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
|
||
212-557-9000
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Page
Number
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PART
I
|
||
Item1.
|
Description
of Business
|
1
|
Item
2.
|
Description
of Property
|
14
|
Item
3.
|
Legal
Proceedings
|
14
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
14
|
PART
II
|
||
Item
5.
|
Market
for Common Equity and Related Stockholder Matters
|
14
|
Item
6.
|
Plan
of Operation
|
16
|
Item
7.
|
Financial
Statements
|
19
|
Item
8.
|
Changes
In and Disagreements With Accountants on Accounting and Financial
Disclosure
|
57
|
Item
8A.
|
Controls and Procedures |
57
|
Item
8B.
|
Other Information |
57
|
PART
III
|
||
Item
9.
|
Directors,
Executive Officers, Promoters, Control Persons and Corporate Governance;
Compliance With Section 16(a) of the Exchange Act
|
57
|
Item
10.
|
Executive
Compensation
|
59
|
Item
11.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
63
|
Item
12.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
65
|
Item
13.
|
Exhibits
|
66
|
Item
14.
|
Principal
Accountant Fees and Services
|
66
|
· |
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 patients; and
|
· |
Setting
up centralized facilities to provide NurOwn™ therapeutic products and
services for transplantation in patients.
|
· |
Riluzole
- the only medication approved by the FDA to slow the progress of
ALS.
While it does not reverse ALS, riluzole has been shown to reduce
nerve
damage. Riluzole may extend the time before a patient needs a ventilator
(a machine to help breathe) and may prolong the patient's life by
several
months;
|
· |
Baclofen
or Diazepam - these medications may be used to control muscle spasms,
stiffness or tightening (spasticity) that interfere with daily activities;
and
|
· |
Trihexyphenidyl
or Amitriptyline - these medications may help patients who have excess
saliva or secretions, and emotional
changes.
|
· |
Bone
marrow aspiration from patient;
|
· |
Isolating
and expanding
the mesenchymal stem cells;
|
· |
Differentiating
the expanded stem cells into neuronal-like dopamine producing cells
and/or
astrocytes-like NTF producing cells; and
|
· |
Implantation
of the differentiated cells into patient from whom the bone marrow
was
extracted.
|
· |
Developing
the cell differentiation process according to health regulation
guidelines;
|
· |
Demonstrating
safety and efficacy, first in animals and then in patients;
and
|
· |
Setting
up centralized facilities to provide NurOwnTM
therapeutic products and services for transplantation in patients.
|
· |
Private
Medical Center Chains - interested in expanding their service offerings
and being associated with an innovative technology, thereby enhancing
their professional standing and revenue potential;
and
|
· |
Major
Pharmaceutical and/or Medical Device Companies - seeking new product
opportunities and/or wishing to maintain interest in the market,
which may
shift away from drugs towards surgical
treatment.
|
· |
The
NurOwnTM
technology for differentiation of dopamine producing neuron-like
cells is
covered by PCT patent application number PCT/IL03/00972 filed on
November
17, 2003.
|
· |
The
NurOwnTM
technology for differentiating astrocyte-like cells is covered by
PCT
patent application number PCT/IL2006/000699 filed on June 18,
2006.
|
· |
The
NurOwnTM
technology for isolating oligodendrocyte-like cells and population
comprising thing for the treatment in CNS diseases covered by PCT
patent
application number PCT/IL/2006/000140 filed on December 7, 2006.
|
· |
We
have filed for a trademark on NurOwnTM.
|
· |
An
up-front license fee payment of
$100,000;
|
· |
An
amount equal to 5% of all Net Sales of Products (as those terms are
defined in the Original Ramot Agreement);
and
|
· |
An
amount equal to 30% of all Sublicense Receipts (as such term is defined
in
the Original Ramot Agreement).
|
· |
We
may not be successful in obtaining the approval to perform clinical
studies, an investigational new drug application, or IND, with respect
to
a proposed product;
|
· |
Preclinical
or clinical trials may not demonstrate the safety and efficacy of
proposed
products satisfactory
to the FDA or foreign regulatory authorities;
or
|
· |
Completion
of clinical trials may be delayed, or costs of clinical trials may
exceed
anticipated amounts (for example, negative
or inconclusive results from a preclinical test or clinical trial
or
adverse medical events during a clinical trial could cause a preclinical
study or clinical trial to be repeated, additional tests to be conducted
or a program to be terminated, even if other studies or trials relating
to
the program are successful).
|
· |
under
our Global Plan, we have granted and not canceled a total of 3,861,778
options with various exercise prices and expiration dates, to officers,
directors, services providers, consultants and employees.
|
· |
under
our U.S. Plan we have issued an additional 1,530,000 shares of restricted
stock and options for grants to Scientific Advisory Board members,
service
providers, consultants and
directors.
|
VOTES
|
|
VOTES
|
|
VOTES
|
|
|||||
|
|
FOR
|
|
WITHHELD
|
|
AGAINST
|
||||
Approval
to reincorporate the Company
|
||||||||||
in
the State of Delaware
|
17,191,105
|
--
|
--
|
Quarter
Ended
|
High
|
Low
|
December
31, 2006
|
$0.33
|
$0.24
|
September
30, 2006
|
$0.49
|
$0.21
|
June
30, 2006
|
$0.55
|
$0.35
|
March
31, 2006
|
$0.66
|
$0.40
|
December
31, 2005
|
$0.86
|
$0.43
|
September
30, 2005
|
$1.19
|
$0.63
|
June
30, 2005
|
$2.90
|
$0.80
|
March
31, 2005
|
$3.50
|
$1.80
|
· |
To
define and optimize our NurOwnTM technology in human bone marrow
cells, in
order to prepare the final production process for clinical studies
in
accordance with health authorities’ guidelines. To reach this goal we
intend to optimize methods for the stem cell growth and differentiation
in
specialized growth media, as well as methods for freezing, thawing,
storing and transporting of the expanded mesenchymal stem cells,
as well
as the differentiated neuronal
cells;
|
· |
To
verify the robustness and the reproducibility of the
process;
|
· |
To
further repeat the process using bone marrow from Parkinson’s
patients;
|
· |
To
conduct large efficacy studies in animal models of PD (such as mice
and
rats) in order to further evaluate the engraftment, survival and
efficacy
of our astrocyte-like cell in these
models;
|
· |
To
conduct safety and efficacy studies in primates-monkeys;
|
· |
To
conduct a full tumorgenicity study in animals;
|
· |
To
generate process SOPs, protocols and reports for the file
submission;
|
· |
To
finalize analytical methodology and product specifications to be
used as
release criteria of the final cell product for clinical trials in
humans;
|
· |
To
set up a quality control system for the processing of our cells;
and
|
· |
To
write up clinical protocols for phase I & II clinical
studies.
|
· |
Improving
the bone marrow
stem cells expansion prior to
differentiation;
|
· |
Evaluation
of methodologies for cryo-preservation of the expanded bone marrow
cells
prior to differentiation;
|
· |
Characterization
of the propagated mesenchymal stem according to established
CD-markers;
|
· |
Determination
of timing and growth conditions for the differentiation process;
|
· |
Development
of molecular tools and cell surface markers to evaluate cell
differentiation;
|
· |
Demonstrating
that the bone marrow derived differentiated cells do produce and
secrete
several neuron-specific markers;
|
· |
Transplantation
of the bone marrow derived neural-like cells in the striatum of model
animals resulting in long-term engraftment;
and
|
· |
Parkinson’s
model animals transplanted with the bone marrow derived neural-like
cells
show significant improvement in their rotational
behavior.
|
· |
Raise
equity or debt financing or a combination of equity and debt financing
of
at least $13,000,000;
|
· |
Complete
preclinical studies in rodents to confirm safety and
efficacy;
|
· |
Complete
preclinical studies to confirm safety in
monkeys;
|
· |
Conduct
full safety study of the final cell product for PD;
and
|
· |
Write
up clinical protocols for Phase I & II clinical
studies.
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
|
Consolidated
Balance Sheets
|
|
Consolidated
Statements of Operations
|
|
Statements
of Changes in Stockholders' Equity (Deficiency)
|
|
Consolidated
Statements of Cash Flows
|
|
Notes
to Consolidated Financial Statements
|
/s/
Kost Forer Gabbay & Kasierer
|
|
Tel-Aviv,
Israel
|
KOST
FORER GABBAY & KASIERER
|
March
30, 2007
|
A
Member of Ernst & Young Global
|
December
31
|
March
31
|
||||||
2006
|
2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
60,430
|
290,219
|
|||||
Restricted
cash
|
31,953
|
28,939
|
|||||
Accounts
receivable and prepaid expenses (Note 5)
|
41,632
|
45,451
|
|||||
Total
current assets
|
134,015
|
364,609
|
|||||
LONG-TERM
INVESTMENTS:
|
|||||||
Prepaid
expenses
|
7,802
|
7,067
|
|||||
Severance
pay fund
|
37,840
|
19,093
|
|||||
45,642
|
26,160
|
||||||
PROPERTY
AND EQUIPMENT, NET (Note 6)
|
491,045
|
411,454
|
|||||
OTHER
ASSETS, NET (Notes 8, 9)
|
51,664
|
57,590
|
|||||
Total
assets
|
722,366
|
859,813
|
|||||
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Trade
payables
|
720,742
|
200,624
|
|||||
Other
accounts payable and accrued expenses (Note 7)
|
651,076
|
370,445
|
|||||
Short-term
convertible loans (Note 8)
|
936,526
|
367,292
|
|||||
Short-term
loans (Note 9)
|
189,000
|
128,559
|
|||||
Total
current liabilities
|
2,497,344
|
1,066,920
|
|||||
OPTIONS
AND WARRANTS (Note 8)
|
-
|
7,679,009
|
|||||
ACCRUED
SEVERANCE PAY
|
40,772
|
24,563
|
|||||
Total
liabilities
|
2,538,116
|
8,770,492
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 10)
|
|||||||
STOCKHOLDERS'
DEFICIENCY:
|
|||||||
Stock
capital: (Note 11)
|
|||||||
Common
stock of $ 0.00005 par value - Authorized: 800,000,000 and 200,000,000
shares at December 31 and March 31, 2006, respectively; Issued and
outstanding: 24,201,812 and 22,854,587 shares at December 31 and
March 31, 2006, respectively
|
1,210
|
1,144
|
|||||
Additional
paid-in capital
|
24,426,756
|
15,802,847
|
|||||
Deferred
stock-based compensation
|
-
|
(1,395,439
|
)
|
||||
Deficit
accumulated during the development stage
|
(26,243,716
|
)
|
(22,319,231
|
)
|
|||
Total
stockholders' deficiency
|
(1,815,750
|
)
|
(7,910,679
|
)
|
|||
Total
liabilities and stockholders' deficiency
|
722,366
|
859,813
|
March
30, 2007
|
||||
Date
of approval of the
|
David
Stolick
|
Yoram
Drucker
|
||
financial
statements
|
Chief
Financial Officer
|
Principal
Executive Officer
|
Nine
months ended
December
31,
|
Year
ended
March
31,
|
Period
from September 22, 2000 (inception date) through December
31,
|
|||||||||||
2006
|
2005
|
2006
|
2006
|
||||||||||
Unaudited
|
|||||||||||||
Operating
costs and expenses:
|
|||||||||||||
Research
and development
|
872,939
|
770,766
|
970,891
|
2,629,128
|
|||||||||
Research
and development expenses (income)
related
to stocks, warrants and options granted to
employees
and service providers
|
(131,016
|
)
|
71,827
|
(123,944
|
)
|
15,258,397
|
|||||||
General
and administrative
|
809,063
|
710,183
|
817,366
|
1,883,227
|
|||||||||
General
and administrative related to stocks, warrants
and
options granted to employees and service
providers
|
1,330,574
|
1,016,691
|
1,636,692
|
5,008,594
|
|||||||||
Total
operating costs and expenses
|
2,881,560
|
2,569,467
|
3,301,005
|
24,779,346
|
|||||||||
Financial
income (expenses), net
|
(1,025,709
|
)
|
(2,223
|
)
|
14,689
|
(907,437
|
)
|
||||||
(3,907,269
|
)
|
(2,571,690
|
)
|
(3,286,316
|
)
|
(25,686,783
|
)
|
||||||
Taxes
on income (Note 12)
|
17,216
|
22,854
|
30,433
|
53,118
|
|||||||||
Loss
from continuing operations
|
(3,924,485
|
)
|
(2,594,544
|
)
|
(3,316,749
|
)
|
(25,739,901
|
)
|
|||||
Net
loss from discontinued operations
|
-
|
-
|
-
|
(163,971
|
)
|
||||||||
Net
loss
|
(3,924,485
|
)
|
(2,594,544
|
)
|
(3,316,749
|
)
|
(25,903,872
|
)
|
|||||
Basic
and diluted net loss per stock from continuing
operations
|
(0.17
|
)
|
(0.119
|
)
|
(0.15
|
)
|
|||||||
Weighted
average number of stocks outstanding used
in
computing basic and diluted net loss per stock
|
23,717,360
|
21,797,624
|
22,011,370
|
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
stock
|
8,500,000
|
850
|
15,150
|
-
|
-
|
16,000
|
|||||||||||||
Stock
issued on March 31, 2001 for cash at $ 0.0375 per
stock
|
1,600,000
|
160
|
59,840
|
-
|
-
|
60,000
|
|||||||||||||
Contribution
of capital
|
-
|
-
|
7,500
|
-
|
-
|
7,500
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(17,026
|
)
|
(17,026
|
)
|
|||||||||||
Balance
as of March 31, 2001
|
10,100,000
|
1,010
|
82,490
|
-
|
(17,026
|
)
|
66,474
|
||||||||||||
Contribution
of capital
|
-
|
-
|
11,250
|
-
|
-
|
11,250
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(25,560
|
)
|
(25,560
|
)
|
|||||||||||
Balance
as of March 31, 2002
|
10,100,000
|
1,010
|
93,740
|
-
|
(42,586
|
)
|
52,164
|
||||||||||||
Contribution
of capital
|
-
|
-
|
15,000
|
-
|
-
|
15,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(46,806
|
)
|
(46,806
|
)
|
|||||||||||
Balance
as of March 31, 2003
|
10,100,000
|
1,010
|
108,740
|
-
|
(89,392
|
)
|
20,358
|
||||||||||||
2-for-1
stock split
|
10,100,000
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||
Stock
issued on August 31, 2003 to purchase mineral option at $ 0.065 per
stock
|
100,000
|
5
|
6,495
|
-
|
-
|
6,500
|
|||||||||||||
Cancellation
of stocks granted to Company's
President
|
(10,062,000
|
)
|
(503
|
)
|
503
|
-
|
-
|
-
|
|||||||||||
Contribution
of capital
|
-
|
-
|
15,000
|
-
|
-
|
15,000
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(73,295
|
)
|
(73,295
|
)
|
|||||||||||
Balance
as of March 31, 2004
|
10,238,000
|
512
|
130,738
|
-
|
(162,687
|
)
|
(31,437
|
)
|
|||||||||||
Stock
issued on June 24, 2004 for private placement at $ 0.01 per stock,
net of $ 25,000 issuance expenses (Note 11c(1)(a))
|
8,510,000
|
426
|
59,749
|
-
|
-
|
60,175
|
|||||||||||||
Contribution
capital (Note 11b)
|
-
|
-
|
7,500
|
-
|
-
|
7,500
|
|||||||||||||
Stock
issued in 2004 for private placement at $ 0.75 per unit
(Note 11c(1)(a))
|
1,894,808
|
95
|
1,418,042
|
-
|
-
|
1,418,137
|
|||||||||||||
Cancellation
of stocks granted to service
providers
|
(1,800,000
|
)
|
(90
|
)
|
90
|
-
|
-
|
-
|
|||||||||||
Deferred
stock-based compensation related to options granted to employees
|
-
|
-
|
5,978,759
|
(5,978,759
|
)
|
-
|
-
|
||||||||||||
Amortization
of deferred stock-based compensation related to stocks and options
granted
to employees (Note 11c(2))
|
-
|
-
|
-
|
584,024
|
-
|
584,024
|
|||||||||||||
Compensation
related to stocks and options granted to service providers (Note
11c(3)(c))
|
2,025,000
|
101
|
17,505,747
|
-
|
-
|
17,505,848
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(18,839,795
|
)
|
(18,839,795
|
)
|
|||||||||||
Balance
as of March 31, 2005
|
20,867,808
|
1,044
|
25,100,625
|
(5,394,735
|
)
|
(19,002,482
|
)
|
704,452
|
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
|
1,044
|
25,100,625
|
(5,394,735
|
)
|
(19,002,482
|
)
|
704,452
|
|||||||||||
Stock
issued on May 12, 2005 for private
placement
at $ 0.8 per stock (Note 11c(1)(d))
|
186,875
|
9
|
149,491
|
-
|
-
|
149,500
|
|||||||||||||
Stock
issued on July 27, 2005 for private
placement
at $ 0.6 per stock (Note 11c(1)(e))
|
165,000
|
8
|
98,992
|
-
|
-
|
99,000
|
|||||||||||||
Stock
issued on September 30, 2005 for private placement at $0.8 per share(Note
11c(1)(f))
|
312,500
|
16
|
224,984
|
-
|
-
|
225,000
|
|||||||||||||
Stock
issued on December 07, 2005 for private placement at $0.8 per share
(Note
11c(1)(f))
|
187,500
|
10
|
134,990
|
-
|
-
|
135,000
|
|||||||||||||
Forfeiture
of options granted to employees
|
-
|
-
|
(3,363,296
|
)
|
3,363,296
|
-
|
-
|
||||||||||||
Deferred
stock-based compensation related
to
stocks and options granted to
directors
and employees
|
200,000
|
10
|
486,490
|
(486,500
|
)
|
-
|
-
|
||||||||||||
Amortization
of deferred stock-based
compensation
related to options and stocks
granted
to employees and directors
(Note
11c(2))
|
-
|
-
|
51,047
|
1,122,500
|
-
|
1,173,547
|
|||||||||||||
Stock-based
compensation related to
options
and stocks granted to service
providers
(Note 11c(3)(c))
|
934,904
|
47
|
662,069
|
-
|
-
|
662,116
|
|||||||||||||
Reclassification
due to application of
EITF
00-19 (Note 8b)
|
(7,906,289
|
)
|
(7,906,289
|
)
|
|||||||||||||||
Beneficial
conversion feature related to
a
convertible bridge loan (Note 8a)
|
-
|
-
|
163,744
|
-
|
-
|
163,744
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,316,749
|
)
|
(3,316,749
|
)
|
|||||||||||
Balance
as of March 31, 2006
|
22,854,587
|
1,144
|
15,802,847
|
(1,395,439
|
)
|
(22,319,231
|
)
|
(7,910,679
|
)
|
||||||||||
Elimination
of deferred stock compensation
due
to implementation of FAS 123(R)
|
-
|
-
|
(1,395,439
|
)
|
1,395,439
|
-
|
-
|
||||||||||||
Stock-based
compensation related to
stocks
and options granted to directors and employees
|
200,000
|
10
|
1,167,737
|
-
|
-
|
1,167,747
|
|||||||||||||
Reclassification
due to application of
EITF
00-19 (Note 8f)
|
-
|
-
|
7,190,829
|
-
|
-
|
7,190,829
|
|||||||||||||
Stock-based
compensation related to
options
and stocks granted to service
providers
(Note 11c)
|
1,147,225
|
56
|
453,698
|
-
|
-
|
453,754
|
|||||||||||||
Warrants
issued to convertible note holder
(Note
8e)
|
-
|
-
|
11,253
|
-
|
-
|
11,253
|
|||||||||||||
Warrants
issued to loan holder (Note 9)
|
-
|
-
|
109,620
|
-
|
-
|
109,620
|
|||||||||||||
Beneficial
conversion feature related to
convertible
bridge loans (Note 8)
|
-
|
-
|
1,086,211
|
-
|
-
|
1,086,211
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(3,924,485
|
)
|
(3,924,485
|
)
|
|||||||||||
Balance
as of December 31, 2006
|
24,201,812
|
1,210
|
24,426,756
|
-
|
(26,243,716
|
)
|
(1,815,750
|
)
|
Nine
months ended
December
31,
|
Year
ended
March
31,
|
Period
from September 22, 2000 (inception date) through December
31,
|
|||||||||||
2006
|
2005
|
2006
|
2006
|
||||||||||
Unaudited
|
|||||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net
loss
|
(3,924,485
|
)
|
(2,594,544
|
)
|
(3,316,749
|
)
|
(26,243,716
|
)
|
|||||
Less
- loss for the period from discontinued operations
|
-
|
-
|
163,971
|
||||||||||
Adjustments
to reconcile net loss to net cash used in
operating
activities:
|
|||||||||||||
Depreciation
|
147,732
|
39,486
|
57,408
|
205,385
|
|||||||||
Accrued
severance pay, net
|
(2,538
|
) |
-
|
5,470
|
2,932
|
||||||||
Accrued
interest on loans
|
65,901
|
-
|
13,210
|
79,111
|
|||||||||
Amortization
of discount on short-term loans
|
799,985
|
-
|
50,765
|
850,750
|
|||||||||
Change
in fair value of options and warrants
|
(488,180
|
) |
-
|
(306,660
|
)
|
(794,840
|
)
|
||||||
Expenses
related to stocks and options granted to
service
providers
|
574,627
|
256,040
|
631,216
|
18,687,491
|
|||||||||
Amortization
of deferred stock-based compensation related to options granted to
employees
|
1,167,747
|
832,476
|
1,173,547
|
2,925,318
|
|||||||||
Decrease
(increase) in accounts receivable and prepaid expenses
|
3,819
|
61,730
|
37,525
|
(41,478
|
)
|
||||||||
Increase
in trade payables
|
520,118
|
170,286
|
162,774
|
720,742
|
|||||||||
Increase
in other accounts payable and accrued expenses
|
280,631
|
389,399
|
239,213
|
645,926
|
|||||||||
Erosion
of restricted cash
|
1,805
|
-
|
|||||||||||
Net
cash used in continuing operating activities
|
(854,643
|
)
|
(843,322
|
)
|
(1,252,281
|
)
|
(2,798,408
|
)
|
|||||
Net
cash used in discontinued operating activities
|
-
|
-
|
(22,766
|
)
|
|||||||||
Total
net cash used in operating activities
|
(854,643
|
)
|
(843,322
|
)
|
(1,252,281
|
)
|
(2,821,174
|
)
|
|||||
Cash
flows from investing activities:
|
|||||||||||||
Purchase
of property and equipment
|
(141,397
|
)
|
(202,382
|
)
|
(209,647
|
)
|
(579,604
|
)
|
|||||
Restricted
cash
|
(3,014
|
)
|
-
|
2,195
|
(31,953
|
)
|
|||||||
Investment
in lease deposit
|
(735
|
)
|
(2,572
|
)
|
(2,477
|
)
|
(7,802
|
)
|
|||||
Net
cash used in continuing investing activities
|
(145,146
|
)
|
(204,954
|
)
|
(209,929
|
)
|
(619,359
|
)
|
|||||
Net
cash used in discontinued investing activities
|
-
|
-
|
(16,000
|
)
|
|||||||||
Total
net cash used in investing activities
|
(145,146
|
)
|
(204,954
|
)
|
(209,929
|
)
|
(635,359
|
)
|
|||||
Cash
flows from financing activities:
|
|||||||||||||
Proceeds
from issuance of Common stock and warrants, net
|
-
|
608,500
|
608,500
|
2,086,812
|
|||||||||
Proceeds
from loans, notes and issuance of warrants, notes and issuance of
warrants, net
|
770,000
|
-
|
617,410
|
1,387,410
|
|||||||||
Net
cash provided by continuing financing activities
|
770,000
|
608,500
|
1,225,910
|
3,474,222
|
|||||||||
Net
cash provided by discontinued financing activities
|
-
|
-
|
42,741
|
||||||||||
Total
net cash provided by financing activities
|
770,000
|
608,500
|
1,225,910
|
3,516,963
|
|||||||||
Increase
(decrease) in cash and cash equivalents
|
(229,789
|
)
|
(439,776
|
)
|
(236,300
|
)
|
60,430
|
||||||
Cash
and cash equivalents at the beginning of the period
|
290,219
|
526,519
|
526,519
|
-
|
|||||||||
Cash
and cash equivalents at end of the period
|
60,430
|
86,743
|
290,219
|
60,430
|
|||||||||
Non-cash
financing activities:
|
|||||||||||||
Non-cash
financing activities from continued operations:
|
-
|
26,400
|
30,900
|
NOTE
1:-
|
GENERAL
|
a.
|
Brainstorm
Cell Therapeutics Inc. (formerly: Golden Hand Resources Inc.) ("the
Company") was incorporated in the State of Washington on September
22,
2000.
|
b.
|
On
May 21, 2004, the former major stockholders of the Company entered
into a
purchase agreement with a group of private investors, who purchased
from
the former major stockholders 6,880,000 shares of the then issued
and
outstanding 10,238,000 shares of the Company's Common stock.
|
c.
|
On
July 8, 2004, the Company entered into a licensing agreement with
Ramot of
Tel Aviv University Ltd. ("Ramot"), an Israeli corporation, to acquire
certain stem cell technology (see Note 3). Subsequent to this agreement,
the Company decided to focus on the development of novel cell therapies
for neurodegenerative diseases, particularly, Parkinson's disease,
based
on the acquired technology and research to be conducted and funded
by the
Company.
|
d.
|
On
November 22, 2004, the Company changed its name from Golden Hand
Resources
Inc. to Brainstorm Cell Therapeutics Inc. to better reflect its new
line
of business in the development of novel cell therapies for
neurodegenerative diseases.
|
e.
|
On
October 25, 2004, the Company formed a wholly-owned subsidiary in
Israel,
Brainstorm Cell Therapeutics Ltd. ("BCT")..
|
f.
|
On
December 21, 2006, the Company changed its state of incorporation
from
Washington to Delaware.
|
g.
|
As
of December 31, 2006, the Company had accumulated a deficit of $
26,243,716, working capital deficiency of $ 2,363,329, incurred net
loss
of $ 3,924,485 and negative cash flows from operating activities
in the
amount of $ 854,643 for the nine months ended December 31, 2006.
In addition, the Company has not yet generated any revenues.
|
NOTE
1:-
|
GENERAL
(Cont.)
|
h.
|
On
September 17, 2006, the Board of Directors of the Company determined
to
change the Company's fiscal year-end from March 31 to December 31.
The
report is covering the transition period beginning April 1, 2006
and
ending December 31, 2006
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
|
a. |
Basis
of presentation:
|
b. |
Use
of estimates:
|
c.
|
Financial
statement in U.S. dollars:
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
d. |
Principles
of consolidation:
|
e.
|
Cash
equivalents:
|
f.
|
Property
and equipment:
|
%
|
||
Office
furniture and equipment
|
7
|
|
Computer
software and electronic equipment
|
33
|
|
Laboratory
equipment
|
15
|
|
Leasehold
improvements
|
Over
the shorter of the lease term (including the option) or useful
life
|
g.
|
Impairment
of long-lived assets:
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
h.
|
Research
and development costs:
|
i.
|
Severance
pay:
|
j.
|
Accounting
for stock-based compensation:
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
Nine
months ended
December
31,
|
Year
ended March 31,
|
||||||
2005
|
2006
|
||||||
Unaudited
|
|||||||
Net
loss as reported
|
(2,594,544
|
)
|
(3,316,749
|
)
|
|||
Deduct:
stock based employee compensation intrinsic value
|
(832,476
|
)
|
(1,122,500
|
)
|
|||
Add:
stock-based compensation expense determined under fair value
method
|
956,542
|
1,330,447
|
|||||
Pro
forma net loss
|
(2,718,610
|
)
|
(3,524,696
|
)
|
|||
Basic
and diluted net loss per share, as reported
|
(0.119
|
)
|
(0.15
|
)
|
|||
Basic
and diluted net loss per share, pro forma
|
(0.125
|
)
|
(0.16
|
)
|
Nine
months ended
December
31,
|
Year
ended March 31,
|
|||
Employee
stock options
|
2005
|
2006
|
||
Unaudited
|
||||
Expected
volatility
|
112%
|
110%
|
||
Risk-free
interest
|
4.46%
|
4.46%
|
||
Dividend
yield
|
0%
|
0%
|
||
Expected
life of up to (years)
|
5
|
7.53
|
l.
|
Basic
and diluted net loss per stock:
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
m.
|
Income
taxes:
|
n.
|
Fair
value of financial instruments:
|
o.
|
Concentrations
of credit risks:
|
p.
|
Impact
of recently issued accounting
standards:
|
NOTE
2:-
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
NOTE
3:-
|
RESEARCH
AND LICENSE AGREEMENT
|
a.
|
On
July 8, 2004, the Company entered into a research and license agreement
("the original agreement") with Ramot, the technology transfer company
of
Tel Aviv University Ltd. ("Ramot"). The license agreement grants
the
Company an exclusive, worldwide, royalty-bearing license to develop,
use
and sell certain stem cell technology. In consideration of the license,
the Company was required to remit an upfront license fee payment
of
$ 100,000; royalties at a rate of 5% of all net sales of products and
30% of all sublicense receipts. In addition, the Company granted
Ramot and
certain of its designees fully vested warrants to purchase 10,606,415
shares of its common stock at an exercise price of $ 0.01 per share.
The
Company will also fund, through Ramot, further research in consideration
of $ 570,000 per year for an initial two-year period and for a further
two-year period if certain research milestones are met. Ramot may
terminate the agreement if the Company fails to reach certain development
milestones or materially breaches the
agreement.
|
NOTE
3:-
|
RESEARCH
AND LICENSE AGREEMENT
(Cont.)
|
b. |
The
Company's total current obligation to Ramot as of December 31, 2006,
is in
the amount of $ 367,365. The Company is negotiating with Ramot to
postpone the payment.
|
NOTE
4:-
|
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 $
6,000 each. In addition, the Company granted each of the Consultants,
a
fully vested warrant to purchase 1,097,215 shares of the Company's
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 five-year
period beginning on November 4,
2005.
|
NOTE
4:-
|
CONSULTING
AGREEMENTS (Cont.)
|
b.
|
As
of December 31, 2006, the Company has a total obligation of $ 48,000
for
services rendered in respect of the Consultants.
|
NOTE
5:-
|
ACCOUNTS
RECEIVABLE AND PREPAID
EXPENSES
|
December
31,
|
March
31,
|
||||||
2006
|
2006
|
||||||
Government
authorities
|
15,832
|
15,411
|
|||||
Prepaid
expenses
|
25,800
|
30,040
|
|||||
41,632
|
45,451
|
NOTE
6:-
|
PROPERTY
AND EQUIPMENT
|
December
31,
|
March
31,
|
||||||
2006
|
2006
|
||||||
Cost:
|
|||||||
Office
furniture and equipment
|
5,309
|
5,309
|
|||||
Computer
software and electronic equipment
|
49,641
|
34,876
|
|||||
Laboratory
equipment
|
184,494
|
65,341
|
|||||
Leasehold
improvements
|
371,059
|
363,581
|
|||||
610,503
|
469,107
|
||||||
Accumulated
depreciation:
|
|||||||
Office
furniture and equipment
|
579
|
301
|
|||||
Computer
software and electronic equipment
|
20,438
|
9,892
|
|||||
Laboratory
equipment
|
26,072
|
8,253
|
|||||
Leasehold
improvements
|
72,369
|
39,207
|
|||||
119,458
|
57,653
|
||||||
Depreciated
cost
|
491,045
|
411,454
|
NOTE
7:-
|
OTHER
ACCOUNTS PAYABLE AND ACCRUED
EXPENSES
|
December
31,
|
March
31,
|
||||||
2006
|
2006
|
||||||
Employees
and payroll accruals
|
153,005
|
121,911
|
|||||
Accrued
expenses
|
498,071
|
248,534
|
|||||
651,076
|
370,445
|
NOTE
8:-
|
SHORT-TERM
CONVERTIBLE LOANS
|
a. |
On
February 7, 2006, the Company issued a $ 500,000 Convertible Promissory
Note to a third party. Interest on the note will accrue at the rate
of 10%
per Annum and will be due and payable in full on February 7, 2007
(the
"Maturity Date"). The note will become immediately due and payable
upon
the occurrence of certain Events of Default, as defined in the note.
The
third party has the right at any time prior to the close of business
on
the Maturity Date to convert all or part of the outstanding principal
and
interest amount of the note into stocks of the Company's Common stock
(the
"Common Stock"). The Conversion Price, as defined in the note, will
be 75%
(50% upon the occurrence of an Event of Default) of the average of
the
last bid and ask price of the Common Stock as quoted on the
Over-the-Counter Bulletin Board for the five trading days prior to
the
Company's receipt of the third party written notice of election to
convert. The Conversion Price will be adjusted in the event of a
stock
dividend, subdivision, combination or stock split of the outstanding
shares.
|
Note
|
500,000
|
|||
Discount
|
(50,685
|
)
|
||
Accrued
interest
|
44,816
|
|||
494,131
|
NOTE
8:-
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
b.
|
On
June 5, 2006, the Company issued a $ 500,000 Convertible Promissory
Note
to a third party under the same terms as the convertible note dated
February 7, 2006. The note will be due and payable in full on June
5,
2007.
|
Note
|
500,000
|
|||
Discount
|
(213,699
|
)
|
||
Accrued
interest
|
28,630
|
|||
314,931
|
c.
|
On
September 14, 2006, the Company issued a $ 100,000 Convertible Promissory
Note ("the note") to a third party under the same terms as the convertible
loan dated February 7, 2006. (See also Note 8a above). The note will
be
due and payable in full on September 14,
2007
|
Note
|
100,000
|
|||
Discount
|
(70,411
|
)
|
||
Accrued
interest
|
2,959
|
|||
32,548
|
NOTE
8:-
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
d. |
On
November 14, 2006, the Company issued a $ 50,000 Convertible Promissory
Note to a shareholder. Interest on the note will accrue at the rate
of 12%
per Annum and will be due and payable in full on February 12, 2007
(the
"Maturity Date"). The note will become immediately due and payable
upon
the occurrence of certain Events of Default, as defined in the note.
The
third party has the right at any time prior to the close of business
on
the Maturity Date to convert all or part of the outstanding principal
and
interest amount of the note into stocks of the Company's Common stock
(the
"Common Stock"). The Conversion Price, as defined in the note, will
be 75%
of the average of the last bid and ask price of the Common Stock
as quoted
on the Over-the-Counter Bulletin Board for the five trading days
prior to
the Company's receipt of the third party written notice of election
to
convert. The Conversion Price will be adjusted in the event of a
stock
dividend, subdivision, combination or stock split of the outstanding
shares.
|
Note
|
50,000
|
|||
Discount
|
(14,521
|
)
|
||
Accrued
interest
|
773
|
|||
36,252
|
e. |
On
December 12, 2006, the Company issued a $ 200,000 Convertible Promissory
Note to a third party. Interest on the note will accrue at the rate
of 8%
per Annum and will be due and payable in full on December 31, 2007.
The
note will become immediately due and payable upon the occurrence
of
certain Events of Default, as defined in the note. The third party
has the
right at any time prior to the close of business on the Maturity
Date to
convert all or part of the outstanding principal and interest amount
of
the note into stocks of the Company's Common stock (the "Common Stock").
The Conversion Price, as defined in the note, will be 75% (60% upon
the
occurrence of an Event of Default) of the average of the last bid
and ask
price of the Common Stock as quoted on the Over-the-Counter Bulletin
Board
for the five trading days prior to the Company's receipt of the third
party written notice of election to convert. The Conversion Price
will be
adjusted in the event of a stock dividend, subdivision, combination
or
stock split of the outstanding
shares.
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