Press ReleaseBioTime, Inc. Reports Third Quarter Results and Recent Clinical Progress |
-
Initial data from OpRegen® trial suggest
cells able to engraft and survive at least 12 months
-
Initial 3-D Imaging data from Renevia® trial run-in patients
suggest volumetric improvements are sustained at least 12 months
ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 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 program progress.
“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®
in Europe.”
Third Quarter and Recent Accomplishments
Clinical Progress
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)
-
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 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 thereafter.
-
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
fat loss.
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
mid-year 2017.
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.
Management Team
-
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
its key programs.
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D Expenses: Research and development expenses were $6.4
million for the third quarter, compared to $11.4 million for the
comparable period in 2015. The 2015 expenses included $4.6
million attributable to Asterias' research and development. The decrease
year over year was primarily due to the deconsolidation of Asterias for
financial reporting purposes commencing May 13, 2016.
G&A Expenses: General and administrative expenses were $4.6
million for the third quarter, compared to $7.5 million for the third
quarter of 2015. The decrease was primarily due to the deconsolidation
of Asterias financial results and reduced expenses incurred by OncoCyte.
Operating Loss: Loss from operations was $9.6 million in the
third quarter compared with a loss of $17.1 million in the third quarter
of 2015. The decrease was primarily due to the lower operating expenses
as a result of the deconsolidation of Asterias operating results and
reduced expenses incurred by OncoCyte.
Net Income (loss) attributable to BioTime: Net income
attributable to BioTime was $31.2 million, or $0.30 per basic and
diluted share for the three months ended September 30, 2016, due
primarily to the gain on our interest in Asterias at fair value using
the equity method of accounting. There was no deferred income tax
provision or benefit recorded in the three months ended September 30,
2016. For the third quarter of 2015, net loss attributable
to BioTime was $14.0 million, or ($0.18) per share. Net income (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 November 3, 2016, at
4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss third quarter
results and recent corporate accomplishments. To participate on the
call, the dial-in number in the U.S./Canada is 1-(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 BioTime’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: 1-844-512-2921; international
callers dial 1-412-317-6671. Use the Conference ID 13648138.
Additionally, the archived webcast will be available on the “Events &
Presentations” page of the “Investors & Media” section on BioTime’s
website at http://www.biotimeinc.com.
About BioTime
BioTime, Inc. is a clinical-stage biotechnology company focused on
developing and commercializing novel therapies in the field of
regenerative medicine. The foundation of its core therapeutic technology
platform is pluripotent cells that are capable of becoming any of the
cell types in the human body, and its HyStem® three
dimensional cell delivery matrix technology. BioTime, Inc.’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, cell research products and
mobile health software applications.
BioTime, Inc.’s 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
Certain statements contained in this release are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements pertaining to future financial and/or
operating results, future growth in research, technology, clinical
development, and potential opportunities for BioTime, Inc. 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, Inc. and its
subsidiaries, particularly those mentioned in the cautionary statements
found in more detail in the “Risk Factors” section of its Annual Reports
on Form 10-K and Quarterly Reports on Form 10-Q filed with
the SEC (copies of which may be obtained at www.sec.gov).
Subsequent events and developments may cause these forward-looking
statements to change. BioTime, Inc. specifically disclaims any
obligation or intention to update or revise these forward-looking
statements as a result of changed events or circumstances that occur
after the date of this release, except as required by applicable law.
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 BALANCE SHEETS
(IN THOUSANDS)
|
|
|
|
|
|
|
|
|
|
September 30,
2016
(Unaudited)
|
|
|
December 31,
2015
|
|
ASSETS
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
30,451
|
|
|
$
|
42,229
|
|
Available for sale securities
|
|
|
903
|
|
|
|
753
|
|
Trade accounts and grants receivable, net
|
|
|
1,604
|
|
|
|
1,078
|
|
Landlord receivable
|
|
|
115
|
|
|
|
567
|
|
Prepaid expenses and other current assets
|
|
|
2,079
|
|
|
|
2,610
|
|
Total current assets
|
|
|
35,152
|
|
|
|
47,237
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net and construction in progress
|
|
|
4,726
|
|
|
|
7,539
|
|
Deferred license fees
|
|
|
145
|
|
|
|
322
|
|
Deposits and other long-term assets
|
|
|
1,011
|
|
|
|
1,299
|
|
Equity method investment in Asterias, at fair value
|
|
|
92,210
|
|
|
|
-
|
|
Equity method investment in Ascendance
|
|
|
3,482
|
|
|
|
4,671
|
|
Intangible assets, net
|
|
|
10,848
|
|
|
|
33,592
|
|
TOTAL ASSETS
|
|
$
|
147,574
|
|
|
$
|
94,660
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
7,176
|
|
|
$
|
9,377
|
|
Capital lease liability, current portion
|
|
|
173
|
|
|
|
38
|
|
Promissory notes, current portion
|
|
|
95
|
|
|
|
95
|
|
Related party convertible debt, net of discount, current portion
|
|
|
357
|
|
|
|
-
|
|
Deferred grant income
|
|
|
-
|
|
|
|
2,513
|
|
Deferred license and subscription revenue, current portion
|
|
|
537
|
|
|
|
439
|
|
Total current liabilities
|
|
|
8,338
|
|
|
|
12,462
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
|
|
Deferred revenues, net of current portion
|
|
|
385
|
|
|
|
615
|
|
Deferred rent liabilities, net of current portion
|
|
|
46
|
|
|
|
158
|
|
Lease liability
|
|
|
1,348
|
|
|
|
4,400
|
|
Related party convertible debt, net of discount, net of current
portion
|
|
|
954
|
|
|
|
324
|
|
Promissory notes, net of current portion
|
|
|
173
|
|
|
|
220
|
|
Capital lease, net of current and other liabilities
|
|
|
89
|
|
|
|
34
|
|
TOTAL LIABILITIES
|
|
|
11,333
|
|
|
|
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, 150,000 shares authorized; 103,392
shares issued and 102,772 shares outstanding at September 30, 2016;
94,894 issued and 90,421 outstanding at December 31, 2015
|
|
|
313,506
|
|
|
|
274,342
|
|
Accumulated other comprehensive loss
|
|
|
(690
|
)
|
|
|
(237
|
)
|
Accumulated deficit
|
|
|
(190,534
|
)
|
|
|
(229,181
|
)
|
Treasury stock at cost: 620 shares at September 30, 2016 and 4,473
shares at December 31, 2015
|
|
|
(2,891
|
)
|
|
|
(18,033
|
)
|
BioTime, Inc. shareholders' equity
|
|
|
119,391
|
|
|
|
26,891
|
|
Non-controlling interest
|
|
|
16,850
|
|
|
|
49,556
|
|
Total shareholders' equity
|
|
|
136,241
|
|
|
|
76,447
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
$
|
147,574
|
|
|
$
|
94,660
|
|
|
|
|
|
|
|
|
|
|
BIOTIME, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income
|
|
$
|
1,109
|
|
|
$
|
1,466
|
|
|
$
|
3,346
|
|
|
$
|
3,596
|
|
Royalties from product sales and license fees
|
|
|
177
|
|
|
|
357
|
|
|
|
463
|
|
|
|
631
|
|
Subscription and advertisement revenues
|
|
|
69
|
|
|
|
343
|
|
|
|
700
|
|
|
|
1,020
|
|
Sale of research products and services
|
|
|
144
|
|
|
|
140
|
|
|
|
331
|
|
|
|
328
|
|
Total revenues
|
|
|
1,499
|
|
|
|
2,306
|
|
|
|
4,840
|
|
|
|
5,575
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
(58
|
)
|
|
|
(432
|
)
|
|
|
(378
|
)
|
|
|
(957
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
1,441
|
|
|
|
1,874
|
|
|
|
4,462
|
|
|
|
4,618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(6,422
|
)
|
|
|
(11,433
|
)
|
|
|
(29,093
|
)
|
|
|
(29,816
|
)
|
General and administrative
|
|
|
(4,574
|
)
|
|
|
(7,545
|
)
|
|
|
(23,083
|
)
|
|
|
(18,911
|
)
|
Total operating expenses
|
|
|
(10,996
|
)
|
|
|
(18,978
|
)
|
|
|
(52,176
|
)
|
|
|
(48,727
|
)
|
Loss from operations
|
|
|
(9,555
|
)
|
|
|
(17,104
|
)
|
|
|
(47,714
|
)
|
|
|
(44,109
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
(167
|
)
|
|
|
(12)
|
|
|
|
(513
|
)
|
|
|
(207
|
)
|
BioTime’s share of losses in equity method investment in Ascendance
|
|
|
(855
|
)
|
|
|
-
|
|
|
|
(1,189
|
)
|
|
|
-
|
|
Gain on deconsolidation of Asterias
|
|
|
-
|
|
|
|
-
|
|
|
|
49,048
|
|
|
|
-
|
|
Gain on equity method investment in Asterias at fair value
|
|
|
40,015
|
|
|
|
-
|
|
|
|
26,532
|
|
|
|
-
|
|
Other income/(expense), net
|
|
|
(173
|
)
|
|
|
(573
|
)
|
|
|
197
|
|
|
|
(408
|
)
|
Total other income/(expense), net
|
|
|
38,820
|
|
|
|
(585
|
)
|
|
|
74,075
|
|
|
|
(615
|
)
|
INCOME (LOSS) BEFORE INCOME TAX BENEFIT
|
|
|
29,265
|
|
|
|
(17,689
|
)
|
|
|
26,361
|
|
|
|
(44,724
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit
|
|
|
-
|
|
|
|
948
|
|
|
|
-
|
|
|
|
3,395
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS)
|
|
|
29,265
|
|
|
|
(16,741
|
)
|
|
|
26,361
|
|
|
|
(41,329
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to non-controlling interest
|
|
|
1,934
|
|
|
|
3,115
|
|
|
|
12,286
|
|
|
|
7,762
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.
|
|
|
31,199
|
|
|
|
(13,626
|
)
|
|
|
38,647
|
|
|
|
(33,567
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on preferred shares
|
|
|
-
|
|
|
|
(363
|
)
|
|
|
-
|
|
|
|
(415
|
)
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON
SHAREHOLDERS
|
|
|
31,199
|
|
|
|
(13,989
|
)
|
|
|
38,647
|
|
|
|
(33,982
|
)
|
NET INCOME (LOSS) PER COMMON SHARE:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
|
|
$
|
0.30
|
|
|
$
|
(0.18
|
)
|
|
$
|
0.40
|
|
|
$
|
(0.43
|
)
|
DILUTED
|
|
$
|
0.30
|
|
|
$
|
(0.18
|
)
|
|
$
|
0.39
|
|
|
$
|
(0.43
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
|
|
|
102,711
|
|
|
|
79,224
|
|
|
|
95,484
|
|
|
|
78,619
|
|
DILUTED
|
|
|
103,613
|
|
|
|
79,224
|
|
|
|
99,073
|
|
|
|
78,619
|
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20161103006699/en/
Source: BioTime, Inc.
Investor Contact: EVC Group, Inc. Matthew Haines, 917-733-9297 mhaines@evcgroup.com or Media
Contact: Gotham Communications, LLC Bill Douglass, 646-504-0890 bill@gothamcomm.com
|
|