Current Report Filing (8-k)
February 17 2015 - 8:31AM
Edgar (US Regulatory)
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): February
15, 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.
Section 1 - Registrant’s Business and Operations
Item 1.01 - Entry into a Material Definitive Agreement.
On February 15, 2015, the option granted by our majority owned
subsidiary Cell Cure Neurosciences Ltd. (“Cell Cure”) to Teva
Pharmaceutical Industries Ltd. (“Teva”) under a Research and Exclusive
Option Agreement (the “Option Agreement”), dated October 7, 2010, to
license-in rights to complete the development and to commercialize Cell
Cure’s OpRegen® product expired
without having been exercised by Teva. As a result the Option Agreement
has terminated. Cell Cure is continuing the clinical development of OpRegen
and will be pursuing discussions with potential strategic partners,
including those that have already indicated interest in participating in
development and commercialization of the product.
See Item 8 below for additional recent developments concerning Cell
Cure’s development of OpRegen.
Section 8 - Other Events
Item 8.01 - Other Events
On February 16, 2015, Cell Cure’s clinical trial of OpRegen
opened at Hadassah University Medical Center in Jerusalem. The clinical
trial is entitled “Phase I/IIa Dose Escalation Safety and Efficacy Study
of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells
Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related
Macular Degeneration with Geographic Atrophy.” Patient enrollment is
expected to begin shortly. OpRegen consists of animal
product-free retinal pigment epithelial (RPE) cells with high purity and
potency that were derived from human embryonic stem cells (hESCs) using
a proprietary directed differentiated method, for which a new US patent
No. 8,956,866 is expected to issue on February 17, 2015.
The Phase I/IIa clinical trial, will evaluate three different dose
regimens of OpRegen. Following transplantation, the patients will
be followed for 12 months at specified intervals, to evaluate the safety
and tolerability of the product. Following the initial 12 month period,
patients will continue to be monitored at longer intervals for an
additional period of time. A secondary objective of the clinical trial
will be to examine the ability of transplanted OpRegen to
engraft, survive, and moderate disease progression in the patients. In
addition to thorough characterization of visual function, a battery of
ophthalmic imaging modalities will be used to quantify structural
changes and rate of geographic atrophy expansion.
The new U.S. patent, entitled “Retinal Pigment Epithelial Cells
Differentiated from Embryonic Stem Cells With Nicotinamide and Activin
A” claims a proprietary method of enhancing the yield of retinal pigment
epithelial cells which are the active ingredient of OpRegen.
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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February
17, 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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