Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — EASL Congress 2023
23 slides from Sequana Medical's conference presentation, Jun 21, 2023
Slide 1: POSEIDON: additional data on safety, quality of life & survival
POSEIDON: additional data on safety, quality of life & survival presented at EASL 2023 Webcast presentation – 21 June 2023
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Chief Executive Officer Sr 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: POSEIDON – strong clinical messages for alfapump
POSEIDON – strong clinical messages for alfapump Data presentation at EASL Congress 2023 by Prof. Wong, Principal Investigator, POSEIDON Effective in control of ascites, virtually eliminating needle paracentesis Safety in line with expectations • Six pumps were explanted: three due to skin erosion
Slide 5: 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 6: alfapump – strong clinical and economic rationale
alfapump – strong clinical and economic rationale FDA breakthrough designation, strong IP, over 950 implants and hundreds of years of patient experience Breakthrough Device Designation • Reduced burden of disease • Improved patient quality of life • Cost savings for hospitals and payers Estimated tr
Slide 7: Large and strongly growing North American market
Large and strongly growing North American market NASH is forecast to drive significant growth for many years – and is changing attitudes to cirrhosis 12+ paracentesis / year 3-5 paracentesis 78,000 6-7% CAGR / year patients with recurrent or >$2.5 Bn refractory ascites alfapump addressable due to li
Slide 8: POSEIDON – North American pivotal study
POSEIDON – North American pivotal study Pivotal Cohort of 40 alfapump 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 Long-
Slide 9: Severely decompensated patients – alcohol and NASH as key drivers of cirrhosis
Severely decompensated patients – alcohol and NASH as key drivers of cirrhosis Age (mean) 63.6 ± 9.5 yr MELD score (mean ± SD) 15.2 ± 3.8 Cirrhosis etiology* - Alcohol - 47.5% - NASH - 37.5% - Viral hepatitis - 12.5% - Others - 11.0% TP per month prior to study (mean ± SD) 3.2 ± 1.5 * Some patients
Slide 10: Primary effectiveness endpoints exceed predefined thresholds for study success
Primary effectiveness endpoints exceed predefined thresholds for study success* • 100% median per-patient reduction in therapeutic paracentesis (p<0.001)** • vs hypothesis of at least a 50% reduction • 77% of patients with at least 50% reduction in therapeutic paracentesis (p<0.001)** • vs hypothesi
Slide 11: Primary safety endpoint in line with expectations
Primary safety endpoint in line with expectations* Primary safety endpoint: • Combined rate of i) open surgical re-intervention due to pump system related AE or to restore pump functionality, ii) pump explant (without replacement) due to pump system related AE, or iii) pump system related death from
Slide 12: Pre-defined MAEs as key secondary safety endpoint
Pre-defined MAEs as key secondary safety endpoint • Major Adverse Events (MAEs) specific to patient population and alfapump as agreed upfront with Principal Investigators and FDA • In POSEIDON, an MAE is defined as one of the following events (adjudicated by the CEC): • AKI > stage 2 • Hepatorenal s
Slide 13: Similar number of MAEs pre vs post implant
Similar number of MAEs pre vs post implant Despite disease progression 3 months pre-implant 3 months post-implant (Day -90 to Day -1) (Day 91 to Day 180) No. of subjects with No. of subjects with No. of events No. of events events events Major Adverse Events 5 3 5 4 AKI > stage 2 0 0 1 1 Hepatorenal
Slide 14: Comparable number of serious infections pre vs post
Comparable number of serious infections pre vs post Despite disease progression 3 months pre-implant 3 months post-implant (Day -90 to Day -1) (Day 91 to Day 180) No. of subjects with No. of subjects with No. of events No. of events events events All Serious Infections 2 2 3 3 Of which: Ascites-Rela
Slide 15: Despite AKIs, stable kidney function over long-term
Despite AKIs, stable kidney function over long-term • AKI events post-implant were manageable 6 months post-implant (Day 0 to Day 180) No. of events No. of subjects with events AKI stage 1 16 14 AKI 1 of limited clinical relevance AKI stage 2 4 4 AKI 2 and 3: three events resolved and three events w
Slide 16: Pre and Post implant AKI rates are not comparable
Pre and Post implant AKI rates are not comparable • Renal function is often impaired in patients with advanced cirrhosis • Patients in POSEIDON were closely monitored for AKIs, hence more events diagnosed • No comparison pre vs post implant – any patient with non-transient AKI in pre-implant period
Slide 17: QoL: Clinically meaningful and statistically significant improvement despite disease progression
QoL: Clinically meaningful and statistically significant improvement despite disease progression SF-36 Physical Component Score (higher is better): Ascites Q Score (lower is better): * * * * 17 17 QoL: Quality of Life * Pre-implant = at baseline; Post-implant = at 6 months post-implantation
Slide 18: Survival: 70% at one year post-implantation
Survival: 70% at one year post-implantation Compares favorably to published literature citing 50% survival at 1 year from diagnosis of refractory ascites(1) Note: POSEIDON study not powered for survival 18 Source 1: Biggins et al., Hepatology, Vol. 74, No. 2, 2021, AASLD Practice Guidance; Moreau R
Slide 19: Strong clinical profile of alfapump
Strong clinical profile of alfapump Conclusions of presentation by Prof. Wong (POSEIDON PI) at EASL Congress 2023 • alfapump system was very effective in the control of ascites, virtually eliminating the need for LVP • Associated improvement in physical aspect of quality of life • Patients with the
Slide 20: Gearing up for US approval in 2024
Gearing up for US approval in 2024 Existing DRG payment and breakthrough device designation de-risk reimbursement of alfapump Publications Additional data US filing & approval Submit POSEIDON data for Patient preference study: top-line data PMA filing planned for Q4 2023 publication in peer-reviewed
Slide 21: US – Go direct to liver transplant centers
US – Go direct to 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines 125 adult centres, of which 90 cover 95% of transplants ~50 person commercial team Source: Organ Procurement & Transplantation Network, US Dept of HHS (optn.transpl
Slide 22: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump study – POSEIDON Liver disease / Q4 ‘22: Q2 ‘23: Q3‘23: Q4 ‘23: NASH Primary endpoint Additional data Data patient FDA submission readout at EASL preference study & for US approval NACSELD registry H2 H1 H2 2022 2023 2023 Q4 ‘22: Q2 ‘23: H
Slide 23: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com