Transparency Notification from Shareholders
Ghent, Belgium - 10 October 2024 - Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), 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 party listed below.
| Reason for notification | Aggregate number of shares and voting rights held | % of total outstanding shares (1) | |
| Sensinnovat BV (2) | Acquisition or transfer of voting securities or voting rights / Downward crossing of the lowest threshold | N.A. (3) | N.A. (3) |
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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 notification, dated 7 October 2024 and received by the Company on 7 October 2024, was made by a parent undertaking or a controlling person with respect to Sensinnovat BV ("Sensinnovat"), Françoise Chombar, Rudi De Winter and Maatschap Chione. The notification states that on 1 October 2024, the total shareholding of Sensinnovat had crossed down the lowest threshold of 3% of the outstanding voting rights of the Company. The notification further specifies that Sensinnovat is jointly controlled by Rudi de Winter and Françoise Chombar via Maatschap Chione.
(3) If the holding has crossed down the lowest threshold of 3%, the shareholder does not have to report the number of shares and voting rights held.
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).
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
Investor relations
E: IR@sequanamedical.com
T: +32 (09) 496 17 27
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.
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.
