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Bioceltix S.A. — Investor Relations & Filings

Ticker · BCX ISIN · PLBCLTX00019 LEI · 259400QZD5JYK8SLZU51 WAR Manufacturing
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Filings indexed 270 across all filing types
Latest filing 2023-12-14 Regulatory Filings
Country PL Poland
Listing WAR BCX

About Bioceltix S.A.

https://bioceltix.com/en/

Bioceltix S.A. is a biopharmaceutical company that develops stem cell-based medicinal products for veterinary use. The company focuses on creating therapies that utilize Mesenchymal Stem Cells (MSCs) as the active pharmaceutical ingredient. Its product pipeline is aimed at treating immunological and inflammatory conditions in companion animals, including dogs, cats, and horses. A key area of development includes treatments for conditions such as atopic dermatitis in dogs and degenerative joint disease.

Recent filings

Filing Released Lang Actions
Uzyskanie zgody na przeprowadzenie terenowego badania klinicznego na pacjentach klinicznych z objawami atopowego zapalenia skóry dla kandydata na produkt leczniczy BCX-CM-AD w Irlandii - Content (PL)
Regulatory Filings Classification · 1% confidence The document text is a formal announcement by the Management Board ("Zarząd") of Bioceltix S.A. regarding obtaining a license (number CT23392/006) from the Irish Health Products Regulatory Authority to conduct a planned veterinary clinical trial on dogs for their medicinal product BCX-CM-AD. This announcement details a significant step in the development pipeline of a product candidate. This type of information, concerning regulatory milestones in product development, is generally classified as an Investor Presentation (IP) if it were a detailed deck, or more specifically, it relates to the progress of the company's core operations and strategy, often shared with investors. However, given the specific definitions, this is not a standard financial report (10-K, IR, ER), nor is it a management change (MANG) or director dealing (DIRS). It is a specific update on product development progress which often falls under Investor Presentation (IP) or sometimes Regulatory Filings (RNS). Since it is a specific, material update on a key asset's progress, 'Investor Presentation' (IP) is the closest fit for strategic operational updates, although 'Regulatory Filings' (RNS) is also plausible as a fallback. Given the content focuses on achieving a regulatory milestone for a product candidate, which is crucial for investor understanding of future value, IP is selected over the general RNS fallback, as it is a specific operational update.
2023-12-14 Polish
Wyniki weterynaryjnego badania klinicznego dla produktu BCX-CM-J: potwierdzenie skuteczności i bezpieczeństwa w zakresie drugorzędowych punktów kontrolnych - Content (PL)
Audit Report / Information Classification · 1% confidence The document is a formal announcement by the Management Board ("Zarząd") of Bioceltix S.A. detailing the final results of a veterinary clinical trial for a product (BCX-CM-J) treating osteoarthritis in dogs. It specifically discusses the statistical significance of secondary endpoints (endpoints beyond the primary ones previously reported). This content relates to the development and testing of a product, which falls under the scope of regulatory or scientific reporting, but it is not a full Annual Report (10-K), a general Earnings Release (ER), or a standard Audit Report (AR). Given the detailed scientific and statistical nature of the findings regarding efficacy and safety endpoints, this document is best classified as a specific type of regulatory or scientific disclosure. It is not a general regulatory filing (RNS) because it is highly specific. It is not a management discussion (MDA) as it focuses purely on trial results, not broader business trends. It is not a legal report (LTR). Since it details the results of a clinical study, it is most closely related to scientific/regulatory updates. However, none of the provided codes perfectly match 'Clinical Trial Results Announcement'. Reviewing the definitions: - AR (Audit Report / Information): Includes results of internal or regulatory stress tests. Clinical trial results are a form of internal testing/validation. - LTR (Legal Proceedings Report): Not applicable. - RNS (Regulatory Filings): A fallback, but the content is very specific. In the context of financial reporting databases, detailed clinical trial outcomes that are material to future commercialization are often categorized under general regulatory disclosures or scientific updates. Since the document is a formal report of findings that will lead to an application to the EMA, it is a significant regulatory/scientific disclosure. Given the options, 'AR' (Audit Report / Information) is the closest fit as it covers 'applied accounting principles, and results of internal or regulatory stress tests'—clinical trials are a form of internal validation/testing required for regulatory approval. If a more specific 'Clinical Trial' code existed, it would be preferred. Lacking that, and recognizing this is a formal report of testing results, AR is the most appropriate category among the choices that deal with formal testing outcomes. FY 2023
2023-12-11 Polish
Wyniki weterynaryjnego badania klinicznego dla produktu BCX-CM-J: potwierdzenie skuteczności i bezpieczeństwa w zakresie drugorzędowych punktów kontrolnych - uzupełnienie informacji - Content (PL)
Earnings Release Classification · 1% confidence The document is a Polish regulatory filing (raport bieżący) from Bioceltix S.A. that explicitly states it is correcting/clarifying information previously provided in another report (raport bieżący nr 60/2023). It details the final results of a veterinary clinical trial for a product (BCX-CM-J) concerning secondary endpoints, including statistical significance findings for lameness, pain scores, and joint scores over various time points (Day 14, 30, 45, 90). This content is a detailed report of clinical trial results and their statistical analysis, which falls under the scope of comprehensive reporting for a specific period or event, rather than just a brief earnings release (ER) or a general announcement of a report (RPA/RNS). Since the text provides comprehensive, detailed financial/operational results for a specific period (the conclusion of a clinical trial phase) and is not the annual report (10-K) or a short interim report (IR), it best fits the category for detailed operational/scientific updates that are not strictly financial results. Given the options, this detailed report on clinical trial outcomes, which is a significant operational event, is most closely aligned with the comprehensive nature of an Interim Report (IR) if it were a standard financial period, or potentially a Regulatory Filing (RNS) if no better fit exists. However, since it is a detailed report of findings, and not just a summary, it is more substantial than a typical RNS. Reviewing the definitions: - 10-K: No, it's not the annual report. - ER: No, it's too detailed for an initial earnings release. - IR: This is a comprehensive report for a specific event (clinical trial conclusion), which shares characteristics with an Interim Report (detailed performance review). - LTR: It relates to regulatory submission plans, but the core content is the trial results, not a legal proceeding. Given the depth of the data presentation (statistical analysis, primary/secondary endpoints, comparison to control groups), it functions as a comprehensive operational/scientific report. In the absence of a specific 'Clinical Trial Report' code, and noting that it is a detailed report covering a specific period/event, it is classified as an Interim Report (IR) due to its comprehensive nature, or RNS as a catch-all for specific regulatory updates. Since it is a full report being re-issued with a correction, and not just a short announcement, RNS is the most appropriate fallback for a specific, non-standard regulatory update that isn't a standard financial period report. Revisiting the context: The document is a 'raport bieżący' (current report) correcting a previous one. These are typically classified under RNS (Regulatory Filings) unless they map perfectly to 10-K, IR, or ER. This is a detailed update on R&D progress, which fits well under the general regulatory announcement category. Q4 2023
2023-12-11 Polish
Informacja dodatkowa w ramach raportu kwartalnego za III kwartał 2023 r.
Interim / Quarterly Report Classification · 1% confidence The document is titled 'RAPORT KWARTALNY SPÓŁKI BIOCELTIX S.A.' (Quarterly Report of Bioceltix S.A.) for the third quarter of 2023. It contains a management letter, a table of contents, financial statements, and a management report on activities. It is a comprehensive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report (IR). Q3 2023
2023-11-22 Polish
Pozostałe informacje w ramach raportu kwartalnego za III kwartał 2023 r.
Interim / Quarterly Report Classification · 1% confidence The document is titled 'RAPORT KWARTALNY SPÓŁKI BIOCELTIX S.A.' (Quarterly Report of Bioceltix S.A.) for the third quarter of 2023. It contains a management letter, a table of contents, financial statements, and a management report on activities. It is a comprehensive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report (IR). Q3 2023
2023-11-22 Polish
Uzyskanie zgody na przeprowadzenie terenowego badania klinicznego na pacjentach klinicznych z objawami atopowego zapalenia skóry dla kandydata na produkt leczniczy BCX-CM-AD na Węgrzech oraz w Port...
Regulatory Filings Classification · 1% confidence The document text is a formal announcement by the Management Board ('Zarząd') of Bioceltix S.A. regarding obtaining necessary permits from veterinary regulatory bodies in Hungary and Portugal to conduct a planned field clinical trial for a veterinary medicinal product (BCX-CM-AD). This information is deemed material because it represents an important step in the development pipeline towards potential commercialization. This type of announcement, detailing regulatory progress or legal/clinical trial milestones, fits best under 'Legal Proceedings Report' (LTR) if it relates to regulatory actions or significant legal/clinical developments, or potentially 'Regulatory Filings' (RNS) as a general regulatory update. Given the specific nature of obtaining permits for a clinical trial, which is a critical regulatory step, and the absence of a more specific category like 'Capital/Financing Update' or 'Earnings Release', 'LTR' (Legal Proceedings Report, often used broadly for significant regulatory/legal milestones) or 'RNS' (General Regulatory Filings) are the closest fits. Since it is a specific regulatory milestone announcement, 'RNS' (Regulatory Filings) serves as the most appropriate general category for non-standard, material regulatory updates that aren't standard periodic reports (10-K, IR) or specific transaction reports (DIV, SHA). The document length is short (1296 chars), but it contains the full substance of the announcement, not just a notice to download another document, so RPA is not applicable. I will classify it as RNS as it is a material regulatory update.
2023-10-23 Polish

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