Full Press Release Details
Inc. Reports Third Quarter Results and Recent Clinical Progress
trial suggest cells able to engraft and survive at least 12 months
3-D Imaging data from Renevia trial run-in patients suggest
volumetric improvements are sustained at least 12 months
ALAMEDA, Calif.--(BUSINESS WIRE)--November 3, 2016--BioTime, Inc. (NYSE
MKT and TASE: BTX), a clinical stage biotechnology company with a focus
on pluripotent cell-based technologies, today reported financial results
for the third quarter ended September 30, 2016, and recent therapeutic
"Through the quarter, we continued to execute on our plan with great
progress across all our programs within the BioTime family of companies.
We are particularly encouraged by the early data reported on Renevia
and OpRegen . Both Asterias and OncoCyte also
reported promising data from their clinical trials," said Adi Mohanty,
Co-Chief Executive Officer. "For the remainder of the year and into
2017, we expect to achieve a substantial number of value-enhancing
milestones, including additional efficacy and safety data from the
second and third patient cohorts in the OpRegen
clinical trial, and pivotal data and potential CE mark approval for Renevia
Third Quarter and Recent Accomplishments
OpRegen (retinal pigment epithelial cells)
The ongoing Phase I/IIa clinical trial is evaluating the safety of
three different dosage regimens of OpRegen in
the advanced form of dry age-related macular degeneration (Dry-AMD).
Dry-AMD is a condition for which there is currently no FDA-approved
therapy. Preliminary data from the first cohort of patients treated in
this trial of OpRegen resulted in no serious
adverse events. Imaging data from the first patient who completed
one-year of post-treatment clinical assessment may indicate that the
graft can survive for at least 12 months. These and other data will be
presented at the International Symposium on Ocular Pharmacology and
Therapeutics (ISOPT), on December 2, in Rome, Italy.
Enrollment in the second cohort, in which patients are receiving a
higher and more clinically meaningful 200,000 cell dose, is expected
to be complete by year end 2016, and data are expected early in 2017.
Additional data, from the third cohort, which is expected to commence
before year end, is anticipated by the end of 2017.
US clinical trial sites are expected to be announced in early 2017.
Renevia (adipose cells + cell delivery matrix)
clinical trial for HIV-related facial lipoatrophy continues to enroll
new patients and is on track to complete patient enrollment by the end
of 2016. The objective of the trial is to assess the safety and
efficacy of Renevia in restoring normal
skin contours in patients whose subcutaneous fat has been lost due to
antiviral drug treatment for HIV. BioTime expects top-line efficacy
data in the first half of 2017. If the data are positive, the company
plans to submit an application for CE mark approval in Europe shortly
Positive data from the pivotal trial could provide support for future
studies of Renevia in certain broader
applications of fat tissue deficits. These include various medical
aesthetics applications, such as age-related and trauma-related facial
AST-OPC1 (oligodendrocyte progenitor cells)
In September, BioTime's affiliate Asterias Biotherapeutics, Inc. (NYSE
MKT: AST), announced positive data from the AST-OPC1 SCiSTAR Phase
1/2a clinical study in patients with complete cervical spinal cord
injuries. All patients in the initial cohort who received 10 million
AST-OPC1 cells showed at least one motor level of improvement
(regaining some function in their arms), while two of five patients
achieved two motor levels of improvement (regaining some function in
their arms, hands and fingers) on at least one side of their body. The
data were presented at the Annual Scientific Meeting of the
International Spinal Cord Society (ISCoS) in Vienna, Austria.
Six-month efficacy data on this first cohort are expected to be
announced in January 2017. Enrollment is also ongoing in a new cohort
in which patients are receiving a higher dose of 20 million cells.
OncoCyte (non-invasive cancer diagnostics)
In August, BioTime's subsidiary OncoCyte Corporation (NYSE MKT: OCX)
closed a financing with both new and existing investors, providing
OncoCyte with gross proceeds of $10.55 million, before deducting
placement agent fees and offering expenses.
Data was presented related to OncoCyte's lead product, a confirmatory
diagnostic for lung cancer screening. OncoCyte expects to complete the
study by year end and, if successful, could launch the product by
Research and Development
In August, BioTime strengthened its regenerative medicine intellectual
property portfolio with the issuance of 31 new patents. This included
nine in the U.S. and 22 in Australia, Canada, China, India, Israel,
and Japan. The new patents supplement the existing portfolio of more
than 700 patents and patent applications owned or licensed by the
BioTime family of companies worldwide.
In October, BioTime strengthened its senior management team with the
appointment of Jim Knight as Senior Vice President, Head of Corporate
Development. Mr. Knight is a highly accomplished professional with an
extensive skill set and knowledge that is applicable immediately, as
the company has started reporting encouraging early clinical data on
Third Quarter Financial Results
Cash Position and Equity Values: Cash and cash equivalents
totaled $30.5 million as of September 30, 2016, compared to $42.2
million as of December 31, 2015, which included Asterias' cash and cash
equivalents of $11.2 million. Based on the September 30, 2016, closing
prices of Asterias and OncoCyte common stock on the NYSE MKT, the shares
of Asterias and OncoCyte owned by BioTime had an estimated market value
of $92.2 million and $74.0 million, respectively, or an aggregate market
value of approximately $166.0 million on that date.
Revenues: Total revenues were $1.5 million for the third quarter,
compared to $2.3 million in the third quarter of 2015. Asterias' total
revenues included in the third quarter of 2015 were $1.4 million as
shown in the table below (in thousands). BioTime's operating revenues
are currently generated primarily from research grants, licensing fees
and advertising from the marketing of online database products.
| Three months ended September 30, 2016 | Three months ended September 30, 2015 | ||||||||||||||||
| Consolidated Results of Operations | Asterias | Consolidated Results less Asterias | Consolidated Results of Operations | Asterias | Consolidated Results less Asterias | ||||||||||||
| REVENUES: | |||||||||||||||||
| Total revenues | 1,499 | - | 1,499 | 2,306 | 1,423 | 883 |