PRESS RELEASE
Regulated information
15 May 2023, 06:00 pm CEST
Ghent, Belgium – 15 May 2023 – 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 transparency notifications from the shareholders listed below, notifying the number of voting rights attached to shares mentioned next to their respective names in the table below.
| Reason for notification | Number of shares and voting rights held | ||
| Number | % of total outstanding shares(1) | ||
| Participatiemaatschappij Vlaanderen NV(2) | Passive crossing of a threshold | 1,346,074 | 4.80% |
| Optiverder BV(3) | Acquisition of voting securities or voting rights | 922,535 | 3.29% |
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Notes:
- The total number of outstanding shares of the Company mentioned in the relevant transparency notifications amounts to 28,050,888, each share giving right to one (1) vote (being 28,050,888 voting rights in total). This number does not take into account the number of new shares that were issued pursuant to a capital increase that was announced on 24 April 2023 and completed on 10 May 2023 through the issuance of a total of 140,845 additional new shares.
- A parent undertaking or a controlling person of Participatiemaatschappij Vlaanderen NV (“PMV“), informed the Company, by means of a notification dated 11 May 2023 that, PMV’s aggregate number of voting rights passively down crossed the threshold of 5% of the then outstanding 28,050,888 voting rights of the Company. The notification specifies furthermore that PMV is controlled by Het Vlaams Gewest and that Het Vlaams Gewest is not controlled.
- A parent undertaking or a controlling person of Optiverder BV (“Optiverder“), informed the Company, by means of a notification dated 10 May 2023 that on 27 April 2023 Optiverder’s aggregate number of voting rights crossed the threshold of 3% of the then outstanding 28,050,888 voting rights of the Company. The notification furthermore specifies that Optiverder is 100% owned by Mr. C.A.C.M. Oomen.
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 copies of the aforementioned transparency notifications, 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
Lies Vanneste
Director Investor Relations
T: +32 (0)498 053579
Optimum Strategic Communications
Nick Bastin, Jonathan Edwards, Vici Rabbetts
T: +44 (0) 208 078 4357
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. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life. Although diuretics are standard of care, the problem is that in many patients they are no longer effective and / or tolerable. There are limited effective treatment options for these patients, 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 has reported positive primary endpoint data from the North American pivotal POSEIDON study of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the Company will commence MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical trial of DSR 2.0, with initial data expected in Q4 2023.
Sequana Medical is listed on 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 cirrhosis. For more information regarding the POSEIDON clinical trial see www.poseidonstudy.com. 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.