Item 1.02 Termination of a Material Definitive Agreement.
On December 30, 2021, Bioverativ Therapeutics Inc. (f/k/a Biogen Idec Ma Inc.)
("Sanofi") notified Sangamo Therapeutics, Inc. ("Sangamo") of its termination
for convenience, effective June 28, 2022 (the "Termination Date"), of the Global
Research, Development and Commercialization Collaboration and License Agreement,
dated as of January 8, 2014, by and between Sangamo and Sanofi (the
"Collaboration Agreement"), pursuant to which Sanofi and Sangamo are engaged in
research programs to develop therapeutics for hemoglobinopathies, including
sickle cell disease (the "Collaboration Research Programs"). In its notice to
Sangamo, Sanofi indicated that its termination relates to Sanofi's change in
strategic direction to focus on allogeneic universal genomic medicine approaches
rather than autologous personalized cell therapies. Under the Collaboration
Agreement, Sangamo granted Sanofi an exclusive, royalty-bearing license, with
the right to grant sublicenses, to use certain zinc finger protein and other
technology controlled by Sangamo for the purpose of researching, developing,
manufacturing and commercializing licensed products developed thereunder, and
Sangamo received a $20 million upfront license payment and is entitled to
receive potential regulatory, clinical development and sales milestone payments,
assuming the achievement of all specified milestones, of up to $276.3 million,
$13.5 million of which has been achieved to date. As of the Termination Date,
the Collaboration Agreement will be terminated in its entirety and following the
Termination Date, Sangamo will not be entitled to receive any further milestone
payments or royalties from Sanofi. As of the Termination Date, Sanofi will have
no further obligations to develop or to fund the development of any
Collaboration Research Programs under the Collaboration Agreement.
In accordance with the terms of the Collaboration Agreement, Sanofi has agreed
to work with Sangamo to develop a transition plan with respect to Sanofi's
activities under the Collaboration Agreement and the transfer of certain data,
information and regulatory materials pertaining thereto generated by or on
behalf of Sanofi. Sangamo expects that the Phase 1/2 PRECIZN study of SAR445136,
the cell therapy candidate for the treatment of sickle cell disease currently in
development under the Collaboration Agreement, will be completed as planned and
that the final patients in the study will be dosed in the third quarter of 2022.
Sangamo expects that Sanofi will continue to pay the costs of the Phase 1/2
PRECIZN-1 study until the Termination Date as contemplated by the Collaboration
Agreement. Sangamo expects to investigate alternative options to advance the
SAR445136 program, including seeking a potential new collaboration partner.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements regarding
Sangamo's current expectations. These forward-looking statements include,
without limitation, statements regarding the anticipated completion of the
PRECIZN-1 study and dosing of the final patients in the PRECIZN-1 study and the
anticipated timing thereof, Sanofi's continued funding of the PRECIZN-1 study,
plans and timing for the transition of the SAR445136 program from Sanofi to
Sangamo, the ability of Sangamo to identify and secure options to bring the
SAR445136 program forward, including a potential new collaboration partner for
the SAR445136 program, the potential for conducting future clinical trials of
SAR445136, and other statements that are not historical fact. These statements
are not guarantees of future performance and are subject to certain risks and
uncertainties that are difficult to predict. Sangamo's actual results may differ
materially and adversely from those expressed in these forward-looking
statements. Factors that could cause actual results to differ include, but are
not limited to, risks and uncertainties related to: the evolving COVID-19
pandemic and its impact on the global business environment, healthcare systems
and the business and operations of Sangamo and Sanofi, including the operation
of clinical trials; the research and development process; the uncertain timing
and unpredictable nature of clinical trial results, including the risks that
therapeutic effects observed in the preliminary proof-of-concept results from
the Phase 1/2 PRECIZN-1 study will not be durable in patients and that final
clinical trial data will not validate the safety and efficacy of SAR445136;
reliance on results of early clinical trials, which results are not necessarily
predictive of future clinical trial results; the unpredictable regulatory
approval process for product candidates across multiple regulatory authorities;
the manufacturing of products and product candidates; the commercialization of
approved products; the potential for technological developments that obviate
technologies used by Sangamo in SAR445136; the potential for Sanofi to breach
its Collaboration Agreement or any related transition agreements with Sangamo;
the potential for Sanofi and Sangamo to fail to come to agreement on appropriate
transition agreements or to execute an orderly transition under the
Collaboration Agreement; the potential that Sangamo will not be able to identify
and secure options or new collaborators for the SAR445136 program; the potential
for Sangamo to cease development of the SAR445136 program, whether due to its
inability to secure options to bring the program forward or otherwise; and
Sangamo's lack of resources to fully develop, obtain regulatory approval for and
commercialize its product candidates. These risks and uncertainties are
described more fully in Sangamo's filings with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year ended December
31, 2020 and the most recent Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021. The information contained in this Current Report on Form 8-K
is as of January 6, 2022, and Sangamo undertakes no duty to update
forward-looking statements contained in this Current Report on Form 8-K except
as required by applicable laws.
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