Item 1.02 Termination of a Material Definitive Agreement.
On January 6, 2023, Sanofi delivered written notice to Regulus Therapeutics Inc.
(the "Company") of Sanofi's election to terminate in its entirety the second
amended and restated collaboration and license agreement entered into between
Sanofi and the Company on February 4, 2014, as amended (the "Agreement").
Previously, on July 12, 2022, the Company received notification from Sanofi of
its decision to terminate the Phase 2 clinical study of lademirsen for the
treatment of Alport syndrome for failure to meet Sanofi's pre-defined futility
criteria. Regulus was notified at that time, that Sanofi was evaluating other
opportunities for the program in other indications and according to Sanofi, the
decision to terminate the study did not stem from any safety issues. In
accordance with the Agreement, the termination will become effective on
February 5, 2023, which is 30 days following the date of delivery of the notice
by Sanofi.
Under the terms of the Agreement, Regulus had granted Sanofi a worldwide,
royalty-free, fee-bearing, exclusive license, with the right to grant
sublicenses, under our know-how and patents to develop and commercialize miR-21
compounds and products for all indications, including Alport Syndrome. Sanofi
assumed all responsibilities and obligations for developing and commercializing
each of our miR-21 programs, including lademirsen for the treatment of Alport
Syndrome. Lademirsen was the only product candidate from the collaboration
advanced against miR-21 into the clinic. In addition, under the Agreement Sanofi
had opt-in rights to our preclinical program targeting miR-221/222 for oncology
indications.
Under the terms of the Agreement, Regulus was eligible to receive $25.0 million
in further development milestone payments in the event the Phase 2 clinical
study of lademirsen achieved its primary clinical endpoint or upon Sanofi's
election to advance the program into later stages of clinical development. In
addition, in the event Sanofi exercised its opt-in rights to the miR221/222
program, Regulus was eligible to receive milestone payments related to the
development and commercialization of miR-221/222 for hepatocellular carcinoma of
up to $38.8 million for proof-of-concept option exercise fees, $25.0 million for
clinical milestones and up to $130.0 million for regulatory and commercial
milestones. Regulus was also eligible to receive royalties based on a percentage
of net sales of any products from the miR-221/222 program.
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