[May 12, 2014] |
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BioTime Announces First Quarter 2014 Results and Recent Developments
ALAMEDA, Calif. --(Business Wire)--
BioTime, Inc. (NYSE MKT: BTX) today reported financial results for the
first quarter ended March 31, 2014 and highlighted recent corporate
accomplishments.
"BioTime's efforts in the first quarter of 2014 were focused on
advancing near-term products through clinical trials while also
preparing certain novel stem cell-based therapeutics for clinical trials
later this year. Enrollment in three diagnostic clinical studies has
remained rapid, with completion expected later in 2014. Following the
successful safety trial of ReneviaTM, we have
made rapid progress in preparing for the pivotal ReneviaTM
trial during the second half of the year," said Michael D. West, Ph.D.,
BioTime's Chief Executive Officer. "At our subsidiary Asterias
Biotherapeutics, we have been preparing to initiate a new Phase 1/2a
clinical trial of OPC1 for the treatment of spinal cord injury in
2014, pending clearance from the FDA, and also preparing our VAC2
cancer vaccine for a potential clinical trial. Also in the quarter,
BioTime's subsidiary Cell Cure Neurosciences Ltd. advanced preclinical
development of OpRegen® for a planned IND filing in
2014 for the treatment of age-related macular degeneration."
"We have continued to develop our subsidiaries' businesses," commented
Dr. West. "Shares of the Series A common stock of our subsidiary
Asterias Biotherapeutics, Inc. are now scheduled to begin trading
publicly this summer following Geron's distribution of those shares to
its stockholders, for which a record date of May 28th has
been set. We were also pleased to recently announce that LifeMap
Solutions, Inc., a newly organized subsidiary of our LifeMap Sciences,
Inc., has entered into an agreement with a major medical center to
create innovative mobile health (mHealth) products powered by biomedical
and other personal big data."
"As the industry leader in regenerative medicine with over 600 patents
and patent applications worldwide, BioTime and its subsidiaries have
assembled a broad array of strategically important regenerative medicine
technologies and assets for the development of therapeutic and
diagnostic products," Dr. West continued. "Our expenditure levels were
higher than usual during the fourth quarter and the recently ended first
quarter, but our recent progress in streamlining our workforce through
shared core resources among our subsidiaries should reduce our cash burn
rate and optimize value for our shareholders during this exciting time
in the company's history. We would like to thank our long-term investors
for their continued support and our collaborators at leading academic
medical institutions for their help in advancing our products toward our
goal of helping patients who have serious unmet medical needs."
First Quarter and Recent Highlighted Corporate Accomplishments
-
BioTime announced the successful completion of its ReneviaTM-01
safety study. ReneviaTM is being
developed as a platform product with a wide array of potential
therapeutic applications. The product is a biocompatible and
injectable hyaluronan and collagen-based matrix designed to promote
the stable engraftment of cells into the body. In the 10-patient study
in Europe, ReneviaTM was injected
subcutaneously without cells and all responses were localized, minor,
and transient. Completion of this trial paves the way for a pivotal
clinical efficacy trial planned for the second half of 2014 in which
the matrix will be tested in combination with adipose stromal fraction
for the treatment of lipoatrophy. The pivotal trial, if successful,
could lead to an application for CE Mark approval for marketing in
Europe and other markets outside the United States.
-
BioTime has submitted to the United States Food and Drug
Administration (FDA) a 510(k) premarket notification for Premvia™
as a Class II wound management medical device, and the FDA has
informed BioTime that the 510(k) notification has been accepted for
review. Premvia™, like ReneviaTM, is
a member of BioTime's HyStem® family of hydrogels.
The product is being developed for use in the management of wounds,
including partial and full-thickness wounds, tunneling wounds,
pressure ulcers, diabetic ulcers, second degree burns, skin tears and
draining wounds where a hydrating tissue matrix is needed.
-
BioTime's subsidiary OncoCyte Corporation initiated clinical
development of PanC-Dx™, its cancer diagnostic product, in both
the United States and China for use in detecting bladder cancer. In
the United States, OncoCyte entered into a Clinical Trial Agreement
with a leading medical institution with an international reputation
for excellence and discovery, while in China, OncoCyte entered into a
Fee-for-Service Agreement with China Medicine Inc., a contract
research organization serving nine major medical institutions,
including top-ranked university hospitals in Shanghai and Wuhan. The
goal of these clinical development initiatives is to determine the
overall relative performance of OncoCyte's PanC-Dx™ markers in
bladder cancer. Enrollment is continuing at multiple clinical sites in
two additional clinical studies that are collecting samples from
patients undergoing screening for either breast or lung cancer. These
patient samples will be used for the detection of lung and breast
cancer.
-
On May 6, 2014, LifeMap Solutions, Inc., a newly formed subsidiary of
LifeMap Sciences, Inc., entered into an agreement with a major medical
institution to work cooperatively to develop internet, web-based,
mobile user or consumer software products to provide users with
information that may aid them in improving lifestyle and healthcare
decisions and outcomes.
-
In 2014 to date, BioTime, and certain of its subsidiaries, have
successfully raised additional financing totaling nearly $19 million.
During the first quarter, BioTime raised $3.5 million through the sale
of 70,000 shares of Series A Convertible Preferred Stock and also
raised $8.8 million of additional equity capital through the sale of
BioTime common shares in "at-the-market" transactions. On May 1, 2014,
BioTime received approximately $6.4 million in additional equity
financing. The funds were raised from current long-term investors in
the company and will be used for funding product development,
including this year's anticipated pivotal Renevia™ clinical
trial, LifeMap Solutions' mobile health applications, as well as other
general operating expenses.
-
BioTime was awarded three SBIR Phase 1 Small Business Grants totaling
$787,434 from the National Institute of General Medical Sciences
(NIGMS) at the National Institutes of Health (NIH). Under the first
grant entitled "Reagents for Targeted Ablation of Residual
Contaminating Pluripotent Stem Cells" BioTime will work to develop
reagents that selectively identify and kill residual pluripotent cells
while leaving the intended therapeutic stem cells unharmed. Under the
second grant entitled "Rapid Multiplexed Nanoprobe Assays for
Pluripotent Stem Cell Differentiation" BioTime will use the funds for
developing improved assays for monitoring stem cell differentiation.
Under the third grant entitled "Cell Targeting Peptides for Isolating
Patient Specific Stem Cells" BioTime will work on streamlining PureStem®
cell line development.
Financial Results
Revenue
For the quarter ended March 31, 2014, on a consolidated basis, total
revenue was $1.1 million, up $0.5 million from $0.6 million for the same
period one year ago. The increase in first quarter revenue is primarily
attributable to grant income awarded to BioTime's subsidiary Cell Cure
Neurosciences Ltd. from Israel's Office of the Chief Scientist.
Expenses
Operating expenses for the three months ended March 31, 2014 were $12.1
million, compared to expenses of $8.8 million for the same period of
2013. The increase in operating expenses is primarily attributable to an
increase in staffing and the expansion of research and development
efforts of Asterias and the amortization expense of intangible assets
recorded in connection with the Geron stem cell asset acquisition in
October 2013.
Net Loss
Net loss attributable to BioTime for the three months ended March 31,
2014 was $8.1 million or $0.14 per share, compared to a net loss of $7.7
million or $0.15 per share for the same period in 2013. The increase in
net loss is primarily attributed to increased research and development
related activity in Asterias. This increase is to some extent offset by
the $1.3 million income tax benefit recorded as of March 31, 2014
compared with none in the same period in 2013. Net losses attributable
to BioTime include losses from BioTime 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 $6.6 million
as of March 31, 2014, compared with $5.5 million as of December 31, 2013.
During the three months ended March 31, 2014, BioTime and certain of its
subsidiaries raised approximately $8.8 million of additional equity
capital through the sale of BioTime common shares in "at-the-market"
transactions through Cantor Fitzgerald & Co. ("Cantor"), as sales agent.
In addition, on March 4, 2014, 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.
On May 1, 2014, BioTime received approximately $6.4 million in equity
financing from current long-term investors in the Company in
transactions for which Cantor acted as sales agent.
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. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. 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 a subsidiary focused on developing
cell therapies. Included in its portfolio are two clinical stage cell
therapy product candidates for use in neurology and oncology. OPC1
is a formulation of human embryonic stem (hES) cell-derived
oligodendrocyte progenitors for the treatment of spinal cord injury
and other neurodegenerative disease. VAC2 is a formulation of
hES cell-derived dendritic cells intended to function as a vaccine to
train a patient's immune system to destroy telomerase positive cancer
cells. Telomerase is a protein abnormally expressed in over 95% of all
human cancers.
-
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
-
Cell Cure Neurosciences Ltd. ("Cell Cure Neurosciences") is an
Israel-based biotechnology company focused on developing stem
cell-based therapies for retinal and neurological disorders, including
the development of retinal pigment epithelial cells for the treatment
of macular degeneration, and treatments for multiple sclerosis.
-
LifeMap Sciences, Inc. ("LifeMap Sciences") 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 products.
-
ES Cell International Pte Ltd., a Singapore private limited company,
developed clinical and research grade hES cell lines and plans to
market those cell lines and other BioTime research products in
over-seas markets as part of BioTime's ESI (News - Alert) BIO Division.
-
BioTime Asia, Limited, a Hong Kong company, may offer and sell
products for research use for BioTime's ESI BIO Division.
-
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.
Additional information about BioTime can be found on the web at www.biotimeinc.com.
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
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BIOTIME, INC. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED BALANCE SHEETS
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|
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|
|
|
|
|
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March 31, 2014 (unaudited)
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December 31, 2013
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ASSETS
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CURRENT ASSETS
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
6,637,834
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$
|
5,495,478
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|
Inventory
|
|
|
236,588
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|
|
|
|
178,694
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|
Trade accounts and grants receivable, net
|
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818,275
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|
|
|
|
998,393
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Prepaid expenses and other current assets
|
|
|
1,554,114
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|
|
|
|
1,277,405
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Total current assets
|
|
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9,246,811
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|
|
|
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7,949,970
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Equipment, net
|
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2,959,150
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|
|
|
|
2,997,733
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|
Deferred license and consulting fees
|
|
|
418,958
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|
|
|
|
444,833
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|
Deposits
|
|
|
428,827
|
|
|
|
|
129,129
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|
Other long-term assets
|
|
|
56,062
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|
|
-
|
|
Intangible assets, net
|
|
|
44,840,087
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|
|
|
|
46,208,085
|
|
TOTAL ASSETS
|
|
$
|
57,949,895
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|
|
|
$
|
57,729,750
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|
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LIABILITIES AND EQUITY
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|
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CURRENT LIABILITIES
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|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
5,443,063
|
|
|
|
$
|
6,722,624
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|
Deferred license and subscription revenue, current portion
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|
|
177,594
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|
|
|
|
235,276
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Total current liabilities
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|
|
5,620,657
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|
|
|
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6,957,900
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|
|
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LONG-TERM LIABILITIES
|
|
|
|
|
|
|
|
Deferred rent, net of current portion
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|
|
28,054
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|
|
|
|
35,997
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|
Deferred tax liability, net
|
|
|
6,928,522
|
|
|
|
|
8,277,548
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Other long-term liabilities
|
|
|
8,441
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|
|
|
|
195,984
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|
Total long-term liabilities
|
|
|
6,965,017
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|
|
|
|
8,509,529
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|
|
|
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|
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Commitments and contingencies
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EQUITY
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Preferred Shares, no par value, authorized 2,000,000 shares as of
March 31, 2014 and December 31, 2013; 70,000 and nil issued and
outstanding as of March 31, 2014 and December 31, 2013, respectively
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3,500,000
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|
|
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|
-
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Common shares, no par value, authorized 125,000,000 shares as of
March 31, 2014 and December 31, 2013; 69,617,329 issued and
59,071,192 outstanding as of March 31, 2014 and 67,412,139 issued
and 56,714,424 outstanding at December 31, 2013
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|
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211,943,421
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|
|
|
|
203,456,401
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Contributed capital
|
|
|
93,972
|
|
|
|
|
93,972
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Accumulated other comprehensive income/(loss)
|
|
|
(44,341
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)
|
|
|
|
62,899
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Accumulated deficit
|
|
|
(153,877,561
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)
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|
|
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(145,778,547
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)
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Treasury stock at cost: 10,546,137 and 10,697,715 shares at March
31, 2014 and at December 31, 2013, respectively
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(42,372,546
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)
|
|
|
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(43,033,957
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)
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Total shareholders' equity
|
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19,242,945
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|
|
|
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14,800,768
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Noncontrolling interest
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26,121,276
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|
|
|
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27,461,553
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Total equity
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|
|
45,364,221
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|
|
|
|
42,262,321
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TOTAL LIABILITIES AND EQUITY
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|
$
|
57,949,895
|
|
|
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$
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57,729,750
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|
|
|
|
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BIOTIME, INC. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
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(UNAUDITED)
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Three Months Ended
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March 31, 2014
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March 31, 2013
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REVENUES:
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License fees
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$
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294,504
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|
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$
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349,824
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Royalties from product sales
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|
|
97,886
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|
|
|
|
|
107,599
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Grant income
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|
|
575,659
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|
|
|
|
|
90,326
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Sale of research products
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|
98,586
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|
|
|
|
|
66,724
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Total revenues
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|
|
1,066,635
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|
|
|
|
614,473
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|
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|
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|
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Cost of sales
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|
|
(131,914
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)
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(182,749
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)
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|
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Total revenues, net
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934,721
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|
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431,724
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EXPENSES:
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|
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Research and development
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(8,405,393
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)
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|
|
|
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(5,395,488
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)
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General and administrative
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|
|
(3,667,171
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)
|
|
|
|
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(3,416,145
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)
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Total expenses
|
|
|
(12,072,564
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)
|
|
|
|
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(8,811,633
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)
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Loss from operations
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|
|
(11,137,843
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)
|
|
|
|
|
(8,379,909
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)
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OTHER INCOME/(EXPENSES):
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|
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|
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|
|
|
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Interest (expense)/income, net
|
|
|
(8,384
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)
|
|
|
|
|
943
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Loss on sale of fixed assets
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|
|
(8,576
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)
|
|
|
|
|
(1,523
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)
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Other income/(expense), net
|
|
|
77,746
|
|
|
|
|
|
(28,056
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)
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Total other income/(expenses), net
|
|
|
60,786
|
|
|
|
|
|
(28,636
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)
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LOSS BEFORE INCOME TAX BENEFIT
|
|
|
(11,077,057
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)
|
|
|
|
|
(8,408,545
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)
|
|
|
|
|
|
|
|
|
|
|
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Income tax benefit
|
|
|
1,349,026
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|
|
|
|
|
-
|
|
|
|
|
|
|
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|
|
|
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NET (News - Alert) LOSS
|
|
|
(9,728,031
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)
|
|
|
|
|
(8,408,545
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)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest
|
|
|
1,629,017
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|
|
|
|
|
689,282
|
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|
|
|
|
|
|
|
|
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|
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NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
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|
|
(8,099,014
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)
|
|
|
|
|
(7,719,263
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)
|
|
|
|
|
|
|
|
|
|
|
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Foreign currency translation (loss)/gain
|
|
|
(104,590
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)
|
|
|
|
|
148,437
|
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Unrealized loss on available-for-sale securities, net
|
|
|
(2,650
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)
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS
|
|
$
|
(8,206,254
|
)
|
|
|
|
$
|
(7,570,826
|
)
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.14
|
)
|
|
|
|
$
|
(0.15
|
)
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC
AND DILUTED
|
|
|
58,257,427
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|
|
|
|
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51,175,649
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