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): August
5, 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))
On August 5, 2014,
Amarantus Bioscience Holdings, Inc., a Nevada corporation (the “Company”) entered into a sponsored research agreement
(the “Agreement”) with the Buck Institute for Research on Aging (the “Institute”) pursuant to which Dr.
Heinrich Jasper shall perform certain research utilizing Mesencephalic-Astrocyte-derived Neurotrophic Factor, subject to certain
terms and restrictions as further described in the Agreement.
Pursuant to the Agreement,
the Company shall provide financial support for the research plan, which is further described in the Agreement (the “Research
Plan”), in the form of four quarterly payments of $75,099.25, based upon the budget set forth in the Agreement (the “Funding”).
Any inventions conceived
and created jointly by the parties (“Joint Inventions”) as a result of the Research Plan shall be jointly owned by
the Company and the Institute. Any inventions conceived and created solely by the Institute (“Institute Inventions”)
as a result of the Research Plan shall be owned solely by the Institute.
In
consideration for the Funding, the Institute granted the Company (i) a non-exclusive, worldwide,
royalty free license to utilize any of the Institute Inventions or Joint Inventions for research purposes, and (ii) an exclusive
option to obtain an exclusive, worldwide license with a right to grant sublicenses to utilize any Institute Inventions or Joint
Inventions upon terms to be negotiated in good faith (the “Option”). The Company may exercise such Option within ninety
(60) days of receipt of notice of such Institute Invention. Moreover, the Institute shall not make an offer to a third-party for
an exclusive license of any of Institute Intentions or Joint Inventions without first making the same offer to the Company, which
the Company may accept within 30 days.
The term of the Agreement
commenced on August 5, 2014 and shall end upon the completion of the Research Plan or the date 12 months after August 5, 2014,
unless earlier terminated pursuant to the terms of the Agreement. Either party may terminate the Agreement if upon a material breach
by the other party upon ninety (90) days written notice of such breach and the non-breaching party’s failure to cure such
breach within nintey (90) days of receipt of such written notice.
The foregoing description
of the Agreement does not purport to be complete and are qualified in its entirety by reference to the complete text of the Agreement.
On August 11, 2014, the Company issued a press release with respect to the foregoing, a copy of the press
release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements
and Exhibits.
(d) Exhibits
| Exhibit No. |
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Description |
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| 99.1 |
|
Amarantus Bioscience Holdings, Inc. Press Release, dated August 11, 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: August 11, 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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Amarantus Enters Into Research Collaboration With the Buck Institute
for Research on Aging for MANF
Company Acquires Exclusive Option to License Undisclosed MANF
IP
SAN FRANCISCO and GENEVA and NOVATO,
Calif., Aug. 11, 2014 (GLOBE NEWSWIRE) --Amarantus Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on the
discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation,
neurodegeneration and apoptosis, announced it has entered into a Research Collaboration with the Buck Institute for Research
on Aging for the development of Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF) in undisclosed therapeutic indications.
MANF is a targeted therapeutic which addresses the underlying programmed cell death (apoptosis) associated with a wide range of
devastating human disorders including orphan indications such as Retinitis Pigmentosa.
"We are very pleased to be working
with Amarantus on this exciting MANF project," said Henri Jasper, PhD, professor at the Buck Institute for Research on Aging.
"Novel aspects of the biology of MANF are beginning to be uncovered, and I believe working with Amarantus is the best way
to coalesce the scientific understanding of MANF and to move the Program forward towards multiple therapeutic applications."
Under the terms of the agreements,
Amarantus has agreed to fund research by Jasper, and his Buck faculty colleague Deepak Lamba, PhD, and Postdoctoral Fellow Joanna
Neves, PhD, to further their scientific insights and generation of intellectual property regarding the therapeutic potential of
MANF. In addition, the Company has acquired an exclusive option to license said intellectual property. The Company has also received
a right to use certain undisclosed scientific findings for the purpose of regulatory submissions and grant applications to obtain
further funding for its programs.
"We are extremely pleased to be
adding the Buck Institute for Research on Aging to our expanding consortium of leading academic research institutions focused on
furthering the scientific understanding of MANF and its implications for therapeutic development," said Gerald E. Commissiong,
President & CEO of Amarantus. "We were highly impressed with preliminary data generated at the Buck Institute. Given the
stellar science from the Jasper and Lamba labs, we are confident that this will be just the beginning of our relationship with
the Buck. As we continue our strategy of attracting all relevant MANF intellectual property into the Company on our path towards
first-in-man human clinical studies, this agreement greatly adds to our war chest of MANF intellectual property and opens the door
to significantly increasing our understanding of this therapeutically relevant, evolutionally conserved protein."
Dr. Neves has presented several oral
presentations on the Buck Institute's scientific findings regarding MANF at international conferences, including the following:
| · | Drosophila Research Conference, San Diego, March 2014: Hemocyte-mediated
repair: promoting retinal repair with MANF. |
| · | ARVO annual meeting, Orlando, May 2014: MANF
in Retinal Therapies: Improving Regenerative Therapies by Promoting Tissue Repair |
Hemocyte-mediated repair: promoting
retinal repair with MANF. Joana Neves, Deepak Lamba, Heinrich Jasper. Buck Institute for Research on Aging, Novato,
CA.
Regeneration and repair are critical to ensure tissue health throughout life. We are exploring the role of hemocytes in the control
of photoreceptor survival and tissue repair in the fly retina. Hemocytes are attracted to the pupal retina and activated by Pvf-1/PvR
signaling in response to UV-induced DNA damage, and are required to prevent excessive cell loss. We are now using this system to
identify hemocyte-derived factors that can promote tissue repair in the retina, and are testing the conservation of their function
in the mammalian retina. We have identified MANF (Mesencephalic Astrocyte-derived Neurotrophic Factor), as a hemocyte derived protein
in Drosophila that can promote retinal repair. We find that MANF is induced in hemocytes in response to stress in a Pvf-1/PvR dependent
manner, is secreted into the hemolymph, and reduces tissue loss after UV-induced and genetically triggered photoreceptor apoptosis.
Moreover, stress-induced MANF results in changes in the hemocyte population that correlate with increased lamellocyte differentiation.
Based on these observations, and on the reported cytoprotective function of MANF in the mammalian brain, we hypothesize that MANF
has a conserved role in mammals, and that this function can promote integration of transplanted retinal cells into the diseased
retina. We find that mouse MANF is induced in microglia and macrophages invading the retina following light damage, and that this
correlates with reduced tissue loss. Importantly, intravitreal delivery of MANF recombinant protein is sufficient to limit photoreceptor
death following light damage, and promotes beneficial M2 polarization of macrophages/microglia, suggesting that the role of MANF
is conserved between flies and mice. Further, we will test the ability of MANF delivery in promoting progenitor cell integration
following transplantation. This work will serve as a proof of concept for the use of factors that promote tissue repair as co-adjuvants
in stem cell regenerative therapies, and for the use of the fly as a tool to identify such factors.
MANF in Retinal Therapies: Improving
Regenerative Therapies by Promoting Tissue Repair.JOANA NEVES, Deepak A. Lamba, Heinrich Jasper. Buck Institute for
Research on Aging, Novato, CA.
Purpose: Stem cell
based therapies, have been shown to hold real promise in the treatment of degenerative diseases of the retina. However, the efficiency
of such strategies is still considerably low. Tissue repair mechanisms are conserved at the organism level and enhance the regenerative
process. We hypothesized that promoting tissue repair may also enhance the efficiency of cell engraftment in the retina. Key
components of the retinal repair network have been identified in Drosophila involving interactions between the damaged retina and
hemocytes. We have used the Drosophila to identify hemocyte derived factors that can promote tissue repair in the retina and have
tested the conservation of their function in the mammalian retina. Our work focused on Mesencephalic Astrocyte-derived Neurotrophic
Factor (MANF).
Methods: We have used
UV induced retinal damage in flies and light induced retinal damage in mouse as model systems to test the effects of MANF. MANF
was overexpressed in flies using the UAS/Gal4 system. In mice, recombinant protein was delivered by intravitreal injection.
Results: We have identified MANF
as a hemocyte derived protein in Drosophila that can promote tissue repair in the fly retina, using RNAseq. We show that MANF is
expressed in hemocytes of Drosophila larvae, it is secreted to the hemolymph and induced in response to stress in a Pvf-1/PvR dependent
manner. Hemocyte specific MANF expression is sufficient to reduce tissue loss after UV and genetically-induced photoreceptor apoptosis.
Moreover, stress induced MANF results in changes in the hemocyte population correlating with increased lamellocyte differentiation.
We have tested the conservation of the pathway in mammalian retinal repair. As in flies, MANF is induced in microglia/macrophages
invading the retina following light damage and this correlates with reduced tissue loss. Importantly, intravitreal delivery of
MANF recombinant protein is sufficient to limit cell death following light damage and promotes alterations in macrophages/microglia.
Conclusions: MANF
is a conserved neuroprotective factor in the retina. MANF acts as an immune-modifying factor to limit cell loss following acute
damage. This work will serve as a proof of concept to the use of tissue repair promoting factors as co-adjutants in stem cell regenerative
therapies.
About Mesencephalic-Astrocyte-derived
Neurotrophic Factor (MANF)
MANF (Mesencephalic-Astrocyte-derived
Neurotrophic Factor) is believed to have broad potential because it is a naturally-occurring protein produced by the body for the
purpose of reducing and preventing apoptosis (cell death) in response to injury or disease, via the unfolded protein response o
the endoplasmic reticulum. By manufacturing MANF and administering it to the body, Amarantus is seeking to use a regenerative medicine
approach to assist the body with higher quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual
property (IP) around MANF, and is initially focusing on the development of MANF-based protein therapeutics. MANF's current lead
indication is Retinitis Pigmentosa, and other applications including Parkinson's disease, and Wolfram's Syndrome. Additional applications
for MANF may include Traumatic Brain Injury (TBI), myocardial infarction, antibiotic-induced ototoxicity and certain other rare
orphan diseases currently under evaluation.
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 ("Eltoprazine"), a phase 2b ready small molecule 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") and is developing MANF-based products as treatments 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
visitwww.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
About the Buck Institute for Research
on Aging
The Buck Institute is the U.S.'s first
independent research organization devoted to Geroscience -- focused on the connection between normal aging and chronic disease.
Based in Novato, CA, The Buck is dedicated to extending "Healthspan", the healthy years of human life and does so utilizing
a unique interdisciplinary approach involving laboratories studying the mechanisms of aging and those focused on specific diseases.
Buck scientists strive to discover new ways of detecting, preventing and treating age-related diseases such as cancer, Alzheimer's
and Parkinson's, cardiovascular disease, macular degeneration, osteoporosis, diabetes and stroke. In their collaborative research,
they are supported by the most recent developments in genomics, proteomics, bioinformatics and stem cell technologies. For more
information: www.thebuck.org
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
Buck Institute for Research on Aging
Kris Rebillot, Director of Communications
415-209-2080
krebillot@buckinstitute.org
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