Full Press Release Details
Announces Second Quarter 2014 Results and Recent Developments
cancer diagnostic products in clinical development
amendment pending for expanded clinical trials of AST-OPC1
obtains over $12 million in financing and awarded a $14 million grant
provides 510(k) premarket clearance for Premvia
ALAMEDA, Calif.--(BUSINESS WIRE)--August 12, 2014--BioTime, Inc. (NYSE
MKT: BTX) today reported financial results for the first quarter ended
June 30, 2014 and highlighted recent corporate accomplishments.
"We are pleased with our success to date in building toward our goal of
developing both near-term commercial applications of our technologies
and maintaining our focus on the power of pluripotent stem cells to
create innovative human therapeutics," said Dr. Michael D. West,
BioTime's Chief Executive Officer. "Near-term product development
underway includes our subsidiary OncoCyte Corporation's three cancer
diagnostic products undergoing clinical studies, mobile health product
development in our subsidiary LifeMap Solutions, Inc., our Renevia
pivotal clinical trial in Europe, steps to prepare for the marketing of
our recently FDA-cleared wound healing product Premvia ,
and growing research product sales by our ESI BIO division."
"BioTime's longer-term major therapeutic product opportunities are based
on the broad range of cell-based regenerative therapies planned for
development from its pluripotent stem cell technology platform. This
platform is protected by over 600 patents and patent applications
worldwide within the BioTime family of companies. Our subsidiary
Asterias Biotherapeutics, Inc. has submitted an amended IND to the FDA
for a Phase 1/2a clinical trial of AST-OPC1 for the treatment of
cervical spinal cord injury and is currently awaiting clearance from the
FDA for that trial. Asterias is also currently undertaking process
development of AST-VAC2, a cancer immunotherapy targeting the
important antigen called telomerase, for a potential clinical trial in
lung cancer. This progress, along with the appointment of Pedro
Lichtinger as Asterias' CEO and the award of a $14 million grant from
the California Institute for Regenerative Medicine, should fuel the
development of these first-in-class therapeutic products. Recently,
Asterias' shares began to trade publicly under the symbol ASTYV, the
first of our subsidiaries to have its shares trade publicly. Lastly, we
expect that BioTime's subsidiary Cell Cure Neurosciences Ltd. will soon
file its IND to begin a clinical trial of OpRegen
for the treatment of age-related macular degeneration. Additional
important cell-based product development is underway in our
disease-focused subsidiaries OrthoCyte Corporation and ReCyte
"As we saw in the first quarter of this year, our expenses have risen
compared to recent quarters, but our progress during the second quarter
in streamlining our workforce through shared core resources among our
subsidiaries should reduce our cash burn rate in the third quarter. We
would like to thank those who share our goal of better health in the
coming era of regenerative medicine. Their continued support and the
diligent efforts of our collaborators at leading academic medical
institutions is critical in advancing our products from the lab bench to
the clinic, where they are desperately needed."
Second Quarter and Recent Highlighted Corporate Accomplishments
The California Institute for Regenerative Medicine ("CIRM") approved a
$14.3 million Strategic Partnership III grant to BioTime's subsidiary
Asterias Biotherapeutics, Inc. ("Asterias"). The grant, entitled "A
Phase 1/2a Dose Escalation Study of AST-OPC1 in Patients with Cervical
Sensorimotor Complete Cervical Spinal Cord Injury," will provide
funding for Asterias to reinitiate clinical development of AST-OPC1 in
subjects with spinal cord injury, to expand clinical testing of
escalating doses in the target population intended for future pivotal
trials, and for product development efforts to refine and scale
manufacturing methods to support eventual commercialization. Asterias
is preparing to initiate the dose escalation Phase 1/2a clinical trial
of AST-OPC1 in patients with cervical injuries in six to nine months
subject to clearance from the United States Food and Drug
Administration ("FDA"). AST-OPC1 is a population of cells derived from
human embryonic stem cells (hESCs) that contains oligodendrocyte
progenitor cells (OPCs). OPCs and their mature derivatives called
oligodendrocytes provide critical functional support for nerve cells
in the spinal cord and brain. The CIRM funding will be conditional on
approval of the trial by the FDA, execution of a definitive agreement
between Asterias and CIRM, and Asterias' continued progress to achieve
certain pre-defined project milestones.
LifeMap Solutions, Inc. ("LifeMap Solutions"), a newly formed
subsidiary of BioTime's subsidiary LifeMap Sciences, Inc., entered
into a Co-Development and Option Agreement with the Icahn School of
Medicine at Mount Sinai to cooperatively develop internet, web-based,
mobile user or consumer software products to provide users with
information that may potentially aid them in improving lifestyle and
healthcare decisions and outcomes. The planned products are envisioned
to provide information based on interpretations of one or more
components of: clinical, genetic, wearable device, and other data
relating to human disease, health or wellness.
BioTime successfully received ISO 13485:2003 certification from BSI
(British Standards Institution) for design, development, manufacture,
and distribution of BioTime HyStem hydrogels
for cell delivery applications. BSI is currently one of the world's
largest independent certification bodies for quality management
systems and ISO 13485:2003 is the world's most recognized standard for
quality management systems for medical devices, and is the most
commonly chosen path for companies to meet the quality system
requirements in Europe, Canada, Japan, Australia, and certain other
countries. This certification is an important milestone also in
BioTime's development program for Renevia , a cell
delivery matrix scheduled to begin pivotal human clinical trials in
2014 at the Stem Center in Palma de Mallorca, Spain. In this first
clinical application, Renevia will be used as a delivery
matrix for autologous adipose cells to treat the facial lipoatrophy
associated with HIV. Restoration of normal skin contour is an
important quality-of-life issue with this chronic condition and
BioTime believes that this cell-based therapy will offer fewer