ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
|
Delaware
|
95-3698422
|
(State
or other jurisdiction of incorporation or
organization)
|
(I.R.S.
Employer Identification No.)
|
14272
Franklin Avenue, Tustin, California
|
92780-7017
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Class
|
Shares
Outstanding at March 3, 2006
|
|
Common
Stock, $0.001 par value per share
|
175,318,259
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
|
16
|
|
Company
Overview
|
16
|
||
Risk
Factors of Our Company
|
26
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
27
|
|
Item
4.
|
Controls
and Procedures
|
27
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
27
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
28
|
|
Item
3.
|
Defaults
upon Senior Securities
|
28
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
28
|
|
Item
5.
|
Other
Information
|
28
|
|
Item
6.
|
Exhibits
|
28
|
|
SIGNATURES
|
29
|
||
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
15,664,000
|
$
|
9,816,000
|
|||
Trade
and other receivables, net of allowance for doubtful accounts
of
nil (January) and $69,000 (April)
|
681,000
|
486,000
|
|||||
Inventories
|
1,060,000
|
627,000
|
|||||
Prepaid
expenses and other current assets
|
867,000
|
1,197,000
|
|||||
Total
current assets
|
18,272,000
|
12,126,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
503,000
|
494,000
|
|||||
Laboratory
equipment
|
3,365,000
|
3,029,000
|
|||||
Furniture,
fixtures and office equipment
|
666,000
|
647,000
|
|||||
4,534,000
|
4,170,000
|
||||||
Less
accumulated depreciation and amortization
|
(2,710,000
|
)
|
(2,532,000
|
)
|
|||
Property,
net
|
1,824,000
|
1,638,000
|
|||||
OTHER
ASSETS:
|
|||||||
Note
receivable, net of allowance of nil (January) and
$1,512,000
(April)
|
-
|
-
|
|||||
Other
|
680,000
|
481,000
|
|||||
Total
other assets
|
680,000
|
481,000
|
|||||
TOTAL
ASSETS
|
$
|
20,776,000
|
$
|
14,245,000
|
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,493,000
|
$
|
1,325,000
|
|||
Accrued
clinical trial site fees
|
211,000
|
8,000
|
|||||
Accrued
legal and accounting fees
|
174,000
|
549,000
|
|||||
Accrued
royalties and license fees
|
158,000
|
149,000
|
|||||
Accrued
payroll and related costs
|
617,000
|
806,000
|
|||||
Notes
payable, current portion
|
363,000
|
234,000
|
|||||
Capital
lease obligation, current portion
|
15,000
|
-
|
|||||
Deferred
revenue
|
612,000
|
517,000
|
|||||
Other
current liabilities
|
267,000
|
563,000
|
|||||
Total
current liabilities
|
3,910,000
|
4,151,000
|
|||||
Notes
payable, less current portion
|
457,000
|
434,000
|
|||||
Capital
lease obligation, less current portion
|
50,000
|
-
|
|||||
Deferred
license revenue
|
25,000
|
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 250,000,000 shares;
outstanding
- 174,109,349 (January); 152,983,460 (April)
|
174,000
|
153,000
|
|||||
Additional
paid-in capital
|
198,305,000
|
180,011,000
|
|||||
Deferred
stock compensation
|
(319,000
|
)
|
(751,000
|
)
|
|||
Accumulated
deficit
|
(181,826,000
|
)
|
(169,803,000
|
)
|
|||
Total
stockholders' equity
|
16,334,000
|
9,610,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,776,000
|
$
|
14,245,000
|
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
||||||||||||
January
31,
2006
|
January
31,
2005
|
January
31,
2006
|
January
31,
2005
|
||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||
REVENUES:
|
|||||||||||||
Contract
manufacturing revenue
|
$
|
1,505,000
|
$
|
1,334,000
|
$
|
2,227,000
|
$
|
3,983,000
|
|||||
License
revenue
|
23,000
|
19,000
|
65,000
|
57,000
|
|||||||||
Total
revenues
|
1,528,000
|
1,353,000
|
2,292,000
|
4,040,000
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of contract manufacturing
|
1,088,000
|
1,273,000
|
1,820,000
|
3,265,000
|
|||||||||
Research
and development
|
3,294,000
|
2,548,000
|
9,330,000
|
8,122,000
|
|||||||||
Selling,
general and administrative
|
1,628,000
|
1,338,000
|
4,715,000
|
3,642,000
|
|||||||||
Total
costs and expenses
|
6,010,000
|
5,159,000
|
15,865,000
|
15,029,000
|
|||||||||
LOSS
FROM OPERATIONS
|
(4,482,000
|
)
|
(3,806,000
|
)
|
(13,573,000
|
)
|
(10,989,000
|
)
|
|||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||
Interest
and other income
|
1,381,000
|
65,000
|
1,585,000
|
197,000
|
|||||||||
Interest
and other expense
|
(12,000
|
)
|
(3,000
|
)
|
(35,000
|
)
|
(3,000
|
)
|
|||||
NET
LOSS
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
WEIGHTED
AVERAGE
SHARES
OUTSTANDING:
|
|||||||||||||
Basic
and Diluted
|
171,355,523
|
145,175,059
|
165,772,373
|
142,677,820
|
|||||||||
BASIC
AND DILUTED LOSS PER
COMMON
SHARE
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.08
|
)
|
NINE
MONTHS ENDED JANUARY 31,
|
|||||||
2006
|
2005
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
302,000
|
235,000
|
|||||
Stock-based
compensation
|
361,000
|
134,000
|
|||||
Stock
issued for research services
|
844,000
|
336,000
|
|||||
Gain
on sale of property
|
(6,000
|
)
|
-
|
||||
Recovery
of note receivable
|
(1,229,000
|
)
|
-
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(195,000
|
)
|
1,006,000
|
||||
Inventories
|
(433,000
|
)
|
(305,000
|
)
|
|||
Prepaid
expenses and other current assets
|
(193,000
|
)
|
30,000
|
||||
Accounts
payable
|
168,000
|
41,000
|
|||||
Accrued
clinical trial site fees
|
203,000
|
(9,000
|
)
|
||||
Deferred
revenue
|
70,000
|
(552,000
|
)
|
||||
Accrued
payroll and related costs
|
(189,000
|
)
|
63,000
|
||||
Other
accrued expenses and current liabilities
|
(662,000
|
)
|
316,000
|
||||
Net
cash used in operating activities
|
(12,982,000
|
)
|
(9,500,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(423,000
|
)
|
(584,000
|
)
|
|||
Proceeds
from sale of property
|
6,000
|
-
|
|||||
Increase
in other assets
|
(199,000
|
)
|
(450,000
|
)
|
|||
Recovery
of note receivable
|
1,229,000
|
-
|
|||||
Net
cash provided by (used in) investing activities
|
613,000
|
(1,034,000
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from borrowings under notes payable
|
370,000
|
733,000
|
|||||
Principal
payments on notes payable
|
(218,000
|
)
|
(9,000
|
)
|
|||
Proceeds
from issuance of common stock, net of issuance costs of
$47,000
(January 2006) and $48,000 (January 2005)
|
18,065,000
|
5,365,000
|
|||||
Net
cash provided by financing activities
|
18,217,000
|
6,089,000
|
|||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
5,848,000
|
(4,445,000
|
)
|
||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
9,816,000
|
14,884,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$
|
15,664,000
|
$
|
10,439,000
|
|||
NON-CASH
INVESTING AND FINANCING ACTIVITIES:
|
|||||||
Property
acquired under capital lease
|
$
|
65,000
|
$
|
-
|
|||
Common
stock issued for research fees and as prepayments for future research
services
|
$
|
321,000
|
$
|
903,000
|
1. |
BASIS
OF PRESENTATION
|
2. |
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
January
31,
2006
|
April
30,
2005
|
||||||
Raw
materials
|
$
|
614,000
|
$
|
445,000
|
|||
Work-in-process
|
446,000
|
182,000
|
|||||
Total
inventories
|
$
|
1,060,000
|
$
|
627,000
|
THREE
MONTHS ENDED
|
NINE
MONTHS ENDED
|
||||||||||||
January
31,
2006
|
January
31,
2005
|
January
31,
2006
|
January
31,
2005
|
||||||||||
Net
loss, as reported
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
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
|
(291,000
|
)
|
(630,000
|
)
|
(1,504,000
|
)
|
(2,232,000
|
)
|
|||||
Pro
forma net loss as if the fair value based method had
been
applied to all awards
|
$
|
(3,404,000
|
)
|
$
|
(4,374,000
|
)
|
$
|
(13,527,000
|
)
|
$
|
(13,027,000
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.08
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.08
|
)
|
$
|
(0.09
|
)
|
3.
|
NOTE
RECEIVABLE
|
4. |
NOTES
PAYABLE
|
January
31,
2006
|
April
30,
2005
|
||||||
Note
payable dated November 2004, 5.78% per annum,
monthly
payments of $11,000 due through December 2007
|
$
|
231,000
|
$
|
314,000
|
|||
Note
payable dated December 2004, 5.85% per annum,
monthly
payments of $12,000 due through January 2008
|
263,000
|
354,000
|
|||||
Note
payable dated June 2005, 6.39% per annum,
monthly
payments of $8,000 due through July 2008
|
226,000
|
-
|
|||||
Note
payable dated November 2005, 6.63% per annum,
monthly
payments of $3,000 due through December 2008
|
100,000
|
-
|
|||||
820,000
|
668,000
|
||||||
Less
current portion
|
(363,000
|
)
|
(234,000
|
)
|
|||
Notes
payable, less current portion
|
$
|
457,000
|
$
|
434,000
|
Year
ending April 30:
|
||||
2006
(remaining 3 months)
|
$
|
89,000
|
||
2007
|
368,000
|
|||
2008
|
314,000
|
|||
2009
|
49,000
|
|||
Total
|
$
|
820,000
|
5. |
CAPITAL
LEASE OBLIGATION
|
Furniture,
fixtures and office equipment
|
$
|
68,000
|
||
Less
accumulated depreciation
|
(1,000
|
)
|
||
Net
book value
|
$
|
67,000
|
Year
ending April 30:
|
||||
2006
(remaining 3 months)
|
$ | 4,000 | ||
2007
|
19,000
|
|||
2008
|
19,000
|
|||
2009
|
19,000
|
|||
2010
|
13,000
|
|||
Total
minimum lease payments
|
74,000
|
|||
Amount
representing interest
|
(9,000
|
)
|
||
Net
present value minimum lease payments
|
65,000
|
|||
Less
current portion
|
15,000
|
|||
$
|
50,000
|
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
|
||||
Common
stock purchase agreement dated November 23, 2005
|
8,000,000
|
$
|
6,719,000
|
||||
Common
stock issued to an unrelated entity for research services
|
299,422
|
$
|
321,000
|
||||
21,006,639
|
$
|
18,296,000
|
Number
of Shares
of
Common Stock Reserved For
Issuance
|
||||
Shares
reserved under shelf registration statements
|
4,179,180
|
|||
Options
issued and outstanding
|
11,116,778
|
|||
Options
available for future grant
|
5,600,851
|
|||
Warrants
issued and outstanding
|
7,777,165
|
|||
Total
shares reserved
|
28,673,974
|
8. |
STOCK
OPTIONS
|
9. |
WARRANTS
|
10.
|
SEGMENT
REPORTING
|
Three
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,505,000
|
$
|
1,334,000
|
|||
Research
and development of targeted therapeutics
|
23,000
|
19,000
|
|||||
Total
net revenues
|
$
|
1,528,000
|
$
|
1,353,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
417,000
|
$
|
61,000
|
|||
Research
and development of targeted therapeutics
|
23,000
|
19,000
|
|||||
Total
gross profit
|
440,000
|
80,000
|
|||||
Research
and development expense
|
(3,294,000
|
)
|
(2,548,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,628,000
|
)
|
(1,338,000
|
)
|
|||
Other
income, net
|
1,369,000
|
62,000
|
|||||
Net
loss
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
Three
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
72
|
%
|
45
|
%
|
|||
United
States (customer B)
|
1
|
%
|
26
|
%
|
|||
Germany
(one customer)
|
20
|
%
|
0
|
%
|
|||
Israel
(one customer)
|
1
|
%
|
29
|
%
|
|||
Other
customers
|
6
|
%
|
0
|
%
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
100
|
%
|
Nine
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
2,227,000
|
$
|
3,983,000
|
|||
Research
and development of targeted therapeutics
|
65,000
|
57,000
|
|||||
Total
net revenues
|
$
|
2,292,000
|
$
|
4,040,000
|
|||
Gross
Profit:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
407,000
|
$
|
718,000
|
|||
Research
and development of targeted therapeutics
|
65,000
|
57,000
|
|||||
Total
gross profit
|
472,000
|
775,000
|
|||||
Research
and development expense
|
(9,330,000
|
)
|
(8,122,000
|
)
|
|||
Selling,
general and administrative expense
|
(4,715,000
|
)
|
(3,642,000
|
)
|
|||
Other
income, net
|
1,550,000
|
194,000
|
|||||
Net
loss
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
Nine
Months Ended January 31,
|
|||||||
2006
|
2005
|
||||||
Customer
revenues as a % of net revenues:
|
|||||||
United
States (customer A)
|
75
|
%
|
45
|
%
|
|||
United
States (customer B)
|
3
|
%
|
17
|
%
|
|||
Germany
(one customer)
|
13
|
%
|
0
|
%
|
|||
Israel
(one customer)
|
2
|
%
|
37
|
%
|
|||
Other
customers
|
7
|
%
|
1
|
%
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
100
|
%
|
January
31,
2006
|
April
30,
2005
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,376,000
|
$
|
1,291,000
|
|||
Research
and development of targeted therapeutics
|
448,000
|
347,000
|
|||||
Total
long-lived assets, net
|
$
|
1,824,000
|
$
|
1,638,000
|
11.
|
SUBSEQUENT
EVENTS
|
ITEM 2. |
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS
OF OPERATIONS
|
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 following clinical sites: MD Anderson Cancer Center
in Houston, Texas; Arizona Cancer Center in Tucson,
Arizona; Premiere Oncology in Scottsdale, Arizona; Premiere
Oncology in Santa Monica, California and; Scott & White
Hospital & Clinic in Temple, Texas.
|
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. Planned enrollment and treatment of
24
patients was completed in February 2006 at Bach and Godofsky Infectious
Diseases located in Bradenton, FL. Based on the safety profile seen
to
date in the first 24 patients, an additional dose level may be added
to
the study. Meanwhile, a repeat dose study and a combination therapy
dose
study are currently being planned.
|
Three
Months Ended
January
31,
|
Nine
Months Ended
January
31,
|
||||||||||||||||||
2006
|
2005
|
$
Change
|
2006
|
2005
|
$
Change
|
||||||||||||||
(in
thousands)
|
(in
thousands)
|
||||||||||||||||||
REVENUES:
|
|||||||||||||||||||
Contract
manufacturing revenue
|
$
|
1,505
|
$
|
1,334
|
$
|
171
|
$
|
2,227
|
$
|
3,983
|
$
|
(1,756
|
)
|
||||||
License
revenue
|
23
|
19
|
4
|
65
|
57
|
8
|
|||||||||||||
Total
revenues
|
1,528
|
1,353
|
175
|
2,292
|
4,040
|
(1,748
|
)
|
||||||||||||
COSTS
AND EXPENSES:
|
|||||||||||||||||||
Cost
of contract manufacturing
|
1,088
|
1,273
|
(185
|
)
|
1,820
|
3,265
|
(1,445
|
)
|
|||||||||||
Research
and development
|
3,294
|
2,548
|
746
|
9,330
|
8,122
|
1,208
|
|||||||||||||
Selling,
general and administrative
|
1,628
|
1,338
|
290
|
4,715
|
3,642
|
1,073
|
|||||||||||||
Total
costs and expenses
|
6,010
|
5,159
|
851
|
15,865
|
15,029
|
836
|
|||||||||||||
LOSS
FROM OPERATIONS
|
(4,482
|
)
|
(3,806
|
)
|
(676
|
)
|
(13,573
|
)
|
(10,989
|
)
|
(2,584
|
)
|
|||||||
OTHER
INCOME (EXPENSE):
|
|||||||||||||||||||
Interest
and other income
|
1,381
|
65
|
1,316
|
1,585
|
197
|
1,388
|
|||||||||||||
Interest
and other expense
|
(12
|
)
|
(3
|
)
|
(9
|
)
|
(35
|
)
|
(3
|
)
|
(32
|
)
|
|||||||
|
|||||||||||||||||||
NET
LOSS
|
$
|
(3,113
|
)
|
$
|
(3,744
|
)
|
$
|
631
|
|
$
|
(12,023
|
)
|
$
|
(10,795
|
)
|
$
|
(1,228
|
)
|
o |
Anti-Phospholipid
Therapy (Tarvacin™) - During
the three months ended January 31, 2006, Anti-Phospholipid Therapy
(Tarvacin™) program expenses increased $1,489,000 from $685,000 in fiscal
year 2005 to $2,174,000 in fiscal year 2006. The increase in
Anti-Phospholipid Therapy (Tarvacin™)
program expenses is primarily due to an increase in manufacturing
and
in-house antibody development expenses combined with an increase
in
various clinical trial expenses
to
support two separate Phase I clinical studies using Tarvacin™ for the
treatment of advanced solid cancers and chronic hepatitis C virus
infection. These increases were supplemented with an increase in
sponsored
research fees and payroll and related expenses associated with the
Anti-Phospholipid Therapy development program. These increases were
offset
by a decrease in pre-clinical toxicology study expenses incurred
in the
prior year quarter to support the Investigational New Drug (“IND”)
applications, which was offset by a similar increase in outside animal
research studies to support the possible expansion of Tarvacin™ clinical
trials in other anti-viral
indications.
|
o |
Vasopermeation
Enhancements Agents (“VEAs”) - During
the three months ended January 31, 2006, VEA program expenses increased
$32,000 from $78,000 in fiscal year 2005 to $110,000 in fiscal year
2006.
The increase in VEA program expenses is primarily due to an increase
in
resources focused on the VEA program compared to the prior year period.
In
January 2005, we entered into an agreement with Merck KGaA of Darmstadt,
Germany, that will give us access to Merck's technology and expertise
in
protein expression to advance the development of our VEA technology
and
other platform technologies. Merck KGaA is presently working on a
clinical
candidate under the VEA technology
platform.
|
o |
Tumor
Necrosis Therapy (“TNT”) (Cotara®) - During
the three months ended January 31, 2006, TNT (Cotara®) program expenses
decreased $571,000 from $1,212,000 in fiscal year 2005 to $641,000
in
fiscal year 2006. The decrease in TNT (Cotara®) program expenses is
primarily due to a decrease in manufacturing, antibody development,
and
radiolabeling expenses incurred in the current quarter as the majority
of
in-house resources have recently been focused on the development
of the
Tarvacin™ program.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis - During
the three months ended January 31, 2006, VTA and Anti-Angiogenesis
program
expenses decreased $204,000 from $573,000 in fiscal year 2005 to
$369,000
in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis program
expenses is primarily due to a decrease in intellectual property
access
fees and sponsored research fees as our outside researchers are primarily
focused on the development of
Tarvacin™.
|
o |
Anti-Phospholipid
Therapy (Tarvacin™) - During
the nine months ended January 31, 2006, Anti-Phospholipid Therapy
(Tarvacin™) program expenses increased $2,849,000 from $3,442,000 in
fiscal year 2005 to $6,291,000 in fiscal year 2006. The increase
in
Anti-Phospholipid Therapy (Tarvacin™)
program expenses is primarily due to an increase in manufacturing
and
in-house antibody development expenses combined with an increase
in
various clinical trial expenses to support two separate Phase I clinical
studies using Tarvacin™ for the treatment of advanced solid cancers and
chronic hepatitis C virus infection. In addition, the increase in
program
expenses was supplemented with an increase in technology access fees
associated with Tarvacin™ Phase I clinical trial milestones achieved
during the current nine month period in accordance with third party
licensing agreements, an increase in sponsored research fees, and
an
increase in outside animal research studies to support the possible
expansion of Tarvacin™ clinical trials in other anti-viral indications.
These increases were primarily offset by a decrease in pre-clinical
toxicology study expenses incurred in the prior year to support the
Tarvacin™ Investigational New Drug (“IND”) applications that were filed in
the prior fiscal year combined with a decrease in outside antibody
development fees related to our humanized antibody in development
and a
decrease in intellectual property access
fees.
|
o |
Tumor
Necrosis Therapy (“TNT”) (Cotara®)
-
During the nine months ended January 31, 2006, TNT (Cotara®) program
expenses decreased $626,000 from $2,336,000 in fiscal year 2005 to
$1,710,000 in fiscal year 2006. The decrease in TNT (Cotara®) program
expenses is primarily due to a decrease in payroll and related expenses
and radiolabeling process development expenses incurred in the same
prior
year period to support the initiation of the first part of the Cotara®
Phase II/III registration trial for the treatment of brain cancer
in
collaboration with the New Approaches to Brain Tumor Therapy consortium,
and to support other development programs associated with our TNT
technology platform. These decreases were further supplemented by
a
decrease in technology access fees incurred in the same prior year
period
supporting the production of monoclonal antibodies for Cotara®.
|
o |
Vascular
Targeting Agents (“VTAs”) and Anti-Angiogenesis -
During the nine months ended January 31, 2006, VTA and Anti-Angiogenesis
program expenses decreased $811,000 from $1,844,000 in fiscal year
2005 to
$1,033,000 in fiscal year 2006. The decrease in VTA and Anti-Angiogenesis
program expenses is primarily due to a decrease in intellectual property
access fees and sponsored research fees as our outside researchers
are
currently focused on the development of
Tarvacin™.
|
o |
Vasopermeation
Enhancements Agents (“VEAs”) - During
the nine months ended January 31, 2006, VEA program expenses decreased
$191,000 from $487,000 in fiscal year 2005 to $296,000 in fiscal
year
2006. The decrease in VEA program expenses is primarily due to a
decrease
in sponsored research fees, combined with a decrease in antibody
development fees regarding expenses incurred in the prior year associated
with a research study that was completed in the prior year. In January
2005, we entered into an agreement with Merck KGaA of Darmstadt,
Germany,
that will give us access to Merck's technology and expertise in protein
expression to advance the development of our VEA technology and other
platform technologies. Merck KGaA is presently working on a clinical
candidate under the VEA technology
platform.
|
1.
|
Tarvacin™
clinical studies 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;
|
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
January
31, 2005
|
R&D
Expenses-Quarter Ended
January
31, 2006
|
R&D
Expenses-
May
1, 1998 to
January
31, 2006
|
|||||||
Anti-Phospholipid
Therapy (Tarvacin™)
|
$
|
685,000
|
$
|
2,174,000
|
$
|
14,405,000
|
||||
TNT
(Cotara®)
|
1,212,000
|
641,000
|
30,526,000
|
|||||||
VTA
and Anti-Angiogenesis
|
573,000
|
369,000
|
11,556,000
|
|||||||
VEA
|
78,000
|
110,000
|
5,664,000
|
|||||||
Other
research programs
|
-
|
-
|
13,441,000
|
|||||||
Total
R&D Expenses
|
$
|
2,548,000
|
$
|
3,294,000
|
$
|
75,592,000
|
§ |
The
uncertainty of our capital resources to fund research, development
and
clinical studies beyond December 31, 2006;
|
§ |
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
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.
|
NINE
MONTHS ENDED
|
|||||||
January
31,
2006
|
January
31,
2005
|
||||||
Net
loss, as reported
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
Less non-cash expenses and adjustments to net loss: | |||||||
Depreciation
and amortization
|
302,000
|
235,000
|
|||||
Stock-based
compensation
|
361,000
|
134,000
|
|||||
Stock
issued for research services
|
844,000
|
336,000
|
|||||
Gain
on sale of property
|
(6,000
|
)
|
- | ||||
Recovery
of note receivable
|
(1,229,000
|
)
|
-
|
||||
Net
cash used in operating activities before changes in
operating
assets and liabilities
|
$
|
(11,751,000
|
)
|
$
|
(10,090,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,231,000
|
)
|
$
|
590,000
|
||
Net
cash used in operating activities
|
$
|
(12,982,000
|
)
|
$
|
(9,500,000
|
)
|
ITEM 3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
ITEM 4. |
CONTROLS
AND
PROCEDURES
|
ITEM 1. |
LEGAL
PROCEEDINGS.
|
ITEM 2. |
UNREGISTERED
SALES OF EQUITY 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.
|
(a)
|
Exhibits:
|
31.1 |
31.2 |
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32 |
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
PEREGRINE
PHARMACEUTICALS, INC.
|
||
|
|
|
Date: March 10, 2006 | By: | /s/ STEVEN W. KING |
|
||
Steven
W. King
President
and Chief Executive Officer,
Director
|
|
|
|
Date: March 10, 2006 | By: | /s/ PAUL J. LYTLE |
|
||
Paul
J. Lytle
Chief
Financial Officer
(signed
both as an officer
duly authorized to sign on
behalf
of the Registrant and principal financial
officer
and
chief accounting officer)
|
Dated: March 10, 2006 |
Signed:
/s/
STEVEN W. KING
|
Dated: March 10, 2006 |
Signed:
/s/
PAUL J. LYTLE
|