[May 10, 2016] |
|
BioTime, Inc. Reports First Quarter Results and Recent Corporate Accomplishments
BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative
medicine company with a focus on pluripotent stem cell technology, today
reported financial results for the first quarter ended March 31, 2016
and provided a corporate update. The Company also announced that
management will host a conference call with investors to discuss the
recent operating progress and corporate developments on Tuesday, May 17,
2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific. Details on how to access
the call are provided later in this news release.
"We are off to a strong start in 2016 as we continue to make progress
with BioTime's key clinical therapeutic programs, Renevia®
in medical aesthetics and OpRegen® in dry AMD (News - Alert),"
said Adi Mohanty, Co-Chief Executive Officer. "We are also pleased with
the significant operating progress achieved by our non-core assets as
these companies mature towards standalone businesses. In particular, we
are excited to see our digital health subsidiary, LifeMap Solutions,
gaining more traction with clients and partners, including best-in-class
institutions. Meanwhile, we in the BioTime organization continue to
sharpen our focus on clinical progress and simplifying our corporate
structure and seeking ways to unlock the value of our more mature
revenue-generating subsidiaries for BioTime shareholders."
First Quarter and Recent Highlights
Clinical Progress
OpRegen® (retinal pigment epithelial cells)
-
The first cohort was successfully dosed earlier this year in a Phase
I/IIa clinical trial evaluating the safety and efficacy of OpRegen®
for the treatment of the advanced form of dry age-related macular
degeneration (AMD). The trial is evaluating three different dose
regimens. BioTime expects the Data Safety Monitoring Board (DSMB), an
independent group of experts established for the Phase I/IIa trial,
will complete its review of the initial safety data from the first
cohort and recommend dose escalation to the second cohort during the
second quarter of 2016. The second cohort will receive a higher, more
clinically significant, dose of OpRegen®. The
Company expects to complete enrollment in 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.
Renevia® (adipose cells + cell delivery
matrix)
-
The Company expects to complete enrollment for its Renevia®
pivotal clinical trial in Europe in the second half of 2016
with top line data availability in early 2017. If the data are
positive, BioTime plans to submit an application for CE Mark approval
in the first half of 2017. The objective of the trial is to assess the
efficacy of Renevia®, which consists of
BioTime's HyStem® hydrogel
cell-transplantation delivery matrix combined with the patient's own
adipose cells, in restoring normal skin contours in patients whose
subcutaneous fat, or adipose tissue, has been lost due to antiviral
drug treatment for HIV. Positive data from the pivotal trial is
expected to provide the foundation for studying Renevia®
in the much broader applications of fat tissue deficits in
various medical aesthetics applications, such as for age-related and
trauma related facial fat loss.
AST-VAC1 (antigen-presenting autologous dendritic cells)
-
In February, BioTime's subsidiary Asterias Biotherapeutics, Inc.
completed the End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) for AST-VAC1, the company's lead clinical program
targeting maintenance of relapse-free-survival in acute myeloid
leukemia (AML) patients. Asterias is planning for the initiation of a
single pivotal Phase 3 trial that could support an accelerated
development pathway towards a potential future biologic license
application (BLA) filing.
-
Asterias presented data from the Phase II clinical trial of its cancer
immunotherapy AST-VAC1 in acute myeloid leukemia (AML) at the American
Society of Gene and Cell Therapy (ASGCT) 19th Annual Meeting on May 5,
2016.
AST-OPC1 (oligodendrocyte progenitor cells)
-
Asterias Biotherapeutics presented an overview of the AST-OPC1
therapeutic development program that is currently in a Phase I/IIa
dose escalation clinical trial in spinal cord injury at the Stem Cell
Summit 2016 meeting on April 27, 2016.
Cancer Diagnostics
-
OncoCyte Corporation, the cancer diagnostics subsidiary of BioTime and
developer of novel, non-invasive blood and urine based tests for the
early detection of cancer, announced that its bladder cancer abstract
has been selected for presentation in a poster session, including a
live panel discussion on the results, at the 2016 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois to be
held on June 3-7, 2016. The study to be presented at the upcoming ASCO
annual meeting is based on the continued development of the diagnostic
first reported at the American Association for Cancer Research (AACR)
2015 Annual Meeting. At AACR, OncoCyte presented interim clinical
study data for the non-invasive detection of bladder cancer that
demonstrated a high level of sensitivity and specificity in the
detection of urothelial carcinoma, the most common type of bladder
cancer.
-
On April 4, 2016, OncoCyte and the Wistar Institute, an international
biomedical research leader in cancer, immunology and infectious
diseases, announced positive research results for a lung cancer
diagnostic test being developed at Wistar. This study of 620 subjects
replicates a previous study that was carried out at Wistar, which was
presented at the American Thoracic Society conference in May 2015. The
results of this study are being further evaluated by OncoCyte and mark
a successful transition of the assay platform from Illumina
microarrays to a Nanostring nCounter® machine, which is the
platform that OncoCyte intends to use for commercialization. OncoCyte
has exclusive commercial rights to the lung cancer diagnostic test
developed by Wistar. OncoCyte must now independently validate these
results in its own follow-up study based on the results of Wistar's
latest study. OncoCyte will attempt to finalize and lock down both the
assay and the classifier or algorithm that interprets test results,
and if successful, will initiate an internal analytical validation
study.
Non-core Assets
-
LifeMap Solutions, the digital health subsidiary of BioTime and
co-developer of ResearchKit-enabled app Asthma Health, launched its
new mobile health app design and development service to help research
institutions and health companies worldwide develop custom smartphone
apps and research studies. Through the new service, LifeMap offers
clients its deep expertise in medical science, consumer behavior, app
analytics, and design. LifeMap's innovative, data-driven mobile health
(mHealth) apps are designed to recruit clinical study participants,
obtain patient consent through the iPhone (News - Alert), and passively collect
participants' health information. LifeMap Solutions has developed
innovative digital health apps in collaboration with leading research
institutions including the Icahn School of Medicine at Mount Sinai,
Stanford University School of Medicine, and National Jewish Health, as
well as with strategic partners like 23andMe.
Corporate Developments
-
On May 10, 2016, Asterias finalized the pricing of an underwritten
public offering of 5,147,059 units at a public offering price of $3.40
per unit. Each unit consists of one share of common stock and 0.5 of a
warrant to purchase a share of common stock at an exercise price of
$4.37 per share. The warrants are immediately exercisable and expire
on the fifth anniversary of the date of issuance. The offering is
expected to close on May 13, 2016, subject to customary closing
conditions. If completed, Asterias would receive net proceeds of
$16,275,000 after underwriting discounts but before paying other costs
of the offering. Asterias has granted the underwriters a 30-day option
to purchase up to an additional 772,059 shares of common stock and/or
additional warrants to purchase up to 386,029 shares of common stock
to cover over-allotments, if any. If the over-allotment option is
exercised in full, net proceeds of the offering after underwriting
discounts but before other expenses are expected to be approximately
$18.7 million.
-
On April 28, 2016, Howard I. Scher, M.D., one of the world's leading
oncology experts, was appointed to the Board of Directors of Asterias
Biotherapeutics.
-
In February, pharmaceutical industry veteran Stephen L. Cartt was
appointed as President and Chief Executive Officer of Asterias, and
member of the company's Board of Directors. Mr. Cartt previously
served as Chief Operating Officer of Questcor Pharmaceuticals Inc.
until its sale in 2014 to Mallinckrodt, plc for $5.6 billion. In
addition, Don M. Bailey was appointed to Asterias' Board of Directors
and named Chairman of the Board of Directors. Mr. Bailey previously
served as President and Chief Executive Officer of Questcor until its
sale in 2014 to Mallinckrodt.
First Quarter Financial Results
Cash (and available-for-sale securities) Position: Cash and cash
equivalents totaled $27.1 million as of March 31, 2016, compared to
$42.2 million as of December 31, 2015. The cash on hand as of March 31,
2016 includes $16.4 million held by subsidiaries. As of March 31, 2016,
BioTime held $829,000 in available-for-sale securities. As of March 31,
2016, BioTime owned 21.7 million shares of Asterias common stock and
14.7 million shares of OncoCyte common stock, which represented an
aggregate market value of $170 million as of that date.
Revenues: BioTime's operating revenues are currently generated
from research grants, licensing fees and advertising from the marketing
of online database products. Total consolidated revenues were $2.1
million for the first quarter, compared to $1.3 million in the first
quarter of 2015. The increase was primarily due to increases in grant
revenue and subscription and advertising revenues.
R&D Expenses: Research and development expenses were $13.7
million for the first quarter, compared to $9.3 million for the
comparable period in 2015. The increase is in part a result of increased
expenses primarily related to regulatory and clinical trials of
Asterias' AST-OPC1 program, and OncoCyte's cancer diagnostics.
G&A Expenses: General and administrative expenses were $11.9
million for the first quarter, compared to $5.2 million for the first
quarter of 2015. The increase is in part a result of $3.1 million in
non-cash expense for the estimated fair value of the distribution of
3,331,229 warrants to purchase Asterias common stock to Asterias
shareholders other than BioTime declared by the Asterias board of
directors on March 30, 2016, increased staffing needed to advance
programs under development at BioTime, including non-cash stock-based
compensation from BioTime, Asterias, and OncoCyte.
Net Loss attributable to BioTime: Net loss attributable to
BioTime was $17.1 million for the three months ended March 31, 2016, or
$0.19 per share. There was no deferred income tax benefit recorded in
the three months ended March 31, 2016. For the first quarter of 2015,
net loss attributable to BioTime was $10.2 million, or $0.13 per share
including deferred income tax benefits of $1.2 million. Net loss
attributable to BioTime includes losses from BioTime's majority owned
and consolidated subsidiaries based upon BioTime's percentage ownership
of those subsidiaries.
Conference Call and Webcast Details
BioTime will host a conference call and webcast on Tuesday, May 17, 2016
at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the first quarter
results and recent corporate developments.
The conference call dial-in number in the U.S./Canada is (877) 407-0784.
For international participants outside the U.S./Canada, the dial-in
number is (201) 689-8560. For all callers, please refer to the "BioTime,
Inc. Conference Call." The live webcast can be accessed on the "Events &
Presentations" page of the "Investors & Media" section on the company's
website at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven business
days beginning about two hours after the conclusion of the live call, by
calling toll-free from U.S./Canada: (877) 870-5176; international
callers dial (858) 384-5517. Use the Conference ID 13636578.
Additionally, the archived webcast will be available on the "Events &
Presentations" page of the "Investors & Media" section on the company's
website at http://www.biotimeinc.com/.
About BioTime
BioTime, Inc. is a clinical-stage biotechnology company focused on
developing and commercializing novel therapies developed from what we
believe to be the world's premier collection of pluripotent cell assets.
The foundation of our core therapeutic technology platform is
pluripotent cells that are capable of becoming any of the cell types in
the human body. Pluripotent cells have potential application in many
areas of medicine with large unmet patient needs, including various
age-related degenerative diseases and degenerative conditions for which
there presently are no cures. Unlike pharmaceuticals that require a
molecular target, therapeutic strategies based on the use of pluripotent
cells are generally aimed at regenerating or replacing affected cells
and tissues, and therefore may have broader applicability than
pharmaceutical products.
In addition to the development of therapeutics, BioTime's research and
other activities have resulted, over time, in the creation of other
subsidiaries that address other non-therapeutic market opportunities
such as cancer diagnostics, drug development and cell research products,
and mobile health software applications.
BioTime common stock is traded on the NYSE MKT and TASE 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
|
(IN THOUSANDS, EXCEPT PER SHARE DATA)
|
(UNAUDITED)
|
|
|
|
Three Months Ended
|
|
|
March 31,
|
|
|
March 31,
|
|
2016
|
2015
|
REVENUES:
|
|
|
|
|
|
|
Subscription and advertisement revenues
|
|
$
|
420
|
|
|
$
|
319
|
|
Royalties from product sales
|
|
|
123
|
|
|
|
156
|
|
Grant income
|
|
|
1,487
|
|
|
|
699
|
|
Sale of research products and services
|
|
|
43
|
|
|
|
90
|
|
Total revenues
|
|
|
2,073
|
|
|
|
1,264
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
(225
|
)
|
|
|
(264
|
)
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
1,848
|
|
|
|
1,000
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
13,734
|
|
|
|
9,323
|
|
General and administrative
|
|
|
11,872
|
|
|
|
5,179
|
|
Total operating expenses
|
|
|
25,606
|
|
|
|
14,502
|
|
Loss from operations
|
|
|
(23,758
|
)
|
|
|
(13,502
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
(132
|
)
|
|
|
(25
|
)
|
BioTime's share of losses in equity method investment in Ascendance
|
|
|
(235
|
)
|
|
|
-
|
|
Other income/(expense), net
|
|
|
128
|
|
|
|
(240
|
)
|
Total other income/(expense), net
|
|
|
(239
|
)
|
|
|
(265
|
)
|
LOSS BEFORE INCOME TAX BENEFIT
|
|
|
(23,997
|
)
|
|
|
(13,767
|
)
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit
|
|
|
-
|
|
|
|
1,177
|
|
|
|
|
|
|
|
|
|
|
NET (News - Alert) LOSS
|
|
|
(23,997
|
)
|
|
|
(12,590
|
)
|
|
|
|
|
|
|
|
|
|
Net loss attributable to non-controlling interest
|
|
|
6,885
|
|
|
|
2,423
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
|
$
|
(17,112
|
)
|
|
$
|
(10,167
|
)
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|
|
$
|
(0.19
|
)
|
|
$
|
(0.13
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC
AND DILUTED
|
|
|
90,421
|
|
|
|
78,262
|
|
|
BIOTIME, INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(IN THOUSANDS)
|
|
|
|
March 31,
|
|
|
|
|
2016
|
December 31,
|
(Unaudited)
|
2015
|
ASSETS
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
27,132
|
|
|
$
|
42,229
|
|
Available for sale securities
|
|
|
829
|
|
|
|
753
|
|
Trade accounts and grants receivable, net
|
|
|
1,125
|
|
|
|
1,078
|
|
Landlord receivable
|
|
|
943
|
|
|
|
567
|
|
Prepaid expenses and other current assets
|
|
|
2,878
|
|
|
|
2,610
|
|
Total current assets
|
|
|
32,907
|
|
|
|
47,237
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net and construction in progress
|
|
|
8,932
|
|
|
|
7,539
|
|
Deferred license fees
|
|
|
293
|
|
|
|
322
|
|
Deposits and other long-term assets
|
|
|
1,268
|
|
|
|
1,299
|
|
Equity method investment
|
|
|
4,436
|
|
|
|
4,671
|
|
Intangible assets, net
|
|
|
32,278
|
|
|
|
33,592
|
|
TOTAL ASSETS
|
|
$
|
80,114
|
|
|
$
|
94,660
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
10,674
|
|
|
$
|
9,377
|
|
Capital lease liability, current portion
|
|
|
22
|
|
|
|
38
|
|
Promissory notes, current portion
|
|
|
95
|
|
|
|
95
|
|
Deferred grant income
|
|
|
2,269
|
|
|
|
2,513
|
|
Deferred license and subscription revenue, current portion
|
|
|
609
|
|
|
|
439
|
|
Total current liabilities
|
|
|
13,669
|
|
|
|
12,462
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
|
|
Deferred revenues, net of current portion
|
|
|
538
|
|
|
|
615
|
|
Deferred rent liabilities, net of current portion
|
|
|
261
|
|
|
|
158
|
|
Lease liability
|
|
|
5,408
|
|
|
|
4,400
|
|
Related party convertible debt, net of discount
|
|
|
394
|
|
|
|
324
|
|
Promissory notes, net of current portion
|
|
|
220
|
|
|
|
220
|
|
Capital lease, net of current and other liabilities
|
|
|
32
|
|
|
|
34
|
|
TOTAL LIABILITIES
|
|
|
20,522
|
|
|
|
18,213
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Preferred shares, no par value, 2,000 shares authorized; none issued
and outstanding
|
|
|
-
|
|
|
|
-
|
|
Common shares, no par value, 125,000 shares authorized; 94,894
issued and 90,421 outstanding as of March 31, 2016 and December 31,
2015
|
|
|
275,238
|
|
|
|
274,342
|
|
Accumulated other comprehensive loss
|
|
|
(60
|
)
|
|
|
(237
|
)
|
Accumulated deficit
|
|
|
(246,293
|
)
|
|
|
(229,181
|
)
|
Treasury stock at cost: 4,473 shares as of March 31, 2016 and
December 31, 2015
|
|
|
(18,033
|
)
|
|
|
(18,033
|
)
|
BioTime, Inc. shareholders' equity
|
|
|
10,852
|
|
|
|
26,891
|
|
Non-controlling interest
|
|
|
48,740
|
|
|
|
49,556
|
|
Total shareholders' equity
|
|
|
59,592
|
|
|
|
76,447
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
$
|
80,114
|
|
|
$
|
94,660
|
|
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