BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority
April 03 2020 - 6:59AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading
developer of adult stem cell technologies for neurodegenerative
diseases, today announced that its wholly-owned subsidiary,
Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of
approximately $1.5 million by the Israel Innovation Authority
(IIA). The grant enables Brainstorm to continue development
of advanced cellular manufacturing capabilities, furthers
development of MSC-derived exosomes as a novel therapeutic
platform, and will ultimately enable Brainstorm to expand the
therapeutic pipeline in neurodegenerative disorders.
BrainStorm's CEO Chaim Lebovits, commented, "The
Israel Innovation Authority's support of our programs provides
further validation for the potential of our treatments to help
patients suffering from neurodegenerative disorders. The continued
financial support for our research and development will further our
ability to execute our strategic objectives, as we finalize our
Phase 3 pivotal trial with NurOwn in ALS patients and advance our
cellular technology pipeline."
The IIA has supported BrainStorm Cell
Therapeutics Ltd. since 2007, providing grants totaling
approximately 11.4 million USD in support of the development of
NurOwn and other projects. BrainStorm will be required to pay
mid-single digit royalties to the IIA based on sales of the
products, up to a total of the cumulative amount of IIA grants
received plus accumulated interest.
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.
CONTACTSInvestor Relations:
Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell
Therapeutics Inc. Phone: + 1.862.397.1860
pshah@brainstorm-cell.comMedia: Sean Leous
Westwicke/ICR PR Phone: +1.646.677.1839 sean.leous@icrinc.com
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