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): March
20, 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 Securities and Exchange
Commission (“SEC”) under the heading “Risk Factors” and other filings
that BioTime may make with the SEC. 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 March 20, 2015, we and our subsidiary OncoCyte Corporation 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 March 20, 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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March
20, 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 March 20, 2015
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Exhibit 99.1
OncoCyte
Announces Availability of Abstracts With New Clinical Data From Studies
of PanC-Dx™
Cancer Diagnostic in Bladder and Breast Cancer
Data
to be Presented at American Association for Cancer Research 2015 Annual
Meeting
ALAMEDA, Calif.--(BUSINESS WIRE)--March 20, 2015--BioTime, Inc. (NYSE
MKT:BTX) and its subsidiary OncoCyte Corporation today announced the
online availability of abstracts providing human clinical data
highlighting the potential of PanC-Dx™, OncoCyte’s class of
non-invasive cancer diagnostics based on OncoCyte’s proprietary set of
cancer markers. These markers were discovered by company scientists
through an analysis of broad gene expression patterns in numerous cancer
types. These markers, including COL10A1, are the subject of multiple
pending patent claims filed in numerous countries worldwide and are
owned by OncoCyte. Data included in the abstracts will be presented in
two poster presentations at the American Association for Cancer Research
(AACR) Annual Meeting being held April 18-22, 2015.
“The presentations on PanC-Dx™ at the AACR 2015
annual meeting will report on the first human clinical data from a key
OncoCyte product development program,” said Joseph Wagner, PhD,
OncoCyte’s Chief Executive Officer. “We, along with our clinical
investigators, are pleased with the high sensitivity and specificity of PanC-Dx
in diagnosing bladder cancer. The levels of accuracy that we report may
give this new diagnostic the potential for widespread adoption as an
improved method of detecting bladder cancer or its recurrence. We
appreciate the effort of our clinical investigators and distinguished
collaborators at Johns Hopkins University School of Medicine, leaders in
bladder cancer research.”
The first abstract describes the clinical data and assay development
progress of OncoCyte’s bladder cancer diagnostic test. Data obtained
from a clinical study recently completed in collaboration with
investigators in the Department of Pathology at Johns Hopkins University
School of Medicine, was to assess the performance of OncoCyte’s
proprietary diagnostic technology in detecting the most common type of
bladder cancer, urothelial carcinoma (UC). Study investigators collected
90 urine samples from patients undergoing urine cytology for the
diagnosis of either primary or recurrent bladder cancer. An analysis was
performed and a panel of markers that discriminates UC from
non-cancerous conditions was identified. Evaluation of the performance
of this gene panel indicated high levels of sensitivity and specificity
(Receiver Operating Characteristic area under the curve of greater than
0.9). Additional evaluation of this gene panel in the context of a
larger multi-site study is ongoing and results from this expanded
clinical study will be included in the presentation.
The second presentation will provide a summary of the clinical data and
assay development progress of OncoCyte’s breast cancer diagnostic test.
Specifically, the abstract describes the potential utility of COL10A1 as
a blood-based biomarker for multiple cancers, including breast cancer.
This study involving over 600 patients is being conducted at Scottsdale
Medical Imaging Laboratories.
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics, it was estimated that in
2015 over 74,000 new cases of bladder cancer would occur in the United
States and a total of over 500,000 men and women alive would have a
history of bladder cancer and be subject to recurrence surveillance
testing using cystoscopy or urine cytology. Bladder cancer has the
highest recurrence rate of any major type of cancer; recurrence
surveillance testing is strongly recommended and widely performed.
In 2010, over 30 million screening mammograms were performed in the US
alone. The American Cancer Society and the National Comprehensive Cancer
Network both recommend screening mammography every year starting at age
40, which has been associated with relative reduction in breast cancer
mortality of 15% to 20%. However, the NCI estimates that approximately
20% of all breast cancers are not detected by mammography during annual
screening which indicates there is an unmet need for a breast-cancer
screening test with superior specificity and sensitivity when compared
to standard screening mammography.
Details for the two poster presentations are as follows:
Presentation Title: Identification of gene-expression biomarkers
in urine pathology specimens for the detection of bladder cancer
Abstract
#: 551
Location: Poster Section 23
Poster Board
Number: Board 21
Date & Time: Sunday, April 19, 2015
at 1:00 PM - 5:00 PM EDT
Presentation Title: Identification of type X collagen as a
pan-cancer serum biomarker
Abstract #: 1578
Location:
Poster Section 22
Poster Board Number: Board 18
Date &
Time: Monday, April 20, 2015, 8:00 AM - 12:00 PM EDT
About OncoCyte Corporation
OncoCyte, a majority-owned subsidiary of BioTime, Inc., is developing
novel products for the diagnosis and treatment of cancer in order to
improve the quality and length of life of cancer patients. Based on
large unmet need, market size, and data generated thus far from patient
sample screening, OncoCyte is initially focusing its efforts on
developing PanC-Dx™ diagnostic products for use in detecting
breast, bladder, and lung cancers. PanC-Dx™ is a class of
non-invasive cancer diagnostics based on a proprietary set of cancer
markers characterized, in part, by broad gene expression patterns in
numerous cancer types. The PanC-Dx™ biomarkers were discovered as
a result of ongoing research within OncoCyte and BioTime on the gene
expression patterns associated with embryonic development. This research
has demonstrated that many of the same genes associated with normal
growth during embryonic development are abnormally reactivated by cancer
cells. These genes regulate such diverse processes as cell
proliferation, cell migration and blood vessel formation. Many of these
genes have not been previously associated with cancer. Moreover,
expression of a large subset of these genes is conserved across numerous
cancer types (e.g. cancers of the breast, colon, ovaries, etc.),
suggesting these genes may control fundamental processes during cancer
growth and progression. In addition to their potential value in
developing diagnostic biomarkers, an understanding of the pattern of
expression of these genes may also enable the development of powerful
new cancer therapeutics that target rapidly proliferating cancer cells.
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
or
Michael
Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug
Sherk, 415-652-9100
dsherk@evcgroup.com
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