x
|
Quarterly
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
¨
|
Transition
Report Under 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)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer ¨ (Do
not check if a small reporting company)
|
Smaller reporting company x |
Page
|
|||
PART
I -
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Financial
Statements
|
3 | |
Balance
Sheets as of June 30, 2010 (Unaudited) and December 31,
2009
|
3
|
||
Statements
of Operations (Unaudited)
|
|||
Three
and six months ended June 30, 2010 and 2009
|
4
|
||
Statements
of Cash Flows (Unaudited)
|
|||
For
the six months ended June 30, 2010 and 2009
|
5
|
||
|
|||
Statements
of Changes in Stockholders’ (Deficit)
Equity (Unaudited)
|
|||
For
the period from January 1, 2010 through June 30,
2010
|
6
|
||
Notes
to Financial Statements (Unaudited)
|
7
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
12
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
23
|
|
Item
4.
|
Controls
and Procedures
|
23
|
|
PART
II -
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
24
|
|
Item
1A.
|
Risk
Factors
|
24
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
31
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
32
|
|
Item
4.
|
(Removed
and Reserved).
|
32
|
|
Item
5.
|
Other
Information
|
32
|
|
Item
6.
|
Exhibits
|
32
|
Neuralstem,
Inc.
|
||||
Balance
Sheets
|
June
30,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
and cash equivalents
|
$ | 14,025,745 | $ | 2,309,774 | ||||
Prepaid
expenses
|
272,613 | 143,600 | ||||||
Total
current assets
|
14,298,358 | 2,453,374 | ||||||
Property
and equipment, net
|
187,113 | 196,755 | ||||||
Intangible
assets, net
|
370,421 | 301,560 | ||||||
Other
assets
|
49,409 | 55,716 | ||||||
Total
assets
|
$ | 14,905,301 | $ | 3,007,405 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable and accrued expenses
|
$ | 1,144,916 | $ | 791,607 | ||||
Accrued
bonus expense
|
588,338 | 769,215 | ||||||
Fair
value of warrant obligations
|
2,189,064 | - | ||||||
Total
current liabilities
|
3,922,318 | 1,560,822 | ||||||
LONG-TERM
LIABILITIES
|
||||||||
Fair
value of warrant obligations
|
- | 6,462,039 | ||||||
Total
liabilities
|
3,922,318 | 8,022,861 | ||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||
Preferred
stock, 7,000,000 shares authorized, zero shares issued and
outstanding
|
- | - | ||||||
Common
stock, $0.01 par value; 150 million shares authorized, 46,008,024 and
35,743,831 shares outstanding in 2010 and 2009
respectively
|
460,080 | 357,438 | ||||||
Additional
paid-in capital
|
89,808,035 | 62,193,937 | ||||||
Accumulated
deficit
|
(79,285,132 | ) | (67,566,831 | ) | ||||
Total
stockholders' equity (deficit)
|
10,982,983 | (5,015,456 | ) | |||||
Total
liabilities and stockholders' equity (deficit)
|
$ | 14,905,301 | $ | 3,007,405 |
Neuralstem,
Inc.
|
||||||||
Statements
of Operations
|
||||||||
(Unaudited)
|
Three Months
|
Six
Months
|
|||||||||||||||
Ended
June 30,
|
Ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development costs
|
2,613,676 | 1,452,793 | 4,513,640 | 2,886,802 | ||||||||||||
General,
selling and administrative expenses
|
1,550,814 | 1,249,947 | 3,238,649 | 2,707,186 | ||||||||||||
Depreciation
and amortization
|
30,601 | 21,424 | 59,663 | 42,220 | ||||||||||||
4,195,091 | 2,724,164 | 7,811,952 | 5,636,208 | |||||||||||||
Operating
loss
|
(4,195,091 | ) | (2,724,164 | ) | (7,811,952 | ) | (5,636,208 | ) | ||||||||
Nonoperating
(expense) income:
|
||||||||||||||||
Interest
income
|
9,653 | 8,516 | 15,463 | 10,780 | ||||||||||||
Interest
expense
|
(1,462 | ) | - | (2,120 | ) | - | ||||||||||
Warrant
issuance and modification expense
|
- | - | (1,906,800 | ) | - | |||||||||||
(Loss)
gain from change in fair value of warrant obligations
|
(764,440 | ) | (473,799 | ) | (2,012,892 | ) | 3,341,659 | |||||||||
(756,249 | ) | (465,283 | ) | (3,906,349 | ) | 3,352,439 | ||||||||||
Net
loss attributable to common shareholders
|
$ | (4,951,340 | ) | $ | (3,189,447 | ) | $ | (11,718,301 | ) | $ | (2,283,769 | ) | ||||
Net
loss per share – basic and diluted
|
$ | (0.12 | ) | $ | (0.09 | ) | $ | (0.29 | ) | $ | (0.07 | ) | ||||
Weighted
average common shares outstanding – basic
|
42,450,338 | 33,760,091 | 40,505,586 | 33,755,720 |
Statements
of Cash Flows
|
||||
(Unaudited)
|
Six
Months
|
||||||||
Ended
June 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (11,718,301 | ) | $ | (2,283,769 | ) | ||
Adjustments
to reconcile net loss to cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
59,663 | 42,220 | ||||||
Share
based compensation expenses
|
2,630,742 | 2,348,656 | ||||||
Warrant
issuance and modification expense
|
1,906,800 | - | ||||||
Loss/(gain)
from change in fair value of warrant obligations
|
2,012,893 | (3,341,659 | ) | |||||
Changes
in operating assets and liabilities:
|
||||||||
Prepaid
expenses
|
50,988 | 75,475 | ||||||
Other
assets
|
6,307 | (5,500 | ) | |||||
Accounts
payable and accrued expenses
|
353,055 | 258,993 | ||||||
Accrued
bonus expenses
|
(180,877 | ) | 377,308 | |||||
Net
cash used in operating activities
|
(4,878,730 | ) | (2,528,276 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Acquisition
of intangible assets
|
(92,493 | ) | (51,692 | ) | ||||
Purchase
of property and equipment
|
(26,391 | ) | (8,380 | ) | ||||
Net
cash used in investing activities
|
(118,884 | ) | (60,072 | ) | ||||
Cash
flows From financing activities:
|
||||||||
Issuance
of common stock from warrants exercised
|
7,442,066 | 903,391 | ||||||
Issuance
of common stock from private placement
|
9,271,519 | - | ||||||
Net
cash provided by financing activities
|
16,713,585 | 903,391 | ||||||
Net
increase (decrease)in cash and cash equivalents
|
11,715,971 | (1,684,958 | ) | |||||
Cash
and cash equivalents, beginning of period
|
2,309,774 | 4,903,279 | ||||||
Cash
and cash equivalents, end of period
|
$ | 14,025,745 | $ | 3,218,321 | ||||
Supplemental
disclosure of cash flows information:
|
||||||||
Cash
paid for interest
|
$ | 1,462 | $ | - | ||||
Cash
paid for income taxes
|
- | - | ||||||
Supplemental
schedule of non cash investing and financing activities:
|
||||||||
Extinguishment
of warrant obligations through exercise, expiration and modification of
common stock warrants
|
(6,285,613 | ) | - | |||||
Payment
of services through common stock issuance
|
(240,000 | ) | - |
Neuralstem,
Inc.
|
STATEMENT
OF CHANGES IN STOCKHOLDERS'(DEFICIT)EQUITY
|
For the period from January 1, 2010 through June 30, 2010 |
(Unaudited)
|
Total
|
||||||||||||||||||||
Common
|
Common
|
Additional
|
Stockholders'
|
|||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Accumulated
|
(Deficit)
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance
at January 1, 2010
|
35,743,831 | $ | 357,438 | $ | 62,193,937 | $ | (67,566,831 | ) | $ | (5,015,456 | ) | |||||||||
Share
based payments
|
2,570,742 | 2,570,742 | ||||||||||||||||||
Issuance
of common stock through Private Placement ($2.80 per share), net of
financing costs of $728,501.
|
3,571,436 | 35,714 | 9,235,805 | 9,271,519 | ||||||||||||||||
Issuance
of common stock for prepaid consulting services.
|
140,000 | 1,400 | 238,600 | 240,000 | ||||||||||||||||
Issuance
of common stock from warrants exercised ($1.25 and $1.10 per share), net
of issuance costs of $631,575.
|
6,552,757 | 65,528 | 7,376,538 | 7,442,066 | ||||||||||||||||
Warrant
issuances and modifications
|
8,167,742 | 8,167,742 | ||||||||||||||||||
Extinguishment
of fair value of warrant obligations from warrant
expiration
|
24,671 | 24,671 | ||||||||||||||||||
Net
loss
|
(11,718,301 | ) | (11,718,301 | ) | ||||||||||||||||
Balance
at June 30, 2010
|
46,008,024 | $ | 460,080 | $ | 89,808,035 | $ | (79,285,132 | ) | $ | 10,982,983 |
For
The Six Months
|
||||||||
Ended
June 30,
|
||||||||
2010
|
2009
|
|||||||
Net
loss attributable to common shareholders
|
$ | (11,718,301 | ) | $ | (2,283,769 | ) | ||
Weighted
average common shares outstanding
|
40,505,586 | 33,755,720 | ||||||
Basic
and diluted loss per common share
|
$ | (0.29 | ) | $ | (0.07 | ) |
Number
of Options
|
Weighted-Average
Exercise Price
|
Weighted-Average
Remaining Contractual Life (in years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding
at January 1, 2010
|
9,070,659 | $ | 2.52 | 7.0 | $ | - | ||||||||||
Granted
|
145,000 | 2.40 | 5.9 | $ | 14,500 | |||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Forfeited
|
- | - | - | - | ||||||||||||
Outstanding
at June 30, 2010
|
9,215,659 | $ | 2.52 | 6.7 | $ | 5,437,800 | ||||||||||
Exercisable
at June 30, 2010
|
6,983,992 | $ | 2.28 | 6.5 | $ | 5,328,350 |
Three
Months Ended
June
30,
|
||||||||
2010
|
2009
|
|||||||
Research
and development costs
|
$ | 703,299 | $ | 740,201 | ||||
General,
selling and administrative expenses
|
626,559 | 409,751 | ||||||
Total
|
$ | 1,329,858 | $ | 1,149,952 |
Six
Months Ended
June
30,
|
||||||||
2010
|
2009
|
|||||||
Research
and development costs
|
$ | 1,539,495 | $ | 1,480,402 | ||||
General,
selling and administrative expenses
|
1,091,247 | 868,254 | ||||||
Total
|
$ | 2,630,742 | $ | 2,348,656 |
Number
of
Warrants
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Life (in
years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
at January 1, 2010
|
15,295,257 | $ | 1.82 | 2.0 | - | |||||||||||
Granted
|
7,509,983 | 2.55 | 4.2 | 1,969,120 | ||||||||||||
Exercised
|
(6,552,757 | ) | 1.23 | - | - | |||||||||||
Forfeited
|
(25,355 | ) | 1.25 | - | - | |||||||||||
Outstanding
at June 30, 2010
|
16,227,128 | $ | 2.40 | 3.5 | 4,634,720 | |||||||||||
Exercisable
at June 30, 2010
|
12,977,127 | $ | 2.24 | 2.9 | 4,634,720 |
Strike
|
Date
|
Date
|
Warrants
|
||||||||
Price
|
of Issue
|
of Expiration
|
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 at January 1,
2009
|
8,547,762 |
June
30,
|
June
30,
|
|||||||
2010
|
2009
|
|||||||
Annual
dividend yield
|
- | - | ||||||
Expected
life (years)
|
0.33 | .75-2.25 | ||||||
Risk
free interest rate
|
0.18 | % | 0.56-1.11 | % | ||||
Expected
volatility
|
61 | % | 82-115 | % |
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.
|
The
fair valued assets we hold that are generally included in this category
are money market securities where fair value is based on publicly quoted
prices and included in cash equivalents.
|
|
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.
|
We
carry no investments classified as Level 2.
|
|
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 items.
|
Fair
value measurements at June 30, 2010 using
|
|||||||||||||||||
June
30, 2010
|
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
|
$ | 14,025,745 | $ | 14,025,745 | $ | - | $ | - | |||||||||
Liabilities:
|
|||||||||||||||||
Fair
value of warrant obligations
|
2,189,064 | - | - | 2,189,064 |
Three
months ended
June
30, 2010
|
Six
months ended
June
30, 2010
|
|||||||
Fair
value of warrant obligations at beginning of period
|
$ | 1,497,863 | $ | 6,462,039 | ||||
Extinguishment
through warrant exercises and modifications
|
(73,239 | ) | (6,285,613 | ) | ||||
Extinguishment
through warrant expirations
|
(254 | ) | ||||||
Net
loss (gain) for change in fair value included in the statement of
operations for period
|
764,440 | 2,012,892 | ||||||
Fair
value of warrant obligations at end of period
|
$ | 2,189,064 | $ | 2,189,064 |
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
·
|
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 secure additional financing to fund our short-term and
long-term financial 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
2.
|
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 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 the three and six months ended June 30, 2010
to the comparable periods of 2009.
|
|
·
|
Liquidity and Capital
Resources-- An analysis of changes in our balance sheet and
cash flows and discussion of our financial condition and future liquidity
needs.
|
Three
Months Ended
June
30,
|
||||||||
2010
|
2009
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating
expenses
|
4,195,091 | 2,724,164 | ||||||
Operating
loss
|
(4,195,091 | ) | (2,724,164 | ) | ||||
Non-operating
(expense)
|
(756,249 | ) | (465,283 | ) | ||||
Net
loss
|
$ | (4,951,340 | ) | $ | (3,189,447 | ) |
Three
Months Ended
June
30,
|
||||||||
2010
|
2009
|
|||||||
Operating
Expenses:
|
||||||||
Research &
development
|
$ | 2,613,676 | $ | 1,452,793 | ||||
General,
selling & administrative expense
|
1,550,814 | 1,249,947 | ||||||
Depreciation
and amortization
|
30,601 | 21,424 | ||||||
Total
expense
|
$ | 4,195,091 | $ | 2,724,164 |
Three
Months Ended
June 30, |
||||||||
2010
|
2009
|
|||||||
Nonoperating
(expense) income:
|
||||||||
Interest
income
|
$ | 9,653 | $ | 8,516 | ||||
Interest
expense
|
(1,462 | ) | - | |||||
Warrant
issuance and modification expense
|
- | - | ||||||
Loss
on change in fair value of warrant obligations
|
(764,440 | ) | (473,799 | ) | ||||
Total
nonoperating (expense)
|
$ | (756,249 | ) | $ | (465,283 | ) |
Six Months Ended
June 30, |
||||||||
2010
|
2009
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating
expenses
|
7,811,952 | 5,636,208 | ||||||
Operating
loss
|
(7,811,952 | ) | (5,636,208 | ) | ||||
Non-operating
income (expense)
|
(3,906,349 | ) | 3,352,439 | |||||
Net
income (loss)
|
$ | (11,718,301 | ) | $ | (2,283,769 | ) |
Six
Months Ended
June 30, |
||||||||
2010
|
2009
|
|||||||
Operating
Expenses
|
||||||||
Research &
development
|
$ | 4,513,640 | $ | 2,886,802 | ||||
General,
selling & administrative expense
|
3,238,649 | 2,707,186 | ||||||
Depreciation
and amortization
|
59,663 | 42,220 | ||||||
Total
expense
|
$ | 7,811,952 | $ | 5,636,208 |
Six
Months Ended
June 30, |
||||||||
2010
|
2009
|
|||||||
Nonoperating
(expense) income:
|
||||||||
Interest
income
|
$ | 15,463 | $ | 10,780 | ||||
Interest
expense
|
(2,120 | ) | - | |||||
Warrant
issuance and modification expense
|
(1,906,800 | ) | - | |||||
(Loss)
Gain on change in fair value of warrant obligations
|
(2,012,892 | ) | 3,341,659 | |||||
Total
nonoperating (expense) income
|
$ | (3,906,349 | ) | $ | 3,352,439 |
Six
Months Ended
June 30, |
||||||||
2010
|
2009
|
|||||||
Cash and
cash equivalents
|
$ | 14,025,745 | $ | 3,218,321 | ||||
Net
cash used in operating activities
|
$ | (4,878,730 | ) | $ | (2,528,277 | ) | ||
Net
cash used in investing activities
|
$ | (118,884 | ) | $ | (60,072 | ) | ||
Net
cash provided by financing activities
|
$ | 16,713,585 | $ | 903,391 |
|
·
|
On
January 29, 2010, we received gross proceeds of $1,000,000 as a result of
the exercise of 800,000 $1.25 Series D warrant exercises. We issued the
holder of the D warrants 400,000 additional warrants with an exercise
price of $1.85 in conjunction with the exercise. The new warrants have a
life of one year.
|
|
·
|
In
February of 2010, we called our $1.25 Series B Warrants. Gross exercise
proceeds totaled $2,492,345.
|
|
·
|
In
the period January through March 2010, several Series A warrant holders
exercised 231,763 warrants to purchase our common stock for $1.25 per
share. Total gross proceeds were
$289,704.
|
|
·
|
In
March of 2010, holders of 2,699,400 Series C warrants exercised their
option to purchase our common stock for 1.25 per share. Gross
proceeds totaled $3,374,250. We issued the holders of the exercised C
Warrants 2,699,400 additional warrants with an exercise price of $2.13 and
a life of 5 years in conjunction with the
exercise.
|
|
·
|
The
holder of 782,005 $1.10 placement agent warrants exercised them in March
of 2010. Gross consideration totaled $860,205. We issued the
holder of the exercised placement agent warrants 782,005 additional
warrants with an exercise price of $2.13 and a life of 5 years in
conjunction with the exercise.
|
|
·
|
In
June of 2010, we sold approximately 3,571,436 units, through a registered
direct offering. Each unit consists of one common share and
0.75 common share purchase warrant. Each unit was sold
for $2.80. Each warrant has an exercise price of $3.25 per
share, and is exercisable for a period of three years. As a
result of the offering, we received gross proceeds of approximately $10
million.
|
|
·
|
In
the period April through June 2010, several Series A warrant holders
exercised 45,713 warrants to purchase our common stock for $1.25 per
share. Total gross proceeds were
$57,141.
|
|
·
|
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.
|
·
|
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.
|
·
|
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.
|
·
|
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; (iii)
is callable by the company in the event our common stock trades above
$5.00 and certain other conditions are met, and (iv) 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 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.
|
·
|
In
June of 2010, we issued Noble International Investment, Inc., D/B/A
Noble Financial Capital Markets a warrant to purchase 250,001 common
shares. The warrant was issued as compensation for placement
agent services which Noble International Investments, Inc., performed in
connection with our $10 million registered direct offering of
units. The warrant is substantially the same as the investor
warrant issued in the offering and has: (i) an exercise price of $3.25,
and (ii) a term of three years.
|
NEURALSTEM,
INC.
|
|||
Date:
August 16, 2010
|
|
/s/ I.
Richard Garr
|
|
Chief
Executive Officer
|
|||
/s/
John Conron
|
|||
Chief
Financial Officer
|
|||
(Principal
Accounting Officer)
|
Incorporated
by Reference
|
|||||||||||||
Exhibit
No.
|
Description
|
Filed
Herewith
|
Form
|
Exhibit
No.
|
File
No.
|
Filing
Date
|
|||||||
1.01
|
Form
of Placement Agent Agreement dated June 28, 2010
|
8-K
|
1.01
|
001-33672
|
6/29/10
|
||||||||
1.02
|
Form
of Amendment to Placement Agent Agreement dated June 28,
2010
|
8-K
|
1.02
|
001-33672
|
6/29/10
|
||||||||
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
|
10-K
|
4.19
|
001-33672
|
3/31/10
|
||||||||
4.20
|
Form
of Consultant Warrant Issued January 8, 2010
|
10-K
|
4.20
|
001-33672
|
3/31/10
|
||||||||
4.21
|
Form
of Replacement Warrant Issued January 29, 2010
|
10-K
|
4.21
|
001-33672
|
3/31/10
|
||||||||
4.22
|
Form
of Replacement Warrant Issued March of 2010
|
10-K
|
4.22
|
001-33672
|
3/31/10
|
||||||||
4.23
|
Form
of employee and consultant option grant
|
10-K
|
4.23
|
001-33672
|
3/31/10
|
||||||||
4.24
|
Form
of Warrants dated June 29, 2010
|
8-K
|
4.01
|
001-33672
|
6/29/10
|
||||||||
4.25**
|
Neuralstem
2010 Equity Compensation Plan
|
8-K
|
10.01
|
001-33672
|
7/14/10
|
||||||||
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
|
||||||||
10.05
|
Form
of Securities Purchase Agreement dated June 29, 2010
|
8-K
|
10.01
|
001-33672
|
6/29/10
|
||||||||
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
|
||||||||
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
|
*
|