Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — BTIG Conference 2021
33 slides from Sequana Medical's conference presentation, Feb 18, 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 BTIG Conference Ian Crosbie, CEO – 18 February 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: Sequana Medical NV
Sequana Medical NV Founded in 2006 Gent, Belgium (HQ): corporate, clinical, commercial Zurich, Switzerland: manufacturing, engineering, QA/RA ~50 employees Euronext Brussels: SEQUA 4
Slide 5: 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 6: One platform – two products
One platform – two products 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 Over 800 devices implanted Clinical proof-of-concept of Direct Sodium Removal (DSR®) >
Slide 7: 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 8: Liver cirrhosis and refractory ascites
Liver cirrhosis and refractory ascites A key complication of liver cirrhosis, with a dramatic impact on quality of life US forecast ~3-4M (1) Viral infections Liver (Hepatitis B & C) “Normal Life” cirrhosis ~5 days ~1.5M Decreased (2) High mortality rate mobility & Alcoholic Liver appetite, Ascites
Slide 9: 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 10: POSEIDON Interim Data: Positive for primary endpoints
POSEIDON Interim Data: Positive for primary endpoints Data from first 13 Roll-In patients EFFICACY Mean values post-implant vs. pre-implant N = 13 Reduction in frequency of TP > 90% Patients with >50% reduction in TP 100% SAFETY • Safety profile of the alfapump consistent with previously reported da
Slide 11: Quality of Life: Indication of fast and persistent improvement
Quality of Life: Indication of fast and persistent improvement Physical Component Score 5 point improvement = clinically relevant Higher is better SF-36 General health- survey questionnaire Total Score 20 point reduction = clinically relevant Ascites Q Specific health- survey questionnaire for ascit
Slide 12: Strong progress towards alfapump US approval
Strong progress towards alfapump® US approval 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
Slide 13: 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) 13 13
Slide 14: 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 15: 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 16: 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 17: 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 18: 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 19: 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 20: Developing high value proprietary DSR Infusate
Developing high value proprietary DSR® Infusate • D10% was chosen as the initial DSR infusate for fastest proof-of-concept • We are developing our proprietary next-generation DSR infusate: Improved therapeutic profile compared to D10% IP protected Recurring revenue from high gross margin consu
Slide 21: 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 22: 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 23: Thank you
Thank you
Slide 24: Back-up
sequanamedical
Slide 25: Strong organisation
Strong organisation Highly experienced leadership team supported by committed and well-reputed shareholders Executive team: Ian Crosbie Kirsten Van Bockstaele Oliver Gödje Chief Executive Officer Chief Financial Officer Chief Medical Officer Gijs Klarenbeek Martijn Blom Timur Resch Andreas Wirth Sen
Slide 26: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 18.4M • Outstanding share options & warrants: 1.8M • Analysts: • KBC Securities – Lenny Van Steenhuyse • Kempen – Ingrid Gafanhão • Kepler Cheuvreux – Matthias Maenhaut • Mirabaud – Daniel Jelovcan • Cas
Slide 27: 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 28: 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 29: Leading experts as Heart Failure Scientific Advisors
Leading experts as Heart Failure Scientific Advisors Dr. Maria Rosa Costanzo Dr. Wilson Tang Medical Director of the Edward Center for Professor of Medicine at Cleveland Clinic Lerner Advanced Heart Failure College of Medicine at Case Western Reserve Medical Director Heart Failure Research for the U
Slide 30: DSR pre-clinical Proof-of-Concept
DSR® pre-clinical Proof-of-Concept Clinically relevant sodium and fluid removal Clinically relevant removal of sodium Effective fluid removal 18 6000 N=5 N=5 16 p<0.0001 p<0.0001 Recommended 5000 14 Mean volume removal (mL) weekly sodium Mean sodium removal (g) intake(1) 12 4000 10 3000 8 N = 10 6 N
Slide 31: DSR first-in-human study met primary and secondary endpoints
DSR® first-in-human study met primary and secondary endpoints DSR therapy was safe & well-tolerated with no adverse events or significant discomfort Substantially higher sodium removal with DSR vs standard Peritoneal Dialysis (PD) solution Minimal inter-patient variability Results presented at ke
Slide 32: Clinical development strategy
Clinical development strategy Exciting impact on diuretic response requires additional investigation to support value of DSR® therapy RED DESERT – repeated dose study in stable heart failure patients • Enrol up to five additional patients, with top-line data expected in H1 2021 SAHARA DESERT – dose-
Slide 33: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com