Amarantus
Provides Corporate
Update
New York, NY --
July
20, 2018
-- InvestorsHub NewsWire -- Amarantus Bioscience Holdings,
Inc. (OTC
Pink: AMBS) (the "Company," or AMBS), a US-based JLABS-alumnus
biotechnology holding company developing first-in-class orphan
neurologic, regenerative medicine and ophthalmic therapies
and
diagnostics through its
subsidiaries, today provided a business update on
each of its subsidiaries Elto Pharma, Inc., Cutanogen Corporation,
NeuroDx
(pending formation
to develop LymPro Test) and MANF Therapeutics,
Inc. In
addition, the Company provided guidance on its
funding plan to complete its recapitalization and
initiate its subsidiary spinoff
plan.
Elto Pharma
The Elto Pharma project team
(Drs. Trzepacz,
Harvey and Brownell) has been focused on revising the Phase 2b
eltoprazine clinical trial design and has now established a revised
synopsis for a
parallel design, Phase 2b Parkinson's disease
levodopa-induced dyskinesia (PD-LID) trial that takes into account changes in the standard of care
being
made
as a result of the
recent approval of Adamas' Gocovri. The team is currently
engaging with experts in the field ahead of regulatory
interactions and expects to initiate the trial in the first half of
2019.
In addition, there has been a
renewed focus on evaluating a potential secondary indication for
eltoprazine that is related to Alzheimer's disease. The team has
made substantial progress, in consultation with our
Alzheimer's
SAB, in
refining the target product profile for
eltoprazine in that area. Further information on our plans in
this area will be provided
in
the second half of
2018.
Cutanogen
The Cutanogen project team
(Drs. Kagan, Ahrenholz, Harvey and Brownell) has been
focused on defining the fastest path to market for Engineered Skin
Substitute (ESS) in pediatric severe
burns, and preparing to re-establish the
ESS manufacturing process at a third-party cell therapy contract
manufacturer. To this end, Cutanogen recently engaged with a new
world-renowned cell therapy contract manufacturing organization
(CMO) to assess and provide a roadmap to optimize the ESS
manufacturing process in preparation for clinical
trials expected to initiate in the first half of
2019.
This effort will
provide guidance on strategies to accelerate time to patient,
reduce costs of good sold (COGS) and
prepare to
scale volume to
meet the commercial
needs. The
Company expects to finalize its
regulatory
strategy in
pediatric burns in the second half of 2018
and
initiate
interaction with relevant regulatory
agencies
to
guide
planning for
ESS'
path to
market.
MANF Therapeutics
In the first half of
2018, MANF
Therapeutics announced the issuance
of several patents and independent peer-reviewed
publications related to MANF
in the areas of
Glaucoma, Parkinson's disease, diabetes and Wolfram's disease,
as well as
TBI and
stroke. The next major steps for the
MANF program revolve around re-initiating cGMP
manufacturing, selection of the indication for first-in-man
studies and
completing the recruiting process with senior
executive-level talent. MANF Therapeutics
owns protein
therapy and gene therapy rights to MANF, including patents and
patent applications in the areas of
ophthalmology,
neurology
and
metabolism.
NeuroDx
In May 2018, Amarantus exercised its
exclusive option with Leipzig University to license additional
intellectual property rights to its LymPro Test generated
from a recently completed
German
clinical trial
designed to assess the LymPro vs. amyloid PET imaging. Amarantus is
currently finalizing the transaction and
will form the legal
entity to house the development of the LymPro Test shortly.
Dr. Ropacki, the LymPro Test Chief Medical
Advisor, will be attending the upcoming
Alzheimer's Association International Conference
(AAIC)
in Chicago, IL, and
will be re-engaging with key stakeholders in the area of
Alzheimer's
diagnostics on behalf of
Amarantus.
AMBS Capital Formation
Plan
In March 2018, the Company
announced the participation of 96%+ of its legacy convertible debt
(LCD)
holders in the Tender Exchange, which
reduced overall balances, removed ratchet provisions,
provided a 9-month moratorium on
conversions, and provided a path to releasing all
outstanding liens and retiring
the LCD
securities. In the first quarter of 2018, the Company also entered into
agreements to raise up to $1.5 million in funding to begin
executing on the restructuring path created via the Tender
Exchange. In
the second quarter of 2018, Amarantus retained Weild & Co. to
advise it on capital formation via the JOBS Act.
After a thorough review, the
Company has concluded that the parent Company's best strategy is to
file a Regulation A offering in
preparation for an eventual equity raise to fund AMBS going
forward.
The Company
maintains the right for its subsidiaries
to raise
capital,
which would have the effect of releasing liens on an individual
subsidiary basis. The Company can also
achieve its
objectives via the issuance of
long-term
debt,
or certain
other restricted
securities. In parallel with this, the
Company is finalizing the plans for Elto Pharma and Cutanogen
that it
believes will drive near-term
value as
those subsidiaries prepare to re-enter clinical
development.
The Company has engaged its
auditors to initiate a review of its 2016, 2017 and
first half of 2018
financials,
which sets the stage for a full audit
to allow
the Company
to
becoming fully
reporting.
Recently-passed legislation allows fully-reporting companies to
utilize the Regulation A funding mechanism to raise capital.
This press release does not constitute an offer to sell or a
solicitation of an offer to buy any securities, nor will there be
any offer, solicitation or sale of securities, in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any state or jurisdiction.
About Amarantus Bioscience
Holdings, Inc.
Amarantus Bioscience
Holdings (AMBS) is a JLABS alumnus
biotechnology company developing treatments and
diagnostics for diseases in the areas of
neurology,
regenerative medicine and orphan diseases through its subsidiaries.
AMBS' wholly-owned subsidiary Elto Pharma,
Inc. has
development rights to eltoprazine, a Phase 2b-ready small molecule
indicated for Parkinson's disease levodopa-induced dyskinesia,
Alzheimer's aggression and adult attention deficit hyperactivity
disorder, commonly known as ADHD. AMBS acquired the rights to the
Engineered Skin Substitute program, a regenerative medicine-based
approach for treating severe burns with full-thickness autologous
skin grown in tissue culture that is being pursued by AMBS'
wholly-owned subsidiary Cutanogen
Corporation.
AMBS' wholly-owned subsidiary MANF Therapeutics, Inc. owns key
intellectual property rights and licenses from a number of
prominent universities related to the development of the
therapeutic protein known as mesencephalic astrocyte-derived neurotrophic
factor ("MANF"). MANF Therapeutics, Inc.
is developing
MANF-based products as treatments for brain and ophthalmic
disorders and Parkinson's
dsiease. MANF was discovered by the
Company's Chief Scientific Officer John Commissiong, PhD. Dr.
Commissiong discovered MANF from AMBS' proprietary discovery engine
PhenoGuard. The Company also
owns
certain
rights to
the
Alzheimer's blood
diagnostic LymPro Test , as well as MSPrecise and NuroPro.
For further
information please visit www.Amarantus.com, or connect with the Amarantus
on Facebook,
LinkedIn, Twitter
and
Google+.
Amarantus
Investor and Media Contact:
Howard Gostfrand
American Capital Ventures,
Inc.
Office: 305-918-7000
Email: hg@amcapventures.com
Source: Amarantus Bioscience
Holdings, Inc.