Full Press Release Details
Inc. Reports Second Quarter Results and Recent Corporate Accomplishments
Candidates Continue Clinical Progress
Simplifies Financials
Public Equity Offering Strengthens Balance Sheet
ALAMEDA, Calif.--(BUSINESS WIRE)--August 9, 2016--BioTime, Inc. (NYSE
MKT:BTX), a clinical-stage regenerative medicine company with a focus on
pluripotent stem cell technology, today reported financial results for
the second quarter ended June 30, 2016 and provided a corporate update.
"During the second quarter, we continued to sharpen our focus on
clinical progress and simplifying our corporate structure," said Adi
Mohanty, Co-Chief Executive Officer. "Our key therapeutic programs, Renevia
in medical aesthetics and OpRegen in dry AMD,
continue to advance in the clinic, and we expect additional meaningful
milestones from these programs in the second half of 2016. Meanwhile,
our public subsidiaries continue to demonstrate their ability to make
solid clinical progress. We strengthened our balance sheet by completing
a successful public equity offering with gross proceeds of approximately
$20.1 million from new and existing investors. Additionally, as we
previously announced in May, we have deconsolidated Asterias
Biotherapeutics, Inc. from our financial statements as result of its
recent financing. We continue to see Asterias playing an important role
in furthering therapies based on pluripotent stem cell technology.
Asterias will continue to file its own financial statements with the
SEC, allowing our shareholders to continue to follow its financial
Second Quarter and Recent Highlights
Renevia (adipose cells + cell delivery matrix)
The Renevia pivotal clinical trial for
HIV-related facial lipoatrophy continues to enroll new patients and is
on track to complete patient enrollment by the second half of 2016.
The objective of the trial is to assess the efficacy of Renevia
in restoring normal skin contours in patients whose subcutaneous fat
has been lost due to antiviral drug treatment for HIV. The Company
expects top-line efficacy data in the first half of 2017, and plans to
submit an application for CE Mark approval in Europe in the first half
of 2017 if the data are positive. Positive data from the pivotal trial
could provide support for future studies of Renevia in
certain broader applications of fat tissue deficits in various medical
aesthetics applications, such as age-related and trauma-related facial
OpRegen (retinal pigment epithelial cells)
In June, the Data Safety Monitoring Board (DSMB) for the OpRegen
Phase I/IIa clinical trial for the treatment of the advanced form of
dry age-related macular degeneration (AMD) completed its review of the
initial safety data from the first cohort and recommended dose
escalation to the second cohort. Enrollment has begun for the second
patient cohort, which is receiving a higher, more clinically
significant, dose of OpRegen cells. The
Company expects completion of enrollment for the second cohort in 2016
and, if the data are positive, anticipates DSMB approval to proceed to
the third cohort by the end of 2016. OpRegen has
received Fast Track designation from the U.S. Food and Drug
Administration for the treatment of dry AMD, which occurs in
approximately 90% of those afflicted with AMD.
AST-OPC1 (oligodendrocyte progenitor cells)
In July, enrollment and dosing of the first efficacy cohort was
completed in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in
complete cervical spinal cord injury. This is the second of three
cohorts in the study and it represents the first cohort in which
patients have been administered a dose high enough to fall within the
potentially efficacious range predicted by preclinical studies
conducted by Asterias. Top-line six-month efficacy and safety results
from this patient cohort are expected in January 2017. As of May 13,
2016, BioTime owned approximately 49% of the common shares outstanding
of Asterias Biotherapeutics (NYSE MKT:AST).
OncoCyte Corporation (NYSE MKT:OCX), the cancer diagnostics subsidiary
of BioTime and developer of novel, non-invasive blood and urine based
tests for the early detection of cancer, presented positive data from
a clinical study for the non-invasive detection of bladder cancer at
the 2016 American Society of Clinical Oncology Annual Meeting. Interim
data from the clinical study, which was first reported at the American
Association for Cancer Research 2015 Annual Meeting, demonstrated a
high level of sensitivity and specificity in the detection of
urothelial carcinoma, the most common type of bladder cancer.
Corporate Developments
In June, BioTime closed a public offering of shares of its common
stock. In July, the underwriters exercised in full their
over-allotment option. Gross proceeds of the offering and full
exercise of the over-allotment option totaled approximately $20.1
million, before deducting underwriting discounts and commissions and
other offering expenses payable by BioTime.
On May 13, 2016, BioTime deconsolidated its former majority-owned
subsidiary, Asterias Biotherapeutics, Inc. As result, Asterias'
financial statements for periods after May 12, 2016 are no longer
included in BioTime's consolidated financial statements, and BioTime
is now accounting for its investment in Asterias at fair value based
on the closing stock price of Asterias common stock on the NYSE MKT
and the number of shares held by BioTime. Changes in the fair value of
Asterias common stock are reflected as unrealized gains or losses in
BioTime's consolidated statements of operations, as a non-operating
item. See Second Quarter Financial results below.
Second Quarter Financial Results
Note on deconsolidation of Asterias and comparability of results:
BioTime's consolidated balance sheet at December 31, 2015, as reported,
included Asterias' assets and liabilities. However, Asterias' assets and
liabilities are not included in BioTime's consolidated balance sheet at
June 30, 2016 due to the deconsolidation of Asterias on May 13, 2016.
Furthermore, BioTime's consolidated statements of operations for the
three and six months ended June 30, 2016 include Asterias' results for
the period through May 12, 2016, the day immediately preceding the
deconsolidation. For the three and six months ended June 30, 2015,
BioTime's consolidated results include Asterias' results for the full