Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (October 2020)
20 slides from Sequana Medical's corporate update, Oct 22, 2020
Slide 1: alfapump DSR RED DESERT interim results
alfapump® DSR RED DESERT interim results Webcast presentation – 22 October 2020
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: 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: RED DESERT: strong interim results
RED DESERT: strong interim results First five patients in alfapump® DSR repeated dose study Results indicate repeated dose alfapump DSR therapy to be safe and effective in diuretic- resistant heart failure patients Results support DSR hypothesis: kidneys eliminate free water to maintain patients
Slide 6: Fluid overload in heart failure – major clinical problem and key driver of healthcare costs
Fluid overload in heart failure – major clinical problem and key driver of healthcare costs ~1M 90% c. 5d $13B Annual US HF-related Typical hospital Annual costs of US hospitalisations hospitalisations due stay HF-related due to HF to volume overload hospitalisations Excess sodium drives fluid overl
Slide 7: Limitations of diuretic therapy in heart failure
Limitations of diuretic therapy in heart failure Loop diuretics are the mainstay of therapy but have significant challenges in their use Diuretics primarily remove Body retains water and cuts back hypotonic urine on urination to restore homeostasis 40% of heart failure patients on IV loop diuretic
Slide 8: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Sequana Medical’s breakthrough approach to volume overload in heart failure DSR therapy directly Body eliminates removes the sodium excess fluid “DSR represents a new potential therapy for non- renal sodium and fluid removal in edematous disorders such as heart failure” 8
Slide 9: alfapump DSR
alfapump® DSR Potential chronic therapy for heart failure patients with fluid overload that are not well controlled on diuretics Administration of sodium-free DSR infusate to 1 peritoneal cavity via implanted port 2 Sodium diffuses into DSR infusate 1 alfapump pumps sodium-rich DSR infusate into the
Slide 10: RED DESERT study design
RED DESERT study design Repeated dose proof-of-concept study of alfapump® DSR in up to 10 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 S
Slide 11: Heart failure patients on high dose diuretics
Heart failure patients on high dose diuretics First five RED DESERT patients Mean values Left ventricular ejection fraction mid 20% NT-proBNP 2,500 – 3,000 pg/mL Furosemide equivalent dose 150 – 200 mg/day (standard of care) NT-proBNP: N-terminal-pro hormone B-type Natriuretic Peptide 11 11
Slide 12: Interim data support DSR hypothesis
Interim data support DSR hypothesis DSR therapy directly Body eliminates removes the sodium excess fluid • DSR removes the sodium and then the body responds to quickly and accurately eliminate the free water to maintain the sodium concentration in the blood • No clinically significant changes in ser
Slide 13: Strong safety & efficacy results from first 5 patients
Strong safety & efficacy results from first 5 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 were manageable: catheter blo
Slide 14: Restoring kidney response
Restoring kidney response Loop diuretic responsiveness restored to near normal levels in all 5 patients • Diuretic response assessed by 6-hour excretion of fluid and sodium following IV administration of 40mg furosemide Baseline: objectively poor diuretic response End of 6-week study period: mor
Slide 15: Developing our proprietary DSR infusate
Developing our 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 consumable
Slide 16: Clinical development strategy
Clinical development strategy Exciting impact on diuretic response requires additional investigation to support value of DSR therapy RED DESERT • Enrol up to five additional patients, with top-line data expected in H1 2021 SAHARA – dose-ranging study in decompensated heart failure patients • Move in
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: Business update
Business update Top-line data from all RED DESERT patients on track to report in H1 2021 First feasibility study of alfapump® DSR (SAHARA DESERT) planned to start in H1 2021 Early interim data from POSEIDON study in recurrent and refractory liver ascites expected in Q4 2020 European commerci
Slide 19: Expected Core Value Drivers & Outlook
Expected Core Value Drivers & Outlook NASH in North Liver disease / Q4 20: Q1 21: H1 21: Q1 22: America POSEIDON POSEIDON POSEIDON POSEIDON early interim enrolment interim primary endpoint results completion results read-out H2 2020 2021 H1 2022 Heart failure in North America Q4 20: & Europe H1 21
Slide 20: Q&A
Q&A