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
|
Number
of Shares Outstanding
|
|
Common
Stock, $0.001 par value
|
166,017,599
shares of common stock as of September 6,
2005
|
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Financial
Statements:
|
||
Condensed
Consolidated Balance Sheets at July 31, 2005 (unaudited) and April
30,
2005
|
1
|
||
Condensed
Consolidated Statements of Operations for the three months ended
July 31,
2005 and 2004 (unaudited)
|
3
|
||
Condensed
Consolidated Statements of Cash Flows for the three months ended
July 31,
2005 and 2004 (unaudited)
|
4
|
||
Notes
to Condensed Consolidated Financial Statements (unaudited)
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
|
16
|
|
Company
Overview
|
16
|
||
Risk
Factors of Our Company
|
24
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
25
|
|
Item
4.
|
Controls
and Procedures
|
25
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
25
|
|
Item
2.
|
Changes
in Securities and Use of Proceeds
|
26
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
26
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
|
Item
5.
|
Other
Information
|
26
|
|
Item
6.
|
Exhibits
and Reports on Form 8-K
|
27
|
|
SIGNATURES
|
28
|
JULY
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
16,495,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts of
$70,000
(July) and $69,000 (April)
|
405,000
|
486,000
|
|||||
Inventories
|
811,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
938,000
|
1,197,000
|
|||||
Total
current assets
|
18,649,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
494,000
|
494,000
|
|||||
Laboratory
equipment
|
3,201,000
|
3,029,000
|
|||||
Furniture,
fixtures and computer equipment
|
683,000
|
647,000
|
|||||
4,378,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,633,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,745,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of $1,494,000 (July) and $1,512,000
(April)
|
-
|
-
|
|||||
Other
|
492,000
|
481,000
|
|||||
Total
other assets
|
492,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
20,886,000
|
$
|
14,245,000
|
JULY
31,
2005
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,078,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
17,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
458,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
184,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
466,000
|
806,000
|
|||||
Notes
payable, current portion
|
321,000
|
234,000
|
|||||
Other
current liabilities
|
418,000
|
563,000
|
|||||
Deferred
revenue
|
725,000
|
517,000
|
|||||
Total
current liabilities
|
3,667,000
|
4,151,000
|
|||||
NOTES
PAYABLE
|
557,000
|
434,000
|
|||||
DEFERRED
LICENSE REVENUE
|
31,000
|
50,000
|
|||||
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 200,000,000 shares; outstanding
-
165,690,677 (July); 152,983,460 (April)
|
166,000
|
153,000
|
|||||
Additional
paid-in capital
|
191,254,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(647,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(174,142,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders' equity
|
16,631,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,886,000
|
$
|
14,245,000
|
THREE
MONTHS ENDED
|
|||||||
July
31, 2005
|
July
31, 2004
|
||||||
Unaudited
|
Unaudited
|
||||||
REVENUES:
|
|||||||
Contract
manufacturing revenue
|
$
|
189,000
|
$
|
485,000
|
|||
License
revenue
|
19,000
|
19,000
|
|||||
Total
revenues
|
208,000
|
504,000
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of contract manufacturing
|
304,000
|
448,000
|
|||||
Research
and development
|
2,792,000
|
2,570,000
|
|||||
Selling,
general and administrative
|
1,517,000
|
967,000
|
|||||
Total
costs and expenses
|
4,613,000
|
3,985,000
|
|||||
LOSS
FROM OPERATIONS
|
(4,405,000
|
)
|
(3,481,000
|
)
|
|||
OTHER
INCOME (EXPENSE):
|
|||||||
Interest
and other income
|
76,000
|
68,000
|
|||||
Interest
and other expense
|
(10,000
|
)
|
-
|
||||
NET
LOSS
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
WEIGHTED
AVERAGE SHARES
OUTSTANDING:
|
|||||||
Basic
and Diluted
|
160,035,717
|
141,312,572
|
|||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
THREE
MONTHS ENDED
|
|||||||
July
31, 2005
|
July
31, 2004
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
101,000
|
83,000
|
|||||
Stock-based
compensation
|
104,000
|
95,000
|
|||||
Stock
issued for research services
|
278,000
|
-
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
81,000
|
304,000
|
|||||
Inventories
|
(184,000
|
)
|
(1,032,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(19,000
|
)
|
114,000
|
||||
Accounts
payable
|
(247,000
|
)
|
(140,000
|
)
|
|||
Accrued
clinical trial site fees
|
9,000
|
(21,000
|
)
|
||||
Deferred
revenue
|
189,000
|
1,309,000
|
|||||
Accrued
payroll and related costs
|
(340,000
|
)
|
(168,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
(201,000
|
)
|
42,000
|
||||
Net
cash used in operating activities
|
(4,568,000
|
)
|
(2,827,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(208,000
|
)
|
(24,000
|
)
|
|||
Increase
in other assets
|
(11,000
|
)
|
(134,000
|
)
|
|||
Net
cash used in investing activities
|
(219,000
|
)
|
(158,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of notes payable
|
267,000
|
-
|
|||||
Principal
payments on notes payable
|
(57,000
|
)
|
-
|
||||
Proceeds
from issuance of common stock, net of issuance costs of $46,000
(July
2005) and $3,000 (July 2004)
|
11,256,000
|
57,000
|
|||||
Net
cash provided by financing activities
|
11,466,000
|
57,000
|
|||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
6,679,000
|
(2,928,000
|
)
|
||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
9,816,000
|
14,884,000
|
|||||
CASH AND CASH EQUIVALENTS, end of period |
$
|
16,495,000
|
$
|
11,956,000
|
1. |
BASIS
OF PRESENTATION
|
2. |
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
July
31,
2005
|
April
30,
2005
|
||||||
Raw
materials
|
$
|
474,000
|
$
|
445,000
|
|||
Work-in-process
|
337,000
|
182,000
|
|||||
Total
inventories
|
$
|
811,000
|
$
|
627,000
|
THREE
MONTHS ENDED
|
|||||||
July
31,
2005
|
July
31,
2004
|
||||||
Net
loss, as reported
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Stock-based
employee compensation cost that would have been
included
in the determination of net loss if the fair value based
method
had been applied to all awards
|
(643,000
|
)
|
(790,000
|
)
|
|||
Pro
forma net loss as if the fair value based method had
been
applied to all awards
|
$
|
(4,982,000
|
)
|
$
|
(4,203,000
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
3. |
NOTE
RECEIVABLE
|
Allowance
balance, April 30, 2005
|
$
|
1,581,000
|
||
Principal
payments received
|
(17,000
|
)
|
||
Allowance
balance, July 31, 2005
|
$
|
1,564,000
|
4. |
NOTES
PAYABLE
|
Year
ending April 30:
|
||||
2006
|
$
|
239,000
|
||
2007
|
336,000
|
|||
2008
|
279,000
|
|||
2009
|
24,000
|
|||
Total
|
$
|
878,000
|
5. |
LICENSING,
RESEARCH AND DEVELOPMENT AGREEMENTS
|
6. |
LITIGATION
|
7.
|
STOCKHOLDERS’
EQUITY
|
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
|
||||
12,707,217
|
$
|
11,256,000
|
Number
of Shares
of
Common Stock Reserved For
Issuance
|
||||
Shares
reserved under shelf registration statements
|
962,558
|
|||
Options
issued and outstanding
|
11,236,215
|
|||
Options
available for future grant
|
600,664
|
|||
Warrants
issued and outstanding
|
13,541,796
|
|||
Total
shares reserved
|
26,341,233
|
8.
|
STOCK
OPTIONS AND WARRANTS
|
9. |
SEGMENT
REPORTING
|
Three
Months Ended July 31,
|
|||||||
2005
|
2004
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
189,000
|
$
|
485,000
|
|||
Research
and development of biotherapeutics
|
19,000
|
19,000
|
|||||
Total
net revenues
|
$
|
208,000
|
$
|
504,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
(115,000
|
)
|
$
|
37,000
|
||
Research
and development of biotherapeutics
|
19,000
|
19,000
|
|||||
Total
gross profit (loss)
|
(96,000
|
)
|
56,000
|
||||
Research
and development expense of biotherapeutics
|
(2,792,000
|
)
|
(2,570,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,517,000
|
)
|
(967,000
|
)
|
|||
Other
income, net
|
66,000
|
68,000
|
|||||
Net
loss
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
July
31,
2005
|
April
30,
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,400,000
|
$
|
1,291,000
|
|||
Research
and development of biotherapeutics
|
345,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,745,000
|
$
|
1,638,000
|
Three
Months Ended July 31,
|
|||||||
2005
|
2004
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
37%
|
|
41%
|
|
|||
United
States (customer B)
|
20%
|
|
1%
|
|
|||
United
States (customer C)
|
37%
|
|
0%
|
|
|||
Israel
(one customer)
|
6%
|
|
56%
|
|
|||
Other
customers
|
0%
|
|
2%
|
|
|||
Total
customer revenues as a % of net revenues
|
100%
|
|
100%
|
|
Products
in Clinical Trials
|
||||
Technology
Platform
|
Product
Name
|
Disease
|
Stage
of
Development
|
Development
Status Overview
|
Tumor
Necrosis Therapy (“TNT”)
|
Cotara®
|
Brain
Cancer
|
Phase
II/III registration trial
|
Peregrine,
in collaboration with New Approaches to Brain Tumor Therapy (“NABTT”), a
brain tumor consortium, have initiated the first part of the Phase
II/III
product registration study to evaluate Cotara® for the treatment of brain
cancer. This study is partially funded by the National Cancer Institute
("NCI”) and will treat up to 28 patients. The study is being conducted
at
the following four NABTT institutions: Wake Forest University, Emory
University, University of Alabama at Birmingham and University of
Pennsylvania.
|
Anti-Phospholipid
Therapy
|
Tarvacin™
|
Advanced
Solid Cancers
|
Phase
I
|
This
phase I clinical study is a single and repeat dose escalation study
designed to enroll up to 28 patients with advanced solid tumors that
no
longer respond to standard cancer treatments. Patient enrollment
is open
at the Scottsdale and Tucson sites of the Arizona Cancer Center and
recently at Premiere Oncology in Santa Monica, CA.
|
Anti-Phospholipid
Therapy
|
Tarvacin™
|
Hepatitis
C Virus
|
Phase
I
|
This
phase I clinical study is a single dose-escalation study in up to
32 adult
patients with chronic hepatitis C virus (HCV) infection who either
no
longer respond to or failed standard therapy with pegylated interferon
and
ribavirin combination therapy. Patient enrollment is open at Bach
and
Godofsky Infectious Diseases located in Bradenton, FL.
|
Three
Months Ended July 31,
|
||||||||||
2005
|
2004
|
$
Change
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
189,000
|
$
|
485,000
|
$
|
(296,000
|
)
|
|||
License
revenue
|
19,000
|
19,000
|
-
|
|||||||
Total
revenues
|
208,000
|
504,000
|
(296,000
|
)
|
||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
304,000
|
448,000
|
(144,000
|
)
|
||||||
Research
and development
|
2,792,000
|
2,570,000
|
222,000
|
|||||||
Selling,
general & administrative
|
1,517,000
|
967,000
|
550,000
|
|||||||
Total
costs and expenses
|
4,613,000
|
3,985,000
|
628,000
|
|||||||
LOSS
FROM OPERATIONS
|
(4,405,000
|
)
|
(3,481,000
|
)
|
(924,000
|
)
|
||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Interest
and other income
|
76,000
|
68,000
|
8,000
|
|||||||
Interest
and other expense
|
(10,000
|
)
|
-
|
(10,000
|
)
|
|||||
NET
LOSS
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
$
|
(926,000
|
)
|
1.
|
Clinical
programs associated with the commencement of two separate Phase I
clinical
trials to evaluate Tarvacin™ for the treatment of solid tumors and chronic
hepatitis C virus infection;
|
2.
|
Cotara®
clinical study for the treatment of brain cancer in collaboration
with New
Approaches to Brain Tumor Therapy (“NABTT”), a brain tumor treatment
consortium, representing the first part of our Phase II/III registration
trial;
|
3.
|
Anti-Phospholipid
Therapy 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.
|
Technology
Platform
|
R&D
Expenses-
Quarter
Ended
July
31, 2004
|
R&D
Expenses-
Quarter
Ended
July
31, 2005
|
R&D
Expenses-
May
1, 1998 to
July
31, 2005
|
|||||||
TNT
(Cotara®)
|
$
|
390,000
|
$
|
768,000
|
$
|
29,584,000
|
||||
Anti-Phospholipid
Therapy (Tarvacin™)
|
1,271,000
|
1,571,000
|
9,453,000
|
|||||||
VTA
and Anti-Angiogenesis
|
604,000
|
351,000
|
11,106,000
|
|||||||
VEA
|
296,000
|
102,000
|
5,470,000
|
|||||||
Other
research programs
|
9,000
|
-
|
13,441,000
|
|||||||
Total
R&D Expenses
|
$
|
2,570,000
|
$
|
2,792,000
|
$
|
69,054,000
|
§ |
The
uncertainty of our capital resources to fund research, development
and
clinical studies beyond the current fiscal year;
|
§ |
The
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-angiogensis 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
clinical trial;
|
§ |
The
uncertainty of the Food and Drug Administration allowing our studies
to
move into and 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,
2005
|
July
31,
2004
|
||||||
Net
loss, as reported
|
$
|
(4,339,000
|
)
|
$
|
(3,413,000
|
)
|
|
Less
non-cash operating expenses:
Depreciation
and amortization
Stock-based
compensation
Stock
issued for services
|
101,000
104,000
278,000
|
83,000
95,000
-
|
|||||
Net
cash used in operating activities before
changes
in operating assets and liabilities
|
$
|
(3,856,000
|
)
|
$
|
(3,235,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(712,000
|
)
|
$
|
408,000
|
||
Net
cash used in operating activities
|
$
|
(4,568,000
|
)
|
$
|
(2,827,000
|
)
|
ITEM 3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
ITEM
4.
|
CONTROLS
AND PROCEDURES
|
ITEM 1. |
LEGAL
PROCEEDINGS.
|
ITEM
2.
|
CHANGES
IN SECURITIES AND USE OF PROCEEDS.
None.
|
ITEM 3. |
DEFAULTS
UPON SENIOR SECURITIES.
None.
|
ITEM 4. |
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
|
ITEM 5.
|
OTHER
INFORMATION.
None.
|
ITEM 6. |
EXHIBITS
AND REPORT ON FORM
8-K.
|
(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.
|
(b)
|
Reports
on Form 8-K:
|
(i)
|
Current
report on Form 8-K as filed with the Commission on July 15, 2005
reporting
the Company’s financial results for the fiscal year ended April 30, 2005.
|