BioTime Acquires Two Clinical-Stage Cell
Therapy Product Candidates Addressing Significant Unmet Needs in
Spinal Cord Injury and Immuno-Oncology
Asterias Stockholders to Receive 0.71 Shares
of BioTime for Each Share of Asterias Biotherapeutics
BioTime, Inc. (NYSE American and TASE: BTX), and Asterias
Biotherapeutics, Inc. (“Asterias”) (NYSE American: AST), today
announced that they have entered into a definitive merger agreement
whereby BioTime will acquire all of the remaining outstanding
common stock of Asterias that are not currently owned by BioTime.
Asterias stockholders will receive 0.71 shares of BioTime common
shares for every share of Asterias common stock and will own
approximately 16.2% of the combined company. Subject to customary
closing conditions, including approval by the respective
shareholders of BioTime and Asterias, the transaction is expected
to be completed in the first quarter of 2019.
“Our vision is to build BioTime into a premier cell therapy
company and this acquisition can support that transformation as it
not only diversifies our pipeline with two additional
clinical-stage assets addressing high unmet medical needs, but also
adds partnerships with notable institutions such as the California
Institute for Regenerative Medicine and Cancer Research UK,” stated
Brian M. Culley, Chief Executive Officer of BioTime. “We believe
this merger is an exciting opportunity for BioTime’s shareholders
to benefit from the potential future value of a more differentiated
pipeline as well as the opportunity to impact disease areas that
are in desperate need of innovative therapeutic approaches.”
“This transaction can create substantial value for our
stockholders, employees and our clinical programs,” stated Michael
Mulroy, Chief Executive Officer of Asterias. “The stock merger
structure provides Asterias stockholders the ability to continue
their investment in our clinical programs in spinal cord injury and
non-small cell lung cancer as part of a larger, more diversified
company with greater resources.”
Asterias’ Pipeline
OPC1 – Innovative Phase 2 Program for the Treatment of Severe
Spinal Cord Injury
- OPC1 is a cellular therapy utilizing
oligodendrocyte progenitor cells (OPCs), which in preclinical
testing has demonstrated potentially reparative functions that
address the complex pathologies observed in demyelination disorders
such as spinal cord injury and multiple neurodegenerative diseases,
including multiple sclerosis and white matter stroke. The potential
reparative functions of OPC1 include the production of neurotrophic
factors, the stimulation of vascularization, and the induction of
remyelination of denuded axons, all of which are critical for
survival, regrowth, and conduction of nerve impulses through axons
at the injury site.
- Asterias is currently completing a
Phase 1/2a clinical trial (the “SCiStar Study”) for severe spinal
cord injury where there currently are no approved therapies. The
results from the SCiStar Study have been promising:
- Safety Profile: Results-to-date
for the SCiStar Study have shown no evidence of adverse changes in
any of the subjects treated with OPC1. To date, there have been no
serious adverse events (SAEs) related to the OPC1 cells.
- Cell Engraftment: Over 95% of
subjects in the SCiStar Study have magnetic resonance imaging (MRI)
scans consistent with the formation of a tissue matrix at the
injury site, which is encouraging evidence that OPC1 cells have
engrafted at the injury site and helped to prevent cavitation.
- Motor Function Recovery: Many of
the patients in the SCiStar Study have shown promising upper
extremity motor recovery in their arms, hands, and fingers.
- An independent data review meeting was
held recently to discuss the latest results from the SCiStar Study
and positive feedback was received from the outside medical and
scientific experts on the panel.
- A meeting with the FDA under OPC1’s
RMAT designation is scheduled for later this year to discuss the
trial design of the next OPC1 study.
- A final update on the SCiStar Study
results is expected in the first quarter of 2019.
- The SCiStar Study has been partially
funded by a $14.3 million grant from the California Institute for
Regenerative Medicine (CIRM) and there is the potential to obtain
additional non-dilutive funding in 2019 to partially offset the
cost of OPC1’s next phase of clinical development.
VAC2 – Phase 1 Program for the Treatment of Non-Small Cell
Lung Cancer (NSCLC) Partnered with Cancer Research UK
- VAC2 is a non-patient-specific, or
“allogeneic,” cancer immunotherapy candidate. VAC2 cells are
engineered to express a protein widely expressed in tumor cells but
rarely found in normal cells. The VAC2 antigen presenting dendritic
cells instruct the immune system to generate responses against
tumor cells.
- VAC2 currently is being investigated in
a Phase 1 study for the treatment of NSCLC and is sponsored and
conducted by Cancer Research UK.
- The safety data from the first three
subjects has been reviewed by the study’s Safety Review Committee
which found VAC2 to be safe and well-tolerated in those
subjects.
- The study currently is enrolling
subjects in the advanced disease cohort of the study and immune
response and survival data are expected during 2019 and 2020. The
study design also includes a cohort of less advanced patients where
tumors have been resected.
- VAC2 is potentially complementary and
synergistic with other immune therapies such as immune checkpoint
inhibitors.
- In addition to being investigated in
NSCLC, a leading cause of cancer deaths, VAC2 is a platform
technology that has the potential to be applied to other solid and
liquid tumors and to deliver additional or different antigens
depending on the cancer type.
About the Proposed Merger
Under the terms of the merger agreement, Asterias stockholders
will receive 0.71 common share of BioTime for each share of common
stock of Asterias they own upon closing of the merger. The merger
agreement, the merger and the other transactions contemplated in
the merger agreement have been approved by the board of directors
of Asterias (by unanimous vote of the disinterested members of the
Asterias board of directors, acting upon the recommendation of a
special committee comprised of only independent and disinterested
members of the board of directors of Asterias). The merger
agreement, the merger, the issuance of the BioTime shares in the
merger and the other transactions contemplated in the merger
agreement have been approved by the board of directors of BioTime
(by unanimous vote of the disinterested members of the BioTime
board of directors acting upon the unanimous recommendation of a
special committee comprised of only disinterested and independent
directors of BioTime). The merger is expected to close during the
first quarter of 2019, subject to approval of the merger by the
BioTime and Asterias stockholders, and other customary closing
conditions.
The combined company will be led by Brian M. Culley, President
and Chief Executive Officer of BioTime. It is expected that,
following closing of the transaction, BioTime’s Board of Directors
will consist of nine members, with Don Bailey, Chairman of
Asterias’ Board of Directors, joining the BioTime Board of
Directors and Mr. Mulroy, Asterias’ Chief Executive Officer,
remaining on the BioTime Board.
Pursuant to the terms of a “go-shop” provision in the merger
agreement, between the date of the merger agreement and December 3,
2018, Asterias and its representatives may solicit, discuss or
negotiate alternative proposals from third parties for the
acquisition of Asterias. Following the expiration of this go-shop
period, Asterias will become subject to customary “no shop”
restrictions on its and its representatives’ ability to solicit,
discuss or negotiate alternative acquisition proposals from third
parties, subject to exceptions for acquisition proposals that the
Asterias board of directors and the Asterias special committee has
determined constitutes or is reasonably expected to constitute a
Superior Proposal (as defined in the merger agreement), and further
subject to compliance with certain conditions.
BioTime’s financial advisor in the transaction is Maxim Group
LLC. Raymond James is acting as financial advisor to Asterias.
Cooley LLP is serving as legal counsel to BioTime and Dentons LLP
is serving as legal counsel to Asterias.
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 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 Asterias Biotherapeutics, Inc.
Asterias Biotherapeutics, Inc. 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 two clinical-stage programs which have the potential to
address areas of 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. The Company's research partner,
Cancer Research UK, has commenced a first-in-human clinical trial
of VAC2 in non-small cell lung cancer. Additional information about
Asterias can be found at www.asteriasbiotherapeutics.com.
Additional Information and Where to Find It
This 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 plan to file 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 and each of BioTime
and Asterias plan to file with the SEC other documents regarding
the proposed transaction. INVESTORS AND SECURITY HOLDERS OF BIOTIME
AND ASTERIAS ARE URGED TO CAREFULLY READ THE JOINT PROXY
STATEMENT/PROSPECTUS (WHEN AVAILABLE) AND OTHER DOCUMENTS FILED
WITH THE SEC BY BIOTIME AND ASTERIAS BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and
security holders may obtain free copies of these documents (when
they are available) 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 will be 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 and the combined
company’s future financial condition performance and operating
results, strategy and plans, including the design, status, funding
and timing of the clinical trials and further development and
potential of the product candidates 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, which Asterias
expects to file on November 9, 2018.
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BioTime Inc. IRIoana C. Hone,
510-871-4188ir@biotimeinc.comorSolebury Trout IRGitanjali
Jain Ogawa, 646-378-2949Gogawa@troutgroup.comorAsterias
Biotherapeutics IRInvestor Relations,
510-456-3892InvestorRelations@asteriasbio.comorEVC Group
LLCMichael Polyviou, 732-232-6914mpolyviou@evcgroup.com
Asterias Biotherapeutics, Inc. (AMEX:AST)
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