Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS) today announced
it has entered into (i) a Joint Research Collaboration Agreement
(the “Collaboration Agreement”), (ii) an investment agreement
relating to an initial equity investment of $80M, and (iii) a
memorandum of understanding (the “MOU”) relating to an additional
equity investment of $140M, with AstraZeneca (LSE/STO/Nasdaq: AZN).
The Collaboration Agreement aims to accelerate the development of
next generation therapeutics in areas of high unmet need, including
oncology, immunology and rare diseases.
Under the terms of the Collaboration Agreement,
AstraZeneca will leverage Cellectis’ proprietary gene editing
technologies and manufacturing capabilities to design novel cell
and gene therapy candidate products. As part of the Collaboration
Agreement, 25 genetic targets have been exclusively reserved for
AstraZeneca, from which up to 10 candidate products could be
explored for development. AstraZeneca will have an option for a
worldwide exclusive license on the candidate products, to be
exercised before IND filing.
Pursuant to the Collaboration Agreement,
Cellectis’ research costs under the collaboration will be funded by
AstraZeneca and Cellectis will receive an upfront payment of $25M.
Under the terms of the Collaboration Agreement, Cellectis is also
eligible to receive an investigational new drug (IND) option fee
and development, regulatory and sales-related milestone payments,
ranging from $70M up to $220M, per each of the 10 candidate
products, plus tiered royalties.
As a condition to the signing of the
Collaboration Agreement, AstraZeneca has agreed to make an initial
equity investment of $80M in Cellectis by subscribing for
16,000,000 ordinary shares, at a price of $5.00 per share (the
“Initial Investment”). The new shares are issued to AstraZeneca by
the board of directors of Cellectis pursuant to the 17th resolution
of Cellectis’ shareholders meeting held on June 27, 2023. Following
settlement and delivery of the new shares (expected to be on
November 6, 2023), AstraZeneca will own approximately 22% of the
share capital, and 21% of the voting rights of the Company, will
have the right to nominate a non-voting observer on the board of
directors of Cellectis, and will have the right to participate pro
rata in Cellectis’s future share offerings.
Additionally, the MOU contemplates that
AstraZeneca will make a potential further equity investment in
Cellectis of $140M by subscribing for two newly created classes of
convertible preferred shares of Cellectis: 10,000,000 “class A”
convertible preferred shares and 18,000,000 “class B” convertible
preferred shares, in each case at a price of $5.00 per share (the
“Additional Investment”). Until they convert into ordinary shares,
the “class A" convertible preferred shares would have single voting
rights and would not carry any double voting right at any moment,
and the “class B” would carry no voting rights except on any
distribution of dividends or reserves. Both class of preferred
shares would enjoy a liquidation preference (if any liquidation
surplus remains after repayment of Cellectis’ creditors and of par
value to all shareholders) and would be convertible into the same
number of ordinary shares with the same rights as the outstanding
ordinary shares. The MOU is non-binding and the Additional
Investment remains to be confirmed by both parties following a
consultation process with Cellectis’ works council. If confirmed,
the closing of the Additional Investment will remain subject to (i)
Cellectis’ shareholders’ approval at a two-thirds majority of the
votes cast by voting shareholders, (ii) clearance of such
investment from the French Ministry of Economy according to the
foreign direct investment French regulations, and (iii) other
customary closing conditions. Immediately following the Additional
Investment, it is anticipated that AstraZeneca would own
approximately 44% of the share capital of the Company and 30% of
the voting rights of the Company (based on the number of voting
rights outstanding immediately after the completion of the Initial
Investment) and would have the right to nominate two directors to
the board of directors of Cellectis. Further, certain business
decisions are subject to AstraZeneca’s approval, including, in
particular, winding up any company of the Cellectis group, issuing
securities senior to or pari passu with the convertible preferred
shares or any shares without offering AstraZeneca the option to
purchase its pro rata share of such securities (subject to
customary exceptions, including issuances under employee equity
incentive plans), declaring or paying dividends, prepaying
indebtedness before due, and disposing of any material assets
concerning gene editing tools or manufacturing facilities and
selling, assigning, licensing, encumbering or otherwise disposing
of certain material IP rights.
Cellectis will use the proceeds received from
the Collaboration Agreement and the proposed equity investments to
develop gene editing tools, for research and development expenses
incurred in developing its programs, and other general corporate
purposes. Cellectis’ clinical-stage assets, UCART22, UCART123 and
UCART20x22 will remain under Cellectis’ ownership and control.
André Choulika, PhD, Chief Executive Officer of
Cellectis, said: “We believe AstraZeneca is the perfect match to
Cellectis by providing world-class expertise in the development and
the commercialization of innovative medicines. This collaboration
will allow us to leverage our pioneering research in gene editing
and cell therapies, as well as our cutting-edge capabilities in
manufacturing with the ambition to bring potentially life-saving
therapies to patients with unmet medical need.”
Marc Dunoyer, Chief Strategy Officer,
AstraZeneca, and Chief Executive Officer, Alexion, AstraZeneca Rare
Disease, said: “The differentiated capabilities Cellectis has in
gene editing and manufacturing complement our in-house expertise
and investments made in the past year. AstraZeneca continues to
advance our ambition in cell therapy for oncology and autoimmune
diseases as well as in genomic medicine, which has potential to be
transformative for patients with rare diseases.”
In the absence of a public offering, no
prospectus will be established in France or outside of France in
connection with the Initial Investment or Additional
Investment.
About CellectisCellectis is a
clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies. Cellectis utilizes an allogeneic approach for CAR-T
immunotherapies in oncology, pioneering the concept of
off-the-shelf and ready-to-use gene-edited CAR T-cells to treat
cancer patients, and a platform to make therapeutic gene editing in
hemopoietic stem cells for various diseases. As a clinical-stage
biopharmaceutical company with over 23 years of experience and
expertise in gene editing, Cellectis is developing life-changing
product candidates utilizing TALEN®, its gene editing technology,
and PulseAgile, its pioneering electroporation system to harness
the power of the immune system in order to treat diseases with
unmet medical needs. Cellectis’ headquarters are in Paris, France,
with locations in New York, New York and Raleigh, North Carolina.
Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and
on Euronext Growth (ticker: ALCLS).
Cautionary StatementThis press
release contains certain “forward-looking” statements within the
meaning of applicable securities laws, including the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by words such as “additional”, “aim”,
“continue”, “could”, “drive”, “enable”, “expect”, “further”, “look
forward”, “may”, “ongoing”, “potential”, “promise”, “realize”,
“subject to”, “success-based”, “up to”, “will”, and “would” or the
negative of these and similar expressions. These forward-looking
statements, which are based on our management’s current
expectations and assumptions and on information currently available
to management, include statements about the potential payments for
which Cellectis is eligible under the Collaboration Agreement; the
possible size of the proposed equity investment by AstraZeneca; and
the financial position of Cellectis. Such forward-looking
statements are made in light of information currently available to
us and based on assumptions that Cellectis considers to be
reasonable. However, these forward-looking statements are subject
to numerous risks and uncertainties, including with respect to the
risk that conditions to closing, including necessary regulatory
approvals, are not satisfied in a timely manner or at all; the
risks arising from Cellectis’s reliance on AstraZeneca to conduct
certain development and commercialization activities, including the
potential for disagreements or disputes under the Collaboration
Agreement; the risk that AstraZeneca may exercise its discretion in
a manner that limits the resources contributed toward the
development of certain projects under the Collaboration Agreement
or may exercise its faculty to terminate without cause the
Agreement; the risk that subsequent studies and ongoing or future
clinical trials may not generate favorable data; and the risk that
the Company may not be able to secure additional capital on
attractive terms, if at all. Furthermore, many other important
risks factors and uncertainties, including those described in our
Annual Report on Form 20-F filed with the U.S. Securities and
Exchange Commission (the SEC) on March 14, 2023 under “Risk
Factors” (copies of which are available on www.cellectis.com), may
adversely affect such forward-looking statements and cause our
actual results, performance or achievements to be materially
different from those expressed or implied by the forward-looking
statements. Except as required by law, we assume no obligation to
update these forward-looking statements publicly, or to update the
reasons why actual results could differ materially from those
anticipated in the forward-looking statements, even if new
information becomes available in the future.
For further information on Cellectis,
please contact:
Media contact:Patricia Sosa
Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93,
media@cellectis.com
Investor Relations
contacts:Arthur Stril, Chief Business Officer, +1 (347)
809 5980, investors@cellectis.comAshley R. Robinson, LifeSci
Advisors, +1 617 430 7577
- 20231101_Cellectis_AZ_ENGLISH_PR
Grafico Azioni Cellectis (NASDAQ:CLLS)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Cellectis (NASDAQ:CLLS)
Storico
Da Giu 2023 a Giu 2024