Press ReleaseBioTime, Inc. Reports First Quarter 2015 Results and Recent Corporate Accomplishments | ALAMEDA, Calif.--(BUSINESS WIRE)--May 11, 2015--
BioTime, Inc. (NYSE MKT:BTX) today reported financial results for the
first quarter ended March 31, 2015 and provided a corporate update.
“BioTime continues to advance its strategic product development
programs. We are currently enrolling patients in a pivotal trial of Renevia™
for the treatment of HIV-associated lipoatrophy,” said Dr. Michael
D. West, BioTime’s Chief Executive Officer. “At this year’s annual
meeting of the American Association for Cancer Research (AACR), our
subsidiary OncoCyte reported interim clinical validation data on its PanC-Dx™
cancer diagnostic tool for the non-invasive detection of bladder and
breast cancers. Our subsidiary Cell Cure Neurosciences presented data on
its product candidate, OpRegen®, at the 2015
annual meeting of the Association for Research in Vision and
Ophthalmology (ARVO). Preclinical study showed that OpRegen®
preserved vision and retinal structure when it was transplanted into the
leading animal model of retinal disease. A Phase I/IIa trial of the
product has been initiated for the treatment of the dry form of
age-related macular degeneration, a condition for which there is
currently no FDA-approved therapy. In addition, we are pleased that the
findings regarding our subsidiary Asterias’s cancer vaccine AST-VAC1
were selected for presentation at the upcoming annual meeting of the
American Society of Clinical Oncology (ASCO). The presentation will
focus on the long-term follow-up data from a Phase II immunotherapy
trial for patients with acute myelogenous leukemia (AML). Taken
together, the results presented at these conferences highlight the
BioTime family of companies’ leading role in the field of regenerative
medicine.”
First Quarter and Recent Highlights
Since BioTime reported fourth-quarter and full-year 2014 results in
March 2015, the Company and its subsidiaries have reported the following
progress.
BioTime, Inc.
-
Renevia™, BioTime’s proprietary cell delivery matrix, is
designed to facilitate the stable engraftment of transplanted cells.
Earlier this year, BioTime announced the successful treatment of the
first patient in the Company’s pivotal clinical trial in Europe of Renevia™
for HIV-associated lipoatrophy. These results could lead to submission
for CE Mark approval for the treatment of HIV-associated facial
atrophy. Potential implications of this trial also include the
development of future therapeutics for other lipoatrophy-related
conditions as well as potential use of Renevia™ to deliver
other types of cells.
OncoCyte Corporation
-
Results from two prospective clinical validation studies of PanC-Dx™,
OncoCyte’s class of proprietary tests for the non-invasive diagnosis
of cancer, were presented at the annual meeting of the AACR in April
of this year. PanC-Dx™ demonstrated a high level of sensitivity
and specificity in the detection of urothelial carcinoma, the most
common type of bladder cancer.
-
Initial data from a large, prospective clinical validation study
showed the potential of PanC-Dx™ as a non-invasive, blood-based
diagnostic test to screen for multiple types of human cancers,
including breast cancer. The clinical data were also presented in
April at the annual meeting of the AACR.
-
OncoCyte expects that interim clinical validation data on markers for
lung cancer will be presented at the American Thoracic Society meeting
later this month.
Cell Cure Neurosciences Ltd.
-
Preclinical data demonstrated that Cell Cure’s product candidate, OpRegen®,
preserved vision and retinal structure when transplanted into the
leading animal model of retinal disease. These findings were presented
at the annual meeting of the Association for Research in Vision and
Ophthalmology (ARVO) in May. OpRegen®
consists of high-purity retinal pigment epithelial cells derived from
human embryonic stem cells using a proprietary directed
differentiation method.
-
Cell Cure is initiating a Phase I/IIa dose escalation study of OpRegen®
to evaluate its safety and efficacy when transplanted
sub-retinally in patients who are in an advanced stage of the dry form
of age-related macular degeneration.
Asterias Biotherapeutics, Inc. (NYSE MKT: AST)
-
The long-term follow-up of AML patients enrolled in the Phase II
clinical trial of AST-VAC1, Asterias’s autologous
telomerase-based dendritic cell cancer vaccine, was selected for oral
presentation at the annual meeting of the American Society of Clinical
Oncology (ASCO) to be held in Chicago, Illinois from May 29 to June 2,
2015.
ES Cell International Pte Ltd
-
ES Cell International Pte Ltd (ESI) and Beckman Research Institute of
the City of Hope (BRICOH) signed a nonexclusive license agreement
under which ESI’s good manufacturing practice (GMP)-compliant,
clinical-grade human embryonic stem (hES) cells will be manufactured
and provided to BRICOH’s collaborators for use in the pre-clinical
development of therapeutic products to treat human disease. The
agreement is an important part of BioTime’s strategy to leverage
third-party funding and potentially generate future revenues by
placing its hES cells in a wide array of therapeutic programs and
medical applications that are not being developed by BioTime or its
subsidiaries.
-
ESI’s hES cell lines will be used by University of California, Irvine
scientist Dr. Leslie Thompson to continue her research on the use of
stem cells to treat Huntington’s disease under a $5 million grant from
the California Institute for Regenerative Medicine (CIRM). The CIRM
grant will further support a collaboration between ESI and University
of California, Davis’s GMP laboratory for the creation of the
GMP-grade cells needed in Dr. Thompson’s preclinical and potentially
subsequent clinical studies.
First Quarter 2015 Financial Results
Total consolidated revenues for the first quarter 2015 were $1.3
million, compared to $1.1 million in the first quarter 2014. BioTime’s
operating revenues are currently generated primarily from research
grants, licensing fees, and advertising from the marketing of the
LifeMap Sciences’s online database products, and from the sale of
hydrogels and stem cell products for research.
Consolidated operating expenses for the first quarter were $14.5
million, compared to $12.1 million for the same period in 2014. Research
and development (R&D) expenses for the first quarter were $9.3 million,
compared to $8.4 million in the year-ago quarter. The increase in R&D
expenses is largely due to the continued ramp-up of the Asterias and
LifeMap Solutions product development programs, OncoCyte’s clinical
trial work to develop its PanC-Dx™ cancer diagnostics, and
increased activity of the ESI BIO division. General and
administrative (G&A) expenses for the first quarter were $5.2 million,
compared to $3.7 million in the first quarter a year ago. This increase
was primarily due to the ramp-up of the Asterias and LifeMap Sciences
development programs.
Net loss attributable to BioTime for the three months ended March 31,
2015 was $10.2 million, including deferred income tax benefits of $1.2
million. For the first quarter of 2014, net loss was $8.1 million,
including deferred income tax benefits of $1.3 million. On a per share
basis, net loss for the first quarter was $0.13 per share, compared to
$0.14 per share for the first quarter of 2014. Net loss attributable to
BioTime includes losses from BioTime majority-owned subsidiaries based
upon BioTime’s percentage ownership of those subsidiaries.
Cash and cash equivalents totaled $25.8 million as of March 31, 2015,
compared to $29.5 million as of December 31, 2014. The cash on hand as
of March 31, 2015 includes $9.0 million held by Asterias and other
subsidiaries. During February 2015, Asterias raised $5.5 million in
aggregate gross proceeds from the public offering and concurrent private
placement of its Series A common stock. In the first quarter 2015,
Asterias received $2.3 million from CIRM under the grant award related
to the AST-OPC1 development program.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage
biotechnology company. BioTime and its subsidiaries are leveraging their
industry-leading experience in pluripotent stem cell technology and a
broad intellectual property portfolio to facilitate the development and
use of cell-based therapies and gene marker-based molecular diagnostics
for major diseases and degenerative conditions for which there presently
are no cures. The lead clinical programs of BioTime and its subsidiaries
include OpRegen®, currently in a Phase I/IIa trial for
the treatment of the dry form of age-related macular degeneration; AST-OPC1,
currently in a Phase I/IIa trial for spinal cord injuries; Renevia™,
currently in a pivotal trial in Europe as an injectable matrix for the
engraftment of transplanted cells to treat HIV-related lipoatrophy; and PanC-Dx™
cancer diagnostics, nearing the completion of initial clinical studies
for the detection of bladder, breast, and lung cancers. AST-VAC2,
a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include the publicly traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1
and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem
cell-based therapies for retinal and neurological disorders, including OpRegen®;
OncoCyte Corporation, developing PanC-Dx™ cancer diagnostics;
LifeMap Sciences, Inc., developing and marketing an integrated on-line
database resource for biomedical and stem cell research; LifeMap
Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile
health (mHealth) products; ES Cell International Pte Ltd, which has
developed cGMP-compliant human embryonic stem cell lines that are being
marketed by BioTime for research purposes under the ESI BIO branding
program; OrthoCyte Corporation, developing therapies to treat orthopedic
disorders, diseases and injuries; and ReCyte Therapeutics, Inc.,
developing therapies to treat a variety of cardiovascular and related
ischemic disorders.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For
more information, please visit www.biotimeinc.com
or connect with the company on Twitter,
LinkedIn,
Facebook,
YouTube,
and Google+.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for BioTime and its subsidiaries, along with
other statements about the future expectations, beliefs, goals, plans,
or prospects expressed by management constitute forward-looking
statements. Any statements that are not historical fact (including, but
not limited to statements that contain words such as “will,” “believes,”
“plans,” “anticipates,” “expects,” “estimates”) should also be
considered to be forward-looking statements. Forward-looking statements
involve risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or regulatory
approvals, need and ability to obtain future capital, and maintenance of
intellectual property rights. Actual results may differ materially from
the results anticipated in these forward-looking statements and as such
should be evaluated together with the many uncertainties that affect the
business of BioTime and its subsidiaries, particularly those mentioned
in the cautionary statements found in BioTime's Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com.
BIOTIME, INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(UNAUDITED)
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
March 31,
|
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
License fees
|
|
$
|
319,146
|
|
|
$
|
294,504
|
|
Royalties from product sales
|
|
|
156,550
|
|
|
|
97,886
|
|
Grant income
|
|
|
698,839
|
|
|
|
575,659
|
|
Sale of research products and services
|
|
|
89,919
|
|
|
|
98,586
|
|
Total revenues
|
|
|
1,264,454
|
|
|
|
1,066,635
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
(264,167
|
)
|
|
|
(131,914
|
)
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
1,000,287
|
|
|
|
934,721
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
9,323,510
|
|
|
|
8,405,393
|
|
General and administrative
|
|
|
5,178,800
|
|
|
|
3,667,171
|
|
Total operating expenses
|
|
|
14,502,310
|
|
|
|
12,072,564
|
|
Loss from operations
|
|
|
(13,502,023
|
)
|
|
|
(11,137,843
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(25,461
|
)
|
|
|
(8,384
|
)
|
Other income/(expense), net
|
|
|
(239,453
|
)
|
|
|
69,170
|
|
Total other income/(expenses), net
|
|
|
(264,914
|
)
|
|
|
60,786
|
|
LOSS BEFORE INCOME TAX BENEFITS
|
|
|
(13,766,937
|
)
|
|
|
(11,077,057
|
)
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit
|
|
|
1,176,882
|
|
|
|
1,349,026
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
|
(12,590,055
|
)
|
|
|
(9,728,031
|
)
|
|
|
|
|
|
|
|
|
|
Net loss attributable to non-controlling interest
|
|
|
2,422,687
|
|
|
|
1,629,017
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
|
$
|
(10,167,368
|
)
|
|
$
|
(8,099,014
|
)
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|
|
$
|
(0.13
|
)
|
|
$
|
(0.14
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING:
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED
|
|
|
78,261,788
|
|
|
|
58,257,427
|
|
|
|
|
|
|
|
|
|
|
BIOTIME, INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December
|
|
|
|
2015
|
|
|
31,
|
|
|
|
(Unaudited)
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
25,829,533
|
|
|
$
|
29,486,909
|
|
Trade accounts and grants receivable, net
|
|
|
866,180
|
|
|
|
1,041,856
|
|
Inventory
|
|
|
299,308
|
|
|
|
266,022
|
|
Landlord receivable
|
|
|
277,206
|
|
|
|
377,981
|
|
Prepaid expenses and other current assets
|
|
|
1,271,895
|
|
|
|
1,231,789
|
|
Total current assets
|
|
|
28,544,122
|
|
|
|
32,404,557
|
|
|
|
|
|
|
|
|
|
|
Equipment, net and construction in progress
|
|
|
2,864,669
|
|
|
|
2,857,846
|
|
Deferred license and consulting fees
|
|
|
309,458
|
|
|
|
336,833
|
|
Deposits
|
|
|
443,003
|
|
|
|
443,289
|
|
Other long-term assets
|
|
|
7,916
|
|
|
|
9,985
|
|
Intangible assets, net
|
|
|
37,534,302
|
|
|
|
38,848,396
|
|
TOTAL ASSETS
|
|
$
|
69,703,470
|
|
|
$
|
74,900,906
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
6,322,407
|
|
|
$
|
6,803,173
|
|
Capital lease liability, current portion
|
|
|
57,500
|
|
|
|
57,500
|
|
Related party convertible debt, net of discount
|
|
|
169,908
|
|
|
|
60,237
|
|
Deferred grant income
|
|
|
1,474,300
|
|
|
|
-
|
|
Deferred license and subscription revenue, current portion
|
|
|
178,546
|
|
|
|
208,357
|
|
Total current liabilities
|
|
|
8,202,661
|
|
|
|
7,129,267
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
|
|
Deferred tax liabilities, net
|
|
|
3,337,662
|
|
|
|
4,514,362
|
|
Deferred rent liabilities, net of current portion
|
|
|
34,967
|
|
|
|
97,280
|
|
Lease liability
|
|
|
560,970
|
|
|
|
377,981
|
|
Capital lease, net of current portion
|
|
|
17,307
|
|
|
|
31,290
|
|
Other long-term liabilities
|
|
|
38,119
|
|
|
|
27,961
|
|
Total long-term liabilities
|
|
|
3,989,025
|
|
|
|
5,048,874
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, no par value, authorized
2,000,000 shares as of March 31, 2015 and December 31, 2014;
70,000 issued and outstanding as of March 31, 2015 and December
31, 2014
|
|
|
3,500,000
|
|
|
|
3,500,000
|
|
Common shares, no par value, authorized 125,000,000 shares as of
March 31, 2015 and December 31, 2014; 83,210,775 issued and
78,316,833 outstanding as of March 31, 2015 and 83,121,698 issued
and 78,227,756 outstanding as of December 31, 2014
|
|
|
234,751,802
|
|
|
|
234,842,998
|
|
Contributed capital
|
|
|
7,145
|
|
|
|
7,145
|
|
Accumulated other comprehensive income
|
|
|
238,820
|
|
|
|
185,835
|
|
Accumulated deficit
|
|
|
(192,357,575
|
)
|
|
|
(182,190,207
|
)
|
Treasury stock at cost: 4,893,942 shares at March 31, 2015 and
December 31, 2014
|
|
|
(19,889,788
|
)
|
|
|
(19,889,788
|
)
|
BioTime, Inc. shareholders' equity
|
|
|
26,250,404
|
|
|
|
36,455,983
|
|
Non-controlling interest
|
|
|
31,261,380
|
|
|
|
26,266,782
|
|
Total shareholders' equity
|
|
|
57,511,784
|
|
|
|
62,722,765
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
$
|
69,703,470
|
|
|
$
|
74,900,906
|
|

Source: BioTime, Inc.
BioTime, Inc. Judith Segall, 510-521-3390, ext 301 jsegall@biotimemail.com or Investor
Contact: EVC Group, Inc. Michael Polyviou, 212-850-6020 mpolyviou@evcgroup.com
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