Sequana Medical N.v · EURONEXT:SEQUA

Sequana Medical — Investor Presentation (July 2021)

52 slides from Sequana Medical's investor presentation, Jul 15, 2021

  1. Slide 1: The impact of Refractory or Recurrent Liver Ascites on Patients and Healthcare systems

    The impact of Refractory or Recurrent Liver Ascites on Patients and Healthcare systems and the potential for alfapump® therapy in NASH-related Ascites Key Opinion Leader Webinar with Hugo E. Vargas, M.D. and Grace Knuttinen, M.D., Ph.D. 15 July 2021

  2. 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

  3. 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

  4. Slide 4: Agenda and Presenters

    Agenda and Presenters 09:00 – Ian Crosbie, CEO Sequana Medical • Welcome and Introduction 09:00 – Testimonial from a patient living with refractory ascites 09:05 – Dr. Hugo Vargas and Dr. Grace Knuttinen, Mayo Clinic Hugo E. Vargas, M.D. Grace Knuttinen, M.D., Ph.D. • Ascites Management 2021 • Treat

  5. Slide 5: Patient testimonial

    Patient testimonial • 63-year old patient from Canada 5 5

  6. Slide 6: alfapump System in the treatment of refractory or recurrent ascites: The POSEIDON Study

    alfapump® System in the treatment of refractory or recurrent ascites The POSEIDON Study M-G Knuttinen, MD PhD Professor of Radiology Dept. of Vascular and Interventional Radiology Mayo Clinic Arizona Hugo E. Vargas, MD; FAASLD, AGAF, FACG Professor of Medicine Division of Gastroenterology and Hepato

  7. Slide 7: Ascites Management 2021

    Ascites Management 2021 2 ©2017 MFMER | 3711365-7

  8. Slide 8: Objectives

    Objectives • During this presentation we will discuss: • The importance of ascites • Clinical implications: • Intensity of clinical burden • Pitfalls and complications of ascites • The progress with alfapump • Opportunities and barriers of alfapump 3 ©2017 MFMER | 3711365-8

  9. Slide 9: Ascites

    Ascites • Most common complication of decompensation in cirrhosis • Develops in 5–10% of patients with compensated cirrhosis per year • Significant impact on patients • Impairs patient working and social life • Frequently leads to hospitalization • Requires chronic treatment • Direct cause of furthe

  10. Slide 10: Cirrhosis is the Most Common Cause of Ascites

    Cirrhosis is the Most Common Cause of Ascites Etiology of cirrhosis is shifting towards NASH ~3-4M Viral (1) infections Liver (Hepatitis B & C) cirrhosis Peritoneal malignancy 10% ~1.5M (2) Alcoholic Liver Cirrhosis Heart failure 3% Disease Ascites Peritoneal tuberculosis 2% Others  Pancreatic ~150

  11. Slide 11: Ascites Grading

    Ascites Grading • Diagnostic paracentesis is very important in Grade 2 and 3 ascites (new diagnosis or clinical change) Grading of ascites* Grade 1 Mild ascites: only detectable by ultrasound examination Grade 2 Moderate ascites: manifest by moderate symmetrical distension of abdomen Grade 3 Large o

  12. Slide 12: Treatment and Challenges

    Treatment and Challenges 7 ©2017 MFMER | 3711365-12

  13. Slide 13: Management of Ascites

    Management of Ascites • Grade 1 • should alert impending decompensation and management is observant • Does not require paracentesis • Discuss Na restriction and follow closely • Grade 2 and 3 • Characterize ascites • Na restriction (80-120 mmol/day 4-7 g of salt); Dietician directed • Therapeutic Pa

  14. Slide 14: Diuretics

    Diuretics Anti-mineralocorticoid (spironolactone or amiloride) • Discontinue for hyperkalemia Loop diuretic (furosemide or torsemide) • Discontinue for hypokalemia or hyponatremia Usual pitfalls: • Unresponsiveness defines RESISTANT ASCITES • Be sure maximum doses are used • Attempt for at least 1 w

  15. Slide 15: Common Complications

    Common Complications • Hyponatremia (Serum Na levels below 125 mEq/mL) • Depending on Na level can be serious • Required diuretic decrease • Spontaneous bacterial peritonitis • Bacterial infection of the ascitic fluid • Ambulatory or in-hospital problem • Hepatic hydrothorax • Extension of the ascit

  16. Slide 16: Therapeutic Paracentesis

    Therapeutic Paracentesis Any patient with G3 ascites (tense) on appropriate diuretic regimen who is struggling with ascites control Consider LVP regimen if: • Ruled out non-compliance with Na restriction • No response or symptoms with maximal regimen of diuretic combination Patients benefit from sta

  17. Slide 17: Refractory/Recurrent Ascites and Paracentesis

    Refractory/Recurrent Ascites and Paracentesis Significant impact on Quality of Life “Normal Life” ~5 days Decreased mobility & High mortality rate Drainage appetite, nausea ~2 days and constipation ~5 days Extreme discomfort Immobile, vomiting, constipated ~3 days Typical patient life(1) Note : Prev

  18. Slide 18: Limitations of Existing Therapies

    Limitations of Existing Therapies Drainage (“Large Volume Transjugular Intrahepatic Paracentesis / LVP”) Portosystemic Shunt (TIPS) Painful, Poor Quality of alfapump® Complications, Life, Short Term Benefit Contraindications Permanent Catheter Liver transplantation System External Catheter, High Cos

  19. Slide 19: alfapump – Reduce the Need for Therapeutic Paracentesis

    alfapump® – Reduce the Need for Therapeutic Paracentesis Therapeutic Paracentesis alfapump® • Painful  Automatic and continuous removal of ascites • Frequent hospitalisations  Fully implanted and wirelessly battery charging • Poor quality of life  FDA breakthrough designation / CE mark • Short-te

  20. Slide 20: alfapump Implantation

    alfapump® Implantation 15 These materials are provided to you solely as an educational resource for your personal use. Any commercial use or distribution of these materials or any portion thereof is strictly prohibited. ©2017 MFMER | 3711365-20

  21. Slide 21: alfapump Implantation

    alfapump® Implantation • Minimally invasive procedure • Takes around 60 minutes • Performed by Interventional Radiologist • Straightforward procedure using standard techniques • Performed under general or local anaesthesia • In standard treatment room • Procedure Protocol: • Place peritoneal cathete

  22. Slide 22: What is an Interventional Radiologist?

    What is an Interventional Radiologist? • Interventional radiologists are physicians who are specially trained to diagnose and treat conditions using tiny, miniaturized tools, while watching their progress on X-ray or other imaging equipment • Typically, the interventional radiologist performs proced

  23. Slide 23: What are “Minimally Invasive” Techniques?

    What are “Minimally Invasive” Techniques?  needles  guide wires  catheters  stents 17 ©2017 MFMER | 3711365-23

  24. Slide 24: alfapump IR Implant Procedure

    alfapump® IR Implant Procedure 1. Pre-Implant ; Choice of the right patient 2. Anesthesia 3. Implant • Peritoneal Catheter • Bladder Catheter • Pump Pocket and Catheter Tunneling • Pump Fixation • Pump Volume, Albumin and Infection 4. Post-implant • Adjust volume (if required) • Out-patient follow-u

  25. Slide 25: What’s in the “Box”?

    What’s in the “Box”? 1) PUMP 2) BLADDER CATHETER 3) PERITONEAL CATHETER 4) IMPLANT ACCESSORIES 20 ©2017 MFMER | 3711365-25

  26. Slide 26: The alfapump Catheters

    The alfapump® Catheters • Standard implantable grade silicone catheters are utilised to move ascites from the abdominal cavity to the bladder YELLOW is BLADDER • Pigtail to ensure safety and no irritation against the bladder wall TRANSPARENT / BLUE is PERITONEAL CAVITY • Pigtail to avoid blockage an

  27. Slide 27: Peritoneal Catheter Placement

    Peritoneal Catheter Placement • Locate the insertion site • Typically near the right pericolic gutter • Can be individualized to patient anatomy • Subcutaneous path of the peritoneal catheter should be at least 10 cm • Use Doppler ultrasound to avoid any large vessels • Incision site should not sit

  28. Slide 28: Ultrasound

    Ultrasound • To locate optimal abdominal entry (ascites) for the peritoneal catheter 23 ©2017 MFMER | 3711365-28

  29. Slide 29: Wire, Dilate and Peel Away Sheath

    Wire, Dilate and Peel Away Sheath Standard methods for (IR) catheter placement 24 ©2017 MFMER | 3711365-29

  30. Slide 30: ©2017 MFMER | 3711365-30

    25 ©2017 MFMER | 3711365-30

  31. Slide 31: Bladder Catheter Placement – Suprapubic Approach

    Bladder Catheter Placement – Suprapubic Approach • Assess the bladder with ultrasound • Locate the incision site above the symphysis pubis and below the palpable bladder dome • Incision site should be right to the midline • Perform a bladder “stab” with the introducer/needle attached to a small syri

  32. Slide 32: Bladder Ultrasound - Use Doppler

    Bladder Ultrasound - Use Doppler!!! Importance of localization of bladder in patient with ascites: peritoneum can “hang over” the bladder 27 ©2017 MFMER | 3711365-32

  33. Slide 33: Bladder Catheter Placement

    Bladder Catheter Placement 28 ©2017 MFMER | 3711365-33

  34. Slide 34: Wire, Dilate and Peel Away Sheath – Similar to PC

    Wire, Dilate and Peel Away Sheath – Similar to PC 29 ©2017 MFMER | 3711365-34

  35. Slide 35: Bladder Catheter Placement

    Bladder Catheter Placement 30 ©2017 MFMER | 3711365-35

  36. Slide 36: Pump Pocket Creation

    Pump Pocket Creation 31 ©2017 MFMER | 3711365-36

  37. Slide 37: Tunneling of Catheters

    Tunneling of Catheters 32 ©2017 MFMER | 3711365-37

  38. Slide 38: Attach Catheters to alfapump and Test

    Attach Catheters to alfapump® and Test 33 ©2017 MFMER | 3711365-38

  39. Slide 39: Closing of Incisions

    Closing of Incisions 34 ©2017 MFMER | 3711365-39

  40. Slide 40: POSEIDON Study

    POSEIDON Study 35 ©2017 MFMER | 3711365-40

  41. Slide 41: Study Design

    Study Design Pivotal study to support future marketing application of the alfapump® in the US and Canada Pivotal Cohort alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implant observation stabilisati

  42. Slide 42: Recurrent or Refractory Ascites – Patient Profile

    Recurrent or Refractory Ascites – Patient Profile • 26 patients from the Roll-In Cohort in the POSEIDON study Age (mean) 63 y MELD score (mean ± SD) 10.3 ± 3.9 Cirrhosis etiology - Alcohol - 50.0% - NASH - 23.1% - NASH / Alcohol - 3.8% - Alcohol / Hepatitis - 11.5% - Alcohol / Primary Sclerosing Cho

  43. Slide 43: Roll-In Cohort: Substantial and Durable Reduction in Therapeutic Paracentesis

    Roll-In Cohort: Substantial and Durable Reduction in Therapeutic Paracentesis (TP) Primary efficacy Interim data Mean values endpoint Pivotal Cohort Roll-In Cohort (N = 26) % reduction in monthly frequency of TP > 50% (1) > 90% (2) % patients with >50% reduction in TP > 50% (1) 100% (2) (1) Monthly

  44. Slide 44: MOSAIC Trial: a Previous North American Feasibility Study with the alfapump

    MOSAIC Trial: a Previous North American Feasibility Study with the alfapump® Phase II study Enrolled 30 patients • Ascites drainage pre-implantation decreased from 2.4 ± 1.4 LVP/patient/month to 0.2±0.4 LVP/patient/month • Patient QOL and weight improved after implantation Consistent with the curren

  45. Slide 45: Roll-In Cohort: Safety In-line with Expectations

    Roll-In Cohort: Safety In-line with Expectations Primary safety endpoint: • Rate of alfapump related re-interventions adjudicated by Clinical Events Committee (CEC) Interim data Roll-In Cohort (N=26): • No unanticipated adverse device effects • Three patients experienced a composite primary safety e

  46. Slide 46: Roll-In Cohort: Clinically Important Improvement in Quality of Life Maintained up to 12 Months

    Roll-In Cohort: Clinically Important Improvement in Quality of Life Maintained up to 12 Months Physical Component Score 5 point increase = clinically important improvement* Higher is better SF-36 General health- survey questionnaire Total Score 20 point decrease = clinically important improvement* A

  47. Slide 47: alfapump - the Challenge and Promise

    alfapump® - the Challenge and Promise • alfapump is well accepted • Patient reported outcomes are solid • Strong interest • Safety • Less hepatic encephalopathy (HE) • Manageable infection rate • Decreased ascites burden • Less albumin need • Can work in liver transplant environment • Serves a popul

  48. Slide 48: alfapump - the Challenge and Promise (cont’d)

    alfapump® - the Challenge and Promise (cont’d) • TIPS may be viewed as a more permanent option • Outside of clinical trial, alfapump may deliver similar results without HE • Albumin replacement protocols remain costly and potentially not fully beneficial • Liver transplant (LT) is not an answer to a

  49. Slide 49: Innovators in the treatment of diuretic-resistant fluid overload

    Innovators in the treatment of diuretic-resistant fluid overload liver disease – malignant ascites – heart failure

  50. Slide 50: Two pillars of growth – € billion opportunities

    Two pillars of growth – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) Heart Failure Proven step change in liver refractory ascites Breakthrough approach to diuretic-resistant congestion and malignant ascites Proven ability to manage fluid balance, restore diuretic Over 850 dev

  51. Slide 51: Expected core value drivers & outlook

    NASH in North Expected core value drivers & outlook Liver disease /  Q2 21: America Q3 21: Q3 22: Q4 22: POSEIDON POSEIDON POSEIDON Filing to interim analysis LPI primary endpoint US FDA 2021 2022 Heart failure in North America Q2RED 21: Q2 21: & Europe Q4 21: H2 22: H2 22: SAHARA SAHARA SAHARA M

  52. Slide 52: Q&A

    Q&A

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