UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event
reported): March 16, 2015
Neuralstem, Inc.
(Exact name of registrant as specified
in Charter)
| Delaware |
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000-1357459 |
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52-2007292 |
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(State or other jurisdiction of
incorporation or organization) |
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(Commission File No.) |
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(IRS Employee Identification No.) |
20271
Goldenrod Lane, 2nd Floor
Germantown, Maryland 20876
(Address of Principal Executive Offices)
(301)
366-4960
(Issuer Telephone
number)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02. | Results of Operations and Financial Condition. |
On March 16, 2015, Neuralstem, Inc. (the
“Company”) reported fiscal 2014 fourth quarter and year-end business results for the year ended December 31, 2014 and
provided an update on clinical programs and business highlights. The press release is attached as Exhibit 99.01 and is incorporated
herein by reference.
The information furnished under Items 2.02,
including the accompanying Exhibit 99.01 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information
be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933 or the Exchange
Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
| Item 9.01. | Financial Statement and Exhibits. |
| Exhibit Number |
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Description |
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| 99.01 |
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Press Release Dated March 16, 2015 |
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SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto
duly authorized.
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NEURALSTEM, INC |
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By: |
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/s/ I. Richard Garr
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I. Richard Garr
Chief Executive Officer |
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Dated: March 16, 2015
Exhibit
Index
| Exhibit Number |
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Description |
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| 99.01 |
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Press Release Dated March 16, 2015 |
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Exhibit 99.01
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.
“Neuralstem
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
| · | NSI-189 Phase II clinical trial for the treatment of MDD is expected
to commence in the second quarter of 2015. Maurizio Fava, M.D., Slater Family Professor of Psychiatry at Harvard Medical School,
Massachusetts General Hospital is the principal investigator for the 150-patient, multi-site clinical trial. |
| · | Top-line data for the NSI-189 Phase Ib MDD trial. The data
was presented at the American Society of Clinical Psychopharmacology (ASCP) and the International College of Neuropyschopharmacology
(CiNP) annual meetings. The randomized, placebo-controlled, dose-escalation study showed clinically meaningful and statistically
significant results in depressive and cognitive measurements at the end of the 28-day dosing period. Moreover, therapeutic benefits
were sustained over the 8-week follow-up period signaling possible hippocampal neurogenesis. |
| · | NSI-189 MDD biomarker data. In November 2014, researchers presented
Phase Ib blood-based biomarker data and analysis for MDD in a poster at the CNS Summit, which identified a rapid and persistently
efficacious response. |
| · | Expansion of NSI-189 development program to a second indication
for the treatment of cognitive deficit in schizophrenia. Cognitive deficit in schizophrenia is a prominent characteristic
of the disorder that is correlated with the occurrence of hippocampal atrophy in this patient population. Commencement of the Company’s
NSI-189 cognitive deficit in schizophrenia Phase Ib trial is expected in 2015. |
Cell Therapy Platform Clinical Development
NSI-566 spinal cord-derived stem cell therapy under development
for the treatment of ALS
| · | Top-line data for the Phase II NSI-566
ALS trial. Topline ALS Phase II data were released on March 12, 2015. Our top-line data in the Phase II ALS clinical trial
met the primary safety endpoints and established what we believe to be the maximum tolerated dose of 16 million cells delivered
in 40 injections. The secondary efficacy endpoints of ALSFRS and grip strength at nine months post-surgery demonstrated statistical
significance in a comparison between responders and non-responders at nine months post-surgery; and as in the Phase I trial, disease
stabilization was seen in the responders. We plan to present the full Phase II trial data later in 2015. This dose-escalating trial
treated 15 ambulatory patients in five cohorts. Each of the three patients in the final cohort received a total dose of 40 injections
of 400,000 cells, 20 injections each in the cervical and lumbar regions, for a total 16 million transplanted cells per patient.
A larger, controlled Phase II trial is expected to commence in 2015. |
| · | Phase I cell survival study data. In
November 2014, a long-term NSI-566 ALS Phase I cell survival study, entitled “Analysis of graft survival in a trial of stem
cell transplant in ALS,” was published in the journal “Annals of Clinical and Translational Neurology.” Researchers
concluded that NSI-566 cells survived for the entire post-operative period of each of the autopsied patients studied from nine
to thirty months post-transplantation. They also concluded that long-term immunosuppression was most likely not required for long-term
survival of the cells. |
NSI-566 spinal cord-derived cell therapy
under development for the treatment of cSCI
| · | Commencement of Phase I cSCI. The
first two patients have been treated in a Phase I trial for cSCI at the UCSD School of Medicine, supported
by the UCSD Sanford Stem Cell Clinical Center. The four-patient stem cell transplantation safety trial is currently enrolling
patients and expects to report full data in the fourth quarter of 2015, following a six-month post-surgery study for each patient.
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NSI-566 spinal cord derived stem cell therapy under development
for the treatment of motor deficits in stroke
| · | Advancement in Phase I/II ischemic
stroke trial. Neuralstem continued to enroll patients in its collaborative Phase I/II ischemic stroke trial with BaYi Brain
Hospital in Beijing. The Phase II, controlled proof-of-concept study, is expected to commence in 2015.
The trial is sponsored by Neuralstem’s wholly owned subsidiary, Suzhou Sun-Now Biopharmaceutical Co. Ltd. (“Neuralstem
China”), which was formed to develop Neuralstem’s cell therapy products in China. |
NSI-532.IGF second generation gene engineered cell therapy
| · | Expansion of cell therapy development
program to include a second cell line engineered to express human insulin-like growth factor 1 (IGF-1). NSI-532.IGF
cells are a cortical neural stem cell line engineered to deliver IGF-1, which is intended to provide an extra therapeutic benefit.
This is the first instance in which Neuralstem is working to demonstrate the ability of it cells to act as a stable CNS delivery
vehicle for gene therapy. |
| · | NSI-532.IGF preclinical Alzheimer’s
data. In October 2014, the first data were presented at the Congress of Neurological Surgeons Annual Meeting. In a presentation
titled, “Peri-hippocampal stem cell transplantation rescues cognitive decline in Alzheimer’s disease,” University
of Michigan Medical School researchers concluded that Neuralstem’s NSI-532.IGF cells rescued spatial learning and memory
deficits in mice with an animal model of Alzheimer’s disease. |
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
December 31, 2014
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. |
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| Consolidated Balance Sheets |
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December 31, | |
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2014 | | |
2013 | |
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| ASSETS | |
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| CURRENT ASSETS | |
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| 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 | |
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| 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 | |
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| LIABILITIES AND STOCKHOLDERS' EQUITY | |
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| CURRENT LIABILITIES | |
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| 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 | |
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| 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 | |
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| STOCKHOLDERS' EQUITY | |
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| 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. |
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| Consolidated Statements of Operations and Comprehensive Loss |
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Year Ended December 31, | |
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2014 | | |
2013 | |
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| Revenues | |
$ | 18,833 | | |
$ | 110,000 | |
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| Operating expenses: | |
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| 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 | ) |
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| Other income (expense): | |
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| 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 | ) |
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| Net loss | |
$ | (22,628,744 | ) | |
$ | (19,831,862 | ) |
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| Net loss per share - basic and diluted | |
$ | (0.26 | ) | |
$ | (0.27 | ) |
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| | | |
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| Weighted average common shares outstanding - basic and diluted | |
| 87,086,345 | | |
| 72,279,210 | |
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| Comprehensive loss: | |
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| Net loss | |
$ | (22,628,744 | ) | |
$ | (19,831,862 | ) |
| Foreign currency translation adjustment | |
| (1,241 | ) | |
| 7,241 | |
| Comprehensive loss | |
$ | (22,629,985 | ) | |
$ | (19,824,621 | ) |
About Neuralstem
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
in 2015.
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
spinal cord injury.
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: |
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| Neuralstem – Investor Relations: |
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| Danielle Spangler |
301.366.1481 |
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| Planet Communications - Media Relations: |
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| Deanne Eagle |
917.837.5866 |
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| MDC Group - Investor Relations: |
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| Susan Roush |
747.222.7012 |
| David Castaneda |
414.351.9758 |