TIDMAZN
RNS Number : 8453X
AstraZeneca PLC
27 December 2023
27 December 2023
AstraZeneca to acquire Gracell, furthering cell therapy
ambition across oncology and autoimmune diseases
Includes clinical-stage autologous BCMA/CD19 CAR-T therapy
targeting haematologic malignancies and autoimmune diseases, and
proprietary cell therapy manufacturing platform
AstraZeneca has entered into a definitive agreement to acquire
Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global
clinical-stage biopharmaceutical company developing innovative cell
therapies for the treatment of cancer and autoimmune diseases,
furthering the AstraZeneca cell therapy ambition.
The proposed acquisition will enrich AstraZenecaÕs growing
pipeline of cell therapies with GC012F, a novel, clinical-stage
FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric
antigen receptor T-cell (CAR-T) therapy, a potential new treatment
for multiple myeloma, as well as other haematologic malignancies
and autoimmune diseases including systemic lupus erythematosus
(SLE) .
Autologous CAR-T is a type of cell therapy created by
reprogramming a patientÕs immune T cells to target disease-causing
cells, and the manufacturing process for this type of treatment is
complex and time-consuming. The Gracell FasTCAR platform
significantly shortens manufacturing time, enhances T cell fitness,
and will potentially improve the effectiveness of autologous CAR-T
treatment in patients. Future applications of this technology may
also include rare diseases.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: ÒThe proposed acquisition of Gracell will
complement AstraZenecaÕs existing capabilities and previous
investments in cell therapy, where we have established our presence
in CAR-T and T-cell receptor therapies (TCR-Ts) in solid tumours.
GC012F will accelerate our cell therapy strategy in haematology,
with the opportunity to bring a potential best-in-class treatment
to patients living with blood cancers using a differentiated
manufacturing process, as well as exploring the potential for cell
therapy to reset the immune response in autoimmune diseases. Ó
Dr. William Cao, founder, Chairman and CEO, Gracell, said: ÒWe
look forward to working with AstraZeneca to accelerate our shared
goal of bringing transformative cell therapies to more patients
living with debilitating diseases. By combining our expertise and
resources, we can unlock new ways to harness the Gracell FasTCAR
manufacturing platform, which we believe has the potential to
optimise the therapeutic profile of engineered T cells, to pioneer
the next generation of autologous cell therapies.Ó
Gracell will operate as a wholly owned subsidiary of
AstraZeneca, with operations in China and the US.
Financial considerations
Under the terms of the definitive agreement, AstraZeneca will
acquire all of GracellÕs fully diluted share capital (including
shares represented by ADSs) through a merger for a price of $2.00
per ordinary share in cash at closing (equivalent to $10.00 per ADS
of Gracell) plus a non-tradable contingent value right of $0.30 per
ordinary share (equivalent to $1.50 per ADS of Gracell) in cash
payable upon achievement of a specified regulatory milestone.
The upfront cash portion of the consideration represents a
transaction value of approximately $1.0bn, a 62% premium to
GracellÕs closing market price on 22(nd) December 2023 and a 154%
premium to the 60-day volume-weighted average price (VWAP) of $3.94
before this announcement. Combined, the upfront and potential
contingent value payments represent, if achieved, a transaction
value of approximately $1.2bn, an 86% premium to Gracell's closing
market price on 22(nd) December 2023 and a 192% premium to the
60-day VWAP. As part of the transaction, AstraZeneca will acquire
the cash, cash equivalents and short-term investments on GracellÕs
balance sheet, which totalled $234.1m as of 30th September
2023.
The transaction is expected to close in the first quarter of
2024, subject to customary closing conditions, including regulatory
clearances, and Gracell shareholder approval. The transaction does
not impact AstraZenecaÕs financial guidance for 2023.
Notes
About GC012F
GC012F is GracellÕs FasTCAR-enabled BCMA/CD19 dual-targeting
autologous CAR-T cell therapy, which aims to transform cancer and
autoimmune disease treatment by seeking to drive deep and durable
responses with an improved safety profile. GC012F is currently
being evaluated in clinical studies in multiple haematologic
malignancies and autoimmune diseases. Gracell has initiated a Phase
Ib/II trial evaluating GC012F for the treatment of relapsed or
refractory multiple myeloma in the US.
AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine
care in haematology. We have expanded our commitment to patients
with haematologic conditions, not only in oncology but also in rare
diseases with the acquisition of Alexion, allowing us to reach more
patients with high unmet needs. By applying our deep understanding
of blood cancers, leveraging our strength in solid tumour oncology
and delivering on AlexionÕs pioneering legacy in complement science
to provide innovative medicines for rare diseases, we are pursuing
the end-to-end development of novel therapies designed to target
underlying drivers of disease.
By targeting haematologic conditions with high unmet medical
needs, we aim to deliver innovative medicines and approaches to
improve patient outcomes. Our goal is to help transform the lives
of patients living with malignant, rare and other related
haematologic diseases, shaped by insights from patients, caregivers
and physicians to have the most meaningful impact.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
AstraZeneca in BioPharmaceuticals: Respiratory and
Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
CompanyÕs growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including SLE), dermatology,
gastroenterology, and systemic eosinophilic-driven diseases.
AstraZenecaÕs ambition in Respiratory & Immunology is to
achieve disease modification and durable remission for millions of
patients worldwide.
Additional Information and Where to Find It
In connection with the proposed transaction, Gracell intends to
file or furnish relevant materials with the Securities and Exchange
Commission (the ÒSECÓ), including a proxy statement. Promptly after
the proxy statement is filed or furnished with the SEC, the Company
will mail or otherwise provide the proxy statement and a proxy card
to each of its shareholders entitled to vote at the extraordinary
general meeting relating to the proposed transaction. This
communication is not a substitute for the proxy statement or any
other document that Gracell may file or furnish with the SEC or
send to its shareholders in connection with the proposed
transaction. BEFORE MAKING ANY VOTING DECISION, SHAREHOLDERS OF
Gracell ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMMENTS OR
SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION
WITH THE PROPOSED TRANSACTION THAT Gracell WILL FILE OR FURNISHED
WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE
PARTIES TO THE PROPOSED TRANSACTION. The proxy statement and other
relevant materials in connection with the proposed transaction
(when they become available), and any other documents filed or
furnished with the SEC by the Company, may be obtained free of
charge at the SECÕs website at www.sec.gov or at GracellÕs website
at www.gracellbio.com.
Participants in the Solicitation
This announcement is neither a solicitation of proxy, an offer
to purchase nor a solicitation of an offer to sell any securities
and it is not a substitute for any proxy statement or other filings
that may be made with the SEC should the transaction proceed.
AstraZeneca, Gracell and certain of their respective directors,
executive officers and other members of management and employees
may, under SEC rules, be deemed to be ÒparticipantsÓ in the
solicitation of proxies from the GracellÔs shareholders with
respect to the proposed transaction. Information regarding the
persons who may be considered ÒparticipantsÓ in the solicitation of
proxies will be set forth in the proxy statement relating to the
transaction when it is filed or furnished with the SEC. Additional
information regarding the interests of such potential participants
will be included in the proxy statement and the other relevant
documents filed or furnished with the SEC when they become
available.
Forward-looking statements
This announcement may include statements that are not statements
of historical fact, or Òforward-looking statements,Ó including with
respect to AstraZenecaÕs proposed acquisition of Gracell. Such
forward-looking statements include, but are not limited to, the
ability of AstraZeneca and Gracell to complete the transactions
contemplated by the acquisition agreement, including the partiesÕ
ability to satisfy the conditions set forth in the merger
agreement, statements about the expected timetable for completing
the transaction, AstraZenecaÕs and GracellÕs beliefs and
expectations and statements about the benefits sought to be
achieved in AstraZenecaÕs proposed acquisition of Gracell, the
potential effects of the acquisition on both AstraZeneca and
Gracell, the possibility of any termination of the merger
agreement, as well as the expected benefits and success of [ GC012F
and any combination product]. These statements are based upon the
current beliefs and expectations of AstraZenecaÕs and GracellÕs
management and are subject to significant risks and uncertainties.
There can be no guarantees that the conditions to the closing of
the proposed transaction will be satisfied on the expected
timetable or at all or that [ GC012F will receive the necessary
regulatory approvals or prove to be commercially successful if
approved]. If underlying assumptions prove inaccurate or risks or
uncertainties materialise, actual results may differ materially
from those set forth in the forward-looking statements. Risks and
uncertainties include, but are not limited to, uncertainties as to
the timing of the merger; uncertainties as to how many of GracellÕs
shareholders will vote in favour of the merger; the possibility
that various conditions to the consummation of the merger
contemplated by the merger agreement may not be satisfied or
waived; the ability to obtain necessary regulatory approvals or to
obtain them on acceptable terms or within expected timing; the
effects of disruption from the transactions contemplated by the
merger agreement and the impact of the announcement and pendency of
the transactions on GracellÕs business; the risk that shareholder
litigation in connection with the offer or the merger may result in
significant costs of defence, indemnification and liability; the
possibility that the achievement of the specified milestone
described in the contingent value rights agreement may take longer
to achieve than expected or may never be achieved and the resulting
contingent milestone payment may never be realised; general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of COVID-19; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; competition from other products; and challenges
inherent in new product development, including obtaining regulatory
approval.
Neither AstraZeneca nor Gracell undertakes any obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise, except to the
extent required by law. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in AstraZenecaÕs Annual Report on Form 20-F
for the year ended 31 December 2022 and GracellÕs Annual Report on
Form 20-F for the year ended 31 December 2022, in each case as
amended by any subsequent filings made with the SEC. These and
other filings made by AstraZeneca and Gracell with the SEC are
available at www.sec.gov.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on social media @AstraZeneca
Contacts
For details on how to contact the Investor Relations Team,
please click here . For Media contacts, click here .
Adrian Kemp
Company Secretary
AstraZeneca PLC
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END
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