UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): May
4, 2015
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California
|
1-12830
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94-3127919
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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1301
Harbor Bay Parkway
Alameda,
California 94502
(Address
of principal executive offices)
(510)
521-3390
(Registrant's
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
Any statements that are not historical fact (including, but not
limited to statements that contain words such as “may,” “will,”
“believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”)
should also be considered to be forward-looking statements. Additional
factors that could cause actual results to differ materially from the
results anticipated in these forward-looking statements are contained in
BioTime’s periodic reports filed with the SEC under the heading “Risk
Factors” and other filings that BioTime may make with the Securities and
Exchange Commission. Undue reliance should not be placed on these
forward-looking statements which speak only as of the date they are
made, and the facts and assumptions underlying these statements may
change. Except as required by law, BioTime disclaims any intent or
obligation to update these forward-looking statements.
This Report and any accompanying exhibits shall be deemed “furnished”
and not “filed” under the Securities Exchange Act of 1934, as amended.
Section 7 - Regulation FD
Item 7.01 - Regulation FD
Disclosure
On May 4, 2015, BioTime, Inc. issued the press release furnished as
Exhibit 99.1, which is incorporated by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01
- Financial Statements and Exhibits.
Exhibit Number
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Description
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99.1
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Press release dated May 4, 2015
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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BIOTIME, INC.
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Date:
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May 4,
2015
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By:
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/s/ Michael D. West
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Chief Executive Officer
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Exhibit Number
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Description
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99.1
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Press release dated May 4, 2015
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2
Exhibit 99.1
Cell Cure
Neurosciences Announces Preclinical Efficacy Data Demonstrating OpRegen®
Preserves Vision
Data
to be Presented at Association for Research in Vision and Ophthalmology
(ARVO) 2015 Annual Meeting
ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)--May 4, 2015--BioTime, Inc.
(NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. (Cell
Cure) today announced that preclinical data demonstrating that Cell
Cure’s product candidate, OpRegen®, preserved
vision and retinal structure when transplanted into the leading animal
model of retinal disease, will be presented at the Association for
Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting taking
place May 3-7, 2015, in Denver, Colorado. OpRegen®
consists of animal product-free retinal pigment epithelial (RPE) cells
with high purity and potency.
The preclinical study was conducted by a scientific team led by Trevor
J. McGill, Ph.D., Research Assistant Professor at the Casey Eye
Institute, Oregon Health and Science University. The abstract accepted
for paper presentation is titled, “Long Term Efficacy of Xeno-free
hESC-derived RPE Cells Following Transplantation into Royal College of
Surgeons Rats.” The data that will be presented by Michael D. Andrews of
the Casey Eye Institute, Oregon Health and Science University, and lead
study investigator, during session 202, titled, “Retinal degeneration
and disease: experimental models,” is scheduled for Monday, May 4, 2015
from 9:00 AM to 9:15 AM Mountain Time Zone. The abstract number is 1275.
The presentation abstract is available online at the ARVO website at http://www.arvo.org/Online_Planner/.
Cell Cure has received regulatory clearance from the U.S. Food and Drug
Administration (FDA) and the Israeli Ministry of Health to initiate a
Phase I/IIa dose escalation safety and efficacy clinical study of OpRegen®
for geographic atrophy (GA), the severe stage of the dry form of
age-related macular degeneration (dry-AMD). Patient enrollment has
started at Hadassah University Medical Center in Jerusalem, Israel. The
trial consists of four cohorts and will evaluate three different dose
regimens. Details of the trial are available at https://clinicaltrials.gov/.
Cell Cure expects to report interim data from the cohorts in the coming
months.
While treatment options exist for the wet form of AMD, which represents
about 10% of the disease prevalence, there is currently no FDA-approved
therapy for the dry form that occurs in approximately 90% of those
afflicted with AMD. Cell Cure intends to transplant OpRegen®
as a single dose into the subretinal space of patients’ eyes in order to
test the safety and efficacy of the product in this leading cause of
blindness.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major diseases of
aging and is the leading eye disease responsible for visual impairment
of older persons in the US, Europe and Australia. AMD affects the
macula, which is the part of the retina responsible for sharp, central
vision that is important for facial recognition, reading and driving.
There are two forms of AMD. The dry form (dry-AMD) advances slowly and
painlessly but may progress to geographic atrophy (GA) in which RPE
cells and photoreceptors degenerate and are lost. Once the atrophy
involves the fovea (the center of the macula), patients lose their
central vision and may develop legal blindness. There are about 1.6
million new cases of dry-AMD in the US annually, and as yet there is no
effective treatment for this condition. About 10% of patients with
dry-AMD develop wet (or neovascular) AMD, the second main form of this
disease, which usually manifests acutely and can lead to severe visual
loss in a matter of weeks. Wet-AMD can be treated with
currently-marketed VEGF inhibitors such as Lucentis or Eylea. However,
such products typically require frequent repeated injections in the eye,
and patients often continue to suffer from continued progression of the
underlying dry-AMD disease process. Current estimated annual sales of
VEGF inhibitors for the treatment of the wet form of AMD are estimated
to be about $8 billion worldwide. The root cause of the larger problem
of AMD is believed to be the dysfunction of RPE cells. One of the most
exciting therapeutic approaches to dry-AMD is the transplantation of
healthy, young RPE cells to support and replace the patient’s old
degenerating RPE cells, which may prevent progression of the atrophy as
well as the development of wet-AMD. Pluripotent stem cells, such as
human embryonic stem cells (hESCs), can provide an unlimited source for
the derivation of such healthy RPE cells for transplantation.
About OpRegen®
Cell Cure's OpRegen® consists of RPE cells that
are produced using a proprietary process that drives the differentiation
of human embryonic stem cells into high purity RPE cells. OpRegen®
is also “xeno-free," meaning that no animal products were used either in
the derivation and expansion of the human embryonic stem cells or in the
directed differentiation process. The avoidance of the use of animal
products eliminates some safety concerns. OpRegen®
is formulated as a suspension of RPE cells. Preclinical studies in mice
have shown that following a single subretinal injection of OpRegen®
as a suspension of cells, the cells can rapidly organize into their
natural monolayer structure and survive throughout the lifetime of the
animal. OpRegen® will be an “off-the-shelf”
allogeneic product. Unlike treatments that require multiple, frequent
injections into the eye, it is expected that OpRegen®
would be administered in a single procedure.
About Cell Cure Neurosciences Ltd.
Established in 2005, Cell Cure is located in Jerusalem, Israel on the
campus of Hadassah Medical Center. Cell Cure's mission is to become a
leading supplier of human cell-based therapies for the treatment of
retinal and neural degenerative diseases. Its technology platform is
based on the manufacture of diverse cell products sourced from
clinical-grade (GMP-compatible) human embryonic stem cells. Its current
focus is the development of retinal pigment epithelial (RPE) cells for
the treatment of age-related macular degeneration. Cell Cure's major
shareholders include BioTime, Inc. (NYSE MKT: BTX), HBL Hadasit
Bio-Holdings Ltd., Teva Pharmaceuticals Industries Ltd., and Asterias
Biotherapeutics, Inc. Additional information about Cell Cure can be
found on the web at www.cellcureneurosciences.com.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage
biotechnology company. BioTime and its subsidiaries are leveraging their
industry-leading experience in pluripotent stem cell technology and a
broad intellectual property portfolio to facilitate the development and
use of cell-based therapies and gene marker-based molecular diagnostics
for major diseases and degenerative conditions for which there presently
are no cures. The lead clinical programs of BioTime and its subsidiaries
include: OpRegen®, currently in a Phase I/IIa
trial for the treatment of the dry form of age-related macular
degeneration; AST-OPC1, currently in a Phase I/IIa trial for
spinal cord injuries; Renevia™, currently in a pivotal trial in
Europe as an injectable matrix for the engraftment of transplanted cells
to treat HIV-related lipoatrophy; and PanC-Dx™ cancer
diagnostics, which are completing initial clinical studies for bladder,
breast, and lung cancer. AST-VAC2, a cancer vaccine, is in the
pre-clinical trial stage.
BioTime’s subsidiaries include: publicly-traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1
and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem
cell-based therapies for retinal and neurological disorders, including OpRegen®;
OncoCyte Corporation, developing PanC-Dx™ cancer diagnostics;
LifeMap Sciences, Inc., developing and marketing an integrated on-line
database resource for biomedical and stem cell research; LifeMap
Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile
health (mHealth) products; ES Cell International Pte Ltd, which has
developed cGMP compliant human embryonic stem cell lines that are being
marketed by BioTime for research purposes under the ESI BIO branding
program; OrthoCyte Corporation, developing therapies to treat orthopedic
disorders, diseases and injuries; and ReCyte Therapeutics, Inc.,
developing therapies to treat a variety of cardiovascular and related
ischemic disorders.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For
more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube, and
Google+.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for BioTime and its subsidiaries, along with
other statements about the future expectations, beliefs, goals, plans,
or prospects expressed by management constitute forward-looking
statements. Any statements that are not historical fact (including, but
not limited to statements that contain words such as “will,” “believes,”
“plans,” “anticipates,” “expects,” “estimates”) should also be
considered to be forward-looking statements. Forward-looking statements
involve risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or regulatory
approvals, need and ability to obtain future capital, and maintenance of
intellectual property rights. Actual results may differ materially from
the results anticipated in these forward-looking statements and as such
should be evaluated together with the many uncertainties that affect the
business of BioTime and its subsidiaries, particularly those mentioned
in the cautionary statements found in BioTime's Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com.
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com
or
Investor
Contact:
EVC Group, Inc.
Gregory Gin, 862-236-0673
ggin@evcgroup.com
Michael
Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk,
415-652-9100
dsherk@evcgroup.com
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