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):
October 6, 2014
AMARANTUS BIOSCIENCE HOLDINGS, INC.
(Exact name of registrant as specified in
its charter)
Nevada |
333-148922 |
26-0690857 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
IRS Employer
Identification No.) |
c/o Janssen Labs @QB3
953 Indiana Street
San Francisco, CA |
94107 |
(Address of Principal Executive Offices) |
(Zip Code) |
(408) 737-2734
(Registrant’s telephone number, including
area code)
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:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act |
| ¨ | 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 5.02 Departure of Directors or Certain Officers; Election
of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Effective October 6,
2014, Amarantus Bioscience Holdings, Inc., a Nevada corporation (the “Company”) entered into an employment agreement
with Gerald E. Commissiong pursuant to the employment letter (the “Employment Letter”) attached hereto as Exhibit 10.1.
Pursuant to the Employment Letter, Mr. Commissiong will continue to serve as the Company’s President and Chief Executive
Officer.
Pursuant to the Employment
Letter, Mr. Commissiong shall be entitled to an initial base salary (“Base Salary”) of $225,000 per year, which shall
automatically increase to $337,500 per year upon the Company becoming listed on the NASDAQ Stock Market. In addition to the Base
Salary, Mr. Commisiong shall be eligible for a performance bonus of up to 35% of his Base Salary, which shall be based upon certain
milestones set by the Company’s Board of Directors in their sole discretion. The Employment Letter provides for the payment
of a signing bonus of $50,000, which payment of which Mr. Commissiong agreed to defer until a later date.
In addition,
pursuant to the Employment Letter, the Company granted Mr. Commissiong stock options to purchase five million (5,000,000)
shares of the Company’s common stock at a per share price equal to fair market value on the date of the grant, subject
to a four year vesting schedule as described in the Employment Letter.
Mr. Commissiong’s
employment with the Company will be “at will”. Should Mr. Commissiong’s employment with the Company be terminated
by the Company for a reason other than for “Cause” (as defined in the Employment Letter) or Mr. Commissiong terminates
his employment with the Company for “Good Reason” (as defined in the Employment Letter), Mr. Commissiong shall, upon
execution of a release agreement with the Company, be entitled to receive as severance: (i) one year of his then Base Salary to
be paid in the form of monthly salary continuation, (ii) one year of continued coverage under the Company’s health care benefit
package, (iii) a full performance bonus equal to 35% of his then Base Salary, and (iv) immediate acceleration of 25% of all outstanding
unvested equity awards then held by Mr. Commissiong.
Should Mr. Commissiong’s
employment with the Company be terminated by the Company for a reason other than for “Cause” or Mr. Commissiong terminates
his employment with the Company for “Good Reason” in connection with or during the twelve (12) month period immediately
following the effective date of a “Change in Control” (as defined in the Employment Letter), and provided such termination
constitutes a “separation from service” as that term is defined pursuant to the Treasury Regulation Section 1-409A-1(h),
in addition to the severance package as described above, Mr. Commissiong shall be entitled to have all outstanding unvested equity
awards then held by Mr. Commissiong become fully vested and, if applicable, exercisable.
The foregoing description
of the Employment Letter does not purport to be complete and is qualified in its entirety by reference to the complete text of
such agreement filed as Exhibits 10.1 hereto and which is incorporated herein by reference.
Item 5.03 Amendments to Articles of
Incorporation or Bylaws; Change in Fiscal Year
Effective October 9,
2014, the Company filed an amendment to its articles of incorporation in Nevada to increase its authorized common stock to 2,000,000,000
shares.
Item 8.01 Other Events.
On October 7, 2014,
the Company issued a press release announcing that that Roman Urfer, PhD, Chief Development Officer at NeuroAssets, the Company’s
investigator, presented animal data on MANF in ocular conditions at the "Targeting Ocular Disorders" Conference and concluded
that MANF provided positive protective functional effects in animal models of central retinal vein occlusion (CRVO), as well as
central retinal artery occlusion (CRAO) and glaucoma.
On October 9, 2014,
the Company issued a press release announcing positive data from its LP-002 study of the Lymphocyte Proliferation Test (LymPro
Test®) blood diagnostic for Alzheimer's disease.
The information disclosed
under this Item 8.01, including Exhibits 99.1 and 99.2 hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into
any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth
in such filing.
Item 9.01 Financial Statements and Exhibits.
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3.1 |
Certificate of Amendment to the Articles of Incorporation filed with the Secretary of State on October 9, 2014. |
| 10.1 | Employment Letter, entered into by and between Gerald E. Commissiong and Amarantus Bioscience Holdings, Inc. |
| 99.1 | Press Release dated October 7, 2014 |
| 99.2 | Press Release dated October 9, 2014 |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
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AMARANTUS BIOSCIENCE HOLDINGS, INC. |
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Date: October 9, 2014 |
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By: |
/s/ Gerald E. Commissiong |
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Name: Gerald E. Commissiong |
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Title: Chief Executive Officer |
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Exhibit
3.1
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ROSS MILLER |
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Secretary of State |
204 North Carson Street, Suite 1 |
Carson City, Nevada 89701-4520 |
(775) 084-5708 |
Website: www.nvsos.gov |
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Filed in the office of |
Document Number |
Certificate
of Amendment |
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20140709021-86
Filling Date and Time |
(PURSUANT TO NRS 78.385 AND 78.390) |
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Ross Miller |
10/09/2014 10:55 AM |
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Secretary of State |
Entity Number |
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State of Nevada |
E0146522013-6 |
USE BLACK INK ONLY - DO NOT
HIGHLIGHT |
ABOVE SPACE IS FOR OFFICE
USE ONLY |
Certificate
of Amendment to Articles of Incorporation
For
Nevada Profit Corporations
(Pursuant
to NRS 78.385 and 78.390 - After Issuance of Stock)
1.
Name of corporation:
Amarantus BioScience Holdings, Inc. |
2.
The articles have been amended as follows: (provide article numbers, if available)
The
articles of incorporation of the Corporation is hereby amended by amending and restating the first paragraph of Article TV to
read in its entirety as follows:
“The total number of shares of capital stock that the Corporation shall have the authority to issue is two billion ten million
(2,010,000,000) shares consisting of two billion (2,000,000,000) shares of common stock with a par value of $0.001 per share
and ten million (10,000,0000) shares of preferred stock having a stated value of $0.001 per share.”
3.
The vote by which the stockholders holding shares in the corporation entitling them to exercise at least a majority of the voting
power, or such greater proportion of the voting power as may be required in the case of a vote by classes or series, or as may
be required by the provisions of the articles of incorporation* have voted in favor of the amendment is: 90.2%
4. Effective date and time of filing: (optional) |
Date: |
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Time: |
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(must not be later than 90
days after the certificate is filed) |
5.
Signature: (required)
Signature
of Officer
*If
any proposed amendment would alter or change any preference or any relative or other right given to any class or series of
outstanding shares, then the amendment must be approved by the vote, in addition to the affirmative vote otherwise required,
of the holders of shares representing a majority of the voting power of each class or series affected by the amendment
regardless to limitations or restrictions on the voting power thereof.
IMPORTANT:
Failure to include any of the above information and submit with the proper fees may cause this filling to be rejected.
This form must be accompanied by appropriate
fees. |
Nevada
Secretary of State Amend Profit After
Revised
11-27-13 |
Exhibit 10.1
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AMARANTUS BIOSCIENCE HOLDINGS,
Inc.
953 Indiana St.
c/o Janssen Labs
San Francisco, CA 94107
Phone: 408 737 2734 Fax: 408 521 3636
www.amarantus.com info@amarantus.com
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September 26, 2014
Gerald E. Commissiong
953 Indiana Street
San Francisco, CA 94107
Dear Mr. Commissiong:
This Offer Letter will
renew your employment with Amarantus Bioscience Holdings, Inc. (the “Company”) as its President and Chief Executive
Officer. This Offer Letter supersedes any and all previous employment agreements with the Company, whether oral or in writing,
including but not limited to the July 10, 2014 offer letter.
Initially your annual
Base Salary shall be $225,000 ($18,750 per month), (your “Base Salary”) which will be paid semi-monthly in accordance
with the Company’s normal payroll procedures. Upon the Company’s “uplisting” to NASDAQ, your annual Base
Salary will be immediately increased to $337,500, consistent with percentage increases across all of the Company’s other
employment agreements. As an employee, you are also eligible to receive certain employee benefits. The Company will also sponsor
you for, and pay the expenses associated with, your application for permanent residency in the United States. Subject to the provisions
below, you should note that the Company may modify job titles, salaries and benefits from time to time as it deems necessary.
In addition to your
Base Salary, you will also be eligible for a discretionary performance bonus (the “Performance Bonus”) equal to up
to 35% of your Base Salary. Award of this Performance Bonus is conditioned upon the Company’s substantial performance in
accordance with its annual plan as determined by the Company’s Board of Directors in its sole discretion. The milestones
and their weight for your 2014 Performance Bonus is attached hereto as Exhibit A. The Performance Bonus, if any, shall be
paid on or before March 15th of each year during which you are still employed by the Company.
The Company will also
provide you with a Signing Bonus of $50,000, less standard deductions and withholdings, within ten (10) days of your execution
of this Employment Agreement.
In addition, it will
be recommended at the first meeting of the Company’s Board of Directors following your acceptance of this Offer Letter that
the Company grant you an option to purchase 5 million shares equivalent to approximately 0.5% of the fully diluted outstanding
shares of the Company’s Common Stock at a price per share equal to the fair market value per share of the Common Stock on
the date of grant, as determined by the Company’s Board of Directors. 25% of the shares subject to the option shall vest
12 months after the date your vesting begins subject to your continuing employment with the Company, and no shares shall vest before
such date. The remaining shares shall vest monthly over the next 36 months in equal monthly amounts subject to your continuing
employment with the Company. This option grant shall be subject to the terms and conditions of the Company’s Equity Incentive
Plan and Stock Option Agreement, including vesting requirements. No right to any stock is earned or accrued until such time that
vesting occurs, nor does the grant confer any right to continue vesting or employment.
Your employment with
the Company shall be “at will,” which means that your employment relationship with the Company is terminable by either
party at any time with or without cause. However, in the event Company terminates your employment without Cause, or you terminate
your employment with Good Reason, you shall, upon execution of a standard release, be entitled to a severance package of (i) one
year of your then current annual Base Salary to be paid in the form of monthly salary continuation; (ii) one year of healthcare
benefit continuation; (iii) a full Performance Bonus of 35% of your then current annual Base Salary; and (iv) immediate acceleration
of 25% of all outstanding unvested equity awards then held by you.
“Cause”
shall mean (i) your gross negligence or willful misconduct in the performance of your duties to the Company where such gross negligence
or willful misconduct has resulted or is likely to result in material damage to the Company or its subsidiaries; (ii) your willful
and habitual neglect of your employment duties; (iii) your commission of any act of fraud with respect to the Company; (iv) your
conviction of or plea of guilty or nolo contendere to felony criminal conduct or any crime involving moral turpitude; or
(v) your violation of any confidentiality agreement that you have entered into with the Company.
“Good Reason”
shall mean either of the following events which is not cured by the Company within 30 days after written notice thereof is provided
to the Company by you: (i) any material reduction of your annual base salary; (ii) any involuntary relocation of your principal
place of business to a location that would increase your one-way commute by more than thirty (30) miles; (iii) a substantial and
material adverse change, without your written consent, in your authority or duties causing your position to have materially less
responsibility; or (iv) any material breach by the Company of any provision of your Employment Agreement, after written notice
delivered to the Company of such breach and the Company's failure to cure such breach.
If your employment
terminates involuntarily without Cause or for Good Reason in connection with or during the twelve (12) month period following the
effective date of a Change in Control, and provided such termination constitutes a “separation from service” under
Treasury Regulation Section 1.409A-1(h), in addition to the severance set forth above, the Company shall cause all outstanding
equity awards then held by you (including, without limitation, stock options, stock appreciation rights, phantom shares, restricted
stock or similar awards) to become fully immediately vested and, if applicable, exercisable with respect to all the shares subject
thereto effective immediately prior to the date of such termination.
“Change of Control”
shall mean the occurrence of: (i) any reorganization, consolidation or merger of the Company with or into any other corporation
or other entity or person, by means of any transaction or series of related transactions, in which the Company’s stockholders
as constituted immediately prior to such transaction(s) hold less than 50% of the voting power of the surviving or acquiring entity;
or (ii) a sale of all or substantially all of the assets of the Company.
We also ask that, if
you have not already done so, you disclose to the Company any and all agreements relating to your prior employment that may affect
your eligibility to be employed by the Company or limit the manner in which you may be employed. It is the Company’s understanding
that any such agreements will not prevent you from performing the duties of your position and you represent that such is the case.
Moreover, you agree that, during the term of your employment with the Company, you will not engage in any other employment, occupation,
consulting or other business activity directly related to the business in which the Company is now involved or becomes involved
during the term of your employment, nor will you engage in any other activities that conflict with your obligations to the Company.
However, the Company agrees that you will be permitted to serve as an advisor or board member for other companies or organizations,
so long as such service does not interfere with your obligations to the Company and such company or organization is not directly
related to the business in which the Company is now involved or becomes involved during the term of your employment. Similarly,
you agree not to bring any third party confidential information to the Company, including that of your former employer, and that
in performing your duties for the Company you will not in any way utilize any such information.
As a Company employee,
you are expected to abide by the Company’s rules and standards. Specifically, you are required to sign an acknowledgment
that you have read and that you understand the Company’s rules of conduct which are included in the Company Handbook.
As a condition of your
employment, you are also required to sign and comply with an At-Will Employment, Confidential Information, Invention Assignment
and Arbitration Agreement which requires, among other provisions, the assignment of patent rights to
any invention made during your employment at the Company, and non-disclosure of Company proprietary information. In the event of
any dispute or claim relating to or arising out of our employment relationship, you and the Company agree that (i) any and
all disputes between you and the Company shall be fully and finally resolved by binding arbitration, (ii) you are waiving
any and all rights to a jury trial but all court remedies will be available in arbitration, (iii) all disputes shall be resolved
by a neutral arbitrator who shall issue a written opinion, (iv) the arbitration shall provide for adequate discovery, and
(v) the Company shall pay all the arbitration fees, except an amount equal to the filing fees you would have paid had you
filed a complaint in a court of law.
To accept the Company’s
offer, please sign and date this Offer Letter in the space provided below. This letter, along with any agreements relating to proprietary
rights between you and the Company, set forth the terms of your employment with the Company and supersede any prior representations
or agreements including, but not limited to, any representations made during your recruitment, interviews or pre-employment negotiations,
whether written or oral. This letter may not be modified or amended except by a written agreement signed by the Chairman of the
Company’s Board of Directors and you.
We look forward to
your favorable reply and to continue working with you at Amarantus Bioscience Holdings, Inc.
Sincerely, |
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/s/ Robert Harris |
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Mr. Robert L. Harris, JD |
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Lead Director |
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Agreed to and accepted: |
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Signature: |
/s/ Gerald Commissong |
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Printed Name: |
Mr. Gerald E. Commissiong |
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Title: |
President & CEO |
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Date: |
October 6, 2014 |
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Exhibit A
MILESTONES |
% OF PERFORMANCE BONUS |
COMPLETION TIMING |
Nasdaq uplist |
30% |
12/31/14 |
Eltoprazine US IND filed and approved for LID |
30% |
12/31/14 |
LymPro partner validation of analytical performance package (APP) and CLIA certification |
25% |
12/31/14 |
MANF Orphan drug designation applications filed and approved for both ocular ischemic syndrome (OIA) and Retinitis pigmentosa |
15% |
12/31/14 |
TOTAL |
100% |
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Exhibit 99.1
Amarantus Investigator Presents Positive MANF Animal Data
in Central Retinal Vein Occlusion and Glaucoma at the Targeting Ocular Disorders Conference
Data Indicates MANF Promise for Ocular Indications
SAN FRANCISCO and GENEVA, Oct. 7, 2014 (GLOBE NEWSWIRE) -- Amarantus
Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on developing diagnostics and therapeutics for Alzheimer's disease,
Parkinson's disease and ophthalmological disorders, announced that Roman Urfer, PhD, Chief Development Officer at NeuroAssets,
presented animal data on mesencephalic-astrocyte-derived neurotrophic factor (MANF) in ocular conditions at the "Targeting
Ocular Disorders" Conference in Boston, MA, yesterday (http://www.healthtech.com/Targeting-Ocular-Disorders). In the presentation,
titled, "MANF - A Novel Neurotrophic Factor for the Treatment of Retinal Disorders," Dr. Urfer concluded that MANF provided
positive protective functional effects in animal models of central retinal vein occlusion (CRVO), as well as central retinal artery
occlusion (CRAO) and glaucoma.
Dr. Urfer reported that a single intravitreal administration
of MANF in rats with ischemia-related optic nerve damage resulted in a statistically significant protective effect of MANF on retinal
function, compared to control animals, as measured by electroretinogram (ERG). Furthermore, this effect was supplemented by a strong
retinal ganglion cell protective effect observed in the treatment groups. He concluded that this is a clear signal that MANF provides
functional benefit in a model of retinal disorders. CRVO, central retinal artery occlusion, is an orphan indication in humans with
limited treatment options. Glaucoma affects approximately 4 million individuals in the United States.
"This is the first observation that a neurotrophic factor
is able to rescue retinal function after significant insult," said David A. Lowe, PhD, President & CEO of NeuroAssets
and member of the Amarantus Board of Directors. "These data clearly support our focus on the further development of MANF in
orphan ophthalmic indications, such as retinitis pigmentosa and CRVO. We plan to pursue complementary IND pathways in these indications,
as well as in glaucoma."
"These results, in a highly-relevant animal model of devastating
ophthalmological diseases, demonstrate MANF's strong ocular activity and suggest a tiered MANF development approach, focusing initially
in orphan indications, and later expanding into larger indications, such as glaucoma," said Gerald E. Commissiong, President
&CEO of Amarantus. "We are encouraged by the recent market trend favoring intravitreal treatments for ocular disorders,
and look to put MANF on a similar trajectory as we build our ophthalmology franchise. More importantly, MANF represents a potentially
new understanding of the biological mechanism at work in these conditions, and the possibility to develop regenerative medicine
treatments for patients who are suffering from a myriad of other diseases that lead to blindness."
About the Study
The study was designed to evaluate the efficacy of MANF intravitreal
injection after an optic nerve ischemia/reperfusion injury in albino rats, as well as gain a better understanding of the MANF dose/effect
relationship. A single intravitreal administration of MANF was delivered after ischemia and reperfusion of the optic nerve. Efficacy
was determined by measuring the b wave amplitudes in electroretinograms (ERGs) seven days after the ischemia and reperfusion. The
b-wave is an important functional signal of the retina in response to light and is the ERG-component most susceptible to ischemia.
MANF treatment resulted in a statistically significant protective effect of MANF on retinal function, as compared with vehicle
treated animals.
The study also showed that MANF effects in the retina mirror
the dose-effect relationship observed for MANF in models of Parkinson's disease. Additionally, MANF dose levels were significantly
lower than the equivalent dose used in the recent rabbit ocular tolerability study, thereby establishing a preliminary safety margin
for MANF in the treatment of optic nerve ischemia.
About CRVO and Glaucoma
Central retinal vein occlusion (CRVO) affects approximately
100,000 patients in the United States, and 140,000 patients in Europe. The market is predicted to grow at approximately 16-18%
per year. Companies that are marketing drugs targeting CRVO include Regeneron, Novartis, Roche and Bayer.
Glaucoma affects approximately 4 million people in the United
States, with a total drug market size of approximately $3B. With its new mechanism of action, MANF represents a possible new understanding
of ocular disease biology, potentially addressing key unmet medical needs in a variety of conditions.
About Mesencephalic-Astrocyte-derived Neurotrophic Factor
(MANF)
MANF (mesencephalic-astrocyte-derived neurotrophic factor) is
a naturally-occurring protein produced by the body for the purpose of reducing and preventing apoptosis (programmed cell death)
in response to injury or disease. Amarantus is developing MANF as a regenerative medicine platform for retinitis pigmentosa (RP)
and other ocular indications leading to blindness. Other potential indications include Parkinson's disease, Alzheimer's disease,
Wolfram's syndrome, traumatic brain injury (TBI) and myocardial infarction.
Amarantus is the front-runner and primary holder of intellectual
property (IP) around MANF.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company
developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related apoptosis.
AMBS has licensed Eltoprazine, a small molecule drug ready for Phase 2b in Parkinson's levodopa induced dyskinesia and adult ADHD.
AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Tes(R) )) for Alzheimer's disease and owns
the intellectual property rights to a therapeutic protein known as mesencephalic-astrocyte-derived nurotrophic factor (MANF) with
which it is developing products for brain disorders. AMBS also owns intellectual property for the diagnosis of Parkinson's disease
(NuroPro) and the discovery of neurotrophic factors (PhenoGuard). Amarantus operations are located at Janssen Labs @QB3 in San
Francisco, CA. For further information please visit www.Amarantus.com, or connect with the company on Facebook, LinkedIn, Twitter
and Google+.
Certain statements, other than purely historical information,
including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the
assumptions upon which those statements are based, are forward-looking statements." These forward-looking statements generally
are identified by the words believes," project," expects," anticipates," estimates," intends," strategy,"
plan," may," will," would," will be," will continue," will likely result," and similar expressions.
Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which
may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual
effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations
and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory
changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties
should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
Contact:
Amarantus Bioscience Holdings, Inc.
Aimee Boutcher, Investor Relations
408.737.2734 x 101
ir@amarantus.com
Planet Communications
Deanne Eagle, Media Contact
(917) 837-5866
deanneeagle@gmail.com
Exhibit 99.2
Amarantus Announces Positive LP-002
Data for Alzheimer's Blood Diagnostic LymPro Test(R)
SAN FRANCISCO and GENEVA, Oct. 9, 2014 (GLOBE NEWSWIRE) --
Amarantus Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on developing
diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and ophthalmological disorders, reported positive data
from its LP-002 study of the Lymphocyte Proliferation Test (LymPro Test(R)) blood diagnostic for Alzheimer's disease (AD). LymPro
achieved highly statistically significant results in correctly distinguishing patients with moderate-to-severe AD from healthy
controls. As a result of these positive findings, Amarantus is expanding the study to assess LymPro's predictive value in diagnosing
early-stage AD patients. Amarantus anticipates launching LymPro in the fourth quarter of 2014.
In a 72 subject study, including 36 patients with moderate-to-severe
AD versus a control group of 36 healthy subjects, the expression of the marker CD69 on specific sub-populations of lymphocytic
cells was statistically significantly lower in the AD groups versus the control group, as measured under two different stimulation
conditions (LymPro Version 1 and LymPro Version 2).
CD69 is a protein expressed when lymphocytic blood cells are
in the process of proliferating, and is considered an early marker that cell division is imminent. Low levels of CD69 under cell
division conditions in AD patients is suggestive of lymphocytic cell cycle dysregulation and a surrogate marker for the neuronal
cell cycle dysregulation that has been observed in the brains of AD patients at autopsy. Cell cycle dysregulation has been identified
as a potential link between amyloid beta plaques and tau tangles in AD.
In Version 1, LymPro correctly classified AD patients and healthy
controls with an overall accuracy of 87% (p=0.0015), with a high degree of sensitivity (80%) and specificity (86%). In Version
2, LymPro correctly classified AD patients and healthy controls with an overall accuracy of 83% (p=.0059) while maintaining a high
degree of sensitivity (90%) and specificity (71%). The range of variations observed in sensitivity and specificity between LymPro
Version 1 and LymPro Version 2 are common findings in diagnostic testing in heterogeneous indications such as Alzheimer's. Of particular
importance is the consistency of the overall accuracy between Version 1 and Version 2. Further, the expression of CD69 did not
change with disease severity, which is consistent with previous work suggesting that LymPro is measuring a fundamental stage-independent
biology in AD patients. Amarantus believes the results from both Version 1 and Version 2 of LymPro are suitable for commercialization,
and is validating both Version 1 and Version 2 for use in the Research Use Only (RUO) market. Amarantus plans to launch LymPro
for RUO in the fourth quarter of 2014, primarily targeting pharmaceutical clinical trials. The company does not require Clinical
Laboratory Improvement Amendments (CLIA) certification to launch LymPro in the RUO market.
"LymPro will have great utility to the pharmaceutical companies
developing drugs for Alzheimer's disease, as it will permit a more reliable way of selecting subjects for inclusion in trials,
thereby assuring an enriched population and mitigating the risk of including non-Alzheimer's disease subjects," said Colin
Bier, PhD, member of the Amarantus Board of Advisors who is tasked with the development of LymPro.
Based on the strength of these results, the company has expanded
the inclusion criteria to also enroll patients diagnosed with mild Alzheimer's disease. 68 additional subjects will be recruited,
including 34 mild-to-severe Alzheimer's patients, and 34 healthy controls. Amarantus anticipates completing enrollment of the 68
patient LP-002 extension in the fourth quarter and will announce data from an in-depth analysis from the full cohort of 140 subjects
(72 patients + 68 patient extension) shortly thereafter.
"Amarantus is aiming to be first to market with an accurate,
reliable and commercially- viable diagnostic blood test for Alzheimer's disease," said Gerald E. Commissiong. "Today's
data gives us all the information we need to move full steam ahead with this strategy. We can now tailor our initial marketing
efforts towards the $150M RUO market, primarily targeting pharmaceutical companies engaged in Alzheimer's disease therapeutic trials.
We have nearly completed assembling the resources needed to launch LymPro to the RUO community in the fourth quarter. Thereafter,
we intend to market LymPro to the broader medical community, initially under CLIA. We estimate the worldwide market for an Alzheimer's
diagnostic is $3B"
The company will make a final decision on which version of LymPro
(Version 1 or Version 2) to launch under the CLIA designation, which will be marketed to the general population, following an in-depth
analysis from the full cohort of 140 subjects. The company anticipates launching LymPro under CLIA shortly after product launch
in the RUO marketplace.
About Alzheimer's disease
It is estimated that over 5.4 million people in the United States
suffer from Alzheimer's disease. Over 500,000 patients are diagnosed annually, with nearly one-in-eight older Americans affected
by the disease. Alzheimer's is the third leading cause of death in the United States. The cost of unpaid care in the United States
is estimated at over $210 billion annually. Total payments for care are estimated at over $200 billion annually, including $140
billion in cost to Medicare and Medicaid. Alzheimer's expenditures in the United States are expected to exceed $1.4 trillion by
2050.
About LymPro Test(R)
The Lymphocyte Proliferation Test (LymPro Test(R)) is a diagnostic
blood test that measures the ability of peripheral blood lymphocytes to withstand an external mitogenic stimulation that induces
them to enter the cell cycle. It is hypothesized that certain diseases, most notably Alzheimer's disease, are the result of compromised
cellular machinery that leads to aberrant cell cycle re-entry by neurons. LymPro is unique in the use of peripheral blood lymphocytes
(PBLs) as a surrogate for neuronal cell function, suggesting a common immune-based relationship between PBLs and neurons in the
brain.
About Amarantus Bioscience Holdings, Inc.
Amarantus Bioscience Holdings (AMBS)
is a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related
apoptosis. AMBS has licensed Eltoprazine, a Phase 2b-ready small molecule drug indicated for Parkinson's Levodopa induced dyskinesia
and adult ADHD. AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test(R)) for Alzheimer's
disease and owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic
Factor (MANF). Amarantus is developing MANF-based products as treatments for orphan ophthalmological disorders and other indications.
AMBS also owns intellectual property for the diagnosis of Parkinson's disease (NuroPro) and the discovery of neurotrophic factors
(PhenoGuard). Amarantus operations are located in offices and labs at Janssen Labs @QB3. For further information please visit
www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
Certain statements, other than purely historical information,
including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the
assumptions upon which those statements are based, are forward-looking statements." These forward-looking statements generally
are identified by the words believes," project," expects," anticipates," estimates," intends," strategy,"
plan," may," will," would," will be," will continue," will likely result," and similar expressions.
Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which
may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual
effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations
and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory
changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties
should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
Contact:
Amarantus Bioscience Holdings, Inc.
Aimee Boutcher, Investor Relations
408.737.2734 x 101
ir@amarantus.com
Planet Communications
Deanne Eagle, Media Contact
(917) 837-5866
Amarantus Bioscience (CE) (USOTC:AMBS)
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