Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (December 2021)
17 slides from Sequana Medical's corporate update, Dec 7, 2021
Slide 1: alfapump DSR SAHARA DESERT Interim Results
Webcast presentation – 7 December 2021 alfapump DSR ® SAHARA DESERT Interim Results
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Oliver Gödje Chief Executive Officer Chief Medical Officer 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: SAHARA DESERT: Strong interim results
SAHARA DESERT: Strong interim results Six diuretic-resistant heart failure patients with persistent congestion treated with alfapump DSR® Indication of the ability of repeated DSR® therapy to Safely, effectively and rapidly eliminate persistent congestion and restore euvolemia Considerably ben
Slide 5: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Clear unmet clinical need and driver of costs for heart failure patients US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(3) due to fluid overload(3) c.5d Typical Annual costs of US hospital stay(4) HF-related $13bn hospitalisations(
Slide 6: Direct Sodium Removal (DSR) platform
Direct Sodium Removal (DSR®) platform Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR infusate 2 Sodium diffuses from 3 DSR infusate + extracted 4 Body eliminates free water administered to peritoneal body into DSR sodium removed from the to resto
Slide 7: alfapump DSR leveraging proven alfapump platform
alfapump DSR® leveraging proven alfapump® platform Fully implanted system for long-term DSR® therapy Sodium-free DSR infusate administered to peritoneal cavity 1 via implanted subcutaneous port 2 Sodium diffuses into DSR infusate 1 3 alfapump pumps sodium-rich DSR infusate into the bladder 3 Body el
Slide 8: SAHARA DESERT: Targeting persistent congestion
SAHARA DESERT: Targeting persistent congestion 20 decompensated heart failure patients with persistent congestion on high dose diuretics Patient Start DSR® Euvolemic End DSR enrolment therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy Maintenanc
Slide 9: Interim analysis: 6 severe heart failure patients with persistent congestion
Interim analysis: 6 severe heart failure patients with persistent congestion on high dose diuretics Mean values at baseline of 6 patients in interim analysis Left ventricular ejection fraction: low 20% NT-proBNP: >6,000 pg/mL Furosemide equivalent dose: ~250 mg/day (standard of care) NT-proBNP: N-te
Slide 10: Interim analysis: Strong efficacy results
Interim analysis: Strong efficacy results Interim data from six patients indicate that alfapump DSR® therapy can: • Safely, effectively and rapidly eliminate persistent congestion and restore euvolemia without any loop diuretics Weight loss* of ~6kg (=7% of body weight) vs. baseline 3 patients r
Slide 11: Interim analysis: Repeated alfapump DSR therapy was safe and well-tolerated
Interim analysis: Repeated alfapump® DSR therapy was safe and well-tolerated • No clinically significant changes in serum sodium levels or other electrolytes after intensive DSR therapy • Reported adverse events were manageable: Diarrhea (1 patient) Catheter blockage (1 patient) Smart charger
Slide 12: SAHARA DESERT: Enrolment
SAHARA DESERT: Enrolment • Overall, 9 patients have been enrolled and implanted with alfapump DSR® across 2 sites • 6 patients were evaluated for interim analysis • 2 further patients just started study treatment* • 1 further patient was enrolled but died due to a cardiac arrest three days after stu
Slide 13: RED DESERT: Long-term follow-up of patients
RED DESERT: Long-term follow-up of patients Durable improvement in diuretic response following alfapump DSR® therapy Daily dose of loop diuretics** During DSR Time since last Currrent known treatment DSR treatment in the Current known reduction in Subject At screening (D0 – D42) study daily dose***
Slide 14: Strong progress in development of proprietary DSR Infusate 2.0
Strong progress in development of proprietary DSR® Infusate 2.0 for first US DSR study in H2 2022 • CMC activities ongoing & pre-clinical development work on track • MOJAVE DESERT – first US study of short-term DSR therapy planned to start in H2 2022 • Diuretic resistant chronic heart failure patien
Slide 15: DSR – Robust development program
DSR® – Robust development program* Step-by-step approach to introduction of breakthrough therapy 2021 2022 2023 2024 - alfapump DSR® feasibility study SAHARA D10% infusate; decompensated heart failure patients - Proprietary DSR infusate 2.0 manufacturing DSR Infusate 2.0 - GLP animal study (chronic
Slide 16: Strong outlook for value drivers
Liver disease / Strong outlook for value drivers Q4 21: Q1 22: Q4 22: Mid 23: NASH POSEIDON POSEIDON POSEIDON FDA submission all patients recruited completion alfapump® implants primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: H1 22: H2 22: H2 22: Mid 23: H2 23: SAHAR
Slide 17: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com