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Pure Biologics S.A. — Investor Relations & Filings

Ticker · PUR ISIN · PLPRBLG00010 LEI · 2594002TXS19AUYHIF82 WAR Manufacturing
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Filings indexed 515 across all filing types
Latest filing 2023-12-22 Regulatory Filings
Country PL Poland
Listing WAR PUR

About Pure Biologics S.A.

https://purebiologics.com/

Pure Biologics S.A. is a biopharmaceutical company engaged in the discovery and development of novel biological drugs and non-systemic therapies. The company leverages its expertise in antibody and aptamer technologies to create innovative treatments. Its therapeutic portfolio is primarily focused on immuno-oncology. A key aspect of its strategy is the development of original, non-generic and non-biosimilar, biological drug candidates.

Recent filings

Filing Released Lang Actions
Zgoda amerykańskiej Agencji ds. Żywności i Leków [Food and Drug Administration - FDA] na przeprowadzenie badania klinicznego Fazy 0 w projekcie PB004 - Content (PL)
Regulatory Filings Classification · 99% confidence The document discusses receiving approval from the US FDA (Food and Drug Administration) to proceed with a Phase 0 clinical trial for a drug candidate (PBA-0405) in patients with solid tumors. It details the nature of the study, the timeline (expected completion mid-2024), and the strategic importance of these results for potential partnering agreements. This content relates directly to the development and testing of a medical product, specifically concerning regulatory milestones and clinical trial progress. This fits best under 'Legal Proceedings Report' (LTR) if it were about a lawsuit, but since it is about regulatory approval for a clinical trial, it is a specific type of regulatory/legal update. However, none of the codes perfectly capture 'Clinical Trial Update'. Given the options, this is a significant regulatory/legal development concerning the company's operations and product pipeline. It is not an earnings release (ER), an annual report (10-K), or a management discussion (MDA). Since it details a critical regulatory step (FDA approval for testing) and the subsequent legal/procedural steps (the trial itself), it aligns most closely with 'Legal Proceedings Report' (LTR) as a broad category for significant external regulatory/legal interactions, or potentially 'Regulatory Filings' (RNS) as a general catch-all for non-financial regulatory news. Given the focus on FDA approval and clinical trial initiation, which often involves detailed regulatory submissions and outcomes, LTR is a plausible fit for significant legal/regulatory milestones, though RNS is the ultimate fallback. Since it is a specific update on a regulatory hurdle being cleared for a product, I will classify it as LTR, as it pertains to the legal/regulatory framework governing their product development, or RNS if LTR is too narrow. Considering the context of FDA approval, LTR seems slightly more appropriate than the generic RNS, as it is a specific, material event impacting the company's legal standing regarding its product. However, upon review, LTR is defined as 'Legal Proceedings Report' (lawsuits/regulatory actions). This is an approval, not a proceeding or action against them. Therefore, the most appropriate category for a material, non-financial regulatory update that doesn't fit elsewhere is the fallback, RNS.
2023-12-22 Polish
Odwołanie oferty publicznej akcji serii I oraz informacja o dalszych planowanych działaniach Spółki - Content (PL)
Capital/Financing Update Classification · 98% confidence The document is a formal announcement by the Management Board of Pure Biologics S.A. regarding the cancellation of a public offering of Series I shares, which was based on a prospectus approved by the Polish Financial Supervision Authority (KNF). The core content discusses the failure to meet the minimum subscription threshold and outlines immediate plans for alternative financing methods, such as a private placement, obtaining a loan, or selling assets. This clearly relates to fundraising, financing activities, and capital structure changes, fitting the definition of 'Capital/Financing Update'.
2023-12-19 Polish
Zawiadomienie na podstawie art. 69 Ustawy o Ofercie_TFI Allianz Polska S.A.
Declaration of Voting Results & Voting Rights Announcements Classification · 99% confidence The document explicitly states that TFI Allianz Polska S.A., acting on behalf of several funds, is informing about a change in the level of engagement (shareholding) in Pure Biologics S.A. following the sale of shares on December 13, 2023. It details the percentage of share capital and voting rights before and after the transaction, citing specific articles of Polish public offering law (art. 69 and art. 87). This type of filing, reporting changes in significant share ownership thresholds, directly corresponds to the Major Shareholding Notification category.
2023-12-16 Polish
Zawiadomienie o zmianie stanu posiadania akcji Spółki - Content (PL)
Major Shareholding Notification Classification · 99% confidence The document text is very short (713 characters) and explicitly states that the Management Board ('Zarząd') received a notification ('zawiadomienie') regarding a change in share ownership ('zmianie stanu posiadania akcji') from TFI Allianz Polska S.A. and is transmitting the content of this notification attached to the current current report ('niniejszym raportu bieżącego'). This structure—announcing the receipt of information and attaching the details—strongly suggests a regulatory notification filing. The reference to 'art. 70 pkt 1 ustawy z dnia 29 lipca 2005 r. o ofercie publicznej' (Polish Public Offering Act) confirms it is a mandatory regulatory disclosure. Since the content is a notification about a change in major shareholding (crossing thresholds), the most specific category is Major Shareholding Notification (MRQ). If MRQ were not available, RNS would be the fallback, but MRQ is a better fit for changes in ownership percentage.
2023-12-16 Polish
Skrócone sprawozdanie finansowe za okres 01.07-30.09.2023 - korekta
Interim / Quarterly Report Classification · 100% confidence The document is a 'Śródroczne skrócone sprawozdanie finansowe' (Interim condensed financial report) for the period 01.07.2023 - 30.09.2023. It contains detailed financial statements, including the Statement of Profit or Loss and Other Comprehensive Income, and the Statement of Financial Position, along with explanatory notes. It is a comprehensive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report. 9M 2023
2023-12-12 Polish
Realizacja zalecenia KNF w zakresie oceny kondycji finansowej Spółki - Content (PL)
Regulatory Filings Classification · 95% confidence The document is a regulatory announcement from Pure Biologics S.A. regarding a correction to their Q3 2023 interim report following feedback from the Polish Financial Supervision Authority (KNF). It explains the nature of the correction (liquidity and going concern analysis) and outlines the company's financial strategy and funding sources. Since it is an announcement about a forthcoming correction to a report rather than the report itself, and it serves as a formal regulatory disclosure, it falls under the RNS category. 9M 2023
2023-12-12 Polish

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