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MESSAGE _ENGLISH VERSION_ |
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Conclusion of an amendment to the global license agreement with Menarini
Group concerning the further clinical development of dapolsertib
The Management Board of Ryvu Therapeutics S.A., with its registered
office in Krakow _the "Issuer", the "Company"_, hereby informs that on
July 22, 2026 the Company concluded with Berlin-Chemie AG, with its
registered office in Berlin, Germany, a member of the Menarini Group
_the "Menarini Group"_, an amendment _the "Amendment"_ to the global
license agreement concerning dapolsertib, also known as MEN1703 / SEL24
_the "Agreement"_, about which the Company informed in current report
no. 4/2017 dated March 28, 2017 and current report no. 40/2023 dated
September 14, 2023.
Pursuant to the Amendment, Menarini Group will expand the clinical
development of dapolsertib by initiating a new Phase II clinical study
in patients with myelofibrosis, a rare hematological malignancy. The
study will evaluate dapolsertib primarily as monotherapy. The decision
to initiate the study is supported by preclinical data indicating
activity of dapolsertib in myelofibrosis models.
The Company will act as sponsor of the study and will be responsible for
its operational conduct on behalf of Menarini Group, including in
particular study management, clinical monitoring, regulatory
submissions, medical oversight and data management. Menarini Group will
be responsible for funding all study activities covered by the Amendment
in accordance with the agreed budgets, and the Company will receive full
reimbursement of costs incurred in connection with the conduct of the
study, in line with those budgets.
Dapolsertib is a selective, small-molecule, dual inhibitor of PIM and
FLT3 kinases, two enzymes strongly implicated in the malignant
transformation of hematopoietic cells. The compound has been discovered
by the Company and is currently in clinical development in collaboration
with Menarini, which holds global development and commercial rights to
dapolsertib.
The conclusion of the Amendment is material for the further clinical
development of the dapolsertib program, as it expands the program into a
new indication, and defines the further scope of the Company's
operational collaboration with Menarini Group.
Disclaimer: This English language translation has been prepared solely
for the convenience of English-speaking readers. Despite all efforts
devoted to this translation, certain discrepancies, omissions or
approximations may exist. In case of any differences between the Polish
and the English versions, the Polish version shall prevail. Ryvu
Therapeutics S.A., its representatives and employees decline all
responsibility in this regard.
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RB: Zawarcie z Grupą Menarini aneksu do globalnej umowy licencyjnej dotyczącego dalszego
rozwoju klinicznego dapolsertibu / Conclusion of an amendment to the global license
agreement with Menarini Group concerning the further clinical development of dapolsertib
