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The Management Board of Bioceltix S.A. with its registered office in Wrocław (the “Issuer”, the “Company”), with reference to current report ESPI No. 19/2025 dated August 12, 2025 informing about the final results of the clinical trial regarding the safety and efficacy of the product BCX-CM-AD in the treatment of atopic dermatitis in dogs (the “Clinical Trial Results Report”), hereby provides additional information regarding the long-term observation of patients participating in the trial.
As part of the additional observation, follow-up visits were conducted on Days 112 +/- 3, 140 +/- 3 and 168 +/- 3. Data from the additional visits are descriptive in nature and do not constitute part of the statistical analysis of the study endpoints.
The additional observation period (up to Day 168 +/- 3) was completed by 23 patients (out of 26 patients who started the observation) in the group treated with the investigational product (IVP) and 4 patients in the control group (CP). The low number of patients in the control group is an expected phenomenon and results from the limited efficacy of placebo – over time, the probability of introducing additional treatment in patients from the control group increases, which results in their exclusion from further observation within the study. Data in the control group, due to its low size (4 patients), should be considered non-representative.
In patients in the IVP group on Days 112 +/- 3, 140 +/- 3 and 168 +/- 3, a sustained reduction in the mean value of the CADESI-4 index describing veterinarian-assessed skin lesions was observed, reaching up to 82% relative to baseline, as well as a sustained reduction in the mean value of the PVAS index describing veterinarian-assessed pruritus level, reaching up to 62% relative to baseline.
Additionally, in the period from Day 84 +/- 3 to Day 168 +/- 3, results of surveys on overall satisfaction with response to treatment were collected. For this purpose, the OST index (Owner Satisfaction to Treatment) and the IST index (Investigator Satisfaction to Treatment) were used. The percentage of surveys indicating a treatment response at the level of Good or Excellent on Day 168 +/- 3 amounted to 82.6% for the OST index and 78.2% for the IST index.
With regard to the safety of use of the investigational medicinal product, in the period from Day 84 +/- 3 to Day 168 +/- 3, results qualitatively consistent with those obtained in the period from Day 0 to Day 84 +/- 3 were obtained, which the Issuer reported in the Clinical Trial Results Report.
The Issuer’s Management Board emphasizes that the obtained long-term data strengthen the profile of the BCX-CM-AD product as a therapy with a potentially long-lasting clinical effect after a single administration, which may be relevant both in the registration process and in the future positioning of the product on the market.
At the same time, the Issuer notes that data from the extended observation period concern only a part of the entire group of clinical trial participants. These data are of a supportive nature, and the lack of their statistical significance does not negatively affect the process of applying for marketing authorization of the product. However, these data may have a positive impact on the regulatory process.
The Issuer’s Management Board considered this information to be material due to the fact that long-term data confirming the durability of the therapeutic effect may be relevant for the assessment of the commercial potential of the BCX-CM-AD product, and thus also for the Issuer’s future market position and its financial standing.
Signatures of persons representing the Company:
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board
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