Sequana Medical announces results of Special General Meeting of Shareholders

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PRESS RELEASE
REGULATED INFORMATION
26 June 2023, 06:00 pm CEST

Dr. Kenneth Macleod appointed as non-executive director

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Ghent, Belgium26 June 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, today announces that all proposed resolutions submitted to the Special General Meeting of Shareholders were approved at the meeting held today at 09:00 am CEST.

The items on the agenda of the meeting included the appointment of Dr. Kenneth Macleod as non-executive director of the Company and the approval in accordance with Article 7:151 of the Belgian Companies and Associations Code of the terms and conditions of the subscription rights issued in the framework of the equity offering that was successfully completed on 25 April 2023 in the event of certain change of control events. The minutes of the shareholders’ meeting can be accessed on the Company’s website.

Dr. Kenneth Macleod is a Partner at Rosetta Capital, a venture capital firm focused on life sciences and medical devices. Dr Macleod has over 35 years’ experience in the life sciences sector in a career combining senior operating roles in healthcare companies (Abbott Laboratories, Serono SA) and life science fund management (SV Health Investors, Paul Capital Partners, Visium Healthcare Partners). Dr Macleod currently holds board positions at JenaValve Technology Inc. and Oxular Limited and has previously held board roles including at Pharming Group N.V. (NASDAQ:PHAR) and On-X Life Technologies, Inc., a mechanical heart valve company sold to Cryogenics Inc. (now NASDAQ:AORT). Dr Macleod received a BSc in Biological Sciences from the University of Manchester and a D.Phil. from the University of York.

Pierre Chauvineau, Chairman of Sequana Medical‘s Board of Directors, commented: Ken brings tremendous expertise and experience to the Board of Directors of Sequana Medical at this key time as we build on our recent successful trial results in liver disease and heart failure. We are gearing up for the commercialization of our alfapump in the US following the submission of our Pre-Market Approval to the FDA planned before the end of the year and enrolling the first patient in MOJAVE, our US DSR study in heart failure.

Commenting on his appointment, Dr. Macleod added: Sequana Medical has made great progress with both its alfapump and DSR programs for the treatment of fluid overload due to liver cirrhosis and heart failure, two widespread disease indications where patients are in urgent need for new and better treatments. I am looking forward to contributing to the work of the Board of Directors to help deliver the next stage of the Company’s development.

For more information, please contact:

Sequana Medical
Lies Vanneste
Director Investor Relations
E: [email protected]
T: +32 (0)498 05 35 79

Optimum Strategic Communications
Nick Bastin, Jonathan Edwards, Vici Rabbetts
E: [email protected]
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, difficulty 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 trial 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 is preparing to 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 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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