Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces its financial results for the year ended 31 December 2020, and provides a business update and an outlook for the remainder of 2021.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We made outstanding progress in 2020, delivering very promising clinical data in both our focus areas, liver disease / NASH[1] in North America and heart failure in North America and Europe. We are very encouraged by the interim POSEIDON data, showing positive outcomes against all primary endpoints of the study, indicating a substantial reduction in the need for therapeutic paracentesis, a good safety profile and clinically relevant improvement in patients’ quality of life. Data from additional Roll-In patients are expected in Q2 2021 and we look forward to the planned reporting of the primary endpoint in Q2 2022.

“2020 was another breakthrough year for our DSR® heart failure program. The RED DESERT interim results showed, for the first time, that not only could repeated alfapump DSR® therapy in diuretic-resistant heart failure patients safely manage their fluid and sodium balance without the need of loop diuretics, but also restore their diuretic response to near normal levels and dramatically reduce their need for oral diuretics post-study. Granting of key DSR patents in the U.S. and Europe strengthened our intellectual property protection, enabling us to invest with confidence in heart failure as well as other fluid overload indications such as renal failure. We are looking forward to reporting final top-line RED DESERT data in Q2 2021.

“To deliver on our next key inflection points, we reinforced our cash position with two successful equity placements of €19 million in January 2020 and €22.5 million in February 2021. We are grateful for the continued support of our existing investors and are pleased to welcome new high-quality local and international institutional investors as shareholders. With our cash runway extended into Q2 2022, we are well positioned to continue on our strategy and bring value to all our stakeholders.”

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