Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (July 2022)
20 slides from Sequana Medical's corporate update, Jul 19, 2022
Slide 1: DSR: A Disease Modifying Heart Failure Drug Therapy
DSR® A Disease Modifying Heart Failure Drug Therapy Webcast presentation – 19 July 2022
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: DSR – A Disease-Modifying Heart Failure Drug Therapy
DSR – A Disease-Modifying Heart Failure Drug Therapy Clinical proof-of-concept of Direct Sodium Removal (DSR) delivered – addressing key unmet clinical needs Proof-of-concept in diuretic- Clear improvements in Targeting key clinical resistant heart failure patients validated clinical measures endpoi
Slide 5: Focus: Short Term DSR with Proprietary DSR 2.0
Focus: Short Term DSR with Proprietary DSR 2.0 Bringing important clinical benefits to a large and underserved patient pool as quickly as possible • 3 to 4 weeks of intensive DSR delivers clinical benefits lasting 6 – 12 months Focus on Short Term DSR • “Drug only” regulatory path – shorter and lowe
Slide 6: Diuretic-Resistance is a Major Problem in HF Patients
Diuretic-Resistance is a Major Problem in HF Patients Clear need to treat drug-resistant congestion in chronically congested patients (the “frequent flyers”) • Heart Failure (HF) is the leading cause of hospitalizations in patients over 65 in the US • Annual cost of $14.5 billion • Congestion is the
Slide 7: Eliminating Congestion While Protecting Kidney is Key
Eliminating Congestion While Protecting Kidney is Key Persistent congestion and worsening renal function predict reduced survival 7 Source: Wattad et al, American Journal of Cardiology, 2015: interaction between worsening renal function and persistent congestion in acute decompensated heart failure
Slide 8: Current Standard of Care is BAD for the Kidneys
Current Standard of Care is BAD for the Kidneys And resistance is common • Fluid overload is initially treated with diuretics Distal tubular cells • Loop diuretics strongly activate the neurohormonal system • Leads to increased sodium retention • Blocking of neurohormones is mainstay of HF therapy (
Slide 9: DSR Tackles the Key Challenge of Sodium Overload
DSR Tackles the Key Challenge of Sodium Overload Sodium overload drives heart failure – and there are limited treatment options today • Primary pathophysiologic driver of water accumulation is sodium retention, with fluid largely passively following the retained salt.1, 2 • Estimated 200,000 chronic
Slide 10: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR product 2 Sodium diffuses from 3 DSR product + extracted 4 Body eliminates free water administered to peritoneal body into DSR product sodium removed from the to restore s
Slide 11: RED DESERT: Successful Proof-of-Concept Study
RED DESERT: Successful Proof-of-Concept Study 8 euvolemic HF patients on high dose diuretics treated with DSR 3x per week up to 6 weeks Highly effective management of fluid and sodium balance • Generally safe and well tolerated; no clinically relevant hyponatremia Significant improvement in cardio-r
Slide 12: SAHARA I (Interim): DSR Tackles Congestion
SAHARA I (Interim): DSR Tackles Congestion 10 evaluable decompensated diuretic-resistant HF patients on intensive DSR therapy1 Safely, effectively and rapidly eliminate persistent congestion & restore euvolemia • Weight loss* of ~6kg vs. baseline • No clinically relevant hyponatremia Considerably be
Slide 13: Long-Term & Major Reduction in Loop Diuretic Dosing
Long-Term & Major Reduction in Loop Diuretic Dosing Clear demonstration of improvement in cardio-renal health – driving improved clinical outcomes 600 ~23 months follow-up mg furosemide equivalents 500 RED DESERT 400 101-001 101-002 300 101-003 200 101-005 101-006 100 101-007 0 101-008† 800 ~11 mont
Slide 14: Strong Reduction in Predicted Mortality
Strong Reduction in Predicted Mortality Over 75% reduction in predicted one-year mortality based on Seattle Heart Failure Model* • Seattle Heart Failure Model is a highly validated model to predict survival in heart failure • Validated in approx. 10,000 heart failure patients in over 46 countries wi
Slide 15: Moving to Proprietary DSR 2.0
Moving to Proprietary DSR 2.0 Improved clinical and safety profile driving high margin recurring revenue stream DSR 1.0 DSR 2.0 Sodium-free D10% (off-the-shelf) Sodium-free dextrose / icodextrin (proprietary) Clinical proof-of-concept Improved therapeutic profile Rapid clinical path Favorabl
Slide 16: MOJAVE as Package for DSR Partnering
MOJAVE as Package for DSR Partnering Leveraging the strengths of established HF player to realise commercial potential of DSR 2021 2022 2023 DSR 1.0 - Phase 2a DSR study SAHARA I - Proprietary DSR 2.0 product development CMC DSR 2.0 - GLP animal studies* (safety) - SAHARA extension* US IND - Phase 1
Slide 17: Multi-Billion Market Opportunity
Multi-Billion Market Opportunity Delivering value through reduced hospitalization and improved survival • ~400,000 HF patients hospitalized per year in the US and EU (“frequent flyers”) • High cost patients with major burden on healthcare systems, payors and patients • Value based pricing of DSR dru
Slide 18: DSR: Disease-Modifying HF Drug for Key Needs
DSR: Disease-Modifying HF Drug for Key Needs Directly targeting sodium overload, complementary to existing guidelines • HF is the leading cause of hospitalizations in patients over 65 in US • Congestion is the primary driver of morbidity and hospitalization in HF patients • Loop diuretics are standa
Slide 19: Strong Outlook for Value Drivers
Strong Outlook for Value Drivers North American Study – POSEIDON Liver disease / Q1 22: H2 23: NASH Q4 22: completion primary endpoint FDA submission alfapump® implants readout for US approval H1 H2 H1 H2 2022 2022 2023 2023 Heart failure Q2 22: all patients recruited Q4 22: top-line results H1 23
Slide 20: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com