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): January
26, 2015
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 the accompanying Exhibit 99.1 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 January 26, 2015, we issued the press release furnished as Exhibits
99.1 to this report, 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 January 26, 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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January
26, 2015
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By:
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s/Robert W. Peabody
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Senior Vice President and
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Chief Financial 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 January 26, 2015
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Exhibit 99.1
BioTime
Announces Issuance of 14 New Patents in the Fields of Regenerative
Medicine, Stem Cell Technology, and Cancer Therapy
ALAMEDA, Calif.--(BUSINESS WIRE)--January 26, 2015--BioTime, Inc. (NYSE
MKT: BTX) announced today the issuance of 14 new patents covering a wide
range of the core technologies of BioTime and its subsidiaries Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), OrthoCyte Corporation, ES Cell
International Pte Ltd, OncoCyte Corporation, and ReCyte Therapeutics,
Inc. The new patents issued over Q3 and Q4 of 2014 add to the BioTime
family of companies’ patent estate of over 600 patents and patent
applications pending worldwide, which is the largest known patent estate
in the field of pluripotent stem cell technology for human therapeutic
application, an emerging field known as “regenerative medicine.”
Pluripotent stem cells are cells capable of indefinite expansion and
then differentiation into any and all of the cell types of the human
body. Examples of pluripotent stem cells are human embryonic stem cells
(“hES”) and induced pluripotent stem (“iPS”) cells. These stem cells
potentially offer a new technology platform for the manufacture of a
wide array of cell types designed to be transplanted into the body to
restore healthy tissue function.
“BioTime and its subsidiaries are focused on developing and
commercializing a broad portfolio of innovative cellular therapeutics
and diagnostic products, while also continuing to build value in other
ways, such as through the addition of new patents to our
industry-leading intellectual property estate,” said Dr. Michael D.
West, Ph.D., BioTime’s Chief Executive Officer. “We are making
significant strides in patenting our core platform of pluripotent stem
cell technology and strengthening our competitive position in
regenerative medicine. For the first time in history, pluripotent stem
cells offer a means of manufacturing previously rare and valuable human
cell types in a cost-effective manner and on an industrial scale. We
plan to utilize our strengthened patent position to drive value for our
shareholders as the field of regenerative medicine begins to address the
large and growing markets associated with chronic and age-related
degenerative disease.”
New Patents Owned by BioTime or one of its subsidiaries:
European patent 1809739 – This issued patent claims cell culture
media for the proliferation and scale-up of hES cells. The patent
issuing in Austria, France, Germany, Ireland, Switzerland and Sweden
provides a propagation medium for culturing hES cells in the laboratory
such that the cells proliferate without differentiating as defined
in the claims. The technology allows the user to rapidly produce
high-quality embryonic stem cells for use in therapy and drug discovery,
in a cost-effective and controlled manner, from defined or commercially
available reagents. The patent is therefore useful for manufacturing
products from hES cells. Patents in the same family have previously
issued in the United States, Australia, UK, Israel, Singapore and Hong
Kong, with additional applications pending.
Canada patent 2559854 and China patent ZL200580008779.0 – These
patents claim a differentiation method for making high purity heart
muscle preparations from pluripotent stem cells such as hES cells
suitable for use in regenerative medicine. The issued claims cover
methods wherein the pluripotent stem cells are treated with specific
growth factors and differentiation conditions to manufacture beating
heart muscle cells. The patents are therefore useful in the manufacture
and commercialization of heart muscle cells for research, for the
testing of drugs on the heart, and potentially for regenerating heart
muscle following a heart attack or heart failure. Patents in the same
family have previously issued in the United States, Australia, UK,
Israel, Japan and Singapore, with additional applications pending.
South Korea patent 1543500B – The patent titled,
“Hematopoietic Cells from Human Embryonic Stem Cells,” claims methods
for using pluripotent stem cell technology for inducing immune tolerance
of cells transplanted into a patient (that is, in helping to prevent the
rejection of transplanted cells). As such, the patent claims may be
useful in commercializing diverse types of transplantable cells. Patents
in the same family have previously issued in Australia, UK, Israel,
Japan and Singapore, with additional applications pending.
Canada patent 2468335 – The patent describes
cartilage-forming cells derived from human pluripotent stem cells such
as hES cells. The claims in the patent relate to a system of making the
cartilage-forming cells using factors of the transforming growth factor
beta (TGF-beta) family, of immortalizing the cells with the human
telomerase gene, pharmaceutical formulations of the cells for
therapeutic use in arthritis, as well as other claims. The patent is
therefore useful for the manufacture of such cells for use in research
and potentially in therapy for a number of applications in orthopedic
medicine. Patents in the same family have previously issued in the
United States, Australia, Singapore, Israel and South Korea, with
additional applications pending.
Israel patent 208116 – The patent titled, “Differentiation
of Primate Pluripotent Stem Cells to Hematopoietic Lineage Cells,”
claims methods for the manufacture of dendritic cells from primate
pluripotent stem cells. Dendritic cells are cells that trigger an immune
response to a particular molecule. Often their role is to stimulate the
immune system to attack microorganisms such as bacteria. BioTime’s
subsidiary Asterias Biotherapeutics is developing hES cell-derived
dendritic cells modified to trigger an immune response to specific
antigens related to cancer. A patent in the same family has previously
issued in the United States, with additional applications pending.
Singapore patent 188098 – The patent titled, “Synthetic Surfaces
for Culturing Stem Cell Derived Cardiomyocytes,” claims certain polymers
upon which heart muscle cells derived from pluripotent stem cells may be
cultured. The patent is potentially useful for the manufacture of human
heart muscle cells for drug screening and toxicity testing and for use
in the manufacture of such cells for transplantation into human subjects
for the treatment of heart disease. A patent in the same family has
previously issued in the United States, with additional applications
pending.
Singapore patent 176957 – The patent titled, “Differentiated
Pluripotent Stem Cell Progeny Depleted of Extraneous Phenotypes,” claims
methods for the purification of pluripotent stem cell-derived
oligodendrocytes by the removal of contaminating cells that display an
antigen called epithelial cell adhesion molecule (EpCAM). This method is
potentially useful in the purification of such oligodendrocytes prior to
their use in research or human therapy. Patents in the same family have
previously issued in the United States and China, with additional
applications pending.
Singapore patent 177694 – The patent titled, “Methods and
Compositions for in vitro and in vivo Chondrogenesis,” claims methods
for the manufacture of cartilage from BioTime’s PureStem®
cell lines 4D20.8, SM30, E15, MEL2, SK11, and 7SMOO32, methods for
combining the cells with matrices, and molding the cartilage to produced
formed tissue. The patent is potentially useful for BioTime’s subsidiary
OrthoCyte Corporation in the manufacture of human cartilage grafts for
the repair of orthopedic disorders such as arthritis and degeneration of
the intervertebral disc. A patent in the same family has previously
issued in the United States, with additional applications pending.
Australia patent 2011258249 – The patent titled, “Improved
Methods of Screening Embryonic Progenitor Cell Lines,” claims
compositions and methods relating to BioTime’s PureStem®
cell lines expressing the gene EYA4 which are capable of
differentiating into skin fat cells, including brown fat cells that have
the potential to be useful to BioTime’s subsidiary ReCyte Therapeutics
and may have uses in the treatment of metabolic disorders such as
obesity and Type II diabetes. Claims were also issued relating to the
manufacture of kits including the components described in the patent
which may be useful in the development of new research products for sale
through BioTime’s ESI BIO Division. Patents in the same family are
currently pending in other jurisdictions.
Australia patent 200735127 – This patent claims methods for
identifying and selecting heart muscle cells made from pluripotent stem
cells. In particular, the patent identifies molecules associated with
cells that can be used to sort heart muscle from other cell types and
thereby generate purified product. Methods are claimed for use of the
cells in drug testing as well as for the transplantation of such cells
into human subjects for the treatment of heart disease. A patent in the
same family has previously issued in the United Kingdom, with additional
applications pending.
Israel patent 179785 – This patent claims methods relating to the
freezing of pluripotent stem cells such as human embryonic stem cells
that are capable of becoming liver cells, heart muscle cells, pancreatic
cells, cartilage cells, as well as other cell types and is therefore
potentially useful for the manufacture and storage of cells for research
and therapy. Patents in the same family have previously issued in
Australia, UK and Singapore, with additional applications pending.
In-licensed Patents:
United States patent 8921104 – The patent titled, “Method
for Producing Dendritic Cells,” claims methods relating to embryonic
stem cell-derived dendritic cells. Dendritic cells are cells that
present molecules to the immune system in order to trigger an immune
response to that particular protein. BioTime’s subsidiary Asterias
Biotherapeutics is developing hES cell-derived dendritic cells modified
to trigger an immune response to certain antigens related to cancer.
Patents in the same family have previously issued in the United States
(3 others issued), China and Australia, with additional applications
pending in multiple jurisdictions.
United States patent 8,815804 – Claims in this case relate to
peptides that selectively home to tumors, blood clots and/or other
injury sites in a subject and are potentially useful in targeting cells
to cancer as a novel therapeutic strategy. The patent is licensed to
BioTime’s subsidiary OncoCyte Corporation. A European patent has
previously issued in this family, with national patents granted in
Finland, France, Germany, Ireland, Lithuania, Luxenbourg, Monaco,
Netherlands, Sweden, Switzerland and the UK. Additional applications
pending in multiple jurisdictions.
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. Renevia™ (a HyStem®
product), is now in a pivotal trial in Europe as a biocompatible,
implantable hyaluronan and collagen-based matrix for cell delivery in
the treatment of HIV-related lipoatrophy. 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. Asterias Series A common stock is traded on the NYSE
MKT under the symbol AST.
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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. OpRegen™ is currently in a Phase I/IIa
clinical trial for the treatment of the dry-form of age-related
macular degeneration.
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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 four
clinical studies 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 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
James
Dawson, 646-445-4800
jdawson@evcgroup.com
Doug Sherk,
415-652-9100
dsherk@evcgroup.com
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