Full Press Release Details
Neuralstem Reports Third Quarter 2015
Depth to Management Team with Appointment of Industry Veterans as Second Asset Advances towards Phase 2
GERMANTOWN, MD, November 9, 2015 -- Neuralstem, Inc. (Nasdaq:
CUR) a biopharmaceutical company leveraging its unique human neural stem cell-derived platform to
identify and develop novel neurogenic therapies for diseases of the central nervous system (CNS), today reported its financial
results and business update for the three and nine months ended September 30, 2015.
Neurogenic Oral, Small Molecule Program with NSI-189 -
Advancing to Phase 2.
Neurogenic Stem Cell Therapy Program with NSI-566 -
Combined Phase 1 and 2 data presented.
Neuralstem Adds Depth to its Senior Management Team with
Appointment of Industry Veterans as Second Asset Advances toward Phase 2.
"We are delighted that Jonathan and Andrew have joined
us," said Richard Garr, President and CEO, Neuralstem, Inc. "Their extensive industry experience in clinical development,
financial, and business development will be invaluable as Neuralstem advances its two lead products through clinical development."
Results of Operations for the Third
Quarter Ended September 30, 2015
Cash, cash equivalents and short-term investments
on hand was approximately $18.1 million at September 30, 2015, compared to approximately $27.5 million at December 31, 2014. The
decrease was primarily due to our cash used in operations partially offset by our raising approximately $6.0 million, net through
the issuance of our common stock from warrant exercises and from the sale of our common stock.
For the three months ended September 30,
2015, we reported a net loss of approximately $5.6 million or $0.06 per share, compared to a net loss of approximately $4.5 million
or $0.05 per share in the comparable quarter of 2014. Our operating loss for the three months ended September 30, 2015 was approximately
$5.2 million compared to a loss of approximately $4.1 million in the same quarter of 2014. The increase in operating loss was due
to an approximately $1.3 million increase in research and development expenses partially offset by an approximately $0.2 million
decrease in general and administrative expenses.
The increase in research and development
expenses was primarily attributable to an increase of approximately $1.3 million in project and laboratory expenses. These increased
expenses are all related to the expansion of our pre-clinical and clinical trial efforts and are expected to continue into subsequent
The decrease in general and administrative
expenses was primarily attributable to a decrease in legal expenses associated with reduced litigation expenses
Results of Operations for the Nine Months
Ended September 30, 2015
For the nine months ended September 30,
2015, we reported a net loss of approximately $16.1 million or $0.18 per share, compared to a net loss of approximately $17.1 million
or $0.20 per share in the comparable period of 2014. Our operating loss for the nine months ended September 30, 2015 was approximately
$14.8 million compared to a loss of approximately $12.8 million in the same period of 2014. The increase in operating loss was
due to an approximately $4.1 million increase in research and development expenses partially offset by an approximately $2.1 million
decrease in general and administrative expenses.
The increase in research and development
expenses was primarily attributable to an increase in project and laboratory expenses, and an increase in payroll and related expenses
due to increased salaries and headcount. These increased expenses are all related to the expansion of our pre-clinical and clinical
trial efforts and are expected to continue into subsequent periods.
The decrease in general and administrative
expense was primarily due to a decrease in non-cash stock based compensation and a decrease in legal fees related to reduced litigation
expense. The decrease in non-cash stock based compensation is largely the result of a first quarter 2014 expense of approximately
$2.0 million in non-cash stock based compensation expense related to a financial advisory and consulting services provider achieving
a performance based milestone that resulted in a term extension of certain common stock purchase warrants. These decreases were
partially offset by an increase in payroll related expenses due to increased salaries and headcount.
In addition, for the three and nine months
ended September 2015, we recognized approximately $0.5 million and $1.4 million respectively, of interest expense related to our
| Neuralstem, Inc. | ||||||||
| Unaudited Condensed Consolidated Balance Sheets | ||||||||
| September 30, 2015 | December 31, 2014 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 13,130,795 | $ | 12,518,980 | ||||
| Short-term investments | 5,017,453 | 15,007,478 | ||||||
| Trade and other receivables | 19,159 | 225,524 | ||||||
| Deferred financing fees, current portion | 107,096 | 135,694 | ||||||
| Prepaid expenses | 1,289,195 | 274,106 | ||||||
| Total current assets | 19,563,698 | 28,161,782 | ||||||
| Property and equipment, net | 335,863 | 301,265 | ||||||
| Patents, net | 1,147,153 | 1,233,172 | ||||||
| Deferred financing fees, net of current portion | 22,825 | 89,143 | ||||||
| Other assets | 72,163 | 58,713 | ||||||
| Total assets | $ | 21,141,702 | $ | 29,844,075 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 2,036,769 | $ | 2,504,978 | ||||
| Accrued bonuses | 767,989 | 646,960 | ||||||
| Current portion of long-term debt, net of discount | 4,457,768 | 730,012 | ||||||
| Other current liabilities | 207,292 | 126,745 | ||||||
| Total current liabilities | 7,469,818 | 4,008,695 | ||||||
| Long-term debt, net of discount and current portion | 4,625,394 | 8,056,470 | ||||||
| Other long-term liabilities | 143,730 | 59,574 | ||||||
| Total liabilities | 12,238,942 | 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, 91,786,290 and 87,789,679 shares outstanding in 2015 and 2014 , respectively | 917,863 | 877,897 | ||||||
| Additional paid-in capital | 175,174,708 | 167,890,220 | ||||||
| Accumulated other comprehensive income | 3,720 | 6,000 | ||||||
| Accumulated deficit | (167,193,531 | ) | (151,054,781 | ) | ||||
| Total stockholders' equity | 8,902,760 | 17,719,336 | ||||||
| Total liabilities and stockholders' equity | $ | 21,141,702 | $ | 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues | $ | 2,500 | $ | 5,000 | $ | 7,917 | $ | 14,167 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 3,392,086 | 2,109,880 | 9,887,750 | 5,747,922 | ||||||||||||
| General and administrative expenses | 1,807,934 | 2,001,865 | 4,925,389 | 7,061,129 | ||||||||||||
| Total operating expenses | 5,200,020 | 4,111,745 | 14,813,139 | 12,809,051 | ||||||||||||
| Operating loss | (5,197,520 | ) | (4,106,745 | ) | (14,805,222 | ) | (12,794,884 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 24,149 | 13,127 | 53,802 | 55,267 | ||||||||||||
| Interest expense | (464,197 | ) | (361,619 | ) | (1,377,004 | ) | (1,191,976 | ) | ||||||||
| Warrant modification expense | - | (3,109,850 | ) | |||||||||||||
| Loss from change in fair value of derivative instruments | - | - | - | (334,133 | ) | |||||||||||
| Other income (expense) | - | - | (10,326 | ) | 250,000 | |||||||||||
| Total other income (expense) | (440,048 | ) | (348,492 | ) | (1,333,528 | ) | (4,330,692 | ) | ||||||||
| Net loss | $ | (5,637,568 | ) | $ | (4,455,237 | ) | $ | (16,138,750 | ) | $ | (17,125,576 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.06 | ) | $ | (0.05 | ) | $ | (0.18 | ) | $ | (0.20 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 91,569,826 | 87,366,234 | 90,532,073 | 86,777,197 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (5,637,568 | ) | $ | (4,455,237 | ) | $ | (16,138,750 | ) | $ | (17,125,576 | ) | ||||
| Foreign currency translation adjustment | (2,275 | ) | 3 | (2,280 | ) | (1,131 | ) | |||||||||
| Comprehensive loss | $ | (5,639,843 | ) | $ | (4,455,234 | ) | $ | (16,141,030 | ) | $ | (17,126,707 | ) |
See accompanying notes to unaudited condensed consolidated financial statements.
Neuralstem's patented technology enables
the commercial-scale production of multiple types of central nervous system stem cells, which are under development for the potential
treatment of central nervous system diseases and conditions.
Neuralstem's ability to generate human
neural stem cell lines for chemical screening has led to the discovery and patenting of compounds that Neuralstem believes may
stimulate the brain's capacity to generate neurons, potentially reversing pathologies associated with certain central nervous system
(CNS) conditions. The company has completed Phase Ia and Ib 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 II study for MDD.
Neuralstem's first stem cell product candidate,
NSI-566, a human 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 that met primary safety endpoints. In addition
to ALS, NSI-566 is also in a Phase I study for the treatment of chronic spinal cord injury at UC San Diego School of Medicine,
as well as in clinical development to treat ischemic stroke.
Neuralstem's next generation stem cell
product, NSI-532.IGF, consists of human cortex-derived neural stem cells that have been engineered to secrete human insulin-like
growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued
spatial learning and memory deficits in an animal model of Alzheimer's disease.
For more information, please visit www.neuralstem.com
or connect with us on Twitter, Facebook and LinkedIn
Cautionary Statement Regarding Forward
Looking Information:
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, 2014, and Form 10-Q for the three and nine months ended September 30, 2015, filed with the Securities and Exchange Commission
(SEC), and in other reports filed with the SEC.
Neuralstem - Investor Relations:
dspangler@neuralstem.com 301.366.1481
MDC Group - Investor Relations:
Susan Roush 747.222.7012
David Castaneda 414.351.9758