Full Press Release Details
Inc. Reports First Quarter Results and Recent Corporate Accomplishments
Call and Webcast Today at 4:30 p.m. Eastern Time
ALAMEDA, Calif--(BUSINESS WIRE)--May 10, 2017--BioTime, Inc. (NYSE MKT
and TASE: BTX), a clinical-stage biotechnology company developing and
commercializing products addressing degenerative diseases, today
reported financial results for the first quarter ended March 31, 2017.
"At BioTime we are continuing to make meaningful clinical progress with
our core development programs in Ophthalmology, Aesthetics and
Therapeutics Delivery. We are generating an increasing amount of
positive human data from our clinical trials that provide a solid
foundation for our optimism," said Adi Mohanty, Co-Chief Executive
Officer. "We are excited to be announcing top line safety and efficacy
data next month from our Renevia pivotal trial
in Europe. This week, we are presenting encouraging ophthalmic clinical
trial data at ARVO from the OpRegen trial in
dry-AMD. Separately at ARVO, tomorrow we are presenting promising
pre-clinical data in retinal restoration."
"Our strategies for Simplification and Unlocking Value are
moving forward with the formation of AgeX Therapeutics last month. AgeX
is a new subsidiary that is doing exciting work in the field of Aging.
BioTime has already successfully demonstrated its ability to create
value by building subsidiary companies. Our publicly-traded affiliates
Asterias and OncoCyte continue to report encouraging positive clinical
data as they move their therapies for spinal cord injury and lung cancer
diagnostics forward," concluded Mr. Mohanty.
Renevia (adipose cells + cell delivery matrix)
The schedule to read-out the Renevia top-line pivotal trial results
was accelerated to June 2017. If the data are positive the Company
plans to submit an application for CE Mark approval in Europe by year
end, which could lead to approval and commercial launch in about a
The ongoing pivotal clinical trial in Europe is assessing the efficacy
and safety of Renevia in treating HIV-associated lipoatrophy (facial
fat loss). The Company intends to conduct additional trials in the
U.S. that target a broader $7 billion aesthetics market opportunity,
which is consistent with the previously stated goal of indication and
geographic expansion for Renevia.
The trial in Europe is fully enrolled and continues to progress well
with no safety related issues to date.
OpRegen (retinal pigment epithelial cells)
New positive clinical data on OpRegen were reported at the
Annual Meeting of the Association for Research in Vision and
Ophthalmology (ARVO) this week. The data show OpRegen cells engraft
(remain in place) and possible evidence of a biological response.
Should the data establish that OpRegen cells safely engraft and remain
alive in the patient, then the Company believes OpRegen may have a
higher probability of success when compared to molecular therapeutics.
The treatment continues to be well-tolerated, which includes some
patients with more than one year of follow-up.
The data presented at ARVO is from the first and second cohorts of the
ongoing Phase I/IIa clinical trial in the advanced form of dry-AMD.
Patients from the second cohort, in which patients are receiving a
higher and more clinically meaningful 200,000 cell dose, were included
The Company anticipates DSMB review of cohort 2 by the end of the
second quarter and, upon approval, to begin enrolling cohort 3
immediately, thereafter. Cohort 3 is expected to enroll more quickly
due to reduced patient staggering requirements. The trial is being
expanded to U.S. sites as previously announced.
AST-OPC1 (oligodendrocyte progenitor cells)
In April, BioTime's affiliate, Asterias (NYSE MKT: AST) announced that
the Data Monitoring Committee (DMC) unanimously recommended
continuation of the SCiStar Phase I/IIa clinical trial for AST-OPC1
following a review of the accumulated safety data. AST-OPC1 is for
patients with spinal cord injury. Following positive results earlier
this year in January, Asterias plans to initiate discussions with
the FDA in mid-2017 to determine the most appropriate clinical and
regulatory path forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)
BioTime's affiliate, OncoCyte (NYSE MKT: OCX) is on track to be first
to market with a lung cancer confirmatory liquid biopsy diagnostic
test in the second half of this year. The test targets a market
opportunity believed to exceed $4 billion annually.
In preparation for commercialization, OncoCyte submitted its
application for CLIA lab certification in late March. Earlier is
month, OncoCyte established a Medical Advisory Committee to provide
guidance and advice in several areas including commercialization,
unmet clinical needs and future pipeline products. The committee is
comprised of four recognized lung cancer experts.
On May 22, 2017, results from OncoCyte's 300-patient R&D validation
study will be presented at the American Thoracic Society 2017
International Conference (ATS) in Washington, D.C. by Dr. Anil
Vachani, and will be discussed on an investor call later that day.
Simplification and Unlocking Value
New Subsidiary AgeX Therapeutics, Inc.
In April, BioTime announced the formation of AgeX Therapeutics, Inc.
as a new subsidiary. AgeX will consolidate
certain BioTime subsidiaries and programs in the field of
interventional gerontology. Two of the objectives in forming AgeX are
to: 1) quickly establish leadership in the emerging biotechnology
field of Aging by accelerating development of its pluripotent cell and
iTR assets; and 2) continue the implementation of
BioTime's strategy to simplify its corporate structure and operations
as well as focus its resources on continued clinical development and
product commercialization in Ophthalmology; Aesthetics and Delivery.
Value of Holdings in Public Affiliates
At March 31, 2017, BioTime held common stock in publicly-traded
affiliates valued at $161.3 million. This amount was the market value
of BioTime's 21.7 million shares in Asterias (NYSE MKT: AST) and 14.7
million shares in OncoCyte (NYSE MKT: OCX).
First Quarter Financial Results
Cash Position and Marketable Securities: Cash and cash