_MACHINE TRANSLATION_
The Management Board of Bioceltix S.A. (the “Company”, the “Issuer”), with reference to current report ESPI No. 51/2025 dated 23 December 2025 regarding receipt of the final report from the Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny, “GIF”) confirming the Company’s compliance with Good Manufacturing Practice (“GMP”), hereby announces that on 17 February 2026 it obtained information on the granting of a GMP certificate to the Issuer.
According to the information obtained, GIF granted the Issuer GMP certificate No. ISF.405.13.2026.IP.1 (Certificate of GMP Compliance, the “GMP Certificate”) for the facility located in Wrocław at ul. Bierutowska 57–59, Building III. The certificate was issued following an inspection conducted on 25–28 November 2025.
The GMP Certificate reflects the compliance status of the facility with GMP principles and guidelines as of the last day of the above-mentioned inspection. The GMP Certificate expires three years after the date of the last inspection, unless this period is shortened by a separate decision of GIF. As of the date of publication of this current report, the GMP Certificate is valid until 28 November 2028.
Obtaining the GMP Certificate confirms that the pharmaceutical manufacturing facility operated by the Issuer meets the applicable GMP requirements for the manufacture of sterile, biological veterinary medicinal products, including cell therapy products, intended for marketing following the granting of the relevant authorizations in accordance with the regulations in force in the European Union.
At the same time, obtaining the GMP Certificate constitutes a prerequisite in the process of applying for marketing authorization for the veterinary medicinal products developed by the Issuer and therefore contributes to reducing regulatory risks. It also represents a significant element of the processes related to the development, registration and commercialization of these products. The GMP Certificate is also of material importance in relations with business partners, including potential counterparties, who expect formal confirmation of compliance with GMP standards.
The full text of the GMP Certificate is available in the EudraGMDP database at: https://eudragmdp.ema.europa.eu/inspections/gmpc/prepReviewSubmittedGMPC.do?key=182927.
The Issuer’s Management Board considers this information to be material due to the fact that obtaining the GMP Certificate constitutes a significant milestone in the development and commercialization process of the veterinary medicinal products developed by the Issuer.
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board