Conference Call and Webcast Today at 4:30 p.m.
Eastern Time
BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage
biotechnology company developing and commercializing products
addressing degenerative diseases, today reported financial results
for the first quarter ended March 31, 2017.
“At BioTime we are continuing to make meaningful clinical
progress with our core development programs in Ophthalmology,
Aesthetics and Therapeutics Delivery. We are generating an
increasing amount of positive human data from our clinical trials
that provide a solid foundation for our optimism,” said Adi
Mohanty, Co-Chief Executive Officer. “We are excited to be
announcing top line safety and efficacy data next month from our
Renevia® pivotal trial in Europe. This week, we are presenting
encouraging ophthalmic clinical trial data at ARVO from the
OpRegen® trial in dry-AMD. Separately at ARVO, tomorrow we are
presenting promising pre-clinical data in retinal restoration.”
“Our strategies for Simplification and Unlocking Value are
moving forward with the formation of AgeX Therapeutics last month.
AgeX is a new subsidiary that is doing exciting work in the field
of Aging. BioTime has already successfully demonstrated its ability
to create value by building subsidiary companies. Our
publicly-traded affiliates Asterias and OncoCyte continue to report
encouraging positive clinical data as they move their therapies for
spinal cord injury and lung cancer diagnostics forward,” concluded
Mr. Mohanty.
Highlights
Clinical Progress
Renevia® (adipose cells + cell delivery matrix)
- The schedule to read-out the Renevia
top-line pivotal trial results was accelerated to June 2017. If the
data are positive the Company plans to submit an application for CE
Mark approval in Europe by year end, which could lead to
approval and commercial launch in about a year.
- The ongoing pivotal clinical trial in
Europe is assessing the efficacy and safety of Renevia in treating
HIV-associated lipoatrophy (facial fat loss). The Company intends
to conduct additional trials in the U.S. that target a broader $7
billion aesthetics market opportunity, which is consistent with the
previously stated goal of indication and geographic expansion for
Renevia.
- The trial in Europe is fully enrolled
and continues to progress well with no safety related issues to
date.
OpRegen® (retinal pigment epithelial cells)
- New positive clinical data on
OpRegen were reported at the Annual Meeting of the Association
for Research in Vision and Ophthalmology (ARVO) this week. The data
show OpRegen cells engraft (remain in place) and possible evidence
of a biological response. Should the data establish that OpRegen
cells safely engraft and remain alive in the patient, then the
Company believes OpRegen may have a higher probability of success
when compared to molecular therapeutics. The treatment continues to
be well-tolerated, which includes some patients with more than one
year of follow-up.
- The data presented at ARVO is from the
first and second cohorts of the ongoing Phase I/IIa clinical trial
in the advanced form of dry-AMD. Patients from the second cohort,
in which patients are receiving a higher and more clinically
meaningful 200,000 cell dose, were included in the data.
- The Company anticipates DSMB review of
cohort 2 by the end of the second quarter and, upon approval, to
begin enrolling cohort 3 immediately, thereafter. Cohort 3 is
expected to enroll more quickly due to reduced patient staggering
requirements. The trial is being expanded to U.S. sites as
previously announced.
AST-OPC1 (oligodendrocyte progenitor cells)
- In April, BioTime’s affiliate, Asterias
(NYSE MKT: AST) announced that the Data Monitoring Committee (DMC)
unanimously recommended continuation of the SCiStar Phase I/IIa
clinical trial for AST-OPC1 following a review of the accumulated
safety data. AST-OPC1 is for patients with spinal cord injury.
Following positive results earlier this year in January, Asterias
plans to initiate discussions with the FDA in mid-2017 to
determine the most appropriate clinical and regulatory path forward
for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)
- BioTime’s
affiliate, OncoCyte (NYSE MKT: OCX) is on track to be
first to market with a lung cancer confirmatory liquid biopsy
diagnostic test in the second half of this year. The test targets a
market opportunity believed to exceed $4 billion annually.
- In preparation for commercialization,
OncoCyte submitted its application for CLIA lab certification in
late March. Earlier is month, OncoCyte established a Medical
Advisory Committee to provide guidance and advice in several areas
including commercialization, unmet clinical needs and future
pipeline products. The committee is comprised of four recognized
lung cancer experts.
- On May 22, 2017, results from
OncoCyte’s 300-patient R&D validation study will be presented
at the American Thoracic Society 2017 International Conference
(ATS) in Washington, D.C. by Dr. Anil Vachani, and will be
discussed on an investor call later that day.
Simplification and Unlocking
Value
New Subsidiary AgeX Therapeutics, Inc.
- In April, BioTime announced the
formation of AgeX Therapeutics, Inc. as a new subsidiary. AgeX will
consolidate certain BioTime subsidiaries and programs in
the field of interventional gerontology. Two of the objectives in
forming AgeX are to: 1) quickly establish leadership in the
emerging biotechnology field of Aging by accelerating development
of its pluripotent cell and iTR™ assets; and 2) continue the
implementation of BioTime’s strategy to simplify its corporate
structure and operations as well as focus its resources on
continued clinical development and product commercialization in
Ophthalmology; Aesthetics and Delivery.
Value of Holdings in Public Affiliates
- At March 31, 2017, BioTime held common
stock in publicly-traded affiliates valued at $161.3 million. This
amount was the market value of BioTime’s 21.7 million shares in
Asterias (NYSE MKT: AST) and 14.7 million shares in OncoCyte (NYSE
MKT: OCX).
First Quarter Financial Results
Cash Position and Marketable Securities: Cash and
cash equivalents totaled $23.8 million as of March
31, 2017, compared to $22.1 million as of December
31, 2016, which included OncoCyte’s cash and cash equivalents of
$10.2 million.
Revenues: BioTime’s revenues are generated primarily
from research grants, licensing fees and royalties, and
subscription and advertising from the marketing of online database
products. Total revenues were $0.4 million for the first
quarter, compared to $2.1 million in the first quarter of
2016. Asterias’ total revenues included in 2016 were $1.6
million compared to no revenues in the first quarter of 2017 due to
the deconsolidation in May 2016.
R&D Expenses: Research and development expenses
were $6.5 million for the first quarter, compared
to $13.7 million for the comparable period in 2016, a
decrease of $7.2 million. This decrease was primarily attributable
to the deconsolidation of Asterias in May 2016 and OncoCyte in
February 2017. Asterias and OncoCyte combined, contributed to $7.4
million of the decrease in research and development expenses in the
first quarter of 2017 as compared to 2016. This decrease was offset
to some extent by an increase of $1.0 million in BioTime’s research
and development programs, including OpRegen®, Renevia®, PureStem®
progenitor and pluripotent cell lines, and orthopedic therapy.
G&A Expenses: General and administrative
expenses were $5.1 million for the first quarter compared to $11.9
million for the comparable period in 2016. The $6.8 million
decrease was primarily due to the deconsolidation of financial
statements of Asterias and OncoCyte. The deconsolidation of these
former subsidiaries contributed to $7.4 million of the total
decrease. This decrease in our general and administrative expenses
was offset by increases in BioTime’s general and administrative
expenses amounting to $0.9 million primarily due to: an increase of
$0.3 million in compensation and related expenses due to additional
key personnel hires.
Cash used by BioTime tends to be higher in the first quarter due
to payments of annual bonuses and other compensation related
costs.
Net Income (loss) attributable to BioTime: Net
income attributable to BioTime was $49.3 million, or $0.46 per
basic and diluted common share for the three months ended March 31,
2017, compared to net loss of $17.1 million, or ($0.19) per basic
and diluted common share. The 2017 net income attributable to
BioTime was primarily due to the $71.7 million gain on
deconsolidation of OncoCyte and $16.1 million gain recognized from
the increase in the market value of the OncoCyte shares owned by
BioTime from February 17, 2017, the date of deconsolidation,
through the end of the quarter. These gains were offset by the
$11.3 million loss in operations, $3.9 million in deferred income
tax expenses, and $26.1 million loss recognized from the decrease
in the market value of the Asterias shares owned by BioTime from
December 31, 2016 to the end of the quarter. BioTime deconsolidated
Asterias in May 2016.
Conference Call and Webcast Details
BioTime is hosting a conference call and webcast today,
Wednesday, May 10, at 4:30 p.m. Eastern Time / 1:30
p.m. Pacific Time to discuss the results and recent corporate
developments.
The conference call 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 1-201-689-8560. 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: 1-844-512-2921;
international callers dial 1-412-317-6671. Use the Conference ID
13661114. 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 the company believes to be the world’s premier collection of
pluripotent cell assets. The foundation of BioTime’s 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. BioTime also
has significant equity holdings in two publicly traded companies,
Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which
BioTime founded and which, until recently, were majority-owned
consolidated subsidiaries of BioTime.
OpRegen is the lead product of BioTime’s ophthalmology
subsidiary Cell Cure Neurosciences Ltd., a majority-owned
subsidiary of BioTime, Inc. OpRegen is a registered trademark of
Cell Cure Neurosciences Ltd.
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
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 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)
March 31,
2017
December 31, (Unaudited) 2016 ASSETS
CURRENT ASSETS Cash and cash equivalents $ 23,816 $ 22,088
Available for sale securities 915 627 Trade accounts and grants
receivable, net 206 446 Landlord receivable - 200 Receivable from
affiliates, net 2,807 511 Prepaid expenses and other current assets
1,513 1,777 Total current assets 29,257
25,649 Property, plant and equipment, net 4,992 5,529
Deferred license fees 90 118 Deposits and other long-term assets
977 1,031 Equity method investment in OncoCyte, at fair value
87,312 - Equity method investment in Asterias, at fair value 73,942
100,039 Intangible assets, net 8,646 10,206 TOTAL
ASSETS $ 205,216 $ 142,572
LIABILITIES AND SHAREHOLDERS'
EQUITY CURRENT LIABILITIES Accounts payable and accrued
liabilities $ 6,947 $ 7,144 Capital lease liability, current
portion - 202 Promissory notes, current portion 124 99 Related
party convertible debt, net of discount 1,070 833 Deferred license
and subscription revenue, current portion 679 572
Total current liabilities 8,820 8,850
LONG-TERM LIABILITIES Deferred revenues, net of current portion 231
308 Deferred rent liabilities, net of current portion 66 50 Lease
liability 1,344 1,386 Capital lease, net of current and other
liabilities - 310 Related party convertible debt, net of discount
1,077 1,032 Promissory notes, net of current portion 95 120 Other
long term liabilities 9 8 Deferred tax liability 3,877
- TOTAL LIABILITIES 15,519 12,064
Commitments and contingencies SHAREHOLDERS' EQUITY Preferred
shares, no par value, authorized 2,000 shares; none issued and
outstanding as of March 31, 2017 and December 31, 2016 - -
Common shares, no par value, 150,000
shares authorized; 110,860 shares issued and outstanding and
103,396 shares issued and 102,776 shares outstanding as of March
31, 2017 and December 31, 2016, respectively
333,997 317,878 Accumulated other comprehensive income (loss) 408
(738 ) Accumulated deficit (147,033 ) (196,321 ) Treasury stock at
cost: no shares as of March 31, 2017; 620 shares as of December 31,
2016 - (2,891 ) BioTime, Inc. shareholders' equity 187,372
117,928 Non-controlling interest 2,325 12,580 Total
shareholders' equity 189,697 130,508 TOTAL
LIABILITIES AND SHAREHOLDERS' EQUITY $ 205,216 $ 142,572
BIOTIME, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT
PER SHARE DATA) (UNAUDITED) Three
Months Ended March 31, 2017 2016
REVENUES: Grant income $ 11 $ 1,487 Royalties from product
sales and license fees 110 200 Subscription and advertisement
revenues 264 343 Sale of research products 5 43 Total
revenues 390 2,073 Cost of sales (57 ) (225 )
Gross profit 333 1,848
OPERATING EXPENSES: Research and development 6,494
13,734 General and administrative 5,101 11,872 Total
operating expenses 11,595 25,606 Loss from operations
(11,262 ) (23,758 )
OTHER INCOME/(EXPENSES):
Interest expense, net (306 ) (132 ) BioTime’s share of losses in
equity method investment in Ascendance Biotechnology, Inc. - (235 )
Gain on deconsolidation of OncoCyte 71,697 - Loss on equity method
investment in Asterias at fair value (26,097 ) - Gain on equity
method investment in OncoCyte at fair value 16,142 - Other income,
net 727 128 Total other income/(expenses), net
62,163 (239 ) INCOME (LOSS) BEFORE INCOME TAXES 50,901
(23,997 ) Deferred income tax provision (3,877 )
- NET INCOME (LOSS) 47,024 (23,997 )
Net loss attributable to non-controlling interest
2,264 6,885
NET INCOME (LOSS) ATTRIBUTABLE TO
BIOTIME, INC. $ 49,288 $ (17,112 ) NET INCOME (LOSS) PER
COMMON SHARE: BASIC $ 0.46 $ (0.19 ) DILUTED $ 0.46 $ (0.19 )
WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK OUTSTANDING:
BASIC 106,712 90,421 DILUTED 107,384
90,421
BIOTIME, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN
THOUSANDS) (UNAUDITED) Three Months
Ended March 31, 2017 2016 CASH FLOWS FROM
OPERATING ACTIVITIES: Net income (loss) attributable to
BioTime, Inc. $ 49,288 $ (17,112 ) Net loss allocable to
non-controlling interest (2,264 ) (6,885 ) Adjustments to reconcile
net income (loss) attributable to BioTime, Inc. to net cash used in
operating activities: Gain on deconsolidation of OncoCyte (71,697 )
- Unrealized loss on equity method investment in Asterias at fair
value 26,097 - Unrealized gain on equity method investment in
OncoCyte at fair value (16,142 ) - Depreciation expense, including
amortization of leasehold improvements 216 429 Amortization of
intangible assets 602 1,314 Stock-based compensation 1,026 3,373
Subsidiary shareholder expense for subsidiary warrants - 3,125
Amortization of discount on related party convertible debt 253 65
Foreign currency remeasurement (gain) or loss and other (829 ) 347
Deferred income tax provision 3,877 - Deferred grant income - (243
) Changes in operating assets and liabilities: Accounts and grants
receivable, net 248 (36 ) Receivables from affiliates, net of
payables 231 - Prepaid expenses and other current assets 338 (259 )
Accounts payable and accrued liabilities 655 1,457 Other 3
112 Net cash used in operating activities (8,098 )
(14,313 )
CASH FLOWS FROM INVESTING
ACTIVITIES: Deconsolidation of cash and cash equivalents of
OncoCyte (8,898 ) - Purchase of equipment and other assets (205 )
(583 ) Restricted cash - (815 ) Payments on construction in
progress - (267 ) Other (51 ) - Cash used in
investing activities (9,154 ) (1,665 )
CASH
FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of
common shares 20,125 - Fees paid on sale of common shares (1,345 )
- Proceeds from exercises of stock options 25 49 Reimbursement from
landlord on construction in progress 200 567 Repayment of capital
lease obligation (31 ) (17 ) Net proceeds from sale of common
shares of subsidiary - 165 Proceeds from issuance of related party
convertible debt 123 - Net cash provided by financing
activities 19,097 764 Effect of exchange rate
changes on cash and cash equivalents (117 ) 117
NET
CHANGE IN CASH AND CASH EQUIVALENTS: 1,728 (15,097 )
CASH
AND CASH EQUIVALENTS: At beginning of the period 22,088
42,229 At end of the period $ 23,816 $ 27,132
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170510006540/en/
for BioTime, Inc.Investor Contact:Brian Moore,
310-770-0389bmoore@evcgroup.comorMedia Contact:Gotham
Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
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