Full Press Release Details
NEURALSTEM REPORTS FISCAL 2014 FOURTH
QUARTER FINANCIAL AND YEAR-END BUSINESS RESULTS
GERMANTOWN, MD, March 16, 2015 -- Neuralstem,
Inc. (NYSE MKT: CUR) (the "Company" or "Neuralstem") today reported its financial results for the fourth
quarter and year ended December 31, 2014.
has progressed into a clinical development stage company focused on the central nervous system (CNS)," said Richard Garr,
Neuralstem President and CEO. "During 2014 we added two established industry leaders as Independent Directors, Catherine
Angell Sohn, Pharm.D. and Sandford Drexel Smith. Dr. Sohn is the former Senior Vice President of Business Development and Strategic
Alliance, GSK Consumer Healthcare, at GlaxoSmithKline. Mr. Smith is the former Executive Vice President of Genzyme Corporation.
The Company moved forward two lead clinical assets: our small molecule neurogenic drug candidate NSI-189 and our spinal derived
neural stem cell therapeutic candidate NSI-566. We established and/or grew clinical research programs with leading investigators
at Emory University, University of California, San Diego (UCSD), University of Michigan and Massachusetts General Hospital. Our
investigators published and presented proof of principle data in both lead assets as highlighted below. In 2015, we plan to begin
clinical development of our NSI-189 small molecule drug in a second indication for the treatment of cognitive deficit from schizophrenia,
and we plan to initiate a Phase II clinical trial for the ongoing development program for the treatment of major depressive disorder
(MDD). The cell therapy programs in amyotrophic lateral sclerosis (ALS), chronic spinal cord injury (cSCI) and stroke will also
move forward. We expect this to be another important year continuing our development and progress across both platforms."
2014 Clinical Program and Business Highlights
Neurogenic Small Molecule Platform Clinical Development
Cell Therapy Platform Clinical Development
NSI-566 spinal cord-derived stem cell therapy under development
for the treatment of ALS
NSI-566 spinal cord-derived cell therapy
under development for the treatment of cSCI
NSI-566 spinal cord derived stem cell therapy under development
for the treatment of motor deficits in stroke
NSI-532.IGF second generation gene engineered cell therapy
2014 Business Highlights
Board of Directors: Neuralstem appointed
two independent directors to its Board of Directors in 2014, Catherine Angell Sohn, Pharm.D. and Sandford Drexel Smith. Dr. Sohn
is the former Senior Vice President of Business Development and Strategic Alliance, GSK Consumer Healthcare, at GlaxoSmithKline.
Mr. Smith is the former Executive Vice President of Genzyme Corporation.
Financial: In January 2014, Neuralstem
closed a $20 million registered direct offering with proceeds intended to fund its ongoing clinical trials and corporate operations.
Financial Results for the Year Ended
Cash, cash equivalents and short-term investments
on hand was approximately $27.5 million at December 31, 2014, compared to approximately $16.8 million at December 31, 2013. The
increase was primarily due to our raising approximately $19.5 million, net, through the sale of our common stock and warrants,
and approximately $4.2 million, net, from our October 2014 debt amendment transaction, partially offset by cash used in our operations.
In the year ended December 31, 2014, we
reported a net loss of approximately $22.6 million or $0.26 per share, compared to a loss of approximately $19.8 million or $0.27
per share in the year ended December 31, 2013. Our operating loss in the year ended December 31, 2014 was approximately $17.4 million,
compared to a loss of approximately $12.5 million in the year ended December 31, 2013. The increase in operating loss was primarily
attributable to an increase of approximately $3.7 million in general and administrative expenses coupled with an increase of approximately
$1.0 million in research and development expenses.
The increase in research and development
expenses was primarily attributable to an increase of approximately $0.7 million in payroll and related expenses due to increased
salaries and headcount, an increase of approximately $0.1 million in project and lab expenses and an increase of approximately
$0.1 million in travel and related expenses due to our clinical trial activities. These increased expenses are all related to a
ramping-up of our pre-clinical and clinical trial efforts and are expected to continue into subsequent periods.
The increase in general and administrative
expenses was primarily attributable to an increase of approximately $2.0 million in non-cash stock based compensation expenses
primarily related to financial advisory and consultant services' achieving a performance based milestone that resulted in
a term extension of certain common stock purchase warrants, an increase of approximately $1.0 million in legal and professional
fees related to patent, litigation and other corporate matters, an increase of approximately $0.6 million in consulting fees primarily
related to new business development efforts and an increase of approximately $0.2 million in payroll and related expenses due to
current year headcount increases.
In addition, in the year ended December
31, 2014 we recorded approximately $5.2 million of other expenses, primarily comprised of approximately $3.1 million related to
our extension of certain common stock purchase warrants, approximately $1.6 million of interest expenses principally related to
our long-term debt, a loss of approximately $0.4 million on our debt amendment transaction and approximately $0.3 million related
to the change in fair value of the Company's warrant liabilities, partially offset by approximately $0.3 million of income
from a milestone payment from a legal settlement.
| Neuralstem, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| December 31, | ||||||||
| 2014 | 2013 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 12,518,980 | $ | 16,846,052 | ||||
| Short term investments | 15,007,478 | - | ||||||
| Trade and other receivables | 225,524 | 10,000 | ||||||
| Deferred financing fees, current portion | 135,694 | 507,334 | ||||||
| Prepaid expenses | 274,106 | 255,733 | ||||||
| Total current assets | 28,161,782 | 17,619,119 | ||||||
| Property and equipment, net | 301,265 | 230,971 | ||||||
| Patents, net | 1,233,172 | 1,137,701 | ||||||
| Deferred financing fees, net of current portion | 89,143 | 360,848 | ||||||
| Other assets | 58,713 | 64,897 | ||||||
| Total assets | $ | 29,844,075 | $ | 19,413,536 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 2,504,978 | $ | 1,196,190 | ||||
| Accrued bonuses | 646,960 | 465,868 | ||||||
| Current portion of long term debt, net of discount | 730,012 | 2,763,121 | ||||||
| Derivative instruments | - | 1,417,527 | ||||||
| Other current liabilities | 126,745 | 93,426 | ||||||
| Total current liabilities | 4,008,695 | 5,936,132 | ||||||
| Long term debt, net of discount and current portion | 8,056,470 | 4,934,210 | ||||||
| Other long term liabilities | 59,574 | 124,995 | ||||||
| Total liabilities | 12,124,739 | 10,995,337 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding | - | - | ||||||
| Common stock, $0.01 par value; 300 million shares authorized , 87,789,679 and 77,886,031 shares issued and outstanding in 2014 and 2013, respectively | 877,897 | 778,860 | ||||||
| Additional paid-in capital | 167,890,220 | 136,058,135 | ||||||
| Accumulated other comprehensive income | 6,000 | 7,241 | ||||||
| Accumulated deficit | (151,054,781 | ) | (128,426,037 | ) | ||||
| Total stockholders' equity | 17,719,336 | 8,418,199 | ||||||
| Total liabilities and stockholders' equity | $ | 29,844,075 | $ | 19,413,536 |
| Neuralstem, Inc. | ||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| Year Ended December 31, | ||||||||
| 2014 | 2013 | |||||||
| Revenues | $ | 18,833 | $ | 110,000 | ||||
| Operating expenses: | ||||||||
| Research and development costs | 8,134,753 | 7,134,301 | ||||||
| General and administrative expenses | 8,971,299 | 5,254,915 | ||||||
| Depreciation and amortization | 348,630 | 244,725 | ||||||
| Total operating expenses | 17,454,682 | 12,633,941 | ||||||
| Operating loss | (17,435,849 | ) | (12,523,941 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 67,651 | 68,000 | ||||||
| Interest expense | (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 extinguishment | (445,787 | ) | - | |||||
| Litigation settlement | 250,000 | 838 | ||||||
| Total other income (expense) | (5,192,895 | ) | (7,307,921 | ) | ||||
| Net loss | $ | (22,628,744 | ) | $ | (19,831,862 | ) | ||
| Net loss per share - basic and diluted | $ | (0.26 | ) | $ | (0.27 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 87,086,345 | 72,279,210 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (22,628,744 | ) | $ | (19,831,862 | ) | ||
| Foreign currency translation adjustment | (1,241 | ) | 7,241 | |||||
| Comprehensive loss | $ | (22,629,985 | ) | $ | (19,824,621 | ) |
Neuralstem's patented technology
enables the production of multiple types of central nervous system (CNS) stem cells in commercial quantities for the potential
treatment of certain CNS diseases and conditions.
The human neural stem cell lines Neuralstem
has generated for chemical screening has led to the discovery and patenting of compounds that may stimulate the brain's capacity
to generate neurons, possibly reversing pathologies associated with certain 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 launch a Phase II study for MDD and a Phase Ib study for cognitive deficit in schizophrenia
Neuralstem's first stem cell product
candidate, NSI-566, a spinal cord-derived neural stem cell line, is in an ongoing clinical trial for the treatment of amyotrophic
lateral sclerosis (ALS, or Lou Gehrig's disease). Phase II surgeries were completed in July 2014. A later stage trial is
anticipated to commence in 2015 at multiple centers. Neuralstem received orphan designation by the FDA for NSI-566 in ALS. In addition
to ALS, NSI-566 is also being tested in a Phase I trial in chronic spinal cord injury at University of California, San Diego School
of Medicine. NSI-566 is also in clinical development for the treatment of neurological diseases such as ischemic stroke and acute
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:
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, 2014, filed with the Securities and Exchange
Commission (SEC) on March 16, 2015, and in other reports filed with the SEC.
| Contact: | |
| Neuralstem - Investor Relations: | |
| Danielle Spangler | 301.366.1481 |
| Planet Communications - Media Relations: | |
| Deanne Eagle | 917.837.5866 |
| MDC Group - Investor Relations: | |
| Susan Roush | 747.222.7012 |
| David Castaneda | 414.351.9758 |