BioTime Awarded $2.5 Million Grant from the Israel Innovation Authority for Continued Development of OpRegen®
May 10 2019 - 8:00AM
Business Wire
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage
biotechnology company developing cellular therapies for unmet
medical needs, has been awarded a new research & development
grant for 2019 of up to 9 million Israeli New Shekels
(approximately $2.5 million USD) from the Israel Innovation
Authority (the “IIA”). The grant provides funding for the continued
development of OpRegen®, the Company’s retinal pigment epithelium
transplant therapy currently in Phase I/IIa development for the
treatment of dry age-related macular degeneration, the leading
cause of blindness in the developed world. To date, the IIA has
provided annual grants totaling approximately $15 million for the
development of the OpRegen program.
“We are pleased to receive the IIA’s financial support and
believe that this grant is indicative of their confidence in
BioTime’s innovative OpRegen program for the treatment of
age-related macular degeneration,” stated Brian M. Culley, Chief
Executive Officer of BioTime. “We are proud of the partnerships we
have built with notable institutions like the IIA, as well as with
the California Institute for Regenerative Medicine, who have
supported the development of our OPC1 program for SCI with grants
totaling $14.3 million and Cancer Research UK, the world’s largest
independent cancer research charity, which is responsible for the
manufacturing and ongoing clinical trial of our VAC2 program in
NSCLC. We believe these noteworthy partnerships provide not only
capital, but also external validation of each of our programs and
we will look to strengthen and expand these alliances as we move
forward.”
About OpRegen®
OpRegen is a retinal pigment epithelium (RPE) transplant therapy
in Phase I/IIa development for the treatment of dry AMD, the
leading cause of adult blindness in the developed world. OpRegen
consists of a suspension of RPE cells delivered subretinally as an
intraocular injection. RPE cells are essential components of the
back lining of the retina and function to help nourish the retina
including photoreceptors. OpRegen has been granted Fast Track
designation from the U.S. Food and Drug Administration.
OpRegen is a registered trademark of Cell Cure Neurosciences Ltd.,
a majority-owned subsidiary of BioTime, Inc.
About The Israel Innovation Authority
The Israel Innovation Authority, an independent publicly funded
agency, was created to provide a variety of practical tools and
funding platforms aimed at effectively addressing the dynamic and
changing needs of the local and international innovation
ecosystems. This includes early-stage entrepreneurs, mature
companies developing new products or manufacturing processes,
academic groups seeking to transfer their ideas to the market,
global corporations interested in collaborating with Israeli
technology, Israeli companies seeking new markets abroad and
traditional factories and plants seeking to incorporate innovative
and advanced manufacturing into their businesses. More information
is available at:
https://innovationisrael.org.il/en/contentpage/israel-innovation-authority.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing new
cellular therapies for unmet medical needs. BioTime’s programs are
based on its proprietary cell-based therapy platform and associated
development and manufacturing capabilities. With this platform
BioTime develops and manufactures specialized,
terminally-differentiated human cells from its pluripotent and
progenitor cell starting materials. These differentiated cells are
developed either to replace or support cells that are dysfunctional
or absent due to degenerative disease or traumatic injury, or
administered as a means of helping the body mount an effective
immune response to cancer. BioTime’s clinical assets include (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
I/IIa development for the treatment of dry age-related macular
degeneration, the leading cause of blindness in the developed
world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in
Phase I/IIa development for the treatment of acute spinal cord
injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of
antigen-presenting dendritic cells currently in Phase I development
for the treatment of non-small cell lung cancer. For more
information, please visit www.biotimeinc.com.
Forward-Looking Statements
BioTime cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” “project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to: BioTime’s
receipt of the full amount of funding available for 2019 under the
grant award from the IIA; BioTme’s ability to strengthen and expand
its relationships with the IIA, the California Institute for
Regenerative Medicine and Cancer Research UK for the ongoing
support of the development of the OpRegen, OPC1 and VAC2 programs,
respectively; and BioTime’s ability to advance its product
candidates. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause BioTime’s
actual results, performance or achievements to be materially
different from future results, performance or achievements
expressed or implied by the forward-looking statements in this
press release, including, without limitation, risk and
uncertainties related to: BioTime’s ability to raise additional
capital when and as needed, to advance its product candidates;
BioTime’s ability to develop and commercialize product candidates;
the failure or delay in starting, conducting and completing
clinical trials or obtaining FDA or foreign regulatory approval for
BioTime’s product candidates in a timely manner; the therapeutic
potential of BioTime’s product candidates, and the disease
indications for which BioTime intends to develop its product
candidates; BioTime’s ability to conduct and design successful
clinical trials, to enroll a sufficient number of patients, to meet
established clinical endpoints, to avoid undesirable side effects
and other safety concerns, and to demonstrate sufficient efficacy
of its product candidates; developments by BioTime competitors that
make BioTime’s product candidates less competitive or obsolete;
BioTime’s ability to manufacture its product candidates for
clinical development and, if approved, for commercialization, and
the timing and costs of such manufacture; the performance of third
parties in connection with the development and manufacture of
BioTime’s product candidates, including third parties conducting
clinical trials as well as third-party suppliers and manufacturers;
the potential of BioTime’s cell therapy platform, and BioTime’s
plans to apply its platform to research, develop and commercialize
our product candidates; BioTime’s ability, and the ability of its
licensors, to obtain, maintain, defend and enforce intellectual
property rights protecting BioTime’s product candidates, and
BioTime’s ability to develop and commercialize its product
candidates without infringing the proprietary rights of third
parties; BioTime’s ability to recruit and retain key personnel; and
BioTime’s ability to successfully integrate the operations of
Asterias into BioTime. BioTime’s forward-looking statements are
based upon its current expectations and involve assumptions that
may never materialize or may prove to be incorrect. All
forward-looking statements are expressly qualified in their
entirety by these cautionary statements. For a detailed description
of BioTime’s risks and uncertainties, you are encouraged to review
its documents filed with the SEC including its recent filings on
Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place
undue reliance on forward-looking statements, which speak only as
of the date on which they were made. BioTime undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made,
except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20190510005103/en/
BioTime Inc. IRIoana C. Honeir@biotimeinc.com(510)
871-4188
Solebury Trout IRGitanjali Jain
OgawaGogawa@troutgroup.com(646) 378-2949
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