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
19, 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 May 19, 2015, we issued the press release furnished as Exhibit 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 May 19, 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
19, 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 19, 2015
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Exhibit 99.1
OncoCyte’s
Collaborators at The Wistar Institute Present Positive Clinical Interim
Results of Blood-Based Diagnostic Test for Non-Invasive Detection of
Lung Cancer
Data
Presented at the 2015 American Thoracic Society International Conference
ALAMEDA, Calif.--(BUSINESS WIRE)--May 19, 2015--BioTime, Inc. (NYSE
MKT:BTX) and its subsidiary OncoCyte Corporation today announced the
presentation of positive interim clinical results demonstrating the high
level of observed sensitivity and specificity in the assayed samples of
a simple blood-based test designed to aid physicians in the early
detection of lung cancer. The large, prospective clinical study was
conducted by The Wistar Institute, an international leader in basic
biomedical research. The test was developed in the laboratory of Louise
Showe, PhD, professor in the Molecular and Cellular Oncogenesis program
of The Wistar Institute’s NCI-designated cancer center. Andrew
Kossenkov, PhD, a senior member of Dr. Showe’s laboratory and Managing
Director of Wistar’s Bioinformatics Facility, will present interim
results from the study at the American Thoracic Society (ATS)
International Conference during an oral presentation beginning at 2:45
PM MDT on Tuesday, May 19, 2015.
As part of the study, clinical investigators used a simple collection
system that is approved by the U.S. Food and Drug Administration (FDA)
to prepare over 600 peripheral blood samples from patients determined to
be at high risk for developing lung cancer based on age and smoking
history. These patients were undergoing either low-dose computed
tomography (CT) scanning for lung cancer or were recently diagnosed with
lung cancer. Wistar scientists then assessed the expression of messenger
RNA and micro RNA in the initial training set of 242 samples and
developed a classifier of 145 markers (125 mRNAs plus 20 micro RNAs)
that most accurately distinguished patients with malignant nodules from
those with benign or no findings. The classifier was then assessed in an
independent test set of 103 samples. Performance of the classifier was
evaluated using several criteria, including Receiver Operating
Characteristic (ROC) area under the curve (AUC) analysis, and yielded an
AUC of 0.88 (sensitivity of 76% with a specificity of 88%) in the test
set. Analysis of the full patient sample set is near completion.
In October 2013, OncoCyte entered into a Sponsored Research Agreement
with The Wistar Institute to identify, develop and test potential lung
cancer biomarkers collaboratively with Dr. Showe’s laboratory. OncoCyte
has exercised options to obtain exclusive licenses to any inventions,
discoveries or technology developed in the course of the collaborative
research, including the technology presented today at the ATS
International Conference, and expects to negotiate definitive license
agreements with Wistar.
Lung cancer remains a primary cause of cancer-related death in part
because there is no effective diagnostic test to screen patients for
lung cancer at an early stage. Annual screening for lung cancer in
certain high-risk patients was recently recommended by the United States
Preventive Services Task Force (USPSTF), an independent panel of experts
in primary care and prevention that systematically reviews the evidence
of effectiveness and develops recommendations for clinical preventive
services. The Task Force recommended screening using low-dose computed
tomography (CT). Although low-dose CT has demonstrated high sensitivity
in detecting early-stage lung cancer in large clinical studies, it also
has a relatively high false-positive rate of approximately 25%. False
positives can lead to unnecessary costs and side effects because of the
need for invasive diagnostic procedures such as lung biopsies.
“Large-scale screening of patients at high risk for lung cancer,
estimated to represent over seven million patients per year in the
United States, could reduce overall lung cancer mortality through
earlier detection. However, the high number of false-positive low-dose
CT tests could lead to over a billion dollars a year in unnecessary
costs to the United States health care system as a result of associated
follow-up testing. Physicians, payers, and patients may therefore
welcome a simple to use, low-cost, blood-based test that can help guide
patient-management decisions by noninvasively ruling out the presence of
cancer. The data presented today by our Wistar collaborators
demonstrates that a high performance, blood-based screening diagnostic
for the early detection of lung cancer may be attainable,” said Joseph
Wagner, PhD, OncoCyte’s Chief Executive Officer.
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. Additional
markers were discovered by collaborators as the Wistar Institute. 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, nearing the completion of initial clinical studies for the
detection of bladder, breast, and lung cancers. AST-VAC2, a
cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include the 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+.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical research
with special expertise in cancer research and vaccine development.
Founded in 1892 as the first independent nonprofit biomedical research
institute in the country, Wistar has long held the prestigious Cancer
Center designation from the National Cancer Institute. The Institute
works actively to ensure that research advances move from the laboratory
to the clinic as quickly as possible. Wistar Science Saves Lives. On the
Web at www.wistar.org.
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.
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
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