x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
Delaware
|
52-2007292
|
State
or other jurisdiction of
incorporation
or organization
|
(I.R.S.
Employer
Identification
No.)
|
9700
Great Seneca Highway
Rockville,
MD
|
20850
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Title
of each class
|
Name
of each exchange on which registered
|
|
Common
stock, $0.01 par value
|
NYSE
Amex
|
Large accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
(Do
not check if a smaller reporting
company)
|
Smaller
reporting company x
|
Page
|
||||
PART I
|
3
|
|||
Item
1.
|
Business
|
3
|
||
Item
1A.
|
Risk
Factors
|
13
|
||
Item
2.
|
Properties
|
21
|
||
Item
3.
|
Legal
Proceedings
|
21
|
||
Item
4.
|
Removed and
Reserved
|
21
|
||
PART II
|
22
|
|||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
22
|
||
Item
6.
|
Selected
Financial Data
|
24
|
||
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
24
|
||
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
30
|
||
Item
8.
|
Financial
Statements and Supplementary Data
|
30
|
||
Item
9.
|
Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure
|
46
|
||
Item
9A.
|
Controls
and Procedures
|
47
|
||
Item
9B.
|
Other
Information
|
48
|
||
PART III
|
48
|
|||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
48
|
||
Item
11.
|
Executive
Compensation
|
52
|
||
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
56
|
||
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
58
|
||
Item
14.
|
Principal
Accounting Fees and Services
|
58
|
||
PART IV
|
58
|
|||
Item
15.
|
Exhibits,
Financial Statement Schedules
|
59
|
·
|
the
success of our research and development activities, the development of a
viable commercial product, and the speed with which regulatory
authorizations and product launches may be
achieved;
|
·
|
whether
or not a market for our product develops, and, if a market develops, the
rate at which it develops;
|
·
|
our
ability to successfully sell or license our products if a market
develops;
|
·
|
our
ability to attract and retain qualified personnel to implement our
business plan and corporate growth
strategies;
|
·
|
our
ability to develop sales, marketing, and distribution
capabilities;
|
·
|
our
ability to obtain reimbursement from third party payers for our proposed
products if they are developed;
|
·
|
the
accuracy of our estimates and
projections;
|
·
|
our
ability to fund our short-term and long-term financing
needs;
|
·
|
changes
in our business plan and corporate strategies;
and
|
·
|
other
risks and uncertainties discussed in greater detail in the section
captioned “Risk
Factors”
|
ITEM
1.
|
BUSINESS
|
Medical Condition
|
Number of Patients
|
||
Stem
cells
|
|||
ALS
|
30,000
|
(1)
|
|
Huntington’s
disease
|
15,000
|
(2)
|
|
Spinal
Cord Injury
|
250,000
|
(4)
|
|
Stroke
|
6.5
million
|
(3)
|
|
Small
molecule compound
|
|||
Alzheimer’s
disease
|
4.5
million
|
(5)
|
|
Depression
|
14.8
million
|
(5)
|
|
Schizophrenia
|
2.4
million
|
(5)
|
|
Stroke
|
6.5
million
|
(3)
|
·
|
Isolation, Propagation, and
Directed Differentiation of Stem Cell from Embryonic and Adult Central
Nervous System of Mammal;
and
|
·
|
In Vitro Generation of
Differentiated Neurons from Cultures of Mammalian Multi-potential CNS Stem
Cell
|
|
·
|
Our
cells are multipotent, so they give rise to the three critical cell types
of the nervous system: neurons (cells that carry signals throughout the
brain and spinal cord), astrocytes (cells that support and protect
neurons), and oligodendrocytes (cells that provide insulation to neurons
to make signaling efficient).
|
|
·
|
The
cells are lineage-restricted, so they only give rise to cells of the
nervous system. For example, our spinal cord stem cells can only form
cells found within the spinal
column.
|
|
·
|
Our technology enables
large-scale expansion of neural stem cells under controlled conditions
without introducing mutations or other adverse events that would
compromise their usefulness.
|
|
·
|
Our
spinal cord cells can be produced in commercial
quantities.
|
|
·
|
We
have isolated and cultured cells from multiple regions of the brain,
allowing application to a number of serious disorders. Cells have been
isolated from spinal cord (ALS, spinal cord injury), hippocampus (stroke,
Alzheimer’s disease), midbrain (Parkinson’s disease), and cortex
(ischemia).
|
|
·
|
Universal
Compatibility. The Company’s stem cell products are provided
to patients as ‘allografts,’ As such, the recipient is not genetically
identical to the donor, and may be treated with a course of
immunosuppressant drugs to prevent rejection of the cells. This strategy
allows for a single stem cell product to be provided to many thousands of
patients, ensuring the highest degree of quality in manufacturing and
predictability in outcome. Because the brain and spinal cord are
considered ‘immune privileged’ by most experts in the field, it is
expected that immune suppression of the patient will only be performed for
a brief period, allowing for minimal disruption of their normal immune
function.
|
|
·
|
Our
biologic drug candidates can be stored frozen at end-user medical
facilities until they are needed. This is a key feature of our
technology.
|
|
·
|
Spinal
Cord Injury
|
|
·
|
Stroke
|
|
·
|
Huntington’s
disease
|
|
·
|
ALS
|
Number
|
Country
|
Filing
Date
|
Issue Date
|
Expiration
Date
|
Title
|
|||||
2257068
|
CA
|
5/7/1997
|
N/A
|
N/A
|
ISOLATION,
PROPOGATION, AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM CENTRAL
NERVOUS SYSTEM OF MAMMALS
|
|||||
2343571
|
CA
|
9/20/1999
|
N/A
|
N/A
|
STABLE
NEURAL STEM CELL LINES
|
|||||
99948396.9
|
EP
|
9/20/1999
|
N/A
|
N/A
|
STABLE
NEURAL STEM CELL LINES
|
|||||
2000-574224
|
JP
|
9/20/1999
|
N/A
|
N/A
|
STABLE
NEURAL STEM CELL LINES
|
|||||
3790356.4
|
EP
|
12/5/2003
|
N/A
|
N/A
|
METHOD
FOR DISCOVERING NEUROGENIC AGENTS
|
|||||
11/281,640
|
US
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
200580039450
|
CN
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
5851748.3
|
EP
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
2613/CHENP/2007
|
IN
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
183092
|
IL
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
2007-543219
|
JP
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
10-2007-7012097
|
KR
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
1-2007-501016
|
PH
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
2007122507
|
RU
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
1-2007-01216
|
VN
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEURODEGENERATIVE
CONDITIONS
|
|||||
20073078
|
NO
|
11/17/2005
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
11/852,922
|
US
|
9/10/2007
|
N/A
|
N/A
|
METHOD
FOR DISCOVERING NEUROGENIC AGENTS
|
|||||
11/932,923
|
US
|
10/31/2007
|
N/A
|
N/A
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|||||
12/404,841
|
US
|
3/16/2009
|
N/A
|
N/A
|
METHODS
OF TREATING ISCHEMIC SPASTITICY
|
|||||
12/424,238
|
US
|
4/15/2009
|
N/A
|
N/A
|
STABLE
NEURAL STEM CELL LINES
|
|||||
12/500,073
|
US
|
7/9/2009
|
N/A
|
N/A
|
USE
OF FUSED NICOTINAMIDES TO PROMOTE
NEUROGENESIS
|
Number
|
Country
|
Filing
Date
|
Issue Date
|
Expiration
Date
|
Title
|
|||||
5,753,506
|
US
|
9/25/1996
|
5/19/1998
|
9/25/2016
|
ISOLATION
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
6,040,180
|
US
|
5/7/1997
|
3/21/2000
|
5/7/2017
|
IN
VITRO GENERATION OF DIFFERENTIATED NEURONS FROM CULTURES OF MAMMALIAN
MULTIPOTENTIAL CNS STEM CELLS
|
|||||
6,284,539
|
US
|
10/9/1998
|
9/4/2001
|
10/9/2018
|
METHOD
FOR GENERATING DOPAMINERGIC CELLS DERIVED FROM NEURAL
PRECURSORS
|
|||||
7,544,511
|
US
|
1/14/2002
|
6/9/2009
|
4/13/2017
|
STABLE
NEURAL STEM CELL LINES
|
|||||
7,560,553
|
US
|
3/17/2008
|
7/14/2009
|
8/9/2024
|
USE
OF FUSED NICOTINAMIDES TO PROMOTE NEUROGENESIS
|
|||||
755849
|
AU
|
9/20/1999
|
4/3/2003
|
9/20/2019
|
STABLE
NEURAL STEM CELL LINES
|
|||||
915968
|
EP
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPOGATION, AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM CENTRAL
NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
ES
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
FR
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
GB
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
IE
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
SE
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
915968
|
CH
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
69737949.3
|
DE
|
5/7/1997
|
7/25/2007
|
5/7/2017
|
ISOLATION,
PROPAGATION AND DIRECTED DIFFERENTIATION OF STEM CELLS FROM EMBRYONIC AND
ADULT CENTRAL NERVOUS SYSTEM OF MAMMALS
|
|||||
132324
|
SG
|
11/17/2005
|
11/30/2009
|
11/17/2025
|
TRANSPLANTATION
OF HUMAN NEURAL CELLS FOR TREATMENT OF NEUROLOGICAL
DISORDERS
|
|
·
|
Phase
1 studies for a cell therapy product are designed to evaluate safety in a
small number of subjects in a selected patient population by assessing
adverse effects, and may include multiple dose levels. This study may also
gather preliminary evidence of a beneficial effect on the
disease.
|
|
·
|
Phase
2 may involve studies in a limited patient population to determine
biological and clinical effects of the product and to identify possible
adverse effects and safety risks of the product in the selected patient
population.
|
|
·
|
Phase
3 trials would be undertaken to conclusively demonstrate clinical benefit
or effect and to test further for safety within a broader patient
population, generally at multiple study sites. The FDA continually reviews
the clinical trial plans and results and may suggest changes or may
require discontinuance of the trials at any time if significant safety
issues arise.
|
ITEM
1A.
|
RISK
FACTORS
|
·
|
the
continued progress and costs of our research and development
programs;
|
·
|
the
progress of pre-clinical studies and clinical
trials;
|
·
|
the
time and costs involved in obtaining regulatory
clearance;
|
·
|
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
|
·
|
The
cost of defending any patent
litigation;
|
·
|
the
costs of developing sales, marketing and distribution channels and our
ability to sell our products if
developed;
|
·
|
the
costs involved in establishing manufacturing capabilities for commercial
quantities of our proposed
products;
|
·
|
competing
technological and market
developments;
|
·
|
market
acceptance of our proposed
products;
|
·
|
the
costs of recruiting and retaining employees and consultants;
and
|
·
|
the
costs associated with educating and training physicians about our proposed
products.
|
|
·
|
the
clinical efficacy and safety of our proposed
products;
|
|
·
|
the
superiority of our products to alternatives currently on the
market;
|
|
·
|
the
potential advantages of our products over alternative treatment methods;
and
|
|
·
|
the
reimbursement policies of government and third-party
payors.
|
|
·
|
We
currently do not maintain “key person” life insurance on the life of Mr.
Garr. As a result, the Company will not receive any compensation upon the
death or incapacity of this key
individual;
|
|
·
|
We
currently do maintain “key person” life insurance on the life of Mr. Johe.
As a result, the Company will receive approximately $1,000,000 in the
event of his death or incapacity.
|
|
·
|
That
we regain compliance with Section 1003(i) of the NYSE AMEX company guide
by December, 2010, and
|
|
·
|
That
we provide the Exchange Staff with updates in conjunction with the
initiatives of the Plan as appropriate or upon request, but no later than
at each quarter completion concurrent with our appropriate filing with the
Securities and Exchange Commission.
|
ITEM
2.
|
PROPERTIES
|
ITEM
3.
|
LEGAL
PROCEEDINGS
|
·
|
On
May 7, 2008, we filed suit against StemCells, Inc., StemCells California,
Inc. (collectively “StemCells”) and Neurospheres Holding Ltd.,
(collectively StemCells and Neurospheres Holding Ltd are referred to as
“Plaintiffs”) in U.S. District Court for the District of Maryland,
alleging that U.S. Patent No. 7,361,505 (the “’505 patent”), alleging that
the ‘505 patent was exclusively licensed to the Plaintiffs, is invalid,
not infringed, and unenforceable. See Civil Action No.
08-1173. On May 13, we filed an Amended Complaint seeking
declaratory judgment that U.S. Patent No. 7,155,418 (the “’418 patent”) is
invalid and not infringed and that certain statements made by our CEO are
not trade libel or do not constitute unfair competition as alleged by the
Plaintiffs. On July 15, 2008, the Plaintiffs filed a Motion to
Dismiss for Lack of Subject Matter Jurisdiction, Lack of Personal
Jurisdiction, and Improper Venue or in the Alternative to Transfer to the
Northern District of California. On August 27, 2008, Judge Alexander
Williams, Jr. of the District of Maryland denied StemCells’ Motion to
Dismiss, but granted Neurospheres’ motion to dismiss. On September 11,
2008, StemCells filed its answer asserting counterclaims of infringement
for the ‘505 patent, the 418 patent, and state law claims for trade libel
and unfair competition. This case was consolidated with the 2006
litigation discussed below and it is not known when, nor on what basis,
this matter will be concluded.
|
·
|
On
July 28, 2006, StemCells, Inc., filed suit against Neuralstem, Inc. in the
U.S. District Court in Maryland, alleging that Neuralstem has been
infringing, contributing to the infringement of, and or inducing the
infringement of four patents owned by or exclusively licensed to StemCells
relating to stem cell culture compositions, genetically modified stem cell
cultures, and methods of using such cultures. See Civil Action
No. 06-1877. We answered the Complaint denying infringement,
asserting that the patents are invalid, asserting that we have intervening
rights based on amendments made to the patents during reexamination
proceedings, and further asserting that some of the patents are
unenforceable due to inequitable conduct. Neuralstem has also
asserted counterclaims that StemCells has engaged in anticompetitive
conduct in violation of antitrust laws. Discovery has commenced
and it is not known when, nor on what basis, this matter will be
concluded.
|
ITEM
4.
|
REMOVED
AND RESERVED.
|
ITEM
5.
|
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
|
High
|
Low
|
|||||
2008
|
||||||
First
Quarter
|
$
|
3.58
|
$
|
2.29
|
||
Second
Quarter
|
$
|
2.59
|
$
|
1.31
|
||
Third
Quarter
|
$
|
1.86
|
$
|
1.20
|
||
Fourth
Quarter
|
$
|
2.15
|
$
|
1.01
|
||
2009
|
||||||
First
Quarter
|
$
|
1.79
|
$
|
0.80
|
||
Second
Quarter
|
$
|
1.30
|
$
|
1.03
|
||
Third
Quarter
|
$
|
2.08
|
$
|
1.04
|
||
Fourth
Quarter
|
$
|
1.91
|
$
|
1.26
|
(a)
|
(b)
|
(c)
|
||||
Number of Securities
to be Issued
upon Exercise of
Outstanding
Options, Warrants
and Rights
|
Weighted-Average
Exercise Price of
Outstanding
Options,
Warrants and
Rights
|
Number of Securities
Remaining Available for
Future Issuance under
Equity Compensation Plans
(Excluding Securities
Reflected in Column (a))
|
||||
Equity
compensation plans approved by security holders
|
|
|
|
|||
2005 Stock Plan, as
amended
|
3,680,659
|
$
|
1.26
|
319,341
|
||
2007
Stock Plan
|
5,615,475
|
3.38
|
534,525
|
|||
Equity
compensation plans not approved by security holders
|
N/A
|
N/A
|
N/A
|
|||
Total
|
9,296,134
|
$
|
2.52
|
853,866
|
|
·
|
On
January 5, 2009 we granted a consultant options to purchase 100,000 common
shares at a price per share of $1.64. The options were issued
as compensation for services rendered. The grant was made
pursuant to our 2005 Stock Plan. The options have a term of 7
years.
|
|
·
|
On
March 30, 2009, we granted a consultant a common stock purchase warrant to
purchase 96,000 common shares at a price per share of
$1.25. The warrant will expire on
3/30/2015.
|
|
·
|
On
June 3, 2009, we granted a consultant100,000 options to purchase common
shares at a price of $1.13. The options were issued as
compensation for services rendered. The grant was made pursuant
to our 2005 Stock Plan. The options vest as
follows: 25,000 vested immediately; 25,000 vest at the six
month anniversary; 25,000 vest at the twelve month anniversary; 25,000
vest at the eighteen month anniversary. The options expire on
June 3, 2019.
|
|
·
|
On
July 2, 2009, pursuant to our director compensation policy, we granted
each of Messrs. Ogilvie and Oldaker options to purchase 35,000 common
shares as compensation for their services on our board of directors and
related committees. For a further description of the
transaction, please refer to the section of this Annual Report entitled
“Executive Compensation
– Director Compensation” contained in Item
11.
|
|
·
|
On
October 1, 2009 we granted a consultant warrants to purchase100,000 shares
at a price of $1.49. The warrants are fully vested and have a
cashless exercise provision. The warrants expire on
10/1/2016.
|
|
·
|
On
December 29, 2009, we completed a private placement of 646,551 common
shares resulting in gross proceeds of $1,500,000. The shares
were sold to 1 accredited investor at a price per share of
$2.32.
|
|
·
|
On
December 30, 2009, we issued Richard Garr and John Conron, our Chief
Executive Officer and Chief Financial Officer, respectively, an aggregate
of 225,475 common shares as consideration for the cancelation of certain
obligations owed to such executives. For a further description
of the transaction, please refer to the section of this Annual Report
entitled “Transactions
with Related Persons, Promoters and Certain Control Person’s”
contained in Item 13.
|
|
·
|
On
January 8, 2010, pursuant to a consulting agreement for investor relations
and business development services, we issued Market Development Consulting
Group, Inc.: (i) 140,000 common shares; and (ii) a common stock purchase
warrant entitling the holder to purchase 400,000 shares of common stock at
$1.70 per share. The warrant is exercisable immediately, shall
expire on December 31, 2019, and is freely assignable in whole or in
part. We also agreed to register the shares underlying
the warrant for resale. In connection with the registration of
the shares underlying the warrant, we agreed to pay consultant a penalty
of 1% additional warrants per each 30 days in the event: (i) a
registration statement covering the shares is not filed by March 21, 2009,
and (ii) the registration statement covering the shares is not declared
effective within 90 days of filing. The date for registration
has been extended to the earlier of: (a) the day following such day as we
file our Annual Report for 2009 ; or (b) April 15,
2010.
|
|
·
|
On
January 15, 2010, we issued a consultant options to purchase an aggregate
of 45,000 common shares at $2.40 per share. The options vest as
follows: (i) 25,000 upon grant; and (ii) 20,000 on December 31,
2010. The options have a term of 5
years.
|
|
·
|
On
January 15, 2010, we issued a consultant options to purchase an aggregate
of 100,000 common shares at $2.40 per share. The options are
100% vested upon grant and have a term of 7
years.
|
|
·
|
On
January 29, 2010, as an inducement to exercise 800,000 Series D Warrants,
we issued Vicis Capital Master Fund a replacement warrant. As a
result of the exercise, we received gross proceeds in the amount of
$1,000,000. The replacement warrant entitles the holder to
purchase 400,000 common shares at price of $1.85 per share. The
warrant has a term of 1 year.
|
|
·
|
In
March of 2010, in connection with the exercise of 2,699,400 Series C
Warrants, we issued the prior warrant holders an aggregate of 2,699,400
replacement warrants. As a result of the exercise, we received
gross proceeds in the amount of $3,374,250. The
replacement warrant is substantially the same as the prior Series C
warrants except that: (i) the exercise price is $2.13; (ii) the
replacement warrants expire 5 years from the date they were issued; and
(iii) the replacement warrants do not provide for any anti-dilution
rights.
|
|
·
|
In
March of 2010, in connection with the exercise of 782,005 placement agent
warrants, we issued T.R. Winston & Company, LLC, a replacement warrant
to purchase 782,005. As a result of the exercise, we
received gross proceeds in the amount
of $860,205. The replacement warrant is
substantially the same as the prior replacement warrants issued to our
Series C Warrant holders except that: (i) the exercise price is $2.13;
(ii) the replacement warrants expire 5 years from the date they were
issued; and (iii) the replacement warrants do not provide for any
anti-dilution rights.
|
|
·
|
In
March of 2010, we amended 706,752 placement agent warrants held
by TR Winston & Company, LLC. Pursuant to the amendment, we
agreed to extend the expiration date of the placement agent warrants from
March 15, 2012 to March 15, 2014 in exchange for the removal of the
anti-dilution provisions from said warrants. We did not receive
any additional consideration in connection with the
amendment.
|
ITEM
6.
|
SELECTED
FINANCIAL DATA
|
ITEM
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
|
•
|
Overview. Discussion
of our business and overall analysis of financial and other highlights
affecting the company in order to provide context for the remainder of
MD&A.
|
|
•
|
Trends &
Outlook. Discussion of
what we view as the overall trends affecting our business and the strategy
for our operating segments and outlook for
2010.
|
|
•
|
Critical Accounting
Policies. Accounting
policies that we believe are important to understanding the assumptions
and judgments incorporated in our reported financial results and
forecasts.
|
|
•
|
Results of
Operations. Analysis of our financial results comparing 2009
to 2008.
|
|
•
|
Liquidity and Capital
Resources. An analysis of changes in our balance sheets and
cash flows, and discussion of our financial condition including potential
sources of liquidity.
|
Change in
|
||||||||||||||||
2009
|
||||||||||||||||
Versus 2008
|
||||||||||||||||
2009
|
2008
|
$
|
%
|
|||||||||||||
Operating
Expenses
|
||||||||||||||||
Research &
development
|
$ | 5,346,904 | $ | 6,513,349 | $ | (1,166,445 | ) | 18 | % | |||||||
General,
selling & administrative expense
|
5,030,981 | 5,252,863 | (221,882 | ) | 4 | % | ||||||||||
Depreciation
and amortization
|
88,664 | 65,761 | 22,903 | 35 | % | |||||||||||
Total
expense
|
$ | 10,466,549 | $ | 11,831,973 | $ | (1,365,424 | ) | 12 | % |
Change
in 2008
|
||||||||||||||||
Versus 2007
|
||||||||||||||||
2009
|
2008
|
$
|
%
|
|||||||||||||
Cash and
cash equivalents
|
$ | 2,309,774 | $ | 4,903,279 | $ | (2,593,505 | ) | (53 | )% | |||||||
Net
cash used in operating activities
|
$ | (5,144,820 | ) | $ | (6,860,039 | ) | $ | (1,715,219 | ) | (25 | )% | |||||
Net
cash used in investing activities
|
$ | (210,784 | ) | $ | (193,630 | ) | $ | 17,154 | (9 | )% | ||||||
Net
cash provided by financing activities
|
$ | 2,762,099 | $ | 4,553,211 | $ | (1,791,112 | ) | (39 | )% |
|
•
|
On
December 18, 2008, we sold $2,000,000 of common stock pursuant to our
shelf registration statement on Form
S-3.
|
|
•
|
On
June 30, 2009, we sold $1,000,000 of common stock and warrants to purchase
an additional 2,440,000 common shares pursuant to our shelf registration
statement on Form S-3.
|
|
•
|
In
September 2009, we received $347,418 as a result of warrant
exercises.
|
|
•
|
In
October and December 2009, we received $53,214 as a result of warrant
exercises.
|
|
•
|
On
December 29, 2009 we sold $1,500,000 of common stock pursuant to a private
placement.
|
|
·
|
On
January 29, 2010, we received $1,000,000 as a result of Series D warrant
exercises.
|
|
·
|
In
February of 2010, we exercised the call provision related to our Series B
Warrants which resulted in $2,460,918from the exercise
thereof.
|
|
·
|
In
March of 2010, we received $3,374,250 as a result of Series C warrant
exercises.
|
|
·
|
In
March of 2010, we received $860,205 as a result of placement agent warrant
exercises.
|
ITEM 7A.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURE ABOUT MARKET
RISK
|
ITEM 8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
|
|
Page
|
|
Report of Independent Registered
Public Accounting Firm
|
31
|
|
Balance
Sheets
|
32
|
|
Statements
of Operations
|
33
|
|
Statements
of Cash Flows
|
34
|
|
Statements
of Stockholders’ Equity
|
35
|
|
Notes
to Financial Statements
|
36
|
/s/
Stegman & Company
|
December 31,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
and cash equivalents
|
$ | 2,309,774 | $ | 4,903,279 | ||||
Prepaid
expenses
|
143,600 | 136,287 | ||||||
Total
current assets
|
2,453,374 | 5,039,566 | ||||||
Property
and equipment, net
|
196,755 | 163,930 | ||||||
Intangible
assets, net
|
301,560 | 212,265 | ||||||
Other
assets
|
55,716 | 52,972 | ||||||
Total
assets
|
$ | 3,007,405 | $ | 5,468,733 | ||||
LIABILITIES
AND STOCKHOLDERS' (DEFICIT) EQUITY
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable and accrued expenses
|
$ | 791,607 | $ | 547,950 | ||||
Accrued
bonus expense
|
769,215 | 717,538 | ||||||
Total
current liabilities
|
1,560,822 | 1,265,488 | ||||||
LONG-TERM
LIABILITIES
|
||||||||
Fair
value of warrant obligations
|
6,462,039 | - | ||||||
Total
liabilities
|
8,022,861 | 1,265,488 | ||||||
STOCKHOLDERS'
(DEFICIT) EQUITY
|
||||||||
Preferred
stock, 7,000,000 shares authorized, zero shares issued and
outstanding
|
- | - | ||||||
Common
stock, $0.01 par value; 150 million shares authorized, 35,743,831 and
33,751,300 shares outstanding in 2009 and 2008,
respectively
|
357,438 | 337,513 | ||||||
Additional
paid-in capital
|
62,193,937 | 61,352,527 | ||||||
Accumulated
deficit
|
(67,566,831 | ) | (57,486,795 | ) | ||||
Total
stockholders' (deficit) equity
|
(5,015,456 | ) | 4,203,245 | |||||
Total
liabilities and stockholders' (deficit) equity
|
$ | 3,007,405 | $ | 5,468,733 |
Years
|
||||||||
Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating
expenses:
|
||||||||
Research
and development costs
|
5,346,904 | 6,513,349 | ||||||
General,
selling and administrative expenses
|
5,030,981 | 5,252,863 | ||||||
Depreciation
and amortization
|
88,664 | 65,761 | ||||||
Total
operating expenses
|
10,466,549 | 11,831,973 | ||||||
Operating
loss
|
(10,466,549 | ) | (11,831,973 | ) | ||||
Nonoperating
(expense) income:
|
||||||||
Interest
income
|
19,614 | 39,806 | ||||||
Interest
expense
|
(776 | ) | - | |||||
Warrant
modification expense
|
- | (38,631 | ) | |||||
Gain
from change in fair value of warrant obligations
|
83,348 | - | ||||||
Total
nonoperating income
|
102,186 | 1,175 | ||||||
Net
loss attributable to common shareholders
|
$ | (10,364,363 | ) | $ | (11,830,798 | ) | ||
Net
loss per share, basic and diluted
|
$ | (0.30 | ) | $ | (0.37 | ) | ||
Weighted
average common shares outstanding, basic and diluted
|
34,280,882 | 32,114,365 |
Twelve Months
|
||||||||
Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (10,364,363 | ) | $ | (11,830,798 | ) | ||
Adjustments
to reconcile net loss to cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
88,664 | 65,761 | ||||||
Share
based compensation expenses
|
4,556,916 | 4,632,847 | ||||||
Warrant
modification expense
|
- | 38,631 | ||||||
Gain
from change in fair value of warrant obligations
|
(83,348 | ) | - | |||||
Changes
in operating assets and liabilities:
|
||||||||
Prepaid
expenses
|
(7,313 | ) | (5,568 | ) | ||||
Other
assets
|
(2,744 | ) | (9,701 | ) | ||||
Accounts
payable and accrued expenses
|
243,657 | 127,301 | ||||||
Accrued
bonus expenses
|
423,711 | 121,488 | ||||||
Net
cash used in operating activities
|
(5,144,820 | ) | (6,860,039 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Acquisition
of intangible assets
|
(122,406 | ) | (116,921 | ) | ||||
Purchase
of property and equipment
|
(88,378 | ) | (76,709 | ) | ||||
Net
cash used in investing activities
|
(210,784 | ) | (193,630 | ) | ||||
Cash
flows From financing activities:
|
||||||||
Issuance
of common stock
|
2,762,099 | 4,553,211 | ||||||
Net
cash provided by financing activities
|
2,762,099 | 4,553,211 | ||||||
Net
decrease in cash
|
(2,593,505 | ) | (2,500,458 | ) | ||||
Cash
and cash equivalents, beginning of period
|
4,903,279 | 7,403,737 | ||||||
Cash
and cash equivalents, end of period
|
$ | 2,309,774 | $ | 4,903,279 | ||||
Supplemental
disclosure of cash flows information:
|
||||||||
Cash
paid for interest
|
776 | - | ||||||
Cash
paid for income taxes
|
- | - | ||||||
Supplemental
schedule of non cash investing and financing activities:
|
||||||||
Common
stock issued to pay accrued employee bonuses
|
372,033 | - |
Common
|
Common
|
Additional
|
Total
|
|||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Accumulated
|
Stockholders'
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity (Deficit)
|
||||||||||||||||
Balance
at January 1, 2008
|
31,410,566 | $ | 314,106 | $ | 52,151,245 | $ | (45,655,997 | ) | $ | 6,809,354 | ||||||||||
Exercise
of Warrants to purchase Common Stock ($1.50 to $2.00 per share), net of
offering costs of $20,889
|
125,425 | 1,254 | 209,957 | 211,211 | ||||||||||||||||
Issuance
of common stock though private placement ($4.06 per
share).
|
615,309 | 6,153 | 2,493,847 | 2,500,000 | ||||||||||||||||
Issuance
of common stock though private placement ($1.25 per share) , net of
offering costs of $158,000
|
1,600,000 | 16,000 | 1,826,000 | 1,842,000 | ||||||||||||||||
Share
Based Payments - Employee Compensation
|
4,632,847 | 4,632,847 | ||||||||||||||||||
Warrant
Modification Expense
|
38,631 | 38,631 | ||||||||||||||||||
Net
loss
|
(11,830,798 | ) | (11,830,798 | ) | ||||||||||||||||
Balance
at December 31, 2008
|
33,751,300 | 337,513 | 61,352,527 | (57,486,795 | ) | 4,203,245 | ||||||||||||||
Cumulative
effect of reclassification of warrants to liabilities
|
(7,044,118 | ) | 284,327 | (6,759,791 | ) | |||||||||||||||
Balance,
January 1, 2009 as adjusted
|
33,751,300 | 337,513 | 54,308,409 | (57,202,468 | ) | (2,556,546 | ) | |||||||||||||
Share
based payment - employee compensation
|
4,556,916 | 4,556,916 | ||||||||||||||||||
Issuance
of common stock through Private Placement ($1.25 per share), net of
financing costs of $96,608.
|
800,000 | 8,000 | 895,392 | 903,392 | ||||||||||||||||
Issuance
of common stock from warrants exercised ($1.25 per share), net of
financing costs of $31,300.
|
320,505 | 3,205 | 575,741 | 578,946 | ||||||||||||||||
Issuance
of common stock in settlement of outstanding 2008 bonus due to officers
(225,475 shares at $1.65 per share)
|
225,475 | 2,255 | 369,778 | 372,033 | ||||||||||||||||
Issuance
of common stock through Private Placement ($2.32 per share), net of
financing costs of $5,833
|
646,551 | 6,465 | 1,487,701 | 1,494,166 | ||||||||||||||||
Net
loss
|
(10,364,363 | ) | (10,364,363 | ) | ||||||||||||||||
Balance
at December 31, 2009
|
35,743,831 | $ | 357,438 | $ | 62,193,937 | $ | (67,566,831 | ) | $ | (5,015,456 | ) |
·
|
On
January 21, 2008, we granted the following options pursuant to our 2007
Stock Plan:
|
·
|
On
April 1, 2008, we granted an officer compensatory options to purchase an
aggregate of 1,050,000 common shares at an exercise price of $2.60. The
options vest as follows: (i) 50,000 vest immediately; and (ii) 1,000,000
vest annually over the next three years so that 100% of the options will
be vested on April 1, 2011. The options were issued pursuant to our two
stock plans as follows: (x) the option to purchase 1,000,000 common shares
was issued pursuant to our 2007 Stock Plan; and (y) option to purchase
50,000 common shares was issued pursuant to our 2005 Stock
Plan.
|
·
|
On
May 28, 2008, we granted independent directors options to purchase an
aggregate of 120,000 common shares at an exercise price of $1.32. The
grant was made pursuant to our 2007 Stock Plan and in compliance with our
non-executive compensation arrangement. The grant consists of: (i) an
option purchase 90,000 common shares as compensation for serving on the
board of directors; (ii) an option to purchase 10,000 common shares as
compensation for serving on our Audit Committee; (iii) an option to
purchase 10,000 common shares as compensation for serving on our
Compensation Committee; and (iv) an option to purchase 10,000 common
shares as compensation for serving on our Governance and Nominating
Committee. The options vest quarterly over the grant year and expire 7
years from the date of grant.
|
·
|
On
August 14, 2008, we granted options to purchase an aggregate of 30,000
common shares at an exercise price of $1.88 to two employees (15,000
each). The grants were made pursuant to our 2005 Stock Plan. The options
vest as follows: (i) 15,000 on the granted date; and (ii) 15,000 on August
14, 2009. The options expire on August 14,
2018.
|
·
|
On
August 14, 2008, we granted one of our employees options to purchase
200,000. The grant is effective as of August 11, 2008, the employee’s
start date. The options vest as follows: (i) 40,000 on the effective date;
and (ii) 40,000 on each of August 11, 2009, 2010, 2011 and 2012. The grant
was made pursuant to the 2005 Stock Plan. The options have an exercise
price of $1.89 and expire on August 14,
2018.
|
·
|
On
November 14, 2008 we granted a consultant 50,000 warrants to purchase
common shares at a price of $2.75, which were reclassed in 2009 to options
with the same terms. The grant was made pursuant to our 2005 Stock
Plan. The options are fully vested. The options were
issued as partial compensation for services rendered. The
options expire on November 13,
2013.
|
·
|
On
January 5, 2009 we granted a consultant 100,000 options to purchase common
shares at a price of $1.64. The options were issued as
compensation for services rendered. The grant was made pursuant to our
2005 Stock Plan. The options are fully vested and have a
cashless exercise provision. The options expire on January 5,
2016.
|
·
|
On
June 3, 2009 we granted a consultant100,000 options to purchase common
shares at a price of $1.13. The options were issued as
compensation for services rendered. The grant was made pursuant
to our 2005 Stock Plan. The options vest as
follows: 25,000 vested immediately; 25,000 vest at the six
month anniversary; 25,000 vest at the twelve month anniversary; 25,000
vest at the eighteen month anniversary. The options expire on
June 3, 2019.
|
·
|
On
July 2, 2009 we granted independent directors options to purchase an
aggregate of 70,000 common shares at an exercise price of
$1.17. The grant was made pursuant to our 2007 Stock Plan and
in compliance with our non-executive compensation
arrangement. The grant consists of: (i) options to purchase
40,000 common shares as compensation for serving on the Board of
Directors; (ii) options to purchase 10,000 common shares as compensation
for serving on the Audit Committee; (iii) options to purchase 10,000
common shares as compensation for serving on the Compensation Committee;
and (iv) options to purchase 10,000 common shares as compensation for
serving on the Governance and Nominating Committee. These
options vest quarterly over the grant year and expire 7 years from the
date of grant.
|
Number of
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual Life
(in years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding
at January 1, 2008
|
3,150,659 | $ | 1.19 | 6.8 | $ | - | ||||||||||
Granted
|
5,650,000 | 3.34 | 9.3 | $ | - | |||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Forfeited
|
- | - | - | - | ||||||||||||
Outstanding
at January 1, 2009
|
8,800,659 | $ | 2.55 | 8.2 | $ | - | ||||||||||
Granted
|
270,000 | 1.33 | 8.2 | $ | 124,400 | |||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Forfeited
|
- | - | - | - | ||||||||||||
Outstanding
at December 31, 2009
|
9,070,659 | $ | 2.52 | 7.2 | $ | 3,276,800 | ||||||||||
Exercisable
at December 31, 2009
|
5,065,659 | $ | 1.88 | 6.6 | $ | 3,222,100 |
Range
of
|
||||||||
Exercise
|
Outstanding
|
|||||||
Price
|
Options
|
Expiration
Dates
|
||||||
$0.50
- 2.00
|
3,070,000 | 2015 - 2019 | ||||||
$
2.01 - 3.00
|
1,115,000 | 2013 - 2018 | ||||||
$3.01
- 4.00
|
4,818,275 | 2012 - 2018 | ||||||
$4..01
- 8.00
|
62,042 | 2011 - 2015 | ||||||
$8.01
- higher
|
5,342 | 2010 - 2011 | ||||||
9,070,659 |
Twelve Months Ended Dec. 31,
|
||||||||
2009
|
2008
|
|||||||
Research
and development costs
|
$ | 2,887,001 | $ | 3,024,537 | ||||
General,
selling and administrative expenses
|
1,669,915 | 1,608,310 | ||||||
Total
|
$ | 4,556,916 | $ | 4,632,847 |
|
·
|
On
December 18, 2008, we completed a registered offering of our shares at a
price per share of $1,25. As a result of this transaction we
issued:
|
|
o
|
112,000
placement agent warrants to purchase common stock at a price per share of
$2.52. The warrants expire December 16,
2013.
|
|
o
|
1,884,672
Series C Warrants to purchase common stock at a price per share of
$1.25. The warrants expire October 31,
2012.
|
|
·
|
On
March 30, 2009 we granted a consultant warrants to purchase 96,000 shares
at a price of $1.25. The warrants shall be fully vested on
3/20/2010 and expire on 3/30/2015.
|
|
·
|
On
June 30, 2009 we completed a registered offering of 800,000 units at a
price per share of $1.25. As a result of this transaction we
issued:
|
|
o
|
800,000
fully paid common shares.
|
|
o
|
800,000
Series D Warrants to purchase common stock at a price of
$1.25. The warrants expire on June 30,
2010.
|
|
o
|
800,000
Series E Warrants to purchase common stock at a price of
$1.25. The warrants expire on June 30,
2012.
|
|
o
|
800,000
Series F Warrants to purchase common stock at a price of
$1.25. The warrants expire on June 30,
2014.
|
|
o
|
40,000
placement agent warrants to purchase common stock at a price of
$1.5625. The warrants expire on June 30,
2014.
|
|
·
|
On
October 1, 2009 we granted a consultant warrants to purchase100,000 shares
at a price of $1.49. The warrants are fully vested and have a
cashless exercise provision. The warrants expire on
10/1/2016.
|
Weighted-
|
||||||||||||||||
Weighted-
|
Average
|
|||||||||||||||
Average
|
Remaining
|
Aggregate
|
||||||||||||||
Number
|
Exercise
|
Contractual
|
Intrinsic
|
|||||||||||||
of Warrants
|
Price
|
Life (in years)
|
Value
|
|||||||||||||
Outstanding
at January 1, 2008
|
11,208,515 | - | ||||||||||||||
Issued
|
1,996,672 | - | ||||||||||||||
Exercised
|
(125,425 | ) | - | |||||||||||||
Forfeited
|
- | |||||||||||||||
Outstanding
at December 31, 2008
|
13,079,762 | $ | 2.27 | 2.0 | - | |||||||||||
Issued
|
2,536,000 | 1.25 | 2.8 | - | ||||||||||||
Exercised
|
(320,505 | ) | 1.25 | - | - | |||||||||||
Forfeited
|
- | - | - | - | ||||||||||||
Outstanding
at December 31, 2009
|
15,295,257 | $ | 1.82 | 2.0 | - | |||||||||||
Exercisable
at December 31, 2009
|
12,199,257 | $ | 1.53 | 2.0 | - |
|
Strike
Price
|
Date
of Issue
|
Date
of Expiration
|
Warrants
Outstanding
|
|||||||
Series
A & B Warrants
|
$ | 1.25 |
February-06
|
February-11
|
4,359,605 | ||||||
Series
A & B Warrants, Placement Agent
|
$ | 1.10 |
February-06
|
February-11
|
782,005 | ||||||
Series
C Warrants
|
$ | 1.25 |
October-07
|
October-12
|
1,227,000 | ||||||
Series
C Warrants, Placement Agent
|
$ | 1.25 |
March-07
|
March-12
|
294,480 | ||||||
Series
C Warrants, anti-dilution awards
|
$ | 1.25 |
December-08
|
October-12
|
1,472,400 | ||||||
Series
C Warrants, Placement Agent, anti-dilution awards
|
$ | 1.25 |
December-08
|
March-12
|
412,272 | ||||||
Total
warrants no longer accounted for as equity
|
8,547,762 |
December 31,
|
January 1,
|
|||||||
2009
|
2009
|
|||||||
Annual
dividend yield
|
- | - | ||||||
Expected
life (years)
|
.60-2.00 | 1.0-2.5 | ||||||
Risk
free interest rate
|
.20%-1.14 | % | 0.40 | % | ||||
Expected
volatility
|
62%-98 | % | 86 | % |
Twelve Months Ended Dec. 31,
|
||||||||
2009
|
2008
|
|||||||
Research
and development costs
|
$ | 2,887,001 | $ | 3,024,537 | ||||
General,
selling and administrative expenses
|
1,669,915 | 1,608,310 | ||||||
Total
|
$ | 4,556,916 | $ | 4,632,847 |
2009
|
2008
|
|||||||
Dividend
yield
|
0 | % | 0 | % | ||||
Expected
volatility range
|
46% to 85 | % | 46% to 82 | % | ||||
Risk-free
interest rate range
|
.74% to 4.96 | % | 1.22% to 4.96 | % | ||||
Expected
life
|
2
to 6.5 yrs
|
2
to 6.5 yrs
|
2009
|
2008
|
|||||||
Furniture
and Fixtures
|
$ | 14,400 | $ | 14,400 | ||||
Computers
and office equipment
|
47,109 | 43,273 | ||||||
Lab
equipment
|
280,579 | 196,036 | ||||||
$ | 342,088 | $ | 253,709 | |||||
Less
accumulated depreciation and amortization
|
(145,333 | ) | (89,779 | ) | ||||
Property
and equipment, net
|
$ | 196,755 | $ | 163,930 |
2009
|
2008
|
|||||||||||||||
Accumulated
|
Accumulated
|
|||||||||||||||
Gross
|
Amortization
|
Gross
|
Amortization
|
|||||||||||||
Patent
filing fees
|
$ | 365,409 | $ | (63,849 | ) | $ | 243,004 | $ | (30,739 | ) |
2009
|
2008
|
|||||||
Net
operating loss carry-forwards
|
$ | 17,842,957 | $ | 15,563,878 | ||||
Valuation
allowance
|
(17,842,957 | ) | (15,563,878 | ) | ||||
Net
deferred tax asset
|
$ | - | $ | - |
Level 1 —
|
Inputs
are unadjusted, quoted prices in active markets for identical assets at
the reporting date. Active markets are those in which transactions for the
asset or liability occur in sufficient frequency and volume to provide
pricing information on an ongoing
basis.
|
Level 2 —
|
Inputs
are other than quoted prices included in Level 1, which are either
directly or indirectly observable for the asset or liability through
correlation with market data at the reporting date and for the duration of
the instrument's anticipated life.
|
Level 3 —
|
Unobservable
inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities and which
reflect management's best estimate of what market participants would use
in pricing the asset or liability at the reporting date. Consideration is
given to the risk inherent in the valuation technique and the risk
inherent in the inputs to the model. Our warranty obligations
are considered Level 3.
|
Fair value measurements at December 31, 2009 using
|
||||||||||||||||
Fair Value on
Balance
Sheet
2009
|
Quoted prices in
active markets for
identical assets
(Level 1)
|
Significant
other
observable
inputs
(Level 2)
|
Significant
unobservable
inputs
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 2,309,774 | $ | 2,309,774 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Fair
value of warrant obligations
|
6,462,039 | - | - | 6,462,039 |
Three months ended
December 31, 2009
|
Twelve months ended
December 31, 2009
|
|||||||
Fair
value of warrant obligations at beginning of period
|
$ | 5,622,339 | $ | - | ||||
Cumulative
effect of reclassification of warrants to liabilities at beginning
period
|
181,498 | 6,759,791 | ||||||
Net
loss (gain) for change in fair value included in the statement of
operations for period
|
677,830 | (83,348 | ) | |||||
Decrease
in value from warrant exercises
|
(19,628 | ) | (214,404 | ) | ||||
Fair
value of warrant obligations at end of period
|
$ | 6,462,039 | $ | 6,462,039 |
ITEM
9.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
ITEM 9A.
|
CONTROLS
AND PROCEDURES
|
|
·
|
pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of the assets of the
Company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the Company
are being made only in accordance with authorizations of management and
directors of the Company; and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the financial
statements.
|
Item 9B.
|
Other
Information
|
|
·
|
During
the first quarter of 2010, and subsequent to the date of the balance sheet
included in this Annual Report, we completed a series of transactions
resulting in us receiving gross proceeds for the exercise of our Series A,
B, C and D warrants of $7.3 million. For a further description
of those transactions, please refer to the Sections of this Annual Report
contained in:
|
|
·
|
Item
5. – Section entitled “Recent Sale of Unregistered
Securities”
|
|
·
|
Item
7. — Section entitled “Management’s Discussion and
Analysis of Financial Conditions and Results of Operations – Liquidity and
Capital Resources.”
|
|
·
|
On
March 31, 2010, our Compensation Committee determined 2009 bonuses for our
executive officers. For a further description of the bonuses,
refer to the section of this Annual Report contained in Item
11. Executive
Compensation.
|
ITEM 10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE
|
Name
|
|
Principal Occupation
|
|
Age
|
|
Director
Since
|
Scott
Ogilvie(1)
|
CEO
and President of Gulf Enterprises International, Ltd.
Director
of Neuralstem, Inc.
|
55
|
2007
|
Name
|
|
Principal Occupation
|
|
Age
|
|
Director
Since
|
I.
Richard Garr
|
Chief
Executive Officer, President, General Counsel and Director of Neuralstem,
Inc.
|
57
|
1996
|
|||
Karl
Johe, Ph.D
|
Chief
Scientific Officer, Chairman of the Board and Director of Neuralstem,
Inc.
|
49
|
1996
|
Name
|
|
Principal Occupation
|
|
Age
|
|
Director
Since
|
William Oldaker(1)
|
Partner
at Oldaker Group LLC
Director
of Neuralstem, Inc.
|
68
|
2007
|
Name
|
|
Position
|
|
Age
|
|
Position Since
|
I.
Richard Garr
|
Chief
Executive Officer, President, General Counsel
|
57
|
1996
|
|||
Karl
Johe, Ph.D.
|
Chief
Scientific Officer
|
49
|
1996
|
|||
John
Conron
|
Chief
Financial Officer
|
59
|
4/1/2007
|
Name
of Reporting Person
|
Type
of Report Filed Late
|
No. of Transactions
Reported Late
|
||
William
Oldaker
|
Form
4 - Statement of Change in Beneficial Ownership
|
1
|
Director
|
Audit Committee
|
Nomination
and Corporate
Governance
Committee
|
Compensation
Committee
|
|||
William
Oldaker
|
Chair
|
Member
|
Member
|
|||
Scott
Ogilvie
|
Member
|
Chair
|
Chair
|
|||
ITEM 11.
|
EXECUTIVE
COMPENSATION
|
Nonequity
|
Non-
qualified
|
|||||||||||||||||||||||||||||||||
Stock
|
Incentive
|
deferred
|
||||||||||||||||||||||||||||||||
Name and
|
Bonus
|
Awards
|
Option
|
Plan
|
compensation
|
All other
|
||||||||||||||||||||||||||||
principal
|
Salary
|
($)
|
($)
|
Award
|
compensation
|
earning
|
Compensation
|
Total
|
||||||||||||||||||||||||||
position
|
Year
|
($)
|
(d)
|
(e)
|
($)
|
($)
|
($)
|
($)
|
($)
|
|||||||||||||||||||||||||
(a)
|
(b)
|
(c)
|
(3)
|
(3)
|
(f)(2)
|
(g)
|
(h)
|
(i)(1)
|
(j)
|
|||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
I.
Richard Garr
|
2009
|
$ | 407,000 | 52,584 | 157,754 | - | 48,688 | $ | 666,026 | |||||||||||||||||||||||||
Chief
Executive
|
2008
|
$ | 436,750 | 33,917 | 312,033 | 3,437,056 | 88,523 | $ | 4,308,279 | |||||||||||||||||||||||||
President,
General Counsel (“PEO”)
|
||||||||||||||||||||||||||||||||||
Karl
Johe
|
2009
|
$ | 422,100 | 204,508 | 68,169 | - | 6,000 | $ | 700,777 | |||||||||||||||||||||||||
Chief
Scientific Officer
|
2008
|
$ | 427,250 | 341,700 | - | 3,437,056 | 6,000 | $ | 4,212,006 | |||||||||||||||||||||||||
John
Conron
|
2009
|
$ | 225,000 | 7,481 | 22,444 | - | 6,000 | $ | 260,925 | |||||||||||||||||||||||||
Chief
Financial Officer
|
2008
|
$ | 208,750 | 18,750 | 60,000 | 1,125,581 | 4,500 | $ | 1,417,581 | |||||||||||||||||||||||||
Thomas
Hazel
|
2009
|
$ | 180,000 | 15,000 | - | - | - | $ | 195,000 | |||||||||||||||||||||||||
Senior
Vice President of Research
|
2008
|
$ | 100,000 | 7,500 | - | 179,411 | - | $ | 286,911 |
2009 Equity Award Calculation
|
||||||||||||||||
Bonus
|
Equity
|
|
||||||||||||||
Present Value
|
Proportion
|
Equity Pool
|
Shares
|
|||||||||||||
Chairman
and Chief Science Officer
|
$ | 272,677 | 25 | % | $ | 68,169 | 33,253 | |||||||||
Chief
Executive Officer
|
$ | 210,338 | 75 | % | $ | 157,754 | 76,953 | |||||||||
Chief
Financial Officer
|
$ | 29,925 | 75 | % | $ | 22,444 | 10,948 |
2009 Cash Award Calculation
|
||||||||||||
Base
|
Cash
|
Cash
|
||||||||||
Salary
|
Proportion
|
Award
|
||||||||||
Chairman
and Chief Science Officer
|
$ | 272,677 | 75 | % | 204,508 | |||||||
Chief
Executive Officer
|
$ | 210,338 | 25 | % | 52,585 | |||||||
Chief
Financial Officer
|
$ | 29,925 | 25 | % | 7,481 |
Officer
|
Termination
Date
|
Salary(1)
|
Auto (2)
|
Accelerated Vesting
of Options(3)
|
Total
|
|||||||||||||
I
Richard Garr
|
||||||||||||||||||
12/31/09
|
$ | 1,153,170 | $ | 17,000 | $ | 1,548,000 | $ | 2,718,170 | ||||||||||
03/31/10
|
$ | 1,051,419 | $ | 15,500 | $ | 1,548,000 | $ | 2,614,919 | ||||||||||
6/30/10
|
$ | 1,000,000 | — | $ | 1,548,000 | $ | 2,548,000 | |||||||||||
After
7/1/10
|
$ | 1,000,000 | — | $ | 1,548,000 | $ | 2,548,000 |
(1)
|
Assumes
an annual salary of $407,000. Does not include annual bonus or
salary increase.
|
(2)
|
Executive
is entitled to a $500 per month automobile
allowance.
|
(3)
|
Derived
from in the money stock options as of 12/31/09 using a market value of
$1.79 for the Company’s common
stock.
|
Officer
|
Termination
Date
|
Salary(1)
|
Auto (2)
|
Accelerated Vesting
of Options(3)
|
Total
|
|||||||||||||
Karl
Johe, Ph.D
|
||||||||||||||||||
12/31/09
|
$ | 1,195,950 | $ | 17,000 | $ | 1,548,000 | $ | 2,760,950 | ||||||||||
03/31/10
|
$ | 1,090,425 | $ | 15,500 | $ | 1,548,000 | $ | 2,653,425 | ||||||||||
6/30/10
|
$ | 1,000,000 | — | $ | 1,548,000 | $ | 2,548,000 | |||||||||||
After
7/1/10
|
$ | 1,000,000 | — | $ | 1,548,000 | $ | 2,548,000 |
(1)
|
Assumes
an annual salary of $422,100. Does not include annual bonus or
salary increase.
|
(2)
|
Executive
is entitled to a $500 per month automobile
allowance.
|
(3)
|
Derived
from in the money stock options as of 12/31/09 using a market value of
$1.79 for the Company’s common
stock.
|
Name
(a)
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
(b)
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
(c)
|
Equity
incentive
plan
awards:
Number of
securities
underlying
unexercised
unearned
options
(#)
(d)
|
Option
exercise
price
($)
(e)
|
Option
expiration
date
(f)
|
Number
of shares
or units
of stock
that have
not
vested
(#)
(g)
|
Market
value of
shares of
units of
stock that
have not
vested
($)
(h)
|
Equity
incentive
plan
award:
Number
of un-
earned
shares,
units or
other
rights that
have not
vested
(#)
(i)
|
Equity
incentive
plan
awards:
Market or
payout
value of
unearned
shares,
units or
other
rights that
have not
vested
($)
(j)
|
||||||||||||||||||||||||||
I.
Richard Garr
|
(1)
|
1,200,000 | 0 | $ | 0.50 |
7/28/15
|
|||||||||||||||||||||||||||||
|
(2)
|
700,000 | 1,400,000 | $ | 3.66 |
1/1/18
|
|||||||||||||||||||||||||||||
Karl
Johe (3)
|
(4)
|
1,200,000 | 0 | $ | 0.50 |
7/28/15
|
|||||||||||||||||||||||||||||
(5)
|
333,333 | $ | 3.01 |
10/31/15
|
|||||||||||||||||||||||||||||||
|
(6)
|
700,000 | 1,400,000 | $ | 3.66 |
1/1/18
|
|||||||||||||||||||||||||||||
John
Conron
|
(7)
|
100,000 | $ | 3.15 |
4/1/15
|
||||||||||||||||||||||||||||||
(8)
|
50,000 | $ | 2.60 |
4/1/18
|
|||||||||||||||||||||||||||||||
(9)
|
333,333 | 666,667 | $ | 2.60 |
4/1/18
|
(1)
|
On
July 28, 2005, we granted our CEO an option to purchase 1,200,000 common
shares. The option was granted under our 2005 Stock
Plan. The option vests annually over 4 years at a rate of
300,000 per year. The applicable vesting dates are July 28,
2006, 2007, 2008 and 2009. The only vesting condition is Mr.
Garr’s continued employment.
|
(2)
|
On
January 21, 2008, we granted our CEO an option to purchase 2,100,000
common shares. The grant has an effective date of January 1,
2008. The option was granted under our 2007 Stock
Plan. The option vests at a rate of 700,000 per 14 month
period. The applicable vesting dates are February 28, 2009,
April 30, 2010, and June 30, 2011. The only vesting condition
is Mr. Garr’s continued employment.
|
(3)
|
Outstanding
equity awards for Mr. Johe do not include warrants to purchase an
aggregate of 3,000,000 common shares that were issued on June 5,
2007. For a further description of the transaction, please
refer to the section of this report entitled “Transactions with Related
Persons, Promoters and Certain Control
Persons.”
|
(4)
|
On
July 28, 2005, we granted our CSO an option to purchase 1,200,000 common
shares. The option was granted under our 2005 Stock
Plan. The option vests annually over 4 years at a rate of
300,000 per year. The applicable vesting dates are July 28,
2006, 2007, 2008 and 2009. The only vesting condition is Mr.
Johe’s continued employment.
|
(5)
|
On
September 20, 2007, we granted our Chairman and Chief Scientific Officer,
an option to purchase an aggregate of 333,333 shares of our common stock
at a price per share of $3.01 pursuant to our 2005 Stock Plan. The option
expires 5 years from the date when they become
exercisable. The option vests on October 31,
2010. The option is immediately exercisable upon an event which
would result in an acceleration of Mr. Johe’s stock option grants under
his employment agreement.
|
(6)
|
On
January 21, 2008, we granted our CSO an option to purchase 2,100,000
common shares. The grant has an effective date of January 1,
2008. The option was granted under our 2007 Stock
Plan. The option vests at a rate of 700,000 per 14 month
period. The applicable vesting dates are February 28, 2009,
April 30, 2010, and June 30, 2011. The only vesting condition
is Mr. Johe’s continued employment.
|
(7)
|
In
April of 2007, we granted our CFO an option to purchase 100,000 common
shares pursuant to his employment contract. The option is fully
vested as of December 31, 2008.
|
(8)
|
On
April 1, 2008, we granted our CFO an option to purchase 50,000 common
shares. The grant was made pursuant to Mr. Conron’s employment
agreement. The option was fully vested at the grant
date.
|
(9)
|
On
April 1, 2008, we granted our CFO an option to purchase 1,000,000 common
shares. The option vests at an annual rate of 333,333 per
year. The vesting dates are April 1, 2009, 2010 and
2011. The only vesting condition is Mr. Conron’s continued
employment.
|
Name
|
Fees Earned
or Paid in
Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan
Compensation
($)
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
All Other
Compensation
($)
|
Total
($)
|
|||||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
|||||||||||||||||||||
William
Oldaker
|
||||||||||||||||||||||||||||
Independent
Director(1)
|
20,000 | $ | 10,959 | $ | 30,959 | |||||||||||||||||||||||
Audit
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 | |||||||||||||||||||||||
Compensation
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 | |||||||||||||||||||||||
Nomination
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 | |||||||||||||||||||||||
Scott
Ogilvie
|
||||||||||||||||||||||||||||
Independent
Director(1)
|
20,000 | $ | 10,959 | $ | 30,959 | |||||||||||||||||||||||
Audit
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 | |||||||||||||||||||||||
Compensation
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 | |||||||||||||||||||||||
Nomination
Committee(2)
|
5,000 | $ | 2,740 | $ | 7,740 |
(1)
|
On
July 2, 2009, pursuant to our adopted director compensation plan, we
issued to each of Messrs Ogilvie and Oldaker options to purchase 20,000
shares of our common stock. The options were issued pursuant to our
2007 Stock Plan. The exercise price per share is $1.17 and will
expire 10 years from the date of grant. The individual grants vest
on July 2, 2010.
|
(2)
|
On
July 2, 2009, pursuant to our adopted director compensation plan, we
issued to each of Messrs Ogilvie and Oldaker, options to purchase 15.000
shares of our common stock (5,000 shares per each committee on which they
serve). The options were issued pursuant to our 2007 Stock Plan. The
exercise price per share is $1.17 and the options vest on July 2,
2010.
|
ITEM
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
|
·
|
each
person, or group of affiliated persons, known by us to be the beneficial
owner of 5% or more of any class of our voting
securities;
|
·
|
each
of our current directors and
nominees;
|
·
|
each
of our current named executive officers;
and
|
·
|
all
current directors and named executive officers as a
group.
|
Common Stock
|
||||||||||||||||
Name and Address of Beneficial Owner(1)
|
Shares
|
Shares
Underlying
Convertible
Securities(2)
|
Total
|
Percent of
Class(2)
|
||||||||||||
Directors
and named executive officers
|
||||||||||||||||
I.
Richard Garr
|
1,413,195 | 2,600,000 | 4,013,195 | 9.77 | % | |||||||||||
Karl
Johe, Ph.D
|
1,705,484 | 2,600,000 | 4,305,484 | 10.48 | % | |||||||||||
Scott
Ogilvie
|
— | 121,250 | 121,250 | * | % | |||||||||||
William
Oldaker
|
79,300 | 181,250 | 260,550 | * | % | |||||||||||
John
Conron
|
51,364 | 816,666 | 868,030 | 2.11 | % | |||||||||||
All
directors and executive officers as a group
(5 persons)
|
3,249,343 | 6,319,166 | 9,568,509 | 23.29 | % |
*
|
Less
than one percent.
|
(1)
|
Except
as otherwise indicated, the persons named in this table have sole voting
and investment power with respect to all shares of common stock shown as
beneficially owned by them, subject to community property laws where
applicable and to the information contained in the footnotes to this
table. Unless otherwise indicated, the address of the beneficial owner is
c/o Neuralstem, Inc. 9700 Great Seneca Highway, Rockville,
MD.
|
(2)
|
Pursuant
to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership
includes any shares as to which a shareholder has sole or shared voting
power or investment power, and also any shares which the shareholder has
the right to acquire within 60 days, including upon exercise of common
shares purchase options or warrant. There are 33,751,300 shares of common
stock issued and outstanding as of March 9,
2009.
|
ITEM 13.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL
ACCOUNTING FEES AND SERVICES
|
Type
of Fees
|
2009
|
2008
|
||||||
Audit
Fees
|
||||||||
Stegman
& Company
|
$ | 69,256 | $ | 66,426 | ||||
Audit
Related Fees
|
- | - | ||||||
Tax
Fees
|
||||||||
Stegman
& Company
|
6,000 | 6,000 | ||||||
All
Other Fees
|
||||||||
Total
Fees
|
$ | 75,256 | $ | 78,426 |
ITEM 15.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
|
1.
|
Financial
Statements: See “Index to Financial Statements” in Part II,
Item 8 of this Form 10-K.
|
|
2.
|
Exhibits:
The exhibits listed in the accompanying index to exhibits are filed or
incorporated by reference as part of this
Form 10-K.
|
|
·
|
may
have been qualified by disclosures that were made to the other parties in
connection with the negotiation of the agreements, which disclosures are
not necessarily reflected in the
agreements;
|
|
·
|
may
apply standards of materiality that differ from those of a reasonable
investor; and
|
|
·
|
were
made only as of specified dates contained in the agreements and are
subject to later developments.
|
NEURALSTEM,
INC
|
||
Dated:
March 30, 2010
|
By:
|
/S/
I Richard Garr
|
I
Richard Garr
President
and Chief Executive
Officer
|
Name
|
|
Title
|
Date
|
|
/s/ I. Richard Garr
|
|
President,
Chief Executive Officer, General Counsel and Director
|
March
30, 2010
|
|
I.
Richard Garr
|
(Principal
executive officer)
|
|||
/s/ John Conron
|
|
Chief
Financial Officer (Principal financial and accounting
officer)
|
March
30, 2010
|
|
John
Conron
|
||||
/s/ Karl Johe
|
|
Chairman
of the Board and Director
|
March
30, 2010
|
|
Karl
Johe
|
||||
/s/ William Oldaker
|
|
Director
|
March
30, 2010
|
|
William
Oldaker
|
||||
/s/ Scott Ogilvie
|
|
Director
|
March
30, 2010
|
|
Scott
Ogilvie
|
|
Incorporated by Reference
|
|||||||||||
Exhibit
No.
|
Description
|
Filed
Herewith
|
Form
|
Exhibit
No.
|
File No.
|
Filing Date
|
||||||
3.01(i)
|
Amended
and Restated Certificate of Incorporation of Neuralstem, Inc. filed on
9/29/05
|
10-K
|
3.01(i)
|
001-33672
|
3/31/09
|
|||||||
3.02(i)
|
Certificate
of Amendment to Certificate of Incorporation of Neuralstem, Inc. filed on
5/29/08
|
DEF
14A
|
Appendix
I
|
001-33672
|
4/24/08
|
|||||||
3.03(ii)
|
Amended
and Restated Bylaws of Neuralstem, Inc. adopted on July 16,
2007
|
10-QSB
|
3.2(i)
|
333-132923
|
8/14/07
|
|||||||
4.01**
|
Amended
and Restated 2005 Stock Plan adopted on June 28, 2007
|
10-QSB
|
4.2(i)
|
333-132923
|
8/14/07
|
|||||||
4.02**
|
Non-qualified
Stock Option Agreement between Neuralstem, Inc. and Richard Garr dated
July 28, 2005
|
SB-2
|
4.4
|
333-132923
|
6/21/06
|
|||||||
4.03**
|
Non-qualified
Stock Option Agreement between Neuralstem, Inc. and Karl Johe dated July
28, 2005
|
SB-2
|
4.5
|
333-132923
|
6/21/06
|
|||||||
4.04
|
Private
Placement Memorandum for March 2006 offering
|
SB-2
|
4.12
|
333-132923
|
6/21/06
|
|||||||
4.05
|
Form
of Placement Agent Warrant issued in connection with the March 2006
offering
|
SB-2
|
4.13
|
333-132923
|
6/21/06
|
|||||||
4.06
|
Form
of Series A Warrant ($1.50) issued in connection with the March 2006
offering
|
SB-2
|
4.14
|
333-132923
|
6/21/06
|
|||||||
4.07
|
Form
of Series B Warrant ($2.00) issued in connection with the March 2006
offering
|
SB-2
|
4.15
|
333-132923
|
6/21/06
|
|||||||
4.08
|
Form
of Subscription Agreement for March 2006 offering
|
SB-2
|
4.16
|
333-132923
|
7/26/06
|
|||||||
4.09
|
Form
of Securities Purchase Agreement dated March 15, 2007
|
8-K
|
4.1
|
333-132923
|
3/16/07
|
|||||||
4.10
|
Form
of Common Stock Purchase Warrant dated March 15, 2007 (Series
C)
|
8-K
|
4.2
|
333-132923
|
3/16/07
|
|||||||
4.11
|
Form
of Registration Rights Agreement dated March 15, 2007
|
8-K
|
4.3
|
333-132923
|
3/16/07
|
|||||||
4.12**
|
Neuralstem,
Inc. 2007 Stock Plan
|
10-QSB
|
4.21
|
333-132923
|
8/14/07
|
4.13
|
Form
of Common Stock Purchase Warrant Issued to Karl Johe on June 5,
2007
|
10-KSB
|
4.22
|
333-132923
|
3/27/08
|
|||||||
4.14
|
Form
of Registration Rights Agreement entered into on February 19, 2008 between
the Company and CJ CheilJedang Corporation
|
8-K
|
10.20
|
001-33672
|
2/25/08
|
|||||||
4.15
|
Form
of Placement Agent Warrant Issued to Midtown Partners & Company on
December 18, 2008
|
8-K
|
4.1
|
001-33672
|
12/18/08
|
|||||||
4.16
|
Form
of Consultant Common Stock Purchase Warrant issued on January 5,
2009
|
S-3/A
|
10.1
|
333-157079
|
02/3/09
|
|||||||
4.17
|
Form
of Series D, E and F Warrants
|
8-K
|
4.01
|
001-33672
|
7/1/09
|
|||||||
4.18
|
Form
of Placement Agent Warrant
|
8-K
|
4.02
|
001-33672
|
7/1/09
|
|||||||
4.19
|
Form
of December 29, 2009 Securities Purchase Agreement
|
*
|
||||||||||
4.20
|
Form
of Consultant Warrant Issued January 8, 2010
|
*
|
||||||||||
4.21
|
Form
of Replacement Warrant Issued January 29, 2010
|
*
|
||||||||||
4.22
|
Form
of Replacement Warrant Issued March of 2010
|
*
|
||||||||||
4.23
|
Form
of employee and consultant option grant
|
*
|
||||||||||
10.01**
|
Employment
Agreement with I. Richard Garr dated January 1, 2007 and amended as of
November 1, 2005
|
SB-2
|
10.1
|
333-132923
|
6/21/06
|
|||||||
10.02**
|
Amended
terms to the Employment Agreement of I Richard Garr dated January 1,
2008
|
10-K
|
10.02
|
001-33672
|
3/31/09
|
|||||||
10.03**
|
Employment
Agreement with Karl Johe dated January 1, 2007 and amended as of November
1, 2005
|
SB-2
|
10.1
|
333-132923
|
6/21/06
|
|||||||
10.04**
|
Amended
terms to the Employment Agreement of Karl Johe dated January 1,
2009
|
10-K
|
10.04
|
001-33672
|
3/31/09
|
|||||||
14.01
|
Neuralstem
Code of Ethics
|
SB-2
|
14.1
|
333-132923
|
6/21/06
|
|||||||
14.02
|
Neuralstem
Financial Code of Profession Conduct adopted on May 16,
2007
|
8-K
|
14.2
|
333-132923
|
6/6/07
|
|||||||
23
|
Consent
of Stegman & Company
|
*
|
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 Principal Executive Officer Pursuant to 18 U.S.C. §
1350
|
*
|
||||||||||
32.2
|
Certification
of Principal Financial Officer Pursuant to 18 U.S.C. §
1350
|
*
|