Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ:
GRCL), a global clinical-stage biopharmaceutical company dedicated
to developing innovative cell therapies for the treatment of cancer
and autoimmune diseases, today announced it has entered into a
definitive agreement to be acquired by AstraZeneca.
The proposed acquisition will enrich
AstraZeneca’s growing pipeline of cell therapies with GC012F, a
novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting
autologous chimeric antigen receptor T (CAR-T) cell 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 patient’s immune T cells to target
disease-causing cells, and the manufacturing process for this type
of treatment is complex and time-consuming. Gracell’s FasTCAR
next-day manufacturing 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.
Dr. William Cao, founder, Chairman and CEO,
Gracell said: “We 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’s 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.”
Susan Galbraith, Executive Vice President,
Oncology R&D, AstraZeneca, said: “The proposed acquisition of
Gracell will complement AstraZeneca’s 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.”
Transaction Terms
Under the terms of the definitive agreement,
AstraZeneca will acquire all of Gracell’s 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 the Company), plus a non-tradable contingent
value right of $0.30 per ordinary share in cash (equivalent to
$1.50 per ADS of the Company) payable upon achievement of a
specified regulatory milestone. The upfront cash portion of the
consideration represents a transaction value of approximately $1.0
billion, a 62% premium to Gracell’s closing market price on
December 22, 2023 and a 154% premium to the 60-day volume-weighted
average price (VWAP) of $3.94 per ADS before this announcement.
Combined, the upfront and potential contingent value payments
represent, if achieved, a transaction value of approximately $1.2
billion, an 86% premium to Gracell’s closing market price on
December 22, 2023 and a 192% premium to the 60-day VWAP. As part of
the proposed transaction, AstraZeneca will acquire the cash, cash
equivalents and short-term investments remaining on Gracell’s
balance sheet, which totaled $234.1 million as of September 30,
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.
If completed, the transaction will result in Gracell becoming a
privately held company and its ADSs will no longer be listed on
Nasdaq.
Advisors
Centerview Partners is acting as exclusive
financial advisor to Gracell.
Cooley LLP is acting as legal advisor to
Gracell. AllBright Law Offices is acting as PRC legal advisor to
Gracell, and Harney Westwood & Riegels is acting as Cayman
Islands legal advisor to Gracell.
Freshfields Bruckhaus Deringer US LLP is acting
as legal advisor to AstraZeneca. RuiMin is acting as PRC legal
advisor to AstraZeneca, and Maples Group is acting as Cayman
Islands legal advisor to AstraZeneca.
About GC012FGC012F is Gracell’s
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 hematological cancers as well as
autoimmune diseases and has demonstrated a consistently strong
efficacy and safety profile. Gracell has initiated a Phase 1b/2
trial evaluating GC012F for the treatment of RRMM in the United
States and a Phase 1/2 clinical trial in China is to be commenced
imminently. An IIT has also been launched to evaluate GC012F for
the treatment of rSLE and the IND applications to study GC012F in
rSLE has been cleared by the U.S. FDA and China NMPA,
respectively.
About FasTCARIntroduced in
2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T
cell manufacturing platform. FasTCAR is designed to lead the next
generation of therapy for cancer and autoimmune diseases, and
improve outcomes for patients by enhancing effect, reducing costs,
and enabling more patients to access critical CAR-T treatment.
FasTCAR drastically shortens cell production from weeks to
overnight, potentially reducing patient wait times and probability
for their disease to progress. Furthermore, FasTCAR T-cells appear
younger than traditional CAR-T cells, making them more
proliferative and effective at killing cancer cells. In 2022 and
2023, FasTCAR was named the winner of the Biotech Innovation
category of the 2022 Fierce Life Sciences Innovation Awards and the
Overall Immunology Solution of 2023 by BioTech Breakthrough Awards,
for its ability to address major industry obstacles.
About Gracell Gracell
Biotechnologies Inc. (“Gracell”) is a global clinical-stage
biopharmaceutical company dedicated to discovering and developing
breakthrough cell therapies for the treatment of cancers and
autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR
technology platforms and SMART CART™ technology module, Gracell is
developing a rich clinical-stage pipeline of multiple autologous
and allogeneic product candidates with the potential to overcome
major industry challenges that persist with conventional CAR-T
therapies, including lengthy manufacturing time, suboptimal cell
quality, high therapy cost, and lack of effective CAR-T therapies
for solid tumors and autoimmune diseases. The lead candidate
BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being
evaluated in clinical studies for the treatment of multiple
myeloma, B-NHL and SLE. For more information on Gracell, please
visit www.gracellbio.com. Follow @GracellBio on LinkedIn.
Additional Information and Where to Find
ItIn connection with the proposed transaction, the Company
intends to file or furnish relevant materials with the Securities
and Exchange Commission (the “SEC”), 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 the Company 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 THE COMPANY ARE URGED TO READ THESE MATERIALS
(INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER
RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT
THE COMPANY 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 SEC’s website at www.sec.gov or
at the Company’s website at www.gracellbio.com.
Participants in the
SolicitationThis 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, the Company and certain of their
respective directors, executive officers and other members of
management and employees may, under SEC rules, be deemed to be
“participants” in the solicitation of proxies from the Company’s
shareholders with respect to the proposed transaction. Information
regarding the persons who may be considered “participants” 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.
Cautionary Note Regarding
Forward-Looking StatementsThis announcement contains
“forward-looking statements” within the meaning of The Private
Securities Litigation Reform Act of 1995. Statements that are not
historical or current facts, including statements about the beliefs
and expectations and statements relating to the proposed
transaction involving Gracell, AstraZeneca and AstraZeneca’s merger
subsidiary, are forward-looking statements. The words “anticipate,”
“look forward to,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Forward-looking statements involve inherent
risks and uncertainties, and important factors could cause actual
results to differ materially from those anticipated, including, but
not limited to: the satisfaction of the conditions precedent to the
consummation of the proposed transaction, including, the receipt of
shareholder approval and regulatory clearances; the possibility
that the milestone related to the contingent value right will not
be achieved, even if the proposed merger is consummated;
unanticipated difficulties or expenditures relating to the proposed
transaction; legal proceedings, judgments or settlements, including
those that may be instituted against the Company, the Company’s
board of directors and executive officers and others following the
announcement of the proposed transaction; disruptions of current
plans and operations caused by the announcement of the proposed
transaction; potential difficulties in employee retention due to
the announcement of the proposed transaction; and other risks and
uncertainties and the factors discussed in the section entitled
“Risk Factors” in Gracell’s most recent annual report on Form 20-F,
as well as discussions of potential risks, uncertainties, and other
important factors in Gracell’s subsequent filings with the SEC. Any
forward-looking statements contained in this press release speak
only as of the date hereof. Gracell specifically disclaims any
obligation to update any forward-looking statement, whether due to
new information, future events, or otherwise. Readers should not
rely upon the information on this page as current or accurate after
its publication date.
Media Contacts
Marvin Tang
marvin.tang@gracellbio.com
Jessica Laub
jessica.laub@westwicke.com
Investor Contacts
Gracie Tong
gracie.tong@gracellbio.com
Stephanie Carrington
stephanie.carrington@westwicke.com
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