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): July 27, 2012 (July 25, 2012)
Neuralstem, Inc.
(Exact name of registrant as specified
in Charter)
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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.)
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9700 Great Seneca Highway, Rockville,
Maryland 20850
(Address of Principal Executive Offices)
(301) 366-4841
(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):
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Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Item 5.02.
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Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
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On July 25, 2012, Neuralstem, Inc. (“Company”)
renewed the employment contracts of: (i) Mr. I. Richard Garr, the Company’s CEO, interim CFO and general counsel, (ii) Dr.
Karl Johe, the Company’s Chief Scientific Officer and (iii) Dr. Tom Hazel, the Company’s Senior Vice President of Research.
The renewals extend the current employment agreements of Mr. Garr, Dr. Johe and Dr. Hazel for an additional period of 60 months.
Accordingly, the termination date for the employment agreements of Mr. Garr and Dr. Johe will now be October 31, 2017. The termination
date for Dr. Hazel’s employment agreement will be August 11, 2017. All other terms and conditions of their respective employment
agreements remained the same.
In connection with Dr. Johe’s renewal,
the Company granted Dr. Johe 5,000,000 common stock purchase options. The options have an exercise price of $0.92 and a term of
10 years. The options vest at a rate of 500,000 shares every six months. In addition to the vesting conditions, vesting of the
final 2,000,000 options is also subject to the Company receiving approval from its shareholders to either: (i) make the grant on
a stand-alone basis, (ii) amend the terms of the Company’s 2010 Equity Compensation Plan (“Plan”) to increase
the number of shares available for grant under the plan by at least 2,000,000 common shares, or (iii) authorize a new equity compensation
plan covering at least 2,000,000 common shares. Additionally, the number of shares into which the final 2,500,000 options to vest
are exercisable into is subject to reduction (but not increase) if the closing price of the Company’s common stock on the
day of exercise is above $5.00. The reduction is applied to the number of shares of common stock underlying the options being exercised
by a fraction of which the numerator is $5.00 and the denominator is the closing price of the Company’s common stock on the
day of exercise, subject to further adjustment as provided for in the Plan.
The foregoing
summary of the terms of the renewal agreements of
Mr. Garr, Dr. Johe and Dr. Hazel
are subject
to, and qualified in their entirety by, the form of each respective agreement attached to this Current Report on Form 8-K as Exhibits
10.01, 10.02 and 10.03 respectively and are incorporated herein by reference.
On July 25, 2012, the Company announced
that the seventeenth patient was treated in the ongoing Phase I trial of its spinal cord neural stem cells for the treatment of
amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). A copy of the press release is attached to this report as Exhibit
99.01.
On July 26, 2012, the Company announced
that it received a notice of issuance for patent number 12/710,097 titled: “Transplantation of Human Neural Cells for Treatment
of Neurodegenerative Conditions.” A copy of the press release is attached to this report as Exhibit 99.02.
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Item 9.01
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Financial Statement and Exhibits.
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Exhibit
Number
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Description
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10.01
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Form of Renewal Agreement of I. Richard Garr
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10.02
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Form of Renewal Agreement of Dr. Karl Johe
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10.03
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Form of Renewal Agreement of Dr. Tom Hazel
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99.01
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Copy of press release issued July 25, 2012
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99.02
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Copy of press release issued July 26, 2012
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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: July 27, 2012
EXHIBITS
Exhibit
Number
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Description
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10.01
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Form of Renewal Agreement of I. Richard Garr
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10.02
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Form of Renewal Agreement of Dr. Karl Johe
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10.03
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Form of Renewal Agreement of Dr. Tom Hazel
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99.01
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Copy of press release issued July 25, 2012
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99.02
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Copy of press release issued July 26, 2012
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EMPLOYMENT AGREEMENT RENEWAL AND AMENDMENT
THIS AGREEMENT (the
“
Agreement
”) is made and entered into on July 25, 2012 by and between Neuralstem, Inc., a Delaware Corporation
(the
“
Company
”), and I. Richard Garr (“
Employee
”).
1. This
Agreement renews and amends that certain Employment Agreement dated January 1, 1997, and subsequently amended on October 31, 2005
and January 1, 2008, made and entered into by the parties hereto (the “
Employment Agreement
”).
2. The
term of the Employment Agreement is renewed for an additional 60 month term upon the expiration of the existing term, to October
31, 2017.
3. All
other provisions of the Employment Agreement shall remain in full force and effect, other than any provision that conflicts with
the terms and spirit of this Agreement.
IN WITNESS WHEREOF
, the Parties have
executed this Agreement on the date first written above.
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NEURALSTEM, INC.:
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By:
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EMPLOYEE:
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I. Richard Garr
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EMPLOYEE AGREEMENT RENEWAL AND AMENDMENT
THIS AGREEMENT (the
“
Agreement
”) is made and entered into on July 25, 2012 by and between Neuralstem, Inc., a Delaware Corporation
(the
“
Company
”), and Dr. Karl Johe (“
Employee
”).
1. This
Agreement renews and amends that certain Employee Agreement dated January 1, 2997, and subsequently amended on October 31, 2005
and January 1, 2008, made and entered into by the parties hereto (the “
Employee Agreement
”).
2. The
term of the Employee Agreement is renewed for an additional 60 month term upon the expiration of the existing term.
3. The
Company grants Employee the stock options as provided for below (“Options”). In connection with such grants, the Employee
shall enter into the Company’s standard stock option agreement which will incorporate the vesting schedule and other terms
described below.
Additional Option Grant:
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Options:
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5,000,000 (subject to: (i) vesting, (ii) adjustment and (iii) the other conditions as provided for below)
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Grant Date:
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July 25, 2012
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Expiration Date:
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July 25, 2022
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Exercise Price:
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$0.92
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Vesting Schedule:
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So long as Employee continues to be employed by the Company, the options shall vest 500,000 on each of the six month anniversaries of the Grant Date so that 100% of the options will be vested on the five year anniversary of the grant date. Notwithstanding the foregoing, the vesting of the final 2,000,000 options is also subject to fulfillment of the Shareholder Approval Condition.
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Adjustment:
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The number of shares into which the final 2,500,000 options to vest are exercisable into is subject to reduction (but not increase) if the closing price of the Company’s common stock on the day of exercise is above $5.00. The reduction is applied to the number of shares of common stock underlying the options being exercised by a fraction of which the numerator is $5.00 and the denominator is the closing price of the Company’s common stock on the day of exercise, subject to further adjustment as provided for in the Company’s 2010 Equity Compensation Plan (“Plan”).
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Shareholder
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Approval Condition:
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Of the Options granted, the final 2,000,000 options to vest are intended to be a conditional grant. As a condition to that portion of the grant, the Company must receive approval from its shareholders to either: (i) make the grant on a stand-alone basis, or (ii) amend the Plan to increase the number of shares available for grant under the plan by at least 2,000,000 common shares, or (iii) authorize a new equity compensation plan covering at least 2,000,000 common shares.
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4. All
other provisions of the Employee Agreement shall remain in full force and effect, other than any provision that conflicts with
the terms and spirit of this Agreement.
IN WITNESS WHEREOF
, the Parties have
executed this Agreement on the date first written above.
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NEURALSTEM, INC.:
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By: I. Richard Garr, CEO
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EMPLOYEE:
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By: Dr. Karl Johe
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EMPLOYEE AGREEMENT RENEWAL AND AMENDMENT
THIS AGREEMENT (the
“
Agreement
”) is made and entered into on July [*], 2012 by and between Neuralstem, Inc., a Delaware Corporation
(the
“
Company
”), and Dr. Thomas G. Hazel (“
Employee
”).
1. This
Agreement renews and amends that certain Employee Agreement dated August 11, 2008, made and entered into by the parties hereto
(the “
Employee Agreement
”).
2. The
term of the Employee Agreement is renewed for an additional 60 month term upon the expiration of the existing term.
3. All
other provisions of the Employee Agreement shall remain in full force and effect, other than any provision that conflicts with
the terms and spirit of this Agreement.
IN WITNESS WHEREOF
, the Parties have
executed this Agreement on the date first written above.
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NEURALSTEM, INC.:
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By: I. Richard Garr
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EMPLOYEE:
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Dr. Thomas G. Hazel
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Contact:
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Deanne Eagle - Media Relations
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917.837.5866
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Susan Roush - Investor Relations
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818.222.8330
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SEVENTEENTH PATIENT DOSED IN NEURALSTEM
ALS STEM CELL TRIAL
ROCKVILLE, Md., July 25, 2012 -- Neuralstem,
Inc. (NYSE MKT: CUR) announced that the seventeenth patient was treated in the ongoing Phase I trial of its spinal cord neural
stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This patient is also the second to
return to the trial for additional injections. In this treatment, the patient received five injections in the cervical (upper back)
region of the spinal cord, in addition to the ten he had previously received in the lumbar (lower back) region, for a total of
15 injections. The final previously treated patient of this cervical cohort is expected to return to the trial in August, provided
the inclusion requirements continue to be met. This ground-breaking stem cell trial is taking place at Emory University Hospital
in Atlanta, Georgia.
“We are pleased that this phase
of the trial, in which we have been permitted by the FDA to take the unprecedented step of dosing patients for the second time,
is progressing as planned,” said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. “These are the
first patients in the world to receive our cells in both the lumbar and cervical regions of their spinal cords, where the stem
cell therapy could support both walking and breathing.”
About the Trial
The Phase I trial to assess the safety
of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January
2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back)
region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.
The trial then advanced to transplantation
in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The current
cohort of three is receiving injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial
design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The second of
these returning patients was just treated. The entire 18-patient trial concludes six months after the final surgery.
About Neuralstem
Neuralstem's patented technology enables
the ability to produce neural stem cells of the human 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 glia. Neuralstem is in
an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease,
and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is
also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic
paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I
safety trial in chronic spinal cord injury.
Neuralstem also has the ability to
generate stable human neural stem cell lines suitable for the 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 new
neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety
trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).
Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.
For more information, please visit
www.neuralstem.com
or connect with us on Twitter and Facebook.
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, 2011 or the Form 10-Q for the period ended March 30, 2012.
# # #
Contact:
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Deanne Eagle - Media Relations
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917.837.5866
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Susan Roush - Investor Relations
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818.222.8330
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NEURALSTEM RECEIVES NOTICE OF ISSUANCE
FOR PATENT COVERING HUMAN NEURAL CELL TRANSPLANTATION FOR NEURODEGENERATIVE CONDITIONS
ROCKVILLE, Md., July 26, 2012 -- Neuralstem,
Inc. (NYSE MKT: CUR) announced that it received a notice of issuance for patent number 12/710,097 titled: “Transplantation
of Human Neural Cells for Treatment of Neurodegenerative Conditions.” This patent covers both the culturing of central nervous
system cells as well as their transplantation into spinal cord tissue to treat neurodegenerative conditions, including amytrophic
lateral sclerosis (ALS or Lou Gehrig’s disease). Neuralstem is currently conducting a Phase I safety trial of its human spinal
cord stem cells in the treatment of ALS.
“This is a major addition to
our patent estate,” said Neuralstem Chairman & Chief Scientific Officer, Karl Johe, PhD. “This patent includes
claims covering processes for dissociating our neural stem cells from central nervous system tissue; culturing the cells; expanding
the cells in vitro and transplanting the neural stem cells into the spinal cord of a patient to treat a wide array of neurodegenerative
conditions including, amyotrophic lateral sclerosis (ALS).”
“We are pleased to have this
new patent issued, which will expire in Q1 2030,” said Neuralstem President & CEO, Richard Garr. “We have currently
transplanted 17 patients in our ALS trial and we have been encouraged by the results so far. We are focused on this program as
our first potential transplantation product. We believe that having this specific patent coverage as well as this patent life into
2030 is reflective of the value we are creating in our cell therapy programs.”
About Neuralstem
Neuralstem's patented technology enables
the ability to produce neural stem cells of the human 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 glia. Neuralstem is in
an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease,
and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is
also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic
paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I
safety trial in chronic spinal cord injury.
Neuralstem also has the ability to
generate stable human neural stem cell lines suitable for the 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 new
neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety
trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).
Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.
For more information, please visit
www.neuralstem.com
or connect with us on Twitter and Facebook.
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, 2011 or the Form 10-Q for the period ended March 30, 2012.
# # #