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Hansa Biopharma — Investor Relations & Filings

Ticker · HNSA ISIN · SE0002148817 LEI · 549300LLEO25ZJJ3NT91 ST Manufacturing
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Filings indexed 501 across all filing types
Latest filing 2017-08-02 Regulatory Filings
Country SE Sweden
Listing ST HNSA

About Hansa Biopharma

https://www.hansabiopharma.com/

Hansa Biopharma is a commercial-stage biopharmaceutical company that develops and commercializes treatments for rare immunologic diseases. The company's core focus is its proprietary antibody-cleaving enzyme technology platform, designed to target and inactivate immunoglobulin G (IgG) antibodies. This approach aims to inhibit harmful IgG-mediated immune responses. Its lead product, imilfidase, is used to enable kidney transplantation in highly sensitized patients who have a low probability of finding a compatible donor. The company is also advancing its enzyme technology to address unmet medical needs in other therapeutic areas, including acute autoimmune diseases, gene therapy, and oncology, where IgG antibodies can be a barrier to treatment or a driver of the disease.

Recent filings

Filing Released Lang Actions
The New England Journal of Medicine publishes results from Phase II studies of Hansa Medical’s lead candidate IdeS in highly sensitized patients
Regulatory Filings Classification · 99% confidence The document is explicitly labeled as a "PRESS RELEASE" dated August 2, 2017. It announces that clinical study results for the drug candidate IdeS will be published in The New England Journal of Medicine on August 3, 2017. Furthermore, it states that the company will host a conference call on August 3, 2017, to present the study results. This structure—announcing the publication of results and scheduling a call to discuss them—is characteristic of an Earnings Release (ER) or a general announcement related to financial/clinical milestones. Since the core content is the announcement of positive clinical trial data and the subsequent investor call details, it aligns best with an Earnings Release (ER), which often includes significant operational or clinical updates alongside financial highlights, or an Investor Presentation (IP) if it were the slides themselves. Given the format is a press release detailing results and announcing a call, ER is the most appropriate fit among the options, as it communicates key performance/development news. It is not the full report (10-K, IR), nor is it just a notice of a report publication (RPA).
2017-08-02 English
The New England Journal of Medicine publicerar resultat från fas II-studier med IdeS i högsensitiserade patienter
Regulatory Filings Classification · 95% confidence The document is a press release from Hansa Medical AB announcing that compiled data from three independent Phase II clinical studies for their drug candidate IdeS has been published in The New England Journal of Medicine (NEJM). The text details the study results, quotes key authors, provides publication details (DOI, date), and announces a subsequent conference call to discuss these results. This structure—announcing the publication of scientific/clinical results and inviting analysts to a call—is characteristic of an Earnings Release (ER) or a general announcement related to scientific progress. Since it is not a full financial report (10-K, IR) or a transcript of the call itself (CT), and it is specifically announcing the publication of scientific data, it aligns best with an Earnings Release (ER) if the company typically uses this format for major clinical updates, or potentially a Regulatory Filing (RNS) if it's mandated disclosure. Given the context of a major scientific publication being the core news, and the inclusion of contact information typical of a corporate announcement, ER is a strong candidate, as many biotech/pharma companies use ERs for significant clinical milestones. However, the primary action is the *publication* of data, which often triggers an ER or a Report Publication Announcement (RPA). Since the document is substantial (11k+ chars) and contains detailed scientific context rather than just saying 'the report is attached,' it is more than just an RPA. It functions as a major corporate update driven by the scientific publication. In the context of financial reporting databases, major clinical trial result announcements are frequently categorized under ER, especially when they are the primary driver of the news cycle for that period. I will classify it as an Earnings Release (ER) because it details significant performance/progress milestones, even if not strictly quarterly financials, which is common for biotech announcements. If ER is too narrow, RNS would be the fallback, but ER captures the significance of the 'results' announcement better.
2017-08-02 Swedish
Interim / Quarterly Report 2017
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Delårsrapport' (Interim Report) for the period April–June 2017. It contains detailed financial tables, a management review (Vd har ordet), business overview, and pipeline information. It is a comprehensive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report (IR). Q2 2017
2017-07-20 Swedish
Interim / Quarterly Report 2017
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Interim report April –June 2017' and contains comprehensive financial summaries, including income statements (Net revenue, Operating profit/loss, Net profit/loss) and balance sheet items (Shareholders' equity, Cash flow) for the Q2 and H1 periods. It also includes a CEO statement, business overview, and pipeline status. This meets the criteria for an Interim/Quarterly Report (IR) as it provides substantive financial data and analysis for a period shorter than a full fiscal year. H1 2017
2017-07-20 English
First patient treated in Phase II study with IdeS in anti-GBM antibody disease
Legal Proceedings Report Classification · 99% confidence The document is explicitly labeled as a "PRESS RELEASE" dated June 20, 2017. It announces a specific corporate event: the first patient being treated in a Phase II study for their drug candidate IdeS. This type of announcement, detailing clinical trial progress and business updates via a press release, is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is not a full financial report (10-K, IR), a transcript (CT), or a specific management discussion (MDA), and it is a direct announcement of operational news, it fits best under the Earnings Release category if it were tied to a reporting period, or RNS if it's general news. Given the context of clinical trial updates, which often accompany or precede earnings announcements, and the fact that it is a direct, non-financial-summary announcement, it is most closely aligned with an Earnings Release (ER) which covers key operational highlights, or RNS as a general regulatory disclosure. Since it is a specific operational update rather than a general regulatory filing fallback, and press releases often serve as the initial release of key news, ER is a strong candidate. However, since it is not reporting financial results (revenue, profit, EPS), RNS (Regulatory Filings/General Announcement) is the most appropriate fallback for specific, non-financial operational news releases that don't fit other categories like M&A or Capital Change. Given the options, RNS is the safest classification for a clinical trial update press release that isn't a formal financial report or earnings summary.
2017-06-20 English
Första patienten behandlad i fas II-studie med IdeS i anti-GBM-sjukdom
Regulatory Filings Classification · 95% confidence The document is explicitly labeled as a "PRESSMEDDELANDE" (Press Release) dated June 20, 2017. It announces a specific corporate event: the first patient treatment in a Phase II study for the drug IdeS in anti-GBM disease. It also contains contact information for Investor Relations and mentions compliance with the EU Market Abuse Regulation (MAR) for public disclosure. This structure—a brief announcement of a clinical/business update, not a full financial report (like 10-K or IR) or a transcript—is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it details a specific operational/clinical milestone rather than summarizing quarterly financial performance (which would lean towards ER), and it is a formal, mandated disclosure under MAR, it fits best as a general Regulatory Filing (RNS) or potentially an Earnings Release if the company uses ERs for all major operational news. Given the focus on clinical trial progress and the explicit mention of MAR disclosure requirements, RNS is the most appropriate general regulatory category for this type of announcement that isn't a standard financial report or call transcript. However, since it is a direct announcement of a significant business event (clinical trial milestone), it often falls under the scope of an Earnings Release (ER) if the company doesn't have a separate category for clinical updates, or RNS as a catch-all. Given the options, RNS is the safest fallback for a non-financial, mandated regulatory announcement. Upon review, ER is typically for financial results. This is a clinical update announced via press release, making RNS the best fit as a general regulatory announcement.
2017-06-20 Swedish

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