Full Press Release Details
Reports Third Quarter Results and Recent Progress
Biotherapeutics approved for listing on NYSE MKT
AST-OPC1 cleared by FDA for Phase 1/2a dose escalation clinical trial
for spinal cord injury
Cure Neuroscience's OpRegen
cleared by FDA for Phase 1/2a dose escalation clinical trial for the
dry form of age-related macular degeneration
cleared for pivotal trial in Europe for treatment of HIV-related
cleared by FDA as Class II medical device for wound management
and its subsidiaries end October with $35 million in cash to fund
additional milestone achievements in 2015
ALAMEDA, Calif.--(BUSINESS WIRE)--November 10, 2014--BioTime, Inc. (NYSE
MKT: BTX), the leader in developing pluripotent stem-cell therapies and
other technologies designed to address major unmet medical needs, today
reported financial results for the third quarter and the nine months
ended September 30, 2014, and highlighted recent corporate
"BioTime and its subsidiaries set in motion a rapid cadence of milestone
achievements in our clinical development of therapeutic and diagnostic
products during the third quarter," said Dr. Michael D. West, CEO. "We
recently obtained authorization to begin our pivotal trial of Renevia
in Europe for HIV-related lipoatrophy; our subsidiary Asterias
Biotherapeutics received clearance from the FDA to initiate a Phase 1/2a
dose escalation clinical trial of its product, AST-OPC1, in
patients with complete cervical spinal cord injury; our subsidiary Cell
Cure Neurosciences received clearance from the FDA for a Phase 1/2a dose
escalation clinical trial of its product, OpRegen ,
in patients with the dry form of age related macular degeneration; and
the FDA cleared BioTime's Premvia as a Class II
medical device for the management of wounds. Also, BioTime's subsidiary
OncoCyte expanded its large clinical studies of PanC-Dx
biomarkers in the diagnosis of breast, bladder, and lung cancer. In
total, we now have six products for which seven clinical studies are
approved or underway. To date, the FDA has approved clinical trials of
only four pluripotent stem cell therapies, and two of those, OpRegen
and AST-OPC1, belong to BioTime subsidiaries."
"On the financial front, we raised $31 million in early October for
BioTime and certain of its subsidiaries through the sale of BioTime
common shares to several institutional investors. As a result, we
finished October with $35 million in cash and cash equivalents within
the BioTime family of companies to fund additional milestone
achievements during 2015. Additionally, our subsidiary Asterias arranged
non-dilutive financing for clinical trials of both of its lead products
by signing two agreements: one with the California Institute for
Regenerative Medicine (CIRM) for the previously announced $14.3 million
award to fund a Phase 1/2a clinical trial and process development of AST-OPC1,
and one with Cancer Research UK (CRUK) and its affiliate Cancer Research
Technology to conduct a Phase 1/2a clinical trial of AST-VAC2, a
product designed as an immunotherapy for non-small cell lung cancer. We
also added two experienced executives with strong track records of
shareholder value creation to our Board of Directors," Dr. West
Third Quarter and Recent Highlights
BioTime received authorization to begin its pivotal human clinical
trial of Renevia in Europe to treat HIV patients with
premature facial aging caused by lipoatrophy. In the trial, Renevia
will be used to deliver fat-derived cells to the patient's face where
there has been a loss of subdermal fat. Lipoatrophy is estimated to
occur in 35-50% of the 10 million HIV patients worldwide on
antiretroviral therapy.
Premvia was cleared for marketing by the FDA as a Class II
medical device for the management of wounds. Premvia is the
first FDA-cleared member of BioTime's HyStem
family of hydrogels, which are designed to mimic the natural
structures of the human body's extracellular matrix.
Michael H. Mulroy and Stephen L. Cartt joined BioTime's Board of
Directors. Mr. Mulroy and Mr. Cartt both had successful careers in
senior management at Questcor Pharmaceuticals, Inc. where Mr. Mulroy
served as Executive Vice President - Strategic Affairs and General
Counsel and Mr. Cartt served as Chief Operating Officer.
BioTime and certain of its subsidiaries raised $31 million through
sales of BioTime common shares in a registered direct offering.
Asterias Biotherapeutics, Inc. (Approximately 71% Owned by BioTime)
AST-OPC1 was cleared by the FDA for the initiation of a dose
escalation Phase 1/2a clinical trial in patients with complete
cervical spinal cord injury. A large portion of the cost of this trial
will be paid by grant support from the California Institute for
Regenerative Medicine (CIRM).
AST-VAC2, an immunotherapy treatment, will be the subject of a
Phase 1/2a clinical trial in patients with non-small cell lung cancer
in the UK, contingent on regulatory approval, through an agreement
entered into by Asterias and Cancer Research UK (CRUK) under which
CRUK will pay for the cost of the trial.
Asterias became the first of BioTime's subsidiaries to be publicly
traded. Asterias common stock now trades on the NYSE MKT under the
Cell Cure Neurosciences Ltd. (Approximately 63% Owned by BioTime on a
OpRegen , a therapy designed for patients with
the severe form of age-related macular degeneration (AMD) called
geographic atrophy, was cleared by the FDA for a Phase 1/2a clinical
trial. AMD is the leading cause of blindness in the aging US
population and many other developed countries around the world. There
is currently no FDA-approved therapy for the dry form of AMD.
OncoCyte Corporation (Approximately 75% Owned by BioTime)
OncoCyte Corporation and The Wistar Institute continued their
collaboration on a large, multi-site clinical study of blood-based
lung cancer diagnostic markers. Over 600 blood samples were obtained
from patients with a high-risk profile for development of lung cancer
at six clinical sites. Wistar investigators are currently assessing
gene expression patterns in blood cells of patients with malignant
versus non-malignant lung disease. The performance of gene markers
tested in the study in determining the presence or the progression of
disease in various categories of patients may determine the specific