ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
quarterly period ended July 31, 2006
|
|
OR
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
|
|
For
the
transition period from _______________ to
_______________
|
Delaware
|
|
95-3698422
|
(State
or other jurisdiction of
|
|
(I.R.S.
Employer
|
incorporation
or organization)
|
|
Identification
No.)
|
14272
Franklin Avenue, Tustin, California
|
|
92780-7017
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Class
|
Shares
Outstanding at September 5, 2006
|
|
Common
Stock, $0.001 par value per share
|
193,796,708
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
|
13
|
|
Company
Overview
|
13
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
21
|
|
Item
4.
|
Controls
and Procedures
|
21
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
21
|
|
Item
1A.
|
Risk
Factors
|
21
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
34
|
|
Item
3.
|
Defaults
upon Senior Securities
|
34
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
34
|
|
Item
5.
|
Other
Information
|
34
|
|
Item
6.
|
Exhibits
|
34
|
|
SIGNATURES
|
35
|
JULY
31,
2006
|
APRIL
30,
2006
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
28,500,000
|
$
|
17,182,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts of
$20,000
(July 2006)
|
262,000
|
579,000
|
|||||
Inventories
|
971,000
|
885,000
|
|||||
Prepaid
expenses and other current assets
|
1,127,000
|
1,466,000
|
|||||
Total
current assets
|
30,860,000
|
20,112,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
640,000
|
618,000
|
|||||
Laboratory
equipment
|
3,468,000
|
3,444,000
|
|||||
Furniture,
fixtures and office equipment
|
666,000
|
666,000
|
|||||
4,774,000
|
4,728,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,937,000
|
)
|
(2,822,000
|
)
|
|||
Property,
net
|
1,837,000
|
1,906,000
|
|||||
Other
assets
|
658,000
|
658,000
|
|||||
TOTAL
ASSETS
|
$
|
33,355,000
|
$
|
22,676,000
|
JULY
31,
2006
|
APRIL
30,
2006
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,148,000
|
$
|
1,233,000
|
|||
Accrued
clinical trial site fees
|
151,000
|
170,000
|
|||||
Accrued
legal and accounting fees
|
135,000
|
250,000
|
|||||
Accrued
royalties and license fees
|
153,000
|
138,000
|
|||||
Accrued
payroll and related costs
|
624,000
|
850,000
|
|||||
Notes
payable, current portion
|
436,000
|
429,000
|
|||||
Capital
lease obligation, current portion
|
15,000
|
15,000
|
|||||
Deferred
revenue
|
317,000
|
563,000
|
|||||
Other
current liabilities
|
940,000
|
836,000
|
|||||
Total
current liabilities
|
3,919,000
|
4,484,000
|
|||||
Notes
payable, less current portion
|
386,000
|
498,000
|
|||||
Capital
lease obligation, less current portion
|
43,000
|
47,000
|
|||||
Deferred
license revenue
|
17,000
|
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
-
193,528,766 and 179,382,191, respectively
|
193,000
|
179,000
|
|||||
Additional
paid-in capital
|
221,118,000
|
204,546,000
|
|||||
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
Accumulated
deficit
|
(192,321,000
|
)
|
(186,864,000
|
)
|
|||
Total
stockholders' equity
|
28,990,000
|
17,626,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
33,355,000
|
$
|
22,676,000
|
THREE
MONTHS ENDED
|
|||||||
July
31, 2006
|
July
31, 2005
|
||||||
Unaudited
|
Unaudited
|
||||||
REVENUES:
|
|||||||
Contract
manufacturing revenue
|
$
|
398,000
|
$
|
189,000
|
|||
License
revenue
|
23,000
|
19,000
|
|||||
Total
revenues
|
421,000
|
208,000
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of contract manufacturing
|
530,000
|
304,000
|
|||||
Research
and development
|
4,041,000
|
2,792,000
|
|||||
Selling,
general and administrative
|
1,641,000
|
1,517,000
|
|||||
Total
costs and expenses
|
6,212,000
|
4,613,000
|
|||||
LOSS
FROM OPERATIONS
|
(5,791,000
|
)
|
(4,405,000
|
)
|
|||
OTHER
INCOME (EXPENSE):
|
|||||||
Interest
and other income
|
349,000
|
76,000
|
|||||
Interest
and other expense
|
(15,000
|
)
|
(10,000
|
)
|
|||
NET
LOSS
|
$
|
(5,457,000
|
)
|
$
|
(4,339,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
184,108,083
|
160,035,717
|
|||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
THREE
MONTHS ENDED JULY 31,
|
|||||||
2006
|
2005
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(5,457,000
|
)
|
$
|
(4,339,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
115,000
|
101,000
|
|||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
373,000
|
104,000
|
|||||
Amortization
of expenses paid in shares of common stock
|
209,000
|
278,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
317,000
|
81,000
|
|||||
Inventories
|
(86,000
|
)
|
(184,000
|
)
|
|||
Prepaid
expenses and other current assets
|
130,000
|
(19,000
|
)
|
||||
Accounts
payable
|
(85,000
|
)
|
(247,000
|
)
|
|||
Accrued
clinical trial site fees
|
(19,000
|
)
|
9,000
|
||||
Deferred
revenue
|
(250,000
|
)
|
189,000
|
||||
Accrued
payroll and related costs
|
(226,000
|
)
|
(340,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
4,000
|
(201,000
|
)
|
||||
Net
cash used in operating activities
|
(4,975,000
|
)
|
(4,568,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(46,000
|
)
|
(208,000
|
)
|
|||
Increase
in other assets
|
-
|
(11,000
|
)
|
||||
Net
cash used in investing activities
|
(46,000
|
)
|
(219,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from borrowings under notes payable
|
-
|
267,000
|
|||||
Principal
payments on notes payable and capital lease
|
(109,000
|
)
|
(57,000
|
)
|
|||
Proceeds
from issuance of common stock, net of issuance costs of $46,000 and
$46,000, respectively
|
16,448,000
|
11,256,000
|
|||||
Net
cash provided by financing activities
|
16,339,000
|
11,466,000
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
11,318,000
|
6,679,000
|
|||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
17,182,000
|
9,816,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
28,500,000
|
$
|
16,495,000
|
July
31,
2006
|
April
30,
2006
|
||||||
Raw
materials
|
$
|
644,000
|
$
|
565,000
|
|||
Work-in-process
|
327,000
|
320,000
|
|||||
Total
inventories
|
$
|
971,000
|
$
|
885,000
|
Three
Months Ended
July
31, 2006
|
||||
Research
and development
|
$
|
166,000
|
||
Selling,
general and administrative
|
133,000
|
|||
Total
|
$
|
299,000
|
Three
Months Ended July 31,
|
|||||||
2006
|
2005
|
||||||
Risk-free
interest rate
|
5.00%
|
|
3.88%
|
|
|||
Expected
life (in years)
|
6.25
|
5.49
|
|||||
Expected
volatility
|
101%
|
|
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
|
280,380
|
$
|
1.49
|
||||||||||
Exercised
|
(34,313
|
)
|
$
|
1.27
|
|||||||||
Canceled
or expired
|
(128,767
|
)
|
$
|
1.77
|
|||||||||
Outstanding,
July 31, 2006
|
11,424,579
|
$
|
1.56
|
6.48
|
$
|
2,410,000
|
|||||||
Exercisable
and expected to vest
|
11,239,902
|
$
|
1.56
|
0.41
|
$
|
2,385,000
|
|||||||
Exercisable,
July 31, 2006
|
8,557,669
|
$
|
1.62
|
5.77
|
$
|
1,988,000
|
Three
Months Ended
|
|||||||
July
31,2006
|
July
31,2005
|
||||||
Net
loss, excluding the effect of employee stock-based
compensation
|
$
|
(5,158,000
|
)
|
$
|
(4,339,000
|
)
|
|
Deduct:
Total stock-based employee compensation expense determined under
the fair
value based method for all awards
|
(299,000
|
)
|
(643,000
|
)
|
|||
Net
loss, including the effect of stock-based compensation
|
$
|
(5,457,000
|
)
|
$
|
(4,982,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
Excluding
the effect of stock-based compensation
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
|
Including
the effect of stock-based compensation
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
Number
of Shares
of
Common Stock Reserved For Issuance
|
||||
Shares
reserved under two effective shelf registration statements
|
5,893,466
|
|||
Options
issued and outstanding
|
11,424,579
|
|||
Options
available for future grant
|
5,167,103
|
|||
Warrants
issued and outstanding
|
2,165,807
|
|||
Total
shares reserved
|
24,650,955
|
Three
Months Ended July 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
398,000
|
$
|
189,000
|
|||
Research
and development of biotherapeutics
|
23,000
|
19,000
|
|||||
Total
net revenues
|
$
|
421,000
|
$
|
208,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
(132,000
|
)
|
$
|
(115,000
|
)
|
|
Research
and development of biotherapeutics
|
23,000
|
19,000
|
|||||
Total
gross loss
|
(109,000
|
)
|
(96,000
|
)
|
|||
Research
and development expense of biotherapeutics
|
(4,041,000
|
)
|
(2,792,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,641,000
|
)
|
(1,517,000
|
)
|
|||
Other
income, net
|
334,000
|
66,000
|
|||||
Net
loss
|
$
|
(5,457,000
|
)
|
$
|
(4,339,000
|
)
|
Three
Months Ended July 31,
|
|||||||
2006
|
2005
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
1%
|
|
37%
|
|
|||
United
States (customer B)
|
1%
|
|
20%
|
|
|||
United
States (customer C)
|
0%
|
|
37%
|
|
|||
Australia
(one customer)
|
93%
|
|
0%
|
|
|||
Other
customers
|
5%
|
|
6%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
July
31,
2006
|
April
30,
2006
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,461,000
|
$
|
1,516,000
|
|||
Research
and development of biotherapeutics
|
376,000
|
390,000
|
|||||
Total
long-lived assets, net
|
$
|
1,837,000
|
$
|
1,906,000
|
Three
Months Ended July 31,
|
||||||||||
2006
|
2005
|
$
Change
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
398,000
|
$
|
189,000
|
$
|
209,000
|
||||
License
revenue
|
23,000
|
19,000
|
4,000
|
|||||||
Total
revenues
|
421,000
|
208,000
|
213,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
530,000
|
304,000
|
226,000
|
|||||||
Research
and development
|
4,041,000
|
2,792,000
|
1,249,000
|
|||||||
Selling,
general & administrative
|
1,641,000
|
1,517,000
|
124,000
|
|||||||
Total
costs and expenses
|
6,212,000
|
4,613,000
|
1,599,000
|
|||||||
LOSS
FROM OPERATIONS
|
(5,791,000
|
)
|
(4,405,000
|
)
|
(1,386,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Interest
and other income
|
349,000
|
76,000
|
273,000
|
|||||||
Interest
and other expense
|
(15,000
|
)
|
(10,000
|
)
|
(5,000
|
)
|
||||
NET
LOSS
|
$
|
(5,457,000
|
)
|
$
|
(4,339,000
|
)
|
$
|
(1,118,000
|
)
|
Technology
Platform
|
R&D
Expenses-Quarter Ended
July
31, 2006
|
|
R&D
Expenses-Quarter Ended
July
31, 2005
|
$
Change
|
||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
2,558,000
|
$
|
1,589,000
|
$
|
969,000
|
||||
TNT
(Cotara®)
|
832,000
|
768,000
|
64,000
|
|||||||
VTA
and Anti-Angiogenesis
|
532,000
|
333,000
|
199,000
|
|||||||
VEA
|
119,000
|
102,000
|
17,000
|
|||||||
Total
R&D Expenses
|
$
|
4,041,000
|
$
|
2,792,000
|
$
|
1,249,000
|
o
|
Anti-Phosphatidylserine
(“Anti-PS”)Immunotherapeutics (bavituximab) -
The increase in Anti-PS Immunotherapeutics program expenses of $969,000
during the three months ended July 31, 2006 resulted primarily from
continuing efforts to support the development and clinical advancement
of
our first Anti-PS Immunotherapeutic agent, bavituximab. During the
current
fiscal year quarter, we increased clinical trial expenses to support
two
separate Phase I clinical studies using bavituximab for the treatment
of
advanced solid cancers and chronic hepatitis C virus infection (“HCV”). In
addition, during the current quarter, we initiated patient enrollment
in a
separate Phase Ib HCV repeat dose clinical study designed to evaluate
the
safety and preliminary efficacy of repeat doses of bavituximab. These
increases in clinical trial expenses were further supplemented with
increases in manufacturing, payroll and related expenses and pre-clinical
studies to support the possible expansion of bavituximab clinical
trials
in other anti-viral indications.
|
o
|
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis -
The increase in VTA and Anti-Angiogenesis program expenses of $199,000
during the current quarter is primarily due to increases in payroll
and
related expenses, sponsored research fees, allocated manufacturing
expenses, and outside animal research studies associated with increased
efforts to advance the pre-clinical development of our Anti-Angiogenesis
program.
|
o
|
Tumor
Necrosis Therapy (“TNT”) (Cotara®) - The
increase in TNT program expenses of $64,000 during the current quarter
compared to the same prior year quarter resulted primarily
from increased clinical trial expenses to support the Cotara® dose
confirmation and dosimetry clinical trial for the treatment of brain
cancer in collaboration with the New Approaches to Brain Tumor Therapy
consortium.
|
§
|
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond fiscal year 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.
|
THREE
MONTHS ENDED
|
|||||||
July
31,
2006
|
July
31,
2005
|
||||||
Net
loss, as reported
|
$
|
(5,457,000
|
)
|
$
|
(4,339,000
|
)
|
|
Less non-cash expenses and adjustments to net loss: | |||||||
Depreciation and amortization | 115,000 | 101,000 | |||||
Stock-based compensation and common stock issued under stock bonus plan | 373,000 | 104,000 | |||||
Amortization
of expenses paid in shares of common stock
|
209,000
|
278,000
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(4,760,000
|
)
|
$
|
(3,856,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(215,000
|
)
|
$
|
(712,000
|
)
|
|
Net
cash used in operating activities
|
$
|
(4,975,000
|
)
|
$
|
(4,568,000
|
)
|
·
|
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
|
||||
Three
months ended July 31, 2006 (unaudited)
|
$
|
5,457,000
|
||
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.
|
·
|
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 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
|
11,424,579
|
|||
Common
shares available for future grant under option plans
|
5,167,103
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
2,165,807
|
|||
Total
|
24,650,955
|
Common
Stock
Sales
Price
|
Common
Stock Daily Trading Volume
(000’s
omitted)
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Fiscal
Year 2007
|
|||||||||||||
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.
|
(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.
|
Date:
September
8, 2006
|
By:
/s/ STEVEN W. KING
|
||
Steven
W. King
|
|||
President
and Chief Executive Officer, Director
|
|||
Date:
September
8, 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)
|
By:
|
/s/
STEVEN W. KING
|
Name:
|
Steven
W. King
|
Title:
|
President
and Chief Executive Officer, Director
|
Date:
|
September
8, 2006
|
By:
|
/s/
PAUL J. LYTLE
|
Name:
|
Paul
J. Lytle
|
Title:
|
Chief
Financial Officer
|
Date:
|
September
8, 2006
|