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Ascelia Pharma — Investor Relations & Filings

Ticker · ACE ISIN · SE0010573113 LEI · 5493002YR9VCJJPWYN08 ST Manufacturing
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Filings indexed 295 across all filing types
Latest filing 2021-01-12 Regulatory Filings
Country SE Sweden
Listing ST ACE

About Ascelia Pharma

https://www.ascelia.com/

Ascelia Pharma is a biotechnology company focused on developing and commercializing novel drugs for orphan oncology. The company aims to address unmet medical needs for patients with rare cancer conditions. Its lead product candidate, Orviglance, is an oral manganese-based contrast agent for magnetic resonance imaging (MRI). It is designed to improve the detection and visualization of liver metastases, particularly in adult patients with severely impaired kidney function for whom existing contrast agents may be contraindicated. The company's strategy involves identifying, developing, and commercializing innovative treatments for niche cancer-related conditions.

Recent filings

Filing Released Lang Actions
Ascelia Pharma presenterar klinisk utvecklingsplan för Oncoral som en ny cellgiftsbehandling
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and is dated January 12, 2021. It announces the clinical development plan for a drug candidate, Oncoral, specifically mentioning the planned Phase 2 study for gastric cancer starting in H2 2021. It details the drug mechanism, comparison to existing treatments (irinotecan), and potential benefits regarding efficacy and safety. The concluding paragraph states: "Denna information är sådan information som Ascelia Pharma AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning." (This information is such information that Ascelia Pharma AB (publ) is obliged to disclose pursuant to the EU's Market Abuse Regulation). This structure—a formal announcement of material, non-public information required under market regulations—is characteristic of a general regulatory announcement rather than a specific periodic report (like 10-K or IR) or a detailed investor presentation (IP). Since it is a formal regulatory disclosure that doesn't fit the specific categories like Director's Dealing (DIRS), Dividend Notice (DIV), or Earnings Release (ER), the most appropriate fallback category for a general regulatory announcement under EU MAR is Regulatory Filings (RNS). The document length (6636 chars) is substantial enough to be the primary announcement itself, not just a brief notice of publication (RPA).
2021-01-12 Swedish
Ascelia Pharma presents clinical development plan for Oncoral as a novel chemotherapy
Regulatory Filings Classification · 99% confidence The document is explicitly titled 'PRESS RELEASE' and dated January 12, 2021. It announces the clinical development plan for a drug candidate ('Oncoral'), detailing upcoming Phase 2 study timelines, endpoints, and scientific rationale. This type of announcement, which communicates key operational and clinical updates to the market, is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a press release detailing significant operational news (clinical plan update) rather than just the formal release of financial results (ER) or a miscellaneous regulatory notice (RNS), it fits best as an Earnings Release (ER) if it were tied to a reporting period, or more generally, a communication of material information. However, given the options, this is a proactive announcement of business/clinical progress, which often accompanies or substitutes for a formal earnings report in biotech/pharma, or it is a general material announcement. Since it is not a full financial report (10-K, IR) or a presentation (IP), and it is a formal press release announcing key operational milestones, 'ER' (Earnings Release, often used broadly for key operational updates in this context) or 'RNS' (Regulatory Filings/General Announcement) are the closest fits. Given the content is focused on clinical development milestones rather than financial performance highlights, 'RNS' (Regulatory Filings/General Announcement) is the most appropriate fallback for a material, non-financial-specific press release, although 'ER' is often used for any major company update press release. I will classify it as RNS as it is a general regulatory announcement of a material event, not strictly an earnings summary.
2021-01-12 English
Ascelia Pharma gets US patent for second generation Mangoral
Regulatory Filings Classification · 100% confidence The document is titled "PRESS RELEASE" and announces a specific corporate event: the granting of a US patent for a second-generation drug formulation (Mangoral). It includes details about the patent protection, the drug candidate, and quotes from the CEO. This type of announcement, which is a specific, material update that doesn't fit neatly into standard financial reports (10-K, IR, ER), capital structure changes (CAP, SHA), or management changes (MANG), is best classified as a general Regulatory Filing or announcement. Since it is a press release detailing a specific, non-financial regulatory/IP event, and there isn't a specific 'Intellectual Property Announcement' code, the most appropriate general category is 'Regulatory Filings' (RNS), which serves as a fallback for miscellaneous regulatory announcements. Given the document length is short (3439 chars) and it is a direct announcement rather than a detailed report, RNS is suitable.
2020-12-15 English
Ascelia Pharma får amerikanskt patent för andra generationens Mangoral
Regulatory Filings Classification · 100% confidence The document is titled "PRESS RELEASE" and announces a specific corporate event: the granting of a US patent for a second-generation drug formulation (Mangoral). It includes details about the patent protection, the drug candidate, and quotes from the CEO. This type of announcement, which is a specific, material update that doesn't fit neatly into standard financial reports (10-K, IR, ER), capital structure changes (CAP, SHA), or management changes (MANG), is best classified as a general Regulatory Filing or announcement. Since it is a press release detailing a specific, non-financial regulatory/IP event, and there isn't a specific 'Intellectual Property Announcement' code, the most appropriate general category is 'Regulatory Filings' (RNS), which serves as a fallback for miscellaneous regulatory announcements. Given the document length is short (3439 chars) and it is a direct announcement rather than a detailed report, RNS is suitable.
2020-12-15 English
Major Shareholding Notification 2020
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding percentage by a specific holder (Handelsbanen Fonder AB) in the issuer (Ascelia Pharma AB). It explicitly shows the 'Before the transaction' and 'After the transaction' share counts and voting rights, and the reason is stated as 'Sell'. This structure perfectly matches the definition of a Major Shareholding Notification, which reports changes in significant ownership levels crossing thresholds. The corresponding code is MRQ.
2020-12-04 English
Ny studie visar att Mangorals visualisering av lesioner är lika effektiv som gadoliniumbaserat kontrastmedel
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces the results of a study comparing their product, Mangoral, against a standard contrast agent. It details clinical findings, quotes management, and concludes with contact information and a statement about regulatory disclosure obligations ("EU:s marknadsmissbruksförordning"). This structure strongly indicates an initial announcement of significant company news, specifically related to clinical trial data or product efficacy, rather than the full regulatory report itself (like 10-K or IR). Since it is the initial release of key financial/clinical highlights, it fits the definition of an Earnings Release (ER) or a general Regulatory Filing (RNS). Given that it is a specific announcement of study results, which often accompanies or precedes formal earnings/quarterly reports, and it is not a transcript (CT) or a formal presentation (IP), the most appropriate classification for a press release announcing key operational/clinical milestones is often the general Regulatory Filing (RNS) or, if it contains key performance indicators, ER. However, since the content is purely clinical/product development news and not quarterly financial performance summary, RNS is a strong candidate. Given the options, and recognizing that press releases announcing study results are often categorized broadly, I will check if it fits better elsewhere. It is not a management change (MANG), dividend (DIV), or capital change (CAP). It is a specific announcement. Since it is a press release announcing results, and not the full report, RNS (Regulatory Filings - general regulatory announcements) is the best fit as a catch-all for non-standard, yet mandatory, disclosures, although ER is sometimes used for positive clinical news releases. Given the context of a clinical study result announcement, RNS is the most neutral and accurate fit for a general regulatory announcement that isn't a standard financial report.
2020-12-02 Swedish

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