BRAINSTORM CELL THERAPEUTICS INC. - Quarter Report: 2009 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x QUARTERLY REPORT UNDER
SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the
Quarterly Period Ended June 30, 2009
o TRANSITION REPORT
UNDER 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, including area code)
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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes ¨ No ¨
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
August 13, 2009, the number of shares outstanding of the registrant’s common
stock, $0.00005 par value per share, was 59,791,418.
TABLE OF
CONTENTS
Page
Number
|
||
PART
I
|
3 | |
Item
1. Financial Statements
|
3 | |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
33 | |
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
38 | |
Item
4. Controls and Procedures
|
38 | |
PART
II
|
39 | |
Item
1. Legal Proceedings
|
39 | |
Item
1A. Risk Factors
|
39 | |
Item
5. Other Information
|
40 | |
Item
6. Exhibits
|
40 |
2
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)
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
UNAUDITED
U.S.
DOLLARS IN THOUSANDS
3
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
UNAUDITED
U.S.
DOLLARS IN THOUSANDS
INDEX
Page
|
|
Consolidated
Balance Sheets
|
5
|
Consolidated
Statements of Operations
|
6
|
Statements
of Changes in Stockholders' Equity (Deficiency)
|
7
-11
|
Consolidated
Statements of Cash Flows
|
12
- 13
|
Notes
to Consolidated Financial Statements
|
14
- 32
|
4
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
CONSOLIDATED
BALANCE SHEETS
U.S.
dollars in thousands (except share data)
June 30,
|
December 31,
|
|||||||
2 0 0 9
|
2 0 0 8
|
|||||||
Unaudited
|
Audited
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 2 | $ | 2 | ||||
Restricted
cash
|
35 | 36 | ||||||
Accounts
receivable and prepaid expenses
|
52 | 21 | ||||||
Total
current assets
|
89 | 59 | ||||||
LONG-TERM
INVESTMENTS:
|
||||||||
Prepaid
expenses
|
7 | 11 | ||||||
Severance
pay fund
|
65 | 62 | ||||||
Total
long-term investments
|
72 | 73 | ||||||
PROPERTY
AND EQUIPMENT, NET
|
664 | 743 | ||||||
Total
assets
|
$ | 825 | $ | 875 | ||||
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Short
term Credit from bank
|
$ | 28 | $ | 72 | ||||
Trade
payables
|
809 | 744 | ||||||
Other
accounts payable and accrued expenses
|
2,009 | 1,672 | ||||||
Short-term
convertible loans
|
178 | 172 | ||||||
Short-term
loans
|
- | 199 | ||||||
Total
current liabilities
|
3,024 | 2,859 | ||||||
ACCRUED
SEVERANCE PAY
|
93 | 92 | ||||||
Total
liabilities
|
3,117 | 2,951 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
STOCKHOLDERS'
DEFICIENCY:
|
||||||||
Stock
capital: (Note 7)
|
||||||||
Common
stock of $0.00005 par value - Authorized: 800,000,000 shares as of June
30, 2009 and December 31,2008; Issued and outstanding: 59,791,418 and
55,241,418 shares as of June 30, 2009 and December
31, 2008 respectively.
|
3 | 3 | ||||||
Additional
paid-in-capital
|
34,722 | 33,881 | ||||||
Deficit
accumulated during the development stage
|
(37,017 | ) | (35,960 | ) | ||||
Total
stockholders' deficiency
|
(2,292 | ) | (2,076 | ) | ||||
Total
liabilities and stockholders' deficiency
|
$ | 825 | $ | 875 |
The
accompanying notes are an integral part of the consolidated financial
statements.
5
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share data)
Three
months
ended
June 30,
|
Six
months
ended
June 30,
|
Period
from
September
22,
2000
(inception
date)
through
June
30,
|
||||||||||||||||||
2
0 0 9
|
2
0 0 8
|
2
0 0 9
|
2
0 0 8
|
2
0 0 9
|
||||||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||||||||||
Operating
costs and expenses:
|
||||||||||||||||||||
Research
and development, net
|
$ | 210 | $ | 283 | $ | 499 | $ | 873 | $ | 22,003 | ||||||||||
General
and administrative
|
314 | 479 | 565 | 1,023 | 12,254 | |||||||||||||||
Total
operating costs and expenses
|
524 | 762 | 1,064 | 1,896 | 34,257 | |||||||||||||||
Financial
expenses (income), net
|
19 | 94 | (7 | ) | 222 | 2,543 | ||||||||||||||
543 | 856 | 1,057 | 2,118 | 36,800 | ||||||||||||||||
Taxes
on income
|
- | - | - | - | 53 | |||||||||||||||
Loss
from continuing operations
|
543 | 856 | 1,057 | 2,118 | 36,853 | |||||||||||||||
Net
loss from discontinued operations
|
- | - | - | - | 164 | |||||||||||||||
Net
loss
|
543 | 856 | 1,057 | 2,118 | 37,017 | |||||||||||||||
Basic
and diluted net loss per share from continuing operations
|
$ | 0.01 | $ | 0.02 | $ | 0.02 | $ | 0.05 | ||||||||||||
Weighted
average number of shares outstanding used in computing basic and diluted
net loss per share
|
59,294,165 | 47,697,713 | 57,278,987 | 44,736,029 |
The
accompanying notes are an integral part of the consolidated financial
statements
6
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
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
|
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 | ) |
7
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
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
|
compensation
|
stage
|
(deficiency)
|
|||||||||||||||||||
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.
8
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
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
|
compensation
|
stage
|
(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.
9
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S. dollars in thousands (except share data)
Additional
|
Deficit
|
|||||||||||||||||||||||
paid-in
|
accumulated
|
Total
|
||||||||||||||||||||||
Capital
and
|
Deferred
|
during
the
|
stockholders'
|
|||||||||||||||||||||
Common
stock
|
subscription on
|
stock-based
|
development
|
equity
|
||||||||||||||||||||
Number
|
Amount
|
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 | - | 33 | - | - | 33 | ||||||||||||||||||
Stock-based
compensation related to stock and options granted to directors and
employees
|
- | 731 | - | - | 731 | |||||||||||||||||||
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 for private placement at $0.1818 per
unit
|
- | - | 281 | - | - | 281 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (3,472 | ) | (3,472 | ) | ||||||||||||||||
Balance
as of December 31, 2008
|
55,241,418 | $ | 3 | $ | 33,881 | $ | - | $ | (35,960 | ) | $ | (2,076 | ) |
*
Represents an amount less than $1.
10
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S. dollars in thousands (except share data)
Common
stock
|
Additional
paid-in
|
Deferred
stock-based
|
Deficit
accumulated
during
the
development
|
Total
stockholders'
|
||||||||||||||||||||
Number
|
Amount
|
capital
|
compensation
|
stage
|
(deficiency)
|
|||||||||||||||||||
Balance
as of December 31, 2008
|
55,241,418 | $ | 3 | $ | 33,881 | $ | - | $ | (35,960 | ) | $ | (2,076 | ) | |||||||||||
Conversion
of convertible loans
|
2,500,000 | - | 200 | - | - | 200 | ||||||||||||||||||
Stock-based
compensation related to options and stock granted to service
providers
|
2,050,000 | - | 183 | - | - | 183 | ||||||||||||||||||
Stock-based
compensation related to stock and options granted to directors and
employees
|
- | - | 199 | - | - | 199 | ||||||||||||||||||
Subscription
of shares for private placement
|
259 | 259 | ||||||||||||||||||||||
Net
loss
|
- | - | - | - | (1,057 | ) | (1,057 | ) | ||||||||||||||||
Balance
as of June 30, 2009
|
59,791,418 | $ | 3 | $ | 34,722 | $ | - | $ | (37,017 | ) | $ | (2,292 | ) |
The
accompanying notes are an integral part of the consolidated financial
statements.
11
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
Six
months
ended
June 30,
|
Period
from
September
22, 2000
(inception
date)
through
June 30,
|
|||||||||||
2
0 0 9
|
2
0 0 8
|
2
0 0 9
|
||||||||||
Unaudited
|
Unaudited
|
|||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (1,057 | ) | $ | (2,118 | ) | $ | (37,017 | ) | |||
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
|
79 | 73 | 599 | |||||||||
Erosion
of restricted cash
|
1 | (5 | ) | (6 | ) | |||||||
Accrued
severance pay, net
|
(2 | ) | 6 | 28 | ||||||||
Accrued
interest on loans
|
7 | 101 | 436 | |||||||||
Amortization
of discount on short-term loans
|
- | 42 | 1,865 | |||||||||
Change
in fair value of options and warrants
|
- | - | (795 | ) | ||||||||
Expenses
related to stocks and options granted to service providers
|
183 | 84 | 20,349 | |||||||||
Amortization
of deferred stock-based compensation related to options granted to
employees and directors
|
199 | 349 | 5,088 | |||||||||
Decrease
(increase) in accounts receivable and prepaid expenses
|
(32 | ) | 69 | (53 | ) | |||||||
Increase
(decrease) in trade payables
|
65 | (129 | ) | 809 | ||||||||
Increase
in other accounts payable and accrued expenses
|
337 | 385 | 2,004 | |||||||||
Net
cash used in continuing operating activities
|
(220 | ) | ( 1,143 | ) | (6,529 | ) | ||||||
Net
cash used in discontinued operating activities
|
- | - | (23 | ) | ||||||||
Total
net cash used in operating activities
|
(220 | ) | (1,143 | ) | (6,552 | ) | ||||||
Cash flows from investing
activities:
|
||||||||||||
Purchase
of property and equipment
|
- | (153 | ) | (1,080 | ) | |||||||
Restricted
cash
|
- | - | (29 | ) | ||||||||
Increase
in lease deposit
|
5 | (4 | ) | (7 | ) | |||||||
Net
cash used in continuing investing activities
|
5 | (157 | ) | (1,116 | ) | |||||||
Net
cash used in discontinued investing activities
|
- | - | (16 | ) | ||||||||
Total
net cash used in investing activities
|
5 | (157 | ) | (1,132 | ) |
The
accompanying notes are an integral part of the consolidated financial
statements.
12
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
UNAUDITED
CONSOLIDATED
STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
Six
months
ended
June 30,
|
Period
from
September
22, 2000
(inception
date)
through
June 30,
|
|||||||||||
2
0 0 9
|
2
0 0 8
|
2
0 0 9
|
||||||||||
Unaudited
|
Unaudited
|
|||||||||||
Cash flows from financing
activities:
|
||||||||||||
Proceeds
from issuance of common stock and warrants
|
$ | 259 | $ | 1,241 | $ | 6,127 | ||||||
Proceeds
from loans, notes and issuance of warrants net
|
- | - | 2,061 | |||||||||
Credit
from bank
|
(44 | ) | 27 | 28 | ||||||||
Repayment
of loans
|
- | - | (601 | ) | ||||||||
Proceeds
from exercise of warrants and options
|
- | 3 | 28 | |||||||||
Net
cash provided by continuing financing activities
|
215 | 1,271 | 7,643 | |||||||||
Net
cash provided by discontinued financing activities
|
- | - | 43 | |||||||||
Total
net cash provided by financing activities
|
215 | 1,271 | 7,686 | |||||||||
Increase
(decrease) in cash and cash equivalents
|
- | (29 | ) | 2 | ||||||||
Cash
and cash equivalents at the beginning of the period
|
2 | 86 | - | |||||||||
Cash
and cash equivalents at end of the period
|
2 | 57 | 2 |
The
accompanying notes are an integral part of the consolidated financial
statements.
13
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE
1
|
-
|
GENERAL
|
|
A.
|
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 3). Subsequent to this agreement,
the Company decided to focus on the development of novel cell therapies
for neurodegenerative diseases, particularly Parkinson's and ALS 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
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 Statement of Financial Accounting Standard
("SFAS") 144, "Accounting for the Impairment or Disposal of Long-Lived
Assets".
|
|
B.
|
On
October 25, 2004, the Company formed a wholly-owned subsidiary in Israel,
Brainstorm Cell Therapeutics Ltd.
("BCT").
|
|
C.
|
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. BCT owns all operational property and
equipment.
|
|
D.
|
In
December 2006, the Company changed its state of incorporation from
Washington to Delaware.
|
|
E.
|
On
September 17, 2006, the Company changed its fiscal year-end from March 31
to December 31.
|
|
F.
|
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").
|
GOING
CONCERN
As
reflected in the accompanying financial statements, the Company’s operations for
the six months ended on June 30, 2009, resulted in a net loss of $1,057 and the
Company’s balance sheet reflects a net stockholders’ deficiency of $2,292,
accumulated deficit of $37,017 and working capital deficiency of $2,935. These
conditions raise substantial doubt about the Company's ability to continue to
operate as a going concern. 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.
14
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE
1
|
-
|
GENERAL
(Cont.)
|
GOING
CONCERN (Cont.)
Accordingly,
as a result of the current economic situation and the difficulty to raise
immediate fund to support all of the Company’s projects, the Company decided to
reduce its activity and downsize it workforce and focus only on the effort to
reach clinical trials in ALS in 2009-2010.
The
Company also reduced its general and administrative expenses and ceased and
delayed some development projects until it is able to obtain sufficient
financing. There can be no assurance that sufficient revenues will be generated
and that additional funds will be available on terms acceptable to the Company,
or at all.
The
Company depends on Ramot to conduct its research and development activities. As
discussed in Note 4, the Company did not make a certain payment in 2008 to
Ramot. As a result, the Company did not meet the payment schedule according to
the agreement with Ramot and Ramot is entitled to terminate the research and
license agreement.
These
financial statements do not include any adjustments relating to the
recoverability and classification of assets carrying amounts or the amount and
classification of liabilities that may be required should the Company be unable
to continue as a going concern.
NOTE 2 -
|
SIGNIFICANT
ACCOUNTING POLICIES
|
The
significant accounting policies applied in the annual financial statements of
the Company as of December 31, 2008, are applied consistently in these financial
statements.
Recently
Issued Accounting Standards
FSP FAS
157-4
In April
2009 the FASB issued FASB staff position 157-4, "Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly". This FSP applies
to all assets and liabilities within the scope of accounting pronouncements that
require or permit fair value measurements, except as discussed in paragraphs 2
and 3 of statement 157. The FSP is Effective for interim and annual reporting
periods ending after June 15, 2009, and shall be applied
prospectively.
FSP FAS
157-4 relates to determining fair values when there is no active market or where
the price inputs being used represent distressed sales. It reaffirms what
Statement 157 states is the objective of fair value measurement—to reflect how
much an asset would be sold for in an orderly transaction (as opposed to a
distressed or forced transaction) at the date of the financial statements under
current market conditions. Specifically, it reaffirms the need to use judgment
to ascertain if a formerly active market has become inactive and in determining
fair values when markets have become inactive.
15
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE
2
|
-
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
Recently Issued Accounting
Standards
(Cont.)
FSP FAS
157-4 provides guidance on (1) estimating the fair value of an asset or
liability (financial and nonfinancial) when the volume and level of activity for
the asset or liability have significantly decreased and (2) identifying
transactions that are not orderly. The adoption of this standard did not
have any impact on the consolidated results of operations or financial position
of the Company.
SFAS
165
In May
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS No. 165”). SFAS
No. 165 establishes general standards of accounting for, and disclosure of,
events that occur after the balance sheet date but before financial statements
are issued or are available to be issued. In particular, this
statement sets forth: (1) the period after the balance sheet date during which
management of a reporting entity should evaluate events or transactions that may
occur for potential recognition or disclosure in the financial statements, (2)
the circumstances under which an entity should recognize events or transactions
occurring after the balance sheet date in its financial statements and (3) the
disclosures that an entity should make about events or transactions that
occurred after the balance sheet date. SFAS No. 165 is effective for
the interim or annual financial periods ending after June 15, 2009.
The adoption of this standard did not have any impact on the consolidated
results of operations or financial position of the Company.
FSP FAS
115-2 and FAS 124-2
In April
2009 the FASB issued FASB staff position 115-2 and 124-2, "Recognition and
Presentation of Other-Than-Temporary Impairments" ("OTTI") for investment in
debt securities. This FSP applies to all entities and are effective for interim
and annual reporting periods ending after June 15, 2009, with early adoption
permitted for periods ending after March 15, 2009. Earlier adoption for periods
ending before March 15, 2009, is not permitted.
Under the
FSP, the primary change to the OTTI model for debt securities is the change in
focus from an entity’s intent and ability to hold a security until recovery.
Instead, an OTTI is triggered if (1) an entity has the intent to sell the
security, (2) it is more likely than not that it will be required to sell the
security before recovery, or (3) it does not expect to recover the entire
amortized cost basis of the security. In addition, the FSP changes the
presentation of an OTTI in the income statement if the only reason for
recognition is a credit loss (i.e., the entity does not expect to recover its
entire amortized cost basis). That is, if the entity has the intent to sell the
security or it is more likely than not that it will be required to sell the
security, the entire impairment (amortized cost basis over fair value) will be
recognized in earnings.
However,
if the entity does not intend to sell the security and it is not more likely
than not that the entity will be required to sell the security, but the security
has suffered a credit loss, the impairment charge will be separated into the
credit loss component, which is recorded in earnings, and the remainder of the
impairment charge, which is recorded in other comprehensive income (OCI). The
adoption of this standard did not have any impact on the consolidated
results of operations or financial position of the Company.
16
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTE
2
|
-
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
Recently Issued Accounting
Standards
(Cont.)
SFAS
166
In June
2009 the FASB issued SFAS No.166 "Accounting for Transfers of Financial Assets"
("SAFS No. 166"). SAFS No. 166 is a revision to Statement No. 140, Accounting
for Transfers and Servicing of Financial Assets and Extinguishments of
Liabilities, and will require more information about transfers of financial
assets, including securitization transactions, and where companies have
continuing exposure to the risks related to transferred financial assets. It
eliminates the concept of a “qualifying special-purpose entity,” changes the
requirements for derecognizing financial assets, and requires additional
disclosures. SFAS No. 166 enhances information reported to users of financial
statements by providing greater transparency about transfers of financial assets
and a company’s continuing involvement in transferred financial assets. SFAS No.
166 will be effective at the start of a company’s first fiscal year beginning
after November 15, 2009. The Company is currently examining this new standard;
The adoption of this standard is not expected to have a material impact on the
Company’s condensed consolidated 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 June 30, 2009 and for the six
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 six months ended June 30, 2009, are not
necessarily indicative of the results that may be expected for the year ended
December 31, 2009.
17
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
4 -
|
RESEARCH
AND LICENSE AGREEMENT
|
|
A.
|
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 Research and 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 Agreement and the
Amended Research and 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 Agreement. The waiver and release
amends and restates the original payment schedule under the Original
Agreement as follows:
|
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 Amended
Research and License Agreement, is extended for an additional three year period
in accordance with the terms of the Amended Research and 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, may be reinstated.
As of
August 13 , 2009, the Company paid to Ramot the first three payments total of
$400 but has not made yet the last two payments total of $240 and for the
extended research period. As a result, the Company is in breach of the new
agreement with Ramot and Ramot may terminate the research and license
agreement.
In
January 29 2009, the Company received a breach warning from Ramot and the
parties are currently negotiating an amendment to postpone the
payments.
B.
|
The
Company's total current obligation to Ramot as of June 30, 2009 is in the
amount of $961. The amount includes $665 for the extended research
period.
|
18
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
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 June 30, 2009, the Company has a total obligation of $298 for services
rendered by the Consultants.
|
NOTE
6
-
|
SHORT-TERM
LOANS
|
On April
13, 2008, the Company entered into a new agreement with a lender 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 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 |
In
addition, the Company issued 2,857,142 shares of common stock to the lender in
lieu of the repayment of $1,000 of the Debt.
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 past agreements.
19
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
6 -
|
SHORT-TERM
LOANS (Cont.)
|
The
Company paid to the lender first payment and on April 6, 2009 the Company and
the lender agreed to convert the entire debt of $200 to 2,500,000 restricted
shares of common stock.
Since the
outcome of the issuance of the shares was to relieve the debtor from its
obligation, based on guidance in 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
|
-
STOCK
CAPITAL
|
A.
|
The
rights of Common Stock are as
follows:
|
Holders
of Common Stock have the right to receive notice to participate and vote in
meetings of stockholders 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 is publicly traded on the Over-the-Counter Bulletin Board service
of the National Association of Securities Dealers, Inc. under the symbol
BCLI.
|
B.
|
Issuance
of shares, 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 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
three tranches which closed in October 2004, November 2004 and February
2005.
|
|
c)
|
On
May 12, 2005, the Company issued to an investor 186,875 shares of Common
Stock for total proceeds of $149 at a price of $0.8 per
share.
|
|
d)
|
On
July 27, 2005, the Company issued to investors 165,000 shares of Common
Stock for total proceeds of $99 at a price of $0.6 per
share.
|
20
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
1.
|
Private
placements: (Cont.)
|
|
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 of $0.8 per
unit. 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 September 30,
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 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
paid
as a convertible
loan
(Note 8i))
|
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 |
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 have an exercise price of $0.20 per share; (ii) the next 10,083,333
warrants will have an exercise price of $0.29 per share; and (iii) the final
10,083,334 warrants issued will have an exercise price of $0.36 per share. All
warrants will expire on November 5, 2011.
21
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7 -
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
1.
|
Private
placements: (Cont.)
|
f)
|
Cont.
|
As of
June 30, 2009, the investor completed payment of the first four installments and
$ 540 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.
On August
18, 2009, the Company entered into an amendment to the investment agreement (See
note 8).
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
June 30, 2009, 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.
22
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
a)
|
Options
to employees and directors:
(Cont.)
|
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
June 30, 2009, 3,671,684 options are available for future grants.
On May
27, 2005, the Company granted one of its directors an option to purchase 100,000
shares of Common Stock at an exercise price of $0.75 per share. The options are
fully vested and expire after 10 years.
On
February 6, 2006, the Company entered into an amendment to the Company's option
agreement with the Company's Chief Financial Officer. The amendment changes the
exercise price of the 400,000 options granted to him on February 13, 2005 from
$0.75 to $0.15 per share.
On May 2,
2006, the Company granted to one of its directors an option to purchase 100,000
shares of Common Stock at an exercise price of $0.15 per share. The options are
fully vested and expire after 10 years. The compensation related to the options,
in the amount of $48, was recorded as general and administrative
expense.
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 from $0.75 to $0.15 per share. The excess of the
fair value resulting from the modification, in the amount of $2, was 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 the director from $0.75 to $0.15
per share.
On March
21, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $43, was recorded as
general and administrative expense.
23
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
-
STOCK CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
a)
|
Options
to employees and directors:
(Cont.)
|
On July
1, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $38, was recorded as
general and administrative expense. On October 22, 2007, the Company and the
director agreed to cancel and relinquish all the options which were granted on
July 1, 2007.
On July
16, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $75, was recorded as
general and administrative expense.
On August
27, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $84, was recorded as
general and administrative expense.
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.
On
November 5, 2008, the Company entered into an amendment to the Company's option
to purchase 1,000,000 shares of common stock agreement with the Company's CEO.
The amendment changes the exercise price of the option from $0.87 to $0.15 per
share. The compensation related the modification of the purchase price in the
amount of $4 was recorded as general and administrative
expense.
24
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
|
a)
|
Options
to employees and directors: (Cont.)
|
On June 29, 2009, the Company granted
to its CEO and director an option to purchase 1,000,000 shares of Common Stock
at an exercise price of $0.067 per share. The option vests with respect to 1/3
of the option on each year anniversary and expires after 10 years. The total
compensation related to the option is $68, which is amortized over the vesting
period 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:
Six months ended
December 31,
|
Year ended
December 31,
|
|||||||||||||||||||||||
2 0 0 9
|
2 0 0 8
|
|||||||||||||||||||||||
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
|||||||||||||||||||
$ |
$
|
$ | $ | |||||||||||||||||||||
Outstanding at beginning
of period
|
5,433,361 | 0.244 | - | 5.280.760 | 0.372 | - | ||||||||||||||||||
Granted
|
1,350,000 | 0.067 | 170,000 | 0.49 | ||||||||||||||||||||
Exercised
|
- | - | (17,399 | ) | 0.15 | |||||||||||||||||||
Outstanding
at end of period
|
6,783,361 | 0.209 | - | 5,433,361 | *0.244 | - | ||||||||||||||||||
Vested
and expected-to-vest at end of period
|
4,371,684 | 0.243 | - | 4,324,437 | 0.238 | - |
25
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
|
b)
|
Restricted
shares to directors:
|
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 a shareholder 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
shareholder from Ramot. The shares were allocated to the director by the
shareholder.
3.
|
Shares
and warrants to service
providers:
|
The
Company accounts for shares and warrant grants issued to non-employees using the
guidance of SFAS 123(R), "Accounting for Stock-Based Compensation" and EITF
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 a
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.
26
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
|
3.
|
Shares
and warrants to service providers:
(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 | 500,000 | - | 1 | - | - | ||||||||||||||||||||||
December
2005
|
20,000 | 20,000 | - | 0.15 | - | - | ||||||||||||||||||||||
December
2005
|
457,163 | 457,163 | 0.15 | 457,163 |
July
2010
|
|||||||||||||||||||||||
February
2006
|
230,000 | 230,000 | 0.65 | 230,000 |
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 | - | - | ||||||||||||||||||||||
March
2007
|
200,000 | 200,000 | 0.47 | 200,000 |
March
2012
|
|||||||||||||||||||||||
March
2007
|
500,000 | 500,000 | 0.47 | 375,000 |
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 | - | - | ||||||||||||||||||||||
March
2007
|
225,000 | 225,000 | - | 0.45 | - | - | ||||||||||||||||||||||
March
2007
|
50,000 | 50,000 | 0.45 | 50,000 |
March
2010
|
|||||||||||||||||||||||
April
2007
|
33,300 | 25,000 | 8,300 | 0.45 | 8,300 |
April
2010
|
||||||||||||||||||||||
May
2007
|
250,000 | 250,000 | - | 0.45 | - | - | ||||||||||||||||||||||
July
2007
|
500,000 | 500,000 | 0.39 | 319,444 |
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 | 200,000 |
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 | 1,008,333 |
November
2011
|
|||||||||||||||||||||||
November
2008
|
100,000 | 100,000 | 0.15 | 100,000 |
September
2018
|
|||||||||||||||||||||||
April
2009
|
200,000 | 200,000 | 0.1 | 0 |
April
2019
|
|||||||||||||||||||||||
A
|
||||||||||||||||||||||||||||
43,523,970 | 5,692,621 | 3,346,112 | 34,485,237 | 33,979,682 |
27
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
a)
|
Warrants:
(Cont.)
|
The fair
value for the warrants to service providers was estimated on the date of grant
using a Black-Scholes option pricing model, with the following weighted-average
assumptions for the year ended December 31, 2008 and December 31, 2007; weighted
average volatility of 126%-165% and 108%, 93%-115%, respectively, risk free
interest rates of 0.37%-2.12% and 3.3%-4.5%, respectively dividend yields of 0%
and a weighted average life of the options of 1-9 and 6-7 years,
respectively.
b)
|
Shares:
|
On June 1
and June 4, 2004, the Company issued 40,000 and 150,000 shares of Common Stock
for 12 months of filing services and legal and due-diligence services,
respectively, with respect to a private placement. Compensation expense related
to filing services, totaling $26, is amortized over a 12-month period.
Compensation related to legal services, totaling $105 was recorded as equity
issuance cost and had no effect on the statement of operations.
On July 1
and September 22, 2004, the Company issued 20,000 and 15,000 shares to a former
director for financial services for the first and second quarters of 2004,
respectively. Related compensation in the amount of $39 was recorded as general
and administrative expense.
On
February 10, 2005, the Company signed an agreement with one of its service
providers according to which the Company issued the service provider 100,000
restricted shares at a purchase price of $0.00005 par value under the U.S Stock
Option and Incentive Plan of the Company. The restricted shares are subject to
the Company's right to repurchase them within one year of the grant date as
follows: (i) in the event that the service provider breaches his obligations
under the agreement, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to par value; and (ii) in the event
that the service provider has not breached his obligations under the agreement,
the Company shall have the right to repurchase the restricted shares at a
purchase price equal to the then fair market value of the restricted
shares.
In March
and April 2005, the Company signed an agreement with four members of its
Scientific Advisory Board according to which the Company issued to the members
of the Scientific Advisory Board 400,000 restricted shares at a purchase price
of $0.00005 par value under the U.S Stock Option and Incentive Plan (100,000
each). The restricted shares will be subject to the Company's right to
repurchase them if the grantees cease to be members of the Company's Advisory
Board for any reason. The restrictions of the shares shall lapse in three annual
and equal portions commencing with the grant date.
28
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
|
b)
|
Shares:
|
In July
2005, the Company issued to its legal advisors 50,000 shares for legal services
for 12 months. The compensation related to the shares in the amount of $37.5 was
recorded as general and administrative expense.
In
January 2006, the Company issued to two service providers 350,000 restricted
shares at a purchase price of $0.00005 par value under the U.S Stock Option and
Incentive Plan of the Company. The restricted shares are subject to the
Company's right to repurchase them within 12 months from the grant date as
follows: (i) in the event that the service providers breach their obligations
under the agreement, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to the par value; and (ii) in the
event that the service providers have not breached their obligations under the
service agreements, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to the fair market value of the
restricted shares. Related compensation in the amount of $23 was recorded as
general and administrative expense.
On March
6, 2006, the Company issued to its legal advisor 34,904 shares of Common Stock.
The shares are in lieu of $18.5 payable to the legal advisor. Related
compensation in the amount of $18.5 was recorded as general and administrative
expense.
On April
13, 2006, the Company issued to service providers 60,000 shares at a purchase
price of $0.00005 par value under the U.S Stock Option and Incentive Plan of the
Company. Related compensation in the amount of $25.8 was recorded as general and
administrative expense.
On May 9,
2006, the Company issued to its legal advisor 65,374 shares of Common Stock in
lieu of payment for legal services. Related compensation in the amount of $33
was recorded as general and administrative expense.
On June
7, 2006, the Company issued 50,000 shares of Common Stock for filing services
for 12 months. Related compensation in the amount of $24.5 was recorded as
general and administrative expense.
On May 5,
2006, the Company issued 200,000 shares to a finance consultant for his
services. Related compensation in the amount of $102 was recorded as general and
administrative expense.
29
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
(Cont.)
|
On August
14, 2006, the Company issued 200,000 shares to a service provider. Related
compensation in the amount of $68 was recorded as general and administrative
expense.
On August
17, 2006, the Company issued 100,000 shares to a service provider. Related
compensation in the amount of $35 was recorded as general and administrative
expense.
On
September 17, 2006, the Company issued to its legal advisor 231,851 shares of
Common Stock. The shares are in lieu of $63 payable to the legal
advisor.
During
April 1 and September 30, 2006, the Company issued to its business development
advisor, based on an agreement, 240,000 shares of Common Stock. Related
compensation in the amount of $74 was recorded as general and administrative
expense.
On
January 3, 2007, the Company issued to its legal advisor 176,327 shares of
Common Stock. The shares are for the $45 payable to the legal advisor. Related
compensation in the amount of $49 was recorded as general and administrative
expense.
On April
12, 2007, the Company issued to its filing and printing service providers 80,000
shares of Common Stock. The shares issued are for the $15 payable to the service
provider. Related compensation in the amount of $30 was recorded as general and
administrative expense. In addition, the Company is obligated to issue the
filing and printing service providers additional shares, in the event that the
total value of the shares previously issued (as quoted on the Over-the-Counter
Bulletin Board or such other exchange where the Common Stock is quoted or
listed) is less than $0.20, on March 20, 2008. In no event shall the Company
issue more than 30,000 additional shares to the service providers. As a result,
the Company recorded a liability in the amount of $20.
On April
12, 2007, the Company issued to its legal advisor 108,511 shares of Common
Stock. The shares are for $29 payable to the legal advisor. Related compensation
in the amount of $40 was recorded as general and administrative
expense.
On May
18, 2007, the Company issued to its legal advisor 99,257 shares of Common Stock.
The shares are for $33, payable to the legal advisor. Related compensation in
the amount of $33 was recorded as general and administrative
expense.
30
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7:
|
-STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
|
b)
|
Shares:
(Cont.)
|
On
October 29, 2007, the Company issued to a scientific advisory board member
80,000 shares of the Company’s Common Stock for scientific services.
Compensation of $67 was recorded as research and development
expense.
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 is recorded as finance expenses.
On April
5, 2009, the Company issued to its Chief Technology Advisor 1,800,000
shares of Common Stock. The shares are for $180 payable to the advisor. Related
compensation in the amount of $144 was recorded as research and development
expense.
On June
24, 2009, the Company issued to its public relation advisor 250,000 shares of
Common Stock. The shares are for $25 payable to the advisor. Related
compensation in the amount of $18 was recorded as general and administrative
expense.
A summary
of the Company's stock awards activity related to shares issued to service
providers and related information is as follows:
Six months ended
June 30,
|
Year ended
December 31,
|
|||||||||||||||
2 0 0 9
|
2 0 0 8
|
|||||||||||||||
Amount
of
shares
|
Weighted
average
issue
price
|
Amount
of
shares
|
Weighted
average
issue
price
|
|||||||||||||
$
|
$
|
|||||||||||||||
Outstanding
at beginning of period
|
2,941,224 | 0.85 | 2,851,224 | 0.86 | ||||||||||||
Issued
|
2,050,000 | 0.075 | 90,000 | 0.40 | ||||||||||||
Outstanding
at end of period
|
4,991,224 | 0.27 | 2,941,224 | 0.85 |
31
BRAINSTORM CELL THERAPEUTICS
INC. AND SUBSIDIARY
(A development stage
company)
NOTE
7:
|
- STOCK
CAPITAL (Cont.)
|
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
(Cont.)
|
The
total stock-based compensation expense, related to shares, options and warrants
granted to employees directors and service providers, was comprised, at each
period, as follows:
Three months
Ended June 30,
|
Six months
ended June 30,
|
Period from
September 22, 2000
(inception date)
through June 30,
|
||||||||||||||||||
2 0 0 9
|
2 0 0 8
|
2 0 0 9
|
2 0 0 8
|
2 0 0 9
|
||||||||||||||||
Unaudited
|
Unaudited
|
Unaudited
|
||||||||||||||||||
Research
and development
|
151 | 60 | 181 | 105 | 16,806 | |||||||||||||||
General
and administrative
|
114 | 68 | 202 | 273 | 7,785 | |||||||||||||||
Financial
expenses, net
|
- | 36 | - | 36 | 56 | |||||||||||||||
Total
stock – based compensation expense
|
265 | 164 | 383 | 414 | 24,647 |
NOTE
8
|
- SUBSEQUENT
EVENTS
|
On
August 18, 2009 the Company entered into an amendment to the investment
agreement ("The Amendment" ) with the investor as
follows:
|
A.
|
The
investor shall invest the remaining amount of the original investment
agreement at Price Per Share of $0.12 in monthly installments of not less
then $50 starting August, 2009.
|
B.
|
The
exercise price of the last 10,083,334 warrants will decrease from an
exercise price of $0.36 per share to $0.29 per
share.
|
C.
|
All
warrants will expire on November 5, 2013 instead of November 5
,2011.
|
D.
|
The
Price Per Share of the investment agreement shall decreased from $0.1818
to $0.12. Therefore the Company shall adjust the number of Common Shares
issuable pursuant the investment agreement retroactively and issue
immediately to the investor additional 9,916,667 Common
Shares.
|
E.
|
The
investor shall have the right to cease payments in the event that the
price per share as of the closing on five consecutive trading days shall
decrease to $0.05.
|
32
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations.
SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS
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-K for the fiscal year ended December 31, 2008. 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
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 ALS, PD and spinal cord
injury.
Our core
technology was developed in collaboration with prominent neurologist, Prof.
Eldad Melamed, the former 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.
33
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.
The
Company holds exclusive worldwide rights to commercialize the technology,
through a licensing agreement with 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.
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 the 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 determined in the forth quarter of 2008
to focus all of its efforts on ALS, and will for now will not allocate resources
towards PD or other Neurodegenerative diseases. As a result of this
new focus and the Company’s limited cash resources, the Company significantly
downsized its employee base and employs only scientific employees that meet the
Company immediate goal: to conduct clinical trials in ALS patients in
Israel.
Results
of Operations
The
Company has been a development stage company since its inception. For the period
from inception (September 22, 2000) until June 30, 2009, 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 other expenses of approximately $543,000 during the six
months ended June 30, 2009, and approximately $37,017,000 for the period from
inception (September 22, 2000) until June 30, 2009. Operating expenses incurred
since inception were approximately $12,254,000 for general and administrative
expenses and $22,003,000 for research and development costs.
34
Research
and Development, net:
Research
and development expenses for the six months ended June 30, 2009 and 2009 were
$499,000 and $873,000, respectively,. In addition, the Company’s grant from The
Office of the Chief Scientist decreased by $255,000 to $40,000 for the six
months ended June 30, 2009 from $295,000 for the six months ended June 30,
2008.
Research
and development expenses, net for the three months ended June 30, 2009 and 2008
were $210,000 and $283,000, respectively. In addition, the Company’s
grant from The Office of the Chief Scientist decreased by $248,000 to $40,000
for the three months ended June 30, 2009 from $288,000 for the six months ended
June 30, 2008. Therefore the gross Research and development
expenses for the
three months ended June 30, 2009 decreased by $321,000 to
$250,000 for the three months ended June 30, 2009 from $571,000 for the six
months ended June 30, 2008.
The
decrease in gross research and development expenses for each of the three and
six month periods ended June 30, 2009 is primarily due to (i) the decrease in
salary expenses as we had fewer employees due to the downsizing of the employee
base in connection with the Company's current financial condition and (ii) the
reduction in development activities as the Company decided to delay development
activities in PD and other neurodegenerative diseases and focus solely on
ALS.
General
and Administrative
General
and administrative expenses for the six months ended June 30, 2009 and 2008 were
$565,000 and $1,023,000, respectively.
General
and administrative expenses for the three months ended June 30, 2009 and 2008
were $314,000 and $479,000, respectively.
The
decrease in general and administrative expenses for each of the three and six
month periods ended June 30, 2009 is primarily due to the decrease in
general and administrative expenses as the Company has decreased
activities due to the Company’s current financial condition.
Financial
Expenses
Financial
expenses decreased by $229,000 to income of $7,000 for the six months ended June
30, 2009 from expenses of $222,000 for the six months ended June 30,
2008.
Financial
expenses decreased by $75,000 to $19,000 for the three months ended June 30,
2009 from $94,000 for the three months ended June 30, 2008.
The
decrease in financial expenses is primarily attributable to a decrease in
amortization of the discount on short-term convertible loans and the exchange
differentials derived from the changes in the exchange rate between the New
Israeli Shekel to U.S. dollar in the three and six months ended June 30,
2009.
Net
Loss
Net loss
for the six months ended June 30, 2009 was $1,057,000, as compared to a net loss
of $2,118,000 for the six months ended June 30, 2008. Net loss per share for the
six months ended June 30, 2009 was $0.02, as compared to a net loss per share of
$0.05 for the six months ended June 30, 2008.
The
weighted average number of shares of common stock used in computing basic and
diluted net loss per share for the six months ended June 30, 2009 was
57,278,987, compared to 44,736,029 for the six months ended June 30,
2008.
35
Net loss
for the three months ended June 30, 2009 was $543,000, as compared to a net loss
of $856,000 for the three months ended June 30, 2008. Net loss per share for the
three months ended June 30, 2009 was $0.01, as compared to a net loss per share
of $0.02 for the three months ended June 30, 2008.
The weighted average number of shares
of common stock used in computing basic and diluted net loss per share for the
three months ended June 30, 2009 was 59,294,165, compared
47,697,713 for the
three months ended June 30, 2008.
The
decrease in the net loss for each of the three and six month periods ended June
30, 2009 is mainly due to a (i) reduction in Company activities, (ii) downsizing
of employees and (iii) amortization of discount on short-term convertible
loans.
The
increase in the weighted average number of shares of common stock used in
computing basic and diluted net loss per share for the three and six months
ended June 30,2009 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 warrants and the issuance of convertible
promissory notes. At June 30, 2009, we had $89,000 in total current assets and
$3,024,000 in total current liabilities.
Net cash
used in operating activities was $220,000 for the six months ended June 30,
2009. Cash used for operating activities in the six months ended June 30, 2009
was primarily for payment of salaries and fees to our employees, consultants,
subcontractors and service providers.
Net cash
provided by financing activities was $215,000 for the six months ended June 30,
2009 and is primarily attributable to funds received from ACCBT Corp. under a
certain subscription agreement.
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
approximately $25,000 over the next three months.
Our other
material cash needs for the next 12 months will include payment of employee
salaries, payments for pre-clinical and clinical trials in ALS, 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 with ACCBT Corp., 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 were scheduled to take place
from August 30, 2007 through November 15, 2008. To date, we have received an
aggregate of approximately $4.05 million from ACCBT Corp.
In August
2009 ACCBT Corp and the Company entered into an amendment to the investment
agreement (the “Amendment"). Pursuant the Amendment:
(i)ACCBT
Corp shall invest the remaining amount of the subscription agreement at a Price
Per Share of $0.12 in monthly installments of not less then $50,000 starting
August, 2009; (ii) the exercise price of the last 10,083,334 warrants issued to
ACCBT Corp. will decrease from an exercise price of $0.36 per share to $0.29 per
share; (iii) all warrants to purchase shares issued to ACCBT Corp. will expire
on November 5, 2013 instead of November 5, 2011; and (iv) the Price Per Share of
the subscription agreement shall decreased from $0.1818 to
$0.12. Therefore, we shall adjust the number of Common Shares
issuable pursuant the investment agreement retroactively and issue immediately
to ACCBT Corp. an additional 9,916,667 Common Shares.
36
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;
|
|
·
|
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;
|
|
·
|
the
effect of competition and market developments; and
|
|
·
|
future
pre-clinical and clinical trial
results.
|
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 June 30, 2009. For information about critical accounting policies,
see the discussion of critical accounting policies in our Annual Report on Form
10-K for the fiscal year ended December 31, 2008.
37
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.
Item
4. 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,
2008, which continued to exist as of June 30, 2009:
|
·
|
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 all accounting issues of
the Company alone as the Company recently terminated the Company’s
accountant as part of the downsizing of the Company’s
staff.
|
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
Based on
financial condition and if we will raise sufficient fund to finance it, we plan
recruit new accountant and 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.
38
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 June 30, 2009 that materially
affected, or are reasonably likely to materially affect, such internal control
over financial reporting other than those remedial actions disclosed
above.
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. The Company believes CSC’s
claims are without merit. 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.
From time
to time, we may become involved in litigation relating to claims arising out of
operations in the normal course of business, which we consider routine and
incidental to our business. We currently are not a party to any legal
proceedings, other than as described above, the adverse outcome of which,
in management’s opinion, would have a material adverse effect on our business,
results of operation or financial condition.
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 factors previously disclosed in the
“Risk Factors” section of our Annual Report on Form 10-K for the fiscal year
ended December 31, 2008, which could materially affect our business, financial
condition or future results. The risks described in our Annual Report on Form
10-K for the fiscal year ended December 31, 2008 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. There has been no
material changes from the risk factors disclosed in our Annual Report on Form
10-K for the fiscal year ended December 31, 2008, except as
follows:
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 make
required payments, we would need to change our business strategy and we may be
forced to cease our operations. Agreements we have with Ramot impose on
us development and commercialization obligations, milestone and royalty payment
obligations and other obligations. Under these agreements, we are obligated to
pay certain fees to Ramot. If we fail to comply with these obligations, Ramot
may have the right to terminate the license. If Ramot elects to terminate our
license, we would need to change our business strategy and we may be forced to
cease our operations. We currently owe Ramot overdue payments, and we recently
received a letter from Ramot informing us of such overdue payments and their
rights under the agreements. If we fail to make these payments to Ramot, then
Ramot may terminate our license to Ramot’s technology that we license and which
is what our business is based upon
39
Item
5. Other Information.
During
the quarter ended June 30, 2009, 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.
40
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.
BRAINSTORM
CELL THERAPEUTICS INC.
|
||
August 19, 2009
|
By:
|
/s/ Rami Efrati
|
Name: Rami Efrati
Title: Chief Executive Officer (Principal
Executive Officer)
|
August 19, 2009
|
By:
|
/s/ David Stolick
|
Name: David Stolick
Title: Chief Financial Officer (Principal Financial
and Accounting Officer)
|
41
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
|
31.1
|
Certification
of the Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of the Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
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.
|
|
32.2
|
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.
|
42