Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — BioCapital Europe 2021
19 slides from Sequana Medical's conference presentation, Mar 11, 2021
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Innovators in the treatment of diuretic-resistant fluid overload liver disease – malignant ascites – heart failure BioCapital Europe Ian Crosbie, CEO – 11 March 2021
Slide 2: 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 3: 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 4: alfapump platform
alfapump® platform Using the bladder to treat fluid overload Fully implanted Easy implantation Long-term implantation & catheter Automatic operation patency Wireless battery charging Moves up to 4 litres / day Settings wirelessly adjusted Virtually non-clogging Remote data monitoring No significant
Slide 5: One platform – two products – € billion opportunities
One platform – two products – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) Heart Failure Proven step change in liver refractory ascites Breakthrough approach to fluid overload in and malignant ascites heart failure CE mark / FDA Breakthrough Device Clinical proof-of-concept o
Slide 6: NASH drives US market attractiveness
NASH drives US market attractiveness Stronger competitive position in a much larger and dynamic market alfapump® market potential ~€0.4 Bn / year >€3 Bn / year Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream” Average age 40-50 yr 70
Slide 7: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway Pivotal Cohort of up to 50 patients implanted; Roll-In (“training”) cohort of up to 30 patients alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implan
Slide 8: POSEIDON Interim Data: Positive for primary endpoints
POSEIDON Interim Data: Positive for primary endpoints Data from first 13 Roll-In patients EFFICACY Over 90% reduction in mean frequency of TP post-implant vs. pre-implant All patients at least a 50% reduction in the mean frequency of TP per month SAFETY Safety profile in line with expectations
Slide 9: Targeting announcement of primary endpoint in Q1 2022
Targeting announcement of primary endpoint in Q1 2022 2019 2020 2021 2022 FDA IDE First Interim Last Full Primary approval patient in analysis 1 patient interim Endpoint in* analysis* Reporting* FDA breakthrough Filing* designation Building out US team MCIT & NTAP – final CMS rules for breakt
Slide 10: US commercialisation through our specialty salesforce
US commercialisation through our specialty salesforce NY MI (7) (4) PA (12) OH Initial focus on key IL (6) (6) CA transplant centres (12) NC (3) ~50-person team: AZ (5) 35 sales reps, 10 clinical, GA (3) 5 corporate TX (13) FL (8) POSEIDON site Target State (# transplant centres) 10 10
Slide 11: Diuretic-resistant fluid overload in heart failure
Diuretic-resistant fluid overload in heart failure Key clinical challenge and driver of costs US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(3) due to fluid overload(3) Excess sodium drives c.5d Typical fluid overload Annual costs of US hospital stay(4) HF-related $13bn hospita
Slide 12: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR®) Proprietary approach to fluid overload – supported by interim RED DESERT clinical data We remove the sodium and then the body “does the math” to maintain serum sodium balance DSR therapy directly Body eliminates removes the sodium excess fluid “DSR represents a new poten
Slide 13: alfapump DSR
alfapump DSR® Potential chronic therapy for diuretic-resistant heart failure patients with fluid overload Sodium-free DSR® infusate administered to 1 peritoneal cavity via implanted port 2 Sodium diffuses into DSR infusate 1 alfapump pumps sodium-rich DSR infusate into the 3 bladder Body eliminates
Slide 14: RED DESERT: Study design
RED DESERT: Study design Repeated dose proof-of-concept study of alfapump DSR® in diuretic-resistant heart failure patients alfapump® + surgical start DSR® therapy discharged from end DSR port implantation in hospital hospital therapy 2 weeks 2 weeks 4 weeks DSR therapy Continued DSR therapy Stabili
Slide 15: Interim RED DESERT: Strong safety & efficacy results
Interim RED DESERT: Strong safety & efficacy results Results from first five patients SAFETY Implant procedure of alfapump DSR® and repeated dosing of DSR® therapy were well-tolerated No clinically significant changes in serum sodium levels / no progressive hyponatremia Reported adverse events
Slide 16: Interim RED DESERT: Restored normal kidney response
Interim RED DESERT: Restored normal kidney response Results from first five patients • Diuretic response restored to near normal levels • Sodium excretion more than doubled after DSR study period (to near normal levels) • Long-lasting improvement in diuretic responsiveness • Dramatic reduction in or
Slide 17: alfapump DSR development strategy
alfapump DSR® development strategy* Study description 2020 2021 2022 2023 Proof-of-concept repeated dose alfapump DSR study RED DESERT D10% infusate; stable heart failure patients FDA discussions on regulatory pathway alfapump DSR dose-ranging feasibility study** SAHARA D10% infusate; decompensated
Slide 18: 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 Q4 2020 2021 Q1 2022 Heart failure in North America Q4 20: & Europe H
Slide 19: Thank You
Thank You IR@sequanamedical.com +32 498 053579 www.sequanamedical.com