BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology
company focused on degenerative diseases, today provided a business
update which included information on AgeX Therapeutics, Inc. (AgeX)
(NYSE American: AGE) and BioTime’s two affiliated companies,
OncoCyte Corporation (OncoCyte) (NYSE American: OCX), and Asterias
Biotherapeutics, Inc. (Asterias) (NYSE American: AST).
“In the past five months, BioTime has made rapid
progress toward its commitment to become a leading cell therapy
company by focusing on clinical-stage cell therapy product
candidates with promising human data and supporting their
development in part through targeted transactions among its
affiliated companies,” stated Brian M. Culley, Chief Executive
Officer of BioTime, Inc.
“An early accomplishment was to sell
approximately half of our shares of AgeX, which we had created to
develop BioTime’s preclinical regenerative medicine assets, to
Juvenescence Limited for a total of $43.2 million. Cash payments
totaling $21.6 million were received in 2018 and the remaining
$21.6 million, along with interest, is due no later than August
2020, or may be converted at BioTime’s option into Juvenescence
common stock if Juvenescence becomes a public company before that
date. Most of the remaining AgeX shares owned by BioTime were then
distributed to BioTime shareholders in late November, launching
AgeX as a public company. BioTime has retained an equity position
in AgeX Therapeutics of 1.7 million shares, or approximately 5% of
AgeX’s common stock. As of February 13, 2019, the value of
BioTime’s AgeX share position was approximately $7.1 million.”
“We next announced an exclusive collaboration
with Orbit Biomedical for the use of Orbit’s proprietary injection
technology to deliver our lead product candidate OpRegen®, for the
treatment of dry age-related macular degeneration. The Orbit device
delivers cells to the sub-retinal space via a suprachoroidal route
as opposed to standard of care delivery directly through the
retina. We are moving quickly to enroll our first patient in the
Orbit portion of our ongoing Phase I/II study in the next quarter
and we anticipate reporting additional clinical data from the study
in the first half of this year.”
“We also intend to close our proposed
acquisition of Asterias assuming approval by the respective
shareholders of BioTime and Asterias during the respective
shareholders meetings on March 7th, 2019. This acquisition would
broaden our pipeline with clinical-stage cell therapy assets in
spinal cord injury and oncology. Last month, Asterias announced top
line 12-month data from a Phase I/II study of its OPC-1 program in
severe spinal cord injury, which included early evidence of cell
engraftment and improved motor function in nearly all treated
patients. The UK clinical trial of Asterias’s off-the-shelf
allogeneic immune-oncology cell therapy product, VAC2, has enrolled
four patients to date.”
“Finally, our affiliated company OncoCyte
recently reported positive results from an R&D validation study
of DetermaVu™, their non-invasive liquid biopsy test intended to
facilitate clinical decision making in lung cancer diagnosis.
Following a recently completed $40.25 million public offering by
OncoCyte at a price of $3.75 per share, BioTime owns approximately
14.7 million shares, or approximately 28% of OncoCyte’s common
stock. As of February 13, 2019, the value of BioTime’s OncoCyte
share position was approximately $56.6 million.”
“We are pleased with the continued progress at
BioTime. In addition to advancing OpRegen® and the proposed
acquisition of Asterias, two public companies, AgeX and OncoCyte,
have been launched with assets which originated from within the
BioTime laboratories. Looking ahead, we believe that we are
delivering on our stated plans to streamline BioTime’s corporate
structure and reduce expenses in a prudent manner, while focusing
on creating value from our most compelling clinical opportunities
and selectively converting assets created within BioTime into cash
or other forms of value on attractive terms. We believe that our
continued efforts will increase our visibility, support our growth,
and help drive our success in 2019 and beyond,” concluded Mr.
Culley.
Select Upcoming BioTime
Events
- Special Meeting of BioTime Stockholders on March 7, 2019 at
9:30 am PT to vote on the proposed acquisition of Asterias. The
closing is expected in Q1 2019 after the approval by the respective
shareholders of Asterias and BioTime.
- Dosing of the first patient with the Orbit proprietary
injection device in the ongoing Phase I/II clinical study of
OpRegen® for the treatment of dry-AMD is planned for Q2 2019.
- Completion of patient enrollment in the ongoing Phase I/II
clinical study of OpRegen® for the treatment of dry-AMD is
anticipated in 2H 2019.
- Decision on BioTime’s CE Mark application for Renevia, an
investigational medical device being developed as an alternative
for whole adipose tissue transfer procedures, is dependent on
European regulatory authorities.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused on
the development and commercialization of novel therapies for the
treatment of degenerative diseases. BioTime’s pipeline is based on
two platform technologies which encompass cell replacement and
cell/drug delivery. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy in Phase 2 development for the treatment of dry age-related
macular degeneration, the leading cause of blindness in the
developed world. BioTime’s lead cell delivery clinical program is
Renevia®, an investigational medical device being developed as an
alternative for whole adipose tissue transfer procedures.
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 Asterias Biotherapeutics,
Inc.Asterias is a biotechnology company dedicated to
developing cell-based therapeutics to treat neurological conditions
associated with demyelination and cellular immunotherapies to treat
cancer. Asterias is presently focused on advancing three
clinical-stage programs which have the potential to address areas
of very high unmet medical need in the fields of neurology and
oncology. OPC1 (oligodendrocyte progenitor cells) is currently in a
Phase 1/2a dose escalation clinical trial in spinal cord injury.
VAC2 (antigen-presenting allogeneic dendritic cells) is an
allogeneic cancer immunotherapy. Asterias’ research
partner, Cancer Research UK, has commenced a first-in-human
clinical trial of VAC2 in non-small cell lung cancer. VAC1
(antigen-presenting autologous dendritic cells) is an autologous
cancer immunotherapy with promising efficacy and safety data from
an earlier Phase 2 study in Acute Myeloid Leukemia (AML). Asterias
is also sponsoring pre-clinical work in two conditions with a
demyelinating component: Multiple Sclerosis and White Matter
Stroke, and is evaluating other cancer indications where its
immunotherapy platform could provide therapeutic benefit.
Additional information about Asterias can be found
at www.asteriasbiotherapeutics.com.
About OncoCyte
CorporationOncoCyte is focused on the development and
commercialization of novel, non-invasive blood (“liquid biopsy”)
diagnostic tests for the detection of cancer. Oncocyte’s diagnostic
tests have the potential to improve health outcomes, reduce the
cost of care, and improve patients’ quality of life. Liquid biopsy
diagnostic tests like those OncoCyte is developing may reduce the
need for costlier and riskier diagnostic procedures such as
invasive biopsy procedures. OncoCyte is focusing its efforts on
developing DetermaVu™ as a non-invasive confirmatory diagnostic
test for lung cancer. Additional information about OncoCyte can be
found at www.oncocyte.com.
About AgeX Therapeutics,
Inc.AgeX is focused on developing and commercializing
innovative therapeutics for human aging. Its PureStem® and
UniverCyte™ manufacturing and immunotolerance technologies are
designed to work together to generate highly defined, universal,
allogeneic, off-the-shelf pluripotent stem cell-derived young cells
of any type for application in a whole host of diseases with a high
unmet medical need. AgeX has two preclinical cell therapy programs:
AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and
AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s
revolutionary longevity platform named induced Tissue Regeneration
(iTR™) aims to unlock cellular immortality and regenerative
capacity to reverse age-related changes within tissues.
AGEX-iTR1547 is an iTR-based formulation in preclinical
development. HyStem® is AgeX’s delivery technology to stably
engraft PureStem cell therapies and slowly release iTR molecules in
the body. AgeX is aggressively developing its core product pipeline
for use in the clinic to extend human healthspan, and is seeking
opportunities to form licensing and partnership agreements around
its broad IP estate and proprietary technology platforms for
non-core clinical applications. For more information on AgeX,
please visit www.agexinc.com or connect with the company
on Twitter, Facebook and YouTube.
Additional Information and Where to Find
ItThis communication is being made in respect of the
proposed business combination involving BioTime, Inc. and Asterias
Biotherapeutics, Inc. In connection with the proposed transaction,
BioTime and Asterias filed documents with the U.S. Securities and
Exchange Commission (the “SEC”), including the filing by BioTime of
a Registration Statement on Form S-4 containing a Joint Proxy
Statement/Prospectus. INVESTORS AND SECURITY HOLDERS OF BIOTIME AND
ASTERIAS ARE URGED TO CAREFULLY READ THE FINAL JOINT PROXY
STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED WITH THE SEC BY
BIOTIME AND ASTERIAS BECAUSE THEY CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION. Investors and security holders may
obtain free copies of these documents and other documents filed
with the SEC at the SEC’s web site at www.sec.gov and by contacting
BioTime Investor Relations at (510) 871-4188 or Asterias Investor
Relations at (510) 456-3892. Investors and security holders may
obtain free copies of the documents filed with the SEC on BioTime’s
website at www.biotimeinc.com or Asterias’ website at
www.asteriasbiotherapeutics.com or the SEC’s website at
www.sec.gov. BioTime, Asterias and their respective directors and
executive officers may be deemed participants in the solicitation
of proxies with respect to the proposed transaction. Information
regarding the interests of these directors and executive officers
in the proposed transaction is included in the Joint Proxy
Statement/Prospectus described above. Additional information
regarding the directors and executive officers of BioTime is also
included in BioTime’s proxy statement for its 2018 Annual Meeting
of Shareholders, which was filed with the SEC on March 29, 2018,
and additional information regarding the directors and executive
officers of Asterias is also included in Asterias’ proxy statement
for its 2018 Annual Meeting of Stockholders, which was filed with
the SEC on April 30, 2018, respectively.
No Offer or Solicitation
This document does not constitute an offer to
sell or the solicitation of an offer to buy any securities or a
solicitation of any vote or approval nor shall there be any sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Forward-Looking Statements
Certain statements in this communication,
including statements relating to the Merger Agreement, the Merger
and the other transactions contemplated by the Merger Agreement,
uncertainties as to the timing of the closing of Merger, including
due to failure to satisfy or delay in satisfying the conditions to
such closing; anticipated closing of OncoCyte public offering and
further development and potential of the product candidates,
including enrollment and timing of the results of our clinical
trials; and expectations related to BioTime’s CE Mark application
for Renevia are “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995 giving
BioTime’s and Asterias’ expectations or predictions of future
financial or business performance or conditions. These
forward-looking statements are subject to numerous assumptions,
risks and uncertainties which change over time. Forward-looking
statements speak only as of the date they are made and we assume no
duty to update forward-looking statements. In addition to factors
previously disclosed in BioTime’s and Asterias’ reports filed with
the SEC and those identified elsewhere in this communication, the
following factors, among others, could cause actual results to
differ materially from forward-looking statements and historical
performance: the ability to meet closing conditions to the Merger,
including requisite approval by BioTime’s and Asterias’
stockholders, on a timely basis or at all; delay in closing the
Merger; the ultimate outcome and results of integrating the
operations of BioTime and Asterias and the ultimate ability to
realize synergies and other benefits; business disruption following
the Merger; the availability and access, in general, of funds to
fund operations and necessary capital expenditures. More
information on potential factors that could affect our results is
included from time to time in the SEC filings and reports of
BioTime and Asterias, including the risks identified under the
sections captioned “Risk Factors” in BioTime’s quarterly report on
Form 10-Q filed with the SEC on November 8 and Asterias’ annual
report on Form 10-K for the year ended December 31, 2017 filed with
the SEC on March 15, 2018, and Asterias’ quarterly report on Form
10-Q for the quarter ended September 30, 2018, filed with the SEC
on November 9, 2018.
BioTime Inc. IRIoana C.
Hone(ir@biotimeinc.com)(510) 871-4188
Solebury Trout IRGitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
OncoCyte (AMEX:OCX)
Historical Stock Chart
From Nov 2024 to Dec 2024
OncoCyte (AMEX:OCX)
Historical Stock Chart
From Dec 2023 to Dec 2024