Full Press Release Details
Reports Fourth Quarter and Fiscal 2017 Results
CE Mark application submitted for European approval
receives DSMB approval to proceed to cohort 4
cohort 4 will include better vision patients and an array of
additional functional assessments
ALAMEDA, Calif.--(BUSINESS WIRE)--March 15, 2018--BioTime, Inc. (NYSE
American: BTX), a clinical-stage biotechnology company focused on
degenerative diseases, today reported financial results for the fourth
quarter and fiscal year ended December 31, 2017.
"2017 was a successful year for BioTime, capped by our recent European
CE Mark submission of Renevia and approval by the DSMB
to proceed with the initiation of Cohort 4 of the OpRegen
clinical trial," said Adi Mohanty, Co-Chief Executive Officer of
BioTime. "We remain committed and focused on BioTime's core pillars of
clinical progress, simplification and unlocking value for our
shareholders as we progress towards becoming a commercial stage company."
Renevia (Facial Lipoatrophy)
Submitted Renevia for CE Marking in Europe.
Renevia met its primary endpoint in a European
pivotal trial of HIV-associated lipoatrophy, which is a severe form of
facial lipoatrophy. The primary endpoint was the change in hemifacial
volume at six months in the treated patients compared to patients in
the delayed treatment arm as measured by 3-D photographic volumetric
assessment. On average, 5.1cc of hemifacial volume was measured after
six months, which represents an approximate 100% retention of
transplanted volume. There were no device-related serious adverse
events noted during the trial.
Additional Renevia data were presented from the
successful pivotal trial at the International Federation for Adipose
Therapeutics and Science conference. The Renevia data
were presented by primary investigator Ramon Llull, MD, PhD, Director
of Stem Europe Mallorca Center, Mallorca, Spain. As well as
successfully meeting the primary endpoint, treated patients retained
an average 70% of the transplanted volume at 12 months and 64% at 18
The independent Data Safety Monitoring Board (DSMB) approved
initiation of the fourth cohort for the OpRegen
clinical trial in patients in the advanced stage of the dry form of
age-related macular degeneration or "dry-AMD."
BioTime completed enrollment of the third cohort of the OpRegen
Positive OpRegen clinical trial data were presented
at the Annual Meeting of the Association for Research in Vision and
Ophthalmology in Baltimore, Maryland, by Eyal Banin, MD, PhD. Images
presented at the meeting appeared to indicate that the transplanted
OpRegen cells engrafted in an area of the scar that
was completely depleted of retinal pigment epithelium cells. There
were also some areas that appeared to show structural improvement
suggesting possible evidence of a biological response, without any
signs of retinal edema, a fluid build-up that can further compromise
BioTime expanded the OpRegen clinical trial to sites
in the U.S., including Los Angeles and San Francisco, headed by two
well-renowned physicians, David S. Boyer, MD of Retina-Vitreous
Associates, and Dr. H. Richard McDonald of the West Coast Retina
BioTime established an innovative cell therapy manufacturing facility
in Jerusalem, Israel. This state-of-the-art cGMP manufacturing
facility is located in the Jerusalem Bio Park on the campus of the
Hadassah University Hospital. It is equipped to produce OpRegen
and a range of cell therapy products for human use in clinical trials
as well as at a grade suitable for commercial production.
BioTime was awarded a new $2 million grant from the Israel Innovation
Authority (IIA) for further development of OpRegen .
To date, the IIA has provided grants to BioTime totaling
approximately $12 million.
BioTime was awarded a grant of up to $1.56 million from the Small
Business Innovation Research program of the National Institutes of
Health for the development of next generation vision restoration
BioTime expanded its ophthalmology portfolio with technology for next
generation retinal disease therapies, including composition and
methodologies to develop 3-D retinal tissue from human pluripotent
stem cells for implantation in patients with advanced stages of
retinal degeneration.
Corporate Highlights
BioTime formed a new subsidiary, AgeX Therapeutics, Inc., to advance
programs focused on degenerative diseases of aging. AgeX consolidated
certain BioTime and subsidiary programs in the field of interventional
gerontology. The formation of AgeX is a further step toward the
implementation of BioTime's strategy to simplify its corporate
structure and operations as well as focus resources on the continued
clinical development of its two lead programs: Renevia
AgeX raised net proceeds of $10 million, valuing AgeX at approximately
$68 million post-money. BioTime now owns approximately 85% of the
outstanding shares of AgeX. The financing is expected to fund AgeX's
general operations and product development well into 2019. BioTime had
previously planned to spend more than $5 million annually on these
programs and associated operational expenses.
The BioTime Board of Directors agreed in principle to distribute some
or all of the AgeX shares to BioTime shareholders. BioTime is working
with investment banks and other financial institutions to finalize and
implement the strategy for taking AgeX public, which may include a
potential tax-free pro rata distribution of all of our AgeX shares
to BioTime shareholders.
BioTime increased its ownership of OpRegen through an
equity swap that allowed BioTime to increase its ownership of its
Israeli subsidiary, Cell Cure Neurosciences, Ltd. that leads the
OpRegen development program. By acquiring the Cell
Cure shares held by other Cell Cure shareholders, BioTime now owns
nearly 99% of Cell Cure.
BioTime successfully raised $49 million in gross proceeds from new and
previous investors in two underwritten public offerings of its common
BioTime successfully defended two key patents providing protection to
OpRegen . The European Patent Office, in an opposition