,000
|
)
|
(9,091,000
|
)
|
|||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||
Interest
and other income
|
339,000
|
128,000
|
688,000
|
204,000
|
|||||||||
Interest
and other expense
|
(9,000
|
)
|
(13,000
|
)
|
(24,000
|
)
|
(23,000
|
)
|
|||||
NET
LOSS
|
$
|
(5,070,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(10,527,000
|
)
|
$
|
(8,910,000
|
)
|
|
WEIGHTED
AVERAGE
COMMON
SHARES OUTSTANDING:
|
|||||||||||||
Basic
and Diluted
|
193,793,766
|
165,925,879
|
188,950,924
|
162,980,798
|
|||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
SIX
MONTHS ENDED OCTOBER 31,
|
|||||||
2006
|
2005
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(10,527,000
|
)
|
$
|
(8,910,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
233,000
|
200,000
|
|||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
970,000
|
161,000
|
|||||
Amortization
of expenses paid in shares of common stock
|
309,000
|
678,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(222,000
|
)
|
(5,000
|
)
|
|||
Inventories
|
(1,014,000
|
)
|
(860,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(166,000
|
)
|
(37,000
|
)
|
|||
Accounts
payable
|
(140,000
|
)
|
(164,000
|
)
|
|||
Accrued
clinical trial site fees
|
145,000
|
53,000
|
|||||
Deferred
revenue
|
816,000
|
534,000
|
|||||
Accrued
payroll and related costs
|
12,000
|
(234,000
|
)
|
||||
Other
accrued expenses and current liabilities
|
(588,000
|
)
|
(463,000
|
)
|
|||
Net
cash used in operating activities
|
(10,172,000
|
)
|
(9,047,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(57,000
|
)
|
(217,000
|
)
|
|||
Increase
in other assets
|
-
|
(73,000
|
)
|
||||
Net
cash used in investing activities
|
(57,000
|
)
|
(290,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from borrowings under notes payable
|
-
|
267,000
|
|||||
Principal
payments on notes payable and capital lease
|
(218,000
|
)
|
(136,000
|
)
|
|||
Proceeds
from issuance of common stock, net of issuance costs of $46,000
and
$46,000, respectively
|
16,659,000
|
11,292,000
|
|||||
Net
cash provided by financing activities
|
16,441,000
|
11,423,000
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
6,212,000
|
2,086,000
|
|||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
17,182,000
|
9,816,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
23,394,000
|
$
|
11,902,000
|
|||
NON-CASH
FINANCING ACTIVITIES:
|
|||||||
Common
stock issued for research fees and prepayments for future research
fees
|
$
|
-
|
$
|
321,000
|
October
31, 2006
|
April
30, 2006
|
||||||
Raw
materials
|
$
|
601,000
|
$
|
565,000
|
|||
Work-in-process
|
1,298,000
|
320,000
|
|||||
Total
inventories
|
$
|
1,899,000
|
$
|
885,000
|
Three
Months Ended
October
31, 2006
|
Six
Months Ended
October
31, 2006
|
||||||
Research
and development
|
$
|
177,000
|
$
|
343,000
|
|||
Selling,
general and administrative
|
133,000
|
266,000
|
|||||
Total
|
$
|
310,000
|
$
|
609,000
|
Three
Months Ended
October
31,
|
Six
Months Ended
October
31,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Risk-free
interest rate
|
4.88%
|
|
3.88%
|
|
4.94%
|
|
3.88%
|
|
|||||
Expected
life (in years)
|
6.25
|
5.49
|
6.25
|
5.49
|
|||||||||
Expected
volatility
|
99%
|
|
103%
|
|
100%
|
|
103%
|
|
|||||
Expected
dividend yield
|
-
|
-
|
-
|
-
|
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
May 1, 2006
|
11,307,279
|
$
|
1.56
|
||||||||||
Granted
|
571,400
|
$
|
1.40
|
||||||||||
Exercised
|
(47,183
|
)
|
$
|
1.12
|
|||||||||
Canceled
or expired
|
(318,217
|
)
|
$
|
1.69
|
|||||||||
Outstanding,
October 31, 2006
|
11,513,279
|
$
|
1.55
|
6.29
|
$
|
2,152,000
|
|||||||
Exercisable
and expected to vest
|
11,335,688
|
$
|
1.55
|
0.39
|
$
|
2,133,000
|
|||||||
Exercisable,
October 31, 2006
|
9,049,410
|
$
|
1.61
|
5.65
|
$
|
1,881,000
|
|||||||
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
||||||||||||
October
31,
2006
|
October
31,
2005
|
October
31,
2006
|
October
31,
2005
|
||||||||||
Net
loss, excluding the effect of employee stock-based
compensation
|
$
|
(4,760,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(9,918,000
|
)
|
$
|
(8,910,000
|
)
|
|
Deduct:
Total stock-based employee compensation determined under the fair
value
based method for all awards
|
(310,000
|
)
|
(570,000
|
)
|
(609,000
|
)
|
(1,213,000
|
)
|
|||||
Net
loss, including the effect of stock-based compensation
|
$
|
(5,070,000
|
)
|
$
|
(5,141,000
|
)
|
$
|
(10,527,000
|
)
|
$
|
(10,123,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||||||||
Excluding
the effect of stock-based compensation
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
|
Including
the effect of stock-based compensation
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.06
|
)
|
$
|
(0.06
|
)
|
Number
of Shares
of
Common Stock
Reserved
For
Issuance
|
||||
Shares
reserved under two effective shelf registration statements
|
5,893,466
|
|||
Options
issued and outstanding
|
11,513,279
|
|||
Options
available for future grant
|
4,845,444
|
|||
Warrants
issued and outstanding
|
1,897,865
|
|||
Total
shares reserved
|
24,150,054
|
Per
Share
Exercise
Price
|
Number
of Warrants Outstanding
|
Weighted
Average Per Share Exercise Price
|
Expiration
Date
|
|||
$0.86
|
62,865
|
6/8/07
|
||||
$1.47
|
350,000
|
3/31/08
|
||||
$2.00
|
275,000
|
1/31/07
|
||||
$2.50
|
10,000
|
3/25/08
|
||||
$0.86
- $2.50
|
697,865
|
$1.64
|
1/31/07
- 3/31/08
|
Three
Months Ended October 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
636,000
|
$
|
533,000
|
|||
Products
in research and development
|
48,000
|
23,000
|
|||||
Total
net revenues
|
$
|
684,000
|
$
|
556,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
142,000
|
$
|
105,000
|
|||
Products
in research and development
|
48,000
|
23,000
|
|||||
Total
gross profit
|
190,000
|
128,000
|
|||||
Research
and development expense
|
(3,920,000
|
)
|
(3,244,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,670,000
|
)
|
(1,570,000
|
)
|
|||
Other
income, net
|
330,000
|
115,000
|
|||||
Net
loss
|
$
|
(5,070,000
|
)
|
$
|
(4,571,000
|
)
|
Three
Months Ended October 31,
|
||||
2006
|
2005
|
|||
Customer
revenues as a % of net revenues:
|
||||
United
States (customer A)
|
6%
|
97%
|
||
United
States (customer B)
|
17%
|
0%
|
||
Australia
(one customer)
|
19%
|
0%
|
||
China
(one customer)
|
55%
|
0%
|
||
Other
customers
|
3%
|
3%
|
||
Total
customer revenues as a % of net revenues
|
100%
|
100%
|
Six
Months Ended October 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,034,000
|
$
|
722,000
|
|||
Products
in research and development
|
71,000
|
42,000
|
|||||
Total
net revenues
|
$
|
1,105,000
|
$
|
764,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
10,000
|
$
|
(10,000
|
)
|
||
Products
in research and development
|
71,000
|
42,000
|
|||||
Total
gross profit
|
81,000
|
32,000
|
|||||
Research
and development expense
|
(7,961,000
|
)
|
(6,036,000
|
)
|
|||
Selling,
general and administrative expense
|
(3,311,000
|
)
|
(3,087,000
|
)
|
|||
Other
income, net
|
664,000
|
181,000
|
|||||
Net
loss
|
$
|
(10,527,000
|
)
|
$
|
(8,910,000
|
)
|
Six
Months Ended October 31,
|
||||
2006
|
2005
|
|||
Customer
revenues as a % of net revenues:
|
||||
United
States (customer A)
|
4%
|
82%
|
||
United
States (customer B)
|
11%
|
0%
|
||
United
States (customer C)
|
0%
|
10%
|
||
Australia
(one customer)
|
48%
|
0%
|
||
China
(one customer)
|
34%
|
0%
|
||
Other
customers
|
3%
|
8%
|
||
Total
customer revenues as a % of net revenues
|
100%
|
100%
|
October
31, 2006
|
April
30, 2006
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,565,000
|
$
|
1,516,000
|
|||
Products
in research and development
|
355,000
|
390,000
|
|||||
Total
long-lived assets, net
|
$
|
1,920,000
|
$
|
1,906,000
|
Product
|
Indication
|
Trial
Design
|
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
Ia repeat dose monotherapy safety study to treat up to 28 patients.
|
Patients
are currently being screened and enrolled at up to 5 centers in the
U.S.
|
Bavituximab
plus chemotherapy
|
Solid
tumor cancers
|
Phase
Ib repeat dose combination therapy safety study to treat up to 12
patients
with 8 weekly doses of bavituximab in combination with chemotherapy
agents.
|
Patients
are currently being screened and enrolled at up to 3 centers in India.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients at
1st
and 2nd
relapse in collaboration with New Approaches to Brain Tumor
Therapy.
|
Patients
are currently being screened and enrolled at up to 4 centers in the
U.S.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme)
|
Phase
II safety and efficacy study to treat up to 40 patients at 1st
relapse.
|
Regulatory
approval has been received for the protocol in India. Manufacturing
development is proceeding in India and approval is anticipated in
the near
term.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection
|
Phase
Ib repeat dose safety study in 24 patients.
|
All
patients have been enrolled at U.S. sites and are currently completing
the
12-week follow-up period.
|
Three
Months Ended
October
31,
|
Six
Months Ended
October
31,
|
||||||||||||||||||
2006
|
2005
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing revenue
|
$
|
636
|
$
|
533
|
$
|
103
|
$
|
1,034
|
$
|
722
|
$
|
312
|
|||||||
License
revenue
|
48
|
23
|
25
|
71
|
42
|
29
|
|||||||||||||
Total
revenues
|
684
|
556
|
128
|
1,105
|
764
|
341
|
|||||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
494
|
428
|
66
|
1,024
|
732
|
292
|
|||||||||||||
Research
and development
|
3,920
|
3,244
|
676
|
7,961
|
6,036
|
1,925
|
|||||||||||||
Selling,
general and administrative
|
1,670
|
1,570
|
100
|
3,311
|
3,087
|
224
|
|||||||||||||
Total
cost and expenses
|
6,084
|
5,242
|
842
|
12,296
|
9,855
|
2,441
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(5,400
|
)
|
(4,686
|
)
|
(714
|
)
|
(11,191
|
)
|
(9,091
|
)
|
(2,100
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Interest
and other income
|
339
|
128
|
211
|
688
|
204
|
484
|
|||||||||||||
Interest
and other expense
|
(9
|
)
|
(13
|
)
|
4
|
(24
|
)
|
(23
|
)
|
(1
|
)
|
||||||||
NET
LOSS
|
$
|
(5,070
|
)
|
$
|
(4,571
|
)
|
$
|
(499
|
)
|
$
|
(10,527
|
)
|
$
|
(8,910
|
)
|
$
|
(1,617
|
)
|
R&D
Expenses -
Three
Months
Ended
October 31,
|
R&D
Expenses -
Six
Months
Ended
October 31,
|
||||||||||||||||||
2006
|
2005
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
Technology
Platform:
|
|||||||||||||||||||
Anti-PS
Immunotherapeutics
(bavituximab)
|
$
|
2,549
|
$
|
2,528
|
$
|
21
|
$
|
5,107
|
$
|
4,116
|
$
|
991
|
|||||||
TNT
(Cotara®)
|
696
|
301
|
395
|
1,528
|
1,069
|
459
|
|||||||||||||
VTA
and Anti-Angiogenesis Agents
|
512
|
331
|
181
|
1,044
|
664
|
380
|
|||||||||||||
VEA
|
163
|
84
|
79
|
282
|
187
|
95
|
|||||||||||||
Total
R&D Expenses
|
$
|
3,920
|
$
|
3,244
|
$
|
676
|
$
|
7,961
|
$
|
6,036
|
$
|
1,925
|
o
|
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) -
The increase in Anti-PS Immunotherapeutics program expenses during
the
three and six months ended October 31, 2006 compared to the same
periods
in the prior year resulted primarily from continuing efforts to
support
the development and clinical development of our first Anti-PS
Immunotherapeutic agent, bavituximab. During the current three
and
six-month periods, clinical trial expenses increased as we advanced
the
development of two separate Phase I clinical programs using bavituximab
for the treatment of advanced solid cancers and chronic hepatitis
C virus
infection (“HCV”). These increases in clinical trial expenses were further
supplemented with increases in payroll and related expenses including
non-cash stock-based compensation expense associated with the amortization
of the fair value of options granted to employees in accordance
with the
adoption of SFAS No. 123R on May 1, 2006 and non-cash expenses
associated
with shares of common stock earned by employees under the our February
2006 Stock Bonus Plan. These increases in Anti-PS Immunotherapeutics
program expenses were offset by a decrease in technology license
and
access fees expensed in the prior year period in support of the
bavituximab clinical program and pre-clinical product candidates.
|
o
|
Tumor
Necrosis Therapy (“TNT”) (Cotara®) - The
increase in TNT program expenses during the three and six months
ended
October 31, 2006 compared to the same periods in the prior year
resulted
primarily from increased clinical trial expenses to support the
Cotara®
dose confirmation and dosimetry clinical trial for the treatment
of
glioblastoma multiforme (a deadly form of brain cancer) in collaboration
with the New Approaches to Brain Tumor Therapy consortium and an
increase
in expenses to support the initiation of a Phase II clinical trial
in
India to treat up to 40 patients with glioblastoma multiforme.
These
increases in clinical trial expenses were further supplemented
with
increases in payroll and related expenses, manufacturing expenses,
and
non-cash stock-based compensation expense associated with the amortization
of the fair value of options granted to employees in accordance
with the
adoption of SFAS No. 123R on May 1, 2006.
|
o
|
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis Agents -
The increase in VTA and Anti-Angiogenesis Agents program expenses
during
the current three and six-month periods is primarily due to increases
in
payroll and related expenses, sponsored research fees, manufacturing
expenses, and outside research studies associated with increased
efforts
to advance the pre-clinical development of our VTA and Anti-Angiogenesis
Agents programs. These increases were further supplemented by an
increase
in non-cash stock-based compensation expense associated with the
amortization of the fair value of options granted to employees
in
accordance with the adoption of SFAS No. 123R on May 1,
2006.
|
o
|
VEA
-
The increase in VEA program expenses during the current three and
six-month periods is primarily due to increases in payroll and
related
expenses and in-house research material procurement associated
with
increased efforts to advance the pre-clinical development of our
VEA
program. These increases were further supplemented by an increase
in
non-cash stock-based compensation expense associated with the amortization
of the fair value of options granted to employees in accordance
with the
adoption of SFAS No. 123R on May 1,
2006.
|
§
|
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond July 2007;
|
§
|
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 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 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 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.
|
SIX
MONTHS ENDED
|
|||||||
October
31,
2006
|
October
31,
2005
|
||||||
Net
loss, as reported
|
$
|
(10,527,000
|
)
|
$
|
(8,910,000
|
)
|
|
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
|
233,000
970,000
309,000
|
200,000
161,000
678,000
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(9,015,000
|
)
|
$
|
(7,871,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,157,000
|
)
|
$
|
(1,176,000
|
)
|
|
Net
cash used in operating activities
|
$
|
(10,172,000
|
)
|
$
|
(9,047,000
|
)
|
ITEM
4.
|
CONTROLS
AND PROCEDURES
|
ITEM
1A.
|
RISK
FACTORS
|
·
|
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.
|
Net
Loss
|
||||
Six
months ended October 31, 2006 (unaudited)
|
$
|
10,527,000
|
||
Fiscal
Year 2006
|
$
|
17,061,000
|
||
Fiscal
Year 2005
|
$
|
15,452,000
|
||
Fiscal
Year 2004
|
$
|
14,345,000
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
·
|
the
inability of patients to meet FDA 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.
|
·
|
production
yields;
|
·
|
quality
control and quality assurance;
|
·
|
shortages
of qualified personnel;
|
·
|
compliance
with FDA regulations, including the demonstration of purity and
potency;
|
·
|
changes
in FDA requirements;
|
·
|
production
costs; and/or
|
·
|
development
of advanced manufacturing techniques and process
controls.
|
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.
|
Number
of Shares
of
Common Stock Reserved For Issuance
|
||||
Shares
reserved for under two effective shelf
registration statements
|
5,893,466
|
|||
Common
shares reserved for issuance under stock option plans
|
11,513,279
|
|||
Common
shares available for future grant under option plans
|
4,845,444
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
1,897,865
|
|||
24,150,054
|
Common
Stock
Sales
Price
|
Common
Stock Daily Trading Volume
(000’s
omitted)
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Fiscal
Year 2007
|
|||||||||||||
Quarter
Ended October 31, 2006
|
$
|
1.49
|
$
|
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
|
|||||||
Fiscal
Year 2004
|
|||||||||||||
Quarter
Ended April 30, 2004
|
$
|
2.85
|
$
|
1.56
|
3,550
|
320
|
|||||||
Quarter
Ended January 31, 2004
|
$
|
3.14
|
$
|
2.01
|
6,062
|
201
|
|||||||
Quarter
Ended October 31, 2003
|
$
|
2.44
|
$
|
1.25
|
18,060
|
314
|
|||||||
Quarter
Ended July 31, 2003
|
$
|
2.19
|
$
|
0.60
|
12,249
|
255
|
·
|
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;
|
·
|
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.
|
·
|
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.
|
Routine
Matters
|
For
|
Withheld
|
|||
1)
Election
of Directors:
|
|||||
Carlton
M. Johnson
|
166,418,368
|
9,677,761
|
|||
Steven
W. King
|
166,431,598
|
9,664,531
|
|||
David
Pohl
|
166,103,964
|
9,992,165
|
|||
Eric
Swartz
|
166,207,829
|
9,888,300
|
|||
Dr.
Thomas Waltz
|
166,446,888
|
9,649,241
|
|||
For
|
Against
|
Abstain
|
|||
2)
To
ratify the appointment of Ernst & Young LLP as independent auditors of
the Company for the fiscal year ending April 30, 2007.
|
174,236,521
|
791,921
|
1,067,686
|
||
3)
To
temporary roll back and freeze all base compensation of the Directors
and
Executive Officers of the Company to their 2005 levels and eliminate
all
future incentive or bonus compensation of the Directors and Executive
Officers of the Company.
|
15,393,032
|
31,793,775
|
960,776
|
(a)
|
Exhibits:
|
31.1
|
|
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:
December 7, 2006
|
By:
/s/ STEVEN W.
KING
|
|
Steven
W. King
|
||
President
and Chief Executive Officer, Director
|
||
Date:
December 7, 2006
|
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) |
Dated: December 7, 2006 |
Signed:
/s/
STEVEN W. KING
|
Dated: December 7, 2006 |
Signed:
/s/
PAUL J. LYTLE
|
By:
|
/s/
STEVEN W. KING
|
|
Name:
|
Steven
W. King
|
|
Title:
|
President
and Chief Executive Officer, Director
|
|
Date:
|
December
7, 2006
|
By:
|
/s/
PAUL J. LYTLE
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Name:
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Paul
J. Lytle
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Title:
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Chief
Financial Officer
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Date:
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December
7, 2006
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