Neuralstem, Inc. (NASDAQ:CUR), a biopharmaceutical company focused
on the development of nervous system therapies based on its neural
stem cell technology, reported its financial results for the
three and six month periods ended June 30, 2017.
“Our recent financing of six million dollars has
further extended the company’s cash runway to sufficiently support
operations and investigation of the mechanism of action,” commented
Rich Daly, Chairman and CEO. “We are encouraged by the
emerging clinical profile of NSI-189. We are continuing to
evaluate the full Phase 2 MDD data set and will provide corporate
strategy update in the fourth quarter of this year.” Recent
Clinical & Business Highlights
- On August 2, 2017, Neuralstem was awarded a Small Business
Innovation Research (SBIR) grant by the National Institutes of
Health (NIH) to evaluate in preclinical studies the potential of
NSI-189, a novel small molecule compound, for the prevention and
treatment of diabetic neuropathy. The award of approximately
$1 million will be paid over a two-year period.
- On July 25, 2017, we announced top-line results from our
exploratory Phase 2 clinical trial examining the efficacy of
NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID)
compared to placebo for the treatment of major depressive disorder
(MDD). The study, which utilized the two-staged sequential
parallel comparison design (SPCD), did not meet its primary
efficacy endpoint of a statistically significant reduction in
depression symptoms on the Montgomery-Asberg Depression Rating
Scale (MADRS). However, the 40 mg QD dose was directionally
positive on the MADRS.
- Of two secondary efficacy endpoints in the Phase 2 MDD trial
results analyzed so far, the patient-rated Symptoms of Depression
Questionnaire (SDQ) achieved statistical significance (p=0.044)
with NSI-189 40 mg QD compared to placebo in the overall SPCD
analysis. Results were also directionally positive on the
Hamilton Depression Rating Scale (HAM-D17) at both doses.
Both the 40 mg QD and 40 mg BID doses were well-tolerated with no
serious adverse events reported. The company will continue to
evaluate the Phase 2 MDD data and provide a full update in the
fourth quarter of 2017.
- In June 2017, Neuralstem (NASDAQ:CUR) was added to the Russell
Microcap® Index as part of the FTSE’s annual reconstitution of its
family of U.S. indexes. The Russell Microcap® Index measures
the performance of the microcap segment of the U.S. equity
market.
- On August 1, 2017, we closed a public offering of 3,000,000
shares of common stock and 2,250,000 common stock purchase warrants
at a public purchase price of $2.00 per share and accompanying
warrant. We received gross proceeds of $6.0 million and
approximately $5.4 million of net proceeds from this offering.
- From March through July 2017, we received approximately
$3,238,000 upon the exercise of 996,156 common stock purchase
warrants issued in our May 2016 registered offering at an exercise
price of $3.25 per share. We expect that our existing cash and cash
equivalents will be sufficient to enable us to fund our anticipated
level of operations based on our current operating plans, into the
fourth quarter of 2018.
Financial Results for the Second Quarter
Ended June 30, 2017
Cash Position and Liquidity:
We had cash, cash equivalents and short-term
investments balances of approximately $11.4 million as at June 30,
2017, compared to $16.7 million at March 31, 2017. The
decrease resulted from use of cash to fund our NSI-189 clinical
programs and ongoing operations and the repayment in full of our
long-term debt.
On August 1, 2017, we closed a public offering
of 3,000,000 shares of common stock and 2,250,000 common stock
purchase warrants at a public purchase price of $2.00 per share and
accompanying warrant. We received gross proceeds of $6.0
million and approximately $5.4 million of net proceeds from this
offering.
Net Loss: In the quarter
ended June 30, 2017, we reported a net loss of approximately $4.6
million or $0.39 per share, compared to a loss of approximately
$3.9 million or $0.47 per share on a split adjusted basis in the
quarter ended June 30, 2016. Our operating loss in the quarter
ended June 30, 2017 was approximately $4.2 million, compared to a
loss of approximately $3.8 million in the quarter ended June 30,
2016.
For the six months ended June 30, 2017, we
reported a net loss of approximately $12.2 million or $1.06 per
share, compared to a loss of approximately $10.5 million or $1.37
per share on a split adjusted basis in the six months ended June
30, 2016. Our operating loss in the six months ended June 30, 2017
was approximately $8.5 million, compared to a loss of approximately
$10.1 million in the six months ended June 30, 2016.
R&D Expenses: The increase
of approximately $110,000 or 4% in research and development
expenses for the three months ended June 30, 2017 compared to the
comparable period of 2016 was primarily attributable to $420,000
increase in clinical trial costs associated with our ongoing Phase
2 MMD study, $170,000 increase in non-cash stock based compensation
expense partially offset by a $480,000 decrease in in personnel
related costs, internal and external research expenditures and
other expenses associated with our May 2016 restructuring.
The decrease of approximately $53,000 or 1% in
research and development expenses for the six months ended June 30,
2017 compared to the comparable period of 2016 was primarily
attributable to a $2.0 million reduction in employment costs,
internal and external research expenditures associated with our May
2016 restructuring almost entirely offset by an increase in
clinical trial costs associated with our ongoing Phase 2 MDD
study.
G&A Expenses: The
increase of approximately $274,000 or 20% in general and
administrative expenses for the three months ended June 30, 2017
compared to the comparable period of 2016 was primarily
attributable to a $530,000 increase in personnel related expenses
due to severances partially offset by $340,000 decrease in non-cash
stock based compensation expense.
The decrease of approximately $1,565,000 or 35%
in general and administrative expenses for the six months ended
June 30, 2017 compared to the comparable period of 2016 was
primarily attributable to personnel related savings associated with
our May, 2016 restructuring partially offset by current period
severance expenses.
Neuralstem, Inc. |
|
|
|
|
Unaudited Condensed Consolidated Balance
Sheets |
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
|
|
|
|
ASSETS |
|
|
|
CURRENT
ASSETS |
|
|
|
Cash and cash
equivalents |
$ |
6,442,484 |
|
|
$ |
15,194,949 |
|
Short-term
investments |
|
5,000,000 |
|
|
|
5,000,000 |
|
Trade and other
receivables |
|
5,345 |
|
|
|
10,491 |
|
Current portion of
related party receivable, net of discount |
|
- |
|
|
|
53,081 |
|
Prepaid expenses |
|
239,309 |
|
|
|
646,195 |
|
Total current
assets |
|
11,687,138 |
|
|
|
20,904,716 |
|
|
|
|
|
Property and equipment,
net |
|
219,382 |
|
|
|
269,557 |
|
Patents, net |
|
945,066 |
|
|
|
990,153 |
|
Related party
receivable, net of discount and current portion |
|
402,965 |
|
|
|
424,240 |
|
Other assets |
|
13,696 |
|
|
|
15,662 |
|
Total
assets |
$ |
13,268,247 |
|
|
$ |
22,604,328 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
CURRENT
LIABILITIES |
|
|
|
Accounts payable and
accrued expenses |
$ |
2,235,908 |
|
|
$ |
2,343,936 |
|
Accrued bonuses |
|
- |
|
|
|
852,963 |
|
Current portion of
long-term debt, net of fees and discount |
|
- |
|
|
|
3,705,787 |
|
Other current
liabilities |
|
67,992 |
|
|
|
430,738 |
|
Total current
liabilities |
|
2,303,900 |
|
|
|
7,333,424 |
|
|
|
|
|
Derivative
instruments |
|
3,267,408 |
|
|
|
3,921,917 |
|
Other long-term
liabilities |
|
4,136 |
|
|
|
18,209 |
|
Total
liabilities |
|
5,575,444 |
|
|
|
11,273,550 |
|
|
|
|
|
Commitments and
contingencies (Note 6) |
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
Convertible preferred
stock, 7,000,000 shares authorized, $0.01 par value;
1,000,000 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively |
|
10,000 |
|
|
|
10,000 |
|
Common stock, $0.01 par
value; 300 million shares authorized, 12,012,877 and 11,032,858
shares issued and outstanding at June 30, 2017 and December 31,
2016, respectively |
|
120,129 |
|
|
|
110,329 |
|
Additional paid-in
capital |
|
212,809,063 |
|
|
|
204,239,837 |
|
Accumulated other
comprehensive income |
|
3,350 |
|
|
|
3,905 |
|
Accumulated
deficit |
|
(205,249,739 |
) |
|
|
(193,033,293 |
) |
Total
stockholders' equity |
|
7,692,803 |
|
|
|
11,330,778 |
|
Total
liabilities and stockholders' equity |
$ |
13,268,247 |
|
|
$ |
22,604,328 |
|
|
|
|
|
Neuralstem, Inc. |
|
|
Unaudited Condensed Consolidated Statements of
Operations and Comprehensive Loss |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
2,500 |
|
|
$ |
2,500 |
|
|
$ |
5,000 |
|
|
$ |
5,000 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development expenses |
|
2,585,079 |
|
|
|
2,474,629 |
|
|
|
5,487,165 |
|
|
|
5,540,219 |
|
|
General and
administrative expenses |
|
1,635,652 |
|
|
|
1,362,140 |
|
|
|
2,968,073 |
|
|
|
4,532,662 |
|
|
Total operating
expenses |
|
4,220,731 |
|
|
|
3,836,769 |
|
|
|
8,455,238 |
|
|
|
10,072,881 |
|
|
Operating loss |
|
(4,218,231 |
) |
|
|
(3,834,269 |
) |
|
|
(8,450,238 |
) |
|
|
(10,067,881 |
) |
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
14,013 |
|
|
|
13,433 |
|
|
|
34,896 |
|
|
|
24,569 |
|
|
Interest expense |
|
(15,728 |
) |
|
|
(322,407 |
) |
|
|
(154,460 |
) |
|
|
(708,913 |
) |
|
Change in fair value of
derivative instruments |
|
(341,611 |
) |
|
|
757,275 |
|
|
|
(3,082,925 |
) |
|
|
757,275 |
|
|
Fees related to
issuance of derivative instruments, warrant inducement and other
expenses |
|
(87,635 |
) |
|
|
(466,541 |
) |
|
|
(563,719 |
) |
|
|
(463,342 |
) |
|
Total other income
(expense) |
|
(430,961 |
) |
|
|
(18,240 |
) |
|
|
(3,766,208 |
) |
|
|
(390,411 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(4,649,192 |
) |
|
$ |
(3,852,509 |
) |
|
$ |
(12,216,446 |
) |
|
$ |
(10,458,292 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.37 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding - basic and diluted |
|
11,906,334 |
|
|
|
8,141,198 |
|
|
|
11,525,730 |
|
|
|
7,606,725 |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
|
|
|
Net loss |
$ |
(4,649,192 |
) |
|
$ |
(3,852,509 |
) |
|
$ |
(12,216,446 |
) |
|
$ |
(10,458,292 |
) |
|
Foreign currency
translation adjustment |
|
(384 |
) |
|
|
3,268 |
|
|
|
(555 |
) |
|
|
1,495 |
|
|
Comprehensive loss |
$ |
(4,649,576 |
) |
|
$ |
(3,849,241 |
) |
|
$ |
(12,217,001 |
) |
|
$ |
(10,456,797 |
) |
|
About Neuralstem Neuralstem is a clinical-stage
biopharmaceutical company developing novel treatments for nervous
system diseases of high unmet medical need. NSI-189 is a
small molecule in clinical development for major depressive
disorder (MDD) and in preclinical development for Angelman’s
syndrome, irradiation-induced cognitive impairment, Type 1 and Type
2 diabetes and stroke.
NSI-566 is a stem cell therapy being tested for treatment of
paralysis in stroke, chronic spinal cord injury (cSCI) and
Amyotrophic Lateral Sclerosis (ALS). Neuralstem’s diversified
portfolio of product candidates is based on its proprietary neural
stem cell technology.
Cautionary Statement Regarding Forward Looking
Information
This news release contains “forward-looking
statements” made pursuant to the “safe harbor” provisions of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements relate to future, not past, events and
may often be identified by words such as “expect,” “anticipate,”
“intend,” “plan,” “believe,” “seek” or “will.” Forward-looking
statements by their nature address matters that are, to different
degrees, uncertain. Specific risks and uncertainties that could
cause our actual results to differ materially from those expressed
in our forward-looking statements include risks inherent in the
development and commercialization of potential products,
uncertainty of clinical trial results or regulatory approvals or
clearances, need for future capital, dependence upon collaborators
and maintenance of our intellectual property rights. Actual results
may differ materially from the results anticipated in these
forward-looking statements. Additional information on potential
factors that could affect our results and other risks and
uncertainties are detailed from time to time in Neuralstem’s
periodic reports, including the Annual Report on Form 10-K for the
year ended December 31, 2016, and filed with the Securities and
Exchange Commission (SEC) on March 31, 2016, Form 10-Q for the
period ended June 30, 2016, and in other reports filed with the
SEC.
Contact:
Danielle Spangler
Neuralstem, Director of Investor Relations
301.366.1481
dspangler@neuralstem.com
Kimberly Minarovich
Argot Partners, Investor Relations
212-600-1902
kimberly@argotpartners.com
Lori Rosen
LDR Communications
Public Relations
917.553.6808
lori@ldrcommunications.com
Neuralstem (NASDAQ:CUR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Neuralstem (NASDAQ:CUR)
Historical Stock Chart
From Apr 2023 to Apr 2024