BioTime Awarded $2.5 Million Grant from the Israel Innovation Authority for Continued Development of OpRegen®
May 10, 2019ALAMEDA, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24BTX&src=ctag" target="_blank"gt;$BTXlt;/agt; lt;a href="https://twitter.com/hashtag/AMD?src=hash" target="_blank"gt;#AMDlt;/agt;–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.
Contacts
BioTime Inc. IR
Ioana C. Hone
[email protected]
(510)
871-4188
Solebury Trout IR
Gitanjali Jain Ogawa
[email protected]
(646)
378-2949