Full Press Release Details
Inc. Reports Fourth Quarter and Fiscal Year End 2014 Financial Results
and Recent Corporate Accomplishments
ALAMEDA, Calif.--(BUSINESS WIRE)--March 11, 2015--BioTime, Inc. (NYSE
MKT: BTX) today reported financial results for the quarter and year
ended December 31, 2014, and highlighted its fourth quarter and recent
corporate accomplishments.
"In 2014, BioTime and its subsidiaries built strong momentum in
advancing the development of therapeutic and diagnostic products that
address unmet medical needs with large market potential," said Dr.
Michael D. West, CEO of BioTime. "Over the next 12 months, we will be
focused on advancing many of these programs in the clinic and we expect
to achieve additional business milestones as well. BioTime and its
subsidiaries are looking forward to announcing results from early
cohorts of OpRegen for dry age-related macular
degeneration and AST-OPC1 for complete cervical spinal cord injury,
completing enrollment of the Renevia pivotal clinical trial and
the commercialization of one or more of the PanC-Dx cancer
screening diagnostics. To help us capitalize on these near-term
opportunities, we have broadened our capabilities by building a
management team and Board of Directors with relevant experience and
expertise in the clinical development and commercialization of
biopharmaceutical products. On the financial front, we have a solid
balance sheet and believe that BioTime and its subsidiaries have
sufficient financial resources to fund their operations at least through
Fourth Quarter and Recent Highlights
In November 2014, BioTime received authorization to begin its Renevia
pivotal clinical trial in HIV- associated lipoatrophy, a disorder that
occurs in almost half of the approximately three million people on
antiretroviral therapy in the U.S. and Europe. In the trial, Renevia
is being tested as a delivery matrix for the patient's own fat-derived
cells and injected into portions of the patient's face where there is
lipoatrophy in order to promote facial tissue reconstruction. The
first patient was treated in this trial in February 2015.
In December 2014, BioTime strengthened its Board of Directors with the
appointment of Angus C. Russell, former Chief Executive Officer of
Shire plc, which is a leading global specialty biopharmaceutical
company. The appointment of Mr. Russell followed the recent
appointments to the board of Steve Cartt and Mike Mulroy, who were
among the top executives of Questcor Pharmaceuticals.
In December 2014, BioTime appointed Adi Mohanty as Chief Operating
Officer, bringing proven leadership in biopharmaceutical product
development and commercialization to the company. Mr. Mohanty is a
former executive of Shire with significant experience in
biopharmaceutical product development, manufacturing, and
commercialization and a background in regenerative medicine.
Asterias Biotherapeutics, Inc.
In February 2015, Asterias raised $5.5 million through the sale of
shares of its Series A common stock.
In March 2015, Asterias Biotherapeutics (NYSE MKT: AST) initiated
patient enrollment for its Phase 1/2a clinical trial of its product,
AST-OPC1 (oligodendrocyte progenitor cells), in complete cervical
Cell Cure Neurosciences Ltd.
In October 2014, the U.S. Food and Drug Administration (FDA) cleared
Cell Cure's Investigational New Drug (IND) application to initiate the
Phase 1/2a clinical trial of OpRegen in
patients with the severe form of age-related macular degeneration with
geographic atrophy. In February 2015, the OpRegen
Phase 1/2a clinical trial opened at Hadassah University Medical Center
in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen
consists of high purity retinal pigment epithelial cells derived from
human embryonic stem cells using a proprietary directed
differentiation method.
LifeMap Solutions, Inc.
In March 2015, the Icahn School of Medicine at Mount Sinai ("Mount
Sinai") launched a large-scale medical research study of asthma that
uses the new ResearchKit software framework developed by Apple to
enable individuals who suffer from asthma to participate in the study
right from their iPhone using an Asthma Health app developed by Mount
Sinai in conjunction with LifeMap Solutions. The Asthma Health App is
designed to facilitate asthma patient education and self-monitoring,
promote positive behavioral changes, and reinforce adherence to
treatment plans according to current asthma guidelines. The study
tracks symptom patterns in an individual and potential triggers for
these exacerbations so that researchers can learn new ways to
personalize asthma treatment. The Asthma Health app was highlighted by
Apple during its senior management public presentation of new products
on March 9, 2015 and is displayed on Apple's website and is available
as a free download on the Apple App Store.
OncoCyte Corporation
OncoCyte completed enrollment in the initial clinical study of its
urine-based PanC-Dx diagnostic product for bladder
cancer. The goal of this clinical study was to assess the performance
of OncoCyte's proprietary diagnostic technology in detecting the most
common type of bladder cancer, urothelial carcinoma (previously
designated transitional cell carcinoma).
Two abstracts, summarizing clinical studies of OncoCyte's PanC-Dx
diagnostic products for bladder and breast cancer, were accepted for
poster presentation at the American Association for Cancer Research
(AACR) Annual Meeting being held April 18-22, 2015.
OncoCyte appointed William Annett to its Board of Directors, bringing
extensive experience within the biotechnology and diagnostics industry
to the board. Mr. Annett is a former senior executive of Genentech and
Accenture, has been CEO of six organizations, has been a successful
entrepreneur, and has substantial diagnostics experience.
Fourth Quarter Financial Results
Total revenue, on a consolidated basis, for the fourth quarter of 2014
was $1.9 million, approximately the same as last year's fourth quarter
total revenue. Operating expenses, on a consolidated basis, for the
fourth quarter of 2014 were $16.1 million, compared to 2013 operating
expenses of $13.5 million net of certain in process research and