_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. 11/2026 dated 14 May 2026, in which the Issuer informed about receiving confirmation of the submission to the European Medicines Agency (the “EMA”) of documentation containing explanations and responses to the EMA’s questions within the ongoing procedure aimed at obtaining a positive recommendation for the marketing authorisation (“MA”) of the veterinary medicinal product BCX-CM-J for the treatment of osteoarthritis in dogs, hereby announces that on 15 July 2026 it received information from the industry advisor supporting the registration process for BCX-CM-J regarding the current EMA timetable.
According to the information provided to the Issuer, the EMA’s final list of questions addressed to the Issuer, i.e. the List of Outstanding Issues (“LoOI”), is expected to be adopted during the meeting of the EMA Committee for Veterinary Medicinal Products (“CVMP”), the conclusion of which is scheduled for 16 July 2026.
Accordingly, the Issuer expects to receive the final list of questions within the next 1-2 business days following the conclusion of the CVMP meeting. The Issuer will inform the market of the receipt of the final list of questions immediately after it has been received by the Company, in a separate current report.
The Management Board of the Issuer notes that the EMA timetable, including the date of adoption and delivery of the final list of questions by the CVMP, forms part of the administrative procedure conducted by the EMA and remains beyond the Issuer’s control. In the Issuer’s Management Board’s assessment, the postponement of the receipt of the final list of questions compared to the date indicated in ESPI Current Report No. 11/2026 is of a technical and organisational nature and is related to the ongoing work on the EMA’s side. As at the date of this report, the Issuer has not identified any impact of this postponement on the substantive course of the BCX-CM-J registration process.
The Issuer publishes this information in view of the previously indicated timeline for the receipt of the additional questions from the EMA disclosed in ESPI Current Report No. 11/2026 and due to the key importance of the MA process for BCX-CM-J in the context of its potential commercialisation.
Attachment: None
Signatures of persons representing the Company:
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board