Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (July 2021)
18 slides from Sequana Medical's corporate update, Jul 1, 2021
Slide 1: POSEIDON 2nd interim analysis Roll-In Cohort
POSEIDON 2nd interim analysis Roll-In Cohort Webcast presentation – 1 July 2021
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Chief Executive Officer Senior Medical Advisor 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: Disclaimers
Disclaimers Regulatory disclaimer: • The alfapump® system has not yet received regulatory approval in the United States and Canada. Any statement in this presentation about safety and efficacy of the alfapump® system does not apply to the United States and Canada. In the United States and Canada, th
Slide 5: Positive results confirmed in larger Roll-In Cohort
Positive results confirmed in larger Roll-In Cohort POSEIDON - Second interim analysis of North American pivotal alfapump® study • Interim data from 26 patients in the POSEIDON Roll-In Cohort reconfirm positive outcomes against all primary endpoints* Over 90% reduction in mean frequency of therape
Slide 6: Recurrent and Refractory ascites
Recurrent and Refractory ascites A key complication of liver cirrhosis, with a dramatic impact on quality of life Viral infections (Hepatitis B & C) “Normal Life” ~5 days Decreased Alcoholic Liver High mortality rate mobility & Disease appetite, Drainage nausea and Extreme discomfort ~2 days constip
Slide 7: US prevalence of NASH is large and growing
US prevalence of NASH is large and growing 1 in 4 POSEIDON patients have ascites due to NASH (1) US population forecast due to NASH Sources: GlobalData Nash Epidemiology Forecast to 2026; Estes (2018); Runyon (2009); Ginès (2004); Fortune (2017); Perri (2013) 7 7
Slide 8: alfapump – Reduce the need for Therapeutic Paracentesis (TP)
alfapump® – Reduce the need for Therapeutic Paracentesis (TP) Therapeutic Paracentesis alfapump® • Painful Automatic and continuous removal of ascites • Frequent hospitalisations Fully implanted and wirelessly battery charging • Poor quality of life FDA breakthrough designation / CE mark • Sho
Slide 9: POSEIDON – study design
POSEIDON – study design Pivotal study to support future marketing application of the alfapump® in the US and Canada Pivotal Cohort alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implant observation
Slide 10: Recurrent or refractory ascites – patient profile
Recurrent or refractory ascites – patient profile 26 patients from the Roll-In Cohort in the POSEIDON study N. American patients are Age (mean) 63 y treated early in MELD score (mean ± SD) 10.3 ± 3.9 their disease Cirrhosis etiology - Alcohol - 50.0% NASH is - NASH - 23.1% becoming a major - NASH /
Slide 11: Roll-In Cohort: Substantial and durable reduction in Therapeutic Paracentesis (TP)
Roll-In Cohort: Substantial and durable reduction in Therapeutic Paracentesis (TP) Primary efficacy endpoint Interim data Mean values Pivotal Cohort Roll-In Cohort (N = 26) % reduction in monthly frequency of TP > 50% (1) > 90% (2) % patients with >50% reduction in TP > 50% (1) 100% (2) (1) Monthly
Slide 12: Roll-In Cohort: Safety in line with expectations
Roll-In Cohort: Safety in line with expectations Primary safety endpoint: • Rate of alfapump related re-interventions adjudicated by Clinical Events Committee (CEC) Interim data Roll-In Cohort (N=26): • No unanticipated adverse device effects • Three patients experienced a composite primary safety e
Slide 13: Roll-In Cohort: Clinically important improvement in quality of life maintained up to 12 months
Roll-In Cohort: Clinically important improvement in quality of life maintained up to 12 months Physical Component Score 5 point increase = clinically important improvement* Higher is better SF-36 General health- survey questionnaire Total Score 20 point decrease = clinically important improvement* A
Slide 14: Pivotal Cohort: Additional patient recruitment
Pivotal Cohort: Additional patient recruitment Completion of enrolment with approx. 10 additional patients in Pivotal Cohort is now expected in Q3 2021 • Pivotal Cohort patients are screened for inclusion / exclusion criteria at enrolment AND prior to planned alfapump implantation (following 3 month
Slide 15: Targeting announcement of primary endpoint in Q3 '22
Targeting announcement of primary endpoint in Q3 ‘22 2019 2020 2021 2022 2023 FDA IDE First Interim Interim Last Primary Secondary approval patient in analysis 1 analysis 2 patient in* Endpoint Endpoint Reporting* Reporting* FDA breakthrough Filing* designation MCIT & NTAP – CMS initiatives
Slide 16: Building Sequana Medical on two technology platforms
Building Sequana Medical on two technology platforms Complementary approaches to diuretic-resistant fluid overload alfapump® alfapump DSR® DSR® Heart Failure Liver Disease / Decongestion NASH & Malignant Ascites Long-term Short-term therapy therapy Evaluating Renal Failure Fluid Overload 16 16
Slide 17: Expected core value drivers & outlook
NASH in North Expected core value drivers & outlook Liver disease / Q2 21: America Q3 21: Q3 22: Q4 22: POSEIDON POSEIDON POSEIDON Filing to interim analysis LPI primary endpoint US FDA 2021 2022 Heart failure in North America Q2RED 21: Q2 21: & Europe Q4 21: H2 22: H2 22: SAHARA SAHARA SAHARA M
Slide 18: Q&A
Q&A