Disclaimer

The alfapump® system is not currently 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. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The 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.
The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.

Transparency Notifications from Shareholders

PRESS RELEASE

Regulated information

18 March 2022, 6 p.m. CET

 

Ghent, Belgium – 18 March 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, 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 Shares and voting rights held
Number % of total outstanding shares(1)
NeoMed IV Extension Limited / NeoMed Innovation V Limited(2) Passive crossing of a threshold 4,288,988 18.06%
Partners in Equity V B.V.(3) Acquisition of voting securities or voting rights 3,636,363 15.31%
Newton Biocapital I SA(4) Passive crossing of a threshold 1,102,529 4.64%
Sensinnovat BV(5) Acquisition of voting securities or voting rights 900,769 3.79%

_____________

Notes:

 

  1. The total number of outstanding shares of the Company on 10 March 2022 amounts to 23,746,528, each share giving right to one (1) vote (being 23,746,528 voting rights in total). This number takes into account the number of new shares that were issued pursuant to a capital increase that was announced on 7 March 2022 and completed on 10 March 2022 by means of a private placement through an accelerated bookbuilding procedure.
  2. A parent undertaking or a controlling person of NeoMed IV Extension Limited (“NeoMed IV“), NeoMed Innovation V Limited (“NeoMed V“) and NeoMed Management (Jersey) Limited (“NeoMed Management“) informed the Company, by means of a notification dated 14 March 2022, that, on 10 March 2022 the aggregate shareholding of NeoMed IV and NeoMed V passively crossed below the threshold of 20% of the outstanding voting rights of the Company. The notification furthermore specifies that NeoMed IV and NeoMed V are each a private limited company incorporated in Jersey, and are each controlled by their investment manager NeoMed Management (a private limited company incorporated in Jersey) and that NeoMed Management is controlled by Erik Amble, Claudio Nessi, Dina Chaya and Pål Jensen within the meaning of Articles 1:14 and 1:16 of the Belgian Companies and Associations Code. The notification also states that (a) NeoMed IV and NeoMed V do not own the securities of the Company but manage funds that own the voting rights attached to the securities, and (b) as general partners to their funds, NeoMed IV and NeoMed V exercise the voting rights attached to the securities at their discretion in the absence of specific instructions.
  3. A parent undertaking or a controlling person of Partners in Equity V B.V. (“PiE V“) and Partners in Equity III B.V. (“PiE III“), informed the Company, by means of a notification dated 16 March 2022, that, on 10 March 2022 PiE V’s shareholding crossed the threshold of 15% of the outstanding voting rights of the Company. The notification furthermore specifies that PiE V is 100% owned by PiE III and that no natural or legal person has exclusive control of PiE III.
  4. Newton Biocapital I SA (“Newton Biocapital“) (acting as a person that notifies alone) informed the Company, by means of a notification dated 15 March 2022, of the passive crossing of a threshold. The notification furthermore specifies that Newton Biocapital is not a controlled entity on 10 March 2022. The notification also states that Newton Biocapital acts as discretionary asset manager and holds the voting rights attached to the shares on behalf of its clients, which it can exercise at its own discretion without instructions from its clients.
  5. A parent undertaking or a controlling person of Sensinnovat BV (“Sensinnovat“) informed the Company, by means of a notification dated 15 March 2022, that, on 10 March 2022 Sensinnovat’s shareholding crossed the threshold of 3% of the outstanding voting rights of the Company. The notification furthermore specifies that Sensinnovat is jointly controlled by Rudi de Winter and Françoise Chombar via Maatschap Chione.

 

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

Tel: +32 (0) 498 05 35 79

Email: IR@sequanamedical.com

 

LifeSci Advisors

Guillaume van Renterghem

Tel: +41 76 735 01 31

Email: gvanrenterghem@lifesciadvisors.com

 

About Sequana Medical

Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases – including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure – with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is Sequana Medical’s unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints and a rapid and persistent clinically important improvement in quality of life. All patients have been enrolled in the study and primary endpoint reporting is planned for Q4 2022. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 900 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT demonstrated that repeated DSR therapy in diuretic-resistant heart failure patients is able to manage their fluid and sodium balance, improve their cardio-renal status and restore their diuretic response for months post-treatment. Interim results from the ongoing SAHARA DESERT study of alfapump DSR in decompensated heart failure patients indicated a safe, effective and rapid elimination of persistent congestion and restoration of euvolemia, together with a considerable benefit in cardio-renal status and a dramatic improvement in diuretic responsiveness. Reporting of top-line data is planned for H2 2022.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

 

Important Regulatory Disclaimers:

The alfapump® system is not currently 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. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The 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. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.

 

Note: alfapump® is a registered trademark. DSR® is a registered trademark in Australia, the Benelux, the EU, United Kingdom, Hong Kong, Israel, Norway, and Switzerland. alfapump DSR® is a registered trademark in Australia, the Benelux, China, the EU, United Kingdom, Hong Kong, Israel, New Zealand, and Norway.

 

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.

 

Download the press release   

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