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
|
3
|
|
Item 1.
|
Financial
Statements
|
3 | |
Balance Sheets as of September 30, 2010 (Unaudited) and December 31,
2009
|
3
|
||
Statements of
Operations
(Unaudited)
|
|||
Three and nine months ended September 30, 2010 and 2009
|
4
|
||
Statements of Cash Flows
(Unaudited)
|
|||
For the nine months ended
September 30, 2010 and 2009
|
5
|
||
Statement of Changes in Stockholders’ Equity
(Deficit) (Unaudited)
|
|||
For the nine months
ended September 30,
2010
|
6
|
||
Notes to Financial Statements
(Unaudited)
|
7
|
||
Item 2.
|
Management's Discussion and
Analysis
of Financial Condition and Results
of Operations
|
13
|
|
Item 3.
|
Quantitative and Qualitative
Disclosures about Market Risk
|
24
|
|
Item 4.
|
Controls and
Procedures
|
25
|
|
PART II -
|
OTHER
INFORMATION
|
25
|
|
Item 1.
|
Legal
Proceedings
|
25
|
|
Item 1A.
|
Risk
Factors
|
26
|
|
Item 2.
|
Unregistered Sales of Equity
Securities and Use of Proceeds
|
32
|
|
Item 3.
|
Defaults Upon Senior
Securities
|
33
|
|
Item 4.
|
(Removed and Reserved).
|
33
|
|
Item 5.
|
Other
Information
|
34
|
|
Item 6.
|
Exhibits
|
36
|
September 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash and cash
equivalents
|
$ | 11,588,824 | $ | 2,309,774 | ||||
Prepaid
expenses
|
302,334 | 143,600 | ||||||
Total
current assets
|
11,891,158 | 2,453,374 | ||||||
Property and equipment,
net
|
163,007 | 196,755 | ||||||
Intangible assets,
net
|
440,195 | 301,560 | ||||||
Other
assets
|
49,409 | 55,716 | ||||||
Total
assets
|
$ | 12,543,769 | $ | 3,007,405 | ||||
LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts payable and accrued
expenses
|
$ | 1,214,275 | $ | 791,607 | ||||
Accrued bonus
expense
|
509,959 | 769,215 | ||||||
Fair value of warrant
obligations
|
2,204,157 | - | ||||||
Total
current liabilities
|
3,928,391 | 1,560,822 | ||||||
LONG-TERM
LIABILITIES
|
||||||||
Fair value of warrant
obligations
|
- | 6,462,039 | ||||||
Total
liabilities
|
3,928,391 | 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, 46,182,178 and 35,743,831 shares outstanding in
2010 and 2009 respectively
|
461,822 | 357,438 | ||||||
Additional paid-in
capital
|
91,368,927 | 62,193,937 | ||||||
Accumulated
deficit
|
(83,215,371 | ) | (67,566,831 | ) | ||||
Total stockholders' equity
(deficit)
|
8,615,378 | (5,015,456 | ) | |||||
Total liabilities and
stockholders' equity (deficit)
|
$ | 12,543,769 | $ | 3,007,405 |
Three Months
|
Nine Months
|
|||||||||||||||
Ended September 30,
|
Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Operating
expenses:
|
||||||||||||||||
Research and development
costs
|
2,112,299 | 1,308,565 | 6,625,939 | 4,195,366 | ||||||||||||
General, selling and
administrative expenses
|
1,769,013 | 1,191,480 | 5,007,662 | 3,898,666 | ||||||||||||
Depreciation and
amortization
|
42,333 | 22,537 | 101,996 | 64,757 | ||||||||||||
3,923,645 | 2,522,582 | 11,735,597 | 8,158,789 | |||||||||||||
Operating
loss
|
(3,923,645 | ) | (2,522,582 | ) | (11,735,597 | ) | (8,158,789 | ) | ||||||||
Nonoperating
(expense)income:
|
||||||||||||||||
Interest
income
|
17,406 | 6,274 | 32,869 | 17,054 | ||||||||||||
Interest
expense
|
(465 | ) | (194 | ) | (2,585 | ) | (194 | ) | ||||||||
Warrant issuance and modification
expense
|
- | - | (1,906,800 | ) | - | |||||||||||
(Loss)
gain from change in fair value of warrant obligations
|
(23,535 | ) | (2,580,481 | ) | (2,036,427 | ) | 761,178 | |||||||||
(6,594 | ) | (2,574,401 | ) | (3,912,943 | ) | 778,038 | ||||||||||
Net loss attributable to common
shareholders
|
$ | (3,930,239 | ) | $ | (5,096,983 | ) | $ | (15,648,540 | ) | $ | (7,380,751 | ) | ||||
Net loss per share - basic and
diluted
|
$ | (0.09 | ) | $ | (0.15 | ) | $ | (0.37 | ) | $ | (0.22 | ) | ||||
Weighted average common shares
outstanding - basic and diluted
|
46,163,905 | 34,562,322 | 42,412,419 | 34,027,542 |
Nine Months
|
||||||||
Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net loss
|
$ | (15,648,540 | ) | $ | (7,380,751 | ) | ||
Adjustments to reconcile net loss
to cash used in operating activities:
|
||||||||
Depreciation and
amortization
|
101,996 | 64,757 | ||||||
Share based compensation
expenses
|
3,942,609 | 3,417,790 | ||||||
Warrant issuance and modification
expense
|
1,906,800 | - | ||||||
Loss/(gain)
from change in fair value of warrant obligations
|
2,036,427 | (761,178 | ) | |||||
Changes
in operating assets and liabilities:
|
||||||||
Prepaid
expenses
|
(38,733 | ) | (23,917 | ) | ||||
Other
assets
|
6,307 | (17,553 | ) | |||||
Accounts payable and accrued
expenses
|
472,415 | 495,845 | ||||||
Accrued bonus
expenses
|
(10,890 | ) | 591,923 | |||||
Net cash used in operating
activities
|
(7,231,609 | ) | (3,613,084 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Acquisition of intangible
assets
|
(178,903 | ) | (75,576 | ) | ||||
Purchase of property and
equipment
|
(27,981 | ) | (13,413 | ) | ||||
Net cash used in investing
activities
|
(206,884 | ) | (88,989 | ) | ||||
Cash
flows From financing activities:
|
||||||||
Proceeds from issuance of common stock from
warrants exercised
|
7,446,023 | - | ||||||
Proceeds from issuance of common stock from
private placement
|
9,271,520 | 1,219,509 | ||||||
Net cash provided by financing
activities
|
16,717,543 | 1,219,509 | ||||||
Net increase (decrease)in cash and
cash equivalents
|
9,279,050 | (2,482,564 | ) | |||||
Cash and cash equivalents,
beginning of period
|
2,309,774 | 4,903,279 | ||||||
Cash and cash equivalents, end of
period
|
$ | 11,588,824 | $ | 2,420,715 | ||||
Supplemental
disclosure of cash flows information:
|
||||||||
Cash paid for
interest
|
$ | 465 | $ | 194 | ||||
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
|
(6,294,055 | ) | - | |||||
Prepayment of services through
common stock issuance
|
(240,000 | ) | - | |||||
Payment of contract services
through common stock issuance
|
(50,000 | ) | - | |||||
Issuance of common stock from
executive bonuses
|
(248,367 | ) | - |
Common
|
Common
|
Additional
|
Total
|
|||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Accumulated
|
Stockholders'
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity (Deficit)
|
||||||||||||||||
Balance
at January 1, 2010
|
35,743,831 | $ | 357,438 | $ | 62,193,937 | $ | (67,566,831 | ) | $ | (5,015,456 | ) | |||||||||
Share
based payments
|
3,822,609 | 3,822,609 | ||||||||||||||||||
Issuance
of common stock through Private Placement ($2.80 per share), net of
financing costs of $728,501.
|
3,571,436 | 35,714 | 9,235,806 | 9,271,520 | ||||||||||||||||
Issuance
of common stock for prepaid consulting services.
|
140,000 | 1,400 | 238,600 | 240,000 | ||||||||||||||||
Issuance
of common stock for consulting services.
|
45,000 | 450 | 49,550 | 50,000 | ||||||||||||||||
Issuance
of common stock from warrants exercised ($1.25 and $1.10 per share), net
of issuance costs of $638,644.
|
6,560,757 | 65,608 | 7,380,415 | 7,446,023 | ||||||||||||||||
Warrant issuances and
modifications
|
8,176,184 | 8,176,184 | ||||||||||||||||||
Extinguishment of fair value of
warrant obligations from warrant expiration
|
24,671 | 24,671 | ||||||||||||||||||
Issuance of restricted common
stock in payment for 2009 executive bonuses ($2.05 per
share)
|
121,154 | 1,212 | 247,155 | 248,367 | ||||||||||||||||
Net
loss
|
(15,648,540 | ) | (15,648,540 | ) | ||||||||||||||||
Balance
at September 30, 2010
|
46,182,178 | $ | 461,822 | $ | 91,368,927 | $ | (83,215,371 | ) | $ | 8,615,378 |
|
For The Nine Months
|
|||||||
Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Basic:
|
||||||||
Net loss attributable to common
shareholders
|
$ | (15,648,540 | ) | $ | (7,380,751 | ) | ||
Weighted average common shares
outstanding
|
42,412,419 | 34,027,542 | ||||||
Basic and diluted loss per common
share
|
$ | (0.37 | ) | $ | (0.22 | ) |
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
|
215,000 | 2.44 | 6.0 | $ | - | |||||||||||
Exercised
|
- | - | - | - | ||||||||||||
Forfeited
|
(62,042 | ) | 4.98 | - | - | |||||||||||
Outstanding
at September 30, 2010
|
9,223,617 | $ | 2.50 | 6.5 | $ | 5,502,800 | ||||||||||
Exercisable
at September 30, 2010
|
7,086,950 | $ | 2.21 | 6.2 | $ | 5,414,550 |
Three Months Ended Sept. 30,
|
||||||||
2010
|
2009
|
|||||||
Research and development
costs
|
$ | 703,299 | $ | 703,300 | ||||
General, selling and
administrative expenses
|
608,568 | 365,834 | ||||||
Total
|
$ | 1,311,867 | $ | 1,069,134 |
Nine Months Ended Sept. 30,
|
||||||||
2010
|
2009
|
|||||||
Research and development
costs
|
$ | 2,242,794 | $ | 2,183,702 | ||||
General, selling and
administrative expenses
|
1,699,815 | 1,234,088 | ||||||
Total
|
$ | 3,942,609 | $ | 3,417,790 |
Weighted-
|
||||||||||||||||
Weighted-
|
Average
|
|||||||||||||||
Average
|
Remaining
|
Aggregate
|
||||||||||||||
Number
|
Exercise
|
Contractual
|
Intrinsic
|
|||||||||||||
of Warrants
|
Price
|
Life (in years)
|
Value
|
|||||||||||||
Outstanding
at January 1, 2010
|
15,295,257 | $ | 1.82 | 2.0 | - | |||||||||||
Granted
|
7,509,983 | 2.55 | 3.9 | - | ||||||||||||
Exercised
|
(6,560,757 | ) | 1.23 | - | - | |||||||||||
Forfeited
|
(25,355 | ) | 1.25 | - | - | |||||||||||
Outstanding
at September 30, 2010
|
16,219,128 | $ | 2.40 | 3.3 | 4,765,198 | |||||||||||
Exercisable
at September 30, 2010
|
12,969,127 | $ | 2.24 | 2.7 | 4,765,198 |
|
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 |
September 30,
|
September 30,
|
|||||||
2010
|
2009
|
|||||||
Annual
dividend yield
|
- | - | ||||||
Expected
life (years)
|
0.21 | 0.75-2.00 | ||||||
Risk
free interest rate
|
0.16 | % | 0.18%-0.95 | % | ||||
Expected
volatility
|
56 | % | 85%-97 | % |
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 September 30, 2010 using
|
||||||||||||||||||
Sept. 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
|
$ | 11,588,824 | $ | 11,588,824 | $ | - | $ | - | ||||||||||
Liabilities:
|
||||||||||||||||||
Fair
value of warrant obligations
|
2,204,157 | - | - | 2,204,157 |
Three months ended
Sept. 30, 2010
|
Nine months ended
Sept. 30, 2010
|
|||||||
Fair
value of warrant obligations at beginning of period
|
$ | 2,189,064 | $ | 6,462,039 | ||||
Extinguishment
through warrant exercises and modifications
|
(8,442 | ) | (6,294,055 | ) | ||||
Extinguishment
through warrant expirations
|
(254 | ) | ||||||
Net
loss for change in fair value included in the statement of operations for
period
|
23,535 | 2,036,427 | ||||||
Fair
value of warrant obligations at end of period
|
$ | 2,204,157 | $ | 2,204,157 |
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 nine months ended September 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 September 30,
|
||||||||
2010
|
2009
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating
expenses
|
3,923,645 | 2,522,582 | ||||||
Operating
loss
|
(3,923,645 | ) | (2,522,582 | ) | ||||
Non-operating (expense)
income
|
(6,594 | ) | (2,574,401 | ) | ||||
Net loss
|
$ | (3,930,239 | ) | $ | (5,096,983 | ) |
Three Months Ended Sept. 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
Expenses
|
||||||||
Research &
development
|
$ | 2,112,299 | $ | 1,308,565 | ||||
General, selling &
administrative expense
|
1,769,013 | 1,191,480 | ||||||
Depreciation and
amortization
|
42,333 | 22,537 | ||||||
Total
expense
|
$ | 3,923,645 | $ | 2,522,582 |
Three Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Nonoperating
income:
|
||||||||
Interest
income
|
$ | 17,406 | $ | 6,274 | ||||
Interest
expense
|
(465 | ) | (194 | ) | ||||
Warrant modification
expense
|
- | - | ||||||
Loss on change in fair value of
warrant obligations
|
(23,535 | ) | (2,580,481 | ) | ||||
Total nonoperating (expense)
income
|
$ | (6,594 | ) | $ | (2,574,401 | ) |
Nine Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Revenues
|
- | - | ||||||
Operating
expenses
|
$ | 11,735,597 | $ | 8,158,789 | ||||
Operating
loss
|
(11,735,597 | ) | (8,158,789 | ) | ||||
Non-operating
(expense) income
|
(3,912,943 | ) | 778,038 | |||||
Net
loss
|
$ | (15,648,540 | ) | $ | (7,380,751 | ) |
Nine Months Ended Sept. 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
Expenses
|
||||||||
Research &
development
|
$ | 6,625,939 | $ | 4,195,366 | ||||
General,
selling & administrative expense
|
5,007,662 | 3,898,666 | ||||||
Depreciation
and amortization
|
101,996 | 64,757 | ||||||
Total
expense
|
$ | 11,735,597 | $ | 8,158,789 |
Nine Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Nonoperating
income:
|
||||||||
Interest
income
|
$ | 32,869 | $ | 17,054 | ||||
Interest
expense
|
(2,585 | ) | (194 | ) | ||||
Warrant
modification expense
|
(1,906,800 | ) | - | |||||
(Loss)
Gain on change in fair value of warrant obligations
|
(2,036,427 | ) | 761,178 | |||||
Total
nonoperating (expense) income
|
$ | (3,912,943 | ) | $ | 778,038 |
Nine Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Cash and
cash equivalents
|
$ | 11,588,824 | $ | 2,420,715 | ||||
Net
cash used in operating activities
|
$ | (7,231,609 | ) | $ | (3,613,084 | ) | ||
Net
cash used in investing activities
|
$ | (206,884 | ) | $ | (88,989 | ) | ||
Net
cash provided by financing activities
|
$ | 16,717,543 | $ | 1,219,509 |
|
·
|
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
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 January through September 2010, Series A warrant holders
exercised an aggregate of 285,476 warrants. The exercise price
of the Series A warrants is $1.25 per share. As a result of the
exercises, we received gross proceeds of
$356,845.
|
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
|
ITEM
4.
|
CONTROLS
AND PROCEDURES.
|
ITEM
1.
|
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
1A.
|
RISK
FACTORS
|
|
·
|
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.
|
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
|
·
|
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.
|
|
·
|
On May 14, 2010, as consideration
for amending a consulting agreement for investor relations and business
development services, we issued Market Development Consulting Group, Inc.
a common stock purchase warrant entitling the holder to purchase 200,000
shares of common stock at $3.17 per share. The warrant is
exercisable immediately, shall expire on May 14, 2020, and is freely
assignable in whole or in part. The warrant is substantially
similar to the consultant warrant issued on January 8,
2010.
|
|
·
|
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.
|
|
·
|
On October 1, 2010 we granted a
consultant warrants to purchase 100,000 shares at a price of
$2.44. The warrants are fully vested and have a cashless
exercise provision. The warrants expire on October 1,
2017.
|
ITEM
3.
|
DEFAULT
UPON SENIOR SECURITIES
|
ITEM
4.
|
(REMOVED
AND RESERVED)
|
ITEM
5.
|
OTHER
INFORMATION
|
Award
|
||||||||||||||
Name
|
Position
|
Percentage of
Base Salary
|
No. of Restricted
Stock Units(1)
|
No. of Stock
Options(2)
|
||||||||||
Karl
Johe
|
Chairman
& Chief
Science
Officer
|
150 | % | 143,247 | 272,909 | |||||||||
Richard
Garr
|
Chief
Executive
Officer/General
Counsel
|
150 | % | 138,122 | 263,147 | |||||||||
John
Conron
|
Chief
Financial
Officer
|
68 | % | 34,615 | 65,948 |
(1)
|
The
Restricted Stock Units vest quarterly over 3 years and cannot be sold for
5 years unless the employee ceases to be employed by the Company or there
is a change in control.
|
(2)
|
The
Stock Options have an exercise price of $2.21, vest quarterly over 3
years, have a term of 10 years and vest immediately upon a change in
control. .
|
|
·
|
Ensure
base pay is competitive for the role or job to be performed and to retain
the executive for succession planning while providing reasonable and
responsible pay arrangements in order to maintain a sustainable cost
framework.
|
|
·
|
Recognize
performance of annual goals and milestones achieved through annual
incentives.
|
|
·
|
Reward
achievement of long-term goals and enhancement of shareholder wealth
through the long-term incentive
program.
|
|
·
|
Provide
a cost effective but competitive benefits package that promotes a positive
work environment fostering teamwork among and high morale within the
executive team.
|
|
·
|
Base
salary: Compensation for ongoing performance throughout the
year.
|
|
·
|
Annual
incentive awards: Awarded to recognize and reward performance, in the
context of individual, team and Company performance, in the fiscal year
just ended.
|
|
·
|
Long-term
incentive awards: Equity compensation to provide an incentive to manage
the Company from the perspective of an owner with an equity stake in the
business.
|
|
·
|
Other
benefits: Employee benefit plans in which executives and all employees
participate.
|
|
·
|
Severance
and change in control benefits: Remuneration paid to executives in the
event of a change in control of the Company or involuntary employment
termination.
|
Name
|
Position
|
Percentage of
Base Salary
|
||||
Karl
Johe
|
Chairman
& Chief Science Officer
|
60 | % | |||
Richard
Garr
|
Chief
Executive Officer/General Counsel
|
60 | % | |||
John
Conron
|
Chief
Financial Officer
|
25 | % |
Name
|
Position
|
Percentage of
Base Salary
|
||||
Karl
Johe
|
Chairman
& Chief Science Officer
|
200 | % | |||
Richard
Garr
|
Chief
Executive Officer/General Counsel
|
200 | % | |||
John
Conron
|
Chief
Financial Officer
|
90 | % |
ITEM
6.
|
EXHIBITS
|
NEURALSTEM,
INC.
|
||
Date:
November 15, 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
|
|||||||
4.26
|
Form of Consultant Warrant issued
October 1, 2009 and 2010
|
S-3
|
4.07
|
333-169847
|
10/8/10
|
|||||||
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
|
10.2
|
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
|
|||||||
10.06
|
Employment Agreement with Thomas
Hazel, Ph.D dated August 11, 2008
|
10-K/A
|
10.05
|
001-33672
|
10/5/10
|
|||||||
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
|
*
|