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Sequana Medical N.V. — Investor Relations & Filings

Ticker · SEQUA ISIN · BE0974340722 LEI · 8755009AN12Y4PEOII07 BR Manufacturing
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Filings indexed 501 across all filing types
Latest filing 2023-10-19 Regulatory Filings
Country BE Belgium
Listing BR SEQUA

About Sequana Medical N.V.

https://www.sequanamedical.com/

Sequana Medical N.V. is a commercial-stage medical device company focused on developing treatments for drug-resistant fluid overload, a frequent complication in patients with liver disease, heart failure, and cancer. The company's primary product is the alfapump®, a fully implanted, wirelessly charged system that automatically and continuously removes ascites (fluid accumulation in the abdomen) into the bladder for natural elimination. It is the first U.S. FDA-approved active implantable medical device for treating recurrent or refractory ascites due to liver cirrhosis, designed to reduce or eliminate the need for therapeutic paracentesis. Sequana Medical is also advancing its DSR® (Direct Sodium Removal) therapy platform, a novel approach for managing fluid overload in heart failure patients.

Recent filings

Filing Released Lang Actions
Press release_Additional alfapump data_19 Oct 2023_NL_vF.pdf
Regulatory Filings Classification · 99% confidence The document is a press release from Sequana Medical dated October 19, 2023, announcing positive clinical data updates for its alfapump, patient preference study results, and a successful pre-PMA meeting with the FDA, confirming they are on schedule for a PMA submission by year-end. It also announces a conference call for the same day to discuss these results. This structure—announcing key results, providing management commentary, detailing study outcomes, and scheduling an investor call—is characteristic of an Earnings Release (ER) or a general press release detailing significant operational/clinical milestones. Since it focuses heavily on clinical trial results and regulatory progress (PMA submission) rather than comprehensive quarterly financial statements (which would suggest 10-K or IR), and it is an initial announcement of these results, 'Earnings Release' (ER) is the most appropriate fit among the options, as these types of operational updates often accompany or substitute for formal earnings reports in biotech/medtech contexts, or serve as a major investor update. It is not a Call Transcript (CT) as it is the announcement itself, not the transcript. It is not a 10-K (Annual Report) or IR (Interim Report) because it lacks the comprehensive financial statements. It is not an RPA because it contains substantial content, not just a notice that a report is attached.
2023-10-19 Dutch
Press release_MOJAVE initial data_18 Oct 2023_ENG_vF.pdf
Earnings Release Classification · 95% confidence The document is explicitly labeled as a "PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION" dated October 18, 2023. It announces initial positive clinical data from the MOJAVE study regarding their DSR 2.0 product. This type of announcement, which releases key financial/operational highlights and schedules a conference call, fits the definition of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a formal announcement of results and operational updates, and not the full financial report (10-K or IR), 'ER' is the most appropriate classification for a press release detailing period results/developments. The document length is substantial (14,575 chars), suggesting it contains more than just a brief announcement, but its primary function is the immediate release of material information, which aligns best with ER. Q4 2023
2023-10-18 English
Press release_MOJAVE initial data_18 Oct 2023_NL_vF.pdf
Regulatory Filings Classification · 95% confidence The document is a press release announcing initial positive data from a clinical trial (MOJAVE study) regarding a medical treatment (DSR® 2.0) for heart failure. It details preliminary results, quotes medical advisors, mentions upcoming conference calls, and provides background on the company and the study protocol. This type of announcement, focusing on clinical trial updates and immediate results dissemination, is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a detailed announcement of specific clinical data and operational updates (like the upcoming conference call), it fits best as an Earnings Release (ER) which often includes key operational and clinical highlights, or potentially a Regulatory Filing (RNS) if it were less focused on financial/operational performance highlights. Given the structure announcing key data points and scheduling a call to discuss them, ER is a strong candidate, but because it is primarily a clinical data update rather than a standard quarterly financial summary, RNS (Regulatory Filings/General Announcement) is often used for such specific, non-standard regulatory disclosures, especially in European contexts where press releases serve this function broadly. However, the content strongly resembles an 'Earnings Release' in function—announcing period performance/updates. Since the definitions prioritize ER for initial periodical financial results announcements, and this is a significant operational/data update, I will lean towards RNS as the most appropriate catch-all for significant, non-standard regulatory/operational news that isn't a full report (10-K, IR) or a specific management/dividend notice. The document is substantial (15k+ chars) and contains detailed data, so it is not an RPA. Given the focus on clinical trial progress and the announcement of an accompanying conference call, RNS is the safest classification for a broad regulatory/operational announcement not covered by other specific codes.
2023-10-18 Dutch
7 -- 7 199 Board Report (ENG) (redacted).pdf
Management Reports Classification · 99% confidence The document is explicitly titled "SPECIAL REPORT OF THE BOARD OF DIRECTORS IN ACCORDANCE WITH ARTICLE 7:199 OF THE BELGIAN COMPANIES AND ASSOCIATIONS CODE". This report details a proposal to renew the board's power to increase the company's share capital under the authorised capital, which is a matter directly related to the company's capital structure and is being presented for approval at an extraordinary general shareholders' meeting. This content strongly aligns with the definition of a document concerning capital/financing activities, specifically related to share issuance authority. While it is a report, it is not a standard Annual Report (10-K) or Interim Report (IR). It is a specific corporate action document related to capital structure changes. The closest fit among the provided codes is 'Capital/Financing Update' (CAP), as it focuses entirely on renewing the authority to issue new shares and the associated terms. It is a formal report detailing a proposed capital structure change, not just a brief announcement (RPA/RNS).
2023-10-10 English
7 -- 7 199 Board Report (NL) (redacted).pdf
Capital/Financing Update Classification · 98% confidence The document is titled "BIJZONDER VERSLAG VAN DE RAAD VAN BESTUUR OVEREENKOMSTIG ARTIKEL 7:199 VAN HET WETBOEK VAN VENNOOTSCHAPPEN EN VERENIGINGEN" (Special Report of the Board of Directors pursuant to Article 7:199 of the Companies and Associations Code). This report details a proposal to renew the authorized capital powers granted to the board of directors, which is a mechanism for future capital increases. This proposal is to be submitted to an Extraordinary General Meeting of Shareholders. Since the document is a detailed report explaining a proposed change to the capital structure and governance mechanism (authorized capital), it directly relates to financing activities and capital structure changes, fitting the 'Capital/Financing Update' category (CAP). It is not a simple announcement of a dividend (DIV), a general earnings release (ER), or a proxy statement (PSI), but a specific legal/governance document concerning capital authorization.
2023-10-10 Dutch
3 -- Proxy (NL ENG).pdf
Proxy Solicitation & Information Statement Classification · 100% confidence The document is explicitly titled "VOLMACHT" (PROXY) and details the process for security holders to appoint a representative for an "EXTRAORDINARY GENERAL MEETING" (Buitengewone Algemene Vergadering) scheduled for November 10, 2023. This document is a form used to grant voting authority for a shareholder meeting, which falls under the category of materials related to soliciting shareholder votes or providing information for such meetings. The definition for Proxy Solicitation & Information Statement (PSI) covers materials sent to shareholders to provide information and request votes for meetings. Although the document explicitly states it is *not* a proxy solicitation under specific Belgian articles, its function is undeniably that of a proxy form for an upcoming meeting, making PSI the most appropriate classification over AGM-R (which is for presentations/materials *during* the meeting) or DEF 14A (which is specifically for remuneration).
2023-10-06 Dutch

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