- Positive OpRegen® Data
Presented at Association for Research in Vision and Ophthalmology
Annual Meeting
- Announced Issuance of New Patent for
Method of Reducing Cavitation in Patients with Acute Spinal Cord
Injury
- Entered Into Exclusive Collaboration
with Orbit Biomedical Ltd.
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage
biotechnology company developing cellular therapies for unmet
medical needs, reported financial and operating results for the
first quarter ended March 31, 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 first quarter 2019 financial
results and to provide a business update.
“We have been transforming BioTime into what we believe is one
of the foremost cell therapy companies, with a pipeline which now
consists of three innovative and promising clinical-stage product
candidates, each with the potential to significantly and positively
impact serious diseases or degenerative conditions,” stated Brian
M. Culley, Chief Executive Officer of BioTime. “We will remain
focused on progressing our clinical programs in a thoughtful and
cost-effective manner throughout 2019. As of March 31, 2019, the
value of our cash, marketable securities, equity positions in our
affiliate companies, and the balance of the promissory note due to
us in August 2020 was more than $100 million, and we believe we are
well-positioned to advance our programs. Our goal is to build
awareness and support for our reinvigorated and repositioned
company with the investment, medical, and patient communities, and
advance our objective of bringing cell therapies to patients who
can most benefit from their extraordinary potential.”
Recent Highlights
- Presented positive results from the
Company’s ongoing Phase I/IIa clinical study of OpRegen for the
treatment of dry-age-related macular degeneration (AMD) with
geographic atrophy (GA), at the 2019 Association for Research in
Vision and Ophthalmology Annual Meeting. Data from the study
demonstrate that treatment with OpRegen continues to be well
tolerated and in some patients, signs of structural improvement in
the treated areas of the retina have been observed. Of note, early
data from Cohort 4 patients with earlier-stage dry-AMD and smaller
areas of GA remain encouraging, with indications of the continued
presence of the transplanted OpRegen cells and improvements in
visual acuity.
- Presented SCiStar Clinical Study
Top-Line Results at the 26th Annual American Society for Neural
Therapy and Repair Annual Conference. The primary goals of the
SCiStar Clinical Study, which were to observe the safety of OPC1 in
cervical spinal cord injury patients and other important metrics
related to the optimal timing of OPC1 injection, the tolerability
of the immunosuppression regimen, the engraftment of OPC1 cells,
and rates of motor recovery observed among different study
subpopulations, were all achieved.
- Announced the issuance of a patent from
the United States Patent and Trademark Office for a method of
reducing spinal cord injury (SCI)-induced parenchymal cavitation in
patients who suffered an acute SCI. The issued patent would have a
term that expires no earlier than 2036.
- Announced exclusive agreement with
Orbit Biomedical Ltd. (Orbit) under which BioTime and Orbit will
collaborate on the use of Orbit’s proprietary U.S. Food and Drug
Administration 510(k) approved injection technology to enhance the
sub-retinal delivery of OpRegen RPE cells for the treatment of
dry-AMD in BioTime’s ongoing Phase I/IIa clinical study.
- 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.
- BioTime affiliate OncoCyte Corporation
(NYSE American: OCX) recently reported successful completion of its
Analytical Validation study and the commencement of a CLIA
Validation study of DetermaVu™, its non-invasive liquid biopsy test
intended to facilitate clinical decision making in lung cancer
diagnosis. BioTime owns approximately 28% of OncoCyte’s common
stock, or 14.7 million shares, as of May 8, 2019. As of that same
date, the value of BioTime’s OncoCyte share position was
approximately $65.7 million, based on the closing price of
OncoCyte’s common stock on that date.
Plans for 2019
- Pursuant to an exclusive collaboration
with Orbit, initiate dosing of the first patient with the Orbit
device and a new thaw and inject formulation in the ongoing Phase
I/IIa clinical study of OpRegen for the treatment of dry-AMD,
anticipated in the second quarter of 2019.
- 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, now expected in the second quarter of 2019.
- Continue advancement of the OPC1
program and meet with the U.S. Food and Drug Administration (FDA)
to discuss plans for next steps in the clinical development of the
program, anticipated by year end 2019.
- Strengthen and expand existing
partnerships with the California Institute for Regenerative
Medicine and Cancer Research UK for the ongoing support of the
development of the OPC1 and VAC2 programs.
- Complete patient enrollment in the
ongoing Phase I/IIa clinical study of OpRegen for the treatment of
dry-AMD, anticipated by year end 2019.
- 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.
- Increase presence and engagement within
the patient, physician, and advocacy communities.
Balance Sheet Highlights
Cash, cash equivalents and marketable securities
totaled $27.1 million as of March 31, 2019.
BioTime’s investment in OncoCyte was valued at $58.0 million as
of March 31, 2019 and at $65.7 million as of May 8, 2019, under the
equity method of accounting, and based on the closing stock price
of OncoCyte as of such dates.
Intangible assets, net increased during the first quarter of
2019 due to the Asterias merger and the acquisition of OPC1 (fair
value of $31.7 million) and VAC2 (fair value of $14.8 million).
BioTime’s promissory note due from Juvenescence Limited had an
outstanding balance (principal plus accrued interest) of $22.5
million as of March 31, 2019. Unless earlier converted into
Juvenescence common 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.
First Quarter Operating Results
Revenues: BioTime’s revenue is generated primarily from
research grants, licensing fees and royalties. Total revenues for
the three months ended March 31, 2019 were $0.9 million, an
increase of $0.2 million, compared to $0.7 million for the same
period in 2018. The increase was primarily related to a $0.4
million increase in grant revenues, offset by a $0.2 million
decrease in subscriptions and advertisement revenues attributable
to the deconsolidation of AgeX. AgeX was deconsolidated from
BioTime on August 30, 2018, and beginning on that date, AgeX’s
revenues are not included in BioTime revenues.
Operating Expenses: Operating expenses are comprised of
research and development (“R&D”) expenses and general and
administrative (“G&A”) expenses. Total operating expenses for
the three months ended March 31, 2019 were $13.6 million, as
reported, and $7.9 million, as adjusted. AgeX was deconsolidated
from BioTime on August 30, 2018, and beginning on that date, AgeX’s
operating expenses are not included in BioTime’s operating
expenses.
As adjusted operating expenses is a non-generally accepted
accounting principles (non-GAAP) financial measure. The
reconciliation between operating expenses determined in accordance
with GAAP and non-GAAP operating expenses, by entity, is provided
in the financial tables included at the end of this press
release.
R&D Expenses: Beginning on August 30, 2018, BioTime
ceased recognizing R&D expenses related to AgeX and its
programs due to the AgeX deconsolidation on that date.
R&D expenses for the three months ended March 31, 2019
were $5.0 million, a decrease of $0.9 million, compared to
$5.9 million for the same period in 2018. The decrease was
primarily related to a $1.6 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 $0.6 million in
BioTime programs primarily related to: (1) an increase of $0.8
million in OpRegen related expenses, (2) an increase of $0.6
million in OPC1 and VAC2 expenses (these programs were acquired in
the Asterias merger) offset by (3) decreases of $0.8 million in
Renevia and HyStem related expenses.
G&A Expenses: Beginning on August 30, 2018, BioTime
ceased recognizing G&A expenses related to AgeX and its
subsidiaries due to the AgeX deconsolidation on that date.
G&A expenses for the three months ended March 31, 2019
were $8.7 million, an increase of $2.7 million, compared
to $6.0 million for the same period in 2018. The increase
was primarily attributable to a $3.5 million increase in severance,
legal, accounting and other expenses related to the Asterias merger
and a $0.5 million increase in stock-based compensation, offset by
a $1.3 million decrease in AgeX related G&A expenses.
Other Income/(Expenses), Net: Other income/(expenses), net for
the three months ended March 31, 2019 reflected other income, net
of $47.7 million, compared to other expense, net of ($51.5) 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
March 31, 2019 was net income of $39.3 million,
or $0.30 per share (basic and diluted), compared to a net
loss attributable to BioTime of ($63.5) million,
or ($0.50) per share (basic and diluted), for the same
period in 2018.
Conference Call and Webcast
BioTime will host a conference call and webcast today, at 1:30pm
PT/4:30pm ET to discuss its first 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 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 May 16th, 2019, by dialing (855) 859-2056 from the
U.S. and Canada and (404) 537-3406 from outside the U.S. and Canada
and entering conference ID number 9155549.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing new
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, the 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.
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: the
potential of BioTime’s cell therapy product candidates to
significantly and positively impact serious diseases or
degenerative conditions; BioTime’s ability to advance its clinical
programs; the cost reductions and benefits expected to result from
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; BioTime’s plans to use
Orbit’s proprietary injection technology and device to initiate
dosing of the first patient in the ongoing Phase I/IIa clinical
study of OpRegen for the treatment of dry-AMD and the timing
thereof; the timing of an announcement of the decision on BioTime’s
CE Mark application for Renevia; BioTime’s ability to advance its
product candidates and the timing thereof; BioTime’s ability to
strengthen and expand its partnerships for the ongoing support of
the development of the OPC1 and VAC2 programs and the timing
thereof; the completion of patient enrollment in the ongoing Phase
I/IIa clinical study of OpRegen for the treatment of dry-AMD and
the timing thereof; BioTime’s ability to evaluate the development
of OPC1 as a candidate for the potential treatment of MS and
ischemic stroke through ongoing research collaborations with major
universities and the timing thereof; and BioTime’s ability to
increase presence and engagement with the patient, physician and
advocacy communities and the timing thereof. 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,
without limitation, risk and uncertainties related to: BioTime’s
ability to raise additional capital when and as needed, to advance
its product candidates; BioTime’s ability to develop and
commercialize product candidates; the failure or delay in starting,
conducting and completing clinical trials or obtaining FDA or
foreign regulatory approval for BioTime’s product candidates in a
timely manner; the therapeutic potential of BioTime’s product
candidates, and the disease indications for which BioTime intends
to develop its product candidates; BioTime’s ability to conduct and
design successful clinical trials, to enroll a sufficient number of
patients, to meet established clinical endpoints, to avoid
undesirable side effects and other safety concerns, and to
demonstrate sufficient efficacy of its product candidates;
developments by BioTime competitors that make BioTime’s product
candidates less competitive or obsolete; BioTime’s ability to
manufacture its product candidates for clinical development and, if
approved, for commercialization, and the timing and costs of such
manufacture; the performance of third parties in connection with
the development and manufacture of BioTime’s product candidates,
including third parties conducting clinical trials as well as
third-party suppliers and manufacturers; the potential of BioTime’s
cell therapy platform, and BioTime’s plans to apply its platform to
research, develop and commercialize our product candidates;
BioTime’s ability, and the ability of its licensors, to obtain,
maintain, defend and enforce intellectual property rights
protecting BioTime’s product candidates, and BioTime’s ability to
develop and commercialize its product candidates without infringing
the proprietary rights of third parties; BioTime’s ability to
recruit and retain key personnel; and BioTime’s ability to
successfully integrate the operations of Asterias into BioTime.
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. For a detailed description of BioTime’s risks and
uncertainties, you are encouraged to review its documents filed
with the SEC including its recent filings on Form 8-K, Form 10-K
and Form 10-Q. 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.
BIOTIME, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED BALANCE SHEETS (IN THOUSANDS)
March
31,2019(Unaudited)
December 31,2018
ASSETS CURRENT ASSETS Cash and cash equivalents $ 18,011 $
23,587 Marketable equity securities 9,085 7,154 Trade accounts and
grants receivable, net 1,402 767 Receivables from affiliates, net -
2,112 Prepaid expenses and other current assets 2,158
2,738 Total current assets 30,656 36,358
NONCURRENT ASSETS Property and equipment, net 8,918 5,835 Deposits
and other long-term assets 890 505 Promissory note from
Juvenescence 22,482 22,104 Equity method investment in OncoCyte, at
fair value 57,963 20,250 Equity method investment in Asterias, at
fair value - 13,483 Goodwill 12,977 - Intangible assets, net
49,829 3,125 TOTAL ASSETS $ 183,715 $ 101,660
LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES
Accounts payable and accrued liabilities $ 7,336 $ 6,463 Financing
lease and right-of-use lease liabilities, current portion 954 237
Promissory notes, current portion 18 70 Deferred grant revenue 43
42 Liability classified warrants, current portion 372
- Total current liabilities 8,723 6,812
LONG-TERM LIABILITIES Deferred tax liability 8,581 - Deferred
revenues, net of current portion 200 - Deferred rent liabilities,
net of current portion - 244 Right-of-use lease liability, net of
current portion 4,016 1,854 Financing lease, net of current portion
103 104 Liability classified warrants, net of current portion, and
other long-term liabilities 856 400 TOTAL LIABILITIES
22,479 9,414 Commitments and contingencies
SHAREHOLDERS’ EQUITY Preferred shares, no par value,
authorized 2,000 shares; none issued and outstanding as of March
31, 2019 and December 31, 2018 - - Common shares, no par value,
250,000 shares authorized; 149,388 shares issued and outstanding as
of March 31, 2019 and 127,136 shares issued and outstanding as of
December 31, 2018 384,553 354,270 Accumulated other comprehensive
income 694 1,426 Accumulated deficit (222,403)
(261,856) BioTime, Inc. shareholders’ equity 162,844 93,840
Noncontrolling interest (deficit) (1,608) (1,594)
Total shareholders’ equity 161,236 92,246 TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY $ 183,715 $ 101,660
BIOTIME, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT
PER SHARE DATA) (UNAUDITED)
Three Months EndedMarch
31,
2019 2018 REVENUES: Grant revenue $ 749 $ 326
Royalties from product sales and license fees 86 136 Subscription
and advertisement revenues - 239 Sale of research products and
services 93 - Total revenues 928 701 Cost of
sales (68) (109) Gross profit 860
592
OPERATING EXPENSES: Research and
development 4,961 5,935 Acquired in-process research and
development - 800 General and administrative 8,660
6,044 Total operating expenses 13,621 12,779 Loss
from operations (12,761 ) (12,187)
OTHER
INCOME/(EXPENSES): Interest income, net 442 52 Gain on sale of
equity method investment in Ascendance - 3,215 Gain (loss) on
equity method investment in OncoCyte at fair value 37,713 (37,419)
Gain (loss) on equity method investment in Asterias at fair value
6,744 (17,398) Unrealized gain on marketable equity securities
1,931 215 Change in fair value of warrant liability 37 -
Other income (expense), net
806 (176)
Total other income (expense), net
47,673 (51,511)
INCOME/(LOSS) BEFORE INCOME
TAXES 34,912 (63,698) Deferred income tax benefit
4,384 -
NET INCOME/(LOSS) 39,296 (63,698)
Net loss attributable to noncontrolling interest 14
150
NET INCOME/(LOSS) ATTRIBUTABLE TO BIOTIME,
INC. $ 39,310 $ (63,548) NET INCOME/(LOSS) PER COMMON
SHARE: BASIC $ 0.30 $ (0.50) DILUTED $ 0.30 $ (0.50)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:
BASIC 132,865 126,869 DILUTED 132,869
126,869
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
Amounts In Thousands For the Three Months
Ended
March 31,
2019(unaudited)
March 31,
2018(unaudited)
GAAP Operating Expenses - as reported (1) $
13,621 $ 12,779 Stock-based and other
noncash compensation expense (2) (1,440) (1,319) Depreciation and
amortization expense (2)
(768)
(873) Transaction related costs (3) (3,468) - Acquired AgeX
in-process research and development expense (4) -
(800)
Non-GAAP Operating Expenses, as adjusted
$
7,945
$ 9,787
GAAP Operating Expenses - by entity
(1) BioTime and subsidiaries other than AgeX Therapeutics,
Inc.(5) $ 13,621 $ 9,098 AgeX Therapeutics Inc. and subsidiaries
(6) - 3,681
GAAP Operating Expenses - by
entity $ 13,621 $ 12,779
Non-GAAP Operating Expenses - as adjusted, by entity
BioTime and subsidiaries other than AgeX Therapeutics, Inc.(5) $
7,945
$ 7,303 AgeX Therapeutics Inc. and subsidiaries (6) -
2,484 Non-GAAP Operating Expenses - as adjusted, by entity
$
7,945
$ 9,787 (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. For the three months ended March
31, 2019 and 2018, the GAAP and non-GAAP operating expenses do not
include grant revenues of $749,000 and $326,000, respectively, as
grants are revenues for BioTime. (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/20190509005923/en/
BioTime Inc. IRIoana C. Honeir@biotimeinc.com(510)
871-4188
Solebury Trout IRGitanjali Jain
OgawaGogawa@troutgroup.com(646) 378-2949
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