MOJAVE – US Phase 1/2a trial of DSR 2.0 to treat heart failure

• Previously reported data remain strong after 3 months of follow-up.
  • Diuretic response remained nearly normalized, and 6-hour urinary sodium excretion increased by an average of 326% compared to baseline.
  • All three patients either took no loop diuretics or continued to take low-dose loop diuretics, with a reduction of at least 95% compared to baseline.

• Following US market approval of alfapump®, we plan to initiate a randomized cohort of up to 30 additional patients

Ghent, Belgium – March 25, 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (“”company” or “Sequana medicineThe company, a pioneer in the treatment of fluid overload in liver disease, heart failure, and cancer, today announced final 3-month follow-up data from all three patients in the company’s U.S. Phase 1/2a, non-randomized cohort of MOJAVE. Announced. The DSR 2.0 study for the treatment of diuretic-resistant heart failure patients confirms dramatic and sustained improvements in diuretic response and virtual elimination of the need for loop diuretics, and these final data supports the mechanism of action of DSR in breaking the vicious cycle of cardiorenal syndrome.

AS Dr. Oliver Gogier, Chief Medical Officer of Sequana Medical, commented: “These final data from the first three patients in the MOJAVE cohort are very encouraging, and together with the positive data from our RED DESERT and SAHARA proof-of-concept studies, we are DSR therapy shows potential as a promising treatment for diuretic resistance and cardiorenal syndrome in heart failure.”

Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “We remain excited about the DSR program and its potential to transform the treatment of diuretic resistance and cardiorenal syndromes in heart failure.” We have once again demonstrated that DSR has the potential to restore renal health and control of volumetric status. We look forward to starting a randomized control cohort in the MOJAVE study and are We are confident that Data provides a strong clinical package that will enable strategic partnerships in this large and growing global market.”

Final data from the non-randomized cohort of the MOJAVE study – corroborating the strong data previously reportedI

All three patients treated in the nonrandomized cohort of the MOJAVE study had preserved ejection fraction (HFpEF) and severe diuretic resistance at baseline (mean furosemide equivalent dose 1,227 mg/day) He was suffering from heart failure. Loop diuretic administration was discontinued at the beginning of the study treatment period, and patients were treated daily with DSR 2.0 for up to 4 weeks, followed by a 3-month safety follow-up period. All three patients successfully completed her 3-month safety follow-up period.

Dramatic improvement in diuretic response and stabilization of renal function: During the 4-week DSR treatment period, all three patients maintained normovolemia without the need for loop diuretics. After a 4-week DSR treatment period, the patient’s diuretic response wasii Urinary sodium excretion after 6 hours increased by an average of 324% compared to baseline and almost normalized. This value was maintained even 3 months after the last DSR treatment. Patients’ kidney function also remained stable throughout the study, as measured by eGFR and blood urea nitrogen.

Loop diuretics have been virtually eliminated: The need for loop diuretics was dramatically reduced or even completely eliminated, with furosemide equivalent doses 3 months after the last DSR treatment decreasing by 97%, 100%, and 95% compared to baseline. did.

Safe and well-tolerated: No clinically relevant changes in serum sodium concentrations or progressive hyponatremia were observed, and no patient required hospitalization for congestion throughout the study. His only two serious adverse events were one short-term hypertension and one non-ST elevation myocardial infarction, both of which were determined to be unrelated to DSR therapy. These events occurred during the 3-month safety follow-up period and are common in this critically ill patient population.

Initiation of Randomized Cohort for MOJAVE Study – Data Safety Monitoring Board (DSMB) Approval

In January 2024, the independent DSMB approved the initiation of the randomized MOJAVE cohort after reviewing safety data reported from the non-randomized cohort. The randomized control cohort will enroll up to 30 additional patients at various centers in the United States, with up to 20 patients receiving DSR 2.0 in addition to optimized usual care for congestive heart failure for up to 4 weeks. treated and up to 10 control patients. Use intravenous loop diuretics as part of maximum usual care for congestive heart failure. After the last her DSR treatment, the patient will be followed for a safety follow-up period of 3 months. The Company plans to begin the randomization phase after receiving approval in the U.S. market. alphaPumps, expected to be completed by the end of Q3 2024.

For more information, please contact us below.

Sequana Medical

Rhys Vaneste
Director Public Relations Activities for Investors
E: IR@sequanamedical.com
Phone: +32 (0)498 053579

About DSR, a disease-modifying heart failure drug therapy that addresses cardiorenal syndrome (CRS)

Cardiorenal syndrome is an important clinical challenge in heart failure, resulting from the combination of a vicious cycle of cardiac and renal dysfunction. Despite the complex pathophysiology, the resulting clinical profile is characterized by decreased glomerular filtration, increased renal sodium binding capacity, and congestion, despite increasing doses of diuretics. It is thought to manifest as a reinforcing negative feedback cycle.

Current treatments have not been shown to improve patient outcomes in this complex and poorly understood indication. Although decongestion is a key component of treatment, loop diuretics exacerbate many of the core mechanisms thought to underlie CRS. DSR has the potential to break this negative feedback cycle by effectively controlling volume status over long periods of time, thereby avoiding the adverse effects of loop diuretics.

Extensive analysis of patients in the RED DESERT and SAHARA studies showed that i) volume status, ii) normalization of diuretic response and significant reduction in loop diuretic dosage, iii) improvement in renal function, and iv) neurohormonal status and signaling. The benefits of DSR therapy regarding transmission have been shown. v) Cardiovascular parameters. These patients had no congestion-related readmissions, a one-class improvement in NYHA status, and a 75% reduction in estimated 1-year mortality (based on the Seattle Heart Failure Model). Initial data from the nonrandomized cohort of the US MOJAVE study support these findings, showing that DSR is safe and well-tolerated, restores diuretic response, and virtually eliminates the need for loop diuretics after DSR treatment. has been shown to eliminate cancer and improve heart and kidney health.

About Sequana Medical

Sequana Medical NV is a pioneer in the treatment of fluid overload, a serious clinical complication that frequently occurs in patients with liver disease, heart failure, and cancer. This causes serious medical problems, including increased mortality, repeated hospitalizations, severe pain, difficulty breathing, and limited mobility. Diuretics are standard treatment, but for many patients, diuretics stop working, can’t be tolerated, or make the problem worse. Effective treatment options are limited, resulting in poor clinical outcomes, high costs, and a significant impact on quality of life. Sequana Medical seeks to provide innovative treatment options to this large and growing “diuretic-resistant” patient population. alphaPump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering significant clinical and quality of life benefits to patients and reducing costs to healthcare systems. Masu.

Our Pre-Market Approval (PMA) Application alphaThe pump was submitted to the U.S. Food and Drug Administration in December 2023 and accepted for substantive review in January 2024, and received initial and Positive data for secondary endpoints were reported.Approved in the US market alphaThe pump is expected to be completed by the end of the third quarter of 2024.

Results from our RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action in breaking the vicious cycle of cardiorenal syndrome. All three patients in the non-randomized cohort of MOJAVE, a US randomized controlled multicenter Phase 1/2a clinical study, were successfully treated with DSR, similar to that seen in the RED DESERT and SAHARA trials. Strong clinical outcomes were confirmed. An independent data safety monitoring board approved the initiation of a randomized MOJAVE cohort of up to 30 additional patients. alphaPump US PMA approved.

Sequana Medical is listed on Euronext Brussels (ticker: SEQUA.BR) and is headquartered in Ghent, Belgium. For more information, please visit www.sequanatical.com.

Important regulatory disclaimer

of alphaThe Pump® System is not currently approved in the United States or Canada. In the US and Canada, alphaThe pump system is currently in clinical research (POSEIDON trial) in adult patients with refractory or recurrent ascites due to liver cirrhosis. Please note that DSR® Therapy is still under development and any statements regarding safety and efficacy are derived from ongoing preclinical and clinical studies that have not yet been completed. There is no link between DSR therapy and ongoing research. alphaEuropean, US, or Canadian pump systems.

Note: alphaPump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain projections, estimates or other information that may be considered forward-looking statements.
Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent Sequana Medical’s current judgment about what the future will hold and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to publicly update or revise any forward-looking statements in this press release, except as specifically required by law or regulation. You should not place undue reliance on forward-looking statements, which reflect Sequana Medical’s opinion only as of the date of this press release.

I See press releases dated January 23, 2024 and November 29, 2023.
ii Diuretic response assessed by sodium excretion during 6 hours after IV administration of furosemide 40 mg

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• Press Release_Final MOJAVE Non-Randomized Cohort_March 25, 2024_NL_vF

• Press Release_Final MOJAVE Non-Randomized Cohort_March 25, 2024_ENG_vF