|
UNITED STATES |
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, 2015
Or
¨ |
Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Commission
File Number 000-1357459
NEURALSTEM,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
52-2007292 |
State or other jurisdiction of |
|
(I.R.S. Employer |
incorporation or organization |
|
Identification No.) |
|
|
|
20271 Goldenrod Lane |
|
|
Germantown, Maryland |
|
20876 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code (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. xYes
¨ No
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
xYes ¨ 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 x |
|
|
Non-accelerated filer ¨ (Do not check if a small reporting company) |
Smaller reporting company ¨ |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) ¨
Yes x No
As of July 31, 2015, there were 91,786,290 shares of common stock, $.01 par value, issued and outstanding.
Neuralstem,
Inc.
Table of Contents
PART I
FINANCIAL INFORMATION
| ITEM 1. | UNAUDITED
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
Neuralstem, Inc.
Unaudited Condensed Consolidated
Balance Sheets
| |
June
30,
2015 | | |
December
31, 2014 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
Cash and cash equivalents | |
$ | 8,649,127 | | |
$ | 12,518,980 | |
Short-term investments | |
| 15,032,419 | | |
| 15,007,478 | |
Trade and other receivables | |
| 18,818 | | |
| 225,524 | |
Deferred financing fees, current portion | |
| 121,202 | | |
| 135,694 | |
Prepaid expenses | |
| 904,222 | | |
| 274,106 | |
Total current
assets | |
| 24,725,788 | | |
| 28,161,782 | |
| |
| | | |
| | |
Property and equipment, net | |
| 342,969 | | |
| 301,265 | |
Patents, net | |
| 1,205,456 | | |
| 1,233,172 | |
Deferred financing fees, net of current portion | |
| 40,830 | | |
| 89,143 | |
Other assets | |
| 57,259 | | |
| 58,713 | |
Total assets | |
$ | 26,372,302 | | |
$ | 29,844,075 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 2,099,952 | | |
$ | 2,504,978 | |
Accrued bonuses | |
| 490,749 | | |
| 646,960 | |
Current portion of long-term debt, net of discount | |
| 3,170,469 | | |
| 730,012 | |
Other current liabilities | |
| 148,536 | | |
| 126,745 | |
Total current
liabilities | |
| 5,909,706 | | |
| 4,008,695 | |
| |
| | | |
| | |
Long-term debt, net of discount and current portion | |
| 5,812,322 | | |
| 8,056,470 | |
Other long-term liabilities | |
| 110,848 | | |
| 59,574 | |
Total liabilities | |
| 11,832,876 | | |
| 12,124,739 | |
| |
| | | |
| | |
Commitments and contingencies (Note
6) | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS' EQUITY | |
| | | |
| | |
Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding | |
| - | | |
| - | |
Common stock, $0.01 par value; 300 million shares authorized, 90,359,761 and 87,789,679 shares
outstanding in 2015 and 2014, respectively | |
| 903,598 | | |
| 877,897 | |
Additional paid-in capital | |
| 175,185,796 | | |
| 167,890,220 | |
Accumulated other comprehensive income | |
| 5,995 | | |
| 6,000 | |
Accumulated deficit | |
| (161,555,963 | ) | |
| (151,054,781 | ) |
Total stockholders'
equity | |
| 14,539,426 | | |
| 17,719,336 | |
Total liabilities
and stockholders' equity | |
$ | 26,372,302 | | |
$ | 29,844,075 | |
See accompanying notes to unaudited condensed consolidated
financial statements.
Neuralstem, Inc.
Unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss
| |
Three Months Ended
June 30, | | |
Six Months Ended
June 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | 2,500 | | |
$ | 5,000 | | |
$ | 5,417 | | |
$ | 9,167 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 3,312,841 | | |
| 1,999,921 | | |
| 6,495,664 | | |
| 3,630,286 | |
General and administrative expenses | |
| 1,684,381 | | |
| 1,516,317 | | |
| 3,117,455 | | |
| 5,067,020 | |
Total operating expenses | |
| 4,997,222 | | |
| 3,516,238 | | |
| 9,613,119 | | |
| 8,697,306 | |
Operating loss | |
| (4,994,722 | ) | |
| (3,511,238 | ) | |
| (9,607,702 | ) | |
| (8,688,139 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 16,084 | | |
| 17,422 | | |
| 29,653 | | |
| 42,140 | |
Interest expense | |
| (459,073 | ) | |
| (397,616 | ) | |
| (912,807 | ) | |
| (830,357 | ) |
Warrant modification expense | |
| - | | |
| (3,109,850 | ) | |
| - | | |
| (3,109,850 | ) |
Loss from change in fair value of derivative instruments | |
| - | | |
| - | | |
| - | | |
| (334,133 | ) |
Other income (expense) | |
| (10,326 | ) | |
| 250,000 | | |
| (10,326 | ) | |
| 250,000 | |
Total other income (expense) | |
| (453,315 | ) | |
| (3,240,044 | ) | |
| (893,480 | ) | |
| (3,982,200 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,448,037 | ) | |
$ | (6,751,282 | ) | |
$ | (10,501,182 | ) | |
$ | (12,670,339 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (0.06 | ) | |
$ | (0.08 | ) | |
$ | (0.12 | ) | |
$ | (0.15 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding - basic and diluted | |
| 90,791,285 | | |
| 87,186,586 | | |
| 90,004,597 | | |
| 86,477,797 | |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,448,037 | ) | |
$ | (6,751,282 | ) | |
$ | (10,501,182 | ) | |
$ | (12,670,339 | ) |
Foreign currency translation adjustment | |
| (18 | ) | |
| 130 | | |
| (5 | ) | |
| (1,134 | ) |
Comprehensive loss | |
$ | (5,448,055 | ) | |
$ | (6,751,152 | ) | |
$ | (10,501,187 | ) | |
$ | (12,671,473 | ) |
See accompanying notes to unaudited condensed consolidated
financial statements.
Neuralstem, Inc.
Unaudited Condensed Consolidated
Statements of Cash Flows
| |
Six Months Ended
June 30, | |
| |
2015 | | |
2014 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (10,501,182 | ) | |
$ | (12,670,339 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 167,376 | | |
| 177,220 | |
Share based compensation expense | |
| 1,315,817 | | |
| 2,982,025 | |
Amortization of deferred financing fees and debt discount | |
| 433,596 | | |
| 432,108 | |
Warrant modification expense | |
| - | | |
| 3,109,850 | |
Loss from change in fair value of derivative instruments | |
| - | | |
| 334,133 | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Trade and other receivables | |
| 206,706 | | |
| (14,468 | ) |
Prepaid expenses | |
| (587,344 | ) | |
| 58,444 | |
Other assets | |
| 1,481 | | |
| 5,997 | |
Accounts payable and accrued expenses | |
| (405,093 | ) | |
| 614,534 | |
Accrued bonuses | |
| (156,211 | ) | |
| (148,955 | ) |
Other current liabilities | |
| 138,859 | | |
| 1,256 | |
Other long term liabilities | |
| (138,214 | ) | |
| (6,677 | ) |
Net cash used in operating activities | |
| (9,524,209 | ) | |
| (5,124,872 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of short-term investments | |
| (15,032,419 | ) | |
| (15,000,000 | ) |
Maturity of short-term investments | |
| 15,007,478 | | |
| - | |
Patent costs | |
| (70,240 | ) | |
| (247,602 | ) |
Purchase of property and equipment | |
| (96,019 | ) | |
| (145,091 | ) |
Net cash used in investing activities | |
| (191,200 | ) | |
| (15,392,693 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from issuance of common stock from warrants exercised, net | |
| 3,073,537 | | |
| 1,651,216 | |
Proceeds from issuance of common stock from options exercised | |
| - | | |
| 133,000 | |
Proceeds from sale of common stock and warrants, net of issuance costs | |
| 2,931,924 | | |
| 19,053,534 | |
Payment of fees for future financing | |
| (42,758 | ) | |
| - | |
Payment of taxes on stock option exercise | |
| - | | |
| (426,212 | ) |
Payments of long-term debt | |
| - | | |
| (1,425,123 | ) |
Payments of short-term notes payable | |
| (117,068 | ) | |
| (81,543 | ) |
Net cash provided by financing activities | |
| 5,845,635 | | |
| 18,904,872 | |
Effects of exchange rates on cash | |
| (79 | ) | |
| (903 | ) |
Net decrease in cash and cash equivalents | |
| (3,869,853 | ) | |
| (1,613,596 | ) |
| |
| | | |
| | |
Cash and cash equivalents, beginning of period | |
| 12,518,980 | | |
| 16,846,052 | |
| |
| | | |
| | |
Cash and cash equivalents, end of period | |
$ | 8,649,127 | | |
$ | 15,232,456 | |
| |
| | | |
| | |
Supplemental disclosure of cash flows
information: | |
| | | |
| | |
Cash paid for interest | |
$ | 481,847 | | |
$ | 398,248 | |
| |
| | | |
| | |
Supplemental schedule of non cash investing
and financing activities: | |
| | | |
| | |
Issuance of common stock for cashless exercise of warrants and options | |
$ | 360,120 | | |
$ | 1,204,412 | |
See accompanying notes to unaudited condensed consolidated
financial statements.
NEURALSTEM, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30 2015 AND 2014
Note 1. Basis of Presentation,
Estimates and Recent Accounting Pronouncements
Basis of Presentation
In management’s opinion, the
accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments,
which are necessary to present fairly our financial position, results of operations and cash flows. The condensed consolidated
balance sheet at December 31, 2014, has been derived from our audited financial statements as of that date. The interim results
of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote
disclosure normally included in the financial statements prepared in accordance with generally accepted accounting principles
in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to instructions, rules and regulations prescribed
by the U.S. Securities and Exchange Commission (SEC). We believe that the disclosures provided herein are adequate to make
the information presented not misleading when these condensed consolidated financial statements are read in conjunction with the
Financial Statements and Notes included in our Annual Report on Form 10-K for the year ended December 31, 2014, filed with
the SEC on March 16, 2015, and as may be amended from time to time. Certain prior period amounts have been reclassified to conform
to current year classifications. Specifically, depreciation and amortization expense is no longer shown as a separate line item;
patent amortization is now included in research and development expense and fixed asset depreciation is included in general and
administrative expense. Management feels that this reclassification better represents the expenses in their functional categories.
Neuralstem, Inc. is referred to as
“Neuralstem,” the “Company,” “us,” or “we” throughout this report. Our wholly-owned
and controlled subsidiary located in China is consolidated in our condensed consolidated financial statements and all intercompany
activity has been eliminated.
Use of Estimates
The preparation
of financial statements in accordance with U.S. GAAP 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. The condensed consolidated financial statements
include significant estimates for the expected economic life and value of our owned and licensed technology, our net operating
loss and related valuation allowance for tax purposes and our stock-based compensation related to employees and directors, consultants
and investment banks, among other things. Because of the use of estimates inherent in the financial reporting process, actual
results could differ significantly from those estimates.
Recent Accounting
Pronouncements
In April 2015,
the FASB issued ASU 2015-03 – Interest-Imputation of Interest, Simplifying the Presentation of Debt Issuance Costs.
This guidance requires that deferred debt issuance costs related to a recognized debt liability be presented in the balance sheet
as a deduction of the carrying amount of the debt liability (similar to debt discounts). This guidance is effective for fiscal
years beginning after December 15, 2015 and early adoption is permitted. This guidance is to be applied retrospectively. This
new pronouncement will result in our reclassifying amounts currently reflected as current and long-term assets to a contra-liability,
which will reduce the carrying value of the associated debt instruments.
We have evaluated
all additional Accounting Standards Updates through the date the financial statements were issued and believe the adoption of
any new accounting and disclosure requirements will not have a material impact to our results of operations or financial position.
Note 2. Fair Value Measurements
Fair value is the price that would
be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous
market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level
of observability of inputs used in measuring fair value. These levels are:
| · | Level
1 – inputs are based upon unadjusted quoted prices for identical instruments
traded in active markets. |
| · | Level
2 – inputs are based upon quoted prices for similar instruments in active markets,
quoted prices for identical or similar instruments in markets that are not active, and
model-based valuation techniques (e.g. the Black-Scholes model) for which all significant
inputs are observable in the market or can be corroborated by observable market data
for substantially the full term of the assets or liabilities. Where applicable, these
models project future cash flows and discount the future amounts to a present value using
market-based observable inputs including interest rate curves, foreign exchange rates,
and forward and spot prices for currencies and commodities. |
| · | Level
3 – inputs are generally unobservable and typically reflect management's estimates
of assumptions that market participants would use in pricing the asset or liability.
The fair values are therefore determined using model-based techniques, including option
pricing models and discounted cash flow models. Our Level 3 non-derivative assets primarily
comprise investments in certain corporate bonds and goodwill when it is recorded at fair
value due to an impairment charge. |
Financial Assets and Liabilities
Measured at Fair Value on a Recurring Basis
We have segregated
our financial assets and liabilities that are measured at fair value into the most appropriate level within the fair value hierarchy
based on the inputs used to determine the fair value at the measurement date.
The inputs used
in measuring the fair value of cash and cash equivalents are considered to be Level 1 in accordance with the three-tier fair value
hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority
of our funds.
We had no financial
assets or liabilities measured at fair value using level 3 inputs on a recurring basis at June 30, 2015 or December 31, 2014.
The following table presents the activity
for those items measured at fair value on a recurring basis using Level 3 inputs for the six months ended June 30, 2014:
| |
Derivative Instruments - Stock
Purchase Warrants | |
Balance at December 31, 2013 | |
$ | 1,417,527 | |
Change in fair value | |
| 334,133 | |
Exercise of underlying warrants | |
| (1,751,660 | ) |
Balance at June 30, 2014 | |
$ | - | |
The (gains) losses
resulting from the changes in the fair value of the derivative instruments are classified as the “change in the fair value
of derivative instruments” in the accompanying condensed statements of operations. The fair value of the common stock purchase
warrants is determined based on the Black-Scholes option pricing model for “plain vanilla” stock options and other
option pricing models as appropriate, and includes the use of unobservable inputs such as the expected term, anticipated volatility
and expected dividends. Changes in any of the assumptions related to the unobservable inputs identified above may change the embedded
conversion options’ fair value; increases in expected term, anticipated volatility and expected dividends generally result
in increases in fair value, while decreases in these unobservable inputs generally result in decreases in fair value.
Non-Financial Assets and Liabilities
Measure at Fair Value on a Recurring Basis
We have no non-financial assets or
liabilities that are measured at fair value on a recurring basis.
Non-Financial Assets and Liabilities
Measured at Fair Value on a Nonrecurring Basis
We measure our long-lived assets,
including property and equipment and patent assets, at fair value on a nonrecurring basis. These assets are recognized at fair
value when they are deemed to be other-than-temporarily impaired. No such fair value impairment was recognized in the six months
ended June 30, 2015 or 2014.
Note 3. Debt
In March 2013,
we entered into a loan and security agreement for an initial $8 million term loan with an additional $2 million of borrowing capacity
if certain conditions involving new partnerships were met. The loan is collateralized by substantially all of our assets, including
our intellectual property.
The loan provided
for interest at a variable rate based on prime with a floor of 11% and was due to mature in June 2016. The variable rate was 11%
and did not change during the period through the loan amendment. The loan provided for interest only payments through December
2013 at which time monthly principal and interest payments of approximately $300,000 were due through maturity. The loan resulted
in net proceeds of approximately $7,551,000 after origination and other cash fees and expenses related to the closing of the loan.
In conjunction
with the loan agreement, we issued the lender a five-year common stock purchase warrant to purchase 648,809 shares of common stock
at an exercise price of $1.0789 per share. This warrant contained non-standard anti-dilution protection and, consequently, was
being accounted for as a derivative instrument, recorded at fair market value each period (see Note 2). The allocation of proceeds
to this warrant resulted in a debt discount which was amortized as interest expense over the term of the debt using the effective
interest method. The warrant was exercised in the first quarter of 2014.
In total we incurred
expenses with various third parties in connection with the debt issuance, consisting of approximately $449,000 in cash, 350,650
shares of common stock valued at approximately $396,000, and a five-year common stock purchase warrant to purchase 648,798 shares
at an exercise price of $1.07892 per share. The warrant is classified as equity. Fees related to the debt offering are recorded
as deferred financing fees and are being amortized as interest expense over the term of the debt using the effective interest
method.
The loan agreement
provided for a conversion feature whereby the lender or the Company could each convert up to a maximum of $1 million in principal
payments into common stock of the Company. In 2014, the lender elected to convert the maximum principal payments of $1 million
into 805,972 shares of our common stock in accordance with the terms of the loan and security agreement.
In October 2014,
we entered into an agreement with the existing lender to refinance and amend the terms of our loan and security agreement. The
amended loan provided for refinancing of approximately $5.6 million of outstanding balance of the initial loan along with approximately
$4.4 million of new principal for a total of $10 million in principal. The amended loan provides for a variable interest rate
based on prime with a floor of 10% and matures in April 2017. The loan provides for monthly interest only payments through September
2015; monthly payments of principal and interest of approximately $461,000 from October 2015 through March 2017 and a final balloon
payment of approximately $2.1 million in April 2017. The loan amendment generated approximately $4.3 million in net proceeds after
fees and expenses. The loan amendment is accounted for as a debt extinguishment in accordance with guidance provided for in ASC
470, Debt resulting in a loss on extinguishment of approximately $446,000. In conjunction with the loan amendment we recorded
a debt discount relating to the beneficial conversion feature. Such discount is being amortized as interest expense over the term
of the debt using the effective interest method.
In conjunction
with the loan amendment, we issued the lender a five-year common stock purchase warrant to purchase 75,188 shares of common stock
at an exercise price of $2.66 per share. The warrant contains standard anti-dilution protection but does not contain any anti-dilution
price protection for subsequent offerings. The value of the warrant was accounted for in calculating the loss on extinguishment.
We also incurred
expenses with various third parties in connection with the loan amendment, consisting of approximately $86,000 in cash, 28,119
shares of common stock valued at approximately $80,000, and a three-year common stock purchase warrant to purchase 58,141 shares
at an exercise price of $2.66 per share. The warrant is classified as equity and has terms substantially similar to the lender
warrant. These fees related to the loan amendment are recorded as deferred financing fees and are being amortized as interest
expense over the term of the debt using the effective interest method.
Note 4. Stockholders’
Equity
We have granted
share-based compensation awards to employees, board members and service providers. Awards may consist of common stock, restricted
common stock, restricted common stock units, warrants, or stock options. Our stock options and warrants have lives of up to ten
years from the grant date. The stock options and 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. Restricted stock units grant the holder the right to receive fully paid common shares with various restrictions
on the holder’s ability to transfer the shares. Vesting of the restricted stock units is similar to that of stock options.
As of June 30, 2015, we have approximately 42.6 million shares of common stock reserved for issuance upon the exercise of such
awards.
Share-based compensation
expense included in the statements of operations for the three and six months ended June 30, 2015 and 2014 was as follows:
| |
Three
Months Ended June 30, | |
| |
2015 | | |
2014 | |
| |
| | |
| |
Research and development expenses | |
$ | 294,574 | | |
$ | 244,985 | |
General and administrative expenses | |
| 331,385 | | |
| 296,041 | |
Total | |
$ | 625,959 | | |
$ | 541,026 | |
| |
Six
Months Ended June 30, | |
| |
2015 | | |
2014 | |
| |
| | |
| |
Research and development costs | |
$ | 572,754 | | |
$ | 478,558 | |
General and administrative expenses | |
| 743,063 | | |
| 2,503,467 | |
Total | |
$ | 1,315,817 | | |
$ | 2,982,025 | |
Included in general
and administrative expenses for the six months ended June 30, 2014 is approximately $2.0 million related to the extension of the
term of a common stock purchase warrant based on the holder achieving certain performance based milestones.
No income tax benefit was recognized
in the consolidated statements of operations for stock-based compensation for the years presented due to the Company’s net
loss position.
Stock Options A summary of
stock option activity during the six months ended June 30, 2015 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, 2015 | |
| 18,986,395 | | |
$ | 1.89 | | |
| 5.1 | | |
$ | 20,306,807 | |
Granted | |
| 540,901 | | |
$ | 3.61 | | |
| | | |
| | |
Exercised | |
| (33,053 | ) | |
$ | 1.64 | | |
| | | |
$ | 68,400 | |
Forfeited | |
| (232,611 | ) | |
$ | 2.27 | | |
| | | |
| | |
Outstanding at June 30, 2015 | |
| 19,261,632 | | |
$ | 1.94 | | |
| 4.8 | | |
$ | 11,043,872 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2015 | |
| 15,480,734 | | |
$ | 2.03 | | |
| 4.1 | | |
$ | 8,243,906 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and expected to vest | |
| 19,255,386 | | |
$ | 1.94 | | |
| 4.8 | | |
$ | 11,043,872 | |
Range of Exercise
Prices | |
Number
of Options Outstanding | | |
Weighted-
Average Exercise
Price | | |
Weighted-
Average Remaining
Contractual Life
(in years) | | |
Aggregate
Intrinsic Value | |
$0.50 - $1.00 | |
| 7,000,000 | | |
$ | 0.80 | | |
| 5.1 | | |
$ | 7,980,000 | |
$1.01 - $2.00 | |
| 4,101,336 | | |
$ | 1.19 | | |
| 6.4 | | |
| 3,063,872 | |
$2.01 - $3.00 | |
| 2,122,669 | | |
$ | 2.50 | | |
| 4.3 | | |
| | |
$3.01 - $5.00 | |
| 6,037,627 | | |
$ | 3.57 | | |
| 3.7 | | |
| | |
| |
| 19,261,632 | | |
$ | 1.94 | | |
| 4.8 | | |
$ | 11,043,872 | |
The Company uses the Black-Scholes option pricing model for
“plain vanilla” options and other pricing models as appropriate to calculate the fair value of options. Significant
assumptions used in these models include:
|
|
Six
Months Ended June 30, |
|
|
2015 |
|
2014 |
|
|
|
|
|
Annual dividend |
|
- |
|
- |
Expected life (in years) |
|
5.8 - 6.0 |
|
4.0 - 8.5 |
Risk free interest rate |
|
1.70% - 1.78% |
|
1.12% - 2.50% |
Expected volatility |
|
69.3% - 71.8% |
|
68.8% - 100.0% |
The options granted
in the six months ended June 30, 2015 and 2014 had weighted average grant date fair values of $2.26 and $2.16, respectively.
Unrecognized
compensation cost for unvested stock option awards outstanding at June 30, 2015 was approximately $4,412,000 to be recognized
over approximately 2.2 years.
RSUs We
have granted restricted stock units (RSUs) to certain employees that entitle the holders to receive shares of our common stock
upon vesting and subject to certain restrictions regarding the exercise of the RSUs. The fair value of RSUs granted is based upon
the market price of the underlying common stock as if they were vested and issued on the date of grant.
A summary of
our restricted stock unit activity for the six months ended June 30, 2015 is as follows:
| |
Number of
RSU's | | |
Weighted-
Average Grant Date
Fair Value | |
| |
| | |
| |
Outstanding at January 1, 2015 | |
| 447,275 | | |
$ | 2.18 | |
Granted | |
| - | | |
| | |
Vested and converted to common shares | |
| - | | |
| | |
Forfeited | |
| - | | |
| | |
Outstanding at June 30, 2015 | |
| 447,275 | | |
$ | 2.18 | |
| |
| | | |
| | |
Exercisable at June 30, 2015 | |
| 447,275 | | |
$ | 2.18 | |
Stock Purchase Warrants Warrants
to purchase common stock were issued to certain officers, directors, stockholders and service providers. We have also issued warrants
in conjunction with debt offerings and equity raises and at various times replacement warrants were issued in conjunction with
warrant exercises.
A summary of warrant activity for
the six months ended June 30, 2015 follows:
| |
Number of
Warrants | | |
Weighted-
Average Exercised
Price | | |
Weighted-
Average Remaining
Contractual Life (in years) | | |
Aggregate
Intrinsic Value | |
| |
| | |
| | |
| | |
| |
Outstanding at January 1, 2015 | |
| 21,422,346 | | |
$ | 2.30 | | |
| 3.8 | | |
$ | 15,984,739 | |
Granted | |
| - | | |
| | | |
| | | |
| | |
Exercised | |
| (1,724,606 | ) | |
$ | 1.94 | | |
| | | |
| | |
Forfeited | |
| (24,794 | ) | |
$ | 2.13 | | |
| | | |
| | |
Outstanding at June 30, 2015 | |
| 19,672,946 | | |
$ | 2.34 | | |
| 3.6 | | |
$ | 6,951,728 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2015 | |
| 19,672,946 | | |
$ | 2.34 | | |
| 3.6 | | |
$ | 6,951,728 | |
Common Stock
In January, 2014,
we closed a registered direct offering of 6,872,859 shares of common stock at a price of $2.91 per share. We received aggregate
gross proceeds of $20 million and net proceeds of approximately $18,630,000 from the offering. In connection with the offering,
we also issued 3,436,435 common stock purchase warrants; the warrants have an exercise price of $3.64, a term of five years and
are classified within equity. This offering was made pursuant to our $50 million shelf registration statement declared effective
by the SEC on September 13, 2013 (Registration No. 333-190936). Additionally, as a result of this transaction an advisor to the
Company met certain capital raising milestones and consequently, the term of their common stock purchase warrant was extended
to 5 years.
In 2014, we issued
249,163 shares of common stock as a result of sales under our At the Market Offering Agreement. The shares were sold at an average
price of $3.55 per share and we received approximately $838,000 in net proceeds.
In 2014, we issued
a total of 1,234,428 shares of our common stock upon the exercise of outstanding common stock purchase warrants and stock options.
The warrants and options were exercised at an average exercise price of $1.44. We received approximately $1,714,000 of net proceeds
from the exercises.
In 2014, we issued
a total of 712,539 shares of our common stock upon the cashless and partial-cashless exercise of 1,194,372 outstanding common
stock purchase warrants and stock options. The warrants and options were exercised at an average price of $1.03. We received approximately
$20,000 of net proceeds from the exercises.
In 2014, we issued
568 shares of common stock upon conversion of certain outstanding RSU’s. We received no proceeds from this transaction.
In 2014, we issued
805,972 shares of common stock upon the conversion by the lender of $1 million of principal payments due under our March 2013
long-term debt in accordance with the terms of the loan and security agreement (see Note 3). We received no proceeds from this
conversion.
In October 2014,
we issued 28,119 shares of common stock and common stock purchase warrants to purchase 133,329 to various parties in conjunction
with our loan amendment (see Note 3).
In the six months
ended June 30, 2015, we issued 812,423 shares of common stock as a result of sales under our At the Market Offering Agreement.
The shares were sold at an average price of $3.77 per share and we received approximately $2,932,000 in net proceeds.
In the six months
ended June 30, 2015, we issued 1,705,400 shares of common stock upon the exercise of outstanding common stock purchase warrants.
The warrants were exercised at an average exercise price of $1.94. We received approximately $3,074,000 of net proceeds from the
exercises.
In the six months
ended June 30, 2015, we issued 52,259 shares of our common stock upon the cashless exercise of 209,000 outstanding common stock
purchase warrants and stock options. The warrants and options were exercised at an average price of $1.72. We received no proceeds
from the exercises.
Note 5. Earnings
(Loss) per Share
Basic income (loss) per common share is
computed by dividing total net income (loss) available to common shareholders by the weighted average number of common shares
outstanding during the period.
For periods of
net income when the effects are dilutive, diluted earnings per share is computed by dividing net income available to common shareholders
by the weighted average number of shares outstanding and the dilutive impact of all dilutive potential common shares. Dilutive
potential common shares consist primarily of stock options, restricted stock units and common stock purchase warrants. The dilutive
impact of potential common shares resulting from common stock equivalents is determined by applying the treasury stock method.
Our unvested restricted shares contain non-forfeitable rights to dividends, and therefore are considered to be participating securities;
the calculation of basic and diluted income per share excludes net income attributable to the unvested restricted shares from
the numerator and excludes the impact of the shares from the denominator.
For all periods
of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential
common shares is anti-dilutive due to the net losses; accordingly, diluted loss per share is the same as basic loss per share
for the three-and six-month periods ended June 30, 2015 and 2014. A total of approximately 38.9 million and 39.7 million potential
dilutive shares have been excluded in the calculation of diluted net income per share for the three- and six-month periods ended
June 30, 2015 and 2014, respectively, as their inclusion would be anti-dilutive.
Note 6. Commitments
and Contingencies
We are parties to legal proceedings that
we believe to be ordinary, routine litigation incidental to the business of present or former operations. It is management’s
opinion, based on the advice of counsel, that the ultimate resolution of such litigation will not have a material adverse effect
on our financial condition, results of operations or cash flows.
On July 28, 2006,
StemCells, Inc., filed suit against Neuralstem, Inc. in the U.S. District Court in Maryland, alleging that Neuralstem has been
infringing, contributing to the infringement of, and or inducing the infringement of four patents allegedly owned by or exclusively
licensed to StemCells. See Civil Action No. 06-1877. We answered the Complaint denying infringement, asserting that the patents
are invalid, asserting that we have intervening rights based on amendments made to the patents during reexamination proceedings,
and further asserting that some of the patents are unenforceable due to inequitable conduct. Neuralstem has also asserted counterclaims
that StemCells has engaged in anticompetitive conduct in violation of antitrust laws.
On May 7, 2008,
we filed suit against StemCells, Inc., StemCells California, Inc. (collectively "StemCells") and Neurospheres Holding
Ltd. in U.S. District Court for the District of Maryland, alleging that U.S. Patent No. 7,361,505 (the "'505 patent")
is invalid, not infringed, and unenforceable. See Civil Action No. 08-1173. On May 13, we filed an Amended Complaint seeking declaratory
judgment that U.S. Patent No. 7,155,418 (the "'418 patent") is invalid and not infringed and that certain statements
made by our CEO are not trade libel or do not constitute unfair competition. On September 11, 2008, StemCells filed its answer
asserting counterclaims of infringement for the '505 patent, the '418 patent, and state law claims for trade libel and unfair
competition. This case was consolidated with the 2006 litigation.
On February 28,
2011, Neuralstem filed a Motion to Dismiss for lack of standing and concurrently filed a Motion for Leave to Amend its Answer
and Counterclaim to allege that StemCells is not the exclusive licensee of the patents-in-suit and also that Neuralstem has obtained
a non-exclusive license to the patents-in-suit. In addition, before the Court decided Neuralstem’s Motion to Dismiss for
lack of standing, StemCells filed a motion for summary judgment on the issue standing. Neuralstem responded to that motion and
cross-moved for summary judgment on the issue of standing. The Court further issued its Markman Order on August 12, 2011. On August
26, 2011, StemCells moved for reconsideration of two terms construed in the Markman Order and that motion remains pending. On
April 6, 2012, the Court granted Neuralstem's Motion for Leave to Amend to assert lack of standing and denied Neuralstem's Motion
to Dismiss and Motion for Summary Judgment without prejudice. The Court also denied StemCells' Motion for Summary Judgment with
prejudice. The Court stayed all other matters pending resolution of the question of standing.
On October 3,
2013, the Court ordered the parties to submit a joint status report regarding the status of the standing discovery. Following
the submission the joint status report, the Court set a briefing schedule to resolve the standing issue. Before Neuralstem filed
its opening brief on whether StemCells has standing, the case was reassigned to Judge Roger W. Titus from Judge Alexander Williams
Jr.
Neuralstem filed
its opening brief in support of the standing issue on December 19, 2013. StemCells responded on January 21, 2014. Finally, Neuralstem
filed its reply brief on February 4, 2014. A summary judgment hearing on the issue of standing was held on July 29, 2014, at which
time the Court determined that the issue of standing could not be decided on summary judgment and set the issue for a bench trial
in December of 2014. A bench trial on the issue of standing was held on December 9, 11, and 12, 2014. The parties filed post-trial
briefs on January 16, 2015. On July 22, 2015, the Court issued its ruling on the issue of standing finding that a third-party
who was not named as an inventor was a co-owner and co-inventor of the patents-in-suit. Thus, the Court determined that StemCells
lacked standing to pursue its patent infringement claims against Neuralstem and the case was dismissed with prejudice.
Note 7. Subsequent Events
The Company has performed an evaluation
of subsequent events through the date the accompanying financial statements were issued and did not identify any material subsequent
transactions that require disclosure.
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Statements
in this Quarterly Report that are not strictly historical are forward-looking statements and include statements about products
in development, results and analyses of pre-clinical studies, clinical trials and studies, research and development expenses,
cash expenditures, and alliances and partnerships, among other matters. You can identify these forward-looking statements because
they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events
or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties
that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors.
These factors include, but are not limited to, risks relating to our ability to conduct and obtain successful results from ongoing
clinical trials, commercialize our technology, obtain regulatory approval for our product candidates, contract with third parties
to adequately test and manufacture our proposed therapeutic products, protect our intellectual property rights and obtain additional
financing to continue our development efforts. Some of these factors are more fully discussed, as are other factors, in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2014, filed with the SEC, as well as in the section of this Quarterly
Report entitled “Risk Factors” and elsewhere herein. We do not undertake to update any of these forward-looking statements
or to announce the results of any revisions to these forward-looking statements except as required by law.
We urge you to
read this entire Quarterly Report on Form 10-Q, including the “Risk Factors” section, the financial statements, and
related notes. As used in this Quarterly Report, unless the context otherwise requires, the words “we,” “us,”
“our,” “the Company,” “Neuralstem” and “Registrant” refers to Neuralstem, Inc.
and its subsidiaries. Also, any reference to “common shares,” “common stock,” or “shares”
refers to our $.01 par value common stock. The information contained herein is current as of the date of this Quarterly Report
(June 30, 2015), unless another date is specified. We prepare our interim financial statements in accordance with U.S. GAAP. Our
financials and results of operations for the three- and six-month periods ended June 30, 2015 are not necessarily indicative of
our prospective financial condition and results of operations for the pending full fiscal year ending December 31, 2015. 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 the reports, statements and information filed by us with the
United States Securities and Exchange Commission or SEC.
Our Management’s
Discussion and Analysis of Financial Condition and Results of Operations or MD&A, is provided in addition to the accompanying
financial statements and notes to assist readers in understanding our results of operations, financial condition and cash flows.
Our MD&A is organized as follows:
| · | Executive
Overview — Discussion of our business and overall analysis of financial and
other highlights affecting the Company in order to provide context for the remainder
of MD&A. |
| · | Trends
& Outlook — Discussion of what we view as the overall trends affecting
our business and overall strategy. |
| · | Critical
Accounting Policies— Accounting policies that we believe are important to understanding
the assumptions and judgments incorporated in our reported financial results and forecasts. |
| · | Results
of Operations— Analysis of our financial results comparing the three- and six-month
periods ended June 30, 2015 to the comparable periods of 2014. |
| · | Liquidity
and Capital Resources— An analysis of cash flows and discussion of our financial
condition and future liquidity needs. |
Executive Overview
We are focused on the development and
commercialization of regenerative medicine treatments based on our human neuronal stem cell technology including cell therapy
and traditional small molecule drugs discovered in-house by screening against our cells. We are headquartered in Germantown, Maryland
and have a wholly-owned and consolidated subsidiary in China, Suzhou Neuralstem Biopharmaceutical Co. Ltd., or NeuralStem China.
We have developed and maintain a portfolio
of patents and patent applications that form the proprietary base for our research and development efforts. We own or exclusively
license one hundred seven (107) U.S. and foreign issued patents and fifty-two (52) U.S. and foreign patent applications in the
field of regenerative medicine, related to our stem cell technologies as well as our small molecule compounds. At times we have
licensed the use of our intellectual property to third parties.
We believe our technology, in combination
with our know-how, and collaborative projects with major research institutions, will facilitate the development and commercialization
of products for use in the treatment of a wide array of neurodegenerative conditions and in regenerative repair of acute disease.
Regenerative medicine is still an emerging
field. Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function
lost due to age, disease, damage, or congenital defects. There can be no assurances that we will ultimately produce any 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 products may not be able to successfully compete against them.
All of our research efforts to date are
at the pre-clinical or clinical stage of development. We are focused on leveraging our key assets, including our intellectual
property, our scientific team and our facilities, to advance our technologies. In addition, we are pursuing strategic collaborations
with members of academia and industry.
In July 2015 our stock began trading on
the NASDAQ Capital Market.
Clinical Programs
We have devoted
substantially all our efforts to the development of our stem cell and small molecule compounds and their pre-clinical and clinical
development. Below is a description of our five most advanced clinical programs, their intended indication, current stage of development
and our expected development plans:
Program |
|
Indication |
|
Development Status |
|
Development
Plan |
|
|
|
|
|
|
|
NSI – 189 |
|
Major Depressive Disorder |
|
Phase II preparation underway. |
|
The Phase II trial is expected to commence
in 2015. |
|
|
|
|
|
|
|
NSI-189 |
|
Cognitive Deficit in Schizophrenia |
|
Phase Ib preparation. |
|
The Phase Ib trial is expected to commence
in 2016. |
|
|
|
|
|
|
|
NSI - 566 |
|
Amyotrophic Lateral Sclerosis (ALS) |
|
Completion of Phase II clinical trial
primarily evaluating safety. |
|
Preparation for a controlled Phase
II trial expected to commence in 2015. |
|
|
|
|
|
|
|
NSI – 566 |
|
Chronic Spinal Cord Injury |
|
Ongoing Phase I clinical trials. |
|
The Phase I trial is ongoing. |
|
|
|
|
|
|
|
NSI – 566 |
|
Motor deficits due to ischemic stroke |
|
Completion of Phase I clinical trial
evaluating safety. |
|
The Phase II trial is expected to commence
in 2015. |
NSI
- 189 (Small Molecule Pharmaceutical Compound)
Major
Depressive Disorder (MDD)
Major
depressive disorder, or MDD (also known as recurrent depressive disorder, clinical depression, major depression, unipolar depression,
or unipolar disorder), is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem
and loss of interest or pleasure in normally enjoyable activities. NSI-189 is being developed for the treatment of major depressive
disorder and other psychiatric and/or cognitive impairment indications associated with hippocampal atrophy. NSI-189 is the lead
compound in our neurogenic small molecule drug platform. We believe that NSI-189 may provide an effective treatment for patients
suffering from MDD by structurally rebuilding the hippocampus.
In
February of 2011, we commenced a Phase I clinical trial (Phase Ia portion) of NSI-189, at California Clinical Trials, LLC, in
Glendale, California. The purpose of the Phase Ia portion of the trial was to evaluate the safety of the drug in healthy volunteers.
The Phase Ia portion tested a single oral administration of NSI-189 in 24 healthy volunteers and was completed in October of 2011.
In December of 2011, we received authorization from the FDA to commence the Phase Ib randomized, dose-escalating, placebo controlled
clinical trial for the treatment of MDD. The primary end points of the Phase Ib portion of the clinical trial were to determine
the drug safety and tolerability in three dosages in diagnosed MDD patients. Secondary endpoints included traditional depression
scales tests, cognition testing and testing for both electrophysiological and traditional plasma biomarkers for Depression. The
Phase Ib trial entailed patients with MDD randomized to receive daily doses, of eitherNSI-189 or placebo, for 28 consecutive days
followed by an eight week post dose observation period. The trial was completed and data was presented at two conferences: the
American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Florida and at the International College of Neuropyschopharmacology
Annual Meeting in Vancouver Canada. We are currently preparing regulatory and clinical protocol for a Phase II, multi-site clinical
trial in approximately 200 patients that is expected to commence in 2015.
Cognitive
Deficit in Schizophrenia
We
have expanded the NSI-189 program to include a second indication for the treatment of cognitive deficit in schizophrenia. Cognitive
deficit is a prominent characteristic of schizophrenia that is correlated with the occurrence of hippocampal atrophy in this patient
population. We expect the Phase Ib trial to commence in 2016.
NSI
- 566 (Stem Cells)
Amyotrophic
Lateral Sclerosis (ALS)
Amyotrophic
lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.
Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. ALS is characterized
by stiff muscles, muscle twitching, and gradually worsening weakness due to muscle wasting. This results in difficulty speaking,
swallowing, and eventually breathing. With voluntary muscle action progressively affected, patients in the later stages of the
disease may become totally paralyzed or may die. The average survival from onset to death is three to four years. NSI-566 is under
development as a potential treatment for ALS by providing cells designed to nurture and protect the patients’ remaining
motor neurons; and possibly repair some of the diseased motor neurons which have not yet died. Neuralstem has received orphan
designation by the FDA for NSI-566 in ALS.
In
January 2010, we commenced the Phase I trial of NSI-566 in ALS at Emory University in Atlanta Georgia. The purpose of the Phase
I trial was to evaluate the safety and transplantation technique of our proposed treatment and procedure specifically in the lumbar
region of the spinal cord. The last cohort received both lumbar and cervical injections. The dosing of patients in the Phase I
trial, as designed, was completed in August of 2012. We commenced our Phase II clinical trial for ALS in September of 2013 primarily
evaluating safety of NSI-566 cells and cervical surgeries. The Phase II dose escalation trial enrolled 15 ambulatory patients
in five different dosing cohorts, under an accelerated dosing and treatment schedule for a total of 18 surgeries. Each patient
in the final cohort received transplantation in both the cervical and lumbar areas with 20 injections of 400,000 cells per injection.
The completion of the Phase II observation period of six months after the last surgery concluded in January 2015. In March, the
company announced topline data concluding that the Phase II ALS clinical trial met the primary safety endpoints and established
what we believe to be the maximum safe tolerated dose of 16 million cells delivered in 40 injections. Secondary efficacy endpoints
such as the Amyotrophic Lateral Sclerosis Functional Rating Scale, or ALSFRS, and grip strength were evaluated at nine months
post-surgery to assess the potential therapeutic benefit of disease stabilization. The company plans to proceed to a larger Phase
II controlled study to demonstrate the safety of the cell and the surgical route of administration in a larger population, and
to confirm a meaningful clinical benefit to patients in the first “non open label” trial of our stem cell therapy.
Chronic Spinal
Cord Injury
A
spinal cord injury, or SCI, generally refers to any injury to the spinal cord that is caused by trauma instead of disease although
in some cases, it can be the result of diseases. Chronic spinal cord injury refers to the time after the initial hospitalization.
Spinal cord injuries are most often traumatic, caused by lateral bending, dislocation, rotation, axial loading, and hyperflexion
or hyperextension of the cord or cauda equina. Motor vehicle accidents are the most common cause of SCIs, while other causes include
falls, work-related accidents, sports injuries, and penetrations such as stab or gunshot wounds. In certain instances, SCIs can
also be of a non-traumatic origin, as in the case of cancer, infection, intervertebral disc disease, vertebral injury and spinal
cord vascular disease. We believe that NSI-566 may provide an effective treatment for chronic spinal cord injury by “bridging
the gap” in the spinal cord circuitry created in traumatic spinal cord injury and providing new cells to help transmit the
signal from the brain to points at or below the point of injury.
During
the first quarter of 2013, we received authorization from the United States Food and Drug Administration, or FDA, to commence
a 4 patient Phase I, open-label, single-site, safety study of human spinal cord-derived neural stem cell (HSSC) transplantation
for the treatment of chronic spinal cord injury. The entire trial will take place at The University of California, San Diego.
The trial commenced during the third quarter of 2014 and the last patient was treated in July 2015. Each patient will be evaluated
over a 6 month post-operative observation period.
Motor Deficits
Due to Ischemic Stroke
Ischemic
strokes, the most common type of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain.
Post-stroke motor deficits include paralysis in arms and legs and can be permanent. We believe that NSI-566 may provide an effective
treatment for restoring motor deficits resulting from ischemic stroke by both creating new circuitry in the area of injury and
through repairing and or nurturing diseased cells to improve function in patients.
In
September of 2012, we received authorization to commence a human clinical trial for treatment of motor deficits due to ischemic
stroke. The trial is being conducted by Neuralstem China, at BaYi Brain Hospital in Beijing, China utilizing our spinal cord stem
cells. The trial authorization encompasses a combined phase I/II/III design and will test direct injections of NSI-566 into the
brain, the same cell product used in our recently-completed Phase II ALS trial in the United States. The trial commenced in the
fourth quarter of 2013 and is designed to enroll up to 118 patients. The first phase of the trial is structured to confirm the
maximum safe tolerated dose and has been fully enrolled. We expect to begin the Phase II portion of the trial in 2015.
Acute Spinal Cord Injury
The Company expects Korean FDA approval and commencement of
an acute spinal cord injury trial utilizing NSI-566 in 2015. The trial will take place at a single center in Seoul. If approved
as submitted, this trial will treat complete patients, who are those who have no sensory or motor function below the point of
injury and also progressively incomplete patients, who have varying degrees of each.
Technology
Stem Cells
Our technology
enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain and spinal
cord, thus enabling the generation of physiologically relevant human neurons of all types. We believe that our stem cell technology
may assist the body in producing new cells to replace malfunctioning or dead cells as a way to treat disease and injury. Many
significant and currently untreatable human diseases arise from the loss or malfunction of specific cell types in the body. Our
focus is the development of effective methods to generate replacement cells from neural stem cells. We believe that replacing
damaged, malfunctioning or dead neural cells with fully functional ones may be a useful therapeutic strategy in treating many
diseases and conditions of the central nervous system. We own or exclusively license forty-seven (47) U.S. and foreign issued
patents and thirty-seven (37) U.S. and foreign patent applications related to our stem cell technologies.
Small Molecule
Pharmaceutical Compounds
We have developed and patented a series
of small molecule compounds. We believe these low molecular weight organic compounds can efficiently cross the blood/brain barrier.
In mice, research indicated that the small molecule compounds both stimulate neurogenesis of the hippocampus and increase its
volume. Our collaborators at Massachusetts General Hospital have presented the human data from the MDD trial which showed clinically
meaningful and statistically significant improvement in depressive and cognitive scales. We believe the small molecule compounds
may assist in reversing atrophy in the human hippocampus documented in indications such as MDD and schizophrenia.
Our small molecule compounds are covered
by sixty (60) exclusively owned U.S. and foreign issued patents and fifteen (15) exclusively owned U.S. and foreign patent applications
related to our small molecule compounds.
Research
Substantial resources are devoted to our
research programs in order to isolate and develop a series of neural stem cell banks that we believe may serve as a basis for
our therapeutic product candidates. Our efforts are directed at developing therapies utilizing our stem cells and small molecule
regenerative drug candidates. This research is conducted internally, through the use of third party laboratories and consulting
companies under our direct supervision, and through collaboration with academic institutes.
Operating Strategy
We generally
employ an outsourcing strategy where we outsource our Good Laboratory Practices, or GLP, preclinical development activities and
Good Manufacturing Practices, or GMP, Good Tissue Practices, or GTP, if applicable, and clinical development activities to contract
research organizations or CROs as needed. We have also used contract manufacturing organizations or CMOs as well. Manufacturing
is also outsourced to organizations with approved facilities and manufacturing practices. This outsource model has allowed us
to better manage cash on hand and minimize non-vital expenditures. During 2015, we are beginning the process of bringing the manufacturing
of our clinical grade spinal cord stem cells, in-house to better assure availability of our stem cells as the number of patients
in our trials increase, and to begin to establish the infrastructure for commercial manufacture as discussed below.
Manufacturing
We currently manufacture our cells both in-house and on an
outsourced basis. We outsource the manufacturing of our pharmaceutical compounds to third party manufacturers. We have manufactured,
in-house, cells that are not required to meet stringent FDA requirements for use in human subjects. We use these cells in some
research and collaborative programs. During 2015, we are beginning the process of bringing the manufacturing of our clinical grade
spinal cord stem cells, in-house to better assure availability of our stem cells as the number of patients in our trials increase
and to reduce per patient costs. We have no quantity or volume commitment with either Charles River Laboratories, Inc. or Albany
Molecular Resources, Inc., our primary outsourced manufacturers, and our cells and pharmaceutical compounds are ordered and manufactured
on an as needed basis with both vendors.
Employees
As of June 30, 2015, we had 25 full-time
employees and three (3) full-time independent contractors. Of these full-time employees and contractors, 20 work on research and
development and eight (8) in administration. We also use the services of numerous outside consultants in business and scientific
matters.
Our Corporate Information
We were incorporated in Delaware in 2001.
Our principal executive offices are located at 20271 Goldenrod Lane, Germantown, Maryland 20876, and our telephone number is (301)
366-4841. Our website is located at www.neuralstem.com.
In addition to announcing material financial
information through our investor relations website, press releases, SEC filings and public conference calls and webcasts, we also
intend to use the following social media channels as a means of disclosing information about the company, its services and other
matters and for complying with our disclosure obligations under Regulation FD:
| • | Neuralstem’s
Twitter Account (https://twitter.com/Neuralstem_Inc) |
| • | Neuralstem’s
Facebook Page (https://www.facebook.com/Neuralstem) |
| • | Neuralstem’s
Company Blog (http://neuralstem.com/neuralstem-ceo-blog) |
| • | Neuralstem’s
Google+ Page (https://plus.google.com/u/0/b/104875574397171789280/104875574397171789280/posts) |
| • | Neuralstem’s
LinkedIn Company Page (http://www.linkedin.com/company/neuralstem-inc-) |
The information we post through these
social media channels may be deemed material. Accordingly, investors should monitor these accounts and the blog, in addition to
following the company’s press releases, SEC filings and public conference calls and webcasts. This list may be updated from
time to time.
We have not incorporated by reference
into this report the information in, or that can be accessed through, our website or social media channels, and you should not
consider it to be a part of this report.
Trends &
Outlook
Revenue
We generated
no revenues from the sale of our proposed therapies for any of the periods presented. We are mainly focused on successfully managing
our current clinical trials related to our stem cell technology and small molecule compounds. We are also pursuing pre-clinical
studies on other central nervous system indications in preparation for potential future clinical trials.
In the first
quarter of 2013 and the third quarter of 2012, we licensed the use of certain of our intellectual property to third parties. During
the six months ended June 30, 2015 and 2014, we recognized approximately $5,000 and $9,000 of revenue, respectively, related to
ongoing fees under these licenses.
On a long-term
basis, we anticipate that our revenue will be derived primarily from licensing fees and sales of our cell based therapy and small
molecule compounds. Because we are at such an early stage in the clinical trials process, we are not yet able to accurately predict
when we will have a product ready for commercialization, if ever.
Research and Development Expenses
Our research
and development expenses consist primarily of contractor and personnel expenses associated with clinical trials and regulatory
submissions; costs associated with preclinical activities such as proof of principle for new indications; toxicology studies;
costs associated with cell processing and process development; facilities-related costs and supplies. Clinical trial expenses
include payments to research organizations, contract manufacturers, clinical trial sites, consultants and laboratories for testing
clinical samples.
We focus on the
development of treatment candidates with potential uses in multiple indications, and use employee and infrastructure resources
across several projects. Accordingly, many of our costs are not attributable to a specifically identified product and we do not
account for internal research and development costs on a project-by-project basis.
For a further description of these clinical trials, see the
section of this report entitled “Clinical Programs” contained in Item 2.
We expect that
research and development expenses, which include expenses related to our ongoing clinical trials, will increase in the future,
as funding allows and we proceed into our anticipated Phase II trials. To the extent that it is practical, we will continue to
outsource much of our efforts, including product manufacture, proof of principle and pre-clinical testing, toxicology, tumorigenicity,
dosing rationale, and development of clinical protocol and IND applications. This approach allows us to use the best expertise
available for each task and permits staging new research projects to fit available cash resources.
We have formed a wholly owned subsidiary
in the People’s Republic of China. We anticipate that this subsidiary will primarily: (i) conduct pre-clinical research
with regard to proposed stem cells therapies, and (ii) oversee our approved future clinical trials in China, including the current
trial to treat motor deficits due to ischemic stroke.
General and Administrative Expenses
General and administrative
expenses are primarily comprised of salaries, benefits and other costs associated with our operations including, finance, human
resources, information technology, public relations, legal fees, facilities and other external general and administrative services.
We anticipate
that our general and administrative expenses will increase in the future as our pipeline grows and matures.
Critical Accounting
Policies
Our discussion and analysis of
our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in
accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires
us to make certain estimates and assumptions that may affect the reported amounts of assets and liabilities, the reported
amounts of revenues and expenses during the reported periods and related disclosures. These estimates and assumptions,
including those related to revenue recognition, inventory valuation and related reserves, research and development expenses
and share-based compensation, are monitored and analyzed by us for changes in facts and circumstances, and material changes
in these estimates could occur in the future. We base our estimates on our historical experience, trends in the industry, and
various other factors that are believed to be reasonable under the circumstances. Actual results may differ from our
estimates under different assumptions or conditions. During the three and six months ended June 30, 2015, there were no
material changes to our critical accounting policies as reported in our Annual Report on Form 10-K for the year ended
December 31, 2014, which was filed with the Securities and Exchange Commission, or SEC, on March 16, 2015.
RESULTS OF
OPERATIONS
Comparison of Three Months Ended
June 30, 2015 and 2014
Revenue
We did not generate
any revenues from the sale of our products in any of the periods presented. For the three months ended June 30, 2015 and 2014,
we recognized approximately $3,000 and $5,000, respectively related to the licensing of certain intellectual properties to third
parties.
Operating Expenses
Operating expenses for the three months
ended June 30, 2015 and 2014 were as follows:
| |
Three
Months Ended June 30, | | |
Increase
(Decrease) | |
| |
2015 | | |
2014 | | |
$ | | |
% | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
$ | 3,312,841 | | |
$ | 1,999,921 | | |
$ | 1,312,920 | | |
| 66 | % |
General and administrative expenses | |
| 1,684,381 | | |
| 1,516,317 | | |
| 168,064 | | |
| 11 | % |
Total operating expenses | |
$ | 4,997,222 | | |
$ | 3,516,238 | | |
$ | 1,480,984 | | |
| 42 | % |
Research and Development Expenses
The increase
of approximately $1,313,000 or 66% in research and development expenses was primarily attributable to a $903,000 increase in project
and laboratory expenses, a $281,000 increase in payroll and related expenses due to increased salaries and headcount and a $99,000
increase in consulting expenses. These increased expenses are related to the expansion of our pre-clinical and clinical trial
efforts and are expected to continue into subsequent periods.
General and Administrative Expenses
The increase
of approximately $168,000 or 11% was primarily due to an increase of $189,000 increase in payroll and related expenses and a $35,000
increase in non-cash stock based compensation expense due to increased salaries and headcount partially offset by decreases in
certain consulting and legal expenses.
Other expense
Other expense totaled
approximately $453,000 and $3,240,000 for the three months ended June 30, 2015 and 2014, respectively. Other expense in 2015 primarily
consisted of $459,000 of interest expense principally related to our long-term debt.
Other expense in 2014 consisted primarily
of a charge of $3,110,000 related to our extension of certain common stock purchase warrants and $398,000 of interest expense
principally related to our long-term debt partially offset by $250,000 of income from a legal settlement.
Comparison of Six Months Ended
June 30, 2015 and 2014
Revenue
We did not generate any revenues from
the sale of our products in any of the periods presented. For the six months ended June 30, 2015 and 2014, we recognized approximately
$5,000 and $9,000, respectively related to the licensing of certain intellectual properties to third parties.
Operating Expenses
Operating expenses for the six months
ended June 30, 2015 and 2014 were as follows:
| |
Six
Months Ended June 30, | | |
Increase
(Decrease) | |
| |
2015 | | |
2014 | | |
$ | | |
% | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
$ | 6,495,664 | | |
$ | 3,630,286 | | |
$ | 2,865,378 | | |
| 79 | % |
General and administrative expenses | |
| 3,117,455 | | |
| 5,067,020 | | |
| (1,949,565 | ) | |
| (38 | )% |
Total operating expenses | |
$ | 9,613,119 | | |
$ | 8,697,306 | | |
$ | 915,813 | | |
| 11 | % |
Research and Development Expenses
The increase
of approximately $2,865,000 or 79% in research in development expenses was primarily attributable to a $2,040,000 increase in
project and lab expenses and a $555,000 increase in payroll and related expenses due to increased salaries and headcount. These
increased expenses are related to the expansion of our pre-clinical and clinical trial efforts and are expected to continue into
subsequent periods. Such increase were coupled with a $94,000 increase in non-cash stock based compensation expense.
General and Administrative Expenses
The decrease
of approximately $1,950,000 or 38% was primarily due to a decrease of $1,760,000 in non-cash stock based compensation largely
the result of an expense in the first quarter of 2014 related to a consultant achieving a performance based milestone coupled
with a $505,000 decrease in legal fees primarily resulting from reimbursement of litigation expenses under our Directors and Officers
insurance policies. These decreases are partially offset by a $267,000 increase in payroll and related expenses due to increased
headcount and salaries and a $43,000 increase in consulting expenses.
Other expense
Other expense totaled
approximately $893,000 and $3,982,000 for the six months ended June 30, 2015 and 2014, respectively. Other expense in 2015 consisted
primarily of $913,000 of interest expense principally related to our long-term debt partially offset by interest income.
Other expense
in 2014 consisted primarily of $3,110,000 related to our extension of certain common stock purchase warrants, $830,000 of interest
expense principally related to our long-term debt and $334,000 related to the change in fair value of the Company’s warrant
liabilities partially offset by $250,000 of income from a legal settlement.
Liquidity and
Capital Resources
We have incurred cumulative operating
losses and negative operating cash flow since inception in 1996, and as of June 30, 2015, we had an accumulated deficit of approximately
$161,556,000. We have financed our operations through the sales of our securities, issuance of long term debt, the exercise of
investor warrants, and to a lesser degree from grants and research contracts. In January 2014, we received approximately
$20 million of gross proceeds from the sale or our securities pursuant to a registered direct offering.
| |
Six
Months Ended June 30, | | |
Increase
(Decrease) | |
| |
2015 | | |
2014 | | |
$ | | |
% | |
| |
| | |
| | |
| | |
| |
Net cash used in operating activities | |
$ | (9,524,209 | ) | |
$ | (5,124,872 | ) | |
$ | (4,399,337 | ) | |
| (86) | % |
Net cash used in investing activities | |
$ | (191,200 | ) | |
$ | (15,392,693 | ) | |
$ | 15,201,493 | | |
| 99 | % |
Net cash provided by financing activities | |
$ | 5,845,635 | | |
$ | 18,904,872 | | |
$ | (13,059,237 | ) | |
| (69) | % |
Our cash and short-term investment balances
was approximately $23,682,000 at June 30, 2015 compared to $27,526,000 at December 31, 2014. The decrease of approximately $3,870,000
was primarily due to our cash used in operations partially offset by our raising $6,005,000, net from the issuance of our common
stock from warrant exercises and from the sale of our common stock.
Net Cash Used in Operating Activities
We used approximately
$9,524,000 and $5,125,000 of cash in our operating activities for the six months ended June 30, 2015 and 2014, respectively.
The increase in our use of cash of approximately $4,399,000 was primarily due to an increase in our net loss as adjusted for stock
based compensation coupled with changes in our operating assets and liabilities.
Net Cash Used in Investing Activities
We used approximately
$191,000 and $15,393,000 of cash in connection with investment activities for the six months ended June 30, 2015 and 2014, respectively. The
decrease in our use of cash of approximately $15,201,000 was primarily due to our purchase in 2014 of short- term investments
using the proceeds from our January 2014 registered direct offering.
Net Cash Provided by Financing Activities
Proceeds from financing activities were
approximately $5,846,000 and $18,905,000 in the six months ended June 30, 2015 and 2014, respectively. The decrease of $13,059,000
was primarily the result of raising $2,932,000, net from the sales of our common stock in 2015 compared to raising approximately
$19,101,000, net from our registered direct offering and other sales of common stock and warrants in 2014.o. In addition, we raised
approximately $3,074,000 and $1,391,000 in 2015 and 2014, respectively from the issuance of our common stock from warrant exercises.
In 2014 we also made $1,425,000 of payments on our long term debt compared to no principal payments being due or made to date
in 2015.
Future
Liquidity and Needs
We have incurred
significant operating losses and negative cash flows since inception. We have not achieved profitability and may not be able to
realize sufficient revenue to achieve or sustain profitability in the future. We do not expect to be profitable in the next several
years, but rather expect to incur additional operating losses. We have limited liquidity and capital resources and must obtain
significant additional capital resources in order to sustain our product development efforts, for acquisition of technologies
and intellectual property rights, for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals,
acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, for general and
administrative expenses and other working capital requirements. We rely on cash balances and the proceeds from the offering of
our securities, exercise of outstanding warrants and grants to fund our operations.
We intend to
pursue opportunities to obtain additional financing in the future through the sale of our securities and additional research grants.
We currently have two shelf registration statements that are effective. On June 19, 2014, our shelf registration statement registering
the sale of up to $100 million of our securities was declared effective by the SEC. To date, we have not sold any securities under
this shelf registration statement. On September 13, 2013, our shelf registration statement (Registration No. 333-190936) registering
the sale of up to $50 million of our securities was declared effective by the SEC. To date, through June 30, 2015 we have sold
or reserved for sale upon the exercise of outstanding warrants approximately $48.2 million of securities under this shelf registration
statement. Additionally, securities sold pursuant to our At the Market Offering Agreement (see below) are being sold pursuant
to this registration statement and accordingly, we have reserved the balance of approximately $1.8 million of securities pursuant
thereto. We anticipate conducting financing in the future based on our shelf registration statement when and if financing opportunities
arise.
In October 2013,
we entered into an At the Market Offering Agreement with T.R. Winston & Company as our sales agent pursuant to which we can
sell up to $25 million of our common stock. The At the Market Offering Agreement was entered into pursuant to a takedown from
our shelf registration statement declared effective on September 13, 2013 (Registration No. 333-190936). To date through June
30, 2015 we have sold 2,202,580 shares under such agreement at an average price per share of $3.16 resulting in gross proceeds
of approximately $6,965,000 and net proceeds of approximately $6,666,000. Future sales under our agreement are limited to approximately
$1.8 million which is the amount available under our shelf registration of which the At the Market Offering Agreement is part
of.
The
source, timing and availability of any future financing will depend principally upon market conditions, interest rates and, more
specifically, our progress in our current and future clinical and development programs. Funding may not be available when needed,
at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate
some or all of our research and product development programs, planned clinical trials, and/or our capital expenditures or to license
our potential products or technologies to third parties.
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Financial instruments
that potentially subject us to concentrations of credit risk consist of cash and cash equivalents which are held at highly rated
United States financial institutions and at times maintain the balances of our deposits in excess of federally insured limits.
We invest our cash in instruments with short-term maturities with the objective of preserving capital. Because of the short-term
maturities, we do not believe that a one-half percentage point increase or decrease in interest rates would have had a material
effect on our interest income.
We are subject
to interest rate risk for our long-term debt which contains a floating interest rate based on Wall Street Journal published prime
rate. For the full year ended December 31, 2015 a one percentage point increase in the prime rate would increase our interest expense
by approximately $90,000.
Our foreign operations
in China subject us to changes in foreign exchange rates. Changes in exchange rates for the year ended December 31, 2015 are not
expected to have a material effect as the operations are expected to be limited. Future changes to foreign exchange rates could
have a material effect on us as our clinical trial activity increases.
ITEM 4. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls
and Procedures
We maintain “disclosure controls
and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the
“Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file
or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities
and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure
controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally,
in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the
cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures
also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design
will succeed in achieving its stated goals under all potential future conditions.
With respect to the quarterly period ending
June 30, 2015, under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness
of the design and operations of our disclosure controls and procedures. Based upon this evaluation, our management has concluded
that as a result of inadequate operation of our existing controls, our disclosure controls and procedures were not effective as
of June 30, 2015.
We are committed to improving our financial
organization. As part of this commitment, we have taken the following steps:
| · | We hired a full-time Chief Financial Officer
in May 2015 |
| · | Enhanced our whistleblower protocols |
| · | Implemented enhanced requirements for
documentation supporting expense reimbursements and disbursements |
| · | Implemented enhanced oversight by the
Company’s Audit Committee of expense reimbursements |
Notwithstanding the forgoing, management
does not anticipate that the deficiencies with regard to the operation of the company’s internal controls will result in
a restatement of the company’s prior financial statements. Management is currently reviewing the operation of its controls
with regard to expense reimbursements and disbursement. Additionally, we will continue to monitor and evaluate the effectiveness
of our internal controls and procedures and our internal controls over financial reporting on an ongoing basis and are committed
to taking further action and implementing additional enhancements or improvements, as necessary.
We believe that the foregoing steps will
remediate the weakness identified above, and we will continue to monitor the effectiveness of these steps and make any changes
that our management deems appropriate.
Changes in Internal Controls
Other than the actions we are taking to
correct the weakness as described above, there have been no changes in our internal control over financial reporting during the
three months ended June 30, 2015 that have materially affected, or are reasonably likely to materially affect, our internal controls
over financial reporting.
PART
II
OTHER
INFORMATION
ITEM 1. |
LEGAL PROCEEDINGS |
We are parties to legal proceedings that
we believe to be ordinary, routine litigation incidental to the business of present or former operations. It is management’s
opinion, based on the advice of counsel, that the ultimate resolution of such litigation will not have a material adverse effect
on our financial condition, results of operations or cash flows.
On July 28, 2006,
StemCells, Inc., filed suit against Neuralstem, Inc. in the U.S. District Court in Maryland, alleging that Neuralstem has been
infringing, contributing to the infringement of, and or inducing the infringement of four patents allegedly owned by or exclusively
licensed to StemCells. See Civil Action No. 06-1877. We answered the Complaint denying infringement, asserting that the patents
are invalid, asserting that we have intervening rights based on amendments made to the patents during reexamination proceedings,
and further asserting that some of the patents are unenforceable due to inequitable conduct. Neuralstem has also asserted counterclaims
that StemCells has engaged in anticompetitive conduct in violation of antitrust laws.
On May 7, 2008,
we filed suit against StemCells, Inc., StemCells California, Inc. (collectively "StemCells") and Neurospheres Holding
Ltd. in U.S. District Court for the District of Maryland, alleging that U.S. Patent No. 7,361,505 (the "'505 patent")
is invalid, not infringed, and unenforceable. See Civil Action No. 08-1173. On May 13, we filed an Amended Complaint seeking declaratory
judgment that U.S. Patent No. 7,155,418 (the "'418 patent") is invalid and not infringed and that certain statements
made by our CEO are not trade libel or do not constitute unfair competition. On September 11, 2008, StemCells filed its answer
asserting counterclaims of infringement for the '505 patent, the '418 patent, and state law claims for trade libel and unfair competition.
This case was consolidated with the 2006 litigation.
On February 28,
2011, Neuralstem filed a Motion to Dismiss for lack of standing and concurrently filed a Motion for Leave to Amend its Answer and
Counterclaim to allege that StemCells is not the exclusive licensee of the patents-in-suit and also that Neuralstem has obtained
a non-exclusive license to the patents-in-suit. In addition, before the Court decided Neuralstem’s Motion to Dismiss for
lack of standing, StemCells filed a motion for summary judgment on the issue standing. Neuralstem responded to that motion and
cross-moved for summary judgment on the issue of standing. The Court further issued its Markman Order on August 12, 2011. On August
26, 2011, StemCells moved for reconsideration of two terms construed in the Markman Order and that motion remains pending. On April
6, 2012, the Court granted Neuralstem's Motion for Leave to Amend to assert lack of standing and denied Neuralstem's Motion to
Dismiss and Motion for Summary Judgment without prejudice. The Court also denied StemCells' Motion for Summary Judgment with prejudice.
The Court stayed all other matters pending resolution of the question of standing.
On October 3,
2013, the Court ordered the parties to submit a joint status report regarding the status of the standing discovery. Following the
submission the joint status report, the Court set a briefing schedule to resolve the standing issue. Before Neuralstem filed its
opening brief on whether StemCells has standing, the case was reassigned to Judge Roger W. Titus from Judge Alexander Williams
Jr.
Neuralstem filed
its opening brief in support of the standing issue on December 19, 2013. StemCells responded on January 21, 2014. Finally, Neuralstem
filed its reply brief on February 4, 2014. A summary judgment hearing on the issue of standing was held on July 29, 2014, at which
time the Court determined that the issue of standing could not be decided on summary judgment and set the issue for a bench trial
in December of 2014. A bench trial on the issue of standing was held on December 9, 11, and 12, 2014. The parties filed post-trial
briefs on January 16, 2015. On July 22, 2015, the Court issued its ruling on the issue of standing finding that a third-party who
was not named as an inventor was a co-owner and co-inventor of the patents-in-suit. Thus, the Court determined that StemCells lacked
standing to pursue its patent infringement claims against Neuralstem and the case was dismissed with prejudice.
Investing
in our common stock involves a high degree of risk. 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, and those included in our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the SEC should be
considered carefully in evaluating our company and our business and the value of our securities.
Risks
Relating to Our Stage of Development and Capital Structure
We
have a history of losses.
Since
inception in 1996 and through June 30, 2015, we have accumulated losses totaling approximately $161,556,000. At June 30,
2015, we had a working capital surplus of approximately $18,816,000 and stockholders’ equity of approximately
$14,539,000. Our net losses for the two most recent fiscal years have been approximately $22,629,000 and $19,832,000 for 2014
and 2013, respectively while our loss for the six months ended June 30, 2015 was approximately $10,501,000. We had no revenue
from the sales of our products during the six months ended June 30, 2015 or 2014.
Our
ability to generate revenues and achieve profitability will depend upon our ability to complete the development of our proposed
products, obtain the required regulatory approvals, manufacture and market and ultimately sell our proposed products. To date,
none of our proposed products have been approved for sale and we have not generated any revenue from the commercial sale of our
proposed products. No assurances can be given as to exactly when, if ever, we will be able to fully develop, receive regulatory
approval, commercialize, market, sell and/or derive any, let alone material, revenues from our proposed products.
We
will need to raise additional capital to continue operations.
Since
our inception, we have funded our operations through the sale of our securities, credit facilities, the exercise of options and
warrants, and to a lesser degree, from grants and research contracts and other revenue generating activities such as licensing.
As of June 30, 2015, we had cash, cash equivalents and short-term investments on hand of approximately $23,682,000. We cannot assure
you that we will be able to secure additional capital through financing transactions, including issuance of debt, licensing agreements
or grants. Our inability to license our intellectual property, obtain grants or secure additional financing will materially impact
our ability to fund our current and planned operations.
We
have spent and expect to continue spending substantial cash in the research, development, clinical and pre-clinical testing of
our proposed products with the goal of ultimately obtaining FDA approval to market such products. We will require additional capital
to conduct research and development, establish and conduct clinical and pre-clinical trials, enter into commercial-scale manufacturing
arrangements and to provide for marketing and distribution of our products. We cannot assure you that financing will be available
if needed. If additional financing is not available, we may not be able to fund our operations, develop or enhance our technologies,
take advantage of business opportunities or respond to competitive market pressures. If we exhaust our cash reserves and are unable
to secure adequate additional financing, we may be unable to meet operating obligations which could result in us initiating bankruptcy
proceedings or delaying, or eliminating some or all of our research and product development programs.
We will need to raise additional
capital to pay our secured indebtedness as it comes due.
We
have a substantial level of debt. As of June 30, 2015, we had approximately $9.5 million
in aggregate principal outstanding of long-term secured indebtedness. Under our amended loan and security agreement, we are required
to make monthly interest only payments through September 2015; interest and principal payments of approximately $461,000 per month
from October 2015 through March 2017 and a balloon payment for the remaining principal in April 2017. As security for such indebtedness,
we have pledged substantially all of our assets, including our intellectual property. If we are unable to make the required payments,
or if we fail to comply with the various requirements and covenants of our indebtedness, we will be in default, which would permit
the holders of our indebtedness to accelerate the maturity and require immediate repayment which could lead to the potential foreclosure
on the assets securing the debt. Any default under our indebtedness would have a material adverse effect on our business, operating
results and financial condition. Additionally, our amended loan and security agreement governing our $10 million credit facility
also contains a number of affirmative and restrictive covenants, including reporting requirements and other collateral limitations,
certain limitations on liens and indebtedness, dispositions, mergers and acquisitions, restricted payments and investments, corporate
changes and limitations on waivers and amendments to certain agreements, our organizational documents, and documents relating to
debt that is subordinate to our obligations under the credit facility. Our failure to comply with the covenants in the amended
loan and security agreement could result in an event of default that, if not cured or waived, could result in the acceleration
of all or a substantial portion of our debt and potential foreclosure on the assets securing the debt. If we are unable to refinance
or repay our indebtedness as it becomes due, including upon an event of default, we may become insolvent and be unable to continue
operations.
Risks
Relating to Our Business
Our
business is dependent on the successful development of our product candidates and our ability to raise additional capital.
Our
business is significantly dependent on our product candidates which are currently at different phases of pre-clinical and clinical
development. The process to approve our product candidates is time-consuming, involves substantial expenditures of resources, and
depends upon a number of factors, including the availability of alternative treatments, and the risks and benefits demonstrated
in our clinical trials. Our success will depend on our ability to achieve scientific and technological advances and to translate
such advances into FDA-approvable, commercially competitive products on a timely basis. Failure can occur at any stage of the process.
If we are not successful in developing our product candidates, we will have invested substantial amounts of time and money without
developing revenue-producing products. As we enter a more extensive clinical program for our product candidates, the data generated
in these studies may not be as compelling as the earlier results. This, in turn, could adversely impact our ability to raise additional
capital and pursue our business plan and planned research and development efforts.
Our
proposed products are not likely to be commercially available for at least several years, if at all. Our development schedules
for our proposed products may be affected by a variety of factors, including technological difficulties, clinical trial failures,
regulatory hurdles, competitive products, intellectual property challenges and/or changes in governmental regulation, many of which
will not be within our control. Any delay in the development, introduction or marketing of our product candidates could result
either in such products being marketed at a time when their cost and performance characteristics would not be competitive in the
marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects, the unproven technology
involved and the other factors described elsewhere in this section, there can be no assurance that we will be able to successfully
complete the development or marketing of any of our proposed product candidates.
Our
business relies on technologies that we may not be able to commercially develop and we are unable to predict when or if we will
be able to earn revenues.
We
have allocated the majority of our resources to the development of our stem cell and small molecule technologies. Our ability to
generate revenue and operate profitably will depend on being able to develop these technologies for human applications. These are
emerging technologies that may have limited human application. We cannot guarantee that we will be able to develop our technologies
or that if developed, our technologies will result in commercially viable products or have any commercial utility or value. We
anticipate that the commercial sale of our proposed products and/or royalty/licensing fees related to our technologies, will be
our primary sources of revenue. If we are unable to develop our technologies, we may never realize any significant revenue. Additionally,
given the uncertainty of our technologies, product candidates and the need for government regulatory approval, we cannot predict
when, or if ever, we will be able to realize revenues related to our products. As a result, we will be primarily dependent on our
ability to raise capital through the sale of our securities for the foreseeable future.
Our
product development programs are based on novel technologies in an emerging field and are inherently risky.
We
are subject to the risks inherent in the development of products based on new technologies. The novel nature of therapies in the
field of regenerative medicine creates significant challenges in regard to product development and optimization, manufacturing,
government regulation, third party reimbursement, and market acceptance. For example, the pathway to regulatory approval for cell-based
therapies, including our product candidates, may be more complex and lengthy than the pathway for conventional drugs. These challenges
may prevent us from developing and commercializing products on a timely or profitable basis or at all. Regenerative medicine
is still an emerging field. There can be no assurances that we will ultimately produce any viable commercialized products and processes.
Even if we are able to produce a commercially viable product, there may be strong competitors in this field and our products may
not be able to successfully compete against them.
Our
stem cell therapy programs rely on an experimental surgical device and procedure and highly invasive surgical operations.
We
are subject to the risks inherent in the use and development of experimental surgical devices and procedures. We have limited experience
with medical devices and must rely on outside consultants and manufacturers to develop and seek any required approvals for the
device we use in connection with our stem cell therapy program. Additionally, the surgical procedures required to administer our
stem cell therapy is experimental, highly invasive and is required to be performed by highly experienced neurosurgeons who have
received special training. We cannot guarantee consistent and safe performance of the device or the surgical procedure. A surgery
related adverse event may result in a clinical hold and may have long-term and damaging effects on our ability to complete development
of the stem cell therapy programs, including the completion of any ongoing or planned clinical trials. Even if one or more of our
programs is successful and receives marketing approval from a regulatory authority, due to the specialized nature of the device
and surgical procedure, there may not be sufficient train surgeons to administer our therapy.
We
are unable to predict when or if we will be able to earn revenues.
Given
the uncertainty of our technologies and the need for government regulatory approval, we cannot predict when, or if ever, we will
be able to realize revenues related to our products.
Our
proposed products are not likely to be commercially available for at least several or more years, if ever. Accordingly, we do not
foresee generating any significant revenue during such time. As a result, we will be primarily dependent on our ability to raise
capital through the sale of our securities to fund our operations for the foreseeable future.
Our
inability to manufacture and store our stem cells in-house that are used in our products could adversely impact our business.
We
currently outsource most of the manufacturing of our stem cells and small molecule pharmaceutical compounds to third party contractors
and as such have limited ability to adequately control the manufacturing process and the safe storage thereof. Any manufacturing
or storage irregularity, error, or failure to comply with applicable regulatory procedure would require us to find new third parties
to outsource our manufacturing and storage responsibilities will impacted our business. Additionally, as part of our business plan,
we are developing in-house manufacturing capabilities but there can be no assurance that such capabilities will be successfully
developed or if developed, be sufficient to meet our demands. Any delays in the development of such in-house manufacturing capabilities
could adversely affect our plans.
If
we are unable to complete pre-clinical and clinical testing, trials or if the clinical trials of our product candidates are prolonged,
delayed, suspended or terminated, our business and results of operations could be materially harmed.
We
are currently in clinical trials for NSI-566 and NSI-189, two of our proposed products, with regard to multiple indications. Although
we have commenced a number of trials, the ultimate outcome of the trials is uncertain. If we are unable to satisfactorily complete
such trials, or if such trials yield unsatisfactory results, we may be unable to obtain regulatory approval for and commercialize
our proposed products. No assurances can be given that our clinical trials will be completed or result in successful outcomes.
A number of events, including any of the following, could delay the completion of our planned clinical trials and negatively impact
our ability to obtain regulatory approval for, and to market and sell, a particular product candidate:
| · | conditions imposed
on us by the FDA or any foreign regulatory authority regarding the scope or design of our clinical trials; |
| · | delays in obtaining,
or our inability to obtain, required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical
sites selected for participation in our clinical trials; |
| · | insufficient
supply or deficient quality of our product candidates or other materials necessary to conduct our clinical trials; |
| · | delays in obtaining
regulatory agency agreement for the conduct of our clinical trials; |
| · | lower than anticipated
enrollment and retention rate of subjects in clinical trials; |
| · | serious and unexpected
side effects experienced by patients in our clinical trials which are related to the use of our product candidates; or |
| · | failure of our
third-party contractors to meet their contractual obligations to us in a timely manner. |
Clinical
trials may also be delayed or terminated as a result of ambiguous or negative interim results. In addition, a clinical trial may
be suspended or terminated by us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring
board, or DSMB, overseeing the clinical trial at issue, or other regulatory authorities due to a number of factors. Additionally,
changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes.
Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the cost, timing
or successful completion of a clinical trial. We do not know whether our clinical trials will be conducted as planned, will need
to be restructured or will be completed on schedule, if at all. Delays in our clinical trials will result in increased development
costs for our drug candidates. In addition, if we experience delays in the completion of, or if we terminate, any of our clinical
trials, the commercial prospects for our drug candidates may be harmed and our ability to generate product revenues will be jeopardized.
Furthermore, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also
ultimately lead to the denial of regulatory approval of a drug candidate. If regulatory authorities do not approve our products
or if we fail to maintain regulatory compliance, we would be unable to commercialize our proposed products, and our business and
results of operations could be materially harmed.
The
results of pre-clinical studies and clinical trials may not be predictive of the results of our later-stage clinical trials and
our proposed products may not have favorable results in later-stage clinical trials or receive regulatory approval.
Encouraging
results from our pre-clinical studies or our Phase I and Phase II trials should not be relied upon as evidence that our clinical
trials will succeed. Even if our product candidates achieve positive results in pre-clinical studies or during our Phase I and
Phase II trials, we will be required to demonstrate through further clinical trials that our product candidates are safe and effective
for use in a diverse population before we can seek regulatory approvals for their commercial sale. There is typically an extremely
high rate of attrition from the failure of product candidates as they proceed through clinical trials. If any product candidate
fails to demonstrate sufficient safety and efficacy in any clinical trial, then we may experience potentially significant delays
in, or be required to abandon, development of that product candidate. Additionally, failure to demonstrate safety and efficacy
results acceptable to the FDA in later stage trials could impair our development prospects and even prevent regulatory approval
of our current and future product candidates. Any such delays or abandonment in our development efforts of any of our product candidates
would materially impair our ability to generate revenues.
Our
research and development expenses are subject to uncertainty.
Factors
affecting our research and development expenses include, but are not limited to:
| · | competition from
companies that have substantially greater assets and financial resources than we have; |
| · | need for acceptance
of our proposed products; |
| · | ability to anticipate
and adapt to a competitive market and rapid technological developments; |
| · | amount and timing
of operating costs and capital expenditures relating to outsourcing of manufacturing and management of pre-clinical and clinical
trials; |
| · | need to rely
on multiple levels of outside funding due to the length of drug development cycles and governmental approved protocols associated
with the pharmaceutical industry; and |
| · | dependence upon
key personnel including key independent consultants and advisors. |
There
can be no guarantee that our research and development expenses will be consistent from period to period. We may be required to
accelerate or delay incurring certain expenses depending on the results of our studies and the availability of adequate funding.
We
are subject to numerous risks inherent in conducting clinical trials using third parties.
We
outsource the management of our clinical trials to third parties. Agreements with clinical investigators and medical institutions
for clinical testing and with other third parties for data management services, place substantial responsibilities on these parties
that, if unmet, could result in delays in, or termination of, our clinical trials. For example, if any of our clinical trial sites
fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. If these clinical
investigators, medical institutions or other third parties do not carry out their contractual duties or obligations or fail to
meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to
adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be
unable to obtain regulatory approval for, or successfully commercialize, our proposed products. Delays in recruitment, lack of
clinical benefit or unacceptable side effects would delay or prevent the completion of our clinical trials.
We
or our regulators may suspend or terminate our clinical trials for a number of reasons. We may voluntarily suspend or terminate
our clinical trials if at any time we believe they present an unacceptable risk to the patients enrolled in our clinical trials
or do not demonstrate clinical benefit. In addition, regulatory agencies may order the temporary or permanent discontinuation of
our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable
regulatory requirements or that they present an unacceptable safety risk to the patients enrolled in our clinical trials.
Our
clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical
trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, we may receive reports
of observations or warning letters detailing deficiencies, and we will be required to implement corrective actions. If regulatory
agencies deem our responses to be inadequate, or are dissatisfied with the corrective actions we or our clinical trial sites have
implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we or our investigators may be
precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve our marketing applications
or allow us to manufacture or market our products, and we may be criminally prosecuted.
The
lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory
approval for our proposed products, which would materially harm our business, results of operations and prospects.
There
are no assurances that we will be able to submit a pre-market application or obtain FDA approval in order to market and sell our
products.
There
can be no assurance that even if the clinical trial of any potential product candidate is successfully initiated and completed,
that we will be able to submit a Biologics License Application (“BLA”) or New Drug Application (“NDA”)
to the FDA, or that any BLA or NDA that we submit will be approved in a timely manner, if at all. If we are unable to submit a
BLA or NDA with respect to any future product, or if such application is not approved by the FDA, we will be unable to commercialize
that product. The FDA can and does reject BLAs and NDAs and may require additional clinical trials, either before approval or as
a condition of approval (known as post-approval commitments), even when product candidates performed well or achieved favorable
results during initial clinical trials. If we fail to commercialize our product candidates and are unable to generate sufficient
revenues to attain profitability our business will be adversely effected.
The
manufacturing of stem cell-based therapeutic products is novel and dependent upon specialized key materials.
The
manufacturing of stem cell-based therapeutic products is a complicated and difficult process, dependent upon substantial know-how
and subject to the need for continual process improvements. We depend almost exclusively on third party manufacturers to supply
our cells. In addition, our suppliers’ ability to scale-up manufacturing to satisfy the various requirements of our planned
clinical trials is uncertain. Manufacturing irregularities or lapses in quality control could have a material adverse effect on
our business. Additionally, many of the materials that we use to prepare our cell-based products are highly specialized, complex
and available from only a limited number of suppliers. The loss of one or more of these sources would likely delay our ability
to conduct planned clinical trials and otherwise adversely affect our business.
We
may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
Our
business may bring us into conflict with licensees, licensors, or others with whom we have contractual or other business relationships
or with our competitors or others whose interests differs from ours. If we are unable to resolve these conflicts on terms that
are satisfactory to all parties, we may become involved in litigation brought by or against such parties. Any 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 our
business. The outcome of litigation is always uncertain, and in some cases could include judgments against us which could have
a materially adverse effect on our business.
We
may not be able to obtain necessary licenses to third-party patents and other rights.
A
number of companies, universities and research institutions have filed patent applications or have received patents relating to
technologies in our field. We cannot predict which, if any, of these applications will issue as patents or how many of these issued
patents will be found valid and enforceable. There may also be existing issued patents on which we would infringe by the commercialization
of our product candidates. If so, we may be prevented from commercializing these products unless the third party is willing to
grant a license to us. We may be unable to obtain licenses to the relevant patents at a reasonable cost, if at all, and may also
be unable to develop or obtain alternative non-infringing technology. If we are unable to obtain such licenses or develop non-infringing
technology at a reasonable cost, our business could be significantly harmed. Also, any infringement lawsuits commenced against
us may result in significant costs, divert our management’s attention and result in an award against us for substantial damages,
or potentially prevent us from continuing certain operations.
We
may not be able to obtain government or third-party payor coverage and reimbursement.
Our
ability to successfully commercialize our product candidates, if approved, depends to a significant degree on the ability of patients
to be reimbursed for the costs of such products and related treatments. We cannot assure you that reimbursement in the U.S. or
in foreign countries will be available for any products developed, or, if available, will not decrease in the future, or that reimbursement
amounts will not reduce the demand for, or the price of, our products. There is considerable pressure to reduce the cost of therapeutic
products. Government and other third party payors are increasingly attempting to contain health care costs by limiting both coverage
and the level of reimbursement for new therapeutic products and by refusing, in some cases, to provide any coverage for uses of
approved products for disease indications for which the FDA or other relevant authority has not granted marketing approval. Moreover,
in some cases, government and other third party payors have refused to provide reimbursement for uses of approved products for
disease indications for which the FDA or other relevant authority has granted marketing approval. Significant uncertainty exists
as to the reimbursement status of newly approved health-care products or novel therapies such as ours. We 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 our business. If additional regulations are overly onerous or
expensive or if healthcare related legislation makes our business more expensive or burdensome than originally anticipated, we
may be forced to significantly downsize our business plans or completely abandon the current business model.
Our
products may not be profitable due to manufacturing costs and our inability to receive favorable pricing.
Our
products may be significantly more expensive to manufacture than other drugs or therapies currently on the market today due to
a fewer number of potential manufacturers, greater level of needed expertise and other general market conditions affecting manufacturers
of our proposed products. Even if we are able to receive approval for the reimbursement of our proposed products the amount of
reimbursement may be significantly less than the manufacturing costs of our products. Additionally, other market factors may limit
the price which we can charge for our proposed products while still being competitive. Accordingly, even if we are successful in
developing our proposed products, we may not be able to charge a high enough price for us to earn a profit.
We
are dependent on the acceptance of our products by the healthcare community.
Our
product candidates, 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 we are attempting to develop represent
substantial departures from established treatment methods and will compete with a number of more conventional therapies marketed
by major pharmaceutical companies. If the healthcare community does not accept our products for any reason, our business will be
materially harmed.
We
depend on key employees and consultants for our continued operations and future success.
We
are highly dependent on our chief executive officer, chief scientific officer and outside consultants. Although we have
entered into employment and consulting agreements with these parties, these agreements can be terminated at any time. The
loss of any of these key employees or consultants could adversely affect our opportunities and materially harm our future prospects. In
addition, we anticipate growth and expansion into areas and activities requiring additional expertise, such as clinical testing,
regulatory compliance, manufacturing and marketing. We anticipate the need for additional management personnel as well
as the development of additional expertise by existing management personnel. There is intense competition for qualified personnel
in the areas of our present and planned activities, and there can be no assurance that we will be able to attract and retain the
qualified personnel necessary for the development our business.
The
employment contracts of certain key employees contain significant anti-termination provisions which could make changes in management
difficult or expensive.
We
have entered into employment agreements with Mr. Garr and Dr. Johe which expire on October 31, 2017. In the event either individual
is terminated prior to the full term of their respective contracts, for any reason other than a voluntary resignation, 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 and could cause difficulty in effecting a change in control. Termination
prior to the full term of these contracts would cost us as much as $1.1 million for Mr. Garr and $1.8 million for Dr. Johe and
result in the immediate vesting of all outstanding options and/or warrants held by Mr. Garr and Dr. Johe.
Our
competition has significantly greater experience and financial resources.
The
biotechnology industry is characterized by rapid technological developments and a high degree of competition. We compete against
numerous companies, many of which have substantially greater resources. Several such enterprises have initiated cell therapy research
programs and/or efforts to treat the same diseases which we target. Given our current stage of development and resources, it may
be extremely difficult for us to compete against more developed companies.
As
a result, our proposed products could become obsolete before we recoup any portion of our related research and development and
commercialization expenses. Competition in the biopharmaceutical industry is based significantly on scientific and technological
factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize
technological developments and the ability to obtain governmental approval for testing, manufacturing and marketing. We compete
with specialized biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical
companies that are applying biotechnology to their operations. Many major pharmaceutical companies have developed or acquired internal
biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as
academic institutions and governmental agencies and private research organizations, also compete with us in recruiting and retaining
highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical
field will also depend to a considerable degree on the continuing availability of capital to us.
We
believe that our proposed products under development and in pre-clinical testing and clinical trials will address unmet medical
needs for those indications for which we are focusing our development efforts. Our competition will be determined in part by the
potential indications for which our proposed products are developed and ultimately approved by regulatory authorities. Additionally,
the timing of market introduction of some of our proposed products or of competitors’ products may be an important competitive
factor. Accordingly, the relative speed with which we can develop our proposed products, complete preclinical testing, clinical
trials and approval processes and supply commercial quantities to market is expected to be important competitive factors. We expect
that competition among products approved for sale will be based on various factors, including product efficacy, safety, reliability,
availability, price and patent position.
Our
outsource model is highly dependent on the use of third parties to assist in the development and testing of our proposed products.
Our
strategy for the development, clinical and pre-clinical testing and commercialization of our proposed products is based in large
part on an outsource model. This model requires us to engage third parties in order to further develop our technology and products
as well as for the day to day operations of our business. In the event we are not able to enter into such relationships in the
future, our ability to operate and develop products may be seriously hindered or we may be required to spend considerable time
and resources to bring such 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.
The
commercialization of therapeutic products exposes us to product liability claims.
Product
liability claims could result in substantial litigation costs and damage awards against us. We attempt to mitigate this risk by
obtaining and maintaining appropriate insurance coverage. Historically, we have obtained liability insurance that covers our clinical
trials. If we begin commercializing products, we will need to increase our insurance coverage. We may not be able to obtain insurance
on acceptable terms, if at all, and the policy limits on our insurance policies may be insufficient to cover our liability.
We
rely heavily upon third party FDA-regulated manufacturers and suppliers for our products
We
currently manufacture our cells both in-house and on an outsource basis and outsource the manufacturing of our pharmaceutical compound
to third party manufacturers. We manufacture cells in-house which are not required to meet stringent FDA requirements. We use these
cells in our research and collaborative programs. At present, we outsource all the manufacturing and storage of our stem cells
and pharmaceuticals compound to be used in pre-clinical and clinical works, and which are subject to higher FDA requirements, to
Charles River Laboratories, Inc., of Wilmington, Massachusetts (stem cells) and Albany Molecular Resources, Inc. (small molecule).
Failure by our contract manufacturer to achieve and maintain high manufacturing standards could result in patient injury or death,
product recalls or withdrawals, delays or failures in testing or delivery, cost overruns, or other problems that could seriously
hurt our business. Contract manufacturers may encounter difficulties involving production yields, quality control, and quality
assurance. These manufacturers are subject to ongoing periodic and unannounced inspections by the FDA and corresponding state and
foreign agencies to ensure strict compliance with cGMPs, GTPs and other applicable government regulations and corresponding foreign
standards; however, we do not have control over third-party manufacturers’ compliance with these regulations and standards.
Because
manufacturing facilities are subject to regulatory oversight and inspection, failure to comply with regulatory requirements could
result in material manufacturing delays and product shortages, which could delay or otherwise negatively impact our clinical trials
and product development. Moreover, we do not have quantity or volume commitment orders from these manufacturers and we cannot assure
you that the manufacturers will be able to manufacture in the quantity we require on a timely basis or at all. In the event we
are required to seek alternative third party suppliers or manufacturers, they may require us to purchase a minimum amount of materials
or could require other unfavorable terms. Any such event would materially impact our business prospects and could delay the development
of our products. Moreover, there can be no assurance that any manufacturer or supplier that we select will be able to supply our
products in a timely or cost effective manner or in accordance with applicable regulatory requirements or our specifications. In
addition, due to the novelty of our products and product development, there can be no assurances that we would be able to find
other suitable third party FDA-regulated manufacturers on a timely basis and at terms reasonable to us. Even if we were to locate
alternative manufacturers there may be delays before they are able to begin manufacturing. Failure to secure such third party manufacturers
or suppliers would materially impact our business.
We
rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays
that prevent us from successfully commercializing our product candidates.
We
do not have the in-house capability to conduct clinical trials for our product candidates. We rely, and will rely in the future,
on medical institutions, clinical investigators, contract research organizations, contract laboratories, and collaborators to perform
data collection and analysis and other aspects of our clinical trials. Our reliance on these third parties for clinical development
activities results in reduced control over these activities. Furthermore, these third parties may also have relationships with
other entities, some of which may be our competitors. Our preclinical activities or clinical trials conducted in reliance on third
parties may be delayed, suspended, or terminated if:
| · | the third parties
do not successfully carry out their contractual duties; |
| · | the third parties
fail to meet FDA and other regulatory obligations or expected deadlines; |
| · | we replace a
third party for any reason; or |
| · | the quality or
accuracy of the data obtained by third parties is compromised due to their failure to adhere to clinical protocols, regulatory
requirements, or for other reasons. |
Third
party performance failures may increase our development costs, delay our ability to obtain regulatory approval, and delay or prevent
the commercialization of our product candidates. While we believe that there are numerous alternative sources to provide these
services, in the event that we seek such alternative sources, we may not be able to enter into replacement arrangements without
incurring delays or additional costs.
Risks
Relating to Intellectual Property
We
may not be able to withstand challenges to our intellectual property rights.
We
rely on our intellectual property, including issued and applied-for patents, as the foundation of our business. Our intellectual
property rights may come under challenge. No assurances can be given that our current and potential future patents will survive
such challenges. For example, in 2005 one of our patents was challenged in the USPTO. Although we prevailed in this particular
matter, these cases are complex, lengthy, expensive, and could potentially be adjudicated adversely to our interests, removing
the protection afforded by an issued patent. The viability of our 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 our business and future prospects. At present, there is litigation with StemCells, Inc., which is further described
in this Quarterly Report in the section entitled “Legal Proceedings.”
We
may not be able to adequately protect against the piracy of the intellectual property in foreign jurisdictions.
We
conduct research in countries outside of the U.S., including through our subsidiary in the People’s Republic of China. A
number of our competitors are located in these countries and may be able to access our technology or test results. The laws protecting
intellectual property in some of these countries may not adequately protect our trade secrets and intellectual property. The misappropriation
of our intellectual property may materially impact our position in the market and any competitive advantages, if any, that we may
have.
Risks
Relating to Our Common Stock
The
market price for our common shares is particularly volatile.
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 those of a seasoned issuer. The volatility in our share price is attributable
to a number of factors. Mainly however, we are a speculative or “risky” investment due to our limited operating history,
lack of significant revenues to date and the uncertainty of FDA approval. 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.
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; offerings of our securities 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 the sale of shares or
the availability of common shares for sale at any time will have on the prevailing market price.
The
requirements of being a public company may strain our resources, divert management’s attention and affect our ability to
attract and retain qualified board members.
As
a public company, we incur significant legal, accounting and other expenses that we would not incur as a private company, including
costs associated with public company reporting requirements. We also incur costs associated with the Sarbanes-Oxley Act of 2002,
as amended, the Dodd-Frank Wall Street Reform and Consumer Protection Act and related rules implemented or to be implemented by
the SEC and the NASDAQ Stock Market. The expenses incurred by public companies generally for reporting, insurance and corporate
governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance
costs and to make some activities more time-consuming and costly. These laws and regulations could also make it more difficult
or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced
to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These
laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of
directors, our board committees or as our executive officers and may divert management’s attention. Furthermore, if we are
unable to satisfy our obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions and
other regulatory action and potentially civil litigation.
Management
has concluded that as of June 30, 2015, our disclosure controls and procedures were not effective.
Disclosures controls and procedures ensure
that information required to be disclosed by us in reports that we file or submit under the Exchange Act are recorded, processed,
summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such
information is accumulated and communicated to our management to allow timely decisions regarding required disclosure. With respect
to the quarterly period ending June 30, 2015, management concluded that as a result of inadequate operation of our existing
controls, our disclosure controls and procedures were not effective as of June 30, 2015.
We
have never paid a cash dividend and do not intend to pay cash dividends on our common stock in the foreseeable future.
We
have never paid cash dividends nor do we anticipate paying cash dividends in the foreseeable future. Accordingly, any return on
your investment will be as a result of stock appreciation if any. Additionally, we are prohibited from paying any cash dividends
under the terms of our loan and security agreement.
Our
anti-takeover provisions may delay or prevent a change of control, which could adversely affect the price of our common stock.
Our
amended and restated certificate of incorporation and amended and restated bylaws contain provisions that may make it difficult
to remove our board of directors and management and may discourage or delay “change of control” transactions, which
could adversely affect the price of our common stock. These provisions include, among others:
| · | our board of
directors is divided into three classes, with each class serving for a staggered three-year term, which prevents stockholders from
electing an entirely new board of directors at an annual meeting; |
| · | advance notice
procedures that stockholders must comply with in order to nominate candidates to our board of directors and propose matters to
be brought before an annual meeting of our stockholders may discourage or deter a potential acquirer from conducting a solicitation
of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and |
| · | our board of
directors may, without stockholder approval, issue series of preferred stock, or rights to acquire preferred stock, that could
dilute the interest of, or impair the voting power of, holders of our common stock or could also be used as a method of discouraging,
delaying or preventing a change of control. |
If
securities or industry analysts do not publish research reports, or publish unfavorable research about our business, the price
and trading volume of our common stock could decline.
The
trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish
about us and our business. We currently have limited research coverage by securities and industry analysts. In the event an analyst
downgrades our securities, the price of our securities would likely decline. If analysts cease to cover us or fails to publish
regular reports on us, interest in our securities could decrease, which could cause the price of our common stock and other securities
and their trading volume to decline.
Our
charter documents and Delaware law contain provisions that could make it difficult for us to be acquired in a transaction that
might be beneficial to our stockholders.
Our
board of directors has the authority to issue shares of preferred stock and to fix the rights, preferences, privileges, and restrictions
of these shares without stockholder approval. Additionally, our Bylaws provide for a staggered board. These
provisions in our charter documents, along with certain provisions under Delaware law, may make it more difficult for a third party
to acquire us or discourage a third party from attempting to acquire us, even if the acquisition might be beneficial to our stockholders.
Our
board of directors has broad discretion to issue additional securities which might dilute the net tangible book value per share
of our common stock for existing stockholders.
We
are entitled under our certificate of incorporation to issue up to 300,000,000 shares of common stock and 7,000,000 “blank
check” shares of preferred stock. Shares of our blank check preferred stock provide our board of directors with broad authority
to determine voting, dividend, conversion, and other rights. As of June 30, 2015 we have issued and outstanding 90,359,761 shares
of common stock and we have 42,589,147 shares of common stock reserved for future grants under our equity compensation plans and
for issuances upon the exercise or conversion of currently outstanding options, warrants and convertible securities. As of June
30, 2015, we had no shares of preferred stock issued and outstanding. Accordingly, we are entitled to issue up to 167,051,092 additional
shares of common stock and 7,000,000 additional shares of “blank check” preferred stock. Our board may generally issue
those common and preferred shares, or convertible securities to purchase those shares, without further approval by our shareholders.
Any preferred shares we may issue will 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 in order 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. The issuance of additional securities may cause substantial dilution to our shareholders.
Risks
Related to Government Regulation and Approval of our Product Candidates.
The
regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable,
and our products may not receive regulatory approval.
The
time required to obtain approval by the FDA and comparable foreign authorities is inherently unpredictable but typically takes
many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion
of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to
gain approval may change during the course of a drug candidate’s clinical development and may vary among jurisdictions. We
have not obtained regulatory approval for any product candidate and it is possible that none of our existing product candidates
or any product candidates we may seek to develop in the future will ever obtain regulatory approval.
Our
drug candidates could fail to receive regulatory approval for many reasons, including the following:
| · | the FDA or comparable foreign regulatory
authorities may disagree with the design or implementation of our clinical trials; |
| · | we may be unable to demonstrate to the
satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed
indication; |
| · | the results of clinical trials may not
meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; |
| · | we may be unable to demonstrate that a
product candidate’s clinical and other benefits outweigh its safety risks; |
| · | the FDA or comparable foreign regulatory
authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
| · | the data collected from clinical trials
of our product candidates may not be sufficient to support the submission of a BLA, NDA or other submission or to obtain regulatory
approval in the United States or elsewhere; |
| · | the FDA or comparable foreign regulatory
authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for
clinical and commercial supplies; or |
| · | the approval policies or regulations of
the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient
for approval. |
We
are currently undertaking clinical trials for our lead products candidates NSI-566 and NSI-189. We cannot assure you
that we will successfully complete any clinical trials in connection with such INDs. Further, we cannot predict when
we might first submit any product license application (BLA or NDA) for FDA approval or whether any such product license application
will be granted on a timely basis, if at all. Moreover, we cannot assure you that FDA approvals for any products developed
by us will be granted on a timely basis, if at all. Any delay in obtaining, or failure to obtain, such approvals could have a material
adverse effect on the marketing of our products and our ability to generate product revenue.
In
addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more
limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent
on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include
the labeling claims necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing scenarios
could materially harm the commercial prospects for our drug candidates.
Development
of our product candidates is subject to extensive government regulation.
Our
research and development efforts, as well as any future clinical trials, and the manufacturing and marketing of any products we
may develop, will be subject to, and restricted by, extensive regulation by governmental authorities in the U.S. and other countries.
The process of obtaining FDA and other necessary regulatory approvals is lengthy, expensive and uncertain. FDA and other legal
and regulatory requirements applicable to our proposed products could substantially delay or prevent us from initiating additional
clinical trials. We may fail to obtain the necessary approvals to commence clinical testing or to manufacture or market our potential
products in reasonable time frames, if at all. In addition, the U.S. Congress and other legislative bodies may enact regulatory
reforms or restrictions on the development of new therapies that could adversely affect the regulatory environment in which we
operate or the development of any products we may develop.
A
substantial portion of our research and development entails the use of stem cells obtained from human tissue. The U.S. federal
and state governments and other jurisdictions impose restrictions on the acquisition and use of human tissue, including those incorporated
in federal Good Tissue Practice, or “GTP,” regulations. These regulatory and other constraints could prevent us from
obtaining cells and other components of our products in the quantity or of the quality needed for their development or commercialization.
These restrictions change from time to time and may become more onerous. Additionally, we may not be able to identify or develop
reliable sources for the cells necessary for our potential products — that is, sources that follow all state and federal
laws and guidelines for cell procurement. Certain components used to manufacture our stem and progenitor cell product candidates
will need to be manufactured in compliance with the FDA’s GMP. Accordingly, we will need to enter into supply agreements
with companies that manufacture these components to GMP standards. There is no assurance that we will be able to enter into any
such agreements.
Noncompliance
with applicable regulatory requirements can subject us, our third party suppliers and manufacturers and our other collaborators
to administrative and judicial sanctions, such as, among other things, warning letters, fines and other monetary payments, recall
or seizure of products, criminal proceedings, suspension or withdrawal of regulatory approvals, interruption or cessation of clinical
trials, total or partial suspension of production or distribution, injunctions, limitations on or the elimination of claims we
can make for our products, refusal of the government to enter into supply contracts or fund research, or government delay in approving
or refusal to approve new drug applications.
We
cannot predict if or when we will be able to commercialize our products due to regulatory constraints.
Federal,
state and local governments and agencies in the U.S. (including the FDA) and governments in other countries have significant regulations
in place that govern many of our activities. We are, 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 our proposed products are subject to extensive government regulation that
may prevent us from creating commercially viable products. In addition, our sale of any commercially viable product will be subject
to government regulation from several standpoints, including manufacturing, advertising, marketing, promoting, selling, labeling
and distributing. If, and to the extent that, we are unable to comply with these regulations, our ability to earn revenues,
if any, will be materially and negatively impacted.
If
our clinical trials fail to demonstrate that any of our product candidates are safe and effective for the treatment of particular
diseases, the FDA may require us to conduct additional clinical trials or may not grant us marketing approval for such product
candidates for those diseases.
We
are not permitted to market our product candidates in the United States until we receive approval of a BLA or NDA from the FDA.
Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate
with evidence gathered in preclinical and well-controlled clinical trials, and, with respect to approval in the United States,
to the satisfaction of the FDA and, with respect to approval in other countries, similar regulatory authorities in those countries,
that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes
and controls used to produce the product are compliant with applicable statutory and regulatory requirements. Our failure to adequately
demonstrate the safety and effectiveness of any of our product candidates for the treatment of particular diseases may delay or
prevent our receipt of the FDA’s approval and, ultimately, may prevent commercialization of our product candidates for those
diseases. The FDA has substantial discretion in deciding whether, based on the benefits and risks in a particular disease, any
of our product candidates should be granted approval for the treatment of that particular disease. Even if we believe that a clinical
trial or trials has demonstrated the safety and statistically significant efficacy of any of our product candidates for the treatment
of a disease, the results may not be satisfactory to the FDA. Preclinical and clinical data can be interpreted by the FDA and other
regulatory authorities in different ways, which could delay, limit or prevent regulatory approval. If regulatory delays are significant
or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our product
candidates involved will be harmed, and our prospects for profitability will be significantly impaired.
Satisfaction of
these and other regulatory requirements is costly, time consuming, uncertain, and subject to unanticipated delays. Despite our
efforts, our drug candidates may not:
| · | offer improvement
over existing comparable products; |
| · | be proven safe
and effective in clinical trials; or |
| · | meet applicable
regulatory standards. |
In
addition, in the course of its review of a BLA or NDA or other regulatory application, the FDA or other regulatory authorities
may conduct audits of the practices and procedures of a company and its suppliers and contractors concerning manufacturing, clinical
study conduct, non-clinical studies and several other areas. If the FDA and/or other regulatory authorities conducts an audit relating
to a BLA, NDA or other regulatory application and finds a significant deficiency in any of these or other areas, the FDA or other
regulatory authorities could delay or not approve such BLA, NDA or other regulatory application. If regulatory delays are significant
or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our products
or product candidates involved will be harmed, and our prospects for profitability will be significantly impaired.
Both
before and after marketing approval, our product candidates are subject to extensive and rigorous ongoing regulatory requirements
and continued regulatory review, and if we fail to comply with these continuing requirements, we could be subject to a variety
of sanctions.
Both
before and after the approval of our product candidates, we, our product candidates, our operations, our facilities, our suppliers,
and our contract manufacturers, contract research organizations, and contract testing laboratories are subject to extensive regulation
by governmental authorities in the United States and other countries, with regulations differing from country to country. In the
United States, the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy,
potency, labeling, packaging, adverse event reporting, storage, record keeping, quality systems, advertising, promotion, sale and
distribution of therapeutic products. These requirements include submissions of safety and other post-marketing information
and reports, registration, as well as continued compliance with cGMP, requirements and current good clinical practice, or cGCP,
requirements for any clinical trials that we conduct post-approval. Failure to comply with
applicable requirements could result in, among other things, one or more of the following actions: restrictions on the marketing
of our products or their manufacturing processes, notices of violation, untitled letters, warning letters, civil penalties, fines
and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product candidate, suspension
or withdrawal of regulatory approvals, product, seizure or detention, voluntary or mandatory product recalls and related publicity
requirements, interruption of manufacturing or clinical trials, operating restrictions, injunctions, import or export bans, and
criminal prosecution. We or the FDA, or an institutional review board, may suspend or terminate human clinical trials at any time
on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk.
The FDA’s policies may change and
additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we
are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely
affect our business, prospects and ability to achieve or sustain profitability.
If side effects are identified during
the time our drug candidates are in development or after they are approved and on the market, we may choose to or be required to
perform lengthy additional clinical trials, discontinue development of the affected drug candidate, change the labeling of any
such products, or withdraw any such products from the market, any of which would hinder or preclude our ability to generate revenues.
Undesirable side effects caused by our
drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more
restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. The drug-related
side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential
product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly. Even
if any of our drug candidates receives marketing approval, as greater numbers of patients use a drug following its approval, an
increase in the incidence of side effects or the incidence of other post-approval problems that were not seen or anticipated during
pre-approval clinical trials could result in a number of potentially significant negative consequences, including:
| · | regulatory authorities may withdraw their
approval of the product; |
| · | regulatory authorities may require the
addition of labeling statements, such as warnings or contraindications; |
| · | we may be required to change the way the
product is administered, conduct additional clinical trials or change the labeling of the product; |
| · | we could be sued and held liable for harm
caused to patients; and |
| · | our reputation may suffer. |
Any of these events could substantially
increase the costs and expenses of developing, commercializing and marketing any such drug candidates or could harm or prevent
sales of any approved products.
Even if our product candidates receive
regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.
In order to market any products outside
of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding
safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative
review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval.
The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the United
States as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure
or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure
to obtain regulatory approval in other countries or any delay or setback in obtaining such approval would impair our ability to
develop foreign markets for our drug candidates.
Our
product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
We expect our stem cell product candidates
to be regulated by the FDA as biologic products and we intend to seek approval for these products pursuant to the BLA pathway.
The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated pathway for the approval of biosimilar
and interchangeable biologic products. The abbreviated regulatory pathway establishes legal authority for the FDA to review and
approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its
similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA
until 12 years after the original branded product was approved under a BLA. The law is complex and is still being interpreted and
implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain
when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have a material adverse
effect on the future commercial prospects for our biologic products.
We believe that any of our product candidates
approved as a biologic product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that
this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our drug candidates
to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated.
Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that
is similar to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace
and regulatory factors that are still developing.
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
The
following information is given with regard to unregistered securities sold during the six months ended June 30, 2015. The
unregistered securities were issued pursuant to section 4(2) of the Securities Act:
We
issued a total of 19,206 shares of common stock upon the cashless exercise of 44,000 outstanding common stock purchase warrants.
The warrants had an average exercise price of $2.13.
ITEM 3. |
DEFAULT UPON SENIOR SECURITIES |
None
ITEM 4. |
MINE SAFETY DISCLOSURE |
Not Applicable
ITEM 5. |
OTHER INFORMATION |
None.
The
exhibits listed in the accompanying index to exhibits are filed or incorporated by reference as part of this Form 10-Q.
SIGNATURES
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 10, 2015 |
|
/s/ I. Richard Garr |
|
|
Chief Executive Officer |
|
|
|
|
|
/s/ Jonathan Lloyd Jones |
|
|
Chief Financial Officer |
|
|
(Principal Accounting Officer) |
INDEX
TO EXHIBITS
|
|
|
|
|
|
Incorporated by Reference |
|
|
|
|
Filed/ |
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
Furnished |
|
|
|
Exhibit |
|
|
|
|
No. |
|
Description |
|
Herewith |
|
Form |
|
No. |
|
File No. |
|
Filing Date |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.01(i) |
|
Amended and Restated Certificate of Incorporation of Neuralstem, Inc. filed on 7/9/14 |
|
|
|
10-Q |
|
3.01(i) |
|
001-33672 |
|
8/8/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.02(ii) |
|
Amended and Restated Bylaws of Neuralstem, Inc. adopted on 7/16/07 |
|
|
|
10-QSB |
|
3.2(i) |
|
333-132923 |
|
8/14/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.01** |
|
Amended and Restated 2005 Stock Plan adopted on 6/28/07 |
|
|
|
10-QSB |
|
4.2(i) |
|
333-132923 |
|
8/14/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.02** |
|
Non-qualified Stock Option Agreement between Neuralstem, Inc. and Richard Garr dated 7/28/05 |
|
|
|
SB-2 |
|
4.4 |
|
333-132923 |
|
6/21/06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.03** |
|
Non-qualified Stock Option Agreement between Neuralstem, Inc. and Karl Johe dated 7/28/05 |
|
|
|
SB-2 |
|
4.5 |
|
333-132923 |
|
6/21/06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.04** |
|
Neuralstem, Inc. 2007 Stock Plan |
|
|
|
10-QSB |
|
4.21 |
|
333-132923 |
|
8/14/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.05 |
|
Form of Common Stock Purchase Warrant Issued to Karl Johe on 6/5/07 |
|
|
|
10-KSB |
|
4.22 |
|
333-132923 |
|
3/27/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.06 |
|
Form of Placement Agent Warrant Issued to Midtown Partners & Company on 12/18/08 |
|
|
|
8-K |
|
4.1 |
|
001-33672 |
|
12/18/08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.07 |
|
Form of Consultant Common Stock Purchase Warrant issued on 1/5/09 |
|
|
|
S-3/A |
|
10.1 |
|
333-157079 |
|
02/3/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.08 |
|
Form of Series D, E and F Warrants |
|
|
|
8-K |
|
4.01 |
|
001-33672 |
|
7/1/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.09 |
|
Form of Placement Agent Warrant |
|
|
|
8-K |
|
4.02 |
|
001-33672 |
|
7/1/09 |
4.10 |
|
Form of Consultant Warrant Issued 1/8/10 |
|
|
|
10-K |
|
4.20 |
|
001-33672 |
|
3/31/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.11 |
|
Form of Replacement Warrant Issued 1/29/10 |
|
|
|
10-K |
|
4.21 |
|
001-33672 |
|
3/31/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.12 |
|
Form of Series C Replacement Warrant Issued March of 2010 and May, June and July of 2013 (Original Ex. Price $2.13 and $1.25) |
|
|
|
10-K |
|
4.22 |
|
001-33672 |
|
3/31/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.13 |
|
Form of employee and consultant option grant pursuant to our 2007 Stock Plan and 2010 Equity Compensation Plan |
|
|
|
10-K |
|
4.23 |
|
001-33672 |
|
3/31/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.14 |
|
Form of Warrants dated 6/29/10 |
|
|
|
8-K |
|
4.01 |
|
001-33672 |
|
6/29/10 |
4.15** |
|
Amended Neuralstem 2010 Equity Compensation Plan adopted on June 21, 2013 |
|
|
|
DEF 14A |
|
Appendix I |
|
001-33672 |
|
4/30/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.16 |
|
Form of Consultant Warrant issued 10/1/09 and 10/1/10 |
|
|
|
S-3 |
|
4.07 |
|
333-169847 |
|
10/8/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.17** |
|
Form of Restricted Stock Award Agreement pursuant to our 2007 Stock Plan and 2010 Equity Compensation Plan |
|
|
|
S-8 |
|
4.06 |
|
333-172563 |
|
3/1/11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.18** |
|
Form of Restricted Stock Unit Agreement |
|
|
|
S-8 |
|
4.08 |
|
333-172563 |
|
3/1/11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.19 |
|
Form of Common Stock Purchase Warrant issued pursuant to February 2012 registered offering |
|
|
|
8-K |
|
4.01 |
|
001-33672 |
|
2/8/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.20 |
|
Form of Common Stock Purchase Warrant issued to Consultants in June of 2012 and March 19, 2013 |
|
|
|
10-Q |
|
4.20 |
|
001-33672 |
|
8/9/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.21 |
|
Form of Underwriter Warrant issued to Aegis Capital Corp. on 8/20/12 |
|
|
|
8-K |
|
4.1 |
|
001-33672 |
|
8/17/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.22 |
|
Form of Placement Agent Warrant issued to Aegis Capital Corp. on 9/13/12 |
|
|
|
8-K |
|
4.1 |
|
001-33672 |
|
9/19/12 |
4.23 |
|
Form of Consulting Warrant issued January 2011 and March 2012 |
|
|
|
S-3 |
|
4.01 |
|
333-188859 |
|
5/24/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Form of Replacement Warrant issued January, February and May of 2013 (Original Ex. Prices $3.17 and $2.14) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.24 |
|
Form of Lender Warrant issued March 22, 2013 |
|
|
|
8-K |
|
4.01 |
|
011-33672 |
|
3/27/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.25 |
|
Form of Advisor Warrant issued March 22, 2013 |
|
|
|
8-K |
|
4.02 |
|
011-33672 |
|
3/27/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.26 |
|
Form of Warrant issued June of 2013 and July of 2014 to Legal Counsel |
|
|
|
10-Q |
|
4.26 |
|
001-33672 |
|
8/8/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.27 |
|
Form of Warrant issued in September 2013 in connection with Issuer’s registered direct offering |
|
|
|
8-K |
|
4.01 |
|
011-33672 |
|
9/10/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.28 |
|
Form of Warrant issued to strategic advisor in August 2013 |
|
|
|
10-Q |
|
4.28 |
|
001-33672 |
|
11/12/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4.29 |
|
Form of Investor Warrant issued January 2014 |
|
|
|
8-K |
|
4.01 |
|
001-33672 |
|
1/6/14 |
4.30 |
|
Form of Lender Warrant Issued October 28, 2014 |
|
|
|
8-K |
|
4.01 |
|
001-33672 |
|
10/29/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.01** |
|
Employment Agreement with I. Richard Garr dated January 1, 2007 and amended as of November 1, 2005 |
|
|
|
SB-2 |
|
10.1 |
|
333-132923 |
|
6/21/06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.02** |
|
Amended terms to the Employment Agreement of I Richard Garr dated January 1, 2008 |
|
|
|
10-K |
|
10.02 |
|
001-33672 |
|
3/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.03** |
|
Amended terms to the employment Agreement of I. Richard Garr dated March 1, 2015 |
|
|
|
8-K |
|
10.01 |
|
001-33672 |
|
3/2/15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.04** |
|
Employment Agreement with Karl Johe dated January 1, 2007 and amended as of November 1, 2005 |
|
|
|
SB-2 |
|
10.2 |
|
333-132923 |
|
6/21/06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.05** |
|
Amended terms to the Employment Agreement of Karl Johe dated January 1, 2009 |
|
|
|
10-K |
|
10.04 |
|
001-33672 |
|
3/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.06** |
|
Employment Agreement with Thomas Hazel, Ph.D dated August 11, 2008 |
|
|
|
10-K/A |
|
10.05 |
|
001-33672 |
|
10/5/10 |
10.07 |
|
Consulting Agreement dated January 2010 between Market Development Consulting Group and the Company and amendments No. 1 and 2. |
|
|
|
10-K |
|
10.07 |
|
001-33672 |
|
3/16/11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.08** |
|
Renewal of I. Richard Garr Employment Agreement dated 7/25/12 |
|
|
|
8-K |
|
10.01 |
|
001-33672 |
|
7/27/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.09** |
|
Renewal of Dr. Karl Johe Employment Agreement dated 7/25/12 |
|
|
|
8-K |
|
10.02 |
|
001-33672 |
|
7/27/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.10** |
|
Renewal of Dr. Tom Hazel Employment Agreement dated 7/25/12 |
|
|
|
8-K |
|
10.03 |
|
001-33672 |
|
7/27/12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.11 |
|
Loan and Security Agreement dated March 2013 |
|
|
|
8-K |
|
10.01 |
|
011-33672 |
|
3/27/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.12 |
|
Intellectual Property and Security Agreement dated March 2013 |
|
|
|
8-K |
|
10.02 |
|
011-33672 |
|
3/27/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.13 |
|
At the Market Offering Agreement entered into on October 25, 2013 |
|
|
|
8-K |
|
10.01 |
|
011-33672 |
|
10/25/13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.14 |
|
Form of Outside Director Agreement |
|
|
|
10-K |
|
10.13 |
|
011-33672 |
|
3/10/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.15** |
|
Form of Amendment to Karl Johe Employment Agreement |
|
|
|
8-K |
|
10.01 |
|
011-33672 |
|
9/18/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.16 |
|
Form of Second Amendment to Loan and Security Agreement dated March of 2013 that was entered into on October 28, 2014 |
|
|
|
8-K |
|
10.01 |
|
011-33672 |
|
10/29/14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.17 |
|
Offer Letter Between Neuralstem, Inc. and Jonathan Lloyd Jones |
|
|
|
8-K |
|
10.01 |
|
001-33672 |
|
5/11/15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
14.01 |
|
Neuralstem Code of Ethics |
|
|
|
SB-2 |
|
14.1 |
|
333-132923 |
|
6/21/06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
14.02 |
|
Neuralstem Financial Code of Profession Conduct adopted on May 16, 2007 |
|
|
|
8-K |
|
14.2 |
|
333-132923 |
|
6/6/07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
31.1 |
|
Certification of the Principal Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
* |
|
|
|
|
|
|
|
|
32.1 |
|
Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. § 1350 |
|
*** |
|
|
|
|
|
|
|
|
101.INS |
|
XBRL Instance Document |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
|
XBRL Taxonomy Extension Schema |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB |
|
XBRL Taxonomy Extension Label Linkbase |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase |
|
* |
|
|
|
|
|
|
|
|
* Filed herein
** Management contracts or compensation plans or arrangements in which directors or executive officers are
eligible to participate.
*** Furnished herein
EXHIBIT
31.1
SECTION
302
CERTIFICATION
OF THE PRINCIPAL EXECUTIVE OFFICER
I,
I Richard Garr, certify that:
(1) I
have reviewed this Quarterly Report on Form 10-Q of Neuralstem, Inc.;
(2) Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
(3) Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
(4) The
registrant's other certifying officer(s) and I am responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its unconsolidated investments, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
(c) Evaluated
the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control
over financial reporting; and
(5) The
registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
Date: August 10, 2015 |
By: |
/s/ I. Richard Garr |
|
I. Richard Garr, Chief Executive Officer |
EXHIBIT
31.2
SECTION
302
CERTIFICATION
OF THE PRINCIPAL FINANCIAL OFFICER
I,
Jonathan Lloyd Jones, certify that:
(1) I
have reviewed this Quarterly Report on Form 10-Q of Neuralstem, Inc.;
(2) Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
(3) Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
(4) The
registrant's other certifying officer(s) and I am responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its unconsolidated investments, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
(c) Evaluated
the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control
over financial reporting; and
(5) The
registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors:
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
Date: August 10, 2015 |
By: |
/s/ Jonathan Lloyd Jones |
|
Jonathan Lloyd Jones, Chief Financial Officer |
EXHIBIT
32.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
18
U.S.C. SECTION 1350 AND EXCHANGE ACT RULES 13a-14(b) AND 15d-14(b)
(Section 906
of the Sarbanes-Oxley Act of 2002)
In
connection with the Quarterly Report of Neuralstem, Inc. (the “Company”) on Form 10-Q for the period ending June 30,
2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, I. Richard Garr, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of
my knowledge and belief:
|
(1) |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the operation of the Company. |
/s/ I. Richard Garr |
|
Chief Executive Officer |
|
Neuralstem, Inc. |
|
This
certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except
to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended.
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by
the Company and furnished to the Securities and Exchange Commission or its staff upon request.
EXHIBIT
32.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
18
U.S.C. SECTION 1350 AND EXCHANGE ACT RULES 13a-14(b) AND 15d-14(b)
(Section 906
of the Sarbanes-Oxley Act of 2002)
In
connection with the Quarterly Report of Neuralstem, Inc. (the “Company”) on Form 10-Q for the period ending June 30,
2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jonathan Lloyd Jones,
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the
best of my knowledge and belief:
|
(1) |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the operation of the Company. |
/s/ Jonathan Lloyd Jones |
|
Chief Financial Officer |
|
Neuralstem, Inc. |
|
This
certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except
to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended.
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by
the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Neuralstem (NASDAQ:CUR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Neuralstem (NASDAQ:CUR)
Historical Stock Chart
From Apr 2023 to Apr 2024