Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (November 2020)
17 slides from Sequana Medical's corporate update, Nov 19, 2020
Slide 1: POSEIDON interim analysis 1 Webcast presentation
alfapump® POSEIDON interim analysis 1 Webcast presentation – 19 November 2020
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, t
Slide 5: POSEIDON interim analysis: Positive outcomes against all primary endpoints
POSEIDON interim analysis 1 Positive outcomes against all primary endpoints Results from first 13 patients in Roll-In Cohort of North American pivotal alfapump® study Over 90% reduction in mean frequency of therapeutic paracentesis (TP) post-implant vs. pre-implant All patients at least a 50% re
Slide 6: Liver cirrhosis and recurrent or refractory ascites
Liver cirrhosis and recurrent or refractory ascites Recurrent or refractory ascites is 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,
Slide 7: US prevalence of NASH is large and growing
US prevalence of NASH is large and growing (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 CE mark / FDA breakthrough designation • Sho
Slide 9: POSEIDON – study cohorts
POSEIDON – study cohorts Patients with recurrent or refractory ascites due to liver cirrhosis in up to 20 centres across US and Canada Two study cohorts with the same inclusion / exclusion criteria •1 Pivotal Cohort • Up to 50 patients implanted with the alfapump® • For primary and secondary endpoin
Slide 10: 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 11: Cirrhotic patients with recurrent or refractory ascites
Cirrhotic patients with recurrent or refractory ascites First 13 patients in Roll-In Cohort of the POSEIDON study Willingness to treat earlier Age (mean) 65 y stage patients? MELD score (mean ± SD) 10.5 ± 4.6 Cirrhosis etiology - Alcohol - 61.5% NASH is already - NASH - 23.1% an important driver - H
Slide 12: Positive outcomes against all primary endpoints in first Roll-In patients
Positive outcomes against all primary endpoints in first 13 Roll-In patients Substantial reduction in therapeutic paracentesis (TP) and safety profile in line with expectations EFFICACY Mean values post-implant vs. pre-implant N = 13 % reduction in frequency of TP > 90% % patients with >50% reductio
Slide 13: Indication of fast and persistent improvement in Quality of Life
Indication of fast and persistent improvement in Quality of Life Physical Component Score Subscales 5 point improvement = clinically relevant Higher is better SF-36 General health- survey questionnaire Total Score Subdomains 20 point reduction = clinically relevant Ascites Q Specific health- survey
Slide 14: Encouraging results from first 13 patients in Roll-In Cohort
Encouraging results from first 13 patients in Roll-In Cohort • Substantial reduction in the need for Therapeutic Paracentesis – primary efficacy endpoint* • Reported safety events generally those seen in decompensated cirrhotic patients and in line with expectations – primary safety endpoint* •
Slide 15: Pursuing approval of the alfapump in North America
Pursuing approval of the alfapump® in North America for recurrent or refractory liver ascites 2019 2020 2021 2022 2023 POSEIDON: FDA IDE First Interim Last Full Primary Final results* approval patient in analysis 1 patient interim Endpoint (2° outcomes) in* analysis* Reporting* FDA breakthrough
Slide 16: Expected core value drivers & outlook
Expected core value drivers & outlook POSEIDON NASH in North Liver disease / Q4 20: Q1 21: H1 21: Q1 22: America POSEIDON POSEIDON POSEIDON interim analysis 1 enrolment full interim primary endpoint completion analysis read-out H2 2020 2021 H1 2022 Heart failure in North America Q4 20: & Europe H
Slide 17: Q&A
Q&A