- Asterias Biotherapeutics approved
for listing on NYSE MKT
- Asterias’ AST-OPC1 cleared by FDA
for Phase 1/2a dose escalation clinical trial for spinal cord
injury
- Cell Cure Neuroscience’s
OpRegen® cleared by FDA for Phase 1/2a dose
escalation clinical trial for the dry form of age-related macular
degeneration
- Renevia™ cleared for pivotal trial
in Europe for treatment of HIV-related lipoatrophy
- Premvia™ cleared by FDA as Class II
medical device for wound management
- BioTime and its subsidiaries end
October with $35 million in cash to fund additional milestone
achievements in 2015
BioTime, Inc. (NYSE MKT: BTX), the leader in developing
pluripotent stem-cell therapies and other technologies designed to
address major unmet medical needs, today reported financial results
for the third quarter and the nine months ended September 30, 2014,
and highlighted recent corporate accomplishments.
“BioTime and its subsidiaries set in motion a rapid cadence of
milestone achievements in our clinical development of therapeutic
and diagnostic products during the third quarter,” said Dr. Michael
D. West, CEO. “We recently obtained authorization to begin our
pivotal trial of Renevia™ in Europe for HIV-related lipoatrophy;
our subsidiary Asterias Biotherapeutics received clearance from the
FDA to initiate a Phase 1/2a dose escalation clinical trial of its
product, AST-OPC1, in patients with complete cervical spinal cord
injury; our subsidiary Cell Cure Neurosciences received clearance
from the FDA for a Phase 1/2a dose escalation clinical trial of its
product, OpRegen®, in patients with the dry form of age related
macular degeneration; and the FDA cleared BioTime’s Premvia™ as a
Class II medical device for the management of wounds. Also,
BioTime’s subsidiary OncoCyte expanded its large clinical studies
of PanC-Dx™ biomarkers in the diagnosis of breast, bladder, and
lung cancer. In total, we now have six products for which seven
clinical studies are approved or underway. To date, the FDA has
approved clinical trials of only four pluripotent stem cell
therapies, and two of those, OpRegen® and AST-OPC1, belong to
BioTime subsidiaries.”
“On the financial front, we raised $31 million in early October
for BioTime and certain of its subsidiaries through the sale of
BioTime common shares to several institutional investors. As a
result, we finished October with $35 million in cash and cash
equivalents within the BioTime family of companies to fund
additional milestone achievements during 2015. Additionally, our
subsidiary Asterias arranged non-dilutive financing for clinical
trials of both of its lead products by signing two agreements: one
with the California Institute for Regenerative Medicine (CIRM) for
the previously announced $14.3 million award to fund a Phase 1/2a
clinical trial and process development of AST-OPC1, and one with
Cancer Research UK (CRUK) and its affiliate Cancer Research
Technology to conduct a Phase 1/2a clinical trial of AST-VAC2, a
product designed as an immunotherapy for non-small cell lung
cancer. We also added two experienced executives with strong track
records of shareholder value creation to our Board of Directors,”
Dr. West concluded.
Third Quarter and Recent Highlights
BioTime, Inc.
- BioTime received authorization to begin
its pivotal human clinical trial of Renevia™ in Europe to treat HIV
patients with premature facial aging caused by lipoatrophy. In the
trial, Renevia™ will be used to deliver fat-derived cells to the
patient’s face where there has been a loss of subdermal fat.
Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV
patients worldwide on antiretroviral therapy.
- Premvia™ was cleared for marketing by
the FDA as a Class II medical device for the management of wounds.
Premvia™ is the first FDA-cleared member of BioTime’s HyStem®
family of hydrogels, which are designed to mimic the natural
structures of the human body’s extracellular matrix.
- Michael H. Mulroy and Stephen L. Cartt
joined BioTime’s Board of Directors. Mr. Mulroy and Mr. Cartt both
had successful careers in senior management at Questcor
Pharmaceuticals, Inc. where Mr. Mulroy served as Executive Vice
President – Strategic Affairs and General Counsel and Mr. Cartt
served as Chief Operating Officer.
- BioTime and certain of its subsidiaries
raised $31 million through sales of BioTime common shares in a
registered direct offering.
Asterias Biotherapeutics, Inc. (Approximately 71% Owned by
BioTime)
- AST-OPC1 was cleared by the FDA for the
initiation of a dose escalation Phase 1/2a clinical trial in
patients with complete cervical spinal cord injury. A large portion
of the cost of this trial will be paid by grant support from the
California Institute for Regenerative Medicine (CIRM).
- AST-VAC2, an immunotherapy treatment,
will be the subject of a Phase 1/2a clinical trial in patients with
non-small cell lung cancer in the UK, contingent on regulatory
approval, through an agreement entered into by Asterias and Cancer
Research UK (CRUK) under which CRUK will pay for the cost of the
trial.
- Asterias became the first of BioTime’s
subsidiaries to be publicly traded. Asterias common stock now
trades on the NYSE MKT under the ticker symbol AST.
Cell Cure Neurosciences Ltd. (Approximately 63% Owned by BioTime
on a Consolidated Basis)
- OpRegen®, a therapy designed for
patients with the severe form of age-related macular degeneration
(AMD) called geographic atrophy, was cleared by the FDA for a Phase
1/2a clinical trial. AMD is the leading cause of blindness in the
aging US population and many other developed countries around the
world. There is currently no FDA-approved therapy for the dry form
of AMD.
OncoCyte Corporation (Approximately 75% Owned by BioTime)
- OncoCyte Corporation and The Wistar
Institute continued their collaboration on a large, multi-site
clinical study of blood-based lung cancer diagnostic markers. Over
600 blood samples were obtained from patients with a high-risk
profile for development of lung cancer at six clinical sites.
Wistar investigators are currently assessing gene expression
patterns in blood cells of patients with malignant versus
non-malignant lung disease. The performance of gene markers tested
in the study in determining the presence or the progression of
disease in various categories of patients may determine the
specific nature of the lung cancer test that OncoCyte will
develop.
- OncoCyte expanded the clinical
development of its urine-based bladder cancer diagnostic test by
initiating a multi-site clinical trial. The trial will involve up
to 1,200 patient samples obtained from at least four large urology
clinics located throughout the United States. The multi-site
clinical trial has been initiated in part due to positive interim
data from the ongoing study in pathology specimens.
- OncoCyte entered into a collaboration
with Abcodia Ltd. to develop OncoCyte’s blood-based PanC-Dx™, a
test for early detection of breast cancer. OncoCyte will test the
performance of PanC-Dx™ cancer markers in detecting breast cancer
in a set of blood samples taken from study subjects both before and
after they developed breast cancer. If the outcome of this initial
study is promising, future studies could proceed and expand into
the use of a larger cohort to assess PanC-Dx™ cancer markers in a
case-controlled longitudinal design.
LifeMap Solutions, Inc. (Approximately 75% Owned by BioTime on a
Consolidated Basis)
- LifeMap Solutions strengthened its
management team with the appointment of Rafhael Cedeno as Chief
Technology Officer and Head of Product. Mr. Cedeno will be
responsible for overseeing all aspects of product development,
including the integration of Mount Sinai’s expertise and data into
LifeMap Solutions’ products. In addition, Joel Dudley, PhD, Rong
Chen, PhD, and Elissa Levin from Mount Sinai’s Icahn School of
Medicine will work with LifeMap Solutions science team to develop
LifeMap Solutions’ mobile health products and services.
Third Quarter Financial Results
Revenue
For the three months ended September 30, 2014, on a consolidated
basis, total revenue was $1.2 million, up $0.5 million or 67% from
$0.7 million for the same period of 2013. The increase in revenue
is primarily attributable to increases in grant income and research
products sales.
Expenses
Operating expenses for the three months ended September 30,
2014, on a consolidated basis, were $13.1 million, compared to
$10.7 million for the same period of 2013. Research and development
expenses were $8.8 million for the three months ended September 30,
2014, an increase of approximately $2.4 million from $6.4 million
during the same period of 2013. The increase in research and
development expenses is largely attributable to the amortization of
intangible assets acquired by Asterias from Geron Corporation and
BioTime in October 2013, and the ramp-up of the Asterias and
LifeMap Solutions product development programs. Expenses of the
OncoCyte and Renevia™ clinical trial programs were also a factor.
General and administrative expenses remained relatively flat when
compared with the third quarter of 2013 at $4.3 million.
Net Loss
Net loss attributable to BioTime for the three months ended
September 30, 2014 declined to $8.3 million or $0.12 per share,
compared to a net loss of $9.0 million or $0.16 per share for the
same period in 2013. The decrease in net loss is primarily
attributed to a $2.3 million deferred income tax benefit recorded
as of September 30, 2014. There was no deferred income tax benefit
recorded in the three months ended September 30, 2013. Net loss
attributable to BioTime includes losses from BioTime majority owned
subsidiaries based upon BioTime’s percentage ownership of those
subsidiaries.
Year-to-Date Financial Results
Revenue
For the nine months ended September 30, 2014, on a consolidated
basis, total revenue was $3.4 million, up $0.9 million or 32% from
$2.5 million for the year ago period. The increase in revenue is
primarily attributable to a $0.9 million increase in grant income,
primarily from a grant awarded to BioTime’s subsidiary Cell Cure
Neurosciences Ltd. by Israel’s Office of the Chief Scientist.
Expenses
Operating expenses for the first nine months of 2014, on a
consolidated basis, were $39.0 million, compared to $28.7 million
for the first nine months of 2013. Research and development
expenses for the nine months ended September 30, 2014 increased to
$26.3 million from $17.4 million for the same period in 2013. The
increase in research and development expenses during the nine
months ended September 30, 2014 is generally attributable to the
same factors that contributed to the increase during the third
quarter. General and administrative expenses for the nine months
ended September 30, 2014 were $12.8 million compared to $11.3
million for the same period of 2013. The increase in general and
administrative expenses reflects in part, the ramp-up of operations
of LifeMap Solutions and Asterias and a decline in spending by
ESI.
Net Loss
Net loss attributable to BioTime for the nine months ended
September 30, 2014 was $25.8 million or $0.41 per share, compared
to a net loss of $24.3 million or $0.45 per share for the same
period in 2013. The increase in net loss is primarily attributable
to increased research and development activity, primarily at
Asterias, LifeMap Solutions, and OncoCyte and in our clinical
development of Renevia™. The increase is offset to some extent by
the $5.2 million income tax benefit recorded as of September 30,
2014. There was no income tax benefit recorded in the nine months
ended September 30, 2013. Net loss attributable to BioTime includes
losses from BioTime’s majority owned subsidiaries based upon
BioTime’s percentage ownership of those subsidiaries.
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents, on a consolidated basis, totaled $7.4
million as of September 30, 2014, compared with $5.5 million as of
December 31, 2013. The cash on hand at September 30, 2014 includes
$5.0 million held by Asterias.
During the nine months ended September 30, 2014, BioTime and
certain of its subsidiaries raised approximately $31.8 million of
equity capital through the sale of BioTime common shares. Of that
amount, approximately $15.8 million was raised through sales in “at
the market transactions,” including $6.4 million from long-term
BioTime investors. In addition, BioTime raised $3.5 million of
equity capital through the sale of 70,000 shares of a newly
authorized Series A Convertible Preferred Stock to private
investors. The remaining $12.5 million was raised by BioTime’s
subsidiary Asterias in June 2014 through the sale of 5,000,000
BioTime common shares, with warrants to purchase 5,000,000 shares
of Asterias common stock, to two private investors who are
long-term BioTime shareholders. Asterias raised an additional $0.5
million from the sale of 200,000 shares of Asterias common stock to
its newly appointed President and Chief Executive Officer.
In addition to the above capital raise, during early October
2014, BioTime and certain of its subsidiaries raised $31 million of
cash through the sale of BioTime common shares in transactions
priced “at the market.” As a result, BioTime and its subsidiaries
had approximately $35 million in cash and cash equivalents as of
October 31, 2014.
About BioTime
BioTime is a biotechnology company engaged in research and
product development in the field of regenerative medicine.
Regenerative medicine refers to therapies based on stem cell
technology that are designed to rebuild cell and tissue function
lost due to degenerative disease or injury. BioTime’s focus is on
pluripotent stem cell technology based on human embryonic stem
(“hES”) cells and induced pluripotent stem (“iPS”) cells. hES and
iPS cells provide a means of manufacturing every cell type in the
human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of
proprietary PureStem® progenitors, HyStem® hydrogels, culture
media, and differentiation kits. Renevia™ (a HyStem® product), is
now in a pivotal trial in Europe as a biocompatible, implantable
hyaluronan and collagen-based matrix for cell delivery in the
treatment of HIV-related lipoatrophy. In addition, BioTime has
developed Hextend®, a blood plasma volume expander for use in
surgery, emergency trauma treatment and other applications.
Hextend® is manufactured and distributed in the U.S. by Hospira,
Inc. and in South Korea by CJ HealthCare Corporation, under
exclusive licensing agreements.
BioTime is also developing stem cell and other products for
research, therapeutic, and diagnostic use through its
subsidiaries:
- Asterias Biotherapeutics, Inc. is
developing pluripotent stem-cell based therapies in neurology and
oncology, including AST-OPC1 oligodendrocyte progenitor cells in
spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an
allogeneic dendritic cell-based cancer vaccine. Asterias trades
publicly on the NYSE MKT under the symbol AST.
- BioTime Asia, Ltd., a Hong Kong
company, may offer and sell products for research use for BioTime’s
ESI BIO Division.
- Cell Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem
cell-based therapies for retinal and neurological disorders.
OpRegen® is currently in a Phase I/IIa clinical trial for the
treatment of the dry-form of age-related macular degeneration.
- ESI BIO is the research and product
marketing division of BioTime, providing stem cell researchers with
products and technologies to enable them to translate their work
into the clinic, including PureStem® progenitors and HyStem®
hydrogels.
- LifeMap Sciences, Inc. markets, sells,
and distributes GeneCards®, the leading human gene database, as
part of an integrated database suite that also includes the LifeMap
Discovery® database of embryonic development, stem cell research,
and regenerative medicine, and MalaCards, the human disease
database.
- LifeMap Solutions, Inc. is a subsidiary
of LifeMap Sciences focused on developing mobile health (mHealth)
products.
- OncoCyte Corporation is developing
products and technologies to diagnose and treat cancer, including
PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing
therapies to treat orthopedic disorders, diseases and
injuries.
- ReCyte Therapeutics, Inc. is developing
therapies to treat a variety of cardiovascular and related ischemic
disorders, as well as products for research using cell
reprogramming technology.
BioTime stock is traded on the NYSE MKT, ticker BTX. For more
information, please visit www.biotimeinc.com or connect with the
company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
Forward-Looking Statements
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for BioTime 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 and
its subsidiaries, particularly those mentioned in the cautionary
statements found in BioTime's Securities and Exchange Commission
filings. BioTime disclaims any intent or obligation to update these
forward-looking statements.
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
September 30, 2014 December 31, (Unaudited)
2013 ASSETS CURRENT ASSETS Cash and cash
equivalents $ 7,416,235 $ 5,495,478 Inventory 253,567 178,694 Trade
accounts and grants receivable, net 1,014,183 998,393 Prepaid
expenses and other current assets 1,255,479 1,277,405
Total current assets 9,939,464 7,949,970 Equipment, net
2,758,456 2,997,733 Deferred license and consulting fees 364,208
444,833 Deposits 435,317 129,129 Other long-term assets 53,127 -
Intangible assets, net 42,104,092 46,208,085 TOTAL
ASSETS $ 55,654,664 $ 57,729,750
LIABILITIES AND
EQUITY CURRENT LIABILITIES Accounts payable and accrued
liabilities $ 5,550,698 $ 6,722,624 Capital lease liability,
current portion 57,500 - Related party convertible debt, net of
discount 3,088 - Deferred license and subscription revenue, current
portion 177,574 235,276 Total current liabilities
5,788,860 6,957,900 LONG-TERM LIABILITIES Capital lease, net
of current portion 44,963 - Deferred tax liability, net 10,787,141
8,277,548 Other long-term liabilities 79,108 231,981
Total long-term liabilities 10,911,212 8,509,529 Commitments
and contingencies STOCKHOLDERS' EQUITY Preferred shares, no
par value, authorized 2,000,000 shares as of September 30, 2014 and
December 31, 2013; 70,000 and nil issued and outstanding as of
September 30, 2014 and December 31, 2013, respectively 3,500,000 -
Common shares, no par value, authorized 125,000,000 shares as of
September 30, 2014 and December 31, 2013; 73,690,302 issued and
68,291,760 outstanding as of September 30, 2014 and 67,412,139
issued and 56,714,424 outstanding at December 31, 2013 201,298,235
203,456,401 Contributed capital 59,934 93,972 Accumulated other
comprehensive (loss)/income (150,691) 62,899 Accumulated deficit
(171,606,642) (145,778,547) Treasury stock at cost: 5,398,542 and
10,697,715 shares at September 30, 2014 and at December 31, 2013,
respectively (22,119,467) (43,033,957) BioTime
stockholders' equity 10,981,369 14,800,768 Non-controlling interest
27,973,223 27,461,553 Total stockholders' equity
38,954,592 42,262,321 TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $ 55,654,664 $ 57,729,750
BIOTIME, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (UNAUDITED)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2014 2013 2014 2013
REVENUES: License fees $ 285,157 $ 382,767 $ 880,740 $
1,094,843 Royalties from product sales 147,811 80,592 321,806
291,505 Grant income 647,580 160,431 1,863,310 941,226 Sale of
research products and services 110,555 90,272
299,615 214,277 Total revenues 1,191,103 714,062 3,365,471
2,541,851 Cost of sales (230,901) (206,678) (614,080)
(570,237)
Gross Profit 960,202 507,384 2,751,391 1,971,614
EXPENSES: Research and development (8,836,341) (6,441,462)
(26,267,792) (17,389,409) General and administrative
(4,261,450) (4,267,875) (12,764,324)
(11,273,948) Total operating expenses (13,097,791)
(10,709,337) (39,032,116) (28,663,357)
Loss from operations (12,137,589) (10,201,953)
(36,280,725) (26,691,743)
OTHER
INCOME/(EXPENSES): Interest (expense)/income, net (7,632) 509
(29,786) 2,033 (Loss)/gain on sale or write off of fixed assets
(133) 5,830 (8,709) 5,120 Other (expense)/income, net
(118,796) (60,704) 165,135 (169,512) Total
other (expenses)/income, net (126,561) (54,365)
126,640 (162,359)
LOSS BEFORE INCOME TAX BENEFIT
(12,264,150) (10,256,318) (36,154,085) (26,854,102) Deferred
income tax benefit
2,312,693
- 5,174,977 -
NET LOSS
(9,951,457) (10,256,318) (30,979,108)
(26,854,102) Net loss attributable to non-controlling
interest 1,683,532 1,253,150 5,151,013 2,583,581
NET LOSS
ATTRIBUTABLE TO BIOTIME, INC. (8,267,925) (9,003,168)
(25,828,095) (24,270,521) Dividends on preferred shares
(34,038) - (34,038) - Net loss attributable to
common shareholders (8,301,963) (9,003,168) (25,862,133)
(24,270,521) Unrealized loss on available-for-sale assets
(1,210) - (2,740) - Foreign currency translation (loss)/gain
(66,768) 7,016 (216,330) 184,310
TOTAL COMPREHENSIVE LOSS $ (8,335,903) $ (8,996,152) $
(26,047,165) $ (24,086,211) BASIC AND DILUTED NET LOSS PER
COMMON SHARE $ (0.12) $ (0.16) $ (0.41) $ (0.45) WEIGHTED
AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED
67,920,853 55,621,564 62,594,212
53,545,834
BioTime, Inc.Judith Segall, 510-521-3390 ext.
301jsegall@biotimemail.comorInvestor Contact:EVC Group, Inc.Brian
Moore, 310-579-6199bmoore@evcgroup.comGregory Gin,
862-236-0673ggin@evcgroup.comDoug Sherk,
415-652-9100dsherk@evcgroup.com
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