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MESSAGE _ENGLISH VERSION_
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Romaciclib development priorities update
The Management Board of Ryvu Therapeutics S.A., with its registered
office in Kraków _the "Company", "Ryvu"_, announces development and
financing priorities for romaciclib _RVU120_.
Following an analysis of Company resources and clinical data generated
so far, the Management Board of the Company decided to prioritize
romaciclib's development on acute myeloid leukemia _AML_, particularly
in patients with relapsed/refractory AML following venetoclax-based
regimens, which represents the area of greatest unmet medical need and
most compelling clinical data observed to date.
This approach is intended to preserve strategic optionality for
romaciclib while, in the short term, focusing resources on the clinical
dataset expected to be most relevant to potential development partners
for romaciclib.
Current discussions with interested parties indicate that the optimal
timing for a partnering transaction will follow the completion of the
dose expansion in the RIVER-81 study with the 150 mg QD cohort.
Accordingly, the Company plans to continue the RIVER-81 study by
enrolling approximately 30 additional patients subject to regulatory
clearances
As part of resource prioritization, the Management Board of the Company
decided to close the POTAMI-61 Phase II study investigating romaciclib
for the treatment of patients with intermediate or high-risk, primary or
secondary myelofibrosis _MF_. Romaciclib demonstrated a favorable safety
profile and clinical activity in MF, both as monotherapy and in
combination with ruxolitinib. The observed spleen volume reductions and
hematologic tolerability support continued clinical evaluation.
POTAMI-61 was initiated on December 4, 2024, as the Company informed in
the Current Report ESPI 37/2024 dated December 5, 2024. Following
completion of Part A _23 patients_ and initial enrollment in Part B _5
patients_, the Company has decided not to proceed with further
enrollment, closing the study at 28 patients. Patients currently
participating in the study and deriving clinical benefit from romaciclib
according to the investigators' assessment will continue to receive
treatment in a new rollover study _ROVER-01_, in accordance with
applicable regulatory and ethical requirements. The Company will analyze
data from POTAMI-61 to inform potential future MF development decisions
and retain the option to resume a modified MF development program.
In addition, the Company expects that the Investigator-Sponsored Trial
in medulloblastoma _MEDWAY_ at the Children's Memorial Health Institute
in Warsaw will be initiated over the coming months.
Based on currently available information and existing development plans,
the above decisions are not expected to have a material adverse impact
on the Company's 2026 and 2027 financial outlook.
Additional data from POTAMI-61 and RIVER-81 studies will be presented at
the EHA 2026 Annual Congress _Stockholm, June 11-14, 2026_, poster
numbers PS2008 and PF529. More details in the Current Report ESPI 8/2026
dated May 12, 2026.
Disclaimer: This English language translation has been prepared solely
for the convenience of English-speaking readers. Despite all the 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: Aktualizacja priorytetów rozwoju romacyklibu / Romaciclib development priorities update
