Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (October 2023)
33 slides from Sequana Medical's corporate update, Oct 19, 2023
Slide 1: Additional data strengthens alfapump & DSR product profiles
Additional data strengthens alfapump & DSR product profiles alfapump: 12 month follow-up, matched registry analysis and patient preference study DSR: First two MOJAVE patients and mechanism of action Webcast presentation – 19 October 2023
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Oliver Gödje Chief Executive Officer Sr Medical Advisor Chief Medical Officer 2 2
Slide 3: Disclaimers
Disclaimers Important Notice IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Sequana Medical NV (the "Company") or any person on behalf of the Company, and any question-and-answer session t
Slide 4: Strong data reported in both programs
Strong data reported in both programs Further strengthening of alfapump PMA submission and encouraging early data from DSR MOJAVE study alfapump® – strong positioning & US approval in liver disease expected in 2024 One-year alfapump data from POSEIDON shows safety and strong efficacy profile is ma
Slide 5: alfapump
alfapump® Proven step change in the treatment of liver refractory ascites
Slide 6: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis Fatty liver disease / NASH is driving dramatic growth and change in attitudes to liver cirrhosis patients Typical patient life(1) Viral Alcoholic Liver infections “Normal Life” Disease (Hepatitis B & C) ~5 days Non-Alcoholic Steatohepatitis De
Slide 7: alfapump – continuous ascites removal to the bladder
alfapump – continuous ascites removal to the bladder Fully implanted automatic device for long term implantation Wireless battery charging Breakthrough Device Designation Settings wirelessly adjusted Remote data monitoring Moves up to 4 litres / day Over 1,000 systems implanted Strong IP barriers th
Slide 8: POSEIDON – Successful North American pivotal study
POSEIDON – Successful North American pivotal study Pivotal Cohort of 40 patients with recurrent or refractory ascites due to liver cirrhosis alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant Lon
Slide 9: Sustained effective control of ascites and robust safety profile at 12 months
Sustained effective control of ascites and robust safety profile at 12 months post-implant Strong efficacy of alfapump maintained • 100% median per-patient reduction in therapeutic paracentesis (N=19, p<0.001)* Robust safety profile despite disease progression • 2 pumps explanted (1 patient with U
Slide 10: QoL: Maintaining clinically meaningful improvement despite disease progression
QoL: Maintaining clinically meaningful improvement despite disease progression SF-36 Physical Component Score (higher is better): Ascites Q Score (lower is better): * * * * QoL: Quality of Life 10 10
Slide 11: Over 70% survival at 12 and 18 months post-implant
Over 70% survival at 12 and 18 months post-implant Compares favorably to literature citing only ~17% predicted survival at 12 months and ~5% at 18 months(1) Note: POSEIDON study not powered for survival Source 1: Salerno et al., Gastroenterology 2007; 133:825-834; predicted survival probability for
Slide 12: Patient preference study completed
Patient preference study completed Recommended study by FDA to elicit patient preference for attributes of an implantable pump as a novel interventional treatment for ascites • Rigorous study design pre-discussed with FDA: • Survey using discrete-choice experiment (DCE*) methodology conducted by RTI
Slide 13: Study indicates profile exceeding patient expectations
Study indicates profile exceeding patient expectations Patient preference study indicates compelling profile for alfapump Patient preference study POSEIDON pivotal cohort Risk tolerance (over 6 months) Maximum acceptable risk Observed rate Major surgery or death >10% 0% Minor procedure >35% 20% Seri
Slide 14: Data support hypothesis that alfapump is a desirable treatment option
Data support hypothesis that alfapump is a desirable treatment option for the majority of patients Reduction in paracentesis frequency and additional ascites good health days are important attributes for a novel interventional treatment for ascites. Patients responded with a 65% likelihood of sele
Slide 15: Matched cohorts: NACSELD registry vs POSEIDON
Matched cohorts: NACSELD registry vs POSEIDON Comparing outcomes of POSEIDON pivotal cohort to matched patient group from NACSELD registry • Consortium of tertiary-care hepatology centers in North America to study patients with cirrhosis • NACSELD-III is an IRB-approved registry for outpatients with
Slide 16: alfapump safety profile comparable to standard of care
alfapump safety profile comparable to standard of care Comparison for the six months post-implantation NACSELD-III Registry POSEIDON Pivotal Six month data(1) Matched Patients Cohort(2) Any Death or Hospitalization 55.0% (22/40) 55.0% (22/40) Death 12.5% (5/40) 12.5% (5/40) Hospitalization 42.5% (17
Slide 17: Data supports strong and durable clinical profile of alfapump
Data supports strong and durable clinical profile of alfapump Patients with recurrent or refractory ascites have strong preference for a treatment profile like the alfapump vs continuing their standard paracentesis procedures Patients implanted with the alfapump benefit from significantly reduced
Slide 18: DSR
DSR® Disease-modifying heart failure drug therapy tackling cardiorenal syndrome (CRS)
Slide 19: Cardiorenal Syndrome – key clinical challenge in HF
Cardiorenal Syndrome – key clinical challenge in HF Decongestion is a key component of CRS but the core therapy – loop diuretics – exacerbates the problem • Combined, and self-reinforcing dysfunction of heart and kidneys with hypothesised complex and interconnected mechanisms • Clinical profile thou
Slide 20: Congestion is key driver of morbidity & hospitalization
Congestion is key driver of morbidity & hospitalization Diuretic-resistance is common and there are few effective clinical alternatives US hospitalizations HF hospitalizations annually due to ~1m 90% due to fluid overload heart failure (HF)(3) (AKA congestion)(3) c.5d Typical Annual costs of US hosp
Slide 21: DSR (Direct Sodium Removal) – targets the key cause
DSR (Direct Sodium Removal) – targets the key cause Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR product 2 Sodium diffuses from 3 DSR product + extracted 4 Body eliminates free water administered to peritoneal body into DSR product sodium remov
Slide 22: Improvement in diuretic response and LD dosing
Improvement in diuretic response and LD dosing Normalization of diuretic-response with dramatic durable reduction in LD needs post-DSR therapy Cumulative 6-hour urine output and urinary sodium excretion following an intravenous 40mg dose of furosemide Oral loop diuretic dose over the first year of f
Slide 23: Significant improvement in volume status
Significant improvement in volume status All SAHARA patients reached euvolemia within seven days of DSR therapy (mean 7kg weight loss) Change in NT-proBNP and Plasma CA125 Change in NT-proBNP for RED DESERT (euvolemic, stable HF) and SAHARA (hypervolemic decompensated HF) Data are presented as Mean
Slide 24: Broad improvement in kidney function
Broad improvement in kidney function Removal of LD for extended period of time results in improved kidney health and function Blood urea nitrogen (BUN) and measured creatinine clearance Cumulative 6-hour uremic toxin excretion - indoxyl sulfate Blue bars indicate data from both RED DESERT and SAHARA
Slide 25: DSR therapy impact on neurohormonal status
DSR therapy impact on neurohormonal status Managing volume status with DSR therapy appear to avoid the neurohormonal activation seen with LDs Urine renin – biomarker of local neurohormonal activation at the level of the kidney Change in plasma renin for RED DESERT (euvolemic, stable HF) and SAHARA (
Slide 26: Improvement in cardiovascular parameters
Improvement in cardiovascular parameters Improvement in LV ejection fraction Change in systolic blood pressure – increase likely rules out any hawthorne impact in study from improvement in medication compliance Blue bars indicate data from both RED DESERT and SAHARA, and red bars indicate data only
Slide 27: DSR – breaking the CRS vicious cycle
DSR – breaking the CRS vicious cycle Detailed biomarker analysis aligns with improved clinical outcomes in RED DESERT and SAHARA Clinical proof-of-concept from RED DESERT and SAHARA studies Complete replacement of loop diuretics with safe, rapid and effective decongestion and maintenance of euvolem
Slide 28: MOJAVE – Phase 1/2a randomized controlled US study
MOJAVE – Phase 1/2a randomized controlled US study Seeking to replicate RED DESERT and SAHARA positive results in US patients using DSR 2.0 4 weeks 3 months (initial follow-up at 30 days) DSR therapy (up to daily) + optimized usual care vs. Safety follow-up period IV loop diuretic + optimized usual
Slide 29: First two US patients successfully treated with DSR 2.0
First two US patients successfully treated with DSR 2.0 MOJAVE non-randomized cohort • At baseline: • Heart failure patients with preserved ejection fraction (HFpEF) and severe diuretic resistance • High dose loop diuretics – furosemide equivalent dose of 1,200 and 800 mg per day • After DSR treatme
Slide 30: On track to start randomized cohort in Q1 2024
On track to start randomized cohort in Q1 2024 Top-line data from all three patients in non-randomized cohort planned by year-end • All three non-randomized cohort patients have been enrolled • Patient 1: 9.5 weeks post DSR treatment commencement without loop diuretics • Patient 2: 4 weeks post DSR
Slide 31: Fluid overload – large markets with strong growth
Fluid overload – large markets with strong growth Poor clinical outcomes and high treatment costs when diuretics are no longer beneficial alfapump in liver disease DSR in heart failure • Market growing to over $2.5 billion by 2035(1) • Multi-billion market opportunity • FDA breakthrough device / App
Slide 32: Strong outlook for key value drivers
Strong outlook for key value drivers North American alfapump study – POSEIDON Liver disease / Q2 ‘23: H2 ‘23: Q4 ‘23: H2 ‘24: NASH Additional data Patient preference PMA submission Anticipated FDA at EASL & Matched registry* to FDA approval data 2023 2024 Q2 ‘23:Mid ‘23: Heart failure Q4 ‘23: H1
Slide 33: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com