BRAINSTORM CELL THERAPEUTICS INC. - Quarter Report: 2008 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
FOR
THE QUARTERLY PERIOD ENDED September 30, 2008
|
|
|
|
or
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
FOR
THE TRANSITION PERIOD FROM ________ TO
________.
|
COMMISSION
FILE NUMBER 333-61610
BRAINSTORM
CELL THERAPEUTICS INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
20-8133057
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
110
EAST
59th STREET
NEW
YORK,
NY 10022
(Address
of principal executive offices)
(212)
557-9000
(Registrant's
telephone number)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
past 12 months (or for such shorter period that the registrant was required
to
file such reports), and (2) has been subject to such filing requirements for
the
past 90 days. Yes x
No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
(Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o
No
x
As
of
November 3, 2008, the number of shares outstanding of the registrant’s common
stock, $0.00005 par value per share, was 55,241,418
TABLE
OF
CONTENTS
|
|
Page
Number
|
PART
I
|
|
|
|
|
|
Item
1. Financial Statements
|
|
1
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
|
21
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
|
25
|
Item
4T. Controls and Procedures
|
|
26
|
|
|
|
PART
II
|
|
|
|
|
27
|
Item
1. Legal Proceedings
|
|
27
|
Item
1A. Risk Factors
|
|
28
|
Item
5. Other Information
|
|
28
|
Item
6. Exhibits
|
|
28
|
PART
I: FINANCIAL INFORMATION
SPECIAL
NOTE
Unless
otherwise specified in this Quarterly Report on Form 10-Q, all references to
currency, monetary values and dollars set forth herein shall mean United States
(U.S.) dollars.
Item
1. Financial Statements.
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage Company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
IN
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
Page
|
|
Consolidated
Balance Sheets
|
2
|
|
|
Consolidated
Statements of Operations
|
3
|
Statements
of Changes in Stockholders' Equity (Deficiency)
|
4
-
6
|
Consolidated
Statements of Cash Flows
|
7
|
Notes
to Consolidated Financial Statements
|
7
-
20
|
1
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
BALANCE SHEETS
In
U.S. dollars in thousands (except share and per share
data)
September
30,
|
December
31,
|
||||||
2
0 0 8
|
2
0 0 7
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
21
|
$
|
86
|
|||
Restricted
cash
|
40
|
35
|
|||||
Other
receivable and prepaid expenses
|
87
|
137
|
|||||
Total
current assets
|
148
|
258
|
|||||
LONG-TERM
INVESTMENTS:
|
|||||||
Prepaid
expenses
|
12
|
9
|
|||||
Severance
pay fund
|
109
|
75
|
|||||
Total
Long-term investments
|
121
|
84
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
783
|
739
|
|||||
Deferred
Charges
|
-
|
2
|
|||||
Total
assets
|
1,052
|
1,083
|
|||||
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Short
term credit from bank
|
95
|
-
|
|||||
Trade
payables
|
737
|
838
|
|||||
Other
accounts payable and accrued expenses
|
1,505
|
1,049
|
|||||
Short-term
convertible loans
|
169
|
396
|
|||||
Short-term
loan
|
197
|
945
|
|||||
Total
current liabilities
|
2,703
|
3,228
|
|||||
LONG
TERM CONVERTIBLE LOANS
|
-
|
200
|
|||||
ACCRUED
SEVERANCE PAY
|
136
|
83
|
|||||
Total
liabilities
|
2,839
|
3,511
|
|||||
STOCKHOLDERS'
DEFICIENCY:
|
|||||||
Stock
capital: (Note 7)
|
|||||||
Common
stock of $0.00005 par value - Authorized: 800,000,000 shares at
September
30, 2008 and December 31, 2007; Issued and outstanding: 55,241,418
and 41,004,409 shares
at September 30, 2008 and December 31, 2007, respectively
|
3
|
2
|
|||||
Subscription
on account of shares
|
133
|
-
|
|||||
Additional
paid-in capital
|
33,411
|
30,058
|
|||||
Deficit
accumulated during the development stage
|
(35,334
|
)
|
(32,488
|
)
|
|||
Total
stockholders' deficiency
|
(1,787
|
)
|
(2,428
|
)
|
|||
Total
liabilities and stockholders' deficiency
|
$
|
1,052
|
$
|
1,083
|
The
accompanying notes are an integral part of the consolidated financial
statements.
2
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
In
U.S. dollars in thousands (except share data)
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
Period
from September 22, 2000 (inception date) through September
30,
|
|||||||||||||||||
2
0 0 8
|
2
0 0 7
|
2
0 0 8
|
2
0 0 7
|
2
0 0 8
|
|||||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
|||||||||||||||||
Operating
costs and expenses:
|
|||||||||||||||||||
Research
and development
|
$
|
455
|
$
|
524
|
$
|
1,623
|
$
|
1,520
|
$
|
21,828
|
|||||||||
Less-
participation by the Office of the Chief scientist
|
163
|
198
|
458
|
198
|
798
|
||||||||||||||
Research
and development, net
|
292
|
326
|
1,165
|
1,322
|
21,030
|
||||||||||||||
General
and administrative
|
405
|
865
|
1,428
|
2,070
|
11,488
|
||||||||||||||
Totaloperating
costs and expenses
|
697
|
1,191
|
2,593
|
3,392
|
32,518
|
||||||||||||||
Financial
expenses, net
|
31
|
266
|
253
|
930
|
2,599
|
||||||||||||||
728
|
1,457
|
2,846
|
4,322
|
35,117
|
|||||||||||||||
Taxes
on income
|
-
|
5
|
-
|
16
|
53
|
||||||||||||||
Loss
from continuing operations
|
728
|
1,462
|
2,846
|
4,338
|
35,170
|
||||||||||||||
Net
loss from discontinued operations
|
-
|
-
|
-
|
-
|
164
|
||||||||||||||
Net
loss
|
$
|
728
|
$
|
1,462
|
$
|
2,846
|
$
|
4,338
|
$
|
35,334
|
|||||||||
Basic
and diluted net loss per share from continuing operations
|
0.01
|
0.05
|
0.06
|
0.16
|
|||||||||||||||
Weighted
average number of shares outstanding used in computing basic and
diluted
net loss per share
|
51,354,951
|
29,868,357
|
46,958,440
|
26,373,349
|
The
accompanying notes are an integral part of the consolidated financial
statements.
3
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
In
U.S. dollars in thousands (except share data)
Deficit
accumulated
|
Total
|
||||||||||||||||||
Additional
|
Deferred
|
during
the
|
stockholders'
|
||||||||||||||||
Common
stock
|
paid-in
|
stock-based
|
development
|
equity
|
|||||||||||||||
Number
|
Amount
|
capital
|
compensation
|
stage
|
(deficiency)
|
||||||||||||||
Balance
as of September 22, 2000 (date of inception)
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||
Stock
issued on September 22, 2000 for cash at $0.00188 per
share
|
8,500,000
|
$
|
1
|
$
|
16
|
$
|
-
|
$
|
-
|
$
|
17
|
||||||||
Stock
issued on March 31, 2001 for cash at $0.0375 per share
|
1,600,000
|
(*)
-
|
60
|
-
|
-
|
60
|
|||||||||||||
Contribution
of capital
|
-
|
-
|
8
|
-
|
-
|
8
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(17
|
)
|
(17
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
as of March 31, 2001
|
10,100,000
|
1
|
84
|
-
|
(17
|
)
|
68
|
||||||||||||
Contribution
of capital
|
-
|
-
|
11
|
-
|
-
|
11
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(26
|
)
|
(26
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
as of March 31, 2002
|
10,100,000
|
1
|
95
|
-
|
(43
|
)
|
53
|
||||||||||||
Contribution
of capital
|
-
|
-
|
15
|
-
|
-
|
15
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(47
|
)
|
(47
|
)
|
|||||||||||
Balance
as of March 31, 2003
|
10,100,000
|
1
|
110
|
-
|
(90
|
)
|
21
|
||||||||||||
2-for-1
stock split
|
10,100,000
|
(*)-
|
-
|
-
|
-
|
-
|
|||||||||||||
Stock
issued on August 31, 2003 to purchase mineral option at $0.065
per
share
|
100,000
|
(*)-
|
6
|
-
|
-
|
6
|
|||||||||||||
Cancellation
of shares granted to Company's President
|
(10,062,000
|
)
|
(*)-
|
(*)
-
|
-
|
-
|
-
|
||||||||||||
Contribution
of capital
|
-
|
-
|
15
|
-
|
-
|
15
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(73
|
)
|
(73
|
)
|
|||||||||||
|
|||||||||||||||||||
Balance
as of March 31, 2004
|
10,238,000
|
1
|
131
|
-
|
(163
|
)
|
(31
|
)
|
|||||||||||
Stock
issued on June 24, 2004 for private placement at $0.01 per share,
net of
$25,000 issuance expenses
|
8,510,000
|
(*)-
|
60
|
-
|
-
|
60
|
|||||||||||||
Contribution
capital
|
-
|
-
|
7
|
-
|
-
|
7
|
|||||||||||||
Stock
issued in 2004 for private placement at $0.75 per unit
|
1,894,808
|
(*)-
|
1,418
|
-
|
-
|
1,418
|
|||||||||||||
Cancellation
of shares granted to service providers
|
(1,800,000
|
)
|
(*)-
|
-
|
-
|
-
|
|||||||||||||
Deferred
stock-based compensation related to options granted to employees
|
-
|
-
|
5,979
|
(5,979
|
)
|
-
|
-
|
||||||||||||
Amortization
of deferred stock-based compensation related to shares and options
granted
to employees
|
-
|
-
|
-
|
584
|
-
|
584
|
|||||||||||||
Compensation
related to shares and options granted to service providers
|
2,025,000
|
(*)-
|
17,506
|
-
|
-
|
17,506
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(18,840
|
)
|
(18,840
|
)
|
|||||||||||
Balance
as of March 31, 2005
|
20,867,808
|
$
|
1
|
$
|
25,101
|
$
|
(5,395
|
)
|
$
|
(19,003
|
)
|
$
|
704
|
(*) Represents
an amount less than $1.
The
accompanying notes are an integral part of the consolidated financial
statements.
4
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Deficit
accumulated
|
Total
|
||||||||||||||||||
Additional
|
Deferred
|
during
the
|
stockholders'
|
||||||||||||||||
Common
stock
|
paid-in
|
stock-based
|
development
|
equity
|
|||||||||||||||
Number
|
capital
|
compensation
|
stage
|
(deficiency)
|
(deficiency)
|
||||||||||||||
Balance
as of March 31, 2005
|
20,867,808
|
$
|
1
|
$
|
25,101
|
$
|
(5,395
|
)
|
$
|
(19,003
|
)
|
$
|
704
|
||||||
Stock
issued on May 12, 2005 for private placement at $0.8 per share
|
186,875
|
(*)
-
|
149
|
-
|
-
|
149
|
|||||||||||||
Stock
issued on July 27, 2005 for private placement at $0.6 per share
|
165,000
|
(*)
-
|
99
|
-
|
-
|
99
|
|||||||||||||
Stock
issued on September 30, 2005 for private placement at $0.8 per
share
|
312,500
|
(*)
-
|
225
|
-
|
-
|
225
|
|||||||||||||
Stock
issued on December 7, 2005 for private placement at $0.8 per share
|
187,500
|
(*)
-
|
135
|
-
|
-
|
135
|
|||||||||||||
Forfeiture
of options granted to employees
|
-
|
-
|
(3,363
|
)
|
3,363
|
-
|
-
|
||||||||||||
Deferred
stock-based compensation related to shares and options granted
to
directors and employees
|
200,000
|
(*)
-
|
486
|
(486
|
)
|
-
|
-
|
||||||||||||
Amortization
of deferred stock-based compensation related to options and shares
granted
to employees and directors
|
-
|
-
|
51
|
1,123
|
-
|
1,174
|
|||||||||||||
Stock-based
compensation related to options and shares granted to service providers
|
934,904
|
(*)
-
|
662
|
-
|
-
|
662
|
|||||||||||||
Reclassification
due to application of EITF 00-19
|
-
|
-
|
(7,906
|
)
|
(7,906
|
)
|
|||||||||||||
Beneficial
conversion feature related to a convertible bridge loan
|
-
|
-
|
164
|
-
|
-
|
164
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,317
|
)
|
(3,317
|
)
|
|||||||||||
Balance
as of March 31, 2006
|
22,854,587
|
1
|
15,803
|
(1,395
|
)
|
(22,320
|
)
|
(7,911
|
)
|
||||||||||
Elimination
of deferred stock compensation due to implementation of SFAS
123(R)
|
-
|
-
|
(1,395
|
)
|
1,395
|
-
|
-
|
||||||||||||
Stock-based
compensation related to shares and options granted to directors
and
employees
|
200,000
|
-
|
1,168
|
-
|
-
|
1,168
|
|||||||||||||
Reclassification
due to application of EITF 00-19
|
-
|
-
|
7,191
|
-
|
-
|
7,191
|
|||||||||||||
Stock-based
compensation related to options and shares granted to service providers
|
1,147,225
|
(*)
-
|
453
|
-
|
-
|
453
|
|||||||||||||
Warrants
issued to convertible note holder
|
-
|
-
|
11
|
-
|
-
|
11
|
|||||||||||||
Warrants
issued to loan holder
|
-
|
-
|
110
|
-
|
-
|
110
|
|||||||||||||
Beneficial
conversion feature related to convertible bridge loans
|
-
|
-
|
1,086
|
-
|
-
|
1,086
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,924
|
)
|
(3,924
|
)
|
|||||||||||
Balance
as of December 31, 2006
|
24,201,812
|
$
|
1
|
$
|
24,427
|
$
|
-
|
$
|
(26,244
|
)
|
$
|
(1,816
|
)
|
(*) Represents
an amount less than $1 .
The
accompanying notes are an integral part of the consolidated financial
statements.
5
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Deficit
accumulated
|
Total
|
||||||||||||||||||
Additional
|
Deferred
|
during
the
|
stockholders'
|
||||||||||||||||
Common
stock
|
paid-in
|
stock-based
|
development
|
equity
|
|||||||||||||||
Number
|
Amount
|
Capital
and subscription of shares
|
compensation
|
stage
|
(deficiency)
|
||||||||||||||
Balance
as of December 31, 2006
|
24,201,812
|
$
|
1
|
$
|
24,427
|
$
|
-
|
$
|
(26,244
|
)
|
$
|
(1,816
|
)
|
||||||
Stock-based
compensation related to options and shares granted to service providers
|
544,095
|
(*)
-
|
1,446
|
-
|
-
|
1,446
|
|||||||||||||
Warrants
issued to convertible note holder
|
-
|
-
|
109
|
-
|
-
|
109
|
|||||||||||||
Stock-based
compensation related to shares and options granted to directors
and
employees
|
200,000
|
(*)
-
|
1,232
|
-
|
-
|
1,232
|
|||||||||||||
Beneficial
conversion feature related to convertible loans
|
-
|
-
|
407
|
-
|
-
|
407
|
|||||||||||||
Conversion
of convertible loans
|
725,881
|
(*)
-
|
224
|
-
|
-
|
224
|
|||||||||||||
Exercise
of warrants
|
3,832,621
|
(*)
-
|
214
|
-
|
-
|
214
|
|||||||||||||
Stock
issued for private placement at $0.1818 per unit, net of finder's
fee
|
11,500,000
|
1
|
1,999
|
-
|
-
|
2,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(6,244
|
)
|
(6,244
|
)
|
|||||||||||
Balance
as of December 31, 2007
|
41,004,409
|
2
|
30,058
|
-
|
(32,488
|
)
|
(2,428
|
)
|
|||||||||||
Stock-based
compensation related to options and stock granted to service providers
|
90,000
|
-
|
97
|
-
|
97
|
||||||||||||||
Stock-based
compensation related to stock and options granted to directors
and
employees
|
-
|
-
|
478
|
-
|
478
|
||||||||||||||
Beneficial
conversion feature related to convertible bridge loans
|
-
|
-
|
-
|
-
|
|||||||||||||||
Conversion
of convertible loans
|
3,644,610
|
(*)-
|
1,276
|
-
|
1,276
|
||||||||||||||
Exercise
of warrants
|
1,860,000
|
(*)-
|
|||||||||||||||||
Exercise
of options
|
17,399
|
(*)-
|
3
|
-
|
3
|
||||||||||||||
Stock
issued for private placement at $0.1818 per unit, net of finder's
fee
|
8,625,000
|
1
|
1,499
|
1,500
|
|||||||||||||||
Subscription
of shares
|
-
|
-
|
133
|
-
|
133
|
||||||||||||||
Net
loss
|
(2,846
|
)
|
(2,846
|
)
|
|||||||||||||||
|
|||||||||||||||||||
Balance
as of September 30, 2008 (unaudited)
|
55,241,418
|
$
|
3
|
$
|
33,544
|
$
|
-
|
$
|
(35,334
|
)
|
$
|
(1,787
|
)
|
(*) Represents
an amount less than $1.
The
accompanying notes are an integral part of the consolidated financial
statements.
6
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
In
U.S. dollars in thousands
Nine
months ended
September
30,
|
Period
from September 22, 2000 (inception date) through September
30,
|
|||||||||
2
0 0 8
|
2
0 0 7
|
2
0 0 8
|
||||||||
Unaudited
|
Unaudited
|
|||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(2,846
|
)
|
$
|
(4,338
|
)
|
$
|
(35,334
|
)
|
|
Less
- loss for the period from discontinued operations
|
-
|
-
|
164
|
|||||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and Amortization of deferred charges
|
113
|
126
|
479
|
|||||||
Erosion
of restricted cash
|
(5
|
)
|
(2
|
)
|
(11
|
)
|
||||
Accrued
severance pay, net
|
20
|
7
|
27
|
|||||||
Accrued
interest on loans
|
108
|
(101
|
)
|
424
|
||||||
Amortization
of discount on short-term loans
|
42
|
670
|
1,865
|
|||||||
Change
in fair value of options and warrants
|
-
|
-
|
(795
|
)
|
||||||
Expenses
related to stocks and options granted to service providers
|
97
|
1,047
|
20,229
|
|||||||
Amortization
of deferred stock-based compensation related to options granted
to
employees and directors
|
478
|
970
|
4,636
|
|||||||
Increase
(decrease) in accounts receivable and prepaid expenses
|
49
|
(33
|
)
|
(87
|
)
|
|||||
Increase
(decrease) in trade payables
|
(101
|
)
|
(226
|
)
|
737
|
|||||
Increase
in other accounts payable and accrued expenses
|
456
|
379
|
1,500
|
|||||||
Net
cash used in continuing operating activities
|
(1,589
|
)
|
(1,501
|
)
|
(6,166
|
)
|
||||
Net
cash used in discontinued operating activities
|
-
|
-
|
(23
|
)
|
||||||
Total
net cash used in operating activities
|
(1,589
|
)
|
(1,501
|
)
|
(6,189
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(154
|
)
|
(129
|
)
|
(1,080
|
)
|
||||
Restricted
cash
|
(4
|
)
|
-
|
(29
|
)
|
|||||
Investment
in lease deposit
|
-
|
(4
|
)
|
(12
|
)
|
|||||
Net
cash used in continuing investing activities
|
(158
|
)
|
(133
|
)
|
(1,121
|
)
|
||||
Net
cash used in discontinued investing activities
|
-
|
-
|
(16
|
)
|
||||||
Total
net cash used in investing activities
|
(158
|
)
|
(133
|
)
|
(1,137
|
)
|
||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from issuance of common stock and warrants
|
1,634
|
1,250
|
5,721
|
|||||||
Proceeds
from loans, notes and issuance of warrants net
|
-
|
673
|
2,061
|
|||||||
Credit
from the bank
|
95
|
-
|
95
|
|||||||
Repayment
of loans
|
(50
|
)
|
(133
|
)
|
(601
|
)
|
||||
Proceeds
from exercise of warrants and options
|
3
|
25
|
28
|
|||||||
Net
cash provided by continuing financing activities
|
1,682
|
1,815
|
7,304
|
|||||||
Net
cash provided by discontinued financing activities
|
-
|
-
|
43
|
|||||||
Total
net cash provided by financing activities
|
1,682
|
1,815
|
7,347
|
|||||||
Increase
(decrease) in cash and cash equivalents
|
(65
|
)
|
181
|
21
|
||||||
Cash
and cash equivalents at the beginning of the period
|
86
|
60
|
-
|
|||||||
Cash
and cash equivalents at end of the period
|
$
|
21
|
$
|
241
|
$
|
21
|
The
accompanying notes are an integral part of the consolidated financial
statements.
7
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 1 - |
GENERAL
|
a. |
Brainstorm
Cell Therapeutics Inc. (formerly: Golden Hand Resources Inc.) ("the
Company") was incorporated in the State of Washington on September
22,
2000.
|
b. |
On
May 21, 2004, the former major stockholders of the Company entered
into a
purchase agreement with a group of private investors, who purchased
from
the former major stockholders 6,880,000 shares of the then issued
and
outstanding 10,238,000 shares of the Company's common stock.
|
c. |
On
July 8, 2004, the Company entered into a licensing agreement with
Ramot of
Tel Aviv University Ltd. ("Ramot"), an Israeli corporation, to
acquire
certain stem cell technology (see Note 4 to the financial statements
as of
December 31, 2007). Subsequent to this agreement, the Company decided
to
focus on the development of novel cell therapies for neurodegenerative
diseases, particularly, Parkinson's disease, based on the acquired
technology and research to be conducted and funded by the
Company.
|
Following
the licensing agreement dated July 8, 2004, the management of the Company
has
decided to abandon all old activities related to the sale of the digital
data
recorder product. The discontinuation of this activity was accounted for
under
the provision of SFAS 144, "Accounting for the Impairment or Disposal of
Long-Lived Assets".
d. |
On
November 22, 2004, the Company changed its name from Golden Hand
Resources
Inc. to Brainstorm Cell Therapeutics Inc. to better reflect its
new line
of business in the development of novel cell therapies for
neurodegenerative diseases.
|
e. |
On
October 25, 2004, the Company formed a wholly-owned subsidiary
in Israel,
Brainstorm Cell Therapeutics Ltd. ("BCT").
|
f. |
On
November, 2006, the Company changed its state of incorporation
from
Washington to Delaware.
|
g. |
On
September 17, 2006, the Company's Board determined to change the
Company's
fiscal year-end from March 31 to December 31.
|
h. |
Since
its inception, the Company has devoted substantially most of its
efforts
to research and development, recruiting management and technical
staff,
acquiring assets and raising capital. In addition, the Company
has not
generated revenues. Accordingly, the Company is considered to be
in the
development stage, as defined in Statement of Financial Accounting
Standards No. 7, "Accounting and reporting by development Stage
Enterprises" ("SFAS No. 7").
|
8
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 1 - |
GENERAL
(Cont.)
|
As
reflected in the accompanying financial statements, the Company’s operations for
the three months ended on September 30, 2008, resulted in a net loss of $
728,000 and the Company’s balance sheet reflects a net stockholders’ deficiency
of $4,043,000. The Company’s ability to continue operating as a “going concern”
is dependent on several factors, among them is its ability to raise sufficient
additional working capital. Management’s plans in this regard include, among
others, raising additional cash from current and potential stockholders and
lenders.
NOTE 2 - |
SIGNIFICANT
ACCOUNTING POLICIES
|
The
significant accounting policies applied in the annual financial statements
of
the Company as of December 31, 2007, are applied consistently in these financial
statements.
NOTE 3 - |
UNAUDITED
INTERIM CONSOLIDATED FINANCIAL
STATEMENTS
|
The
accompanying unaudited interim financial statements have been prepared in
a
condensed format and include the consolidated financial operations of the
Company and its fully owned subsidiary as of September 30, 2008 and for the
three months then ended, in accordance with accounting principles generally
accepted in the United States relating to the preparation of financial
statements for interim periods. Accordingly, they do not include all the
information and footnotes required by generally accepted accounting principles
for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for a fair
presentation have been included. Operating results for the three months ended
September 30, 2008, are not necessarily indicative of the results that may
be
expected for the year ended December 31, 2008.
NOTE 4 - |
RESEARCH
AND LICENSE AGREEMENT
|
On
July
26, 2007, the Company entered into a Second Amended and Restated Research
and
License Agreement with Ramot. On August 1, 2007, the Company obtained a waiver
and release from Ramot pursuant to which Ramot agreed to an amended payment
schedule regarding the Company’s payment obligations under the amended license
agreement, dated March 30, 2006, and waived all claims against the Company
resulting from the Company's previous defaults and non-payment under the
original and first amended license agreement. The payments described in the
waiver and release covered all payment obligations that were past due and
not
yet due pursuant to the original license agreement. The waiver and release
amends and restates the original payment schedule under the license agreement
as
follows:
9
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 4 - |
RESEARCH
AND LICENSE AGREEMENT
(Cont.)
|
Payment
date
|
Amount
|
|
|
||
September
5, 2007
|
100
|
|
November
20, 2007
|
150
|
|
February
20, 2008
|
150
|
|
May
20, 2008
|
150
|
|
August
4, 2008
|
90
|
In
addition, in the event that the "research period", as defined in the license
agreement, is extended for an additional three year period in accordance
with
the terms of the license agreement, then the Company is obligated to the
following payments to Ramot during the first year of the extended research
period:
Payment
date
|
Amount
|
|
|
||
August
4, 2008
|
60
|
|
November
20, 2008
|
150
|
|
February
20, 2009
|
170
|
If
the
Company fails to make a payment to Ramot on any required payment date, and
the
Company does not cure the default within seven business days of notice of
the
default, all claims of Ramot against the Company, which were waived and released
by the waiver and release, will be reinstated.
The
company paid to Ramot the first three payments total of $400 but has not
made
yet the last two payments . As a result, the Company is in breach of the
new
agreement with Ramot and Ramot may terminate the research and license agreement.
The Company is negotiating with Ramot to postpone the payments.
As
of
September 30, 2008 the company’s obligation to Ramot is in the amount of $ 600.
NOTE 5 - |
CONSULTING
AGREEMENTS
|
a. |
On
July 8, 2004, the Company entered into two consulting agreements
with
Prof. Eldad Melamed and Dr. Daniel Offen (together, the "Consultants"),
upon which the Consultants shall provide the Company scientific
and
medical consulting services in consideration for a monthly payment
of $6
each. In addition, the Company granted each of the Consultants,
a fully
vested warrant to purchase 1,097,215 shares of Common Stock at
an exercise
price of $0.01 per share. The warrants issued pursuant to the agreement
were issued to the Consultants effective as of November 4, 2004.
Each of
the warrants is exercisable for a seven-year period beginning on
November
4, 2005.
|
b. |
As
of September 30, 2008, the Company had a total obligation of $190
for
services rendered by the Consultants.
|
10
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 6 - |
SHORT-TERM
LOANS
|
On
April
13, 2008, the Company entered into a new agreement with a lender that amended
and restated the previous agreement dated September 10,2007 pursuant to which
the lender agreed to partially defer and partially convert to the Company’s
common stock the payment of $1,250 owed by the Company to the lender based
on
the payment agreement between the two parties.
Pursuant
to the new agreement, the Company agreed to issue 2,857,142 shares of common
stock to the lender in lieu of the repayment of $1,000 of the Debt and to
pay
$250 of the Debt in accordance with the following schedule:
Payment
Date
|
Amount
|
|
May
30, 2008
|
50
|
|
July
31, 2008
|
50
|
|
September
30, 2008
|
50
|
|
December
31, 2008
|
50
|
|
February
28, 2009
|
50
|
The
Company paid the May 30, 2008 amounts. The Company has not made the July
31,
2008 and September 30 , 2008 payments.
In
addition, on May 13, 2008 the Company issued 2,857,142 shares of common stock
to
the lender.
The
lender agreed that upon payment of the foregoing amounts in accordance with
the
foregoing schedule and the receipt of the stock grant, all of the Company’s
outstanding obligations owed to the lender under the notes will be satisfied
in
full. The lender also waived any breach or default that may have arisen prior
to
the date of the new agreement from the failure of the Company to make payments
to the lender under any of the past agreements.
Since
the
outcome of the issuance of the shares was to relieve the debtor from its
obligation, based on paragraph 16a of FASB No 140 “accounting for transfer and
servicing of financial assets and extinguishment of liabilities “ the company
derecognized the liability with the difference recognized
in earning.
NOTE 7 - |
CAPITAL
STOCK
|
a.
|
The
rights of common stock are as
follows:
|
Shares
of
common stock confer upon their holders the right to receive notice to
participate and vote in general meetings of the Company, the right to a share
in
the excess of assets upon liquidation of the Company and the right to receive
dividends, if declared.
The
common stock of the Company is registered and publicly traded on the
Over-the-Counter Bulletin Board service of the National Association of
Securities Dealers, Inc. under the symbol BCLI.
11
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
b. |
Issuance
of stocks warrants and options:
|
1. |
Private
placements
|
a) |
On
June 24, 2004, the Company issued to investors 8,510,000 shares
of common
stock for total proceeds of $60 (net of $25 issuance
expenses).
|
b) |
On
February 23, 2005, the Company completed a private placement round
for
sale of 1,894,808 units for total proceeds of $1,418. Each unit
consists
of one share of common stock and a three year warrant to purchase
one
share of common stock at $2.50 per share. This private placement
was
consummated in four tranches which closed in October 2004, November
2004
and February 2005.
|
c) |
On
May 12, 2005, the Company issued to a certain investor 186,875
shares of
its common stock for total proceeds of $149 at a price per stock
of
$0.8.
|
d) |
On
July 27, 2005, the Company issued to certain investors 165,000
shares of
its common stock for total proceeds of $99 at a price per stock
of
$0.6.
|
e) |
On
August 11, 2005, the Company signed a private placement agreement
with
investors for the sale of up to 1,250,000 units at a price per
unit of
$0.8. Each unit consists of one share
of common
stock and one warrant to purchase one share
of common
stock at $1.00 per share. The warrants are exercisable for a period
of
three years from issuance. On March 31, 2005, the Company sold
312,500
units for total net proceeds of $225. On December 7, 2005, the
Company
sold 187,500 units for total net proceeds of $135.
|
f) |
On
July 2, 2007 the Company entered into an investment agreement,
pursuant to
which the Company agreed to sell up to 27,500,000 shares of the
Company's
common stock, for an aggregate subscription price of up to $5 million
and
warrants to purchase up to 30,250,000 shares of common stock. Separate
closings of the purchase and sale of the shares and the warrants
shall
take place as follows:
|
Purchase
date
|
Purchase
price
|
Number
of subscription shares
|
Number
of warrant shares
|
|||||||
August
30, 2007
|
$
|
1,250
(includes $250 that paid as a convertible loan (Note 6c)
|
|
6,875,000
|
7,562,500
|
|||||
November
15, 2007
|
$
|
750
|
4,125,000
|
4,537,500
|
||||||
February
15, 2008
|
$
|
750
|
4,125,000
|
4,537,500
|
||||||
May
15, 2008
|
$
|
750
|
4,125,000
|
4,537,500
|
||||||
July
30, 2008
|
$
|
750
|
4,125,000
|
4,537,500
|
||||||
November
15, 2008
|
$
|
750
|
4,125,000
|
4,537,500
|
12
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
1. |
Private
placements (Cont)
|
f) |
(Cont.)
|
At
each
closing date, the Company shall deliver to the investor the number of shares
and
warrants, subject to customary closing conditions and the delivery of funds,
described above. The warrants shall have the following exercise prices: (i)
the
first 10,083,333 warrants will have an exercise price of $0.20 per stock;
(ii)
the next 10,083,333 warrants will have an exercise price of $0.29 per stock;
and
(iii) the final 10,083,334 Warrants issued will have an exercise price of
$0.36
per stock. All warrants will expire on November 5, 2011.
As
of
September 30,2008, the investor completed payments of the first four
installments and $133 of the fifth installment and the Company issued to
the
investor and its designee an aggregate of 19,250,000 shares of common stock
and
a warrant to purchase 10,083,333 shares of the company's common stock at
an
exercise price of $0.20 per share , a warrant to purchase 10,083,333 shares
of
common stock at an exercise price of $0.29 per share and a warrant to purchase
1,008,334 shares of common stock at an exercise price of $0.36 per share.The
warrants may be exercised at any time and expire on November 5,
2011.
In
addition, the Company agreed to issue an aggregate of 1,250,000 shares of
common
stock to a related party as an introduction fee for the investment. The shares
shall be issued pro rata to the funds received from the investor.
As
of
September 30, 2008, 875,000 shares of common stock had been issued as an
introduction fee.
2. |
Share-based
compensation to employees and to
directors
|
a) |
Options
to employees and directors:
|
On
November 25, 2004, the Company's stockholders approved the 2004 Global Stock
Option Plan and the Israeli Appendix thereto (which applies solely to
participants who are residents of Israel) and on March 28, 2005, the Company's
stockholders approved the 2005 U.S. Stock Option and Incentive Plan, and
the
reservation of 9,143,462 shares of common stock for issuance in the aggregate
under these stock option plans.
Each
option granted under the plans is exercisable until the earlier of ten years
from the date of grant of the option or the expiration dates of the respective
option plans. The 2004 and 2005 options plans will expire on November 25,
2014
and March 28, 2015, respectively. The exercise price of the options granted
under the plans may not be less than the nominal value of the shares into
which
such options are exercised. The options vest primarily over three or four
years.
Any options that are canceled or forfeited before expiration become available
for future grants.
On
June
5, 2008, the Company's stockholders approved to amend and restate the
Company’s 2004 Global Share Option Plan and 2005 U.S. Stock Option and Incentive
Plan to increase the number of shares of common stock available for issuance
under these stock option plans in the aggregate by 5,000,000
shares.
As
of
September 30, 2008, 5,151,684 options are available for future
grants.
13
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors
(Cont.)
|
a) |
(Cont.)
|
On
May
27, 2005, the Company granted to one of its directors an option to purchase
100,000 shares of its common stock, at an exercise price of $0.75. The options
are fully vested and are exercisable for a period of 10 years.
On
February 6, 2006, the Company entered into an amendment to the Company's
option
agreement with Mr. David Stolick, the Company's Chief Financial Officer.
The
amendment changes the exercise price of the 400,000 options granted to him
on
February 13, 2005 to $0.15 per share from $0.75 per share.
On
May 2,
2006, the Company granted to one of its directors an option to purchase 100,000
shares of its common stock, at an exercise price of $0.15. The options are
fully
vested and are exercisable for a period of 10 years. The compensation related
to
the options, in the amount of $48,was recorded as general and administrative
expenses
On
June
22, 2006, the Company entered into an amendment to the Company's option
agreement with two of its employees. The amendment changes the exercise price
of
270,000 options granted to them to $0.15 per share from $0.75 per share.
The
excess of the fair value resulting from the modification amounts to $2 is
recorded as general and administration expense over the remaining vesting
period
of the option.
On
September 17, 2006, the Company entered into an amendment to the Company's
option agreement with one of its directors. The amendment changes the exercise
price of 100,000 options granted to them to $0.15 per share from $0.75 per
share.
On
March
21, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of its common stock, at an exercise price of $0.15. The option
is
fully vested and is exercisable for a period of 10 years. The compensation
related to the options in the amount of $43 was recorded as general and
administrative expenses.
On
July
1, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of its common stock, at an exercise price of $0.15. The option
is
fully vested and is exercisable for a period of 10 years. The compensation
related to the options in the amount of $38 was recorded as general and
administrative expenses. On October 22, 2007, the Company and the director
agreed to cancel and relinquish all the options which were granted om July
1 ,
2007
On
July
16, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of its common stock, at an exercise price of $0.15. The option
is
fully vested and is exercisable for a period of 10 years. The compensation
related to the options in the amount of $75 was recorded as general and
administrative expenses.
On
August
27, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of its common stock, at an exercise price of $0.15. The option
is
fully vested and is exercisable for a period of 10 years. The compensation
related to the options in the amount of $84 was recorded as general and
administrative expenses.
14
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
2. |
Share-based
compensation to employees and to directors:
(Cont.)
|
a) |
(Cont.)
|
On
October 23, 2007, the Company granted to its CEO an option to purchase 1,000,000
shares of Common Stock at an exercise price of $0.87 per share. The option
vests
with respect to 1/6 of the option on each six month anniversary and expires
after 10 years. The total compensation related to the option is $733, which
is
amortized over the vesting period as general and administrative expense.
An
amount of $46 was recorded as general and administrative expense.
A
summary
of the Company's option activity related to options to employees and directors,
and related information is as follows:
Nine
months ended
September
30, 2008
|
|||||||
Amount
of options
|
Weighted
average exercise price
|
||||||
$
|
|||||||
Outstanding
at beginning of the period
|
5,280,760
|
$
|
0.372
|
||||
Granted
|
170,000
|
0.49
|
|||||
Exercised
|
(17,399
|
)
|
0.15
|
||||
Outstanding
at end of period
|
5,433,361
|
$
|
0.377
|
||||
Vested
and expected-to-vest options at end of the period
|
3,723,127
|
$
|
0.247
|
||||
Compensation
expenses recorded by the Company in respect to its stock based employee and
directors' compensation award in accordance with SFAS-123(R) for the nine
months
ended September 30 , 2008, amounted to $478.
b) |
Restricted
shares to directors:
|
On
May
27, 2005, the Company issued to two of its directors 200,000 restricted shares
of common stock (100,000 each). The restricted shares are subject to the
Company's right to repurchase them at a purchase price of par value ($0.00005).
The restrictions on the shares shall lapse in three annual and equal portions
commencing with the grant date.
15
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
2. |
Share-based
compensation to employees and to directors
(Cont.)
|
b) |
Restricted
shares to directors: (Cont.)
|
On
May 2,
2006, the Company issued to two of its directors 200,000 restricted shares
of
common stock (100,000 each). The restricted shares are subject to the Company's
right to repurchase them at a purchase price of par value ($0.00005). The
restrictions of the shares shall lapse in three annual and equal portions
commencing with the grant date. The compensation related to the stocks issued
amounted to $104, which will be amortized over the vesting period as general
and
administrative expenses.
On
April
20, 2007, based on a board resolution dated March 21, 2007, the Company issued
to its director 100,000 restricted shares of common stock. The restricted
shares
are subject to the Company's right to repurchase them at a purchase price
of par
value ($0.00005). The restrictions of the shares shall lapse in three annual
and
equal portions commencing with the grant date. The compensation related to
the
shares issued amounted to $47, which will be amortized over the vesting period
as general and administrative expenses.
In
addition, on April 20, 2007, based on a board resolution dated March 21,
2007,
the Company issued to another director 100,000 restricted shares of common
stock. The restricted shares are not subject to any right to repurchase,
and the
compensation related to the shares issued amounted to $47 was recorded as
prepaid general and administrative expenses in the three months ended March
31,
2007.
On
August
27, 2008, the Company issued to its director 960,000 shares of common stock
upon
a cashless exercise by the director of a warrant to purchase 1,000,000 shares
of
Common Stock at an exercise price of $.01 per share that was acquired by
the
director from Ramot.
3. |
Stock
and warrants to service providers and
investors:
|
The
Company accounts for stock option and warrant grants issued to non-employees
using the guidance of SFAS No. 123(R), "Accounting for Stock-Based Compensation"
and EITF No. 96-18: "Accounting for Equity Instruments that are Issued to
Other
Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services," whereby the fair value of such option and warrant grants is
determined using the Black-Scholes options pricing model at the earlier of
the
date at which the non-employee's performance is completed or a performance
commitment is reached.
16
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
3. |
Stock
and warrants to service providers and investors:
(Cont.)
|
a) |
Warrants:
|
Issuance date |
Number
of warrants issued
|
Exercised
|
Forfeited
|
Outstanding
|
Exercise
Price
$
|
Warrants
exercisable
|
Exercisable
through
|
|||||||||||||||
November
2004
|
12,800,845
|
3,141,925
|
40,000
|
9,618,920
|
0.01
|
9,618,920
|
November
2012
|
|||||||||||||||
December
2004
|
1,800,000
|
1,800,000
|
-
|
0.00005
|
--
|
-
|
||||||||||||||||
February
2005
|
1,894,808
|
1,894,808
|
-
|
2.5
|
-
|
|||||||||||||||||
May
2005
|
47,500
|
47,500
|
1.62
|
47,500
|
May
2010
|
|||||||||||||||||
June
2005
|
30,000
|
30,000
|
0.75
|
30,000
|
June
2010
|
|||||||||||||||||
August
2005
|
70,000
|
70,000
|
-
|
0.15
|
-
|
-
|
||||||||||||||||
September
2005
|
3,000
|
3,000
|
-
|
0.15
|
-
|
-
|
||||||||||||||||
September
2005
|
36,000
|
36,000
|
0.75
|
36,000
|
September
2010
|
|||||||||||||||||
September-December
2005
|
500,000
|
312,500
|
187,500
|
1
|
187,500
|
December
2008
|
||||||||||||||||
December
2005
|
20,000
|
20,000
|
-
|
0.15
|
-
|
-
|
||||||||||||||||
December
2005
|
457,163
|
457,163
|
0.15
|
419,066
|
July
2010
|
|||||||||||||||||
February
2006
|
230,000
|
230,000
|
0.65
|
153,333
|
February
2008
|
|||||||||||||||||
February
2006
|
40,000
|
40,000
|
1.5
|
40,000
|
February
2011
|
|||||||||||||||||
February
2006
|
8,000
|
8,000
|
0.15
|
8,000
|
February
2011
|
|||||||||||||||||
February
2006
|
189,000
|
97,696
|
91,304
|
-
|
0.
5
|
-
|
-
|
|||||||||||||||
May
2006
|
50,000
|
50,000
|
0.0005
|
50,000
|
May
2016
|
|||||||||||||||||
May
-December 2006
|
48,000
|
48,000
|
0.35
|
48,000
|
May
- December 2011
|
|||||||||||||||||
May
-December 2006
|
48,000
|
48,000
|
0.75
|
48,000
|
May
- December 2011
|
|||||||||||||||||
May
2006
|
200,000
|
200,000
|
1
|
200,000
|
May
2011
|
|||||||||||||||||
June
2006
|
24,000
|
24,000
|
0.15
|
24,000
|
June
2011
|
|||||||||||||||||
May
2006
|
19,355
|
19,355
|
0.15
|
19,355
|
May
2011
|
|||||||||||||||||
October
2006
|
630,000
|
630,000
|
-
|
0.3
|
-
|
-
|
||||||||||||||||
December
2006
|
200,000
|
200,000
|
0.45
|
200,000
|
December
2008
|
|||||||||||||||||
March
2007
|
200,000
|
200,000
|
0.47
|
200,000
|
March
2012
|
|||||||||||||||||
March
2007
|
500,000
|
500,000
|
0.47
|
250,000
|
March
2017
|
|||||||||||||||||
March
2007
|
50,000
|
50,000
|
0.15
|
50,000
|
March
2010
|
|||||||||||||||||
March
2007
|
15,000
|
15,000
|
0.15
|
15,000
|
February
2012
|
|||||||||||||||||
February
2007
|
50,000
|
50,000
|
0.45
|
50,000
|
February
2009
|
|||||||||||||||||
March
2007
|
225,000
|
225,000
|
0.45
|
225,000
|
March
2009
|
|||||||||||||||||
March
2007
|
50,000
|
50,000
|
0.45
|
50,000
|
March
2010
|
|||||||||||||||||
April
2007
|
33,300
|
33,300
|
0.45
|
33,300
|
April
2009
|
|||||||||||||||||
May
2007
|
250,000
|
250,000
|
-
|
0.45
|
-
|
-
|
||||||||||||||||
July
2007
|
500,000
|
500,000
|
0.39
|
194,444
|
July
2017
|
|||||||||||||||||
September
2007
|
500,000
|
500,000
|
0.15
|
500,000
|
August
2017
|
|||||||||||||||||
August
2007
|
7,562,500
|
7,562,500
|
0.2
|
7,562,500
|
November
2011
|
|||||||||||||||||
July
2007
|
30,000
|
30,000
|
0.45
|
30,000
|
July
2009
|
|||||||||||||||||
July
2007
|
100,000
|
100,000
|
0.45
|
100,000
|
July
2010
|
|||||||||||||||||
October
2007
|
200,000
|
200,000
|
0.15
|
150,000
|
August
- October 2017
|
|||||||||||||||||
November
2007
|
2,520,833
|
2,520,833
|
0.20
|
2,520,833
|
November
2011
|
|||||||||||||||||
November
2007
|
2,016,667
|
2,016,667
|
0.29
|
2,016,667
|
November
2011
|
|||||||||||||||||
April
2008
|
4,537,500
|
4,537,500
|
0.29
|
4,537,500
|
November
2011
|
|||||||||||||||||
August
2008
|
3,529,166
|
3,529,166
|
0.29
|
3,529,166
|
November
2011
|
|||||||||||||||||
August
2008
|
1,083,333
|
1,083,333
|
0.36
|
1,008,334
|
November
2011
|
|||||||||||||||||
43,223,970
|
5,692,621
|
2,658,612
|
34,872,737
|
34,152,418
|
17
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
3. |
Stock
and warrants to service providers and investors:
(Cont.)
|
b) |
Recent
stock developments
|
On
February 18, 2008, the Company issued 75,937 shares of the Company’s common
stock to an investor pursuant to conversion request of the entire accrued
principal and interest amount of a $27 Convertible Promissory Note issued
to
such investor on April 10, 2007 .
On
February 21, 2008, the Company issued 619,523 shares of the Company’s common
stock to an investor pursuant to conversion request of the entire accrued
principal and interest amount of a $217 Convertible Promissory Note issued
to
such investor on December 12, 2006.
On
May
13, 2008, the Company issued 2,857,142 shares of the Company’s common stock to
an investor pursuant to a payments and conversion agreement of the investor’s
loans to the company (see note 6).
On
May
20, 2008, the Company issued to its finance advisor 90,000 shares of the
Company's common stock. The shares are for $35 payable to the finance advisor
for introduction fee of past convertible loans. Related compensation in the
amount of $36 was recorded as finance expenses.
On
June
5, 2008, the Company issued 92,008 shares of the Company’s common stock to an
investor pursuant to conversion request of the entire accrued principal and
interest amount of a $32 Convertible Promissory Note issued to such investor
on
July 3, 2007.
18
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE 7 - |
CAPITAL
STOCK
(Cont.)
|
3. |
Stock
and warrants to service providers and investors:
(Cont.)
|
b) |
Recent
stock developments
|
A
summary
of the Company's stock award activity related to shares issued to service
providers, and related information is as follows:
Nine
months ended
September
30, 2008
|
|||||||
Amount
of shares
|
Weighted
average issue price
|
||||||
$
|
|||||||
Outstanding
at beginning of the period
|
2,851,224
|
0.86
|
|||||
Issued
|
90,000
|
0.40
|
|||||
Outstanding
at end of the period
|
2,941,224
|
0.85
|
c) |
Stock-based
compensation recorded by the Company in respect of stock and warrants
granted to service providers amounted to $76 for the nine months
ended
September 30, 2008.
|
The
total
stock-based compensation expense, related to shares, options and warrants
granted to employees and service providers, was comprised, at each period,
as
follows:
Nine
months ended
September
30,
|
Period
from September 22, 2000 (inception date) through September
31
|
|||||||||
2
0 0 8
|
2
0 0 7
|
2
0 0 8
|
||||||||
Unaudited
|
||||||||||
Research
and development
|
121
|
513
|
17,338
|
|||||||
General
and administrative
|
397
|
1,504
|
7,471
|
|||||||
Financial
expenses
|
36
|
20
|
56
|
|||||||
Total
stock-based compensation expense
|
554
|
2,037
|
24,865
|
19
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE
8-
|
SUBSEQUENT
EVENTS
|
a. |
On
November 5, 2008, the Company's Board of Directors approved the
following resolutions :
|
1. |
As
a result of the current economic situation and the difficulty to
raise
immediate funds to support all of the Company’s projects, the Board
of Directors decided to reduce the Company's activity and
focus only on the effort to reach clinical trials in ALS in
2009.
|
2. |
To
amend the exercise price of the option to purchase 1,000,000 shares
of
common stock granted to the Company’s CEO on October 23, 2007 to $0.15 per
share from $0.87 per share.
|
3. |
To
extend the exercise period after termination of the employees current
option to purchase shares of common stock to one
year.
|
20
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations.
This
quarterly report contains numerous statements, descriptions, forecasts and
projections, regarding Brainstorm Cell Therapeutics Inc. and its potential
future business operations and performance. These statements, descriptions,
forecasts and projections constitute “forward-looking statements,” and as such
involve known and unknown risks, uncertainties, and other factors that may
cause
our actual results, levels of activity, performance and achievements to be
materially different from any results, levels of activity, performance and
achievements expressed or implied by any such “forward-looking statements.” Some
of these are described under “Risk Factors” in this report and in our annual
report on Form 10-KSB for the fiscal year ended December 31, 2007. In some
cases
you can identify such “forward-looking statements” by the use of words like
“may,” “will,” “should,” “could,” “expects,” “hopes,” “anticipates,” “believes,”
“intends,” “plans,” “estimates,” “predicts,” “likely,” “potential,” or
“continue” or the negative of any of these terms or similar words. These
“forward-looking statements” are based on certain assumptions that we have made
as of the date hereof. To the extent these assumptions are not valid, the
associated “forward-looking statements” and projections will not be correct.
Although we believe that the expectations reflected in these “forward-looking
statements” are reasonable, we cannot guarantee any future results, levels of
activity, performance or achievements. It is routine for our internal
projections and expectations to change as the year or each quarter in the year
progresses, and therefore it should be clearly understood that the internal
projections and beliefs upon which we base our expectations may change prior
to
the end of each quarter or the year. Although these expectations may change,
we
may not inform you if they do and we undertake no obligation to do so. We
caution investors that our business and financial performance are subject to
substantial risks and uncertainties. In evaluating our business, prospective
investors should carefully consider the information set forth under the caption
“Risk Factors” in addition to the other information set forth herein and
elsewhere in our other public filings with the Securities and Exchange
Commission.
Company
Overview
Brainstorm
Cell Therapeutics Inc. (“Brainstorm” or the “Company”) is a leading company
developing stem cell therapeutic products based on breakthrough technologies
enabling the in-vitro
differentiation of bone marrow stem cells to neural-like cells. We aim to become
a leader in adult stem cell transplantation for neurodegenerative diseases.
Our
focus is on utilizing the patient’s own bone marrow stem cells to generate
neuron-like cells that may provide an effective treatment initially for
Parkinson’s Disease (“PD”), Amyotrophic Lateral Sclerosis (“ALS”) and spinal
cord injury.
Our
core
technology was developed through a collaboration between prominent neurologist,
Prof. Eldad Melamed, Head of Neurology of the Rabin Medical Center and member
of
the Scientific Committee of the Michael J. Fox Foundation for Parkinson's
Research, and expert cell biologist Dr. Daniel Offen, of the Felsenstein Medical
Research Center of Tel Aviv University.
The
Company’s team is among the first to demonstrate creation of neurotrophic-factor
secreting cells (glial cells) from in-vitro
differentiated bone marrow cells that produce neurotrophic factors (“NTF”)
including GDNF, BDNF, NGF and IGF-1.
The
team
is also among the first to have successfully demonstrated release of dopamine
from in-vitro
differentiated bone marrow cells. Moreover, in research conducted by this team,
implantation of these differentiated cells into brains of animal models that
had
been induced to Parkinsonian behavior markedly improved their
symptoms.
Our
aim
is to provide neural stem cell transplants that (i) “replace” damaged
dopaminergic nerve cells and diseased tissue by augmentation with healthy
dopamine producing cells; and (ii) maintain, preserve and restore the damaged
and remaining dopaminergic cells in the patient’s brain, protecting them from
further degeneration.
21
Brainstorm
holds exclusive worldwide rights to commercialize the NurOwn(TM) technology,
through a licensing agreement with Ramot at Tel Aviv University Ltd. (“Ramot”),
the technology transfer company of Tel Aviv University. The agreement also
provides for further research, funded by Brainstorm, to be performed by Prof.
Melamed, Dr. Offen and members of their research team at the Felsenstein Medical
Research Center. The results of this research are licensed to us under the
terms
of the license agreement.
On
December 21, 2007, we entered into a Cooperative Research Agreement with Rutgers
University. Pursuant to the Cooperative Research Agreement, our subsidiary
and
Rutgers University will work jointly in researching the use of differentiated
stem cells for the treatment of spinal cord injury. This research project began
in January and is expected to conclude during 2008.
On
April
1, 2008, we started to operate our new animal house and we are conducting new
experiments following our work plan.
We
are
currently in the developmental stage of our technology and products and we
are
going to begin the process of seeking regulatory approval from regulatory
agencies in the U.S., Israel and Europe. Our efforts are directed at the
development of the technology from the lab to the clinic with the following
main
objectives:
·
|
Developing
the cell differentiation process according to Food and Drug Administration
(“FDA”) and the European agency for evaluation of medical product (“EMEA”)
guidelines;
|
·
|
Demonstrating
safety and efficacy first in animals and then in human patients;
and
|
·
|
Setting
up centralized facilities to provide NurOwn(TM) therapeutic products
and
services for transplantation in
patients.
|
As
a
result of limited cash resources at this time and the faster path through
necessary clinical trials, the Company recently determined to focus all of
its
efforts on ALS, and will for now will not allocate resources towards Parkinson’s
Disease. As a result of this new focus and the Company’s limited cash resources,
the Company recently significantly downsized its employee-base.
The
Company was incorporated under the laws of the State of Washington on September
22, 2000. On July 8, 2004, the Company entered into the licensing agreement
with
Ramot to acquire certain stem cell technology and decided to discontinue all
activities related to the sales of digital data recorder products. On October
25, 2004, the Company opened its wholly-owned subsidiary, Brainstorm Cell
Therapeutics Ltd. in Israel. On December 18, 2006, the stockholders of the
Company approved a proposal to change the state of incorporation of the Company
from the State of Washington to the State of Delaware. The reincorporation
was
completed on December 21, 2006 through the merger of the Company into a newly
formed, wholly-owned Delaware subsidiary of Brainstorm, also named Brainstorm
Cell Therapeutics Inc.
Results
of Operations
The
Company has been a development stage company since its inception. For the period
from inception (September 22, 2000) until September 30, 2008, the Company has
not earned any revenues from operations. The Company does not expect to earn
revenues from operations until 2013. In addition, the Company has incurred
operating costs and expenses of approximately $2,593,000 during the nine months
ending September 30, 2008, and approximately $32,518,000 for the period from
inception (September 22, 2000) until September 30, 2008. Operating expenses
incurred since inception were approximately $11,488,000 for general and
administrative expenses and $21,030,000 for research and development costs.
22
Research
and Development, net:
Research
and development expenses for the nine months ended September 30, 2008 and 2007
were $1,165,000 and $1,322,000, respectively, which includes stock-based
compensation expense in each of the nine month periods. Stock-based compensation
decreased by $392,000 to $121,000 for the nine months ended September 30, 2008
from $513,000 for the nine months ended September 30, 2007. In addition, the
Company grant from The Office of the Chief Scientist increased by $260,000
to
$458,000 for the nine months ended September 30, 2008 from $198,000 for the
nine
months ended September 30, 2007.
Research
and development expenses for the three months ended September 30, 2008 and
2007
were $292,000 and $326,000, respectively, which includes stock-based
compensation expense in each of the three month periods. Stock-based
compensation decreased by $118,000 to $17,000 for the three months ended
September 30, 2008 from $135,000 for the three months ended September 30, 2007.
Therefore,
although there was a decrease in research and development, net expenses for
each
of the three and nine month periods ended September 30, 2008 from the research
and development expenses, net for each of the three and nine month periods
ended
September 30, 2007, research and development expenses, excluding stock-based
compensation expenses, and participation from The Office of the Chief Scientist
have increased. The increase in research and development expenses is primarily
due to an increase in salary expenses as we have a greater number of employees
and subcontractors due in part to the Cooperative Research Agreement with
Rutgers University and in part on an expansion of our research activities,
including operating our new animal house.
General
and Administrative
General
and administrative expenses for the nine months ended September 30, 2008 and
2007 were $1,428,000 and $2,070,000, respectively. General and administrative
expenses for the nine months ended September 30, 2008 consisted of $397,000
in
stock-based compensation expenses and $1,031,000 in salary, legal, audit, public
and investor relations and other expenses. General and administrative expenses
for the nine months ended September 30, 2007 consisted of $1,504,000 in
stock-based compensation expenses and $566,000 in other expenses.
General
and administrative expenses for the three months ended September 30, 2008 and
2007 were $405,000 and $865,000, respectively. General and administrative
expenses for the three months ended September 30, 2008 consisted of $125,000
in
stock-based compensation expenses and $280,000 in salary, legal, audit, public
and investor relations and other expenses. General and administrative expenses
for the three months ended September 30, 2007 consisted of $638,000 in
stock-based compensation expenses and $227,000 in other expenses.
General
and administrative expenses, excluding stock-based compensation expenses, have
increased primarily due to (i) an increase in salary expenses as we have a
greater number of employees and consultants and (ii) an increase in our legal
and public relations expenses.
Financial
Expenses
Financial
expenses decreased by $677,000 to $253,000 for the nine months ended September
30, 2008 from $930,000 for the nine months ended September 30, 2007. Financial
expenses decreased by $235,000 to $31,000 for the three months ended September
30, 2008 from $266,000 for the three months ended September 30, 2007.
The
decrease in financial expenses for both the three and nine month period ended
September 30, 2008 is primarily attributable to a decrease in amortization
of
the discount on short-term convertible loans.
23
Net
Loss
Net
loss
for the nine and three months ended September 30, 2008 was $2,846,000 and
$728,000, respectively, as compared to a net loss of $4,338,000 and $1,462,000
for the nine and three months ended September 30, 2007. Net loss per share
for
the nine and three months ended September 30, 2008 was $0.06 and $0.01,
respectively, as compared to a net loss per share of $0.16 and $0.05 for the
nine and three months ended September 30, 2007. The decrease in the net loss
is
mainly due to a decrease in stock-based compensation expenses and a decrease
in
amortization of discount on short-term convertible loans. The weighted average
number of shares of common stock used in computing basic and diluted net loss
per share for the nine and three months ended September 30, 2008 was 46,958,440,
and 51,354,951, respectively, compared to 26,373,349 and 29,868,357 for the
nine
and three months ended September 30, 2007. This increase was due to (i) the
issuance of shares in a private placement, (ii) the conversion of convertible
loans, (iii) the exercise of warrants and (iv) the issuance of shares to service
providers.
Liquidity
and Capital Resources
The
Company has financed its operations since inception primarily through private
sales of its common stock and the issuance of convertible promissory notes.
At
September 30, 2008, we had $148,000 in total current assets and $2,703,000
in
total current liabilities.
Net
cash
used in operating activities was $1,589,000 for the nine months ended September
30, 2008. Cash used for operating activities in the nine months ended September
30, 2008 was primarily for payment of salaries and fees to our employees,
consultants, subcontractors and services providers and purchase of laboratory
materials.
Net
cash
used in investing activities was $158,000 for the nine months ended September
30, 2008. Cash used for investing activities in the nine months ended September
30, 2008 was primarily for building the animal house.
Net
cash
provided by financing activities was $1,682,000 for the nine months ended
September 30, 2008 and is primarily attributable to funds received from ACCBT
(defined below) under the Subscription Agreement (defined below).
We
have a
licensing agreement with Ramot under which we owe approximately $95,000 per
quarter. In addition, we have an agreement with a lender under which we must
pay
$30,000 over the next three months.
Our
other
material cash needs for the next 12 months will include payment of employee
salaries, payments for clinical trials in ALS and animal experiments, lease
payments, payments to Ramot, payments with respect to patents, payment of
construction fees for facilities to be used in our research and development,
payment of fees to our consultants and legal advisors and capital equipment
expenses.
On
July
2, 2007, we entered into a subscription agreement (the “Subscription Agreement”)
with ACCBT Corp. (“ACCBT”), pursuant to which we agreed to sell and issue (i) up
to 27,500,000 shares of our common stock for an aggregate subscription price
of
up to $5.0 million, and (ii) for no additional consideration, warrants to
purchase up to 30,250,000 shares of our common stock. Subject to certain closing
conditions, separate closings of the purchase and sale of the shares and the
warrants are scheduled to take place from August 30, 2007 through November
15,
2008. To date, we have received an aggregate of $3.7 million from ACCBT.
24
We
will
need to raise substantial additional capital in order to meet our anticipated
expenses. If we are not able to raise substantial additional capital, we may
not
be able to continue to function as a going concern and we may have to cease
operations. Even if we obtain funding sufficient to continue functioning as
a
going concern, we will be required to raise a substantial amount of capital
in
the future in order to reach profitability and to complete the commercialization
of our products. Our ability to fund these future capital requirements will
depend on many factors, including the following:
· |
our
ability to obtain funding from third parties, including any future
collaborative partners;
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· |
the
scope, rate of progress and cost of our clinical trials and other
research
and development programs;
|
· |
the
time and costs required to gain regulatory approvals;
|
· |
the
terms and timing of any collaborative, licensing and other arrangements
that we may establish;
|
· |
the
costs of filing, prosecuting, defending and enforcing patents, patent
applications, patent claims, trademarks and other intellectual property
rights;
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· |
the
effect of competition and market developments; and
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· |
Future
pre-clinical and clinical trial results.
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Critical
Accounting Policies
Our
discussion and analysis of our financial condition and results of operations
are
based on our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the U.S. The preparation of these
financial statements requires us to make judgments, estimates, and assumptions
that affect the reported amounts of assets and liabilities and the disclosure
of
contingent assets and liabilities at the date of the financial statements as
well as the reported revenue and expenses during the reporting periods. We
continually evaluate our judgments, estimates and assumptions. We base our
estimates on the terms of underlying agreements, our expected course of
development, historical experience and other factors we believe are reasonable
based on the circumstances, the results of which form our management’s basis for
making judgments about the carrying value of assets and liabilities that are
not
readily apparent from other sources. Actual results may differ from these
estimates.
There
were no significant changes to our critical accounting policies during the
quarter ended September 30, 2008. For information about critical accounting
policies, see the discussion of critical accounting policies in our Annual
Report on Form 10-KSB for the fiscal year ended December 31, 2007.
Off
Balance Sheet Arrangements
We
have
no off balance sheet arrangements that have or are reasonably likely to have
a
current or future material effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures, or capital resources.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
This
information has been omitted as the Company qualifies as a smaller reporting
company.
25
Item
4T. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
As
of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our Chief Executive Officer and
Chief Financial Officer, of the effectiveness of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)). Based on this
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that, as a result of the material weakness in our internal control over
financial reporting described below, our disclosure controls and procedures
were
not effective, as of the end of the period covered by this report, to ensure
that information required to be disclosed by us in the reports we file under
the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission's rules and forms,
and that the information required to be disclosed by us in such reports is
accumulated and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions
regarding required disclosure.
Internal
Control Over Financial Reporting
Management
identified the following material weakness in its assessment of the
effectiveness of internal control over financial reporting as of December 31,
2007, which continued to exist as of September 30, 2008:
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·
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The
Company did not maintain effective controls over certain aspects
of the
financial reporting process because we lacked a sufficient complement
of
personnel with a level of accounting expertise and an adequate supervisory
review structure that is commensurate with the Company’s financial
reporting requirements. Specifically, our Chief Financial Officer
handles
certain accounting issues of the Company alone as there is no one
in our
accounting and finance departments who is qualified to assist
him.
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Nevertheless,
based on a number of factors, including the performance of additional procedures
performed by management designed to ensure the reliability of our financial
reporting, our Chief Executive Officer and Chief Financial Officer believe
that
the consolidated financial statements included with this Quarterly Report on
Form 10-Q fairly present, in all material respects, our financial position,
results of operations, and cash flows as of the dates, and for the periods,
presented, in conformity with U.S. GAAP.
Management’s
Remediation Initiatives
We
plan
to develop policies and procedures for training of personnel or external
advisers to verify that we have a sufficient number of personnel with knowledge,
experience and training in the application of generally accepted accounting
principles commensurate with our financial reporting and U.S. GAAP requirements.
Where necessary, we will supplement personnel with qualified external advisors.
Additionally, where appropriate, we plan to identify training on accounting
principles and procedures that would benefit our accounting and finance
personnel.
Changes
in Internal Control Over
Financial Reporting
Other
than as described above, no changes in our internal controls over financial
reporting were identified during the quarter ended September 30, 2008 that
materially affected, or are reasonably likely to materially affect, such
internal control over financial reporting other than those remedial actions
disclosed above.
26
PART
II: OTHER INFORMATION
Item
1. Legal Proceedings.
On
April
17, 2008, Chapman, Spira & Carson, LLC (“CSC”), filed a breach of contract
complaint in the Supreme Court of the State of New York (the “Court”) against
the Company. The complaint alleges that CSC performed its obligations to the
Company under a consulting agreement entered into between the parties and that
the Company failed to provide CSC with the compensation outlined in the
consulting agreement. The complaint seeks compensatory damages in an amount
up
to approximately $896,667, as well as costs and attorneys’ fees. On June 5,
2008, the Company filed an answer with the Court. We intend to vigorously defend
our actions. We cannot predict the scope, timing or outcome of this matter.
We
cannot predict what impact, if any, this matter may have on our business,
financial condition, results of operations and cash flow.
Item
1A. Risk Factors.
In
addition to the other information set forth in this Quarterly Report on Form
10-Q, you should carefully consider the risk factor discussed below and the
risk
factors previously disclosed in the “Risk Factors” section of our Annual Report
on Form 10-KSB for the fiscal year ended December 31, 2007, which could
materially affect our business, financial condition or future results, and
in
our Quarterly Reports on Form 10-Q filed for the current fiscal year. The risks
described below and in our Annual Report on Form 10-KSB for the fiscal year
ended December 31, 2007 and in our subsequent Quarterly Reports on Form 10-Q
are
not the only risks we face. Additional risks and uncertainties not currently
known to us or that we currently deem to be immaterial also may materially
adversely affect our business, financial condition and/or operating results.
Other than with respect to the risk factor below, there have been no material
changes from the risk factors disclosed in our Annual Report on Form 10-KSB
for
the fiscal year ended December 31, 2007 or in our Quarterly Reports on Form
10-Q filed for the current fiscal year. The risk factor below was disclosed
in
our Annual Report on Form 10-KSB and is being updated as set forth
below.
Our
business in the foreseeable future will be based on technology licensed from
Ramot and if this license were to be terminated for any reason, including
failure to pay the required research funding or royalties, we would need to
change our business strategy and we may be forced to cease our
operations.
We
entered into a Second Amended and Restated Research and License Agreement with
Ramot on July 31, 2007 (the “Amended Agreement”). The Amended Agreement imposes
on us development and commercialization obligations, milestone and royalty
payment obligations and other obligations.
On
August
1, 2007, we obtained a waiver and release from Ramot pursuant to which Ramot
agreed to an amended payment schedule regarding our payment obligations under
the Amended Agreement and waived all claims against us resulting from our
previous breaches and non-payment under the original license agreement. The
payments described in the waiver and release cover all of our payment
obligations (including interest) that were past due and not yet due pursuant
to
the original license agreement. To date, we have not yet made the May 2008
payment of $150,000 or the August 2008 payment of $90,000 to Ramot We are
negotiating an agreement with Ramot to postpone such payments. If we fail to
negotiate an agreement with Ramot or if we fail to pay the amounts owed to
Ramot
in accordance with the new payment schedule, Ramot may have the right to
terminate the license and all claims waived by Ramot pursuant to the August
2007
waiver and release may be reinstated. If Ramot elects to terminate our license,
we would need to change our business strategy and we may be forced to cease
our
operations.
In
order to execute our business plan, we will need to raise additional capital.
If
we are unable to raise additional capital on favorable terms and in a timely
manner, we will not be able to execute our business plan and we could be forced
to restrict or cease our operations. We
will
need to raise additional funds to meet our anticipated expenses so that we
can
execute our business plan. We expect to incur substantial and increasing net
losses for the foreseeable future as we increase our spending to execute our
development programs. Our auditors have expressed in their audit report that
there is substantial doubt regarding our ability to continue as a going concern.
27
Pursuant
to the subscription agreement with ACCBT, we expect to issue and sell additional
shares and warrants to ACCBT through November 2008 for aggregate consideration
of up to $5,000,000. However, if we do not satisfy the closing conditions
contained in the subscription agreement, and if ACCBT does not elect to purchase
additional shares and warrants, we will need to seek additional financings
to
allow us to execute our business plan. Even if ACCBT purchases all of the shares
and warrants under the subscription agreement, we will still need to secure
additional funds to effect our plan of operations. Recent funding installments
(due July 2008) from ACCBT have not been made when expected and we continue
to
be in need of raising additional cash. We may not be able to raise additional
funds on favorable terms, or at all. If we are unable to obtain additional
funds
on favorable terms and in a timely fashion, we will be unable to execute our
business plan and we will be forced to restrict or cease our operations.
Assuming
we raise additional funds through the issuance of equity, equity-related or
debt
securities, these securities may have rights, preferences or privileges
(including registrations rights) senior to those of the rights of our common
stock and our stockholders will experience additional dilution.
Disruption
in financial and currency markets could have a negative effect on our
business.
As
has
been widely reported, financial markets in the U.S., Europe, Asia and elsewhere
have been experiencing extreme disruption in recent months, including, among
other things, extreme volatility in security prices, severely diminished
liquidity and credit availability, rating downgrades of certain investments
and
declining valuations of others. Governments have taken unprecedented actions
intended to address extreme market conditions that include severely restricted
credit and declines in real estate values. While currently these conditions
have
not impaired our ability to operate our business, there can be no assurance
that
there will not be a further deterioration in financial markets and confidence
in
major economies, which can then lead to challenges in the operation of our
business. These economic developments affect businesses such as ours in a number
of ways, including our ability to obtain the financing that is necessary to
continue operating our business. We are unable to predict the likely duration
and severity of the current disruption in financial markets and adverse economic
conditions and the effects they will have on our business and financial
condition.
Item
5. Other Information.
During
the quarter ended September 30, 2008, we made no material changes to the
procedures by which stockholders may recommend nominees to our Board of
Directors, as described in our most recent proxy statement.
Item
6. Exhibits.
The
Exhibits listed in the Exhibit Index immediately preceding such Exhibits are
filed with or incorporated by reference in this report.
28
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
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BRAINSTORM
CELL THERAPEUTICS INC.
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November
19, 2008
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By:
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/s/ Rami
Efrati
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Name:
Rami Efrati
Title:
Chief Executive Officer
(Principal
Executive Officer)
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November
19, 2008
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By:
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/s/ David
Stolick
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Name:
David Stolick
Title:
Chief Financial Officer
(Principal
Financial and Accounting Officer)
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29
EXHIBIT
INDEX
Exhibit
Number
|
|
Description
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31.1
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|
Certification
of the Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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31.2
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Certification
of the Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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32.1
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|
Certification
of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
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32.2
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Certification
of the Principal Financial Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
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30