- Announced Rebranding and Name Change to Lineage Cell
Therapeutics and Corporate Relocation
- Awarded $2.5 Million Grant from the Israel Innovation
Authority for Continued Development of OpRegen®
- Conducted Sale of 2.25 Million Shares of OncoCyte
Corporation
- Initiated Dosing in Phase I/IIa Clinical Study of OpRegen
for Treatment of Dry-AMD Utilizing Orbit Subretinal Delivery
System
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage
biotechnology company developing novel cellular therapies for unmet
medical needs, reported financial and operating results for the
second quarter ended June 30, 2019. BioTime management will host a
conference call and webcast today at 4:30 p.m. Eastern Time/1:30
p.m. Pacific Time to discuss its second quarter 2019 financial
results and to provide a business update.
“Over the past several quarters, BioTime has completed several
transactions to simplify our corporate structure and highlight our
cell therapy programs as our top priority. Acquiring Asterias,
distributing AgeX, reducing our OncoCyte ownership, hiring a new
management team, reducing overhead and headcount, and relocating
clinical operations for our OpRegen program to the U.S. are all
constructive components of a larger vision we have to become a
premier cell therapy company,” stated Brian M. Culley, Chief
Executive Officer of BioTime. “As a result, we are changing our
name to reflect our mission and bring attention to our leadership
position in the administration of differentiated human cells to
treat serious medical conditions such as dry-AMD, spinal cord
injuries, and cancer.”
Recent Highlights
- Announced dosing of the first patient with the Orbit Subretinal
Delivery System (Orbit SDS) and with the new Thaw-and-Inject
formulation of OpRegen, its retinal pigment epithelium (RPE)
transplant therapy, in the Company’s ongoing Phase I/IIa clinical
study for the treatment of dry age-related macular degeneration
(dry-AMD), a leading cause of adult blindness in the developed
world.
- Announced the planned launch of its new corporate brand and
identity as well as a change in corporate name to Lineage Cell
Therapeutics, Inc., reflecting its commitment to becoming an
innovative, leading cell therapy company and highlighting its
extensive cell therapy platform. In conjunction with the name
change, the Company's ticker symbol will change to "LCTX" on
August 12, 2019. The Company also will be relocating its corporate
headquarters to Carlsbad, California, effective August 12, 2019, a
move which will provide proximity to world-leading academic
centers, public and private cell therapy peers, and is expected to
offer more centralized decision-making, cost-savings, and access to
an extensive network of experienced staff.
- Awarded a new research & development grant for 2019 of up
to 9 million Israeli New Shekels (approximately $2.5 million) from
the Israel Innovation Authority. The grant provides funding for the
continued development of OpRegen and to date, the IIA has provided
annual grants totaling approximately $16 million for the
development of the OpRegen program.
- Converted approximately 15% of our investment in OncoCyte
Corporation into cash to support our operations with the sale of
2,250,000 shares of OncoCyte common stock for gross proceeds
totaling $4,500,000. BioTime continues to own approximately 23.9%
or 12.4 million shares of OncoCyte’s outstanding common stock.
Based on the closing price of OncoCyte’s common stock on August 6,
2019, the value of our remaining OncoCyte shares is approximately
$21.7 million.
- The ongoing transfer of assets acquired in the Asterias merger
to BioTime’s existing GMP manufacturing facility in Jerusalem in
preparation for the hand off of Asterias’s Fremont facility to Novo
Nordisk in the third quarter of 2019. These actions are expected to
lead to significant cost savings via headcount and facility
reductions, as well as support BioTime’s innovative and diversified
clinical-stage pipeline.
Current Plans for 2019
- Complete patient enrollment in the United States with the Orbit
SDS in the ongoing Phase I/IIa clinical study of OpRegen for the
treatment of dry-AMD.
- Present new OpRegen data from the ongoing Phase I/IIa clinical
study for the treatment of dry-AMD at the 2019 American Academy of
Ophthalmology Annual Meeting in October (AAO 2019).
- Continue to tech transfer and advance the OPC1 program by
introducing improvements to the manufacturing process.
- Strengthen existing partnerships with the National Institutes
of Health, the Israel Innovation Authority, the California
Institute for Regenerative Medicine and Cancer Research UK.
- Announce decision on BioTime’s CE Mark application for Renevia,
an investigational medical device being developed as an alternative
for whole adipose tissue transfer procedures.
- Evaluate the development of OPC1 as a candidate for the
potential treatment of multiple sclerosis (MS) and ischemic stroke
through ongoing research collaborations with major
universities.
- Launch new corporate brand, website and social media
presence.
Balance Sheet Highlights
Cash, cash equivalents and marketable securities totaled $16.7
million as of June 30, 2019. BioTime sold 2,250,000 shares of
OncoCyte’s common stock on July 2, 2019 for gross proceeds of $4.5
million. BioTime also sold 647,397 shares of Hadasit Bio-Holdings
Ltd. common stock in July 2019 for gross proceeds of $1.2
million.
BioTime’s investment in OncoCyte was valued at $36.5 million as
of June 30, 2019. As of August 6, 2019, BioTime’s remaining
investment in OncoCyte was valued at $21.7 million, under the
equity method of accounting, based on the closing stock price of
OncoCyte as of such date.
BioTime’s promissory note due from Juvenescence Limited had an
outstanding balance (principal plus accrued interest) of $22.9
million as of June 30, 2019. Unless earlier converted into
Juvenescence ordinary shares, the promissory note is payable in
cash, plus accrued interest at 7% per year, at maturity in August
2020. If Juvenescence completes an initial public offering (IPO)
resulting in gross proceeds of not less than $50.0 million, the
promissory note automatically converts into the Juvenescence
securities issued in the IPO based on the per-share price to the
public in the IPO, subject to an upward adjustment in the number of
shares that would be issued to BioTime upon such conversion if the
20-day volume-weighted average trading price of one share of common
stock of AgeX Therapeutics, Inc. (AgeX) before the IPO is priced
above $3.00. If the promissory note is converted, the Juvenescence
ordinary shares will be a marketable security that BioTime may use
to supplement its liquidity, as needed and as market conditions
allow.
In summary, as of June 30, 2019, the value of the Company’s
cash, marketable securities, equity holdings in OncoCyte, and the
balance of a promissory note due to it in August 2020 were in
excess of $76.0 million.
Second Quarter Operating Results
Note regarding AgeX: On August 30, 2018, BioTime deconsolidated
AgeX from its consolidated financial statements due to the sale by
BioTime of 14,400,000 shares of AgeX common stock to Juvenescence
and the related decrease of BioTime’s ownership position in AgeX
from 80.4% to 40.2%. Accordingly, BioTime ceased recognizing
revenue and expenses related to AgeX and its programs on such
date.
Revenues: BioTime’s revenue is generated primarily from research
grants, licensing fees and royalties. Total revenues for the three
months ended June 30, 2019 were $0.8 million, a decrease of $1.8
million as compared to the same period in 2018. The decrease was
primarily related to a $1.4 million decrease in grant revenues, and
a $0.3 million decrease in subscriptions and advertisement revenues
attributable to the deconsolidation of AgeX.
Operating Expenses: Operating expenses are comprised of research
and development (R&D) expenses and general and administrative
(G&A) expenses. Total operating expenses, as reported, for the
three months ended June 30, 2019 were $11.5 million, a decrease of
$0.1 million as compared to the same period in 2018. Total
operating expenses, as adjusted, for the three months ended June
30, 2019, were $9.0 million, a decrease of $0.4 million as compared
to the same period in 2018.
The reconciliation between operating expenses determined in
accordance with accounting principles generally accepted in the
United States (GAAP) and operating expenses, as adjusted, a
non-GAAP measure, is provided in the financial tables included at
the end of this press release.
R&D Expenses: R&D expenses for the three months ended
June 30, 2019 were $5.2 million, a decrease of $1.1 million as
compared to the same period in 2018. The decrease was primarily
related to a $1.4 million decrease from the AgeX deconsolidation
and the absence of AgeX R&D expenses incurred after August 30,
2018, offset by a net increase of $0.3 million in BioTime programs
primarily related to: (1) an increase of $1.7 million in OPC1 and
VAC2 expenses (these programs were acquired in the Asterias merger)
offset by (2) decreases of $1.4 million in Renevia, HyStem and
PureStem related expenses.
G&A Expenses: G&A expenses for the three months ended
June 30, 2019 were $6.3 million, an increase of $1.0 million as
compared to the same period in 2018. The increase was primarily
attributable to a $1.9 million increase in severance, legal,
accounting and other expenses related to the Asterias merger which
was offset by a $1.1 million decrease in AgeX related G&A
expenses.
Other Income/(Expenses), Net: Other income/(expenses), net for
the three months ended June 30, 2019 reflected other expense, net
of ($20.5) million, compared to other income, net of $4.5 million
for the same period in 2018. The variance was primarily related to
changes in the value of equity investments in OncoCyte and Asterias
for the applicable periods.
Net income/(loss) attributable to BioTime: The net income/(loss)
attributable to BioTime for the three months ended June 30, 2019
was a net loss of ($30.0) million, or ($0.20) per share (basic and
diluted), compared to a net loss attributable to BioTime of ($4.2)
million, or ($0.03) per share (basic and diluted), for the same
period in 2018.
In line with previous estimates, BioTime expects to spend $14
million to $15 million in the second half of 2019. BioTime
anticipates that cash spend in 2020 will range from $24 million to
$28 million, a reduction from 2019 spending levels of $32 million
to $34 million due to corporate simplification and cost savings
initiatives implemented in 2019, and a significant reduction from
2018 spending levels of $43 million for BioTime and Asterias
combined.
Conference Call and Webcast
BioTime will host a conference call and webcast today, at 1:30pm
PT/4:30pm ET to discuss its second quarter 2019 financial results
and to provide a business update. Interested parties may access the
conference call by dialing (866) 888-8633 from the U.S. and Canada
and (636) 812-6629 from elsewhere outside the U.S. and Canada and
should request the “BioTime Inc. Call”. A live webcast of the
conference call will be available online in the Investors section
of BioTime’s website. A replay of the webcast will be available on
BioTime’s website for 30 days and a telephone replay will be
available through August 15th, 2019, by dialing (855) 859-2056 from
the U.S. and Canada and (404) 537-3406 from elsewhere outside the
U.S. and Canada and entering conference ID number 8783397.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing
novel cellular therapies for unmet medical needs. BioTime’s
programs are based on its proprietary cell-based therapy platform
and associated development and manufacturing capabilities. With
this platform, BioTime develops and manufactures specialized,
terminally-differentiated human cells from its pluripotent and
progenitor cell starting materials. These differentiated cells are
developed either to replace or support cells that are dysfunctional
or absent due to degenerative disease or traumatic injury or
administered as a means of helping the body mount an effective
immune response to cancer. BioTime’s clinical assets include (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
I/IIa development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase
I/IIa development for the treatment of acute spinal cord injuries;
and (iii) VAC2, an allogeneic cancer immunotherapy of
antigen-presenting dendritic cells currently in Phase I development
for the treatment of non-small cell lung cancer. For more
information, please visit www.biotimeinc.com or follow the Company
on Twitter @BioTimeBTX. BioTime announced that it is changing its
name to Lineage Cell Therapeutics, effective August 12, 2019.
Forward-Looking Statements
BioTime cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to BioTime’s
cost-savings efforts, enrollment activities, data presentations,
clinical study advancement, drug evaluation, rebranding and
relocation activities, and anticipated spend for the second half of
2019 and full year 2020. Forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause
BioTime’s actual results, performance or achievements to be
materially different from future results, performance or
achievements expressed or implied by the forward-looking statements
in this press release, including risks and uncertainties inherent
in BioTime’s business and other risks in BioTime’s filings with the
Securities and Exchange Commission (the SEC). BioTime’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. Further
information regarding these and other risks is included under the
heading “Risk Factors” in BioTime’s periodic reports with the SEC,
including BioTime’s Annual Report on Form 10-K filed with the SEC
on March 14, 2019 and its other reports, which are available from
the SEC’s website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. BioTime undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
Tables to follow
BIOTIME, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS)
June 30,
2019 (Unaudited)
December 31,
2018
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
8,210
$
23,587
Marketable equity securities
8,477
7,154
Trade accounts and grants receivable,
net
1,671
767
Receivables from affiliates, net
-
2,112
Prepaid expenses and other current
assets
2,101
2,738
Total current assets
20,459
36,358
NONCURRENT ASSETS
Property and equipment, net
8,720
5,835
Deposits and other long-term assets
815
505
Promissory note from Juvenescence
22,860
22,104
Equity method investment in OncoCyte, at
fair value
36,539
20,250
Equity method investment in Asterias, at
fair value
-
13,483
Goodwill
12,977
-
Intangible assets, net
49,321
3,125
TOTAL ASSETS
$
151,691
$
101,660
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
6,859
$
6,463
Financing lease and right of use lease
liabilities, current portion
956
237
Promissory notes, current portion
-
70
Deferred grant revenue
44
42
Total current liabilities
7,859
6,812
LONG-TERM LIABILITIES
Deferred tax liability
7,334
-
Deferred revenues, net of current
portion
200
-
Deferred rent liabilities, net of current
portion
-
244
Right-of-use lease liability, net of
current portion
3,825
1,854
Financing lease, net of current
portion
93
104
Liability classified warrants, net of
current portion, and other long-term liabilities
621
400
TOTAL LIABILITIES
19,932
9,414
Commitments and contingencies
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized
2,000 shares; none issued and outstanding as of June 30, 2019 and
December 31, 2018
-
-
Common shares, no par value, 250,000
shares authorized; 149,643 shares issued and outstanding as of June
30, 2019 and 127,136 shares issued and outstanding as of December
31, 2018
385,615
354,270
Accumulated other comprehensive income
207
1,426
Accumulated deficit
(252,435)
(261,856)
BioTime, Inc. shareholders’ equity
133,387
93,840
Noncontrolling interest (deficit)
(1,628)
(1,594)
Total shareholders’ equity
131,759
92,246
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
151,691
$
101,660
BIOTIME, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
(UNAUDITED)
Three Months Ended
June 30,
Six Months Ended
June 30,
2019
2018
2019
2018
REVENUES:
Grant revenue
$
529
$
1,941
$
1,278
$
2,266
Royalties from product sales and license
fees
140
91
226
227
Subscription and advertisement
revenues
-
333
-
572
Sale of research products and services
110
182
203
182
Total revenues
779
2,547
1,707
3,247
Cost of sales
(107
)
(106
)
(175
)
(215
)
Gross profit
672
2,441
1,532
3,032
OPERATING EXPENSES:
Research and development
5,235
6,358
10,196
12,293
Acquired in-process research and
development
-
-
-
800
General and administrative
6,258
5,227
14,918
11,163
Total operating expenses
11,493
11,585
25,114
24,256
Loss from operations
(10,821
)
(9,144
)
(23,582
)
(21,224
)
OTHER INCOME/(EXPENSES):
Interest income, net
437
52
879
105
Gain on sale of equity method investment
in Ascendance
-
-
-
3,215
(Loss) gain on equity method investment in
OncoCyte at fair value
(21,425
)
6,603
16,288
(30,816
)
(Loss) gain on equity method investment in
Asterias at fair value
-
(2,175
)
6,744
(19,573
)
Unrealized (loss) gain on marketable
equity securities
(607
)
397
1,324
612
Unrealized gain on warrant liability
234
460
271
351
Other (expense) income, net
882
(839
)
1,688
(1,014
)
Total other (expense) income, net
(20,479
)
4,498
27,194
(47,120
)
(LOSS)/INCOME BEFORE INCOME
TAXES
(31,300
)
(4,646
)
3,612
(68,344
)
Deferred income tax benefit
1,248
-
5,632
-
NET (LOSS)/INCOME
(30,052
)
(4,646
)
9,244
(68,344
)
Net loss attributable to noncontrolling
interest
20
431
34
581
NET (LOSS)/INCOME ATTRIBUTABLE TO
BIOTIME, INC.
$
(30,032
)
$
(4,215
)
$
9,278
$
(67,763
)
NET (LOSS)/INCOME PER COMMON SHARE:
BASIC
$
(0.20
)
$
(0.03
)
$
0.07
$
(0.53
)
DILUTED
$
(0.20
)
$
(0.03
)
$
0.07
$
(0.53
)
WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK OUTSTANDING:
BASIC
149,582
126,873
141,270
126,871
DILUTED
149,582
126,873
141,270
126,871
Non-GAAP Financial Measures
This press release includes: (1) operating expenses prepared in
accordance with accounting principles generally accepted in the
United States (GAAP); (2) operating expenses, by entity, prepared
in accordance with GAAP; (3) operating expenses not prepared in
accordance with GAAP (non-GAAP operating expenses); and (4)
non-GAAP operating expenses, by entity. In particular, this press
release includes both (a) non-GAAP total operating expenses,
adjusted to exclude noncash stock-based and other compensation,
depreciation and amortization expense; Asterias transaction related
costs and acquired in-process research and development expense
incurred by AgeX Therapeutics, Inc. (AgeX), considered to be
nonrecurring items, and (b) non-GAAP operating expenses, by entity,
to exclude those same charges by the respective entities for
consistency. Non-GAAP financial measures are not meant to be
considered in isolation or as a substitute for comparable financial
measures prepared in accordance with GAAP. However, BioTime
believes the presentation of non-GAAP total operating expenses and
non-GAAP operating expenses, by entity, when viewed in conjunction
with its GAAP total operating expenses and GAAP operating expenses
by entity, respectively, is helpful in understanding BioTime’s
ongoing operating expenses and its programs within various
entities, including BioTime’s programs in clinical development.
Management uses these non-GAAP financial measures in the
aggregate and on an entity basis to establish budgets and
operational goals, to manage BioTime’s business and to evaluate its
performance and its programs in clinical development.
BIOTIME, INC. AND
SUBSIDIARIES
RECONCILIATION OF
NON-GAAP FINANCIAL MEASURE
ADJUSTED OPERATING
EXPENSES
For the Three Months
Ended
June 30,
For the Six Months
Ended
June 30,
2019
(unaudited)
2018
(unaudited)
2019
(unaudited)
2018
(unaudited)
GAAP Operating Expenses - as reported
(1)
$
11,493
$
11,585
$
25,114
$
24,256
Stock-based and other noncash compensation
expense (2)
(762)
(1,268)
(2,202)
(2,587)
Depreciation and amortization expense
(2)
(764)
(861)
(1,532)
(1,734)
Transaction related costs (3)
(935)
-
(4,405)
-
Acquired AgeX in-process research and
development expense (4)
-
-
-
(800)
Non-GAAP Operating Expenses, as
adjusted
$
9,032
$
9,456
$
16,975
$
19,135
GAAP Operating Expenses - by entity
(1)
BioTime and subsidiaries other than AgeX
Therapeutics, Inc.(5)
$
11,493
$
9,131
$
25,114
$
18,121
AgeX Therapeutics Inc. and subsidiaries
(6)
-
2,454
-
6,135
GAAP Operating Expenses - by
entity
$
11,493
$
11,585
$
25,114
$
24,256
Non-GAAP Operating Expenses - as
adjusted, by entity
BioTime and subsidiaries other than AgeX
Therapeutics, Inc.(5)
$
9,032
$
7,323
$
16,975
$
14,518
AgeX Therapeutics Inc. and subsidiaries
(6)
-
2,133
-
4,617
Non-GAAP Operating Expenses - as adjusted,
by entity
$
9,032
$
9,456
$
16,975
$
19,135
(1)
Beginning on August 30, 2018, BioTime
deconsolidated AgeX’s results and therefore BioTime’s results will
not include AgeX’s results for periods after August 30, 2018.
(2)
Noncash charges.
(3)
One-time transaction related expenses due
to the Asterias acquisition.
(4)
AgeX acquired certain in-process research
and development in March 2018, considered to be a nonrecurring
item. See note (1).
(5)
BioTime includes Cell Cure Neurosciences
Ltd, ES Cell International Pte. Ltd. and OrthoCyte Corporation.
(6)
AgeX includes LifeMap Sciences Inc.,
LifeMap Sciences Ltd., and ReCyte Therapeutics, Inc. (See note
(1)).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190808005737/en/
BioTime Inc. IR Ioana C. Hone (ir@biotimeinc.com) (510)
871-4188
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Apr 2024 to May 2024
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From May 2023 to May 2024