Financial and Business Update
Sequana Medical NV, based in Ghent, Belgium, has shared its financial results for the year ending 31 December 2023, providing insights into its operational achievements and future outlook. The company, known for its innovative treatments for fluid overload, has made significant progress in its clinical programs and regulatory submissions.
Key Highlights:
- alfapump PMA Submission: The company submitted its Premarket Approval (PMA) application for the alfapump to the US FDA in December 2023, which was accepted for substantive review in January 2024. This marks a critical step towards US commercialization, focusing on liver transplant centers.
- DSR Heart Failure Program: Sequana Medical presented strong data from its DSR (Direct Sodium Removal) therapy at an international heart failure conference, showcasing its potential as a treatment for cardiorenal syndrome. The data from the RED DESERT and SAHARA studies demonstrated significant improvements in diuretic responsiveness and a reduction in loop diuretic requirements.
- Financial Performance: The company reported a net loss of €32.56 million for 2023, an increase from €30.76 million in 2022. Despite this, Sequana Medical has extended its cash runway to the end of Q3 2024 through strategic financing measures, including a €11.5 million equity placement in March 2024.
Looking Ahead
Sequana Medical is focused on navigating the PMA approval process for the alfapump and advancing its DSR heart failure program. The company plans to initiate the randomized phase of the US MOJAVE study post alfapump PMA approval, with interim data expected in the second half of 2025.
2024 Outlook:
- The company is reviewing extensive feedback from the FDA on its alfapump PMA application and plans to update the market following a day-100 meeting scheduled for April 9th, 2024.
- For the DSR heart failure program, the randomized cohort of the US Phase 1/2a MOJAVE study is anticipated to start in Q1 2025, with interim data expected in H2 2025.
Sequana Medical remains committed to addressing the unmet needs of patients with fluid overload, leveraging its proprietary platforms, alfapump and DSR, to improve clinical outcomes and quality of life.