Disclaimer

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 Study) and is being studied in adult patients with refractory or recurrent ascites due to 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 the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Transparency Notifications from Shareholders

PRESS RELEASE

Regulated information

11 April 2024, 06:00 pm CEST

Ghent, Belgium – 11 April 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 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 notificationAggregate number of shares and voting rights held% of total outstanding shares
LSP Management Group B.V.(1)Acquisition or disposal of the control of an undertaking that holds a participating interest in an issuer / Downward crossing of the lowest thresholdN.A.(2)N.A.(2)
EQT Life Sciences Group B.V. (3)Acquisition or disposal of the control of an undertaking that holds a participating interest in an issuer1,706,0779.18%(4)
EQT Life Sciences Group B.V.(5)Acquisition of voting securities or voting rights4,695,407  13.08%(6)  
Adrianus van Herk(7)Downward crossing of the lowest threshold / Disposal of voting securities or voting rightsN.A.(8)N.A.(8)

_____________

Notes:

(1) LSP Management Group B.V., a parent undertaking or a controlling person of LSP Health Economics Fund Management B.V. (“LSP”) informed the Company, by means of a notification dated 8 April 2024, that since 28 February 2022, LSP is no longer controlled by LSP Management Group B.V. The notification specifies furthermore that LSP Management Group B.V. was the holding company of the LSP management organization that was acquired in 2022 by the Swedish listed private equity company EQT AB. As part of that transaction, LSP Management Group B.V. has transferred the shares of LSP, among other, to EQT AB. Since then, EQT AB has held (through a pair of intermediate holding companies) all shares in LSP. This company is the sole director of LSP Sequana Holding B.V., which is a shareholder of the issuer Sequana Medical. As such, LSP exercises the voting rights of the shares of Sequana Medical. This notice is made to make it clear that LSP is no longer controlled by LSP Management Group B.V. Finally, the name of the last company has now been changed to MRMJ Holding B.V.

(2) The transparency notification does not mention how many voting securities or voting rights are held by LSP Management Group B.V. since LSP is no longer controlled by LSP Management Group B.V.

(3) EQT Life Sciences Group B.V., a parent undertaking or a controlling person of LSP, informed the Company, by means of a notification dated 4 April 2024, that on 28 February 2022 the aggregate number of voting rights of EQT Life Sciences Group B.V. crossed the threshold of 5% of the outstanding voting rights of the Company back then. The notification specifies furthermore that LSP is controlled by EQT Life Sciences Group B.V. (as 100% shareholder), which in turn is controlled by EQT Treasury AB (as 100% shareholder), which in turn is controlled by EQT AB (as 100% shareholder). EQT AB is a Swedish listed company and is not a controlled entity. The notification also states that the LSP management organization has been acquired by the Swedish listed private equity company EQT AB, effective as of 28 February 2022. As a result, among other things, the ownership of the shares of LSP transferred to EQT AB, which now (indirectly) holds all shares in LSP. LSP is the sole director of LSP Sequana Holding B.V., which is a shareholder of the issuer Sequana Medical. As such, LSP exercises the voting rights of the shares of Sequana Medical, at its sole discretion, in the absence of specific instructions.

(4) The total number of outstanding shares of the Company on 28 February 2022 as mentioned in the relevant transparency notification was 18,579,260, each share giving right to one (1) vote (being 18,579,260 voting rights in total).

(5) EQT Life Sciences Group B.V., a parent undertaking or a controlling person of LSP and EQT Health Economics 3 Management B.V. (“EQT”), informed the Company, by means of a notification dated 10 April 2024, that on 25 March 2024 the aggregate number of voting rights of EQT Life Sciences Group B.V. crossed the threshold of 10% of the outstanding voting rights of the Company. The notification specifies furthermore that LSP and EQT are controlled by EQT Life Sciences Group B.V. (as 100% shareholder), which in turn is controlled by EQT Treasury AB (as 100% shareholder), which in turn is controlled by EQT AB (as 100% shareholder). EQT AB is a Swedish listed company and is not a controlled entity. The notification also states that LSP and EQT are not owners of the shares of the Company, but manages the two funds managed by EQT Life Sciences Group B.V. who jointly hold their shares in the Company through the pooling entity LSP HEF Sequana Holding B.V. LSP and EQT are both directors of LSP HEF Sequana Holding B.V. and as such jointly exercise discretionary voting rights over the shares held in the Company, held through LSP HEF Sequana Holding B.V.

(6) The total number of outstanding shares of the Company on 25 March 2024 as mentioned in the relevant transparency notification amounts to 35,909,420, each share giving right to one (1) vote (being 35,909,420 voting rights in total).

(7) Adrianus van Herk (“van Herk“), acting as a person that notifies alone, informed the Company, by means of a notification dated 8 April 2024, that on 3 April 2024 the aggregate number of voting rights of van Herk crossed the lowest threshold of 3% of the outstanding voting rights of the Company.

(8) The transparency notification does not mention how many voting securities or voting rights are held by van Herk after downward crossing of the lowest threshold of 3%.

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

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, untolerable 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.

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.

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