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): May 12, 2014
Neuralstem, Inc.
(Exact name of registrant as specified
in Charter)
Delaware |
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000-1357459 |
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52-2007292 |
(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 2 40.13e-4(c)) |
| Item 2.02. | Results of Operations and Financial Condition. |
On May 12, 2014, Neuralstem, Inc. (the
“Company”) issued a press release announcing its financial results for the three months ended March 31, 2014 and providing
a business and clinical programs update. 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 May 12, 2014 |
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: May 12, 2014
Exhibit 99.01
Contact: |
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Planet Communications - Media Relations: |
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Deanne Eagle |
917.837.5866 |
MDC Group - Investor Relations: |
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Susan Roush |
747.222.7012 |
David Castaneda |
414.351.9758 |
NEURALSTEM REPORTS FIRST QUARTER FINANCIAL
RESULTS
AND PROVIDES BUSINESS AND CLINICAL UPDATE
ROCKVILLE, MD, May 12, 2014 -- Neuralstem,
Inc. (NYSE MKT: CUR) today reported its financial results for the three months ended March 31, 2014 and provided a business and
clinical update.
“During the
first quarter of 2014, we continued to advance the NSI-566 cell therapy platform through human clinical trials. We have completed
treatment of the fourth cohort in our ALS Phase II escalating dose trials, in collaboration with our sites at University of Michigan,
Emory and Massachusetts General. Patients 10, 11 and 12 each received a total of 8 million cells (20 bilateral injections of 400,000
cells) into the cervical region of the spinal cord. As our Principal Investigator, Dr. Eva Feldman, noted in her complete Phase
I data analysis this past quarter, we believe that increasing total cell dose, by increasing the number of injections and the number
of cells per injection, may increase both the duration and magnitude of the potential benefit. This is consistent with our hypothesized
neuroprotective mechanism-of-action for this cell therapy,” said Karl Johe, PhD, Neuralstem’s Chairman of the Board
and Chief Scientific Officer. “We are now treating the fifth and final cohort in the Phase II ALS trial. During May, these
patients will undergo lumbar transplantation and then return for the cervical treatment during a second surgery approximately four
weeks later. Each of these patients will then have received a total of 16 million NSI-566 neural stem cells, through 40 surgical
injections of 400,000 cells per injection. The trial will conclude after an observation period of six months from the last surgery.
Our hope and expectation is that the data from this trial will enable a registration trial that can start in early 2015.”
Dr. Johe continued:
“The second indication for NSI-566 in the U.S. is chronic spinal cord injury (cSCI). This FDA-approved trial will be conducted
in its entirety at the University of California, San Diego, School of Medicine, under the guidance of Principal Investigator, Joseph
Ciacci, MD. The Phase I trial is being made possible, in part, by generous financial support from UCSD. The eight patients will
have AIS-A level impairment, or complete paralysis, between one and two years after injury.
“Turning to Neuralstem’s
neurogenic small molecule drug program, we are currently completing our review of the data from our NSI-189 Phase Ib randomized
placebo controlled trial to treat major depressive disorder. While that task is ongoing, the early review is encouraging enough
that we have already committed to filing a Phase II trial application and hope to start that trial later this year,” concluded
Dr. Johe.
“2014 is a pivotal year for Neuralstem,”
said Richard Garr, Neuralstem’s President & CEO. “We are advancing to new clinical levels on both the small molecule
and cell therapy platforms in multiple indications. Along with our collaborators, we are proud to be pushing for breakthroughs
in the field of neurogenic medicine.”
Mr. Garr added: “As
the Company’s clinical programs mature, my fellow Directors and I were pleased
to have welcomed Dr. Catherine Sohn and Mr. Sandy Smith to our Board. Dr. Sohn formerly spearheaded global commercialization for
one of the world’s largest pharmaceutical companies, and Mr. Smith was directly responsible for launching 12 new products
in diverse therapeutic areas for one of the world’s most successful rare disease companies. Their expertise will prove invaluable
as we build the infrastructure necessary to move our company to the next level of development.”
First Quarter Clinical Program and Business
Highlights
In March, a study entitled, “Behavioral
and Histopathological Assessment of Adult Ischemic Rat Brains after Intracerebral Transplantation of NSI-566RSC Cell Lines”
was published in the peer-reviewed journal, PLOS ONE. The study, whose lead author was Cesar V. Borlongan, PhD, Professor, Department
of Neurosurgery, Morsani College of Medicine and Director of University of South Florida’s Center of Excellence for Aging
and Brain Repair, showed that ischemic-stroke rats transplanted with NSI-566 in the brain experienced functional improvements.
Furthermore, the grafts survived and differentiated into neurons. The researchers concluded that NSI-566 are potent cell donors
for transplantation therapy to treat paralysis in stroke patients.
In March, the final results from the NSI-566/ALS
Phase I trial were published in the peer-reviewed journal, ANNALS OF NEUROLOGY. In “Intraspinal Neural Stem Cell Transplantation
in Amyotrophic Lateral Sclerosis: Phase I Trial Outcomes,” results were updated from Phase I interim data, reported earlier,
to include data from the last six patients in the trial. These six patients were the first to receive cervical stem cell transplants.
The results showed that NSI-566 cells can be safely transplanted in both the lumbar and cervical spinal cord segments, did not
accelerate disease progression, and warrant further study on dosing and therapeutic efficacy.
In March, President and CEO Richard Garr
presented an NSI-566 clinical trials program update at the eighth annual Bio-Europe Spring Conference 2014.
In February, Richard Garr presented an
NSI-566 clinical update at the sixteenth annual BIO CEO & Investor Conference 2014.
In January, Neuralstem announced that the
first patient was treated, on December 27, 2013, in the NSI-566 Phase I/II trial to treat motor deficits from ischemic stroke at
BaYi Brain Hospital in Beijing. The trial is sponsored by Neuralstem’s wholly owned subsidiary, Neuralstem China (Suzhou
Sun-Now Biopharmaceutical Co. Ltd.), which was formed to develop Neuralstem’s cell therapy products in China. The stroke
motor deficit trial, expected to last two years, is the first in which Neuralstem’s cells are being transplanted directly
into the patient’s brain.
In January, Neuralstem appointed Catherine
Sohn, Doctor of Pharmacy (Pharm.D.), to its Board of Directors. Dr. Sohn is the former Senior Vice President of Business Development
and Strategic Alliance, GSK Consumer Healthcare, at GlaxoSmithKline, where she spearheaded global commercialization for this $8
billion division and led a series of international licensing deals. Earlier during her 28-year tenure at GlaxoSmithKline, Dr. Sohn
established the U.S. Vaccine Business Unit, leading to the launch of the company’s first vaccine in the U.S., which grew
to more than $100 million in sales. She was also involved in the U.S. launch of the company’s CNS product, Paxil, which subsequently
grew to more than $1 billion in sales.
In January, Neuralstem closed a $20 million
registered direct offering from leading institutional investors, including dedicated healthcare investors, with proceeds intended
to fund its ongoing clinical trials and for working capital and general corporate purposes.
In January, Richard Garr presented a business
overview and NSI-566 clinical update at the sixth annual 2014 Biotech Showcase.
Subsequent Events:
In April, the FDA-approved NSI-566 Phase
I trial to treat chronic spinal cord injury (cSCI) was approved to commence at the University of California, San Diego, School
of Medicine by its Institutional Review Board. The open-label, ascending-dose study has a one-year completion goal and will enroll
up to eight patients with thoracic spinal cord injuries who have an American Spinal Injury Association AIS-A level of impairment
(patients who are considered to be in complete paralysis) between one and two years post injury. NSI-566/cSCI patients will also
receive post-surgery immunosuppressive therapy as tolerated and physical therapy for three months. The trial study period will
end six months post-surgery for each patient.
In April, NSI-566/ALS Principal Investigator,
Eva Feldman, PhD, MD, presented published Phase I data at the Keystone Symposia, “Engineering Cell Fate and Function.”
Dr. Feldman took part in a workshop, organized in collaboration with California Institute for Regenerative Medicine, called “Clinical
Progress for Stem Cell Therapies. Dr. Feldman also provided the first public update on Phase II of the trial.
In May, Sandford Drexel Smith was appointed
to Neuralstem’s Board of Directors. Mr. Smith is the former President, International Group, and Executive Vice President
of Genzyme Corporation. As President of the International Group, Mr. Smith opened markets in Latin America, China, India, Russia
and Eastern Europe, establishing more than 45 offices worldwide, and was responsible for the launch of 12 new products in diverse
therapeutic areas. He grew Genzyme’s international business to $3.1 billion, or 60% of the company’s total revenues.
In 2011, Genzyme was acquired by Sanofi, one of the world’s largest healthcare companies.
First Quarter Financial Results
For the first quarter of 2014, the Company
reported a net loss of approximately $5,919,000 or $0.07 per share, compared with a net loss of approximately $3,590,000 or $0.05
per share, for the comparable 2013 period. The increase in net loss was primarily comprised of a $2,286,000 increase in operating
loss due to a non-cash charge of approximately $2,018,000 related to a consultant achieving
a performance based milestone which resulted in a term extension of certain common stock purchase warrants and an increase of approximately
$227,000 in legal and professional fees, partially offset by a $233,000 decrease in project and lab expenses related to certain
projects not continuing into the first quarter of 2014 and the cost of certain studies in 2014 being subsidized by third parties.
The net loss in the first quarter of 2014
also included other expenses comprised of approximately $432,000 in interest expense related to our long term debt and a $334,000
non-cash expense related to the change in the fair value of the our derivative instruments. The first quarter of 2013 included
a $667,000 non-cash expense related to the modification of certain stock purchase warrants.
Our cash, cash
equivalents and short-term investments on hand was approximately $33,343,000 at March 31, 2014, compared to approximately $16,846,000
at December 31, 2013. The increase of approximately $16,497,000, was primarily due to our raising $18.7 million through
our January 2014 registered direct offering coupled with $1.4 million of proceeds from the exercise of certain common stock purchase
warrants, partially offset by cash used in operations.
Neuralstem, Inc. |
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Unaudited Condensed Consolidated Balance Sheets |
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March 31, 2014 | | |
December 31, 2013 | |
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ASSETS | |
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CURRENT ASSETS | |
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Cash and cash equivalents | |
$ | 18,342,736 | | |
$ | 16,846,052 | |
Short-term investments | |
| 15,000,000 | | |
| - | |
Billed and unbilled receivables | |
| 11,359 | | |
| 10,000 | |
Deferred financing fees, current portion | |
| 435,547 | | |
| 507,334 | |
Prepaid expenses | |
| 319,616 | | |
| 255,733 | |
Total current assets | |
| 34,109,258 | | |
| 17,619,119 | |
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Property and equipment, net | |
| 310,375 | | |
| 230,971 | |
Patents, net | |
| 1,190,625 | | |
| 1,137,701 | |
Deferred financing fees, net of current portion | |
| 248,688 | | |
| 360,848 | |
Other assets | |
| 64,850 | | |
| 64,897 | |
Total assets | |
$ | 35,923,796 | | |
$ | 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 | |
$ | 1,771,111 | | |
$ | 1,662,058 | |
Current portion of long term debt, net of discount | |
| 2,849,812 | | |
| 2,763,121 | |
Derivative instruments | |
| - | | |
| 1,417,527 | |
Other current liabilities | |
| 53,280 | | |
| 93,426 | |
Total current liabilities | |
| 4,674,203 | | |
| 5,936,132 | |
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Long term debt, net of discount and current portion | |
| 4,192,538 | | |
| 4,934,210 | |
Other long term liabilities | |
| 160,338 | | |
| 124,995 | |
Total liabilities | |
| 9,027,079 | | |
| 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; 150 million shares authorized, 86,688,613 and 77,886,031 shares outstanding in 2014 and 2013, respectively | |
| 866,886 | | |
| 778,860 | |
Additional paid-in capital | |
| 160,368,948 | | |
| 136,058,135 | |
Accumulated other comprehensive income | |
| 5,977 | | |
| 7,241 | |
Accumulated deficit | |
| (134,345,094 | ) | |
| (128,426,037 | ) |
Total stockholders' equity | |
| 26,896,717 | | |
| 8,418,199 | |
Total liabilities and stockholders' equity | |
$ | 35,923,796 | | |
$ | 19,413,536 | |
Neuralstem, Inc. |
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Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Three Months Ended March 31, | |
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2014 | | |
2013 | |
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Revenues | |
$ | 4,167 | | |
$ | 102,500 | |
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Operating expenses: | |
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Research and development expenses | |
| 1,571,221 | | |
| 1,748,347 | |
General and administrative expenses | |
| 3,519,359 | | |
| 1,195,840 | |
Depreciation and amortization | |
| 90,488 | | |
| 50,093 | |
Total operating expenses | |
| 5,181,068 | | |
| 2,994,280 | |
Operating loss | |
| (5,176,901 | ) | |
| (2,891,780 | ) |
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Other income (expense): | |
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Interest income | |
| 24,718 | | |
| 9,925 | |
Interest expense | |
| (432,741 | ) | |
| (48,257 | ) |
Warrant modification expense | |
| - | | |
| (666,736 | ) |
Gain (loss) from change in fair value of derivative instruments | |
| (334,133 | ) | |
| 6,518 | |
Other income | |
| - | | |
| 243 | |
Total other income (expense) | |
| (742,156 | ) | |
| (698,307 | ) |
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Net loss | |
$ | (5,919,057 | ) | |
$ | (3,590,087 | ) |
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Net loss per share - basic and diluted | |
$ | (0.07 | ) | |
$ | (0.05 | ) |
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Weighted average common shares outstanding - basic and diluted | |
| 85,750,298 | | |
| 68,700,709 | |
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Comprehensive loss: | |
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Net loss | |
$ | (5,919,057 | ) | |
$ | (3,590,087 | ) |
Foreign currency translation adjustment | |
| (1,264 | ) | |
| - | |
Comprehensive loss | |
$ | (5,920,321 | ) | |
$ | (3,590,087 | ) |
About Neuralstem
Neuralstem's patented technology enables
the production of neural stem cells of the brain and spinal cord in commercial quantities, and the ability to control the differentiation
of these cells constitutively into mature, physiologically relevant human neurons and glial cells. Neuralstem’s NSI-566 spinal
cord-derived stem cell therapy is in Phase II clinical trials for amyotrophic lateral sclerosis (ALS), often referred to as Lou
Gehrig's disease. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy. The company has received
approval to commence an FDA-approved Phase I safety trial in chronic spinal cord injury at the University of California, San Diego,
School of Medicine. Neuralstem is also targeting additional major central nervous system conditions with its NSI-566 cell therapy
platform, including ischemic stroke and acute spinal cord injury.
Neuralstem also maintains the ability to
generate stable human neural stem cell lines suitable for systematic screening of large chemical libraries. Through this proprietary
screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate neurons,
possibly reversing pathologies associated with certain central nervous system conditions. The company has completed a Phase
I safety trial evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive
disorder (MDD). Additional indications might include traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic
stress disorder (PTSD).
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 may contain forward-looking
statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors
are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies
constitute forward-looking statements that involve risks and uncertainties, including, without limitation, 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, 2013 and the Form 10-Q for the period ended March 31,
2014.
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