Full Press Release Details
Inc. Reports First Quarter 2015 Results and Recent Corporate
ALAMEDA, Calif.--(BUSINESS WIRE)--May 11, 2015--BioTime, Inc. (NYSE
MKT:BTX) today reported financial results for the first quarter ended
March 31, 2015 and provided a corporate update.
"BioTime continues to advance its strategic product development
programs. We are currently enrolling patients in a pivotal trial of Renevia
for the treatment of HIV-associated lipoatrophy," said Dr. Michael
D. West, BioTime's Chief Executive Officer. "At this year's annual
meeting of the American Association for Cancer Research (AACR), our
subsidiary OncoCyte reported interim clinical validation data on its PanC-Dx
cancer diagnostic tool for the non-invasive detection of bladder and
breast cancers. Our subsidiary Cell Cure Neurosciences presented data on
its product candidate, OpRegen , at the 2015
annual meeting of the Association for Research in Vision and
Ophthalmology (ARVO). Preclinical study showed that OpRegen
preserved vision and retinal structure when it was transplanted into the
leading animal model of retinal disease. A Phase I/IIa trial of the
product has been initiated for the treatment of the dry form of
age-related macular degeneration, a condition for which there is
currently no FDA-approved therapy. In addition, we are pleased that the
findings regarding our subsidiary Asterias's cancer vaccine AST-VAC1
were selected for presentation at the upcoming annual meeting of the
American Society of Clinical Oncology (ASCO). The presentation will
focus on the long-term follow-up data from a Phase II immunotherapy
trial for patients with acute myelogenous leukemia (AML). Taken
together, the results presented at these conferences highlight the
BioTime family of companies' leading role in the field of regenerative
First Quarter and Recent Highlights
Since BioTime reported fourth-quarter and full-year 2014 results in
March 2015, the Company and its subsidiaries have reported the following
Renevia , BioTime's proprietary cell delivery matrix, is
designed to facilitate the stable engraftment of transplanted cells.
Earlier this year, BioTime announced the successful treatment of the
first patient in the Company's pivotal clinical trial in Europe of Renevia
for HIV-associated lipoatrophy. These results could lead to submission
for CE Mark approval for the treatment of HIV-associated facial
atrophy. Potential implications of this trial also include the
development of future therapeutics for other lipoatrophy-related
conditions as well as potential use of Renevia to deliver
other types of cells.
OncoCyte Corporation
Results from two prospective clinical validation studies of PanC-Dx ,
OncoCyte's class of proprietary tests for the non-invasive diagnosis
of cancer, were presented at the annual meeting of the AACR in April
of this year. PanC-Dx demonstrated a high level of sensitivity
and specificity in the detection of urothelial carcinoma, the most
common type of bladder cancer.
Initial data from a large, prospective clinical validation study
showed the potential of PanC-Dx as a non-invasive, blood-based
diagnostic test to screen for multiple types of human cancers,
including breast cancer. The clinical data were also presented in
April at the annual meeting of the AACR.
OncoCyte expects that interim clinical validation data on markers for
lung cancer will be presented at the American Thoracic Society meeting
Cell Cure Neurosciences Ltd.
Preclinical data demonstrated that Cell Cure's product candidate, OpRegen ,
preserved vision and retinal structure when transplanted into the
leading animal model of retinal disease. These findings were presented
at the annual meeting of the Association for Research in Vision and
Ophthalmology (ARVO) in May. OpRegen consists
of high-purity retinal pigment epithelial cells derived from human
embryonic stem cells using a proprietary directed differentiation
Cell Cure is initiating a Phase I/IIa dose escalation study of OpRegen
to evaluate its safety and efficacy when transplanted
sub-retinally in patients who are in an advanced stage of the dry form
of age-related macular degeneration.
Asterias Biotherapeutics, Inc. (NYSE MKT: AST)
The long-term follow-up of AML patients enrolled in the Phase II
clinical trial of AST-VAC1, Asterias's autologous
telomerase-based dendritic cell cancer vaccine, was selected for oral
presentation at the annual meeting of the American Society of Clinical
Oncology (ASCO) to be held in Chicago, Illinois from May 29 to June 2,
ES Cell International Pte Ltd
ES Cell International Pte Ltd (ESI) and Beckman Research Institute of
the City of Hope (BRICOH) signed a nonexclusive license agreement
under which ESI's good manufacturing practice (GMP)-compliant,
clinical-grade human embryonic stem (hES) cells will be manufactured
and provided to BRICOH's collaborators for use in the pre-clinical
development of therapeutic products to treat human disease. The
agreement is an important part of BioTime's strategy to leverage
third-party funding and potentially generate future revenues by
placing its hES cells in a wide array of therapeutic programs and
medical applications that are not being developed by BioTime or its
ESI's hES cell lines will be used by University of California, Irvine
scientist Dr. Leslie Thompson to continue her research on the use of
stem cells to treat Huntington's disease under a $5 million grant from
the California Institute for Regenerative Medicine (CIRM). The CIRM
grant will further support a collaboration between ESI and University
of California, Davis's GMP laboratory for the creation of the
GMP-grade cells needed in Dr. Thompson's preclinical and potentially
subsequent clinical studies.
First Quarter 2015 Financial Results
Total consolidated revenues for the first quarter 2015 were $1.3
million, compared to $1.1 million in the first quarter 2014. BioTime's
operating revenues are currently generated primarily from research
grants, licensing fees, and advertising from the marketing of the
LifeMap Sciences's online database products, and from the sale of
hydrogels and stem cell products for research.
Consolidated operating expenses for the first quarter were $14.5
million, compared to $12.1 million for the same period in 2014. Research