Full Press Release Details
Reports Third Quarter Results and Recent Corporate Accomplishments
$40M in recent funding
advancing toward anticipated regulatory approval in Europe
advancing in clinical trials
distribution expected to be completed by early second quarter 2018
ALAMEDA, Calif.--(BUSINESS WIRE)--November 9, 2017--BioTime, Inc. (NYSE
American: BTX), a late stage clinical biotechnology company developing
and commercializing products addressing degenerative diseases, today
reported financial results for the third quarter ended September 30,
"BioTime achieved several significant milestones during the third
quarter, both in its clinical programs and in the execution of its
corporate strategy," said Adi Mohanty, Co-Chief Executive Officer. "With
the additional positive long-term data from our EU Renevia trial, and
the expansion of the OpRegen trial into the U.S., physicians and
patients that may benefit from these products are one step closer to
approved therapies."
"BioTime successfully secured over $40 million in funding including a
public equity offering, which will enable the advancement of our
clinical programs into the middle of 2019," continued Mr. Mohanty.
Corporate Highlights
AgeX completed a $10 million financing, which is expected to fund its
operations well into 2019.
BioTime Board of Directors approved a distribution of some or all of
the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime's
shareholders. The Board also authorized management to work with
investment banks and other financial institutions to finalize and
implement the strategy for taking AgeX public, which may include a
tax-free distribution.
BioTime successfully completed a public equity offering raising net
proceeds of approximately $26.7 million. The raise was completed on
attractive terms and included both new and existing investors.
BioTime was awarded two grants, one from the Israel Innovation
Authority and one from the National Institutes of Health, totaling
approximately $3.6 million.
BioTime announced positive secondary and additional positive long-term
data from the Renevia pivotal trial. Treated patients
retained an average 70% of the transplanted volume at 12 months and
64% at 18 months. The results thus far are encouraging and the
long-term performance exceeded management expectations. All Renevia
transplants were shown to be well tolerated and there were no
device-related serious adverse events noted during this trial.
BioTime announced that an investigator-led clinical trial successfully
treated its first patient in a study of Premvia , in combination with
stromal vascular fraction cells, for the treatment of volume loss in
the face, as was done in the Renevia pivotal trial.
This clinical trial is studying Premvia in a cosmetic application.
Premvia has 510(k) clearance in the U.S. for wound management.
BioTime expects to file for CE Mark in Europe under the name Renevia
for the treatment of facial lipoatrophy in HIV patients early next
Awarded a $2 million grant from the Israel Innovation Authority (IIA)
for further development of OpRegen for Dry
age-related macular degeneration. To date the IIA has provided grants
totaling approximately $12 million.
Successful defense of two key patents providing protection to OpRegen .
The patents were upheld during an opposition proceeding in March. In
September, we announced the successful conclusion of the appeals. The
two European patents (EP2554661 and EP2147094), cover the proprietary
directed differentiation methods to produce pluripotent stem
cell-derived cell replacement therapies being developed to treat
retinal degenerative diseases, such as age-related macular
Vision Restoration Program
Awarded a grant of up to $1.6 million from the Small Business
Innovation Research program of the National Institutes of Health. The
grant provides funding to further develop BioTime's innovative, next
generation vision restoration program for more advanced retinal
diseases and injuries, which severely impact the quality of life for
millions of people with no treatment option. This initiative aims at
improving vision in people affected by blindness, whether caused by
retinal injuries, age-related macular degeneration, retinitis
pigmentosa or other causes.
AST-OPC1 (oligodendrocyte progenitor cells)
Asterias Biotherapeutics announced new 12-month data from the first
efficacy cohort in the company's ongoing Phase 1/2a SCiStar study
designated to evaluate safety and efficacy of AST-OPC1 in spinal cord
injury. The 12-month data showed 67% of Cohort 2 subjects have
recovered 2 or more motor levels on at least one side through 12
months, which is more than double the rates of recovery seen in both
matched historical controls and published data in a similar
population. Also, the FDA granted the company's request for AST-OPC1
to be designated a Regenerative Medicine Advanced Therapy under the 21st Century
AST-VAC2 (patient specific cancer vaccine)
Asterias Biotherapeutics announced that the Medicines and Healthcare
Products Regulatory Agency and the NHS Research Ethics Committee have
provided the necessary approvals to initiate the first-in-human
clinical trial of AST-VAC2 in the United Kingdom. The trial, which is
being sponsored and managed by Cancer Research UK, will examine the
safety, tolerability, immunogenicity and activity of AST-VAC2 in
non-small cell lung cancer patients and is expected to be initiated
Liquid Biopsy (lung cancer confirmatory blood test)
OncoCyte received Clinical Laboratory Improvements Amendments (CLIA)
certification of registration from the Centers for Medicare and
Medicaid Services. In addition, OncoCyte's laboratory has passed
inspection by the California Department of Public Health and is now
fully licensed and operational. Clinical validation study initiated.
OncoCyte announced positive results from the Analytical Validation
Study of its liquid biopsy lung cancer diagnostic test, DetermaVU .
Simplification and Unlocking Value
New Subsidiary AgeX Therapeutics, Inc.
BioTime Board of Directors approved a distribution of some or all of
the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime's