PALISADE BIO, INC. - Quarter Report: 2008 June (Form 10-Q)
U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
one)
x
|
Quarterly
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For
the Quarterly Period Ended June 30, 2008
Or
¨
|
Transition
Report Under Section 13 or 15(d) of the Securities Exchange Act of
1934
|
Commission
File Number 000-1357459
Neuralstem,
Inc.
(Name
of small business issuer in its charter)
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)
|
Issuer's
telephone number: (301) 366-4841
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes
x No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨ Accelerated
filer ¨
Non-accelerated
filer ¨
(Do not
check if a small reporting company) Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company
(as
defined in Rule 12b-2 of the Exchange Act) Yes¨
No
x
As
of
August 5, 2008 there were 32,151,300
shares of common stock, $.01 par value, issued and outstanding.
Neuralstem,
Inc.
|
|
|
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
|
2
PART
I
FINANCIAL
INFORMATION
NEURALSTEM,
INC.
BALANCE
SHEETS
|
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
|
See
accompanying notes to Financial Statements.
3
NEURALSTEM,
INC.
STATEMENTS
OF OPERATIONS
(Unaudited)
|
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
|
See
accompanying notes to Financial Statements.
4
NEURALSTEM,
INC.
STATEMENT
OF STOCKHOLDERS' EQUITY
For
the period from January 1, 2008 through June 30, 2008
(Unaudited)
|
|
|
|
|
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
|
See
accompanying notes to financial statements
5
NEURALSTEM,
INC.
STATEMENTS
OF CASH FLOWS
(Unaudited)
|
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
|
See
Accompanying Notes to Financial Statements
6
NEURALSTEM,
INC.
NOTES
TO FINANCIAL STATEMENTS
(Unaudited)
Note
1. Basis
of Presentation
The
accompanying unaudited financial statements of Neuralstem, Inc. (the “Company”)
have been prepared in accordance with generally accepted accounting principles
in the United States and the rules and regulations of the Securities and
Exchange Commission (the “SEC”), for interim financial information.
Therefore, they do not include all of the information and footnotes required
by
generally accepted accounting principles for complete financial statements
and
should be read in conjunction with Company’s Annual Report on Form 10-KSB for
the year ended December 31, 2007.
The
interim financial statements are unaudited, but in the opinion of management
all
adjustments, consisting only of normal recurring accruals, considered necessary
to present fairly the results of these interim periods have been included.
The
results of the Company’s operations for any interim period are not necessarily
indicative of results that may be expected for any other interim period or
for
the full year.
Note
2. Significant Accounting Policies and Recent Accounting
Pronouncements
Use
of
Estimates
The
preparation of financial statements in accordance with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period.
Because of the use of estimates inherent in the financial reporting process,
actual results could differ significantly from those estimates.
The
Company's business currently generates limited amounts of cash which will not
be
sufficient to meet its future capital requirements. The Company's management
does not know when this will change. The Company has expended and will continue
to expend substantial funds in the research, development and clinical and
pre-clinical testing of the Company's stem cell technologies and products with
the goal of ultimately obtaining approval from the United States Food and Drug
Administration ("FDA") to market and sell our products. We believe our long-term
cash position is inadequate to fund all of the costs associated with the full
range of testing and clinical trials required by the FDA for our core products.
Based on our current operating levels, we believe that we have sufficient levels
of cash, short-term investments and access to funds that we will not require
additional debt or equity financing during 2008.
No
assurance can be given that (i) we will be able to expand our operations
prior to FDA approval of our products, or (ii) that FDA approval will ever
be granted for our products.
Revenue
Recognition
Our
revenue recognition policies are in accordance with the SEC’s Staff Accounting
Bulletin No. 101,
Revenue Recognition in Financial
Statements
as
amended by SAB 104.
Our
revenue is derived primarily from providing treated samples for gene expression
data from stem cell experiments, from providing services under various grant
programs and through the licensing of the use of our intellectual
property. Revenue is recognized when there is persuasive evidence that an
arrangement exists, delivery of goods and services has occurred, the price
is
fixed and determinable, and collection is reasonably assured.
Research
and Development
Research
and development expenses consist primarily of costs associated with basic and
pre-clinical research, exclusively in the field of human neural stem cell
therapies and regenerative medicine, related to our clinical cell therapy
candidates. These expenses represent both pre-clinical development costs and
costs associated with non-clinical support activities such as quality control
and regulatory processes. Research and development costs are expensed as they
are incurred.
Loss
per Common Share
Basic
loss per common share is calculated by dividing net loss by the weighted average
number of common shares outstanding during the period. Diluted loss per common
share adjusts basic loss per share for the potentially dilutive effects of
shares issuable under our stock option plan, using the treasury stock method.
Common equivalent shares from the exercise of stock options and warrants are
excluded from the computation of diluted loss per share as their effect is
antidilutive.
Share
Based Payments
We
have
granted stock-based compensation awards to employees and board members.
Awards may consist of common stock, warrants, or stock options. Our stock
options and warrants have up to a ten year life. The stock options or
warrants vest either upon the grant date or over varying periods of time. The
stock options we grant provide for option exercise prices equal to or greater
than the fair market value of the common stock at the date of the
grant.
7
During
the six months ended June 30, 2008, we granted 5,370,000 options and in the
similar period ended June 30, 2007, we granted 270,000 options. We recorded
related compensation expenses as our options vest in accordance with the
Statement of Financial Accounting Standards (“SFAS”) 123(R),
Share-Based Payment.
We
recognized $1,066,362 and $398,911 in share-based compensation expense
during the three months ended June 30, 2008 and 2007, respectively, from the
vesting of stock options or warrants. We recognized $2,160,900 and $474,393
in
share-based compensation expense during the six months ended June 30, 2008
and
2007, respectively, from the vesting of stock options or warrants.
A
summary
of stock option activity during the six months ended June 30, 2008 and related
information is included in the table below:
|
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
|
Share-based
compensation included in the statements of operations for the three months
and
six months ended June 30, 2008 and 2007 was as follows:
|
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
|
Options
to purchase common stock were issued to certain officers, directors,
stockholders and consultants.
|
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
|
8
In
the
first half of 2008 holders of warrants to purchase 125,425 shares of our common
stock for between $1.50 and $2.00 exercised them for $224,787 net of offering
costs of $7,313.
Recent
Accounting Pronouncements
In
June 2006, the FASB issued Interpretation No. 48,“Accounting
for Uncertainty in Income Taxes—an Interpretation of FASB Statement
No. 109”
(“FIN
48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized
in an entity’s financial statements in accordance with SFAS
No. 109,“Accounting
for Income Taxes,”
and
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. Additionally, FIN 48 provides guidance on subsequent
derecognition of tax positions, financial statement classification, recognition
of interest and penalties, accounting in interim periods, and disclosure and
transition requirements. The Company adopted the provisions of FIN 48 on
January 1, 2007.
The
Company recognizes accrued interest related to unrecognized tax benefits in
interest expense and penalties in operating expense. No amounts were accrued
for
the payment of interest and penalties at January 1, 2008 or June 30, 2008.
The Company’s adoption of FIN 48 did not have a material effect on the Company’s
financial condition, results of operations or cash flows.
In
September 2006, the FASB issued SFAS No. 157, “Fair
Value Measurements.”
This
Statement defines fair value, establishes a framework for measuring fair value,
and expands disclosures about fair value measurements. It clarifies that fair
value is the price that would be received to sell an asset or paid to transfer
a
liability in an orderly transaction between market participants in the market
in
which the reporting entity transacts. This Statement does not require any new
fair value measurements, but rather, it provides enhanced guidance to other
pronouncements that require or permit assets or liabilities to be measured
at
fair value. This Statement is effective for fiscal years beginning after
November 15, 2007, with earlier adoption permitted. In February 2008, the FASB
issued FASB Staff Position (“FSP”) No. FAS 157-2, “Effective
Date of FASB Statement No.157.”
This FSP
defers the effective date of SFAS No.157 for nonfinancial assets and
nonfinancial liabilities, except those that are recognized or disclosed at
fair
value in the financial statements on a recurring basis (at least annually),
to
years beginning after November 15, 2008, and interim periods within those fiscal
years. The adoption of this Statement did not have a material impact on the
Company’s financial position, results of operations or cash flows. As of June
30, 2008, Cash was our only financial asset and was valued using Level I
observable inputs. We had no financial liabilities as of June 30,
2008.
In
February 2007, the FASB issued Statement No. 159, “The
Fair
Value Option for Financial Assets and Financial Liabilities — Including an
amendment of FASB Statement No. 115”
(SFAS
159). SFAS 159 provides companies with an option to report selected financial
assets and liabilities at fair value. SFAS 159’s objectives are to reduce both
complexity in accounting for financial instruments and the volatility in
earnings caused by measuring related assets and liabilities differently. SFAS
159 is effective as of the beginning of an entity’s first fiscal year beginning
after November 15, 2007. The adoption of this statement did not have a
material impact on the Company’s financial condition, result of operations or
cash flows.
In
June 2007, the Financial Accounting Standards Board ratified a consensus
opinion reached by the Emerging Issues Task Force (EITF) on EITF Issue
07-3,“Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities.”
The
guidance in EITF Issue 07-3 requires the Company to defer and capitalize
nonrefundable advance payments made for goods or services to be used in research
and development activities until the goods have been delivered or the related
services have been performed. If the goods are no longer expected to be
delivered nor the services expected to be performed, the Company would be
required to expense the related capitalized advance payments. The consensus
in
EITF Issue 07-3 is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2007 and is to be applied
prospectively to new contracts entered into on or after December 15, 2007.
Early adoption is not permitted. Retrospective application of EITF Issue 07-3
is
also not permitted. The Company adopted EITF Issue 07-3 effective
January 1, 2008. The impact of applying this consensus will depend on the
terms of the Company’s future research and development contractual arrangements
entered into on or after December 15, 2007 and has not had a material
impact upon the Company’s operations.
In
March
2008, the FASB issued SFAS No. 161, “ Disclosures
about Derivative Instruments and Hedging Activities - an Amendment of FASB
Statement No. 133 .”
This
Statement amends and expands the disclosure requirements of SFAS No. 133, “
Accounting
for Derivative Instruments and Hedging Activities .”
The
Statement requires qualitative disclosures about objectives and strategies
for
using derivatives, quantitative disclosures about fair value amounts of and
gains and losses on derivative instruments, and disclosures about
credit-risk-related contingent features in derivative agreements. This Statement
is effective for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008. The Company does not expect that
the
adoption of this Statement will have a material impact on its financial
position, results of operations or cash flows.
In
May
2008, the FASB issued SFAS No. 162, “The Hierarchy
of Generally Accepted Principles .”
This
statement identifies the sources of accounting principles and the framework
for
selecting the principles used in the preparation of financial statements of
nongovernmental entities that are presented in conformity with generally
accepted accounting principles (“GAAP”) in the United States. The Statement is
directed to entities rather than auditors because entities are responsible
for
the selection of accounting principles for financial statements that are
presented in conformity with GAAP. This Statement is effective 60 days following
the SEC’s approval of the Public Company Accounting Oversight Board amendments
to AU Section 411, “ The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles .”
The
Company does not expect that the adoption of this Statement will have a material
impact on its financial position, results of operations or cash flows.
9
Note
3. Stockholders’ Equity
In
the
first half of 2008, holders of warrants to purchase 125,425 shares of our common
stock for between $1.50 and $2.00 exercised them for $224,787 net of offering
costs of $7,313.
The
Company also completed a private placement of 615,309 common shares at $4.06
per
share increasing equity by $2,500,000 in February 2008.
During
the first half of 2008, the Company granted 5,370,000 options on shares of
common stock to the Company’s Chief Scientific Officer and Chairman of the
Board; the CEO, the CFO and the company’s outside directors as an incentive for
these officers’ continued employment. The options vest in periods between one
and three years six months.. The Company valued these options using the
Black-Scholes option pricing model using the following assumptions: exercise
price of between $1.32 and $3.73, term between two and five and a half years,
volatility rate between 51% and 77% and discount rate between 1.77 and 3.28%.
The total value of these options will be expensed over the vesting period.
The
Company began to record the expense related to these options in the first
quarter of 2008.
Note
4. Subsequent
Events
In
August
2008,
Dr. Thomas Hazel will be rejoining the company as Executive Vice President,
Research. He will be working with Dr. Karl Johe, Neuralstem's Chairman and
Chief
Science Officer, to manage the company's upcoming clinical trial for ALS
(Amytrophic Lateral Sclerosis, or Lou Gehrig's disease), and complete
development of Neuralstem's small molecule neurogenesis compound targeted to
treat depression.
In
July
2008, the Company notified CJ Cheiljedang Corp. (C.J.) that Neuralstem will
exercise its right to commence negotiations with C.J. concerning the potential
addition of China to the list of Asian countries for which C.J. has purchased
an
option to negotiate for the exclusive license to Neuralstem's stem cell-products
and technology. In February 2008, C.J. purchased options to negotiate exclusive
licenses for: Korea, Indonesia, Philippines, Malaysia, Singapore and Vietnam.
CJ
CheilJedang Corporation is a subsidiary company of CJ Group whose core
businesses consists of Food & Food Services, Bio Pharma, Entertainment
Media, and Home Shopping & Logistics.
10
NEURALSTEM,
INC.
ADVISEMENT
Unless
the context requires otherwise, “Neuralstem,”
“the
Company,”
“we,”
“us,”
“our”
and
similar terms refer to Neuralstem, Inc. Our common stock, par value $.01
per share is commonly referred to in this quarterly report as our “common
shares.”
The information contained herein is current as of the date of this
quarterly report (June 30, 2008), unless another date is specified.
We
prepare our interim financial statements in accordance with United States
generally accepted accounting principles. Our financial condition and
results of operations for the three and six-month interim period ended June
30,
2008 are not necessarily indicative of our prospective financial condition
and
results of operations for the pending full fiscal year ending December 31,
2008.
The interim financial statements presented in this quarterly report as
well as other information relating to our company contained in this quarterly
report should be read in conjunction and together with any reports, statements
and information filed by us with the United States Securities and Exchange
Commission (“SEC”).
FORWARD
LOOKING STATEMENTS
In
this
quarterly report we make a number of statements, referred to as “forward-looking
statements,” within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"), which
are intended to convey our expectations or predictions regarding the occurrence
of possible future events or the existence of trends and factors that may impact
our future plans and operating results. These forward-looking statements are
derived, in part, from various assumptions and analyses we have made in the
context of our current business plan and information currently available to
use
and in light of our experience and perceptions of historical trends, current
conditions and expected future developments and other factors we believe are
appropriate in the circumstances. You can generally identify forward looking
statements through words and phrases such as“believe,”
“expect,” “seek,” “estimate,” “anticipate,” “intend,” “plan,” “budget,”
“project,” “may likely result,” “may be,” “may continue”
and
other similar expressions.
When
reading any forward-looking statement you should remain mindful that actual
results or developments may vary substantially from those expected as expressed
in or implied by such statement for a number of reasons or factors, including
but not limited to:
·
|
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”
|
Each
forward-looking statement should be read in context with and in understanding
of
the various other disclosures concerning our company and our business made
elsewhere in this report as well as our public filings with the Securities
and
Exchange Commission. You should not place undue reliance on any forward-looking
statement as a prediction of actual results or developments. We are not
obligated to update or revise any forward-looking statements contained in this
report or any other filing to reflect new events or circumstances unless and
to
the extent required by applicable law.
11
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION, RESULTS OF OPERATIONS AND PLAN OF OPERATION
Recent
Developments
In
July
2008 the Company notified CJ Cheiljedang Corp. (C.J.) that Neuralstem will
exercise its right to commence negotiations with C.J. concerning the potential
addition of China to the list of Asian countries for which C.J. has purchased
an
option to negotiate for the exclusive license to Neuralstem's stem cell-products
and technology. In February 2008, C.J. purchased options to negotiate exclusive
licenses for: Korea, Indonesia, Philippines, Malaysia, Singapore and Vietnam.
CJ
CheilJedang Corporation is a subsidiary company of CJ Group whose core
businesses consists of Food & Food Services, Bio Pharma, Entertainment
Media, and Home Shopping & Logistics.
General
The
following discussion of our financial condition and results of operations should
be read in conjunction with (1) our unaudited interim financial statements
and their explanatory notes included as part of this quarterly report, (2)
our
quarterly report for the period ended March 31, 2008, and (3) our audited
annual financial statements and explanatory notes for the year ended
December 31, 2007 as filed with the SEC, and as may be
amended.
This
quarterly report contains forward-looking statements that involve risks and
uncertainties. See "Risk Factors" set forth on page [__]
of this report for a more complete discussion of these factors. Readers are
cautioned not to place undue reliance on these forward-looking statements,
which
speak only as of the date that they are made. We undertake no obligation to
publicly update or revise any forward-looking statements, whether as a result
of
new information, future events or otherwise.
Overview
Neuralstem
is focused on the development and commercialization of treatments based on
transplanting human neural stem cells.
We
have
developed and maintain a portfolio of patents and patent applications that
form
the proprietary base for our research and development efforts in the area of
neural stem cell research. We own or exclusively license four (4) issued patents
and thirteen
(13)
patent
pending applications in the field of regenerative medicine and related
technologies. We believe our technology base, in combination with our know-how,
and collaborative projects with major research institutions provides a
competitive advantage and will facilitate the successful development and
commercialization of products for use in the treatment of a wide array of
neurodegenerative conditions and in regenerative repair of acute
disease.
This
is a
young and emerging field. There can be no assurances that our intellectual
property portfolio will ultimately produce viable commercialized products and
processes. Even if we are able to produce a commercially viable product, there
are strong competitors in this field and our product may not be able to
successfully compete against them.
All
of
our research efforts to date are at the level of basic research or in the
pre-clinical stage of development. We are focused on leveraging our key assets,
including our intellectual property, our scientific team, our facilities and
our
capital, to accelerate the advancement of our stem cell technologies. In
addition, we are pursuing strategic collaborations with members of academia.
We
are headquartered in Rockville, Maryland.
In
addition to our core tissue based technology we have begun developing a
Small-Molecule compound. We have performed preliminary
in
vitro
and
in
vivo
tests on
the compound with regard to neurogenesis. Based on the results of these tests
we
have applied for a U.S. patent on the compound.
Technology
Our
technology is the ability to isolate human neural stem cells from most areas
of
the developing human brain and spinal cord and our technology includes the
ability to grow them into physiologically relevant human neurons of all types.
Our two issued core patents entitled: (i)
Isolation, Propagation, and Directed Differentiation of Stem Cell from Embryonic
and Adult Central Nervous System of Mammals
; and
(ii)
In
Vitro Generation of Differentiated Neurons from Cultures of Mammalian
Multi-potential CNS Stem Cell
contain
claims which cover the process of deriving the cells and the cells created
from
such process.
What
differentiates our stem cell technology from others is that our patented
processes do not require us to “push” the cells towards a certain fate by adding
specific growth factors. Our cells actually “become” the type of cell they are
fated to be. We believe this process and the resulting cells create a technology
platform that allows for the efficient isolation and ability to produce, in
commercially reasonable quantities, neural stem cells from the human brain
and
spinal cord.
12
Our
technology allows for cells to grow in cultured dishes, also known
as
in
vitro
growth,
without mutations or other adverse events that would compromise their
usefulness.
Research
We
have
devoted substantial resources to our research programs in order to isolate
and
develop a series of neural stem cell banks that we believe can serve as a basis
for therapeutic products. Our efforts to date have been directed at methods
to
identify, isolate and culture large varieties of stem cells of the human nervous
system, and to develop therapies utilizing these stem cells. This research
is
conducted both internally and through the use of third party laboratory
consulting companies under our direct supervision.
As
of
June 30, 2008, we had 7 full-time employees.
Of these employees, 3 are directly involved in research and development
activities and 4 are engaged in business development and administration. We
also
use the services of numerous outside consultants in business and scientific
matters. We believe that we have good relations with our employees and
consultants.
Trends
& Outlook
Revenue:
Our
revenue in 2007 was from grant reimbursements and licensing fees. As our focus
is now on pre-clinical work in anticipation of entering clinical trials
in
2008,
we are
not concentrated on increasing revenue. We have completed work on previously
awarded grants.
Long-term,
we anticipate that grant revenue as a percentage of overall revenue will
decrease and our revenue will be derived primarily from licensing fees and
the
sale of our cell therapy products. At present, we are in our pre-clinical stage
of development and as a result, we can not accurately predict when or if we
will
be able to produce a product for commercialization. Accordingly, we cannot
accurately estimate when such a change in revenue composition will occur or
if
it will ever occur.
Research
and Development Expenses:
Our
research and development expenses consist primarily of costs associated with
basic and pre-clinical research, exclusively in the field of human neural stem
cell therapies and regenerative medicine, related to our clinical cell therapy
candidates. These expenses represent both pre-clinical development costs and
costs associated with non-clinical support activities such as quality control
and regulatory processes. The cost of our research and development personnel
is
the most significant category of expense. However, we also incur expenses with
third parties, including license agreements, third-party contract services,
sponsored research programs and consulting expenses.
We
do not
segregate research and development costs by project because our research is
focused exclusively on human stem cell therapies as a unitary field of study.
Although we have different areas of focus for our research, these areas are
completely intertwined and have not yet matured to the point where they are
separate and distinct projects. The intellectual property, scientists and other
resources dedicated to these efforts are not separately allocated to individual
projects, but rather are conducting our research on an integrated
basis.
We
expect
that research and development expenses will continue to increase in the
foreseeable future as we add personnel, expand our pre-clinical research (animal
surgeries, manufacturing of cells, and in vitro characterization of cells which
includes testing and cell quality control), begin clinical trial activities,
increase our regulatory compliance capabilities, and ultimately begin
manufacturing.
In
2006
we
retained Quintiles, Inc. to assist with regulatory compliance, preparation
of
our first Investigative New Drug (“IND”) application, and patient enrollment for
our first human trial. While recruitment for the trial cannot commence until
we
have received an FDA approved protocol, much of the infrastructure required
must
be developed and in place well in advance. For instance, we can begin to
identify, contact, and educate prospective patients as well as the treatment
community prior to commencing these trials.
Although
we feel the above increase in personnel will be sufficient for our short term
needs, the cost of increased personnel and expenses as we move from pre-clinical
to clinical state is difficult to predict due to the uncertainty inherent in
the
timing and extent of progress in our research programs, and initiation of
clinical trials. In addition, the results from our basic research and
pre-clinical trials, as well as the results of trials of similar therapeutics
under development by others, will influence the number, size and duration of
planned and unplanned trials. As our research efforts mature, we will continue
to review the direction of our research based on an assessment of the value
of
possible commercial applications emerging from these efforts. Based on this
continuing review, we expect to establish discrete research programs and
evaluate the cost and potential for cash inflows from commercializing products,
partnering with others in the biotechnology industry, or licensing the
technologies associated with these programs to third parties.
We
believe that it is not possible at this stage to provide a meaningful estimate
of the total cost to complete our ongoing projects and bring any proposed
products to market. The use of human stem cells as a therapy is an emerging
area
of medicine, and it is not known what clinical trials will be required by the
FDA in order to gain marketing approval. The costs to complete such clinical
trials could vary substantially depending upon the projects selected for
development, the number of clinical trials required and the number of patients
needed for each study. At a minimum, we estimate that a trial for an individual
indication such as Ischemic Spastic Paraplegia will require at least
10
to 12
patients at an estimated cost of $100,000 to $150,000 per patient.
It is
possible that the completion of these studies could be delayed for a variety
of
reasons, including difficulties in enrolling patients, delays in manufacturing,
incomplete or inconsistent data from the pre-clinical or clinical trials, and
difficulties evaluating the trial results. Any delay in completion of a trial
would increase the cost of that trial, which would harm our operating results.
Due to these uncertainties, we cannot reasonably estimate the size, nature,
nor
timing of the costs to complete, or the amount or timing of the net cash inflows
from our current activities. Until we obtain further relevant pre-clinical
and
clinical data, we will not be able to estimate our future expenses related
to
these programs or when, if ever, and to what extent, we will receive cash
inflows from resulting products.
13
General
and Administrative Expenses:
Our
general and administrative expenses consist of the general costs, expenses
and
salaries for the operation and maintenance of our business as well as
professional service fees (legal, accounting, audit) relating thereto. We
anticipate that general and administrative expenses will increase as we progress
from pre-clinical to a clinical phase.
In
May of
2008 we initiated litigation against StemCells, Inc. We believe in response
to
such litigation, StemCells, Inc. initiated an action against us. The litigation
is in its initial stages and it is hard to estimate what the actual costs
stemming there from will be. We have currently budgeted an additional $50,000
per month but this amount could significantly increase. For a further
description of the litigation, refer to the section of this report entitled
“Legal
Proceedings.”
Notwithstanding,
we anticipate that General and Administrative Expense related to our core
business will increase at a slower rate than that of similar companies making
such transition due in large part to our outsourcing model.
Critical
Accounting Policies
Our
financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“GAAP”). The preparation of
these financial statements requires management to make estimates and assumptions
that affect the reported amounts of assets, liabilities, revenues and expenses.
Note 2 of the Notes to Financial Statements describes certain significant
accounting policies used in the preparation of the financial statements. Certain
of these significant accounting policies are considered to be critical
accounting policies, as defined below.
A
critical accounting policy is defined as one that is both material to the
presentation of our financial statements and requires management to make
difficult, subjective or complex judgments that could have a material effect
on
our financial condition and results of operations. Specifically, critical
accounting estimates have the following attributes: (1) we are required to
make assumptions about matters that are highly uncertain at the time of the
estimate; and (2) different estimates we could reasonably have used, or
changes in the estimate that are reasonably likely to occur, would have a
material effect on our financial condition or results of
operations.
Estimates
and assumptions about future events and their effects cannot be determined
with
certainty. We base our estimates on historical experience and on various other
assumptions believed to be applicable and reasonable under the circumstances.
These estimates may change as new events occur, as additional information is
obtained and as our operating environment changes. These changes have
historically been minor and have been included in the consolidated financial
statements as soon as they became known.
Based
on
a critical assessment of our accounting policies and the underlying judgments
and uncertainties affecting the application of those policies, management
believes that our financial statements are fairly stated in accordance with
GAAP, and present a meaningful presentation of our financial condition and
results of operations. We believe the following critical accounting policies
reflect our more significant estimates and assumptions used in the preparation
of our financial statements:
Use
of Estimates—These
financial statements have been prepared in accordance with GAAP, accordingly,
they require management to make estimates and assumptions that affect the
reported amounts of assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Specifically, our management has estimated the expected
economic life and value of our licensed technology, our net operating loss
for
tax purposes and our stock, option and warrant expenses related to compensation
to employees and directors, consultants and investment banks. Actual results
could differ from those estimates.
Revenue
Recognition—Our
revenue, to date, has been derived primarily from providing treated samples
for
gene expression data from stem cell experiments and from providing services
as a
subcontractor under federal grant programs. Revenue is recognized when there
is
persuasive evidence that an arrangement exists, delivery of goods and services
has occurred, the price is fixed and determinable, and collection is reasonably
assured.
Intangible
and Long-Lived Assets—We
follow SFAS No. 144, "Accounting for Impairment or Disposal of Long-Lived
Assets," which established a "primary asset" approach to determine the cash
flow
estimation period for a group of assets and liabilities that represents the
unit
of accounting for a long lived asset to be held and used. Long-lived assets
to
be held and used are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. The carrying amount of a long-lived asset is not recoverable if
it
exceeds the sum of the undiscounted cash flows expected to result from the
use
and eventual disposition of the asset. Long-lived assets to be disposed of
are
reported at the lower of carrying amount or fair value less cost to sell. During
the six month periods ended
June 30, 2008 and June 30, 2007 no
impairment losses were recognized.
Research
and Development Costs—Research
and development costs consist of expenditures for the research and
development of patents and technology, which are not capitalizable and charged
to operations when incurred. Our research and development costs consist mainly
of payroll and payroll related expenses, research supplies and costs incurred
in
connection with specific research grants.
14
Share
Based Compensation—Beginning
in 2006, we adopted SFAS No. 123R “Share
Based Payment”
which
superseded APB Opinion No. 25. SFAS No. 123R requires compensation costs related
to share-based payment transactions to be recognized in the financial
statements.
RESULTS
OF OPERATIONS
Summary
Income Statement for the Three and Six Months Ended June 30, 2008 &
2007
|
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
|
)
|
RESULTS
OF OPERATIONS
For
the
second quarter of 2008, the Company
reported a net loss of $2,957,672, or $(0.09) per share, compared to a net
loss
of $1,798,911 or $(0.06) per share, for the comparable 2007 period. Net loss
attributable to common stockholders for the first six months of 2008 was
$5,232,124 or $(0.16) per share, compared to $2,748,153, or $(0.10) per share,
for the comparable period in 2007.The increase in net loss year to year was
due
to an increase in non cash stock-based compensation expense, salaries, and
legal
fees.
Result
of Operations for the Three Months ending June 30, 2008 and
2007
Revenues
for the three months ended June 30, 2008 and 2007 were $0 and $78,499
respectively as 2007 included funding from a grant which has ended.
Research
and development expenses for the three months ended June 30, 2008 and 2007
were
$1,633,729
and
$744,149, respectively. The increase in expenses in current period consists
mainly of payroll and payroll related expenses, stock-based compensation
expense, research supplies and costs incurred in connection with specific
research grants.
General
and administrative expenses for the three months ended June 30, 2008 and 2007
were $1,318,708, and $1,178,015, respectively. The principal increase in
expenses in 2008 versus 2007 is a result of increased stock-based compensation
expenses, payroll and legal (both patent and corporate).
Other
income for the three months ended June 30, 2008 and 2007 were $10,545, and
$58,058, respectively. The decrease in 2008 relates to a reduction in short
term
interest rates which drives income derived from our cash balance.
Net
loss
for the three months ended June 30, 2008 and 2007 was $2,957,672 and $1,798,911,
respectively.
Results
of Operations for the Six Months ending June 30, 2008 and
2007
There
were no revenues for the six month period ending June 30, 2008. In the same
period in the prior year we had $260,324 from a licensing agreement, sales
of
tissue products, and the substantial completion of a discontinued National
Institute of Health grant.
Research
and development expenses for the six month periods ending June 30, 2008 and
2007
were $2,832,572 and $1,626,639, respectively. The increase in expenses in
current period consists mainly of payroll and payroll related expenses, stock
based compensation expense, research supplies and costs incurred in connection
with our current effort to produce preclinical data which results in animal
surgeries, manufacturing of cells, and in vitro characterization of cells which
includes testing and cell quality control.
General
and administrative expenses for the six month periods ending June 30, 2008
and
2007 were $2,401,877 and $1,432,167, respectively. The principal increase in
expenses in the current period versus the same period last year is a result
of
increases in professional fees and expenses related to accountants, legal and
business advisors, stock based compensation expense and the introduction of
an
incentive bonus plan.
15
Non-operating
income, net for the six month period ending June 30, 2008 and 2007 were $31,862,
and $76,291, respectively. The largest factor influencing the reduction in
2008
is the drop in short term interest rates on cash deposits.
Net
loss
for the six months ended June 30, 2008 and 2007 was $5,232,124
and $2,748,153,
respectively.
Recent
Accounting Pronouncements
In
June 2006, the FASB issued Interpretation No. 48,“Accounting
for Uncertainty in Income Taxes—an Interpretation of FASB Statement
No. 109”
(“FIN
48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized
in an entity’s financial statements in accordance with SFAS
No. 109,“Accounting
for Income Taxes,”
and
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. Additionally, FIN 48 provides guidance on subsequent
derecognition of tax positions, financial statement classification, recognition
of interest and penalties, accounting in interim periods, and disclosure and
transition requirements. The Company adopted the provisions of FIN 48 on
January 1, 2007.
The
Company recognizes accrued interest related to unrecognized tax benefits in
interest expense and penalties in operating expense. No amounts were accrued
for
the payment of interest and penalties at January 1, 2007. The Company’s
adoption of FIN 48 did not have a material effect on the Company’s financial
condition, results of operations or cash flows.
In
September 2006, the FASB issued SFAS No. 157, “Fair
Value Measurements.”
This
Statement defines fair value, establishes a framework for measuring fair value,
and expands disclosures about fair value measurements. It clarifies that fair
value is the price that would be received to sell an asset or paid to transfer
a
liability in an orderly transaction between market participants in the market
in
which the reporting entity transacts. This Statement does not require any new
fair value measurements, but rather, it provides enhanced guidance to other
pronouncements that require or permit assets or liabilities to be measured
at
fair value. This Statement is effective for fiscal years beginning after
November 15, 2007, with earlier adoption permitted. In February 2008, the FASB
issued FASB Staff Position (“FSP”) No. FAS 157-2, “Effective
Date of FASB Statement No.157.”
This FSP
defers the effective date of SFAS No.157 for nonfinancial assets and
nonfinancial liabilities, except those that are recognized or disclosed at
fair
value in the financial statements on a recurring basis (at least annually),
to
years beginning after November 15, 2008, and interim periods within those fiscal
years. The adoption of this Statement did not have a material impact on the
Company’s financial position, results of operations or cash flows.
In
February 2007, the FASB issued Statement No. 159, “The
Fair
Value Option for Financial Assets and Financial Liabilities — Including an
amendment of FASB Statement No. 115”
(SFAS
159). SFAS 159 provides companies with an option to report selected financial
assets and liabilities at fair value. SFAS 159’s objectives are to reduce both
complexity in accounting for financial instruments and the volatility in
earnings caused by measuring related assets and liabilities differently. SFAS
159 is effective as of the beginning of an entity’s first fiscal year beginning
after November 15, 2007. The adoption of this standard did not have a
material impact on the Company’s financial condition, result of operations or
cash flows.
In
June 2007, the Financial Accounting Standards Board ratified a consensus
opinion reached by the Emerging Issues Task Force (EITF) on EITF Issue
07-3,“Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities.”
The
guidance in EITF Issue 07-3 requires the Company to defer and capitalize
nonrefundable advance payments made for goods or services to be used in research
and development activities until the goods have been delivered or the related
services have been performed. If the goods are no longer expected to be
delivered nor the services expected to be performed, the Company would be
required to expense the related capitalized advance payments. The consensus
in
EITF Issue 07-3 is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2007 and is to be applied
prospectively to new contracts entered into on or after December 15, 2007.
Early adoption is not permitted. Retrospective application of EITF Issue 07-3
is
also not permitted. The Company adopted EITF Issue 07-3 effective
January 1, 2008. The impact of applying this consensus will depend on the
terms of the Company’s future research and development contractual arrangements
entered into on or after December 15, 2007 and has not had a material
impact upon the Company’s operations.
In
March
2008, the FASB issued SFAS No. 161, “ Disclosures
about Derivative Instruments and Hedging Activities - an Amendment of FASB
Statement No. 133 .”
This
Statement amends and expands the disclosure requirements of SFAS No. 133, “
Accounting
for Derivative Instruments and Hedging Activities .”
The
Statement requires qualitative disclosures about objectives and strategies
for
using derivatives, quantitative disclosures about fair value amounts of and
gains and losses on derivative instruments, and disclosures about
credit-risk-related contingent features in derivative agreements. This Statement
is effective for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008. The Company does not expect that
the
adoption of this Statement will have a material impact on its financial
position, results of operations or cash flows.
In
May
2008, the FASB issued SFAS No. 162, “The Hierarchy
of Generally Accepted Principles .”
This
statement identifies the sources of accounting principles and the framework
for
selecting the principles used in the preparation of financial statements of
nongovernmental entities that are presented in conformity with generally
accepted accounting principles (“GAAP”) in the United States. The Statement is
directed to entities rather than auditors because entities are responsible
for
the selection of accounting principles for financial statements that are
presented in conformity with GAAP. This Statement is effective 60 days following
the SEC’s approval of the Public Company Accounting Oversight Board amendments
to AU Section 411, “ The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles .”
The
Company does not expect that the adoption of this Statement will have a material
impact on its financial position, results of operations or cash flows.
16
Liquidity
and Capital Resources
We
are
financing our operations primarily with the proceeds from the private placement
of our securities and the exercise of investor warrants. During the six months
ended June 30, 2008, we raised $2,500,000,
through
the private placement of our securities. In addition, we raised an additional
$224,787
as a
result of warrant exercises from our current investors. To a substantially
lesser degree, financing of our operations is provided through grant funding,
payments received under license agreements, and interest earned on cash. We
received no payments from our grants, cell sales and licensing agreements for
the six months ended June 30, 2008. Interest earned on cash and cash equivalents
equaled
$31,862.
We
have
incurred substantial net losses each year since inception as a result of
research and development and general and administrative expenses in support
of
our operations. We anticipate incurring substantial net losses in the
future.
Cash
at
June 30, 2008 was
$6,966,587. Cash at December 31, 2007 was $7,403,737. The decrease in the
current period
is the
result of the above described factors, net of amounts spent for payment of
notes
and accounts payable, increased legal and accounting fees, fees paid to the
placement agent, and increases in other research and development and general
and
administrative expenses.
Our
cash
is limited. We will require substantial additional funding. Our future cash
requirements will depend on many factors, including the pace and scope of our
research and development programs, the costs involved in filing, prosecuting,
maintaining and enforcing patents and other costs associated with
commercializing our potential products. We intend to seek additional funding
primarily through public or private financing transactions, and, to a lesser
degree, new licensing or scientific collaborations, grants from governmental
or
other institutions, and other related transactions. If we are unable to raise
additional funds, we will be forced to either scale back our business efforts
or
curtail our business activities entirely. Our currently monthly cash burn rate
is $500,000.
We anticipate that our available cash and expected income will be sufficient
to
finance most of our current activities for at least the next 12 months from
June
30, 2008, although certain of these activities and related personnel may need
to
be reduced.
Additionally,
in the event we are able to file a successful Investigative New Drug Application
(“IND”) with the FDA, we anticipate we will enter clinical trials in the last
half of 2008. In the event of such trials, we would incur additional expenses
associated with such trials which are estimated to exceed $1,000,000. Assuming
our current monthly cash burn rate of $500,000, the
increased expense from regulatory compliance and personnel required for the
pre-trial and clinical trial work, as well as the estimated cost of the trial,
our cash on hand is sufficient to finance our current operations, pre-clinical
and clinical work for at
least twelve months
from
June 30, 2008. We cannot assure you that public or private financing or grants
will be available on acceptable terms, if at all. Several factors will affect
our ability to raise additional funding, including, but not limited to, the
volatility of our common shares.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are
not required to provide the information required by this items as we are
considered a smaller reporting company, as defined by Rule
229.10(f)(1).
CONTROLS
AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Disclosure
controls and procedures are designed to ensure that information required to
be
disclosed in the quarterly reports filed or submitted under the Exchange Act
is
recorded, processed, summarized and reported, within the time period specified
in the SEC’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information
required to be disclosed in the reports filed under the Exchange Act is
accumulated and communicated to management, including our Chief Executive
Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure.
Our
Chief
Executive Officer and Chief Financial Officer, in consultation with our other
members of management and advisors as appropriate, carried out an evaluation
of
the effectiveness of our disclosure controls and procedures as of the end of
the
period covered by this quarterly report pursuant to Rule 15d-15(b)
promulgated under the Exchange Act. Based upon that evaluation, our Chief
Executive Officer and our Chief Financial Officer concluded that our disclosure
controls and procedures are effective in alerting them in a timely fashion
to
all material information required to be included in our periodic filings with
the SEC.
17
Changes
in Internal Control over Financial Reporting
The
term
internal control over financial reporting is defined as a process designed
by,
or under the supervision of, our Chief Executive Officer and Chief Financial
Officer, and effected by our board of directors, management and other personnel,
to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. There were no changes in
our internal control over financial reporting identified in connection with
our
evaluation of these controls as of the end of the period covered by this
quarterly report that could have significantly affected those
controls.
PART
II
OTHER
INFORMATION
LEGAL
PROCEEDINGS
As
of the
date of this quarterly report, there are no material pending legal or
governmental proceedings relating to our company or properties to which we
are a
party, and to our knowledge there are no material proceedings to which any
of
our directors, executive officers or affiliates are a party adverse to us or
which have a material interest adverse to us, other than the
following:
· |
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.
|
RISK
FACTORS
We
have
described below a number of uncertainties and risks which, in addition to
uncertainties and risks presented elsewhere in this quarterly report, may
adversely affect our business, operating results and financial condition.
The uncertainties and risks enumerated below as well as those presented
elsewhere in this quarterly report should be considered carefully in evaluating
our company and our business and the value of our securities.
Risks
Relating to the Company's Stage of Development
Since
the Company has a limited operating history and has significantly shifted its
operations and strategies since inception, you cannot rely upon the Company's
limited historical performance to make an investment
decision.
Since
inception in 1996 and through June 30, 2008, the Company has raised in
aggregate, approximately $57,351,038 capital and recorded accumulated losses
totaling $50,888,121. On June 30, 2008, the Company had a working capital
surplus of $7,047,290
and
stockholders’ equity of $6,462,917. Our net losses for the two most recent
fiscal years have been $7,063,272 and $3,147,488 for 2007 and 2006 respectively.
Our net loss for the six month period ended June 30, 2008 was $5,232,124. We
had
no revenues for the six months ended June 30, 2008.
The
Company's ability to generate revenues and achieve profitability depends upon
its ability to complete the development of its stem cell products, obtain the
required regulatory approvals, manufacture, and market and sell its products.
In
part because of the Company’s past operating results, no assurances can be given
that the Company will be able to accomplish all or any these goals.
18
Although
the Company has generated some revenue to date, the Company has not generated
any revenue from the commercial sale of its proposed stem cell products. Since
inception, the Company has engaged in several related lines of business and
has
discontinued operations in certain areas. For example, in 2002, the Company
lost
a material contract with the Department of Defense and was forced to close
its
principal facility and lay off almost all of its employees in an attempt to
focus the Company’s strategy on its stem cell technology. This limited and
changing history may not be adequate to enable you to fully assess the Company's
current ability to develop and commercialize its technologies and proposed
products, obtain approval from the U.S. Food and Drug Administration (“FDA”),
achieve market acceptance of its proposed products and respond to competition.
No assurances can be given as to exactly when, if at all, the Company will
be
able to fully develop, commercialize market, sell and derive material revenues
from its proposed products in development.
The
Company will
need to raise additional capital to continue operations, and failure to do
so
will impair the Company's ability to fund operations, develop its technologies
or promote its products.
The
Company has relied almost entirely on external financing to fund operations.
Such financing has historically come primarily from the sale of common and
preferred stock and convertible debt to third parties, the exercise of investor
warrants and to a lesser degree from grants, loans and revenue from license
and
royalty fees. The Company anticipates, based on current proposed plans and
assumptions relating to its operations (including the timetable of, and costs
associated with, new product development) and financings the Company has
undertaken prior to the date of this quarterly report, that its current working
capital will be sufficient to satisfy contemplated cash requirements for
approximately nine months, assuming that the Company does not engage in an
extraordinary transaction or otherwise face unexpected events or contingencies,
any of which could effect cash requirements. As of June 30, 2008, the
Company
had cash and cash equivalents on hand of $6,966,587. Presently, the Company
has
a monthly cash burn rate of approximately $500,000. Accordingly, the Company
will need to raise additional capital to fund anticipated operating expenses
and
future expansion after such period. Among
other
things, external financing will be required to cover the further development
of
the Company's technologies and products and other operating costs. The Company
cannot assure you that financing whether from external sources or related
parties will be available if needed or on favorable terms. If additional
financing is not available when required or is not available on acceptable
terms, the Company may be unable to fund operations and planned growth, develop
or enhance its technologies, take advantage of business opportunities or respond
to competitive market pressures. Any negative impact on the Company's operations
may make capital raising more difficult and may also resulting a lower price
for
the Company's securities.
The
Company may have difficulty raising needed capital in the future as a result
of,
among other factors, the Company's limited operating history and business risks
associated with the Company.
The
Company's business currently generates limited amounts of cash which will not
be
sufficient to meet its future capital requirements. The Company's management
does not know when this will change. The Company has expended and will continue
to expend substantial funds in the research, development and clinical and
pre-clinical testing of the Company's stem cell technologies and products with
the goal of ultimately obtaining FDA approval. The Company will require
additional funds to conduct research and development, establish and conduct
clinical and pre-clinical trials, commercial-scale manufacturing arrangements
and to provide for the marketing and distribution. Additional funds may not
be
available on acceptable terms, if at all. If adequate funds are unavailable
from
any available source, the Company may have to delay, reduce the scope of or
eliminate one or more of its research, development or commercialization programs
or product launches or marketing efforts which may materially harm the Company's
business, financial condition and results of operations.
The
Company's long term capital requirements are expected to depend on many factors,
including:
·
|
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;
|
19
·
|
costs
for recruiting and retaining employees and consultants;
and
|
·
|
Costs
for educating and training physicians about its stem cell
products.
|
The
Company may consume available resources more rapidly than currently anticipated,
resulting in the need for additional funding. The Company may seek to raise
any
necessary additional funds through the exercising of warrants, options, equity
or debt financings, collaborative arrangements with corporate partners or other
sources, which may be dilutive to existing stockholders or otherwise have a
material effect on the Company's current or future business prospects. If
adequate funds are not available, the Company may be required to significantly
reduce or refocus its development and commercialization efforts.
The
Company relies on stem cell technologies that it may not be able to commercially
develop, which will prevent the Company from generating revenues, operating
profitably or providing investors any return on their
investment.
The
Company has concentrated its research on its stem cell technologies, and the
Company's ability to generate revenue and operate profitably will depend on
it
being able to develop these technologies for human applications. These are
emerging technologies with, as yet, limited human applications. The Company
cannot guarantee that it will be able to develop its stem cell technologies
or
that such development will result in products or services with any significant
commercial utility. The Company anticipates that the commercial sale of such
products or services, and royalty/licensing fees related to its technology,
will
be the Company’s primary sources of revenues. If the Company is unable to
develop its technologies, investors will likely lose their entire
investment.
Inability
to complete pre-clinical and clinical testing and trials will impair the
viability of the Company.
The
Company is in its development stage and has not yet applied for approval by
the
FDA to conduct clinical trials. Even if the Company successfully files an IND
and receives approval from the FDA to commence trials, the outcome of
pre-clinical, clinical and product testing of the Company's products is
uncertain, and if the Company is unable to satisfactorily complete such testing,
or if such testing yields unsatisfactory results, the Company will be unable
to
commercially produce its proposed products. Before obtaining regulatory
approvals for the commercial sale of any potential human products, the Company's
products will be subjected to extensive pre-clinical and clinical testing to
demonstrate their safety and efficacy in humans. No assurances can be given
that
the clinical trials of the Company's products, or those of licensees or
collaborators, will demonstrate the safety and efficacy of such products at
all,
or to the extent necessary to obtain appropriate regulatory approvals, or that
the testing of such products will be completed in a timely manner, if at all,
or
without significant increases in costs, program delays or both, all of which
could harm the Company's ability to generate revenues. In addition, the
Company's proposed products may not prove to be more effective for treating
disease or injury than current therapies. Accordingly, the Company may have
to
delay or abandon efforts to research, develop or obtain regulatory approval
to
market its proposed products. Many companies involved in biotechnology research
and development have suffered significant setbacks in advanced clinical trials,
even after promising results in earlier trials. The failure to adequately
demonstrate the safety and efficacy of a therapeutic product under development
could delay or prevent regulatory approval of the product and could harm the
Company's ability to generate revenues, operate profitably or produce any return
on an investment in the Company.
The
Company's additional financing requirements could result in dilution to existing
stockholders.
At
present, the Company is not able to finance it operations because it does not
sell any products. Accordingly, the Company will be required to secure
additional financing. If the Company is able to obtain such additional
financings such financing may be dilutive to current shareholders. The Company
has the authority to issue additional shares of common stock and preferred
stock, as well as additional classes or series of ownership interests or debt
obligations which may be convertible into any one or more classes or series
of
ownership interests. The Company is authorized to issue 150,000,000 shares
of
common stock and 7,000,000 shares of preferred stock. Such securities may be
issued without the approval or other consent of the Company's
stockholders.
Risks
Relating to Intellectual Property and Government
Regulation
The
Company may not be able to withstand challenges to its intellectual property
rights, such as patents, should contests be initiated in court or at the U.S
Patent and Trademark Office.
The
Company relies on its intellectual property, including its issued and applied
for patents, as the foundation of its business. The intellectual property rights
of the Company may come under challenge, and no assurances can be given that,
even though issued, the Company's current and potential future patents will
survive claims commencing in the court system alleging invalidity or
infringement on other patents. For example, in 2005, the Company's neural stem
cell technology was challenged in the U.S. Patent and Trademark Office by a
competitor. Although the Company prevailed in this particular matter upon
re-examination by the patent office, these cases are complex, lengthy and
expensive, and could potentially be adjudicated adversely to the Company,
removing the protection afforded by an issued patent. The viability of the
Company's business would suffer if such patent protection were limited or
eliminated. Moreover, the costs associated with defending or settling
intellectual property claims would likely have a material adverse effect on
the
Company. At present, the litigation is in its initial stages and any likely
outcome is difficult to predict. It is not known when nor on what basis this
matter will be concluded.
20
The
Company may not be able to adequately protect against piracy of intellectual
property in foreign jurisdictions.
Considerable
research in the area of stem cell therapies is being performed in countries
outside of the United States, and a number of the Company's competitors are
located in those countries. The laws protecting intellectual property in
some of those countries may not provide protection for the Company's trade
secrets and intellectual property adequate to prevent its competitors from
misappropriating the Company's trade secrets or intellectual property. If
the Company's trade secrets or intellectual property are misappropriated in
those countries, the Company may be without adequate remedies to address the
issue.
The
Company's products may not receive FDA approval, which would prevent the Company
from commercially marketing its products and producing
revenues.
The
FDA
and comparable government agencies in foreign countries impose substantial
regulations on the manufacture and marketing of pharmaceutical products through
lengthy and detailed laboratory, pre-clinical and clinical testing procedures,
sampling activities and other costly and time-consuming procedures. Satisfaction
of these regulations typically takes several years or more and varies
substantially based upon the type, complexity and novelty of the proposed
product. The Company cannot yet accurately predict when it might first submit
any Investigational New Drug, or IND, application to the FDA, or whether any
such IND application would be granted on a timely basis, if at all, nor can
the
Company assure you that it will successfully complete any clinical trials in
connection with any such IND application. Further, the Company cannot yet
accurately predict when it might first submit any product license application
for FDA approval or whether any such product license application would be
granted on a timely basis, if at all. As a result, the Company cannot
assure you that FDA approvals for any products developed by it will be granted
on a timely basis, if at all. Any such delay in obtaining, or failure to obtain,
such approvals could have a material adverse effect on the marketing of the
Company's products and its ability to generate product revenue.
Because
the Company or its collaborators must obtain regulatory approval to market
its
products in the United States and other countries, the Company cannot predict
whether or when it will be permitted to commercialize its
products.
Federal,
state and local governments and agencies in the United States (including the
FDA) and governments in other countries have significant regulations in place
that govern many of the Company's activities. The Company is or may become
subject to various federal, state and local laws, regulations and
recommendations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and
disposal of hazardous or potentially hazardous substances used in connection
with its research and development work. The preclinical testing and clinical
trials of the products that the Company or its collaborators develop are subject
to extensive government regulation that may prevent the Company from creating
commercially viable products from its discoveries. In addition, the sale by
the
Company or its collaborators of any commercially viable product will be subject
to government regulation from several standpoints, including manufacturing,
advertising and promoting, selling and marketing, labeling, and distributing.
If, and to the extent that, the Company is unable to comply with these
regulations, its ability to earn revenues will be materially and negatively
impacted.
Risks
Relating to Competition
The
Company's competition includes both public and private organizations and
collaborations among academic institutions and large pharmaceutical companies,
most of which have significantly greater experience and financial resources
than
the Company does.
The
biotechnology industry is characterized by intense competition. The Company
competes against numerous companies, many of which have substantially greater
financial and other resources than it has. Several such enterprises have
initiated cell therapy research programs and/or efforts to treat the same
diseases targeted by the Company. Although not necessarily direct competitors,
companies such as Geron Corporation, Genzyme Corporation, StemCells, Inc.,
Advanced Cell Technology, Inc., Aastrom Biosciences, Inc. and Viacell, Inc.,
as
well as others, have substantially greater resources and experience in the
Company's fields than it does. Of course, any of the world's largest
pharmaceutical companies represent a significant actual or potential competitor
with vastly greater resources than the Company's.
Risks
Relating to the Company's Reliance on Third Parties
The
Company's outsource model depends on collaborators, non-employee consultants,
research institutions, and scientific contractors to help it develop and test
its proposed products. Our ability to develop such relationships could impair
or
delay our ability to develop products.
The
Company's strategy for the development, clinical testing and commercialization
of its proposed products is based on an outsource model. This model requires
that the Company enter into collaborations with corporate partners, research
institutions, scientific contractors and licensors, licensees and others in
order to further develop its technology and develop products. In the event
the
Company is not able to enter into such relationships in the future, our: ability
to develop products may be seriously hindered; or we would be required to expend
considerable money and research to bring such research and development functions
in house. Either outcome could result in our inability to develop a commercially
feasible product or in the need for substantially more working capital to
complete the research in-house. Also, we are currently dependent on
collaborators for a substantial portion of our research and development.
Although our collaborative agreements do not impose any duties or obligations
on
us other than the licensing of our technology, the failure of any of these
collaborations may hinder our ability to develop products in a timely fashion.
By way of example, our collaboration with John Hopkins University, School of
Medicine yielded findings that contributed to our patent application entitled
Transplantation of Human Cells for Treatment of Neurological Disorder. Had
the
collaboration not have existed, our ability to apply for such patent would
have
been greatly hindered. We currently have 4 key collaborations. They are
with:
21
|
·
|
The
University of California, San
Diego;
|
|
·
|
University
of Central Florida; and
|
|
·
|
John
Hopkins University.
|
|
·
|
University
of Michigan
|
As
we are
under no financial obligation to provide additional funding under any of these
collaborations, our primary risk is that no results are derived from their
research.
We
intend to rely upon the third-party FDA-approved manufacturers for our stem
cells. Should these manufacturers fail to perform as expected, we will need
to
develop or procure other manufacturing sources, which would cause delays or
interruptions in our product supply and result in the loss of significant sales
and customers.
We
currently have no internal manufacturing capability, and will rely extensively
on FDA-approved licensees, strategic partners or third party contract
manufacturers or suppliers. We current have an agreement with Charles River
Laboratories for the manufacturing and storage of our cells. In the event
Charles River Laboratories fails to provide suitable cells, we would be forced
to either manufacture the cells ourselves or seek other third party vendors.
Should we be forced to manufacture our stem cells, we cannot give you any
assurance that we will be able to develop an internal manufacturing capability
or procure third party suppliers. Moreover, we cannot give you any assurance
that any contract manufacturers or suppliers we procure will be able to supply
our product in a timely or cost effective manner or in accordance with
applicable regulatory requirements or our specifications
General
Risks Relating to the Company's Business
The
Company may be subject to litigation that will be costly to defend or pursue
and
uncertain in its outcome.
The
Company's business may bring it into conflict with its licensees, licensors,
or
others with whom it has contractual or other business relationships or with
its
competitors or others whose interests differ from the Company's. If the Company
is unable to resolve those conflicts on terms that are satisfactory to all
parties, the Company may become involved in litigation brought by or against
it.
That litigation is likely to be expensive and may require a significant amount
of management's time and attention, at the expense of other aspects of the
Company's business. The outcome of litigation is always uncertain, and in some
cases could include judgments against us that require the Company to pay
damages, enjoin it from certain activities, or otherwise affect its legal or
contractual rights, which could have a significant adverse effect on its
business. By way of example, in May of 2008, we filed a complaint against
StemCells Inc., alleging that U.S. Patent No. 7,361,505 (the “‘505 patent”),
allegedly exclusively licensed to StemCells, Inc., is invalid, not infringed,
and unenforceable. On the same day, StemCells, Inc. filed a complaint alleging
that we had infringed, contributed to the infringement of, and or induced the
infringement of two patents owned by or exclusively licensed to StemCells
relating to stem cell culture compositions. At present, the litigation is in
its
initial stages and any likely outcome is difficult to predict.
The
Company may not be able to obtain third-party patient reimbursement or favorable
product pricing, which would reduce its ability to operate
profitably.
The
Company's ability to successfully commercialize certain of its proposed products
in the human therapeutic field may depend to a significant degree on patient
reimbursement of the costs of such products and related treatments at acceptable
levels from government authorities, private health insurers and other
organizations, such as health maintenance organizations. The Company cannot
assure you that reimbursement in the United States or foreign countries will
be
available for any products it may develop or, if available, will not be
decreased in the future, or that reimbursement amounts will not reduce the
demand for, or the price of, its products with a consequent harm to the
Company's business. The Company cannot predict what additional regulation or
legislation relating to the health care industry or third-party coverage and
reimbursement may be enacted in the future or what effect such regulation or
legislation may have on the Company's business. If additional regulations are
overly onerous or expensive or if health care related legislation makes its
business more expensive or burdensome than originally anticipated, the Company
may be forced to significantly downsize its business plans or completely abandon
its business model.
22
The
Company's products may be expensive to manufacture, and they may not be
profitable if the Company is unable to control the costs to manufacture
them.
The
Company's products may be significantly more expensive to manufacture than
most
other drugs currently on the market today due to a fewer number of potential
manufactures, greater level of needed expertise, and other general market
conditions affecting manufacturers of stem cell based products. The
Company would hope to substantially reduce manufacturing costs through process
improvements, development of new science, increases in manufacturing scale
and
outsourcing to experienced manufacturers. If the Company is not able to make
these, or other improvements, and depending on the pricing of the product,
its
profit margins may be significantly less than that of most drugs on the market
today. In addition, the Company may not be able to charge a high enough price
for any cell therapy product it develops, even if they are safe and effective,
to make a profit. If the Company is unable to realize significant profits from
its potential product candidates, its business would be materially
harmed.
In
order to secure market share and generate revenues, the Company's proposed
products must be accepted by the health care community, which can be very slow
to adopt or unreceptive to new technologies and
products.
The
Company's proposed products and those developed by its collaborative partners,
if approved for marketing, may not achieve market acceptance since hospitals,
physicians, patients or the medical community in general may decide not to
accept and utilize these products. The products that the Company is attempting
to develop represents substantial departures from established treatment methods
and will compete with a number of more conventional drugs and therapies
manufactured and marketed by major pharmaceutical companies. The degree of
market acceptance of any of the Company's developed products will depend on
a
number of factors, including:
·
|
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.
|
If
the
health care community does not accept the Company's products for any of the
foregoing reasons, or for any other reason, the Company's business would be
materially harmed.
We
depend on two key employees for our continued operations and future success.
A
loss of either employee could significantly hinder our ability to move forward
with our business plan.
The
loss
of either of our key executive officers, Richard Garr and Karl Johe, would
be
significantly detrimental to us.
|
·
|
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.
|
In
addition, the Company's anticipated growth and expansion into areas and
activities requiring additional expertise, such as clinical testing, regulatory
compliance, manufacturing and marketing, will require the addition of new
management personnel and the development of additional expertise by existing
management personnel. There is intense competition for qualified personnel
in
the areas of the Company's present and planned activities, and there can be
no
assurance that the Company will be able to continue to attract and retain the
qualified personnel necessary for the development of its business. The failure
to attract and retain such personnel or to develop such expertise would
adversely affect the Company's business.
The
Company has entered into long-term contracts with key personnel and
stockholders, with significant anti-termination provisions, which could make
future changes in management difficult or expensive.
Messrs.
Garr and Johe have entered into employment agreements with the Company which
expire on November 1, 2012 and which include termination provisions stating
that
if either employee is terminated for any reason other than a voluntary
resignation, then all compensation due to such employee under the terms of
the
respective agreement shall become due and payable immediately. These provisions
will make the replacement of either of these employees very costly to the
Company, and could cause difficulty in effecting a change in control of the
Company. Termination prior to full term on the contracts would cost the Company
as much as $1,800,000 per contract, and immediate vesting of all outstanding
options held by Messrs Garr and Johe.
23
The
Company has no product liability insurance, which may leave it vulnerable to
future claims that the Company will be unable to
satisfy.
The
testing, manufacturing, marketing and sale of human therapeutic products entails
an inherent risk of product liability claims, and the Company cannot assure
you
that substantial product liability claims will not be asserted against it.
The
Company has no product liability insurance. In the event the Company is forced
to expend significant funds on defending product liability actions, and in
the
event those funds come from operating capital, the Company will be required
to
reduce its business activities, which could lead to significant
losses.
The
Company cannot assure you that adequate insurance coverage will be available
in
the future on acceptable terms, if at all, or that, if available, the Company
will be able to maintain any such insurance at sufficient levels of coverage
or
that any such insurance will provide adequate protection against potential
liabilities.
The
Company has limited director and officer insurance and commercial insurance
policies. Any significant claim would have a material adverse effect on its
business, financial condition and results of operations. Insurance availability,
coverage terms and pricing continue to vary with market conditions. The Company
endeavors to obtain appropriate insurance coverage for insurable risks that
it
identifies, however, the Company may fail to correctly anticipate or quantify
insurable risks, may not be able to obtain appropriate insurance coverage,
and
insurers may not respond as the Company intends to cover insurable events that
may occur. The Company has observed rapidly changing conditions in the insurance
markets relating to nearly all areas of traditional corporate insurance. Such
conditions may result in higher premium costs, higher policy deductibles, and
lower coverage limits. For some risks, the Company may not have or maintain
insurance coverage because of cost or availability.
Risks
Relating to the Company's Common Stock
Our
common shares are sporadically or “thinly” traded, so you may be unable to sell
at or near ask prices or at all if you need to sell your shares to raise money
or otherwise desire to liquidate your shares
Our
common shares have historically been sporadically or “thinly” traded, meaning
that the number of persons interested in purchasing our common shares at or
near
ask prices at any given time may be relatively small or non-existent. This
situation is attributable to a number of factors, including the fact that we
are
a small company which is relatively unknown to stock analysts, stock brokers,
institutional investors and others in the investment community that generate
or
influence sales volume, and that even if we came to the attention of such
persons, they tend to be risk-averse and would be reluctant to follow an
unproven development stage company such as ours or purchase or recommend the
purchase of our shares until such time as we became more seasoned and viable.
As
a consequence, there may be periods of several days or more when trading
activity in our shares is minimal or non-existent, as compared to a seasoned
issuer which has a large and steady volume of trading activity that will
generally support continuous sales without a material reduction in share price.
We cannot give you any assurance that a broader or more active public trading
market for our common shares will develop or be sustained, or that current
trading levels will be sustained. Due to these conditions, we can give you
no
assurance that you will be able to sell your shares at or near ask prices or
at
all if you need money or otherwise desire to liquidate your shares.
The
market price for our common shares is particularly volatile given our status
as
a relatively unknown company with a small and thinly-traded public float,
limited operating history and lack of revenues or profits to date could lead
to
wide fluctuations in our share price. The price at which you purchase our common
shares may not be indicative of the price that will prevail in the trading
market. You may be unable to sell your common shares at or above your purchase
price, which may result in substantial losses to you. The volatility in our
common share price may subject us to securities
litigation.
The
market for our common shares is characterized by significant price volatility
when compared to seasoned issuers, and we expect that our share price will
continue to be more volatile than a seasoned issuer. The volatility in our
share
price is attributable to a number of factors. First, as noted above, our common
shares are sporadically or thinly traded. As a consequence of this lack of
liquidity, the trading of relatively small quantities of shares by our
shareholders may disproportionately influence the price of those shares in
either direction. The price for our shares could, for example, decline
precipitously in the event that a large number of our common shares are sold
on
the market without commensurate demand, as compared to a seasoned issuer which
could better absorb those sales without a material reduction in share price.
Secondly, we are a speculative or “risky” investment due to our limited
operating history and lack of significant revenues to date, and uncertainty
of
future market acceptance for our products if successfully developed. As a
consequence of this enhanced risk, more risk-adverse investors may, under the
fear of losing all or most of their investment in the event of negative news
or
lack of progress, be more inclined to sell their shares on the market more
quickly and at greater discounts than would be the case with the stock of a
seasoned issuer. Additionally, in the past, plaintiffs have often initiated
securities class action litigation against a company following periods of
volatility in the market price of its securities. We may in the future be the
target of similar litigation. Securities litigation could result in substantial
costs and liabilities and could divert management’s attention and
resources.
24
The
following factors may add to the volatility in the price of our common
shares: actual or anticipated variations in our quarterly or annual
operating results; government regulations, announcements of significant
acquisitions, strategic partnerships or joint ventures; our capital commitments;
and additions or departures of our key personnel. Many of these factors are
beyond our control and may decrease the market price of our common shares,
regardless of our operating performance. We cannot make any predictions or
projections as to what the prevailing market price for our common shares will
be
at any time, including as to whether our common shares will sustain their
current market prices, or as to what effect that the sale o f shares or the
availability of common shares for sale at any time will have on the prevailing
market price.
The
Company faces risks related to compliance with corporate governance laws and
financial reporting standards.
The
Sarbanes-Oxley Act of 2002, as well as related new rules and regulations
implemented by the Securities and Exchange Commission and the Public Company
Accounting Oversight Board, require changes in the corporate governance
practices and financial reporting standards for public companies. These new
laws, rules and regulations, including compliance with Section 404 of the
Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting
(“Section 404”), will materially increase the Company's legal and financial
compliance costs and made some activities more time-consuming and more
burdensome. Starting in 2007, Section 404 of the Sarbanes-Oxley Act of 2002
will
require that the Company's management assess the Company's internal control
over
financial reporting annually and include a report on its assessment in its
filings with the SEC.
The
Company does not intend to pay cash dividends on its common stock in the
foreseeable future.
Any
payment of cash dividends will depend upon the Company's financial condition,
results of operations, capital requirements and other factors and will be at
the
discretion of the Board of Directors. The Company does not anticipate paying
cash dividends on its common stock in the foreseeable future. Furthermore,
the
Company may incur additional indebtedness that may severely restrict or prohibit
the payment of dividends.
Our
issuance of additional common shares or preferred shares, or options or warrants
to purchase those shares, could dilute your proportionate ownership and voting
rights and negatively impact the value of your investment in our common
shares as the result of preferential voting rights or veto powers, dividend
rights, disproportionate rights to appoint directors to our board, conversion
rights, redemption rights and liquidation provisions granted to the preferred
shareholders, including the grant of rights that could discourage or prevent
the
distribution of dividends to you, or prevent the sale of our assets or a
potential takeover of our company.
We
are
entitled under our amended and restated certificate of incorporation to issue
up
to 150,000,000 common and 7,000,000 “blank check” preferred shares.
As
of
June 30, 2008, we have issued and outstanding 32,151,300 common shares,
19,653,749 common shares reserved for issuance upon the exercise of current
outstanding options and warrants, 950,000 common shares reserved for issuances
of additional grants under our 2005 incentive stock plan, and 630,341 shares
reserved for issuance of grants under our 2007 stock plan. Accordingly, we
will
be entitled to issue up to 96,614,610 additional common shares
and 7,000,000 additional preferred shares. Our board may generally issue
those common and preferred shares, or options or warrants to
purchase those shares, without further approval by our shareholders based upon
such factors as our board of directors may deem relevant at that time. Any
preferred shares we may issue shall have such rights, preferences, privileges
and restrictions as may be designated from time-to-time by our board, including
preferential dividend rights, voting rights, conversion rights, redemption
rights and liquidation provisions. It is likely that we will be required to
issue a large amount of additional securities to raise capital to further our
development and marketing plans. It is also likely that we will be required
to
issue a large amount of additional securities to directors, officers, employees
and consultants as compensatory grants in connection with their services, both
in the form of stand-alone grants or under our various stock plans. We cannot
give you any assurance that we will not issue additional common or preferred
shares, or options or warrants to purchase those shares, under circumstances
we
may deem appropriate at the time.
AND
USE OF PROCEEDS
We
incorporate by reference the information pertaining to unregistered sales of
equity securities as disclosed in our annual report file on Form 10-KSB for
the
period ended December 31, 2007.
|
·
|
On
January 21, 2008, we issued the following:
|
Karl
Johe, Chairman and Chief Science Officer –
options to purchase 2.1 million common shares at a price of $3.66 per share.
The
options vest over 3.5 years with the vesting period commencing on January 1,
2008 with 700,000 options vesting on each of February 28, 2009, April 30, 2010,
and June 30, 2011. The options expire on January 1, 2018. Additionally, the
options will become immediately exercisable upon an event which would result
in
an acceleration of Mr. Johe’s stock options granted under his employment
agreement.
Richard
Garr, Chief Executive Officer and General Council –
options to purchase 2.1 million common shares at a price of $3.66 per share.
The
options vest over 3.5 years with the vesting period commencing on January 1,
2008 with 700,000 options vesting on each of February 28, 2009, April 30, 2010,
and June 30, 2011 . The options expire on January 1, 2018. Additionally,
the options will become immediately exercisable upon an event which would result
in an acceleration of Mr. Johe’s stock options granted under his employment
agreement.
25
|
·
|
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.
|
DEFAULT
UPON SENIOR SECURITIES
None
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
We
held
our 2008 Annual Meeting of Stockholders on May 28, 2008. At the meeting,
stockholders present or by proxy voted on the following matters:
1. Election
of 4 directors to the following classes of our Board of Directors:
a. Election
as two Class III Directors to serve until our 2011 annual meeting.
Votes For
|
Votes Abstained
|
||||||
I. Richard
Garr
|
26,244,750
|
52,289
|
|||||
Karl
Johe
|
26,243,777
|
53,262
|
b. Election
of one Class II Director to serve until our 2010 annual meeting.
Votes For
|
Votes Abstained
|
||||||
William Oldaker
|
25,379,508
|
917,531
|
c. Election
of one Class I Director to serve until our 2009 annual meeting
Votes For
|
Votes Abstained
|
||||||
Scott
Ogilvie
|
25,377,635
|
919,404
|
26
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
|
EXHIBITS.
The
following exhibits are hereby filed as part of this Quarterly Report on Form
10-Q or incorporated by reference.
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
|
27
In
accordance with the requirements of the Securities Exchange Act of 1934, the
Registrant has caused this report to be signed by the undersigned hereunto
duly
authorized.
|
NEURALSTEM,
INC.
|
|
|
|
|
Date: August
14, 2008
|
|
/s/ I.
Richard Garr
|
|
Chief
Executive Officer
|
|
|
|
|
|
/s/
John Conron
|
|
|
Chief
Financial Officer
|
|
|
(Principal
Accounting Officer)
|
28