Sequana Medical NV
SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM
SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM
Ghent - Belgium, Nov. 20, 2025 (GLOBE NEWSWIRE) -- SEQUANA MEDICAL ANNOUNCES THE ISSUANCE OF A SUBSCRIPTION REQUEST NOTICE UNDER THE SHARE SUBSCRIPTION FACILITY AGREEMENT WITH GEM
PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
20 November 2025, 6:00 pm CET
Ghent, Belgium, 20 November 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today that it issued a subscription request notice in accordance with the terms of the share subscription facility agreement (the "Facility") entered into on 17 March 2025 between the Company and GEM Global Yield LLC SCS ("GEM"). Under the terms of the Facility, GEM has agreed, subject to certain conditions, to commit an amount of up to EUR 20 million in cash (with the Company's option to increase the commitment to up to EUR 60 million in cash, once the aforementioned EUR 20 million has been drawn down), within a maximum term of three years, in exchange for new shares in the Company and subject to certain share lending arrangements being in place. For more information about the Facility, reference is made to the Company's press release dated 18 March 2025 (which can be accessed here).
The new subscription request notice is expected to be settled into new shares on or around 22 December 2025. The number of new shares the Company has requested GEM to subscribe for amounts to up to 1,995,014 shares in the Company (the "Draw Down Amount"). The issue price of the relevant new shares to be issued will be equal to 90% of the average volume weighted average price (VWAP) of the Company's shares during a forward-looking pricing period and will be subject to certain corrections. Following the aforementioned pricing period, GEM will have to subscribe for a number of new shares ranging between a minimum of 50% and a maximum of 150% of the Draw Down Amount (subject to certain adjustments as set out in the Facility).
For more information, please contact:
Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917
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, intolerable 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, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.
The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. In Sequana Medical's POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life1,2.
Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.
Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 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 requirements3. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.
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 Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.
The alfapump® System is currently not approved in Canada.
DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.
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.
1 Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
2 As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).
3 Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period.
Attachments
- Sequana Medical -- Press Release (ENG) (20 November 2025)
- Sequana Medical -- Press Release (NL) (20 November 2025)
Documents
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