Amarantus Appoints Barney
Monte as Interim COO/CFO and Promotes Brian Harvey to Chief
Regulatory Advisor
San Francisco, CA and New
York, NY -- April 5, 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 through
its subsidiaries, today announced the appointment of Barney Monte
as interim Chief Operating Officer and Chief Financial Officer. Mr.
Monte brings over 20 years of capital markets experience to
Amarantus, including 15+ year in investment banking and is being
brought into Amarantus to assist in completing the Company's
restructuring plan and concurrent capital raise via regulations
created under JOBS Act. Concurrently, the Company promoted Brian E.
Harvey, MD, PhD to the role of Chief Regulatory Advisor, assisting
the Company's subsidiaries in updating their regulatory strategy in
preparation for launching the next phase of their respective
clinical development programs. Dr. Harvey brings over 30 years of
biopharmaceutical experience to Amarantus, including over 11 years
at the US Food & Drug Administration (FDA).
"I believe Amarantus
represents a tremendous opportunity provided the Company can
navigate the completion of its restructuring process and related
capital raise," said Barney Monte, Interim-COO/CFO of Amarantus.
"The assets that underpin the Company's subsidiaries have
significant potential to improve or replace the standard of care in
compelling therapeutic areas, with limited or no competition on the
market. I believe the value inherent in the subsidiaries will drive
Amarantus' value and ability to complete its restructuring and
capital raising efforts."
Mr. Monte has over 20 years
of experience in the financial services industry where he has held
senior level positions within investment banking and private
equity. Mr. Monte co-founded Ozado Partners LLC, a direct
investment and merchant banking business, where he was responsible
for sourcing, structuring and negotiating investment opportunities
across various industries, including the acquisition of an ~80
megawatt natural gas-fired combined cycle power plant and
cogeneration facility. Prior to co-founding Ozado Partners, Mr.
Monte's senior-level investment banking positions included head of
International and Asia investment banking for a middle market
focused U.S. based broker-dealer. Over his tenure, Mr. Monte has
acted as a principal and agent in assisting companies raise private
capital, IPOs, secondary offerings, debt offerings and M&A
advisory services where he has invested, raised or advised on over
$10.0 billion worth of transactions. Mr. Monte graduated from
Skidmore College with a Bachelor of Science in Business
Administration with a concentration in Finance.
"Having been involved in
many development programs while at the agency, as well as the
Biopharmaceutical industry, I believe that the Amarantus portfolio
is impressive, especially given that each therapeutic asset has
received orphan drug designations from FDA" said Brian E. Harvey,
MD, PhD. "I am looking forward to helping guide the regulatory
strategy of each subsidiary, so that as new medical and management
teams are brought in to drive development forward, they have a
sound regulatory strategy upon which to build."
Dr. Harvey recently served
as Vice President of U.S Regulatory Strategy at Pfizer, where he
led U.S. FDA regulatory interactions across all Pfizer business
units and was a member of the CEO's Senior Leadership Council
(SLC). He led the Pfizer efforts on the PhRMA Regulatory Affairs
Coordinating Committee (RACC). In addition, he was responsible for
supervisory oversight of U.S. Regulatory Policy & Intelligence
functions and the U.S. Advertising & Promotion activities. He
played an early role in PDUFA VI Preparation, the PhRMA Steering
Committee and the 21st Century Cures initiatives.
Prior to his time at Pfizer,
Dr. Harvey served as Vice President of Regulatory Policy at Sanofi,
where he was the head Liaison with U.S. Food and Drug
Administration (FDA), served on the International Biologics and
Biotechnology Taskforce and Biologics Key Issues Team, was on the
Biotechnology Industry Organization (BIO) Regulatory Affairs
Committee (RAC). He was the Signatory authority for Sanofi written
comments to the FDA docket and was a Member of the Sanofi Policy
Development Committee.
Prior to Sanofi, Dr. Harvey
spent 11 years with FDA in increasing positions of responsibility
across the organization including Center for Drug Evaluation and
Research (CDER), Center for Biologics Evaluation and Research
(CBER) and the Center for Devices and Radiological Health (CDRH).
From 2000 to 2001, Dr. Harvey served as an American Political
Science Association (APSA) Congressional Fellow on behalf of FDA.
Dr. Harvey received his PhD, then MD from the University of
Connecticut.
His Internal Medicine
Internship and Residency at Beth Israel Hospital/Harvard was
followed by a 3-year Gastroenterology/Hepatology Fellowship at
Johns Hopkins Hospital prior to joining FDA.
About Amarantus
Bioscience Holdings, Inc.
Amarantus Bioscience
Holdings (AMBS), a JLABS alumnus company, is a 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. MANF was discovered by the Company's Chief
Scientific Officer John Commissiong, PhD. Dr. Commissiong
discovered MANF from AMBS' proprietary discovery engine PhenoGuard.
AMBS also owns approximately 79.25 million shares of Avant
Diagnostics, Inc. (OTC Pink: AVDX) via the sale of its wholly-owned
subsidiary Amarantus Diagnostics, Inc. that occurred in May
2016.
For further information
please visit www.Amarantus.com,
or connect with the Amarantus on Facebook, LinkedIn, Twitter and Google+.
About Elto
Pharma, Inc.
Elto Pharma, Inc. is
developing Eltoprazine, an oral small molecule 5HT1A/1B partial
agonist in clinical development for the treatment of Parkinson's
disease levodopa-induced dyskinesia (PD-LID), Alzheimer's
aggression and adult attention deficit hyperactivity disorder
(adult ADHD). Eltoprazine has been evaluated in over 680 human
subjects to date, and has a well-established safety profile, with
statistically significant efficacy results across multiple central
nervous system indications. Eltoprazine has received orphan drug
designation (ODD) from the US FDA for the treatment of
PD-LID.
Eltoprazine was originally
developed by Solvay (now Abbvie) in aggression-related indications.
The eltoprazine program was out-licensed to PsychoGenics, Inc.
(PGI). PGI licensed eltoprazine to Amarantus in 2014 after a
successful proof-of-concept trial in PD-LID.
In April 2017, Amarantus
incorporated the wholly-owned subsidiary Elto Pharma, Inc. for the
purpose of raising capital to finance the further clinical
development of Eltoprazine.
About Cutanogen
Corporation
Engineered Skin Substitute
(ESS) is a tissue-engineered skin prepared from autologous
(patient's own) skin cells. It is a combination of cultured
epithelium and a collagen-dermal fibroblast implant that produces a
skin substitute which contains both epidermal and dermal
components. This model has been shown in preclinical studies to
generate a functional skin barrier. Most importantly, because ESS
is composed of a patient's own cells, it is less likely to be
rejected by the immune system of the patient, unlike with porcine
or cadaver grafts in which immune system rejection is a
possibility. A non-GMP version ESS has been used in
investigator-initiated and compassionate-use clinical settings in
over 150 human subjects, primarily pediatric patients, for the
treatment of severe burns up to 95% of total body surface area. The
non-GMP version has also been used in the treatment of two patients
with Giant Congenital Melanocytic Nevi (GCMN).
In July 2015, Amarantus'
acquired Lonza Walkersville's wholly-owned subsidiary Cutanogen
Corporation, the sole licensor of intellectual property rights to
ESS from Cincinnati's Shriner's Hospital for Children and the
University of Cincinnati. Cutanogen Corporation is a wholly-owned
subsidiary of Amarantus.
About MANF
Therapeutics, Inc.
MANF
(mesencephalic-astrocyte-derived neurotrophic factor) is believed
to have broad potential because it is a naturally-occurring protein
produced by the body to reduce/prevent apoptosis (cell death) in
response to injury or disease, via the unfolded protein response.
By administering exogenously produced MANF 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
frontrunner and primary holder of intellectual property around
MANF, and is initially focusing on the development of MANF-based
protein therapeutics.
In April 2017, Amarantus
incorporated the wholly-owned subsidiary MANF Therapeutics, Inc. to
focus on the preclinical and clinical development of MANF. MANF's
lead indication is retinitis pigmentosa, and additional indications
including Parkinson's disease, diabetes and Wolfram's syndrome are
envisioned. Further applications for MANF may include Alzheimer's
disease, traumatic brain injury, myocardial infarction,
antibiotic-induced ototoxicity and certain other orphan
diseases.
Forward-Looking
Statements
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 includes 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.
Amarantus
Investor and Media
Contact:
Howard Gostfrand
American Capital Ventures, Inc.
Office: 305-918-7000
Email: hg@amcapventures.com
Source: Amarantus Bioscience
Holdings, Inc.