- Renevia® CE Mark application
successfully submitted for European approval
- OpRegen® cohort 4 initiated in
better-vision patients
- OpRegen® data slides, conference call
and webcast today at 1:30pm PT/4:30pm ET
BioTime, Inc. (NYSE American: BTX), a clinical-stage
biotechnology company focused on degenerative diseases, today
reported financial results for the first quarter ended March 31,
2018 and recent corporate accomplishments.
“With the European CE Mark submission of Renevia, the initiation
of patient recruitment for the fourth cohort of our OpRegen
clinical trial, sufficient capital to get us well into 2019 and the
excellent OpRegen data we reported at ARVO, 2018 is shaping up to
be a transformative year for BioTime,” said Adi Mohanty,
Co-Chief Executive Officer of BioTime.
First Quarter Highlights and Financial Results
Clinical Progress
Highlights
Renevia® (Facial Lipoatrophy)
- Submitted Renevia® for CE Marking in
Europe.
- U.S. investigator-initiated study in
facial aesthetics is continuing to enroll patients.
OpRegen® (dry-AMD)
- The independent Data Safety Monitoring
Board approved initiation of the fourth cohort for the OpRegen®
clinical trial in patients in the advanced stage of the dry form of
age-related macular degeneration.
- Positive OpRegen® clinical trial data
from the first nine patients from the first three cohorts were
presented at the Annual Meeting of the Association for
Research in Vision and Ophthalmology in Honolulu, Hawaii.
Corporate Highlights
- Ascendance Biotechnology was sold in
March 2018. AgeX received approximately $3.2 million for its
interest in Ascendance.
First Quarter Financial Results
Cash Position and Marketable Securities: Cash, cash
equivalents and marketable securities totaled $31.4 million as
of March 31, 2018, compared to $38.2 million as
of December 31, 2017.
Value of Holdings in Public
Affiliates: At March 31, 2018, BioTime held
common stock in publicly-traded affiliates valued
at approximately $62.4 million. This amount was the market
value of BioTime’s 21.7 million shares in Asterias
Biotherapeutics (NYSE American: AST) and 14.7 million shares
in OncoCyte (NYSE American: OCX).
Cash Used in Operating Activities: Cash used for
operating activities for the three months ended March 31, 2018 was
approximately $10.3 million, as reported, of which approximately
$8.3 million was used by BioTime and subsidiaries other than AgeX,
and approximately $2.0 million was used by AgeX. The cash used for
BioTime's and AgeX's operating activities during the first quarter
was in line with our expectations. The first quarter is generally
our highest cash use quarter within the year, attributable to
seasonal cashflows, such as annual bonus payments and seasonal
fluctuations in grant receipts timing. We also had certain
non-recurring payments related to the planned distribution of
AgeX.
Revenues: BioTime’s revenue is generated primarily
from research grants, licensing fees and royalties, and
subscription and advertising from the marketing of online database
products. Total revenue was $0.7 million for the first
quarter of 2018, compared to $0.4 million in the first
quarter of 2017. Revenues increased by $0.3 million primarily due
to our grants, particularly from the new SBIR grant from the NIH
which was awarded to BioTime last September.
Operating Expenses: Total operating expenses for the
first quarter of 2018 were $12.8 million, as reported, which
is comprised of $9.1 million for BioTime and $3.7 million for AgeX.
BioTime’s consolidated operating expenses, as adjusted, were $9.8
million, which is comprised of $7.3 million for BioTime and $2.5
million for AgeX. The difference in consolidated operating
expenses, as reported, and total operating expenses, as adjusted,
is approximately $3 million in non-cash and non-recurring
expenses.
R&D Expenses: First quarter research and
development expenses were $5.9 million compared to $6.5
million for the comparable period in 2017, a decrease of $0.6
million. The decrease was primarily related to nonrecognition of
OncoCyte research and development expenses due to the
deconsolidation of OncoCyte on February 17, 2017, and LifeMap
Solutions expenses which ceased operations in July 2017. The
current quarter also includes an acquired in-process research and
development expense of $0.8 million purchased by AgeX from
Ascendance, which is a non-recurring expense.
G&A Expenses: First quarter general and
administrative expenses were $6.0 million compared
to $5.1 million for the comparable period in 2017, an
increase of $0.9 million. The increase in general and
administrative expenses was primarily attributable to increased
legal and compliance costs, including costs incurred for the
planned distribution of AgeX, and license and patent fees for
patent prosecution and patent fees.
The reconciliation between GAAP and non-GAAP operating expenses
by entity is provided in the financial tables included with this
earnings release.
Net Income or loss attributable
to BioTime: First quarter net loss attributable to
BioTime was $63.5 million, or ($0.50) per share,
compared to net income attributable to BioTime of $49.3
million, or $0.46 per share, for the first quarter of
2017. Net loss attributable to BioTime for the first quarter of
2018 includes combined unrealized losses of $54.8 million from a
decrease in the value of marketable securities and the $3.2 million
gain sale of Ascendance. Net income attributable to BioTime for the
first quarter of 2017 includes the noncash gain of $71.7 million
for the deconsolidation of OncoCyte and net unrealized losses of
$10.0 million from a decrease in the value of marketable
securities.
Conference Call and Webcast Details
BioTime will host a conference call and webcast today, May 10,
2018 at 1:30pm PT/4:30pm ET to discuss results and corporate
developments. The conference call dial-in number in the
U.S./Canada is 1-866-888-8633. For international participants
outside the U.S./Canada, the dial-in number is 1-636-812-6629. For
all callers, please refer to Conference ID number 7797422. The live
webcast and OpRegen® presentation slides can be accessed on the
“Events & Presentations” page of the “Investors & Media”
section on the company’s website.
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: 1-855-859-2056;
international callers dial 1-404-537-3406. Use the Conference ID
number 7797422. Additionally, the archived webcast and OpRegen®
presentation slides will be available on the “Events &
Presentations” page of the “Investors & Media” section on the
company’s website.
About Renevia®
Renevia® is an investigational medical device that is being
developed as an alternative for whole adipose tissue transfer (fat
grafting) procedures. Renevia® is part of the
HyStem® hydrogel family of proprietary injectable matrices,
being developed as devices for various applications and for cell
and drug delivery.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry
form of AMD, consists of a suspension of retinal pigment epithelial
(RPE) cells that are delivered subretinally during a simple
intraocular injection. RPE cells are essential components of the
back lining of the retina, and function to help nourish the retina
including photoreceptors. A proprietary process that drives the
differentiation of human pluripotent stem cells is used to generate
high purity OpRegen® RPE cells. OpRegen® RPE cells are
also “xeno-free,” meaning that no animal products are used at any
point in the derivation and production process. The avoidance of
the use of animal products eliminates some potential safety
concerns. Preclinical studies in rats have shown that following a
single subretinal injection of OpRegen®, the cells can rapidly
organize into its natural monolayer structure in the subretinal
space and survive throughout the lifetime of the animal.
OpRegen® is designed to be an “off-the-shelf” allogeneic
(non-patient specific) product. Unlike treatments that require
multiple, frequent injections into the eye, it is expected that
OpRegen® will be administered in a single procedure.
OpRegen® was granted Fast Track designation
from the FDA, which allows more frequent interactions
with the agency, and eligibility for accelerated approval and
priority review. OpRegen® is a registered trademark
of Cell Cure Neurosciences Ltd., a majority-owned subsidiary
of BioTime, Inc.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused
on degenerative diseases. Its clinical programs are based on two
platform technologies: cell replacement and cell/drug delivery.
With its cell replacement platform, BioTime is producing
new cells and tissues with its proprietary pluripotent cell
technologies. These cells and tissues are developed to replace
those that are either rendered dysfunctional or lost due to
degenerative diseases or injuries. BioTime’s cell/drug delivery
programs are based upon its proprietary HyStem® cell and drug
delivery matrix technology. HyStem® was designed, in part, to
provide for the transfer, retention and/or engraftment of cellular
replacement therapies. BioTime’s lead cell delivery clinical
program is Renevia®, which consists of HyStem® combined with
the patient's own adipose (fat) progenitor cells. Renevia® met
its primary endpoint in an EU pivotal clinical trial for the
treatment of facial lipoatrophy in HIV patients in
2017. BioTime has submitted Renevia® for CE Mark
approval in the EU. There were no device related serious adverse
events reported to date. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy, which is in a Phase I/IIa multicenter clinical trial for
the treatment of dry age-related macular degeneration, the leading
cause of blindness in developing countries. There were no related
serious adverse events reported in the first nine
patients. BioTime also has significant equity holdings in
two publicly traded companies, Asterias Biotherapeutics,
Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE
American: OCX), and a private company, AgeX Therapeutics,
Inc.
BioTime common stock is traded on the NYSE American and
TASE under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company on
Twitter, LinkedIn, Facebook, YouTube,
and Google+.
To receive ongoing BioTime corporate communications,
please click on the following link to join the Company’s email
alert list: http://news.biotime.com.
About AgeX Therapeutics
AgeX Therapeutics, Inc., a subsidiary of BioTime, is a
biotechnology company applying technology relating to cellular
immortality and regenerative biology to aging and age-related
degenerative diseases. AgeX has three initial areas of product
development: pluripotent stem cell-derived brown adipocytes
(AGEX-BAT1); vascular progenitors (AGEX-VASC1); and induced Tissue
Regeneration (iTR). Initial planned indications for these products
are Type 2 diabetes, cardiac ischemia, and tissue regeneration
respectively. For more information, please
visit www.agexinc.com or connect with the company
on Twitter or Facebook.
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
product technology, clinical development, regulatory approval
timelines, the success of potential cosmetic applications 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
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 as to 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 BioTime’s 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.
BIOTIME, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED BALANCE SHEETS (IN THOUSANDS)
March 31, December 31, 2018
2017 ASSETS CURRENT ASSETS Cash and cash equivalents
$ 29,827 $ 36,838 Marketable equity securities 1,552 1,337 Trade
accounts and grants receivable, net 916 780 Receivable from
affiliates, net 2,082 2,266 Prepaid expenses and other current
assets 1,749 1,402 Total current assets 36,126
42,623 Property, plant and equipment, net 5,366 5,533
Deposits and other long term assets 236 1,018 Equity method
investment in OncoCyte, at fair value 30,816 68,235 Equity method
investment in Asterias, at fair value 31,534 48,932 Intangible
assets, net 6,317 6,900 TOTAL ASSETS $ 110,395 $
173,241
LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT
LIABILITIES Accounts payable and accrued liabilities $ 4,703 $
5,718 Capital lease and lease liabilities, current portion 222 212
Promissory notes, current portion 120 152 Deferred license and
subscription revenues 563 488 Deferred grant revenues 202
309 Total current liabilities 5,810 6,879
LONG-TERM LIABILITIES Deferred rent liabilities, net of
current portion 114 105 Lease liability, net of current portion 968
1,019 Capital lease, net of current portion and other liabilities
122 132 Promissory notes, net of current portion - 18 Liability
classified warrants and other long-term liabilities 926
825 TOTAL LIABILITIES 7,940 8,978
Commitments and contingencies SHAREHOLDERS’ EQUITY Preferred
shares, no par value, authorized 2,000 shares; none issued and
outstanding as of March 31, 2018 and December 31, 2017 - - Common
shares, no par value, 150,000 shares authorized; 126,869 shares
issued and outstanding as of March 31, 2018, and 126,866 shares
issued and outstanding as of December 31, 2017 379,186 378,487
Accumulated other comprehensive income 198 451 Accumulated deficit
(279,416) (216,297) BioTime, Inc. shareholders’
equity 99,968 162,641 Noncontrolling interest 2,487
1,622 Total shareholders’ equity 102,455 164,263
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 110,395 $ 173,241
BIOTIME, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT
PER SHARE DATA) (UNAUDITED) Three Months Ended
March 31, 2018 2017
REVENUES: Grant revenue $ 326 $ 11 Royalties from product
sales and license fees 136 110 Subscription and advertisement
revenues 239 264 Sale of research products and services -
5 Total revenues 701 390 Cost of sales (109) (57)
Gross profit 592 333
OPERATING EXPENSES: Research and development 5,935
6,494 Acquired-in-process research and development 800 - General
and administrative 6,044 5,101 Total operating
expenses 12,779 11,595 Loss from operations
(12,187) (11,262)
OTHER INCOME/(EXPENSE): Interest
income (expense), net 52 (306) Gain on sale of equity method
investment in Ascendance 3,215 - Gain on deconsolidation of
OncoCyte - 71,697 Gain (loss) on equity method investment in
OncoCyte at fair value (37,419) 16,142 Loss on equity method
investment in Asterias at fair value (17,398) (26,097) Unrealized
gain on marketable equity securities 215 - Other income (expense),
net (176) 727 Total other income (expense), net
(51,511) 62,163 INCOME (LOSS) BEFORE INCOME TAXES
(63,698) 50,901 Deferred income tax expense -
(3,877) NET INCOME (LOSS) (63,698) 47,024 Net loss
attributable to noncontrolling interests 150 2,264
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. $
(63,548) $ 49,288 NET INCOME (LOSS) PER COMMON SHARE: BASIC
$ (0.50) $ 0.46 DILUTED $ (0.50) $ 0.46 WEIGHTED AVERAGE
NUMBER OF SHARES OF COMMON STOCK OUTSTANDING: BASIC 126,869
106,712 DILUTED 126,869 107,384
BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (IN THOUSANDS)
(UNAUDITED) Three Months Ended March 31,
2018 2017 CASH FLOWS FROM OPERATING
ACTIVITIES: Net income (loss) attributable to BioTime, Inc. $
(63,548) $ 49,288 Net loss allocable to noncontrolling interests
(150) (2,264) Adjustments to reconcile net income (loss)
attributable to BioTime, Inc. to net cash used in operating
activities: Gain on deconsolidation of OncoCyte - (71,697) Gain on
sale of equity method investment in Ascendance (3,215) - Acquired
in-process research and development 800 - Unrealized (gain) loss on
equity method investment in OncoCyte at fair value 37,419 (16,142)
Unrealized loss on equity method investment in Asterias at fair
value 17,398 26,097 Unrealized gain on marketable equity securities
(215) - Depreciation expense, including amortization of leasehold
improvements 281 216 Amortization of intangible assets 582 602
Stock-based compensation 984 1,026 Liability classified warrants
108 - Amortization of discount on related party convertible debt -
253 Foreign currency remeasurement and other (gain) loss 87 (829)
Deferred income tax provision - 3,877 Changes in operating assets
and liabilities: Accounts and grants receivable, net (37) 248
Receivables from affiliates, net of payables 175 231 Prepaid
expenses and other current assets (213) 338 Accounts payable and
accrued liabilities (840) 655 Other liabilities 46 3
Net cash used in operating activities (10,338)
(8,098)
CASH FLOWS FROM INVESTING ACTIVITIES:
Deconsolidation of cash and cash equivalents of OncoCyte - (8,898)
Proceeds from the sale of equity method investment in Ascendance
3,215 - Purchase of in-process research and development (800) -
Purchase of equipment and other assets (198) (215) Security deposit
paid (6) (41) Cash provided by (used in) investing
activities 2,211 (9,154)
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 Common shares received and retired
for employee taxes paid (7) - Proceeds from sale of subsidiary
warrants 737 - Repayment of lease liability and promissory notes
(97) (31) Reimbursement from landlord on construction in progress -
200 Proceeds from issuance of related party convertible debt
- 123 Net cash provided by financing activities 633
19,097 Effect of exchange rate changes on cash, cash
equivalents, and restricted cash 60 (117)
NET CHANGE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH
(7,434) 1,728
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH:
At beginning of the period 37,685 22,935 At end of
the period $ 30,251 $ 24,663
Non-GAAP Financial Measures
This press release includes operating expenses prepared in
accordance with accounting principles generally accepted in the
United States (GAAP) and, includes operating expenses, by entity,
prepared in accordance with GAAP. This press release also includes
certain historical non-GAAP operating expenses and non-GAAP
operating expenses, by entity. In particular, BioTime has provided
both (a) non-GAAP total operating expenses, adjusted to exclude
noncash stock-based and other compensation, depreciation and
amortization expense, and acquired in-process research and
development expense, a non-recurring item, 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 our 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.
Furthermore, 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 MonthsEnded March
31, 2018(unaudited)
GAAP Operating Expenses - as reported $ 12,779
Stock-based and other noncash compensation expense (1) (1,319)
Depreciation and amortization expense (1) (873) Acquired in-process
research and development expense (2) (800) Non-GAAP Operating
Expenses, as adjusted $ 9,787
GAAP Operating Expenses -
by entity BioTime and subsidiaries other than AgeX
Therapeutics, Inc. $ 9,098 AgeX Therapeutics Inc. and subsidiaries
3,681
GAAP Operating Expenses - by entity $ 12,779
Non-GAAP Operating Expenses - as adjusted, by entity BioTime
and subsidiaries other than AgeX Therapeutics, Inc. (3) $ 7,303
AgeX Therapeutics Inc. and subsidiaries (4) 2,484 Non-GAAP
Operating Expenses - as adjusted, by entity $ 9,787 (1)
Noncash charges (2)
AgeX acquired certain in-process research
and development as part of an asset acquisition from Ascendance,
considered to be a non-recurring item.
(3) BioTime, Inc. includes Cell Cure Neurosciences Ltd., ES Cell
International Pte. Ltd. and OrthoCyte Corporation. For the three
months ended March 31, 2018, the GAAP and non-GAAP operating
expenses do not include grant revenue of $326,000 as grants are
revenues for the Company, but do contain certain non-recurring
costs related to the formation and planned distribution of AgeX
Therapeutics to BioTime shareholders. (4) AgeX Therapeutics, Inc.
includes LifeMap Sciences Inc., LifeMap Sciences Ltd., and ReCyte
Therapeutics, Inc. The non-GAAP operating expenses include $471,000
incurred by LifeMap Sciences, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180510006208/en/
Investor and Media Contact:BioTimeDavid Nakasone,
510-871-4188Dnakasone@biotime.com
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Apr 2023 to Apr 2024