Full Press Release Details
Neuralstem Reports Fiscal First
Quarter 2016 Results and Business Update
GERMANTOWN, MD, May 9, 2016 -- Neuralstem,
Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural
stem cell technology, reported its financial results for the three months ended March 31, 2016 and provided a business update.
"The Company's ability
to raise significant capital from institutional investors provides us a cash runway to continue to fund our clinical development
programs, specifically the NSI-189 Phase 2 MDD clinical trial," said Richard Daly, CEO. "We recently commenced our
Phase 2 MDD trial which confirms the Company is on track to have results in the second half of 2017. We are committed to continue
to execute our clinical and corporate strategy to create additional stakeholder value."
Small Molecule Pharmaceutical Compounds
Clinical Development
Lead asset, NSI-189 Phase 2 clinical trial
for the treatment of major depressive disorder (MDD)
Cell Therapy Platform Clinical Developments
NSI-566 Phase 1 safety trial for the treatment
NSI-566 Phase 1 and 2 safety trials for
the treatment of amyotrophic lateral sclerosis (ALS)
NSI-566 Phase 1 safety trial for the treatment
of motor deficits in stroke
Results of Operations for the Quarter
Ended March 31, 2016:
Cash, cash equivalents and short-term investments
on hand was approximately $7.6 million at March 31, 2015, compared to approximately $12.2 million at December 31, 2015. The decrease
was primarily due to our ongoing operating expenses primarily related to preparations for the initiation of our NSI-189 Phase 2
clinical trial for the treatment of MDD.
In the quarter ended March 31, 2016, we
reported a net loss of approximately $6.6 million or $0.07 per share, compared to a loss of approximately $5.1 million or $0.06
per share in the first quarter of 2015. Our operating loss in the quarter ended March 31, 2016 was approximately $6.2 million compared
to a loss of $4.6 million in the same quarter of 2015. The increase in operating loss was primarily attributable to the severance
accrual and acceleration of stock based compensation expense related to the departure of our previous CEO. A decrease of approximately
$0.1 million in research and development expense was offset by an increase of approximately $1.7 million in general and administrative
Research and development expenses decreased
approximately $117,000 or 4% for the period ended March 31, 2016 compared to the comparable period of 2015 primarily as a result
of a decrease in pre-clinical and clinical costs partially offset by an increase in headcount and stock based compensation.
General and administrative expenses increased
approximately $1,737,000 or 121% for the period ended March 31, 2016 compared to the comparable period of 2015 primarily due to
a severance accrual and increased stock based compensation resulting from the accelerated vesting of options, both related to the
termination of our former Chief Executive Officer.
In addition, in the first quarter of 2016
we recognized approximately $0.4 million of other expenses primarily comprised of interest expenses related to our long-term debt.
Unaudited Condensed Consolidated Balance
| March 31, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 7,620,746 | $ | 4,716,533 | ||||
| Short-term investments | - | 7,517,453 | ||||||
| Trade and other receivables | 39,167 | 37,316 | ||||||
| Prepaid expenses | 1,077,762 | 1,159,782 | ||||||
| Total current assets | 8,737,675 | 13,431,084 | ||||||
| Property and equipment, net | 336,974 | 343,200 | ||||||
| Patents, net | 1,066,577 | 1,103,467 | ||||||
| Other assets | 57,692 | 71,797 | ||||||
| Total assets | $ | 10,198,918 | $ | 14,949,548 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 2,627,137 | $ | 1,455,826 | ||||
| Accrued bonuses | 287,046 | 161,362 | ||||||
| Current portion of long term debt, net of fees and discount | 4,466,081 | 4,634,742 | ||||||
| Other current liabilities | 241,008 | 173,542 | ||||||
| Total current liabilities | 7,621,272 | 6,425,472 | ||||||
| Long term debt, net of fees, discount and current portion | 2,546,296 | 3,391,808 | ||||||
| Other long term liabilities | 200,739 | 164,990 | ||||||
| Total liabilities | 10,368,307 | 9,982,270 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding | - | - | ||||||
| Common stock, $0.01 par value; 300 million shares authorized, 92,044,042 and 92,005,705 shares outstanding in 2016 and 2015, respectively | 920,440 | 920,057 | ||||||
| Additional paid-in capital | 177,473,335 | 176,002,832 | ||||||
| Accumulated other comprehensive income | 1,298 | 3,071 | ||||||
| Accumulated deficit | (178,564,462 | ) | (171,958,682 | ) | ||||
| Total stockholders' equity (deficit) | (169,389 | ) | 4,967,278 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 10,198,918 | $ | 14,949,548 |
Unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenues | $ | 2,500 | $ | 2,917 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 3,065,590 | 3,182,823 | ||||||
| General and administrative expenses | 3,170,522 | 1,433,074 | ||||||
| Total operating expenses | 6,236,112 | 4,615,897 | ||||||
| Operating loss | (6,233,612 | ) | (4,612,980 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 11,136 | 13,569 | ||||||
| Interest expense | (386,506 | ) | (453,734 | ) | ||||
| Other income | 3,199 | - | ||||||
| Total other income (expense) | (372,171 | ) | (440,165 | ) | ||||
| Net loss | $ | (6,605,783 | ) | $ | (5,053,145 | ) | ||
| Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.06 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 92,009,782 | 89,654,634 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (6,605,783 | ) | $ | (5,053,145 | ) | ||
| Foreign currency translation adjustment | (1,773 | ) | 13 | |||||
| Comprehensive loss | $ | (6,607,556 | ) | $ | (5,053,132 | ) |
Neuralstem's patented technology
enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential
therapies for multiple central nervous system diseases and conditions.
Neuralstem's ability to generate
neural stem cell lines from human hippocampus, which were used for systematic chemical screening for neurogenesis effect, led to
the discovery and patenting of molecules that Neuralstem believes may stimulate the brain's capacity to generate new neurons, potentially
reversing pathophysiologies associated with certain central nervous system (CNS) conditions.
The Company has completed Phase
1a and 1b trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive
disorder (MDD), and is currently conducting a Phase 2 efficacy study for MDD.
Neuralstem's first stem cell
product candidate, NSI-566, a spinal cord-derived neural stem cell line, is under development for treatment of amyotrophic lateral
sclerosis (ALS). Neuralstem has completed two clinical studies, in a total of 30 patients, which met primary safety endpoints.
In addition to ALS, NSI-566 is
also in a Phase 1 study to treat paralysis due to chronic spinal cord injury, as well as in a Phase 1 study to treat paralysis
from ischemic stroke.
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, 2015, and filed with the Securities and Exchange Commission
(SEC) on March 14, 2016, Form 10-Q for the period ended March 31, 2016, and in other reports filed with the SEC.
Neuralstem - Investor Relations:
Danielle Spangler 301.366.1481
Planet Communications - Media Relations:
Deanne Eagle 917.837.5866