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,
Maryland
|
20850
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
|
|
Page
|
PART
I -
|
|
FINANCIAL
INFORMATION
|
3
|
|
|
|
|
Item
1.
|
|
Financial
Statements
|
3
|
|
|
|
|
|
|
Balance
Sheets as of June 30, 2008 (Unaudited) and December 31,
2007
|
3
|
|
|
|
|
|
|
Statements
of Operations (Unaudited)
|
|
|
|
Three
and Six months ended June 30, 2008 and 2007
|
4
|
|
|
Statements
of Changes in Stockholders' Equity (Unaudited)
|
|
|
|
For
the period from January 1,
2008 through June 30, 2008
|
5
|
|
|
|
|
|
|
Statements
of Cash Flows (Unaudited)
|
|
|
|
Six
months ended June 30, 2008 and 2007
|
6
|
|
|
|
|
|
|
Notes
to Financial Statements (Unaudited)
|
7
|
|
|
|
|
Item
2.
|
|
Management's
Discussion and Analysis of Financial Condition, Results
of Operations and Plan of Operation
|
12
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
17
|
|
Item
4.
|
|
Controls
and Procedures
|
17
|
|
|
|
|
PART
II -
|
|
OTHER
INFORMATION
|
18
|
|
|
|
|
Item
1.
|
|
Legal
Proceedings
|
18
|
|
|
|
|
Item
1A.
|
Risk
Factors
|
18
|
|
Item
2.
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
25
|
|
|
|
|
Item
3.
|
|
Defaults
Upon Senior Securities
|
26
|
|
|
|
|
Item
4.
|
|
Submission
of Matters to a Vote of Security Holders.
|
26
|
|
|
|
|
Item
5.
|
|
Other
Information
|
|
|
|
|
|
Item
6.
|
|
Exhibits
|
27
|
|
Jun. 30,
|
Dec. 31,
|
|||||
|
2008
|
2007
|
|||||
|
(Unaudited)
|
|
|||||
ASSETS
|
|||||||
|
|||||||
CURRENT
ASSETS
|
|||||||
|
|||||||
Cash
|
$
|
6,966,587
|
$
|
7,403,737
|
|||
Prepaid
expenses
|
80,702
|
130,719
|
|||||
Total
current assets
|
7,047,289
|
7,534,456
|
|||||
|
|||||||
Property
and equipment, net
|
175,238
|
136,920
|
|||||
Other
assets
|
49,272
|
43,271
|
|||||
Intangible
assets, net
|
127,228
|
111,406
|
|||||
|
|||||||
Total
assets
|
$
|
7,399,027
|
$
|
7,826,053
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable and accrued expenses
|
$
|
936,110
|
$$
|
1,016,699
|
|||
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
|
|||||||
Preferred
Stock, 7,000,000 shares authorized, zero issued and
outstanding
|
—
|
—
|
|||||
Common
stock, $.01 par value, 150 million shares authorized, 32,151,300
and
31,410,566 shares outstanding in 2008 and 2007
|
321,513
|
314,016
|
|||||
Additional
paid-in capital
|
57,029,525
|
52,151,245
|
|||||
Accumulated
deficit
|
(50,888,121
|
)
|
(45,655,997
|
)
|
|||
Total
stockholders' equity
|
6,462,917
|
6,809,354
|
|||||
Total
liabilities and stockholders' equity
|
$
|
7,399,027
|
$
|
7,826,053
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||
|
|
|
|||||||||||
Revenues
|
$
|
-
|
$
|
78,499
|
$
|
-
|
$
|
260,324
|
|||||
|
|||||||||||||
Operating
expenses
|
|||||||||||||
Research
and development costs
|
1,633,729
|
744,149
|
2,832,572
|
1,626,639
|
|||||||||
General,
selling and administrative expenses
|
1,318,708
|
1,178,015
|
2,401,877
|
1,432,167
|
|||||||||
Depreciation
and amortization
|
15,780
|
12,981
|
29,537
|
25,962
|
|||||||||
Total
operating expenses
|
2,968,217
|
1,935,145
|
5,263,986
|
3,084,768
|
|||||||||
Operating
loss
|
(2,968,217
|
)
|
(1,856,646
|
)
|
(5,263,986
|
)
|
(2,824,444
|
)
|
|||||
|
|||||||||||||
Non-operating
income (expense)
|
|||||||||||||
Interest
income
|
10,545
|
58,058
|
31,862
|
76,961
|
|||||||||
Interest
expense
|
-
|
(323
|
)
|
-
|
(670
|
)
|
|||||||
Total
non-operating income
|
10,545
|
57,735
|
31,862
|
76,291
|
|||||||||
Net
loss
|
$
|
(2,957,672
|
)
|
$
|
(1,798,911
|
)
|
$
|
(5,232,124
|
)
|
$
|
(2,748,153
|
)
|
|
|
|||||||||||||
Net
loss per share, basic and diluted
|
$
|
(0.09
|
)
|
$
|
(0.06
|
)
|
$
|
(0.16
|
)
|
$
|
(0.10
|
)
|
|
Average
number of shares of common stock outstanding
|
32,109,858
|
29,024,012
|
31,936,365
|
27,811,517
|
|
|
|
|
|
Additional
|
|
|
|||||||||||||||
|
Preferred Stock
|
Common Stock
|
Paid-In
|
Accum.
|
|
|||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
|||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||
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 - $2.00 per share), net
of offering costs of $0.15 per share or $7,313.
|
-
|
-
|
125,425
|
1,254
|
223,533
|
-
|
224,787
|
|||||||||||||||
|
||||||||||||||||||||||
Issuance
of common stock though Private
|
|
|
|
|
||||||||||||||||||
Placement
($4.06 per share).
|
-
|
-
|
615,309
|
6,153
|
2,493,847
|
-
|
2,500,000
|
|||||||||||||||
|
|
|
|
|
||||||||||||||||||
Share
Based Payment - Employee
|
|
|
|
|
||||||||||||||||||
Compensation
|
-
|
-
|
-
|
-
|
2,160,900
|
-
|
2,160,900
|
|||||||||||||||
|
|
|
|
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(5,232,124
|
)
|
(5,232,124
|
)
|
|||||||||||||
|
||||||||||||||||||||||
Balance
at June 30, 2008
|
-
|
$
|
-
|
32,151,300
|
$
|
321,513
|
$
|
57,029,525
|
$
|
(50,888,121
|
)
|
$
|
6,462,917
|
|
Six Months Ended June
30,
|
||||||
|
2008
|
2007
|
|||||
|
|
|
|||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(5,232,124
|
)
|
$
|
(2,748,153
|
)
|
|
Adjustment
to reconcile net loss to cash used in operating activities:
|
|||||||
Depreciation
and amortization
|
29,537
|
25,962
|
|||||
Share
based compensation
|
2,160,900
|
474,393
|
|||||
Changes
in assets and liabilities:
|
|||||||
Accounts
receivable
|
-
|
(4,359
|
)
|
||||
Prepaid
expenses
|
50,017
|
23,343
|
|||||
Other
assets
|
(6,001
|
)
|
(5,624
|
)
|
|||
Accounts
payable and accrued expenses
|
(80,589
|
)
|
189,820
|
||||
Net
cash used in operating activities
|
(3,078,260
|
)
|
(2,044,618
|
)
|
|||
|
|||||||
Cash
flow from investing activities:
|
|||||||
Capital
outlay for intangible assets
|
(22,456
|
)
|
(5,191
|
)
|
|||
Purchase
of property and equipment
|
(61,221
|
)
|
(75,020
|
)
|
|||
Net
cash used in investing activities
|
(83,677
|
)
|
(80,211
|
)
|
|||
|
|||||||
Cash
flows from financing activities:
|
|||||||
Issuance
of common stock
|
2,724,787
|
6,020,300
|
|||||
Payments
on notes payable
|
-
|
(3,859
|
)
|
||||
Net
cash provided by financing activities
|
2,724,787
|
6,016,441
|
|||||
|
|||||||
Net
(decrease) increase in cash
|
(437,150
|
)
|
3,891,612
|
||||
|
|||||||
Cash,
beginning of period
|
7,403,737
|
1,807,041
|
|||||
|
|||||||
Cash,
ending of period
|
$
|
6,966,587
|
$
|
5,698,653
|
|
Number
of
Options
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Life
(in years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding
at January 1, 2008
|
3,200,659
|
$
|
1.19
|
6.8
|
$
|
-
|
|||||||
Granted
|
5,370,000
|
3.46
|
9.6
|
-
|
|||||||||
Exercised
|
-
|
||||||||||||
Forfeited
|
-
|
||||||||||||
|
|||||||||||||
Outstanding
at June 30, 2008
|
8,570,659
|
$
|
2.59
|
8.6
|
$
|
2,415,580
|
|||||||
|
|||||||||||||
Exercisable
at June 30, 2008
|
1,691,326
|
$
|
1.26
|
7.1
|
$
|
1,233,580
|
|
Three Months Ended June 30,
|
||||||
|
2008
|
2007
|
|||||
|
|
|
|||||
Research
and development costs
|
$
|
696,661
|
$
|
37,741
|
|||
General,
selling and administrative expenses
|
369,701
|
361,170
|
|||||
Total
|
$
|
1,066,362
|
$
|
398,911
|
|
Six Months Ended June 30,
|
||||||
|
2008
|
2007
|
|||||
|
|
|
|||||
Research
and development costs
|
$
|
1,448,675
|
$
|
75,482
|
|||
General,
selling and administrative expenses
|
712,225
|
398,911
|
|||||
Total
|
$
|
2,160,900
|
$
|
474,393
|
|
Number of
Warrants
|
Weighted-
Average
Exercise
Price
|
|||||
Outstanding at January 1, 2008
|
11,208,515
|
$
|
2.44
|
||||
Issued
|
—
|
||||||
Exercised
|
125,425
|
1.79
|
|||||
Forfeited
|
—
|
||||||
|
|||||||
Outstanding
at June 30, 2008
|
11,083,090
|
$
|
2.45
|
||||
|
|||||||
Exercisable
at June 30, 2008
|
8,083,090
|
$
|
2.24
|
·
|
the
success of our research and development activities, the development
of a
viable commercial production model, 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 our products if a market
develops;
|
·
|
our
ability to attract and retain qualified personnel to implement our
growth
strategies;
|
·
|
our
ability to develop sales, marketing, and distribution
capabilities;
|
·
|
our
ability to obtain reimbursement from third party payers for the products
that we sell;
|
·
|
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”
|
|
Three Months Ended June 30
|
Six Months Ended June 30
|
|||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||
|
|
|
|||||||||||
Revenues
|
$
|
-
|
$
|
78,499
|
$
|
$-
|
$
|
260,324
|
|||||
Operating
Expenses
|
2,968,217
|
1,935,145
|
5,263,986
|
3,084,768
|
|||||||||
(2,968,217
|
)
|
(1,856,646
|
)
|
(5,263.986
|
)
|
(2,824,444
|
)
|
||||||
|
|||||||||||||
Non-operating
income
|
10,545
|
57,735
|
31,862
|
76,291
|
|||||||||
|
|||||||||||||
Net
Loss
|
$
|
(2,957,672
|
)
|
$
|
(1,798,911
|
)
|
$
|
(5,232,124
|
)
|
$
|
(2,748,153
|
)
|
· |
On
May 7, 2008, we filed suit against StemCells, Inc., StemCells California,
Inc. and Neurospheres Holding Ltd., (collectively “StemCells”) in U.S.
District Court for the District of Maryland, alleging that U.S. Patent
No.
7,361,505 (the “‘505 patent”), allegedly exclusively licensed to
StemCells, Inc., 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 Neuralstem’s CEO are not trade libel or do not constitute unfair
competition as alleged by StemCells. On July 15, 2008, StemCells
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. Briefing on that
motion
is ongoing. It is not known when nor on what basis this matter will
be
concluded.
|
· |
On
May 7, 2008, StemCells filed suit against us, I. Richard Garr and
Karl K.
Johe (collectively “Defendants”) in U.S. District Court in Northern
District of California, alleging that we have been infringing,
contributing to the infringement of, and or inducing the infringement
of
two patents owned by or exclusively licensed to StemCells relating
to stem
cell culture compositions. See Civil Action No. 08-02364. On May 9,
2008, StemCells filed an Amended Complaint and added claims against
Neuralstem for trade libel and unfair competition under California
state
law. This case involves the same claims as the Declaratory Judgment
Action
initiated by Neuralstem on May 7, 2008 pending in the District of
Maryland. See Civil Action No. 08-1173. Defendants’ filed a Motion
to Dismiss based on the first-to-file rule. On July 1, 2008, the
Court in
California issued an Order agreeing that the first-to-file rule applies
and “defer[red] to the District of Maryland to decide the appropriate
forum and whether an exception to the first-to-file rule is applicable.”
If the District in Maryland action does not move forward our Answer
is due
on September 24, 2008. It is not known when nor on what basis will
this
matter be concluded.
|
·
|
continued
progress and cost of its research and development
programs;
|
·
|
progress
with pre-clinical studies and clinical
trials;
|
·
|
time
and costs involved in obtaining regulatory
clearance;
|
·
|
costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
|
·
|
costs
of developing sales, marketing and distribution channels and its
ability
to sell the Company's stem cell
products;
|
·
|
costs
involved in establishing manufacturing capabilities for commercial
quantities of its products;
|
·
|
competing
technological and market
developments;
|
·
|
market
acceptance of its stem cell
products;
|
·
|
costs
for recruiting and retaining employees and consultants;
and
|
·
|
Costs
for educating and training physicians about its stem cell
products.
|
|
·
|
The
University of California, San
Diego;
|
|
·
|
University
of Central Florida; and
|
|
·
|
John
Hopkins University.
|
|
·
|
University
of Michigan
|
·
|
the
Company's establishment and demonstration to the medical community
of the
clinical efficacy and safety of its proposed
products;
|
·
|
the
Company's ability to create products that are superior to alternatives
currently on the market;
|
·
|
the
Company's ability to establish in the medical community the potential
advantage of its treatments over alternative treatment methods;
and
|
·
|
Reimbursement
policies of government and third-party
payors.
|
|
·
|
We
currentlydo
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 individuals;
|
|
·
|
We
currentlydo
maintain “key person” line 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.
|
|
·
|
On
January 21, 2008, we issued the following:
|
|
·
|
On
February 19, 2008, we entered into an agreement with CJ CheilJedang
Corporation (KSE: CJ CheilJedang) for the sale of $2.5 million of
common
shares at $4.063 per share. Pursuant to the transaction, we issued
an
aggregate of 615,309 common shares to CJ CheilJedang. Please refer
to our
Current Report filed on form 8-K on February 25, 2008 for a further
description of the transaction.
|
· |
On
April 1, 2998, we granted John Conron 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) the option to
purchase
50,000 common shares was issued pursuant to our 2005 Stock Plan.
|
· |
On
May 28, 2008, we granted Scott Ogilvie options to purchase an aggregate
of
60,000 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
45,000 common shares as compensation for serving on the board of
directors; (ii) an option to purchase 5,000 common shares as compensation
for serving on our Audit Committee; (iii) an option to purchase 5,000
common shares as compensation for serving on our Compensation Committee;
and (iv) an option to purchase 5,000 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
May 28, 2008, we granted William Oldaker options to purchase an aggregate
of 60,000 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
45,000 common shares as compensation for serving on the board of
directors; (ii) an option to purchase 5,000 common shares as compensation
for serving on our Audit Committee; (iii) an option to purchase 5,000
common shares as compensation for serving on our Compensation Committee;
and (iv) an option to purchase 5,000 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.
|
Votes For
|
Votes Abstained
|
||||||
I. Richard
Garr
|
26,244,750
|
52,289
|
|||||
Karl
Johe
|
26,243,777
|
53,262
|
Votes For
|
Votes Abstained
|
||||||
William Oldaker
|
25,379,508
|
917,531
|
Votes For
|
Votes Abstained
|
||||||
Scott
Ogilvie
|
25,377,635
|
919,404
|
2.
|
Ratification
of the appointment of Stegman & Company as the company’s independent
registered public accounting firm for
2008.
|
Votes For
|
Votes Against
|
Votes Abstained
|
Broker No Votes
|
|||||||
26,222,801
|
34,290
|
39,948
|
0
|
3.
|
Approval
of an amendment to the company’s certificate of incorporation to increase
the number of shares of common stock which the company is authorized
to
issue from 75,000,000 shares to 150,000,000
shares.
|
Votes
For
|
Votes
Against
|
Votes
Abstained
|
Broker
No Votes
|
|||||||
25,756,534
|
512,153
|
28,348
|
0
|
Exhibit
Number:
|
|
Description
|
|
|
|
31.1
|
|
Certification
of the Chief Executive Officer pursuant to Rule 13a-14(a) and Rule
15d-14(a) of the Securities Exchange Act, as amended
|
|
|
|
31.2
|
|
Certification
of the Chief Financial Officer pursuant to Rule 13a-14(a) and Rule
15d-14(a) of the Securities Exchange Act, as amended
|
|
|
|
32.1
|
|
Certification
of the Chief Executive Officer Pursuant to 18 U.S.C. 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
|
32.2
|
|
Certification
of the Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
NEURALSTEM,
INC.
|
|
|
|
|
Date: August
14, 2008
|
|
/s/ I.
Richard Garr
|
|
Chief
Executive Officer
|
|
|
|
|
|
/s/
John Conron
|
|
|
Chief
Financial Officer
|
|
|
(Principal
Accounting Officer)
|