Full Press Release Details
Neuralstem Reports Fourth Quarter
and Year End 2015 Fiscal Results and Business Update
FDA Approval to Commence
Phase 2 Major Depressive Disorder Clinical Trial
Strengthening of Executive
GERMANTOWN, MD, March 14, 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 fourth quarter and year ended December 31, 2015.
Clinical Program and Business
"The FDA approval to commence
our Phase 2 Major Depressive Disorder (MDD) trial is a meaningful milestone for the Company," commented Richard Daly. "We
believe NSI-189 may provide this large patient population with an alternative therapy without many of the typical side effects
of current commercial drugs. Our strengthened team provides incremental expertise and we are committed to executing a diligently
run trial to deliver data in the second half of 2017."
Neurogenic Small Molecule
Platform Clinical Development
Lead asset, NSI-189 Phase
2 clinical trial for the treatment of major depressive disorder (MDD)
Cell Therapy Platform Clinical
NSI-566 Phase 1 safety trial
for the treatment of cSCI
NSI-566 Phase 1 / 2 safety
trial for the treatment of amyotrophic lateral sclerosis (ALS)
NSI-566 Phase 1 safety trial
for the treatment of motor deficits in stroke
Financial Results for the
Year Ended December 31, 2015
Cash, cash equivalents and short-term
investments on hand was approximately $12.2 million at December 31, 2015, compared to approximately $27.5 million at December 31,
2014. The decrease was associated with cash used in our operations.
In the year ended December 31,
2015, we reported a net loss of approximately $20.9 million or $0.23 per share, compared to a loss of approximately $22.6 million
or $0.26 per share in the year ended December 31, 2014.
Our operating loss in the year
ended December 31, 2015 was approximately $19.2 million, compared to a loss of approximately $17.5 million in the year ended December
31, 2014. The increase in operating loss was primarily attributable to an increase of approximately $4.3 million in research and
development expenses partially offset by a decrease of general and administrative expenses of approximately $2.6 million.
The increase in research and
development expenses was primarily attributable to an increase in headcount, and an increase clinical, pre-clinical and CMC expenses,
all related to the ramp-up of our pre-clinical and clinical trial efforts and are expected to continue into subsequent periods.
The decrease in general and administrative
expenses was primarily attributable to a decrease in non-cash stock based compensation expense and a decrease in legal, consulting
and other external advisory fees. These were partially offset by an increase in personnel and related expenses associated with
changes in headcount.
We had 92.0 million and 87.8 million common shares
issued and outstanding at December 31, 2015 and 2014, respectively.
Consolidated Balance Sheets
| December 31, | ||||||||
| 2015 | 2014 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 4,716,533 | $ | 12,518,980 | ||||
| Short term investments | 7,517,453 | 15,007,478 | ||||||
| Trade and other receivables | 37,316 | 225,524 | ||||||
| Deferred financing fees, current portion | 89,562 | 135,694 | ||||||
| Prepaid expenses | 1,159,782 | 274,106 | ||||||
| Total current assets | 13,520,646 | 28,161,782 | ||||||
| Property and equipment, net | 343,200 | 301,265 | ||||||
| Patents, net | 1,103,467 | 1,233,172 | ||||||
| Deferred financing fees, net of current portion | 9,154 | 89,143 | ||||||
| Other assets | 71,797 | 58,713 | ||||||
| Total assets | $ | 15,048,264 | $ | 29,844,075 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 1,455,826 | $ | 2,504,978 | ||||
| Accrued bonuses | 161,362 | 646,960 | ||||||
| Current portion of long-term debt, net of discount | 4,634,742 | 730,012 | ||||||
| Other current liabilities | 263,104 | 126,745 | ||||||
| Total current liabilities | 6,515,034 | 4,008,695 | ||||||
| Long-term debt, net of discount and current portion | 3,391,808 | 8,056,470 | ||||||
| Other long term liabilities | 174,144 | 59,574 | ||||||
| Total liabilities | 10,080,986 | 12,124,739 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding | - | - | ||||||
| Common stock, $0.01 par value; 300 million shares authorized, 92,005,705 and 87,789,679 shares issued and outstanding in 2015 and 2014, respectively | 920,057 | 877,897 | ||||||
| Additional paid-in capital | 176,002,832 | 167,890,220 | ||||||
| Accumulated other comprehensive income | 3,071 | 6,000 | ||||||
| Accumulated deficit | (171,958,682 | ) | (151,054,781 | ) | ||||
| Total stockholders' equity | 4,967,278 | 17,719,336 | ||||||
| Total liabilities and stockholders' equity | $ | 15,048,264 | $ | 29,844,075 |
Consolidated Statements of Operations
and Comprehensive Loss
| Year Ended December 31, | ||||||||||||
| 2015 | 2014 | 2013 | ||||||||||
| Revenues | $ | 10,417 | $ | 18,833 | $ | 110,000 | ||||||
| Operating expenses: | ||||||||||||
| Research and development costs | 12,637,278 | 8,361,559 | 7,285,752 | |||||||||
| General and administrative expenses | 6,529,667 | 9,093,123 | 5,348,189 | |||||||||
| Total operating expenses | 19,166,945 | 17,454,682 | 12,633,941 | |||||||||
| Operating loss | (19,156,528 | ) | (17,435,849 | ) | (12,523,941 | ) | ||||||
| Other income (expense): | ||||||||||||
| Interest income | 69,549 | 67,651 | 68,000 | |||||||||
| Interest expense | (1,816,206 | ) | (1,620,776 | ) | (1,394,274 | ) | ||||||
| Warrant modification expense | - | (3,109,850 | ) | (5,017,156 | ) | |||||||
| Loss from change in fair value of derivative instruments | - | (334,133 | ) | (965,329 | ) | |||||||
| Loss on debt extinguisment | - | (445,787 | ) | - | ||||||||
| Other expense | (716 | ) | - | - | ||||||||
| Litigation settlement | - | 250,000 | 838 | |||||||||
| Total other income (expense) | (1,747,373 | ) | (5,192,895 | ) | (7,307,921 | ) | ||||||
| Net loss | $ | (20,903,901 | ) | $ | (22,628,744 | ) | $ | (19,831,862 | ) | |||
| Net loss per share - basic and diluted | $ | (0.23 | ) | $ | (0.26 | ) | $ | (0.27 | ) | |||
| Weighted average common shares outstanding - basic and diluted | 90,866,938 | 87,086,345 | 72,279,210 | |||||||||
| Comprehensive loss: | ||||||||||||
| Net loss | $ | (20,903,901 | ) | $ | (22,628,744 | ) | $ | (19,831,862 | ) | |||
| Foreign currency translation adjustment | (2,929 | ) | (1,241 | ) | 7,241 | |||||||
| Comprehensive loss | $ | (20,906,830 | ) | $ | (22,629,985 | ) | $ | (19,824,621 | ) |
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, has 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 expecting to initiate a Phase 2 efficacy study for MDD in 2016.
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 thirty 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, and in other reports filed with the SEC.
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