Neuralstem Reports First Quarter 2017 Fiscal Results Provides Clinical and Business Update
May 10 2017 - 3:05PM
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company
developing next generation treatments for nervous system diseases,
reported its financial results for the quarter ended March 31,
2017.
“This is an exciting time for the company as we
approach a large clinical milestone of NSI-189 Phase 2 major
depressive disorder (MDD) study results, which remain ahead of
schedule for the third quarter of this year,” commented Rich Daly,
chairman and CEO. “We also continue to strengthen our balance sheet
and have extended our cash runway an additional quarter into late
2018.”
Clinical Highlights
- NSI-189 Phase 2 MDD study results expected 4 months ahead of
schedule in 3Q17. Neuralstem’s Phase 2 clinical study
evaluating NSI-189 for the indication of MDD was initiated in May
2016. The company announced 50% enrollment in September 2016 and
last patient enrolled in February 2017. 220 subjects were
randomized for a 12-week interventional study with NSI-189 or
placebo. Subjects completing the study are eligible to enroll in a
24-week non-interventional, observation-only durability study, from
which the results are expected in 1H 2018.
- NSI-189 preclinical data published in the Journal of Cellular
Physiology showed oral administration of NSI-189 in rats with
ischemic stroke led to a significant recovery from motor deficit.
The improvements were maintained post cessation of dosing for the
additional 12-week observational period. The sustained improvement
suggests that NSI-189 initiated a host brain repair mechanism
enabling tissue remodeling of the stroke brain.
- In April 2017, a new cohort (Group B) of four subjects with
stable cervical injuries was added for recruitment to the Phase 1
chronic spinal cord injury (cSCI) human clinical trial evaluating
the safety and feasibility of treatment with NSI-566. The amended
protocol was approved by the U.S. Food and Drug Administration and
the Institutional Review Board at the study site, University of
California San Diego (UCSD).
- NSI-566 preclinical data in a rat model of penetrating
ballistic-like brain injury (PBBI) was published in the Journal of
Neurotrauma. These data showed robust engraftment and
long-term survival of NSI-566 post transplantation.
Corporate Highlights
- 1-for-13 reverse stock split. In January 2017, the Company
executed a 1-for-13 reverse stock split of the Company’s common
stock. The reverse stock split enabled Neuralstem to regain
compliance with the $1.00 minimum bid price condition and thereby
fulfill all of the NASDAQ Capital Market continued listing
requirements.
- In March and April 2017, we received approximately $2,750,000
upon the exercise of 846,156 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
3Q18.
Financial Results for the Quarter Ended
March 31, 2017
Cash Position: Cash, cash
equivalents and short-term investments on hand was approximately
$16.7 million at March 31, 2017, compared to approximately $20.2
million at December 31, 2016. The decrease resulted from use
of cash to fund our NSI-189 clinical programs and to meet our debt
repayment obligations partially offset by cash raised of
approximately $2.2 million, net primarily from the exercise of
warrants in March 2017. As of March 31, 2017 we had approximately
$2.58 million of debt outstanding as compared to $3.8 million at
December 31, 2016.
Net Loss: In the quarter ended
March 31, 2017, we reported a net loss of approximately $7.6
million or $0.68 per share, compared to a loss of approximately
$6.6 million or $0.93 per share on a split adjusted basis in the
quarter ended March 31, 2016. Our operating loss in the quarter
ended March 31, 2017 was approximately $4.2 million, compared to a
loss of approximately $6.2 million in the quarter ended March 31,
2016.
R&D Expenses: Research and
development expenditures, at $2.9 million, decreased by
approximately $0.2 million in the quarter ended March 31, 2017 as
compared to expenditures of $3.1 million in the quarter ended March
31, 2016. The decrease in research and development expenses was
primarily attributable to a $1.8 million reduction in employment
costs, internal and external research expenditures associated with
our May, 2016 restructuring partially offset by a $1.6 million
increase in clinical trial costs associated with our ongoing Phase
2 MDD study.
G&A Expenses: General and
administrative expenses decreased by approximately $1.8 million
dollars to $1.3 million in the quarter ended March 31, 2017 as
compared to $3.2 million for the quarter ended March 31, 2016. The
decrease was primarily attributable to employment costs savings
associated with our May, 2016 restructuring.
Equity and Reverse Stock Split:
The Board of Directors approved a 1-for-13 reverse stock split of
the Company’s common stock effective January 6, 2017.
Stockholders' equity and all references to share and per share
amounts in the accompanying consolidated financial statements have
been retroactively adjusted to reflect the 1-for-13 reverse stock
split for all periods presented.
We had 11.7 million and 7.1 million common
shares issued and outstanding on a reverse split adjusted basis and
1.0 million and no preferred shares issued and outstanding at March
31, 2017 and 2016, respectively.
Liquidity: We expect that our
existing cash, cash equivalents and short-term investments will
fund our anticipated level of operations based on our current
operating plans, into the second half of 2018.
|
Neuralstem, Inc. |
|
|
|
|
Unaudited Condensed Consolidated Balance
Sheets |
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
|
|
|
|
ASSETS |
|
|
|
CURRENT
ASSETS |
|
|
|
Cash and cash
equivalents |
$ |
11,680,499 |
|
|
$ |
15,194,949 |
|
Short-term
investments |
|
5,000,000 |
|
|
|
5,000,000 |
|
Trade and other
receivables |
|
14,715 |
|
|
|
10,491 |
|
Current portion of
related party receivable, net of discount |
|
- |
|
|
|
53,081 |
|
Prepaid expenses |
|
477,072 |
|
|
|
646,195 |
|
Total current
assets |
|
17,172,286 |
|
|
|
20,904,716 |
|
|
|
|
|
Property and equipment,
net |
|
242,810 |
|
|
|
269,557 |
|
Patents, net |
|
904,732 |
|
|
|
990,153 |
|
Related party
receivable, net of discount and current portion |
|
392,840 |
|
|
|
424,240 |
|
Other assets |
|
15,824 |
|
|
|
15,662 |
|
Total
assets |
$ |
18,728,492 |
|
|
$ |
22,604,328 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
CURRENT
LIABILITIES |
|
|
|
Accounts payable and
accrued expenses |
$ |
2,167,615 |
|
|
$ |
2,343,936 |
|
Accrued bonuses |
|
- |
|
|
|
852,963 |
|
Current portion of
long-term debt, net of fees and discount |
|
2,530,922 |
|
|
|
3,705,787 |
|
Other current
liabilities |
|
349,087 |
|
|
|
430,738 |
|
Total current
liabilities |
|
5,047,624 |
|
|
|
7,333,424 |
|
|
|
|
|
Derivative
instruments |
|
3,884,972 |
|
|
|
3,921,917 |
|
Other long-term
liabilities |
|
16,129 |
|
|
|
18,209 |
|
Total
liabilities |
|
8,948,725 |
|
|
|
11,273,550 |
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
Convertible preferred
stock, 7,000,000 shares authorized, $0.01 par value;
1,000,000 shares issued and outstanding at March 31, 2017 and
December 31, 2016 respectively |
|
10,000 |
|
|
|
10,000 |
|
Common stock, $0.01 par
value; 300 million shares authorized, 11,743,244 and 11,032,858
shares outstandingat March 31, 2017 and December 31, 2016
respectively |
|
117,432 |
|
|
|
110,329 |
|
Additional paid-in
capital |
|
210,249,148 |
|
|
|
204,239,837 |
|
Accumulated other
comprehensive income |
|
3,734 |
|
|
|
3,905 |
|
Accumulated
deficit |
|
(200,600,547 |
) |
|
|
(193,033,293 |
) |
Total
stockholders' equity |
|
9,779,767 |
|
|
|
11,330,778 |
|
Total
liabilities and stockholders' equity |
$ |
18,728,492 |
|
|
$ |
22,604,328 |
|
|
|
|
|
Neuralstem, Inc. |
|
Unaudited Condensed Consolidated Statements of
Operations and Comprehensive Loss |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
2,500 |
|
|
$ |
2,500 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and
development expenses |
|
2,902,086 |
|
|
|
3,065,590 |
|
|
|
General and
administrative expenses |
|
1,332,421 |
|
|
|
3,170,522 |
|
|
|
Total operating
expenses |
|
4,234,507 |
|
|
|
6,236,112 |
|
|
|
Operating loss |
|
(4,232,007 |
) |
|
|
(6,233,612 |
) |
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
Interest income |
|
20,883 |
|
|
|
11,136 |
|
|
|
Interest expense |
|
(138,732 |
) |
|
|
(386,506 |
) |
|
|
Change in fair value of
derivative instruments |
|
(2,741,314 |
) |
|
|
- |
|
|
|
Warrant inducement and
other expenses |
|
(476,084 |
) |
|
|
3,199 |
|
|
|
Total other income
(expense) |
|
(3,335,247 |
) |
|
|
(372,171 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(7,567,254 |
) |
|
$ |
(6,605,783 |
) |
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.68 |
) |
|
$ |
(0.93 |
) |
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding - basic and diluted |
|
11,140,898 |
|
|
|
7,077,676 |
|
|
|
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
Net loss |
$ |
(7,567,254 |
) |
|
$ |
(6,605,783 |
) |
|
|
Foreign currency
translation adjustment |
|
(171 |
) |
|
|
(1,773 |
) |
|
|
Comprehensive loss |
$ |
(7,567,425 |
) |
|
$ |
(6,607,556 |
) |
|
|
|
|
|
|
|
|
About Neuralstem
Neuralstem is a clinical-stage biopharmaceutical
company developing next-generation treatments for nervous system
diseases of high unmet medical need. Neuralstem’s lead asset,
NSI-189, is an oral antidepressant in Phase 2 clinical development
for major depressive disorder (MDD). NSI-566 is a stem cell
therapy being tested 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, filed with the Securities and
Exchange Commission (SEC) on March 23, 2017, and in other reports
filed with the SEC. We do not assume any obligation to update any
forward-looking statements.
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
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