Full Press Release Details
Announces First Quarter 2014 Results and Recent Developments
products currently in clinical development
therapeutic products currently in late-stage preparation for clinical
of Asterias subsidiary scheduled to trade publicly in near term
Solutions subsidiary launched to develop mobile health products
ALAMEDA, Calif.--(BUSINESS WIRE)--May 12, 2014--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
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