BioTime Acquires Two Clinical-Stage Cell Therapy Product Candidates
Addressing Significant Unmet Needs in Spinal Cord Injury and
Asterias Stockholders to Receive 0.71 Shares of BioTime for Each
Share of Asterias Biotherapeutics
ALAMEDA, Calif. & FREMONT, Calif.--(BUSINESS WIRE)--Nov. 8, 2018--
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.”
OPC1 – Innovative Phase 2 Program for the Treatment of Severe Spinal
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
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
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
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,
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
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005314/en/
Source: BioTime, Inc.
BioTime Inc. IR
Ioana C. Hone, 510-871-4188
Gitanjali Jain Ogawa, 646-378-2949
Investor Relations, 510-456-3892
Michael Polyviou, 732-232-6914