Delaware
|
95-3698422
|
||
(State
of incorporation)
|
(I.R.S.
Employer Identification No.)
|
||
14282
Franklin Avenue, Tustin, California
|
92780
|
||
(Address
of principal executive offices)
|
(Zip
Code)
|
Title
of Class
|
|
Name
of Each Exchange on Which Registered
|
Common
Stock ($0.001 par value)
Preferred
Stock Purchase Rights
|
|
The
Nasdaq Stock Market LLC
|
Large
accelerated filer o
|
|
Accelerated
filer
x
|
|
Non-accelerated
filer o
|
Item
1.
|
Business
|
1
|
|
Item
1A.
|
Risk
Factors
|
19
|
|
Item
1B.
|
Unresolved
Staff Comments
|
29
|
|
Item
2.
|
Properties
|
29
|
|
Item
3.
|
Legal
Proceedings
|
30
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
30
|
|
PART
II
|
|||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
31
|
|
Item
6.
|
Selected
Financial Data
|
32
|
|
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
33
|
|
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
46
|
|
Item
8.
|
Financial
Statements and Supplementary Data
|
46
|
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
46
|
|
Item
9A
|
Controls
and Procedures
|
46
|
|
Item
9B.
|
Other
Information
|
46
|
|
PART
III
|
|||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
49
|
|
Item
11.
|
Executive
Compensation
|
49
|
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
49
|
|
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
49
|
|
Item
14.
|
Principal
Accountant Fees and Services
|
49
|
|
PART
IV
|
|||
Exhibits
and Consolidated Financial Statement Schedules
|
50
|
||
Signatures
|
57
|
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 and/or radiation therapy
|
Solid
tumor cancers
|
Phase
II studies.
|
Studies
are being planned and are expected to initiate later this year
in
India.
|
|||
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)
|
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 and is expected to initiate later this year in
the
U.S.
|
1.
|
Pre-clinical
testing.
This generally includes laboratory testing of our products in animals
to
determine safety, efficacy and potential toxicity. Some pre-clinical
studies must be conducted by laboratories that comply with FDA regulations
regarding good laboratory practice.
|
2.
|
Submission
to the FDA of an investigational new drug application
(“IND”). The
results of pre-clinical studies, together with manufacturing information,
analytical data and proposed clinical trial protocols, are submitted
to
the FDA as part of an IND, which must become effective before the
clinical
trials can begin. Once
the IND
is filed, the FDA has 30 days to review it. The IND will automatically
become effective 30 days after the FDA receives it, unless the FDA
indicates prior to the end of the 30-day period that the proposed
protocol
raises concerns that must be resolved to the FDA’s satisfaction before the
trial may proceed. If the FDA raises concerns, we may be unable to
resolve
the proposed protocol to the FDA’s approval in a timely fashion, if at
all.
|
3.
|
Completion
of clinical trials.
Human clinical trials are necessary to seek approval for a new drug
or
biologic and typically involve a three-phase process. In Phase I,
small
clinical trials are generally conducted to determine the safety of
the
product. In Phase II, clinical trials are generally conducted to
assess
safety, acceptable dose, and gain preliminary evidence of the efficacy
of
the product. In Phase III, clinical trials are generally conducted to
provide sufficient data for the statistically valid proof of safety
and
efficacy. A clinical
trial must be conducted according to good clinical practices under
protocols that detail the trial’s objectives, inclusion and exclusion
criteria, the parameters to be used to monitor safety and the efficacy
criteria to be evaluated, and informed consent must be obtained from
all
study subjects. Each protocol must be submitted to the FDA as part
of the
IND. The FDA may impose a clinical hold on an ongoing clinical trial
if,
for example, safety concerns arise, in which case the study cannot
recommence without FDA authorization under terms sanctioned by the
Agency. In addition, before
a clinical trial can be initiated, each
clinical site or hospital administering the product must have the
protocol
reviewed and approved by an institutional review board (“IRB”). The IRB
will consider, among other things, ethical factors and the safety
of human
subjects. The IRB may require changes in a protocol, which may delay
initiation or completion of a study. Phase I, Phase II or
Phase III clinical trials may not be completed successfully within
any specific period of time, if at all, with respect to any of our
potential products. Furthermore, we, the FDA or an IRB may suspend
a
clinical trial at any time for various reasons, including a finding
that
the healthy individuals or patients are being exposed to an unacceptable
health risk.
|
4.
|
Submission
to the FDA of a Biologics License Application (“BLA”) or New Drug
Application (“NDA”).
After completion of clinical studies for an investigational product,
a
Biologics License Application (“BLA”) or New Drug Application (“NDA”) is
submitted to the FDA for product marketing approval. No action can
be
taken to market any new drug or biologic product in the United States
until the FDA has approved an appropriate marketing application.
|
5.
|
FDA
review and approval of the BLA or NDA before the product is commercially
sold or shipped. The
results of pre-clinical studies and clinical trials and manufacturing
information are submitted to the FDA in the form of a BLA or NDA
for
approval of the manufacture, marketing and commercial shipment of
the
product. The FDA may take a number of actions after the BLA or NDA
is
filed, including but not limited to, denying
the BLA or NDA if applicable regulatory criteria are not satisfied,
requiring additional clinical testing or information; or requiring
post-market testing and surveillance to monitor the safety or efficacy
of
the product. Adverse events that are reported after marketing approval
can
result in additional limitations being placed on the product’s use and,
potentially, withdrawal of the product from the market. Any adverse
event,
either before or after marketing approval, can result in product
liability
claims against us.
|
Net
Loss
|
|||||
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
|
16,144,355
|
||
Common
shares issuable upon exercise of outstanding warrants
|
360,000
|
||
Total
|
21,534,989
|
Common
Stock
Sales
Price
|
Common
Stock Daily Trading Volume
(000’s
omitted)
|
||||||||
High
|
Low
|
High
|
Low
|
||||||
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 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.
|
·
|
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.
|
Common
Stock Sales Price
|
||||
High
|
Low
|
|||
Fiscal
Year 2007
|
||||
Quarter
Ended April 30, 2007
|
$1.26
|
$0.86
|
||
Quarter
Ended January 31, 2007
|
$1.39
|
$1.09
|
||
Quarter
Ended October 31, 2006
|
$1.48
|
$1.12
|
||
Quarter
Ended July 31, 2006
|
$1.99
|
$1.30
|
||
Fiscal
Year 2006
|
||||
Quarter
Ended April 30, 2006
|
$1.76
|
$1.20
|
||
Quarter
Ended January 31, 2006
|
$1.40
|
$0.88
|
||
Quarter
Ended October 31, 2005
|
$1.28
|
$0.91
|
||
Quarter
Ended July 31, 2005
|
$1.31
|
$0.92
|
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Revenues
|
$
|
3,708,000
|
$
|
3,193,000
|
$
|
4,959,000
|
$
|
3,314,000
|
$
|
3,921,000
|
||||||
Net
loss
|
$
|
(20,796,000
|
) |
$
|
(17,061,000
|
) |
$
|
(15,452,000
|
) |
$
|
(14,345,000
|
) |
$
|
(11,559,000
|
) | |
Basic
and diluted loss per common share
|
$
|
(0.11
|
) |
$
|
(0.10
|
) |
$
|
(0.11
|
) |
$
|
(0.11
|
) |
$
|
(0.10
|
) | |
Weighted
average common shares outstanding
|
$
|
192,297,309
|
$
|
168,294,782
|
$
|
144,812,001
|
$
|
134,299,407
|
$
|
116,468,353
|
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Cash
and cash equivalents
|
$
|
16,044,000
|
$
|
17,182,000
|
$
|
9,816,000
|
$
|
14,884,000
|
$
|
3,137,000
|
||||||
Working
capital
|
$
|
14,043,000
|
$
|
15,628,000
|
$
|
7,975,000
|
$
|
13,631,000
|
$
|
1,949,000
|
||||||
Total
assets
|
$
|
22,997,000
|
$
|
22,676,000
|
$
|
14,245,000
|
$
|
19,137,000
|
$
|
5,399,000
|
||||||
Long-term
debt
|
$
|
149,000
|
$
|
545,000
|
$
|
434,000
|
$
|
-
|
$
|
760,000
|
||||||
Accumulated
deficit
|
$
|
(207,660,000
|
)
|
$
|
(186,864,000
|
)
|
$
|
(169,803,000
|
)
|
$
|
(154,351,000
|
)
|
$
|
(140,006,000
|
)
|
|
Stockholders’
equity
|
$
|
16,989,000
|
$
|
17,626,000
|
$
|
9,610,000
|
$
|
14,759,000
|
$
|
2,131,000
|
Years
Ended April 30,
|
Years
Ended April 30,
|
||||||||||||||||||
2007
|
2006
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing
|
$
|
3,492
|
$
|
3,005
|
$
|
487
|
$
|
3,005
|
$
|
4,684
|
$
|
(1,679
|
)
|
||||||
License
revenue
|
216
|
188
|
28
|
188
|
275
|
(87
|
)
|
||||||||||||
Total
revenues
|
3,708
|
3,193
|
515
|
3,193
|
4,959
|
(1,766
|
)
|
||||||||||||
COST
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
3,296
|
3,297
|
(1
|
)
|
3,297
|
4,401
|
(1,104
|
)
|
|||||||||||
Research
and development
|
15,876
|
12,415
|
3,461
|
12,415
|
11,164
|
1,251
|
|||||||||||||
Selling,
general and administrative
|
6,446
|
6,564
|
(118
|
)
|
6,564
|
5,098
|
1,466
|
||||||||||||
|
|||||||||||||||||||
Total
cost and expenses
|
25,618
|
22,276
|
3,342
|
22,276
|
20,663
|
1,613
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(21,910
|
)
|
(19,083
|
)
|
(2,827
|
)
|
(19,083
|
)
|
(15,704
|
)
|
(3,379
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Recovery
of note receivable
|
-
|
1,229
|
(1,229
|
)
|
1,229
|
-
|
1,229
|
||||||||||||
Interest
and other income
|
1,160
|
846
|
314
|
846
|
265
|
581
|
|||||||||||||
Interest
and other expense
|
(46
|
)
|
(53
|
)
|
7
|
(53
|
)
|
(13
|
)
|
(40
|
)
|
||||||||
NET
LOSS
|
$
|
(20,796
|
)
|
$
|
(17,061
|
)
|
$
|
(3,735
|
)
|
$
|
(17,061
|
)
|
$
|
(15,452
|
)
|
$
|
(1,609
|
)
|
R&D
Expenses -
Fiscal
Year Ended
April 30,
|
||||||||||
2007
|
2006
|
$
Change
|
||||||||
Technology
Platform:
|
||||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
9,324,000
|
$
|
8,271,000
|
$
|
1,053,000
|
||||
TNT
(Cotara®)
|
3,898,000
|
2,372,000
|
1,526,000
|
|||||||
VTA
and Anti-Angiogenesis Agents
|
2,037,000
|
1,416,000
|
621,000
|
|||||||
VEA
|
617,000
|
356,000
|
261,000
|
|||||||
Total
R&D Expenses
|
$
|
15,876,000
|
$
|
12,415,000
|
$
|
3,461,000
|
1.
|
Ongoing
and anticipated bavituximab clinical studies for the treatment of
solid
tumors and chronic hepatitis C virus
infection;
|
2.
|
Cotara®
clinical studies for the treatment of glioblastoma multiforme in
two
separate clinical studies;
|
3.
|
Anti-PS
Immunotherapeutics
research
and development program;
|
4.
|
2C3
(anti-angiogenesis antibody) research and development
program;
|
5.
|
Vascular
Targeting Agent research and development program;
and
|
6.
|
Vasopermeation
Enhancement Agent research and development
program.
|
R&D
Expenses -
Fiscal
Year Ended
April 30,
|
||||||||||
2006
|
2005
|
$
Change
|
||||||||
Technology
Platform:
|
||||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
8,271,000
|
$
|
5,069,000
|
$
|
3,202,000
|
||||
TNT
(Cotara®)
|
2,372,000
|
3,183,000
|
(811,000
|
)
|
||||||
VTA
and Anti-Angiogenesis Agents
|
1,416,000
|
2,338,000
|
(922,000
|
)
|
||||||
VEA
|
356,000
|
567,000
|
(211,000
|
)
|
||||||
Other
research programs
|
-
|
7,000
|
(7,000
|
)
|
||||||
Total
R&D Expenses
|
$
|
12,415,000
|
$
|
11,164,000
|
$
|
1,251,000
|
·
|
the
uncertainty of our capital resources to fund research, development
and
clinical studies beyond fiscal year 2008;
|
|
·
|
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.
|
Year
Ended April 30,
|
||||||||
2007
|
2006
|
|||||||
Net
loss, as reported
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
||
Less
non-cash operating expenses:
|
||||||||
Depreciation
and amortization
|
475,000
|
415,000
|
||||||
Stock-based
compensation and common stock issued under stock bonus plan
|
1,324,000
|
543,000
|
||||||
Amortization
of expenses paid in shares of common stock
|
391,000
|
1,048,000
|
||||||
Loss
(gain) on sale of property
|
1,000
|
(6,000
|
)
|
|||||
Recovery
of note receivable
|
-
|
(1,229,000
|
)
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(18,605,000
|
)
|
$
|
(16,290,000
|
)
|
||
Net
change in operating assets and liabilities
|
$
|
126,000
|
$
|
(667,000
|
)
|
|||
Net
cash used in operating activities
|
$
|
(18,479,000
|
)
|
$
|
(16,957,000
|
)
|
Payments
Due by Period (in thousands)
|
||||||||||||||||
Total
|
<
1 year
|
1-3
years
|
4-5
years
|
After
5 years
|
||||||||||||
Operating
leases, net (1)
|
$
|
8,945
|
$
|
815
|
$
|
2,394
|
$
|
1,654
|
$
|
4,082
|
||||||
Notes
payable (2)
|
520
|
398
|
122
|
-
|
-
|
|||||||||||
Capital
lease obligation (3)
|
51
|
19
|
32
|
-
|
-
|
|||||||||||
Other
long-term liabilities - minimum license obligations (4)
|
100
|
100
|
-
|
-
|
-
|
|||||||||||
Total
contractual obligations
|
$
|
9,616
|
$
|
1,332
|
$
|
2,548
|
$
|
1,654
|
$
|
4,082
|
(1)
|
Represents
our (i) facility operating lease in Tustin, California under a
non-cancelable lease agreement, (ii) facility operating lease in
Houston,
Texas, which has an original three year lease term, and (iii) various
office equipment leases, which generally have five year lease terms.
|
(2)
|
Represents
our note payable agreements entered into with General Electric Capital
Corporation during fiscal years 2006 and 2005 to finance laboratory
equipment. Amounts include principal and
interest.
|
(3)
|
Represents
our capital lease agreement to finance certain office equipment.
Amounts
include principal and interest.
|
(4)
|
Represents
licensing agreements we periodically enter into with third parties
to
obtain exclusive or non-exclusive licenses for certain technologies.
The
terms of certain of these agreements require us to pay future milestone
payments based on product development success. We anticipate we may
make
milestone payments in the amount of $100,000 during fiscal year 2008
under
in-licensing agreements pertaining to our bavituximab clinical trials.
Other milestones fees under these and other licensing agreements
cannot be
predicted due to the uncertainty of future clinical trial results
and
development milestones and therefore, cannot be reasonably predicted
or
estimated at the present time.
|
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately
and
fairly reflect the transactions and dispositions of the Company’s
assets;
|
·
|
provide
reasonable assurance that transactions are recorded as necessary
to permit
preparation of consolidated financial statements in accordance with
generally accepted accounting principles, and that receipts and
expenditures of the Company are being made only in accordance with
authorizations of the Company’s management and directors;
and
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the consolidated financial
statements.
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/Steven
W. King
|
|
By:
|
|
/s/Paul
J. Lytle
|
|
|
|
Steven
W. King,
|
|
|
|
Paul
J. Lytle
|
|
|
|
|
President
and Chief Executive Officer
|
|
|
|
Chief
Financial Officer
|
|
|
ITEM
15.
|
EXHIBITS
AND FINANCIAL STATEMENT SCHEDULES
|
|
(a)
|
(1)
Consolidated
Financial Statements
|
|
Index
to consolidated financial statements:
|
||
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-1
|
|
Consolidated
Balance Sheets as of April 30, 2007 and 2006
|
F-2
|
|
Consolidated
Statements of Operations for each of the three years in the period
ended
April 30, 2007
|
F-4
|
|
Consolidated
Statements of Stockholders' Equity for each of the three years
in the
period ended April 30, 2007
|
F-5
|
|
Consolidated
Statements of Cash Flows for each of the three years in the period
ended
April 30, 2007
|
F-6
|
|
Notes
to Consolidated Financial Statements
|
F-8
|
|
(2)
Financial
Statement Schedules
|
||
The
following schedule is filed as part of this Form 10-K:
|
||
Schedule
II- Valuation of Qualifying Accounts for each of the three years
in the
period ended April 30, 2007
|
F-30
|
|
Exhibit
Number
|
Description
|
|
3.1
|
Certificate
of Incorporation of Techniclone Corporation, a Delaware corporation
(Incorporated by reference to Exhibit B to the Company’s 1996 Proxy
Statement as filed with the Commission on or about August 20,
1996).
|
|
3.2
|
Amended
and Restated Bylaws of Peregrine Pharmaceuticals, Inc. (formerly
Techniclone Corporation), a Delaware corporation (Incorporated
by reference to Exhibit 3.1 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended October 31, 2003).
|
|
3.3
|
Certificate
of Designation of 5% Adjustable Convertible Class C Preferred Stock
as
filed with the Delaware Secretary of State on April 23, 1997.
(Incorporated by reference to Exhibit 3.1 contained in Registrant’s
Current Report on Form 8-K as filed with the Commission on or about
May
12, 1997).
|
|
3.4
|
Certificate
of Amendment to Certificate of Incorporation of Techniclone Corporation
to
effect the name change to Peregrine Pharmaceuticals, Inc., a Delaware
corporation. (Incorporated by reference to Exhibit 3.4 contained
in
Registrant’s Annual Report on Form 10-K for the year ended April 30,
2001).
|
|
3.5
|
Certificate
of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals,
Inc. to increase the number of authorized shares of the Company’s common
stock to two hundred million shares (Incorporated
by reference to Exhibit 3.5 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended October 31, 2003).
|
|
3.6
|
Certificate
of Amendment to Certificate of Incorporation of Peregrine Pharmaceuticals,
Inc. to increase the number of authorized shares of the Company’s common
stock to two hundred fifty million shares (Incorporated by reference
to
Exhibit 3.6 to Registrant’s Quarterly Report on Form 10-Q for the quarter
ended October 31, 2005).
|
|
3.7
|
Certificate
of Designation of Rights, Preferences and Privileges of Series D
Participating Preferred Stock of the Registrant, as filed with the
Secretary of State of the State of Delaware on March 16, 2006.
(Incorporated by reference to Exhibit 3.7 to Registrant’s Current Report
on Form 8-K as filed with the Commission on March 17,
2006).
|
|
4.1
|
Form
of Certificate for Common Stock (Incorporated by reference to the
exhibit
of the same number contained in Registrant’s Annual Report on Form 10-K
for the year end April 30, 1988).
|
4.13
|
Form
of Stock Purchase Warrant to be issued to the Equity Line Subscribers
pursuant to the Regulation D Common Stock Equity Subscription Agreement
(Incorporated by reference to Exhibit 4.7 contained in Registrant’s
Current Report on Form 8-K as filed with the Commission on or about
June
29, 1998).
|
|
4.16
|
Form
of Non-qualified Stock Option Agreement by and between Registrant,
Director and certain consultants dated December 22, 1999 (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
on Form S-3 (File No. 333-40716)).*
|
Exhibit
Number
|
Description
|
|
4.17
|
Peregrine
Pharmaceuticals, Inc. 2002 Non-Qualified Stock Option Plan (Incorporated
by reference to the exhibit contained in Registrant’s Registration
Statement in Form S-8 (File No. 333-106385)).*
|
|
4.18
|
Form
of 2002 Non-Qualified Stock Option Agreement (Incorporated by reference
to
the exhibit contained in Registrant’s Registration Statement in Form S-8
(File No. 333-106385)).*
|
|
4.19
|
Preferred
Stock Rights Agreement, dated as of March 16, 2006, between the Company
and Integrity Stock Transfer, Inc., including the Certificate of
Designation, the form of Rights Certificate and the Summary of Rights
attached thereto as Exhibits A, B and C, respectively (Incorporated
by
reference to Exhibit 4.19 to Registrant’s Current Report on Form 8-K as
filed with the Commission on March 17,
2006).
|
10.40
|
1996
Stock Incentive Plan (Incorporated by reference to the exhibit contained
in Registrant's Registration Statement in form S-8 (File No.
333-17513)).*
|
|
10.41
|
Stock
Exchange Agreement dated as of January 15, 1997 among the stockholders
of
Peregrine Pharmaceuticals, Inc. and Registrant (Incorporated by reference
to Exhibit 2.1 to Registrant's Quarterly Report on Form 10-Q for
the
quarter ended January 31, 1997).
|
|
10.42
|
First
Amendment to Stock Exchange Agreement among the Stockholders of Peregrine
Pharmaceuticals, Inc. and Registrant (Incorporated by reference to
Exhibit
2.1 contained in Registrant’s Current Report on Form 8-K as filed with the
Commission on or about May 12, 1997).
|
|
10.43
|
Termination
and Transfer Agreement dated as of November 14, 1997 by and between
Registrant and Alpha Therapeutic Corporation (Incorporated by reference
to
Exhibit 10.1 contained in Registrant’s Current Report on Form 8-K as filed
with the commission on or about November 24, 1997).
|
|
10.47
|
Real
Estate Purchase Agreement by and between Techniclone Corporation
and 14282
Franklin Avenue Associates, LLC dated December 24, 1998 (Incorporated
by
reference to Exhibit 10.47 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended January 31, 1999).
|
|
10.48
|
Lease
and Agreement of Lease between TNCA, LLC, as Landlord, and Techniclone
Corporation, as Tenant, dated as of December 24, 1998 (Incorporated
by
reference to Exhibit 10.48 to Registrant's Quarterly Report on Form
10-Q
for the quarter ended January 31, 1999).
|
|
10.49
|
Promissory
Note dated as of December 24, 1998 between Techniclone Corporation
(Payee)
and TNCA Holding, LLC (Maker) for $1,925,000 (Incorporated by reference
to
Exhibit 10.49 to Registrant's Quarterly Report on Form 10-Q for the
quarter ended January 31, 1999).
|
|
10.50
|
Pledge
and Security Agreement dated as of December 24, 1998 for $1,925,000
Promissory Note between Grantors and Techniclone Corporation (Secured
Party) (Incorporated by reference to Exhibit 10.50 to Registrant's
Quarterly Report on Form 10-Q for the quarter ended January 31,
1999).
|
Exhibit
Number
|
Description
|
|
10.56
|
License
Agreement dated as of March 8, 1999 by and between Registrant and
Schering
A.G. (Incorporated
by reference to Exhibit 10.56 to Registrant's Annual Report on Form
10-K
for the year ended April 30, 1999).**
|
|
10.57
|
Patent
License Agreement dated October 8, 1998 between Registrant and the
Board
of Regents of the University of Texas System for patents related
to
Targeting the Vasculature of Solid Tumors (Vascular Targeting Agent
patents) (Incorporated
by reference to Exhibit 10.57 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.58
|
Patent
License Agreement dated October 8, 1998 between Registrant and the
Board
of Regents of the University of Texas System for patents related
to the
Coagulation of the Tumor Vasculature (Vascular Targeting Agent patents)
(Incorporated
by reference to Exhibit 10.58 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.59
|
License
Agreement between Northwestern University and Registrant dated August
4,
1999 covering the LYM-1 and LYM-2 antibodies (Oncolym) (Incorporated
by reference to Exhibit 10.59 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 1999).
|
|
10.67
|
Warrant
to purchase 750,000 shares of Common Stock of Registrant issued to
Swartz
Private Equity, LLC dated November 19, 1999 (Incorporated
by reference to Exhibit 10.67 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended January 31, 2000).
|
10.73
|
Common
Stock Purchase Agreement to purchase up to 6,000,000 shares of Common
Stock of Registrant issued to ZLP Master Fund, LTD, ZLP Master Technology
Fund, LTD, Eric Swartz, Michael C. Kendrick, Vertical Ventures LLC
and
Triton West Group, Inc. dated November 16, 2001 (Incorporated by
reference
to Exhibit 10.73 to Registrant’s Current Report on Form 8-K dated November
19, 2001, as filed with the Commission on November 19,
2001).
|
|
10.74
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock
Purchase
Agreement dated November 16, 2001 (Incorporated by reference to Exhibit
10.74 to Registrant’s Current Report on Form 8-K dated November 19, 2001,
as filed with the Commission on November 19, 2001).
|
|
10.75
|
Common
Stock Purchase Agreement to purchase 1,100,000 shares of Common Stock
of
Registrant issued to ZLP Master Fund, LTD and Vertical Capital Holdings,
Ltd. dated January 28, 2002 (Incorporated by reference to Exhibit
10.75 to
Registrant’s Current Report on Form 8-K dated January 31, 2002, as filed
with the Commission on February 5, 2002).
|
|
10.76
|
Form
of Warrant to be issued to Investors pursuant to the Common Stock
Purchase
Agreement dated January 28, 2002 (Incorporated by reference to Exhibit
10.76 to Registrant’s Current Report on Form 8-K dated January 31, 2002,
as filed with the Commission on February 5, 2002).
|
|
10.77
|
Securities
Purchase Agreement dated as of August 9, 2002 between Registrant
and
Purchasers (Incorporated by reference to Exhibit 10.77 to Registrant’s
Registration Statement on Form S-3 (File No. 333-99157), as filed
with the
Commission on September 4, 2002).
|
Exhibit
Number
|
Description
|
|
10.78
|
Form
of Convertible Debentures issued to Purchasers pursuant to Securities
Purchase Agreement dated August 9, 2002 (Incorporated by reference
to
Exhibit 10.78 to Registrant’s Registration Statement on Form S-3 (File No.
333-99157), as filed with the Commission on September 4,
2002).
|
|
10.79
|
Registration
Rights Agreement dated August 9, 2002 between Registrant and Purchasers
of
Securities Purchase Agreements dated August 9, 2002 (Incorporated
by
reference to Exhibit 10.79 to Registrant’s Registration Statement on Form
S-3 (File No. 333-99157), as filed with the Commission on September
4,
2002).
|
|
10.80
|
Form
of Warrant to be issued to Purchasers pursuant to Securities Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.80
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4, 2002).
|
|
10.81
|
Form
of Warrant issued to Debenture holders pursuant to Securities Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.81
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4, 2002).
|
|
10.82
|
Form
of Adjustment Warrant issued to Investors pursuant to Securities
Purchase
Agreement dated August 9, 2002 (Incorporated by reference to Exhibit
10.82
to Registrant’s Registration Statement on Form S-3 (File No. 333-99157),
as filed with the Commission on September 4, 2002).
|
|
10.83
|
Securities
Purchase Agreement dated as of August 9, 2002 between Registrant
and ZLP
Master Fund, Ltd. (Incorporated by reference to Exhibit 10.83 to
Registrant’s Registration Statement on Form S-3 (File No. 333-99157), as
filed with the Commission on September 4, 2002).
|
|
10.84
|
Registration
Rights Agreement dated August 9, 2002 between Registrant and ZLP
Master
Fund, Ltd. (Incorporated by reference to Exhibit 10.84 to Registrant’s
Registration Statement on Form S-3 (File No. 333-99157), as filed
with the
Commission on September 4, 2002).
|
|
10.85
|
Form
of Warrant to be issued to ZLP Master Fund, Ltd. pursuant to Securities
Purchase Agreement dated August 9, 2002 (Incorporated by reference
to
Exhibit 10.85 to Registrant’s Registration Statement on Form S-3 (File No.
333-99157), as filed with the Commission on September 4,
2002).
|
|
10.86
|
Form
of Adjustment Warrant issued to ZLP Master Fund, Ltd. pursuant to
Securities Purchase Agreement dated August 9, 2002 (Incorporated
by
reference to Exhibit 10.86 to Registrant’s Registration Statement on Form
S-3 (File No. 333-99157), as filed with the Commission on September
4,
2002).
|
|
10.87
|
Common
Stock Purchase Agreement dated June 6, 2003 between Registrant and
eight
institutional investors (Incorporated
by reference to Exhibit 10.87 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
|
10.88
|
Common
Stock Purchase Agreement dated June 6, 2003 between Registrant and
one
institutional investor (Incorporated
by reference to Exhibit 10.88 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
Exhibit
Number
|
Description
|
10.89
|
Common
Stock Purchase Agreement dated June 26, 2003 between Registrant and
seven
institutional investors (Incorporated
by reference to Exhibit 10.89 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
|
10.90
|
Common
Stock Purchase Agreement dated July 24, 2003 between Registrant and
one
institutional investor (Incorporated
by reference to Exhibit 10.90 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended July 31, 2003).
|
|
10.91
|
Common
Stock Purchase Agreement dated September 18, 2003 between Registrant
and
one institutional investor (Incorporated
by reference to Exhibit 10.91 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended October 31, 2003).
|
|
10.92
|
Common
Stock Purchase Agreement dated January 22, 2004 between Registrant
and one
institutional investor (Incorporated
by reference to Exhibit 10.92 to Registrant's Quarterly Report on
Form
10-Q for the quarter ended January 31, 2004).
|
|
10.93
|
Common
Stock Purchase Agreement dated March 31, 2004 between Registrant
and one
institutional investor (Incorporated by reference to Exhibit 10.93
to
Registrant’s Annual Report on Form 10-K for the year ended April 30,
2005).
|
|
10.95
|
2003
Stock Incentive Plan Non-qualified Stock Option Agreement (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
in form S-8 (File No. 333-121334).*
|
|
10.96
|
2003
Stock Incentive Plan Incentive Stock Option Agreement (Incorporated
by
reference to the exhibit contained in Registrant’s Registration Statement
in form S-8 (File No. 333-121334)).*
|
|
10.97
|
Common
Stock Purchase Agreement dated January 31, 2005 between Registrant
and one
institutional investor (Incorporated by reference to Exhibit 10.97
to
Registrant’s Quarterly Report on Form 10-Q for the quarter ended January
31, 2005).
|
|
10.98
|
Form
of Incentive Stock Option Agreement for 2005 Stock Incentive Plan
(Incorporated by reference to Exhibit 10.98 to Registrant’s Current Report
on Form 8-K as filed with the Commission on October 28,
2005).*
|
|
10.99
|
Form
of Non-Qualified Stock Option Agreement for 2005 Stock Incentive
Plan
(Incorporated by reference to Exhibit 10.99 to Registrant’s Current Report
on Form 8-K as filed with the Commission on October 28,
2005).*
|
|
10.100
|
Peregrine
Pharmaceuticals, Inc. 2005 Stock Incentive Plan (Incorporated by
reference
to Exhibit B to Registrant’s Definitive Proxy Statement filed with the
Commission on August 29, 2005).*
|
|
10.101
|
First
Amendment to Lease and Agreement of Lease between TNCA, LLC, as Landlord,
and Peregrine Pharmaceuticals, Inc., as Tenant, dated December 22,
2005
(Incorporated by reference to Exhibit 99.1 and 99.2 to Registrant’s
Current Report on Form 8-K as filed with the Commission on December
23,
2005).
|
|
Exhibit
Number
|
Description
|
|
10.102
|
Common
Stock Purchase Agreement dated May 11, 2005 between Registrant and
one
institutional investor (Incorporated by reference to Registrant’s Current
Report on Form 8-K as filed with the Commission on May 11,
2005).
|
|
10.103
|
Common
Stock Purchase Agreement dated June 22, 2005 between Registrant and
one
institutional investor (Incorporated by reference to Exhibit 99.1
to
Registrant’s Current Report on Form 8-K as filed with the Commission on
June 24, 2005).
|
|
10.104
|
Common
Stock Purchase Agreement dated November 23, 2005 between Registrant
and
one institutional investor (Incorporated by reference to Registrant’s
Current Report on Form 8-K as filed with the Commission on November
23,
2005).
|
|
10.105
|
Common
Stock Purchase Agreement dated April 5, 2006 between Registrant and
one
institutional investor (Incorporated by reference to Exhibit 99.2
to
Registrant’s Current Report on Form 8-K as filed with the Commission on
April 6, 2006).
|
|
10.106
|
Form
of Performance Share Award Agreement / Stock Bonus Plan dated February
13,
2006 between Registrant and key employees and consultants.
**
|
|
10.107
|
Common
Stock Purchase Agreement dated June 16, 2006 between Registrant and
one
institutional investor (Incorporated by reference to Exhibit 99.2
to
Registrant's Current Report on Form 8-K as filed with the Commission
on
June 19, 2006).
|
|
21
|
Subsidiaries
of Registrant ***
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm ***
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.***
|
|
31.2
|
Certification
of 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.***
|
|
_______________________________
|
*
|
This
Exhibit is a management contract or a compensation plan or
arrangement.
|
|
**
|
Portions
omitted pursuant to a request of confidentiality filed separately
with the
Commission.
|
|
***
|
Filed
herewith.
|
PEREGRINE PHARMACEUTICALS, INC. | ||
|
|
|
Dated: July 9, 2007 | By: | /s/ STEVEN W. KING |
|
||
Steven
W. King, President and Chief Executive Officer
|
Signature
|
Capacity
|
Date
|
||
/s/
Steven W. King
|
President
& Chief Executive
|
July
9, 2007
|
||
Steven
W. King
|
Officer
(Principal Executive Officer)
|
|||
/s/
Paul J. Lytle
|
Chief
Financial Officer
|
July
9, 2007
|
||
Paul
J. Lytle
|
(Principal
Financial and Principal Accounting Officer)
|
|||
/s/
Carlton M. Johnson
|
Director
|
July
9, 2007
|
||
Carlton
M. Johnson
|
||||
/s/
David H. Pohl
|
Director
|
July
9, 2007
|
||
David
H. Pohl
|
||||
/s/
Eric S. Swartz
|
Director
|
July
9, 2007
|
||
Eric
S. Swartz
|
||||
/s/
Dr. Thomas A. Waltz
|
Director
|
July
9, 2007
|
||
Thomas A. Waltz |
2007
|
2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
16,044,000
|
$
|
17,182,000
|
|||
Trade
and other receivables
|
750,000
|
579,000
|
|||||
Inventories,
net
|
1,916,000
|
885,000
|
|||||
Prepaid
expenses and other current assets
|
1,188,000
|
1,466,000
|
|||||
Total
current assets
|
19,898,000
|
20,112,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
646,000
|
618,000
|
|||||
Laboratory
equipment
|
3,533,000
|
3,444,000
|
|||||
Furniture,
fixtures and computer equipment
|
873,000
|
666,000
|
|||||
5,052,000
|
4,728,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,212,000
|
)
|
(2,822,000
|
)
|
|||
Property,
net
|
1,840,000
|
1,906,000
|
|||||
Other
assets
|
1,259,000
|
658,000
|
|||||
TOTAL
ASSETS
|
$
|
22,997,000
|
$
|
22,676,000
|
2007
|
2006
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,683,000
|
$
|
1,233,000
|
|||
Accrued
clinical trial site fees
|
228,000
|
170,000
|
|||||
Accrued
legal and accounting fees
|
392,000
|
250,000
|
|||||
Accrued
royalties and license fees
|
337,000
|
138,000
|
|||||
Accrued
payroll and related costs
|
874,000
|
850,000
|
|||||
Notes
payable, current portion
|
379,000
|
429,000
|
|||||
Capital
lease obligation, current portion
|
17,000
|
15,000
|
|||||
Deferred
revenue
|
1,060,000
|
563,000
|
|||||
Other
current liabilities
|
885,000
|
836,000
|
|||||
Total
current liabilities
|
5,855,000
|
4,484,000
|
|||||
Notes
payable, less current portion
|
119,000
|
498,000
|
|||||
Capital
lease obligation, less current portion
|
30,000
|
47,000
|
|||||
Deferred
license revenue
|
4,000
|
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
–
196,112,201 and 179,382,191, respectively
|
196,000
|
179,000
|
|||||
Additional
paid-in-capital
|
224,453,000
|
204,546,000
|
|||||
Deferred
stock compensation
|
-
|
(235,000
|
)
|
||||
Accumulated
deficit
|
(207,660,000
|
)
|
(186,864,000
|
)
|
|||
Total
stockholders’ equity
|
16,989,000
|
17,626,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
22,997,000
|
$
|
22,676,000
|
2007
|
2006
|
2005
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
3,492,000
|
$
|
3,005,000
|
$
|
4,684,000
|
||||
License
revenue
|
216,000
|
188,000
|
275,000
|
|||||||
Total
revenues
|
3,708,000
|
3,193,000
|
4,959,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
3,296,000
|
3,297,000
|
4,401,000
|
|||||||
Research
and development
|
15,876,000
|
12,415,000
|
11,164,000
|
|||||||
Selling,
general and administrative
|
6,446,000
|
6,564,000
|
5,098,000
|
|||||||
Total
costs and expenses
|
25,618,000
|
22,276,000
|
20,663,000
|
|||||||
LOSS
FROM OPERATIONS
|
(21,910,000
|
)
|
(19,083,000
|
)
|
(15,704,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Recovery
of note receivable
|
-
|
1,229,000
|
-
|
|||||||
Interest
and other income
|
1,160,000
|
846,000
|
265,000
|
|||||||
Interest
and other expense
|
(46,000
|
)
|
(53,000
|
)
|
(13,000
|
)
|
||||
NET
LOSS
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
192,297,309
|
168,294,782
|
144,812,001
|
|||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.11
|
)
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
Additional
|
Deferred
|
Total
|
|||||||||||||||||
Common
Stock
|
Paid-In
|
Stock
|
Accumulated
|
Stockholders’
|
|||||||||||||||
Shares
|
Amount
|
Captital
|
Compensation
|
Deficit
|
Equity
|
||||||||||||||
BALANCES,
April 30, 2004
|
141,268,182
|
$
|
141,000
|
$
|
168,969,000
|
$
|
-
|
$
|
(154,351,000
|
)
|
$
|
14,759,000
|
|||||||
Common
stock issued for cash under March 31, 2004 Financing, net of issuance
costs of $43,000
|
3,000,000
|
3,000
|
3,204,000
|
-
|
-
|
3,207,000
|
|||||||||||||
Common
stock issued for cash under January 31, 2005 Financing, net of
issuance
costs of $1,000
|
3,000,000
|
3,000
|
3,276,000
|
-
|
-
|
3,279,000
|
|||||||||||||
Common
stock issued to various unrelated entities for research
services
|
1,174,682
|
1,000
|
1,448,000
|
-
|
-
|
1,449,000
|
|||||||||||||
Common
stock issued upon exercise of options and warrants, net of issuance
costs
of $5,000
|
4,540,596
|
5,000
|
2,132,000
|
-
|
-
|
2,137,000
|
|||||||||||||
Deferred
stock compensation
|
-
|
-
|
982,000
|
(982,000
|
)
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
231,000
|
-
|
231,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(15,452,000
|
)
|
(15,452,000
|
)
|
|||||||||||
BALANCES,
April 30, 2005
|
152,983,460
|
153,000
|
180,011,000
|
(751,000
|
)
|
(169,803,000
|
)
|
9,610,000
|
|||||||||||
Common
stock issued for cash under January 31, 2005 Financing, net of
issuance
costs of $6,000
|
1,582,217
|
1,000
|
1,575,000
|
-
|
-
|
1,576,000
|
|||||||||||||
Common
stock issued for cash under May 11, 2005 Financing, net of issuance
costs
of $11,000
|
3,125,000
|
3,000
|
2,986,000
|
-
|
-
|
2,989,000
|
|||||||||||||
Common
stock issued for cash under June 22, 2005 Financing, net of issuance
costs
of $29,000
|
8,000,000
|
8,000
|
6,683,000
|
-
|
-
|
6,691,000
|
|||||||||||||
Common
stock issued for cash under November 23, 2005 Financing, net of
issuance
costs of $1,000
|
8,000,000
|
8,000
|
6,711,000
|
-
|
-
|
6,719,000
|
|||||||||||||
Common
stock issued for cash under April 5, 2006 Financing, net of issuance
costs
of $1,000
|
4,000,000
|
4,000
|
4,915,000
|
-
|
-
|
4,919,000
|
|||||||||||||
Common
stock issued to various unrelated entities for research
services
|
695,820
|
1,000
|
906,000
|
-
|
-
|
907,000
|
|||||||||||||
Common
stock issued upon exercise of options and warrants
|
966,742
|
1,000
|
732,000
|
-
|
-
|
733,000
|
|||||||||||||
Common
stock issued under the Company's stock bonus plan
|
28,952
|
-
|
44,000
|
-
|
-
|
44,000
|
|||||||||||||
Deferred
stock compensation
|
-
|
-
|
(17,000
|
)
|
17,000
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
-
|
499,000
|
-
|
499,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(17,061,000
|
)
|
(17,061,000
|
)
|
|||||||||||
BALANCES,
April 30, 2006
|
179,382,191
|
179,000
|
204,546,000
|
(235,000
|
)
|
(186,864,000
|
)
|
17,626,000
|
|||||||||||
Common
stock issued for cash under June 16, 2006 Financing, net of issuance
costs
of $30,000
|
9,285,714
|
10,000
|
12,960,000
|
-
|
-
|
12,970,000
|
|||||||||||||
Common
stock issued to various unrelated entities for prepaid research
services
|
862,832
|
1,000
|
930,000
|
-
|
-
|
931,000
|
|||||||||||||
Common
stock issued upon exercise of options
|
65,350
|
-
|
59,000
|
-
|
-
|
59,000
|
|||||||||||||
Common
stock issued upon exercise of warrants, net of issuance costs of
$16,000
|
6,266,788
|
6,000
|
4,830,000
|
-
|
-
|
4,836,000
|
|||||||||||||
Common
stock issued under stock bonus plan
|
249,326
|
-
|
342,000
|
-
|
-
|
342,000
|
|||||||||||||
Elimination
of deferred stock compensation upon adoption of SFAS No. 123R
|
-
|
-
|
(235,000
|
)
|
235,000
|
-
|
-
|
||||||||||||
Stock-based
compensation
|
-
|
-
|
1,021,000
|
-
|
-
|
1,021,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(20,796,000
|
)
|
(20,796,000
|
)
|
|||||||||||
BALANCES,
April 30, 2007
|
196,112,201
|
$
|
196,000
|
$
|
224,453,000
|
$
|
-
|
$
|
(207,660,000
|
)
|
$
|
16,989,000
|
2007
|
2006
|
2005
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
475,000
|
415,000
|
325,000
|
|||||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
1,324,000
|
543,000
|
231,000
|
|||||||
Amortization
of expenses paid in shares of common stock
|
391,000
|
1,048,000
|
485,000
|
|||||||
Loss
(gain) on sale of property
|
1,000
|
(6,000
|
)
|
-
|
||||||
Recovery
of note receivable
|
-
|
(1,229,000
|
)
|
-
|
||||||
Changes
in operating assets and liabilities:
|
||||||||||
Trade
and other receivables
|
(171,000
|
)
|
(93,000
|
)
|
1,034,000
|
|||||
Inventories
|
(1,031,000
|
)
|
(258,000
|
)
|
613,000
|
|||||
Prepaid
expenses and other current assets
|
(113,000
|
)
|
(410,000
|
)
|
7,000
|
|||||
Accounts
payable
|
450,000
|
(92,000
|
)
|
(6,000
|
)
|
|||||
Accrued
clinical trial site fees
|
58,000
|
162,000
|
(46,000
|
)
|
||||||
Deferred
revenue
|
480,000
|
17,000
|
(1,082,000
|
)
|
||||||
Accrued
payroll and related expenses
|
63,000
|
44,000
|
303,000
|
|||||||
Other
accrued expenses and current liabilities
|
390,000
|
(37,000
|
)
|
420,000
|
||||||
Net
cash used in operating activities
|
(18,479,000
|
)
|
(16,957,000
|
)
|
(13,168,000
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
Property
acquisitions
|
(220,000
|
)
|
(618,000
|
)
|
(1,090,000
|
)
|
||||
Decrease
(increase) in other assets, net
|
140,000
|
(171,000
|
)
|
(101,000
|
)
|
|||||
Recovery
of note receivable
|
-
|
1,229,000
|
-
|
|||||||
Net
cash (used in) provided by investing activities
|
(80,000
|
)
|
440,000
|
(1,191,000
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Proceeds
from issuance of common stock, net of issuance costs of $46,000,
$48,000, and $49,000, respectively
|
17,865,000
|
23,627,000
|
8,623,000
|
|||||||
Proceeds
from issuance of notes payable
|
-
|
566,000
|
733,000
|
|||||||
Principal
payments on notes payable and capital lease
|
(444,000
|
)
|
(310,000
|
)
|
(65,000
|
)
|
||||
Net
cash provided by financing activities
|
17,421,000
|
23,883,000
|
9,291,000
|
2007
|
2006
|
2005
|
||||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
$
|
(1,138,000
|
)
|
$
|
7,366,000
|
$
|
(5,068,000
|
)
|
||
CASH
AND CASH EQUIVALENTS, Beginning of year
|
17,182,000
|
9,816,000
|
14,884,000
|
|||||||
CASH
AND CASH EQUIVALENTS, End of year
|
$
|
16,044,000
|
$
|
17,182,000
|
$
|
9,816,000
|
||||
SUPPLEMENTAL
INFORMATION:
|
||||||||||
Interest
paid
|
$
|
50,000
|
$
|
49,000
|
$
|
13,000
|
||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||
Property
acquired under capital lease
|
$
|
-
|
$
|
65,000
|
$
|
-
|
||||
Common
stock issued for research fees and prepayments for future research
services
|
$
|
931,000
|
$
|
907,000
|
$
|
1,449,000
|
1.
|
ORGANIZATION
AND BUSINESS DESCRIPTION
|
2007
|
2006
|
||||||||
Raw
materials, net
|
$
|
810,000
|
$
|
565,000
|
|||||
Work-in-process
|
1,106,000
|
320,000
|
|||||||
Total
inventories
|
$
|
1,916,000
|
$
|
885,000
|
2007
|
||||
Research
and development
|
$
|
589,000
|
||
Selling,
general and administrative
|
375,000
|
|||
Total
|
$
|
964,000
|
||
Year
Ended April 30,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Risk-free
interest rate
|
4.83%
|
|
3.88%
|
|
3.38%
|
|
||||
Expected
life (in years)
|
6.25
|
5.49
|
4.00
|
|||||||
Expected
volatility
|
98%
|
|
103%
|
|
115%
|
|
||||
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
|
1,005,260
|
$
1.29
|
||||||||
Exercised
|
(65,350)
|
$
0.90
|
||||||||
Canceled
or expired
|
(709,243)
|
$
1.63
|
||||||||
Outstanding,
April 30, 2007
|
11,537,946
|
$
1.54
|
5.84
|
$
916,000
|
||||||
|
||||||||||
Exercisable
and expected to vest
|
11,321,992
|
$
1.54
|
5.79
|
$
912,000
|
||||||
Exercisable,
April 30, 2007
|
9,251,102
|
$
1.59
|
5.20
|
$
888,000
|
||||||
YEAR
ENDED APRIL 30,
|
|||||||
2006
|
2005
|
||||||
Net
loss, as reported
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
|
Deduct:
Total stock-based employee compensation expense determined under
the fair
value based method for all awards
|
(1,755,000
|
)
|
(2,828,000
|
)
|
|||
Net
loss, pro forma
|
$
|
(18,816,000
|
)
|
$
|
(18,280,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
Net
loss, as reported
|
$
|
(0.10
|
)
|
$
|
(0.11
|
)
|
|
Net
loss, pro forma
|
$
|
(0.11
|
)
|
$
|
(0.13
|
)
|
April
30,
2007
|
April
30,
2006
|
||||||
Note
payable dated November 2004; 5.78% per annum; monthly payments of
$11,000
due through December 2007
|
$
|
83,000
|
$
|
202,000
|
|||
Note
payable dated December 2004; 5.85% per annum; monthly payments of
$12,000
due through January 2008
|
103,000
|
232,000
|
|||||
Note
payable dated June 2005; 6.39% per annum; monthly payments of $8,000
due
through July 2008
|
117,000
|
205,000
|
|||||
Note
payable dated November 2005; 6.63% per annum; monthly payments of
$3,000
due through December 2008
|
60,000
|
92,000
|
|||||
Note
payable dated March 2006; 6.87% per annum; monthly payments of $6,000
due
through April 2009
|
135,000
|
196,000
|
|||||
498,000
|
927,000
|
||||||
Less
current portion
|
(379,000
|
)
|
(429,000
|
)
|
|||
Notes
payable, less current portion
|
$
|
119,000
|
$
|
498,000
|
2007
|
2006
|
||||||
Prepaid
expenses and other current assets
|
$
|
183,000
|
$
|
-
|
|||
Other
long-term assets
|
142,000
|
325,000
|
|||||
Total
security deposits
|
$
|
325,000
|
$
|
325,000
|
Year
ending April 30:
|
||||
2008
|
379,000
|
|||
2009
|
119,000
|
|||
Total
|
$
|
498,000
|
Furniture,
fixtures and office equipment
|
$
|
68,000
|
||
Less
accumulated depreciation
|
(18,000
|
)
|
||
Net
book value
|
$
|
50,000
|
Year
ending April 30:
|
||||
2008
|
19,000
|
|||
2009
|
19,000
|
|||
2010
|
13,000
|
|||
Total
minimum lease payments
|
51,000
|
|||
Amount
representing interest
|
(4,000
|
)
|
||
Net
present value minimum lease payments
|
47,000
|
|||
Less
current portion
|
17,000
|
|||
$
|
30,000
|
6.
|
COMMITMENTS
AND CONTINGENCIES
|
Year
ending April 30:
|
Minimum
Lease Payments
|
|||
2008
|
$
|
815,000
|
||
2009
|
793,000
|
|||
2010
|
796,000
|
|||
2011
|
805,000
|
|||
2012
|
822,000
|
|||
Thereafter
|
4,914,000
|
|||
|
$
|
8,945,000
|
Registration
Statement No.
|
Shelf
Effective Date
|
Number
of Shares of
Common
Stock Registered
|
333-109982
|
October
2003
|
12,000,000
|
333-121450
|
December
2004
|
12,000,000
|
333-128322
|
September
2005
|
12,000,000
|
333-132872
|
March
2006
|
15,000,000
|
Fiscal
Year 2005
|
|||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Net
Issuance Value
|
|||||
Common
stock purchase agreement dated March 31, 2004
|
3,000,000
|
$
|
3,207,000
|
||||
Common
stock purchase agreement dated January 31, 2005
|
3,000,000
|
$
|
3,279,000
|
||||
Common
stock issued to unrelated entities for research services
|
1,174,682
|
$
|
1,449,000
|
||||
7,174,682
|
$
|
7,935,000
|
Fiscal
Year 2006
|
|||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Net
Issuance Value
|
|||||
Common
stock purchase agreement dated January 31, 2005
|
1,582,217
|
$
|
1,576,000
|
||||
Common
stock purchase agreement dated May 11, 2005
|
3,125,000
|
$
|
2,989,000
|
||||
Common
stock purchase agreement dated June 22, 2005
|
8,000,000
|
$
|
6,691,000
|
||||
Common
stock purchase agreement dated November 23, 2005
|
8,000,000
|
$
|
6,719,000
|
||||
Common
stock purchase agreement dated April 5, 2006
|
4,000,000
|
$
|
4,919,000
|
||||
Common
stock issued to unrelated entities for research services
|
695,820
|
$
|
907,000
|
||||
25,403,037
|
$
|
23,801,000
|
Fiscal
Year 2007
|
|||||||
Description
of Financing Transaction
|
Number
of Common Stock Shares Issued
|
Net
Issuance Value
|
|||||
Common
stock purchase agreement dated June 16, 2006
|
9,285,714
|
$
|
12,970,000
|
||||
Common
stock issued to unrelated entities for research services
|
862,832
|
$
|
931,000
|
||||
10,148,546
|
$
|
13,901,000
|
Number
of
shares
reserved
|
||||
Shares
reserved under two effective shelf registration statements
|
5,030,634
|
|||
Options
issued and outstanding
|
11,537,946
|
|||
Options
available for future grant
|
4,651,409
|
|||
Warrants
issued and outstanding
|
422,865
|
|||
Total
shares reserved
|
21,642,854
|
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
|
|||||
$2.50
|
10,000
|
3/25/08
|
|||||
$0.86
- $2.50
|
422,865
|
$1.40
|
6/8/07
- 3/31/08
|
2007
|
2006
|
2005
|
||||||||
Net
Revenues:
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
3,492,000
|
$
|
3,005,000
|
$
|
4,684,000
|
||||
Products
in research and development
|
216,000
|
188,000
|
275,000
|
|||||||
Total
revenues, net
|
$
|
3,708,000
|
$
|
3,193,000
|
$
|
4,959,000
|
||||
Gross
Profit (Loss):
|
||||||||||
Contract
manufacturing and development of biologics
|
$
|
196,000
|
$
|
(292,000
|
)
|
$
|
283,000
|
|||
Products
in research and development
|
216,000
|
188,000
|
275,000
|
|||||||
Total
gross profit (loss)
|
$
|
412,000
|
$
|
(104,000
|
)
|
$
|
558,000
|
|||
Research
and development expense
|
(15,876,000
|
)
|
(12,415,000
|
)
|
(11,164,000
|
)
|
||||
Selling,
general and administrative expense
|
(6,446,000
|
)
|
(6,564,000
|
)
|
(5,098,000
|
)
|
||||
Other
income, net
|
1,114,000
|
2,022,000
|
252,000
|
|||||||
Net
loss
|
$
|
(20,796,000
|
)
|
$
|
(17,061,000
|
)
|
$
|
(15,452,000
|
)
|
2007
|
2006
|
2005
|
|||||||||||
Customer
revenues as a % of net revenues:
|
|||||||||||||
United
States (customer A)
|
11
|
%
|
|
73
|
%
|
|
51
|
%
|
|||||
United
States (customer B)
|
0
|
%
|
|
2
|
%
|
|
15
|
%
|
|||||
Germany
(one customer)
|
51
|
%
|
|
10
|
%
|
|
0
|
%
|
|||||
Israel
(one customer)
|
8
|
%
|
|
1
|
%
|
|
32
|
%
|
|||||
Australia
(one customer)
|
14
|
%
|
|
5
|
%
|
|
0
|
%
|
|||||
China
(one customer)
|
10
|
%
|
|
0
|
%
|
|
2
|
%
|
|||||
Other
customers
|
6
|
%
|
|
9
|
%
|
|
0
|
%
|
|||||
Total
customer revenues as a % of net revenues
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
2007
|
2006
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,527,000
|
$
|
1,516,000
|
|||
Products
in research and development
|
313,000
|
390,000
|
|||||
Total
long-lived assets, net
|
$
|
1,840,000
|
$
|
1,906,000
|
2007
|
2006
|
2005
|
||||||||
Provision
for federal income taxes at statutory rate
|
$
|
(7,071,000
|
)
|
$
|
(5,801,000
|
)
|
$
|
(5,254,000
|
)
|
|
State
income taxes, net of federal benefit
|
(1,202,000
|
)
|
(995,000
|
)
|
(902,000
|
)
|
||||
Expiration
and adjustment of loss carryforwards
|
73,000
|
719,000
|
4,513,000
|
|||||||
Change
in valuation allowance
|
8,132,000
|
6,048,000
|
1,628,000
|
|||||||
Increase
of effective tax rate for net state deferred tax asset
|
-
|
-
|
-
|
|||||||
Other,
net
|
68,000
|
29,000
|
15,000
|
|||||||
Income
tax (expense) benefit
|
$
|
-
|
$
|
-
|
$
|
-
|
2007
|
2006
|
||||||
Net
operating loss carryforwards
|
$
|
55,756,000
|
$
|
48,147,000
|
|||
Stock-based
compensation
|
2,067,000
|
1,676,000
|
|||||
General
business and research and development credits
|
118,000
|
118,000
|
|||||
Deferred
revenue
|
424,000
|
233,000
|
|||||
Accrued
liabilities
|
1,067,000
|
1,126,000
|
|||||
Total
deferred tax assets
|
59,432,000
|
51,300,000
|
|||||
Less
valuation allowance
|
(59,432,000
|
)
|
(51,300,000
|
)
|
|||
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
Quarter
Ended
|
|||||||||||||||||||||||||
April
30,
2007
|
January
31,
2007
|
October
31,
2006
|
July
31,
2006
|
April
30,
2006
|
January
31,
2006
|
October
31,
2005
|
July
31,
2005
|
||||||||||||||||||
Net
revenues
|
$
|
2,240,000
|
$
|
363,000
|
$
|
684,000
|
$
|
421,000
|
$
|
901,000
|
$
|
1,528,000
|
$
|
556,000
|
$
|
208,000
|
|||||||||
Cost
of sales
|
$
|
2,049,000
|
$
|
223,000
|
$
|
494,000
|
$
|
530,000
|
(a)
|
$
|
1,477,000
|
(b)
|
$
|
1,088,000
|
$
|
428,000
|
$
|
304,000
|
(c)
|
||||||
Gross
profit (loss)
|
$
|
191,000
|
$
|
140,000
|
$
|
190,000
|
$
|
(109,000
|
)
|
$
|
(576,000
|
)
|
$
|
440,000
|
$
|
128,000
|
$
|
(96,000
|
)
|
||||||
Operating
expenses
|
$
|
5,630,000
|
$
|
5,420,000
|
$
|
5,590,000
|
$
|
5,682,000
|
$
|
4,934,000
|
$
|
4,922,000
|
$
|
4,814,000
|
$
|
4,309,000
|
|||||||||
Net
loss
|
$
|
(5,244,000
|
)
|
$
|
(5,025,000
|
)
|
$
|
(5,070,000
|
)
|
$
|
(5,457,000
|
)
|
$
|
(5,038,000
|
)
|
$
|
(3,113,000
|
)
|
$
|
(4,571,000
|
)
|
$
|
(4,339,000
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
(a)
|
Cost
of sales for the quarter ended July 31, 2006 includes the write-off
of
unusable work-in-process inventory combined with an estimated contract
loss provision associated with one customer, which in the aggregate
totaled $208,000.
|
(b)
|
Cost
of sales for the quarter ended April 30, 2006 includes the write-off
of
unusable work-in-process inventory generated during the quarter
ended
April 30, 2006 in the amount of $698,000 combined with a contract
loss
provision associated with one customer in the amount of
$184,000.
|
(c)
|
Cost
of sales for the quarter ended July 31, 2005 includes additional
costs of
$99,000 incurred during the quarter ended July 31, 2005 to provide
additional data to support required studies for current
customers.
|
Balance
at
|
Charged
|
Balance
|
|||||||||||
Beginning
|
to
costs and
|
at
end
|
|||||||||||
Description
|
of
period
|
expenses
|
Deductions
|
of
period
|
|||||||||
Valuation
reserve for note and other receivables for the year ended April 30,
2005
|
$
|
1,645,000
|
$
|
-
|
$
|
(64,000
|
)
|
$
|
1,581,000
|
||||
Valuation
reserve for note and other receivables for the year ended April 30,
2006
|
$
|
1,581,000
|
$
|
-
|
$
|
(1,581,000
|
)
|
$
|
-
|
||||
Valuation
reserve for note and other receivables for the year ended April 30,
2007
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
Dated:
July
9, 2007
|
|
Signed:
/s/
STEVEN W. KING
|
|
Steven
W. King
|
|||
President
and Chief Executive Officer
|
Dated:
July
9, 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
|
Date:
|
July
9, 2007
|
By:
|
/s/
PAUL J. LYTLE
|
Name:
|
Paul
J. Lytle
|
Title:
|
Chief
Financial Officer
|
Date:
|
July
9, 2007
|