_MACHINE TRANSLATION_
The Management Board of Bioceltix S.A. with its registered office in Wrocław (the “Issuer” or the “Company”), with reference to ESPI Current Report No. 24/2026 dated 15 July 2026, hereby informs that on 16 July 2026 the Company received from the European Medicines Agency (the “EMA”) a list of questions regarding BCX-CM-J, a medicinal product being developed by the Company for the treatment of osteoarthritis in dogs.
The receipt of the list of questions constitutes a subsequent stage of the procedure conducted before the EMA in connection with the Company’s application for a positive recommendation for the marketing authorisation of BCX-CM-J.
The Company has commenced the analysis of the questions received, including with the support of the industry advisor assisting in the registration process. Upon completion of this analysis, the Issuer will inform the market, in a separate current report, about the next steps in the procedure, including in particular the anticipated timeline for the preparation and submission of responses to the EMA.
The Issuer considers this information to be material due to the significance of the registration process for BCX-CM-J for the further development and commercialisation of this product.
Attachment: None
Signatures of persons representing the Company:
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board