Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (May 2021)
24 slides from Sequana Medical's corporate update, May 11, 2021
Slide 1: RED DESERT top-line results & expansion of DSR development programme
RED DESERT top-line results & expansion of DSR® development programme Webcast presentation – 11 May 2021
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, th
Slide 5: Strong top-line results from RED DESERT
Strong top-line results from RED DESERT Confirming the potential clinical benefits of alfapump DSR® therapy • RED DESERT data of all 8 patients confirm: alfapump DSR is highly effective at managing fluid and sodium balance in diuretic-resistant heart failure patients without need for loop diuretic
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: Proprietary Direct Sodium Removal (DSR)
Proprietary Direct Sodium Removal (DSR®) We remove the sodium and then the body “does the math” to maintain serum sodium balance Key Principle DSR therapy directly Body eliminates removes the sodium excess fluid 7 7
Slide 8: Proprietary Direct Sodium Removal (DSR)
Proprietary Direct Sodium Removal (DSR®) We remove the sodium and then the body “does the math” to maintain serum sodium balance Key Principle DSR therapy directly Body eliminates removes the sodium excess fluid DSR therapy Administer Sodium diffuses Remove DSR Body restores sodium-free DSR from the
Slide 9: 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 1 peritoneal cavity via implanted port 2 Sodium diffuses into DSR infusate 1 alfapump pumps sodium-rich DSR infusate into the 3 bladder 3 Body eliminates exce
Slide 10: RED DESERT – The first repeated DSR therapy study
RED DESERT – The first repeated DSR® therapy study Repeated dose proof-of-concept study of alfapump DSR® in stable heart failure patients on high dose diuretics alfapump® + surgical start DSR therapy discharged from end DSR port implantation in hospital hospital therapy 2 weeks 2 weeks 4 weeks DSR t
Slide 11: RED DESERT – Concluded at 8 patients implanted
RED DESERT – Concluded at 8 patients implanted Key lessons learned – so we can move ahead to our target patient population ASAP N=8 Ejection Fraction – % 24.4 ± 3.1 (Mean ± SD) NT-proBNP – pg/mL* 4,589 ± 2,945 (Mean ± SD) Furosemide equivalents – mg/day 323 ± 263 (Mean ± SD) * NT-proBNP: N-terminal-
Slide 12: Highly effective management of fluid & sodium
Highly effective management of fluid & sodium No loop diuretics required during study despite mean baseline dose of >300 mg/day furosemide equivalents Daily Dose of loop diuretics (mg)** During DSR Treatment Subject At screening (D0 - 42) 101-001 80 0 101-002 200 0 101-003 400 0 101-005 120 0 101-00
Slide 13: Dramatic improvement in diuretic efficiency
Dramatic improvement in diuretic efficiency Over 250% increase in mean diuretic response* Diuretic efficiency 8 p<.001 6h Na excretion (gr) 6 4 2 0 Baseline End * 6 hour Na excretion following administration of 40mg intravenous furosemide; paired statistical analysis of patients with baseline and D4
Slide 14: Long term improvement in diuretic response
Long term improvement in diuretic response 79% reduction in mean diuretic dose at median follow-up of 10 months Daily Dose of loop diuretics (mg)*** During DSR Time since last Treatment DSR study Current Reduction in 5 Subject At screening (D0 - 42) treatment** Daily dose (mg)*** diuretic dosage 101
Slide 15: Significant improvement in cardio-renal function
Significant improvement in cardio-renal function* NT-proBNP Creatinine p<.001 6000 p<.001 1.5 4000 1.0 mg/dL pg/mL 2000 0.5 0 0.0 Baseline End Baseline End 30% decrease 22% increase 22% decrease in mean natriuretic peptides in mean eGFR in mean creatinine “The simultaneous normalisation of diuretic
Slide 16: Adverse event overview
Adverse event overview No clinically significant changes in serum sodium levels / no progressive hyponatremia • Study system related adverse events: 3 in 2 patients • 2x SAE blockage of peritoneal catheter in 1 patient • 1x site AE hematoma in 1 patient • Therapy related adverse events: 1 in 1 patie
Slide 17: SAHARA DESERT – On track to start in Q2 2021
SAHARA DESERT – On track to start in Q2 2021 20 decompensated heart failure patients with residual congestion on high doses of loop diuretics Patient Start DSR® Euvolemic End DSR enrolment therapy state therapy Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy Maintenance DSR therapy
Slide 18: Development of proprietary DSR Infusate 2.0 ongoing
Development of proprietary DSR® Infusate 2.0 ongoing • 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
Slide 19: Short-term DSR – Expanding development programme
Short-term DSR® – Expanding development programme Building upon the success of RED DESERT to extend and strengthen the DSR franchise Short-term DSR therapy: Long-term alfapump DSR® therapy: • “one off” ~2 weeks intensive DSR treatment • Intermittent, recurring, intensive DSR treatment • With periton
Slide 20: DSR and alfapump DSR development strategy
DSR® and alfapump DSR® development strategy Short-term DSR therapy extends portfolio Study description* 2021 2022 2023 2024 - alfapump DSR dose-ranging feasibility study SAHARA D10% infusate; decompensated heart failure patients - Proprietary DSR infusate 2.0 manufacturing DSR Infusate 2.0 Short-ter
Slide 21: Evaluating potential for DSR in renal failure
Evaluating potential for DSR® in renal failure Complementary opportunity leveraging heart failure programme capabilities • Like heart failure, kidney failure / dialysis is one of the leading burdens for healthcare systems and carries a high mortality / morbidity burden • Hemodialysis seeks to tackle
Slide 22: Building Sequana Medical on Two Platforms
Building Sequana Medical on Two Platforms Complementary approaches to diuretic-resistant fluid overload alfapump® alfapump DSR® DSR® Heart Failure Liver Disease / Decongestion NASH & Malignant Ascites Long-term Short-term therapy therapy 22 22
Slide 23: Expected core value drivers & outlook
NASH in North Expected core value drivers & outlook Liver disease / America Q2 21: Q2 21: Q2 22: H2 22: POSEIDON POSEIDON POSEIDON Filing to interim analysis 2 LPI primary endpoint US FDA 2021 2022 Heart failure in North America Q2RED & Europe 21: Q2 21: Q4 21: H2 22: H2 22: SAHARA SAHARA SAHARA MO
Slide 24: Q&A
Q&A