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): July
14, 2014
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California
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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 July 14, 2014, 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 July 14, 2014.
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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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July
14, 2014
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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 July 14, 2014.
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3
Exhibit 99.1
BioTime
Announces Issuance of 14 Patents in the Fields of Regenerative Medicine,
and Cancer Diagnosis and Therapy
- New
issued patents add to existing estate of over 600 patents and patent
applications worldwide in the emerging field of pluripotent stem cell
technology -
ALAMEDA, Calif.--(BUSINESS WIRE)--July 14, 2014--BioTime, Inc. (NYSE
MKT:BTX) announced today the issuance of 14 new patents to BioTime and
its subsidiary companies. The patents issued in Australia, Canada,
China, Japan, and the United States, cover a wide range of core
technologies foundational to BioTime’s businesses. The new patents add
to the largest known patent estate under one corporate umbrella in the
field of pluripotent stem cell technology known as “regenerative
medicine” with over 600 existing patents and patent applications owned
or licensed to BioTime and its subsidiaries worldwide.
“As a biotechnology company, our intellectual property portfolio is an
important asset that supports our product development programs and
drives value in our business transactions,” said Dr. Michael D. West,
Ph.D., BioTime’s Chief Executive Officer. “The new patents are expected
to contribute to shareholder value for BioTime generally, for our
corporate partners, and for our individual subsidiary businesses that
are focused on applying our platform technologies to specific medical
applications. These patents also provide BioTime with new opportunities
to partner critical stem cell technologies with companies developing and
commercializing advanced technologies in the regenerative medicine
field.”
Background
BioTime is a leader in the emerging field of regenerative medicine whose
foundation is based on pluripotent stem cell technology. Its current
leadership position is in part based on the early nature of the research
performed by its inventors. Scientists at BioTime, and its subsidiary
Asterias Biotherapeutics, Inc. previously led the world in isolation of
the first human pluripotent stem cells known as human embryonic stem
cells. These first-in-class intellectual property assets originally
built at Geron Corporation are now being developed within Asterias.
Being the first company in the world to have access to these cells, our
scientists and our collaborators were able to file numerous broad
foundational patents in the field such as US patent number 8,637,311
described herein which claims human embryonic stem cells cultured on a
matrix free of feeder cells wherein the stem cells are genetically
modified.
In competition with Geron, the Singapore-based company ES Cell
International and Cell Cure Neurosciences Ltd also built key assets and
were later acquired as subsidiaries of BioTime. In addition, after
leaving Geron in 1998, Dr. West led the competing company Advanced Cell
Technology from 1998-2005 and after coming to BioTime he licensed
certain other key patent applications from ACT. These included
compositions and methods for deriving more than 200 purified lineages of
cells, a technology known as “PureStem®”
(US Patent number 8,685,386) as well as US Patent number 8,753,884 which
describes an important and broad pathway of making all human cell types
without ever creating or using human embryonic or induced pluripotent
stem cells.
Pluripotent stem cells are capable for the first time in the history of
medicine of becoming all the cell types of the human body. The unlimited
replicative capacity of pluripotent stem cells also allows for the first
time, the production of master cell banks of the stem cells from which
any human cell type can be manufactured in limitless quantities. This
power to make the hundreds of cell types that comprise the human body
combine with the massive scalability of the manufacturing platform,
together leads to the interest the scientific and pharmaceutical
communities have in using the technology to manufacture cells, instead
of drugs, that can be used to regenerate tissues impaired by injury or
degenerative disease. The rapid rise in age-related degenerative
diseases such as age-related macular degeneration, arthritis, coronary
disease, Parkinson’s, and stroke, to name a few, make regenerative
medicine one of the most anticipated new technologies for the future of
health care.
New Patents Owned by BioTime or one of its subsidiaries:
United States patent 8,685,386 – This patent is based on
work performed at BioTime on the PureStem® cell
lines capable of becoming cell types useful in the repair of cartilage
and bone. The claims cover certain PureStem® cell
types as well as certain products made from them used in patients.
Titled “Methods and Compositions for In Vitro and In Vivo
Chondrogenesis,” this patent is one of numerous patents useful to
BioTime’s subsidiary OrthoCyte Corporation.
United States patent 8,728,457 – Methods of inducing the
differentiation of embryonic stem cells into mesodermal cells (one of
the three major branches of cell types in the human body that includes
heart muscle and blood vessel cells) by contacting the stem cells with
certain cells from one of the other major branches of cells (such as the
endoderm or ectoderm). The patent relates to methods of making
cardiomyocytes and vascular endothelial cells and is therefore useful
for BioTime’s subsidiary ReCyte Therapeutics, Inc.
United States patent 8,637,311 – The claims in this patent
related to human embryonic stem cells that are cultured on extracellular
matrix free of feeder cells and that are genetically modified.
Australia patent 2012203810 – Methods and Compositions for the
Treatment and Diagnosis of Bladder Cancer. The patent relates to methods
of detecting bladder cancer by contacting a sample from a subject with
agents that bind certain proprietary markers expressed in patients with
bladder cancer. The patent is useful for BioTime’s subsidiary OncoCyte
Corporation for its cancer diagnostic product development.
Australia patent 2010200610 – The claims in this patent relate to
cell cultures comprising endoderm cells, one of the three major lineages
of cells that make up the human body. In particular, endoderm cells make
cells of internal organs such as the lung, pancreas, and liver as well
as other internal cell types.
Canada patent 2,459,957 – This patent contains claims
related to the feeder-free culture of pluripotent stem cells wherein the
stem cells are grown on an extracellular matrix and stimulated to grow
with a fibroblast growth factor. In addition, the patent contains
additional claims such as to genetically-modified pluripotent stem cells
grown on such feeder-free conditions.
China patent 1543500B – The claims of this patent relate to
heart muscle cells (cardiomyocytes) produced under certain conditions
from human embryonic stem cells in conditions essentially free of feeder
cells.
China patent 102803472B – The claims in this patent relate to
methods to purify cellular formulations made from pluripotent stem cell
progeny wherein the cell population comprises oligodendrocytes.
Japan patent 5479661 – Methods of Inducing Differentiation of
Stem Cells. The patent relates to methods of making cardiomyocytes and
vascular endothelial cells.
Japan patent 5460677 – is a patent with claims related to
endoderm cells. Endoderm is one of the three major branches of cells
originating from pluripotent stem cells. Endodermal cells contribute to
internal organs such as the esophagus, stomach, lungs, liver, pancreas,
as well as other tissues. The issued claims relate to such cells
produced from human embryonic stem cells cultured in the presence of a
growth factor known as activin.
Japan patent 2011-047716 – Oligodendrocytes derived from human
embryonic stem cells for remyelination and treatment of spinal cord
injury are described. The patent relates to methods of making
oligodendrocytes from human embryonic stem cells. The patent is useful
to Asterias Biotherapeutics, Inc. for its AST-OPC1 product development.
In-licensed Patents:
United States patent 8,691,793 – Certain claims in this patent
relate to chemical modifications of glycosaminoglycans such as
hyaluronic acid (one of the components of at least two HyStem®-related
products in development by BioTime).
United States patent 8,753,884 – This patent has broad claims
related to methods of producing human differentiated cells of any type
from the morula or inner cell mass of an embryo without making human
embryonic stem cell lines or induced pluripotent stem cell lines.
United States patent 8,637,635 – Claims in this case
related to peptides that selectively home to heart vasculature and
related conjugates and methods.
About BioTime
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem®
progenitors, HyStem® hydrogels, culture media,
and differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications, and is planning
to initiate a pivotal clinical trial around Renevia™, in 2014. In
addition, BioTime has developed Hextend®, a blood
plasma volume expander for use in surgery, emergency trauma treatment
and other applications. Hextend® is manufactured
and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ
HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
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Asterias Biotherapeutics, Inc. is developing pluripotent
stem-cell based therapies in neurology and oncology, including
AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury,
multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic
cell-based cancer vaccine.
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BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
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Cell Cure Neurosciences Ltd. is an Israel-based biotechnology
company focused on developing stem cell-based therapies for retinal
and neurological disorders, including the development of retinal
pigment epithelial cells for the treatment of macular degeneration,
and treatments for multiple sclerosis.
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ESI BIO is the research and product marketing division of
BioTime, providing stem cell researchers with products and
technologies to enable them to translate their work into the clinic,
including PureStem® progenitors and HyStem®
hydrogels.
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LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®,
the leading human gene database, as part of an integrated database
suite that also includes the LifeMap Discovery®
database of embryonic development, stem cell research, and
regenerative medicine, and MalaCards, the human disease
database.
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LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences
focused on developing mobile health (mHealth) products.
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OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer, including PanC-Dx™, with three
clinical trials currently underway.
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OrthoCyte Corporation is developing therapies to treat
orthopedic disorders, diseases and injuries.
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ReCyte Therapeutics, Inc. is developing therapies to treat a
variety of cardiovascular and related ischemic disorders, as well as
products for research using cell reprogramming technology.
BioTime stock is traded on the NYSE MKT, ticker 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
businesses of BioTime and its subsidiaries, including Asterias
Biotherapeutics, Inc., particularly those mentioned in the cautionary
statements found in BioTime's and Asterias’ 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
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