a8499x
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of December 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca acquires Gracell
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 22nd 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 22nd 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 AMENDMENTS 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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
27 December 2023
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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