Transparency Notifications from Shareholders

Transparency Notifications from Shareholders

PRESS RELEASE
REGULATED INFORMATION
19 July 2024, 06:30 pm CEST

Ghent, Belgium – 19 July 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces today that it received a transparency notification from the shareholder listed below, notifying the number of voting rights attached to the shares mentioned next to its name in the table below.

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Notes:

            (1)   The total number of outstanding shares of the Company mentioned in the relevant transparency notification amounts to 40,243,518, each share giving right to one (1) vote (being 40,243,518 voting rights in total).
            (2)   The notice was made on 16 July 2024 by Société Fédérale de Participations et d’Investissement SA / Federale Participatie- en Investeringsmaatschappij NV (“SFPI-FPIM“), acting as a parent undertaking or a controlling person, and was made for itself and with respect to Belfius Banque SA (“Belfius Bank“) and Belfius Insurance SA (“Belfius Insurance“). The notification stated that on 10 July 2024, the total shareholding of SFPI-FPIM (holding 1,885,806 shares and voting rights, which corresponds to 4.69% of the outstanding voting rights of the Company) had passively crossed below the threshold of 5% of the outstanding voting rights of the Company. The notification specifies that the shareholding in the Company is held by SFPI-FPIM, that SFPI-FPIM is owned for 100% by the Belgian State, that SFPI-FPIM, acting in its own name, but on behalf of the Belgian State, is the parent company of Belfius Bank, and that Belfius Bank is the parent company of Belfius Insurance. The notification also states that Belfius sold its participation in the Company and no longer holds any shares in the Company. It follows from the notification that Belfius Insurance previously owned 24,393 voting securities or voting rights in the Company.

This announcement is made in accordance with Article 14 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

To access a copy of the aforementioned transparency notification, reference is made to Sequana Medical’s website (https://www.sequanamedical.com/investors/shareholder-information/).

Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (FSMA) is required by all natural and legal persons in each case where the percentage of voting rights attached to the securities held by such persons in the Company reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.

For more information, please contact:

Sequana Medical

Ian Crosbie
CEO
E: IR@sequanamedical.com
T: +44 7973 42 99 17

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic-resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems.

The Company’s Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024, having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study in recurrent or refractory ascites due to liver cirrhosis. US market approval of the alfapump is anticipated before the end of Q1 2025 with US commercial launch planned for H2 2025.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is planned after alfapump US PMA approval.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Attachments

• Sequana Medical – Transparency notification PR (ENG) – 19 July 2024
• Sequana Medical – Transparency notification PR (NL) – 19 July 2024