BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI), a leading
developer of cellular therapies for neurodegenerative diseases,
today announced that David Setboun, Pharm.D., MBA, has been
appointed Executive Vice President and Chief Operating Officer.
International pharmaceutical executive Dr.
Setboun, has directed commercial development, business strategy,
and product launches for 2 decades at 3 major biopharmaceutical
companies. Most recently, Dr. Setboun served as VP Corporate
Development, Strategy & Business at Life Biosciences. In this
role, David was instrumental in the development of various critical
commercial, operating and funding milestones. From June 2015 to
June 2018, he served as President, Biogen, France where he launched
Biogen’s rare disease franchise. In addition, he supervised the
launch of key neurology products and oversaw the Biosimilar
business unit. Prior to his tenure at Biogen, Dr. Setboun, served
as President, AstraZeneca, Portugal from 2012 to 2015, where he
managed a product portfolio that grossed over $200 million
annually. Prior to this role, David led the European Sales &
Marketing function as AstraZeneca’s VP Europe where he directed a
team of executives in marketing, commercial excellence, pricing and
market access. During his tenure, he expanded AstraZeneca’s
Oncology, Diabetes and Cardiovascular franchises. From 2002 to
2009, Dr. Setboun directed national and international teams and
projects for Eli Lilly and Company in France and the USA. Fluent in
French, English, Spanish and Portuguese, Dr. Setboun received his
Pharmaceutical Doctorate (Pharm.D.) from University Paris XI in
1997 and his MBA from H.E.C Paris in 2001. More recently, David
graduated from Harvard Business School (AMP 194).
“BrainStorm’s investigational therapy, NurOwn®
is an amazing technology platform that has the potential to bring
treatment to those with ALS and progressive MS and other
neurodegenerative indications. With a fully enrolled Phase 3
Pivotal Trial for ALS in place, a Phase 2 Trial for progressive MS,
an investigational platform in exosomes and the most ambitious
biomarker program in ALS, I know I am joining a company with
outstanding potential,” said Dr. Setboun.
"David’s experience launching products for
international biopharmaceutical companies and his expertise in
commercial, business development and investments, make him an
outstanding new member of the BrainStorm leadership team. His
extensive experience at all levels of sales and marketing, coupled
with his business strategy experience comes to us at a critical
time in the evolution of NurOwn® and helps us achieve our goal of
bringing new treatment options to patients afflicted with
neurodegenerative diseases, including ALS and progressive MS,"
said Chaim Lebovits, Chief Executive Officer
of BrainStorm.
“Additionally, I am very pleased to announce
Ralph Kern MD, MHSc, has been promoted to President of BrainStorm.
Ralph joined BrainStorm in March 2017 as Chief Operating Officer
and Chief Medical Officer. Directing our clinical
development, Ralph has helped the Company rapidly achieve clinical
milestone, after clinical milestone, while guiding the Company to
expand its product pipeline to investigate additional applications
and disease indications. In recognition of his ongoing, outstanding
service, Ralph has been elevated to the position of President and
Chief Medical Officer of BrainStorm.”
About NurOwn®NurOwn® (autologous MSC-NTF
cells) represent a promising investigational approach to targeting
disease pathways important in neurodegenerative disorders. MSC-NTF
cells are produced from autologous, bone marrow-derived mesenchymal
stem cells (MSCs) that have been expanded and differentiated ex
vivo. MSCs are converted into MSC-NTF cells by growing them under
patented conditions that induce the cells to secrete high levels of
neurotrophic factors. Autologous MSC-NTF cells can effectively
deliver multiple NTFs and immunomodulatory cytokines directly to
the site of damage to elicit a desired biological effect and
ultimately slow or stabilize disease progression. NurOwn® is
currently being evaluated in a Phase 3 ALS randomized
placebo-controlled trial and in a Phase 2 open-label multicenter
trial in Progressive MS.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of
innovative autologous adult stem cell therapeutics for debilitating
neurodegenerative diseases. The Company holds the rights to
clinical development and commercialization of the
NurOwn® Cellular Therapeutic Technology Platform used to
produce autologous MSC-NTF cells through an exclusive, worldwide
licensing agreement as well as through its own patents, patent
applications and proprietary know-how. Autologous MSC-NTF cells
have received Orphan Drug status designation from the U.S.
Food and Drug Administration (U.S. FDA) and
the European Medicines Agency (EMA) in ALS. BrainStorm
has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056),
investigating repeat-administration of autologous MSC-NTF cells at
six sites in the U.S., supported by a grant from
the California Institute for Regenerative Medicine (CIRM
CLIN2-0989). The pivotal study is intended to support a BLA filing
for U.S. FDA approval of autologous MSC-NTF cells in ALS.
BrainStorm received U.S. FDA clearance to initiate a
Phase 2 open-label multi-center trial of repeat intrathecal dosing
of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718)
in December 2018 and has been enrolling clinical trial
participants since March 2019. For more information, visit the
company's website.
Safe-Harbor Statement
Statements in this announcement other than
historical data and information, including statements regarding
future clinical trial enrollment and data, constitute
"forward-looking statements" and involve risks and uncertainties
that could cause BrainStorm Cell Therapeutics
Inc.'s actual results to differ materially from those stated
or implied by such forward-looking statements. Terms and phrases
such as "may", "should", "would", "could", "will", "expect",
"likely", "believe", "plan", "estimate", "predict", "potential",
and similar terms and phrases are intended to identify these
forward-looking statements. The potential risks and uncertainties
include, without limitation, BrainStorm’s need to raise additional
capital, BrainStorm’s ability to continue as a going concern,
regulatory approval of BrainStorm’s NurOwn® treatment candidate,
the success of BrainStorm’s product development programs and
research, regulatory and personnel issues, development of a global
market for our services, the ability to secure and maintain
research institutions to conduct our clinical trials, the ability
to generate significant revenue, the ability of BrainStorm’s
NurOwn® treatment candidate to achieve broad acceptance as a
treatment option for ALS or other neurodegenerative diseases,
BrainStorm’s ability to manufacture and commercialize the NurOwn®
treatment candidate, obtaining patents that provide meaningful
protection, competition and market developments, BrainStorm’s
ability to protect our intellectual property from infringement by
third parties, heath reform legislation, demand for our services,
currency exchange rates and product liability claims and
litigation,; and other factors detailed in BrainStorm's annual
report on Form 10-K and quarterly reports on Form 10-Q available
at http://www.sec.gov. These factors should be considered
carefully, and readers should not place undue reliance on
BrainStorm's forward-looking statements. The forward-looking
statements contained in this press release are based on the
beliefs, expectations and opinions of management as of the date of
this press release. We do not assume any obligation to update
forward-looking statements to reflect actual results or assumptions
if circumstances or management's beliefs, expectations or opinions
should change, unless otherwise required by law. Although we
believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance or achievements.
CONTACTS
Investor Relations: Preetam Shah, MBA, PhD
Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +
1.862.397.1860 pshah@brainstorm-cell.com
Media: Sean Leous Westwicke/ICR PR Phone:
+1.646.677.1839 sean.leous@icrinc.com
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