Full Press Release Details
Neuralstem Reports First Quarter 2015
And Provides Business
GERMANTOWN, MD, May 8, 2015 -- Neuralstem,
Inc. (NYSE MKT: CUR) a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments
for central nervous system diseases, reported its financial results for the three months ended March 31, 2015 and provided a business
and clinical update.
"Neuralstem made substantial clinical
progress this quarter in both our cell therapy and small molecule programs. We announced positive top-line safety data and encouraging
secondary efficacy data for our Phase II ALS clinical trial, and look forward with anticipation to the release of the comprehensive
data and analysis," said Richard Garr, Neuralstem CEO. "Additionally, as we began to prepare for the NSI-189 MDD Phase
II trial, we announced a second NSI-189 indication, cognitive deficit in schizophrenia, in which we will also commence a trial
Neurogenic Small Molecule Program
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 chronic spinal cord injury (cSCI)
NSI-566 spinal cord derived stem cell therapy under development
for the treatment of motor deficits in stroke
Neuralstem announced the appointment of
Jonathan Lloyd Jones to the position of Chief Financial Officer, effective May 18, 2015. Mr. Lloyd Jones brings to the
position more than 25 years of corporate finance and business development experience. He previously served as Chief Financial Officer
at Columbia Laboratories (Juniper Pharmaceuticals), CFO and VP of Corporate Development at TetraLogic, and Senior Director, Corporate
Development at Genzyme Corporation (Sanofi-Aventis). Mr. Lloyd Jones is a Chartered Accountant who holds a MBA degree from the
Wharton School of the University of Pennsylvania a BS from the University of Bradford.
Neuralstem's President and CEO, Richard
Garr presented an overview of the company's cell therapy and neurogenic small molecule clinical trials at three investor
conferences in the first quarter of 2015: Biotech Showcase in San Francisco, BIO CEO & Investor Conference in New York City,
and Barclays Global Healthcare Conference in Miami.
In March, New Zealand issued a patent (623207) for "Methods
for Treating and/or Reversing Neurodegenerative Diseases and/or Disorders."
Results of Operations for the Quarter
Ended March 31, 2015:
Cash, cash equivalents and short-term investments
on hand was approximately $28.6 million at March 31, 2015, compared to approximately $27.5 million at December 31, 2014. The increase
was primarily due to 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 largely offset by cash used in our operations.
In the quarter ended March 31, 2015, we
reported a net loss of approximately $5.1 million or $0.06 per share, compared to a loss of approximately $5.9 million or $0.07
per share in the first quarter of 2014. Our operating loss in the quarter ended March 31, 2015 was approximately $4.6 million compared
to a loss of $5.2 million in the same quarter of 2014. The decrease in operating loss was primarily attributable to a decrease
of approximately $2.1 million in general and administrative expenses largely offset by an increase of approximately $1.6 million
in research and development expenses.
The increase in research and development
expenses was primarily attributable to an increase of approximately $1.2 million in project and lab expenses and an increase of
approximately $0.3 million in payroll and related expenses due to increased salaries and headcount. 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 decrease in general and administrative
expenses was primarily attributable to a decrease of approximately $1.8 million in non-cash stock based compensation 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. This was coupled with a decrease of approximately $0.5 million in legal fees resulting
from insurance claims related to litigation expense. These decreases were partially offset by increases of approximately $0.1 million
in each of consulting fees and payroll related expenses due to increased salaries and headcount.
In addition, in the first quarter of 2015
we recognized approximately $0.4 million of other expenses primarily comprised of interest expenses related to our long-term debt.
| Neuralstem, Inc. |
| Unaudited Condensed Consolidated Balance Sheets |
| March 31, 2015 | December 31, 2014 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 13,593,461 | $ | 12,518,980 | ||||
| Short-term investments | 15,032,419 | 15,007,478 | ||||||
| Trade and other receivables | 8,173 | 225,524 | ||||||
| Deferred financing fees, current portion | 130,677 | 135,694 | ||||||
| Prepaid expenses | 388,065 | 274,106 | ||||||
| Total current assets | 29,152,795 | 28,161,782 | ||||||
| Property and equipment, net | 282,057 | 301,265 | ||||||
| Patents, net | 1,242,026 | 1,233,172 | ||||||
| Deferred financing fees, net of current portion | 62,992 | 89,143 | ||||||
| Other assets | 59,098 | 58,713 | ||||||
| Total assets | $ | 30,798,968 | $ | 29,844,075 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 2,129,199 | $ | 2,504,978 | ||||
| Accrued bonuses | 225,321 | 646,960 | ||||||
| Current portion of long term debt, net of discount | 1,929,010 | 730,012 | ||||||
| Other current liabilities | 52,856 | 126,745 | ||||||
| Total current liabilities | 4,336,386 | 4,008,695 | ||||||
| Long term debt, net of discount and current portion | 6,954,895 | 8,056,470 | ||||||
| Other long term liabilities | 146,165 | 59,574 | ||||||
| Total liabilities | 11,437,446 | 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, 90,336,643 and 87,789,679 shares outstanding in 2015 and 2014 , respectively | 903,366 | 877,897 | ||||||
| Additional paid-in capital | 174,596,927 | 167,890,220 | ||||||
| Accumulated other comprehensive income | 6,013 | 6,000 | ||||||
| Accumulated deficit | (156,144,784 | ) | (151,054,781 | ) | ||||
| Total stockholders' equity | 19,361,522 | 17,719,336 | ||||||
| Total liabilities and stockholders' equity | $ | 30,798,968 | $ | 29,844,075 |
| Neuralstem, Inc. | ||||||||
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| Three Months Ended March 31, | ||||||||
| 2015 | 2014 | |||||||
| Revenues | $ | 2,917 | $ | 4,167 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 3,134,394 | 1,571,221 | ||||||
| General and administrative expenses | 1,434,588 | 3,519,359 | ||||||
| Depreciation and amortization | 83,773 | 90,488 | ||||||
| Total operating expenses | 4,652,755 | 5,181,068 | ||||||
| Operating loss | (4,649,838 | ) | (5,176,901 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 13,569 | 24,718 | ||||||
| Interest expense | (453,734 | ) | (432,741 | ) | ||||
| Loss from change in fair value of derivative instruments | - | (334,133 | ) | |||||
| Other income | - | - | ||||||
| Total other income (expense) | (440,165 | ) | (742,156 | ) | ||||
| Net loss | $ | (5,090,003 | ) | $ | (5,919,057 | ) | ||
| Net loss per share - basic and diluted | $ | (0.06 | ) | $ | (0.07 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 89,654,634 | 85,750,298 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (5,090,003 | ) | $ | (5,919,057 | ) | ||
| Foreign currency translation adjustment | 13 | (1,264 | ) | |||||
| Comprehensive loss | $ | (5,089,990 | ) | $ | (5,920,321 | ) |
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, Form 10-Q for the period ended March 31,
2015, 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
MDC Group - Investor Relations:
Susan Roush 747.222.7012
David Castaneda 414.351.9758