_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. 28/2026 dated 16 July 2026 regarding the receipt from the European Medicines Agency (“EMA”) of a list of questions as part of the process of seeking a positive recommendation for the marketing authorisation of the veterinary medicinal product BCX-CM-J, developed by the Company for the treatment of osteoarthritis in dogs, hereby informs that, following a detailed analysis and consultations with the industry advisor supporting the registration process, it has assessed the questions received and determined the anticipated scope and timetable of further activities.
In the Management Board’s assessment, the nature and scope of the questions received from the EMA are consistent with the Company’s expectations and with the typical course of the evaluation of a registration dossier at this stage of the procedure. In the Management Board’s opinion, the questions received do not indicate the emergence of any new or unexpected issues that would require a fundamental change to the registration strategy adopted to date.
At the same time, the industry advisor responsible for the BCX-CM-J registration process indicated that, based on its previous experience, the number of questions submitted by the EMA is relatively limited compared with the typical scope of comments raised in comparable registration procedures. The Management Board emphasises, however, that this assessment represents the expert opinion of the industry advisor and does not prejudge the final outcome of the procedure conducted by the EMA.
The Management Board also positively assesses the fact that the list of questions received does not contain any additional comments regarding the potency marker for BCX-CM-J, which may indicate that the explanations previously provided have been considered sufficient by the assessors.
The analysis conducted indicates that the issues raised by the EMA are focused primarily on two areas.
The first area concerns a further extension of the quality control testing programme through the implementation of additional analytical methods. As at the date of publication of this current report, the Issuer has engaged a specialised external contractor to develop the most time-consuming methods. Before being introduced into the routine quality control process, these methods will require validation. Due to the nature of these activities, their completion currently constitutes the main factor affecting the timing of the preparation of the Company’s responses to the EMA.
The second area concerns the need to perform a revalidation of the manufacturing process as a consequence of the planned implementation of the above-mentioned changes. This is a standard procedure applied when modifications are introduced to the manufacturing process of medicinal products.
The remaining questions and comments raised by the EMA will be addressed in parallel with the activities described above and, according to the Issuer’s current assessment, do not constitute factors determining the timeline for the submission of responses to the EMA.
Based on the current state of knowledge, the Management Board estimates that the completion of all necessary activities and the submission of the full set of responses and supporting documentation to the EMA should take place within approximately six months from the date of publication of this current report.
At the same time, the Management Board notes that the deadline for submitting responses to the EMA must be declared in advance and that any subsequent modification may be difficult due to the limited availability of time slots within the EMA schedule. Consequently, acting in accordance with the principle of prudence and on the basis of the risk assessment performed, the Management Board intends to request that the EMA set the final deadline for the submission of the documentation as 18 May 2027. This means that the estimated completion time for the required activities remains shorter than the deadline the Issuer intends to request from the EMA.
The adoption of such a deadline reflects the fact that the remaining activities include, among other things, the development and validation of analytical methods, i.e. research and development activities, as well as the revalidation of the product manufacturing process, the course of which may require the repetition of certain stages. In addition, the timetable takes into account standard operational risks associated with research and development and manufacturing activities, including planned downtime of infrastructure used within the quality control system and other events that may affect the timely completion of individual tasks.
In the Management Board’s opinion, the proposed deadline is conservative in nature and reflects a responsible approach to the management of the registration process. At the present stage, the Management Board believes that completion of the activities within a shorter timeframe remains possible. If all activities progress efficiently, the Issuer may request that the EMA set an earlier submission deadline, provided that a suitable slot is available within the EMA timetable. Conversely, in the Management Board’s opinion, committing to a shorter deadline at this stage could create unnecessary organisational risk, as the possibility of modifying such a deadline at a later stage could be significantly limited should unforeseen circumstances arise.
Following the submission of the responses, the documentation will be subject to further assessment by the Committee for Veterinary Medicinal Products (CVMP). Assuming that the deadline of 18 May 2027 is maintained, the current procedural timetable provides for the CVMP recommendation to be issued on 17 June 2027. If the CVMP issues a positive recommendation, the European Commission’s decision granting the marketing authorisation is generally issued within 67 days of the date of the CVMP recommendation.
The Management Board of the Issuer notes that the estimates concerning the timetable for the completion of the activities described above, with the exception of deadlines resulting directly from applicable administrative procedures of the EMA and the European Commission, are indicative and based on the information currently available and may therefore be subject to change. The Management Board further emphasises that the assessment of the questions received, the anticipated timetable of further activities and the opinion of the industry advisor presented in this report do not constitute any assurance or guarantee that the EMA will issue a positive recommendation or that a marketing authorisation for BCX-CM-J will ultimately be granted.
The Issuer considers this information to be material due to the significance of the BCX-CM-J registration process for the further development of the Company’s business and the commercialisation of the product, which may have a material impact on the Issuer’s future financial position.
Signatures of persons representing the Company:
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board