Slide 1: Sensorion KOL Webinar
Sensorion KOL Webinar SENS-401 to Prevent Residual Hearing Loss after Cochlear Implantation July 5, 2023 1 Sensorion KOL Webinar – July 5, 2023
Slide 2: Disclaimer
DISCLAIMER • This document has been prepared by Sensorion (the “Company”) and is provided for • This document contains certain forward-looking statements. These statements are not information purposes only. This document does not purport to contain comprehensive guarantees of the Company’s future pe
Slide 3: Welcome and Introduction
WELCOME AND INTRODUCTION Nawal Ouzren CEO, Sensorion JulyApril 5, 6,2023 2023 3 Sensorion KOL Webinar – July 5, 2023
Slide 4: Agenda
Agenda Nawal Ouzren – Sensorion • Welcome and Introduction Yann Nguyen – Pitié Salpêtrière Hospital • Why Hearing Preservation is Important for Cochlear Implantation Géraldine Honnet – Sensorion • Sensorion’s Phase 2a Study Preliminary Results Overview 4 Sensorion KOL Webinar – July 5, 2023
Slide 5: A Franchise to Transform Lives & Connect People
A Franchise to Transform Lives & Connect People Our vision is to help people with inner ear hearing disorders to live life with unlimited connections 5 Sensorion KOL Webinar – July 5, 2023
Slide 6: Hearing Loss is a Massive Global Health Issue
Hearing Loss is a Massive Global Health Issue Hearing loss is the most frequently occurring congenital sensory deficit, the largest modifiable risk factor for dementia and has a significant impact as people live longer.1-4 Number of people in millions 3000 Drug-induced PREVENT 2497 ~375 M Aging 2500
Slide 7: SENS-401, Three Key Indications for Treatment and Prevention
SENS-401, Three Key Indications for Treatment and Prevention Protected by a solid SENS-401 is a first-in-class intellectual property with drug aiming at treating or SENS-401 demonstrated two patent families. protecting against inner ear hearing loss and Orphan Drug Designation lesions that lead to s
Slide 8: SENS-401 Has Enormous Potential and Enables our Franchise Vision
SENS-401 Has Enormous Potential and Enables our Franchise Vision CI + SSNHL CIO For treatment And prevention Blockbuster Potential SENS-401 SSNHL clinical data and insight derisked further development of SENS-401 in other indications SENS-401 CI preliminary data supports findings in SSNHL 8 Sensorio
Slide 9: The Importance of Residual Hearing Preservation
THE IMPORTANCE OF RESIDUAL HEARING PRESERVATION Professor Yann Nguyen ENT Surgeon Pitié Salpêtrière Hospital, Paris, France July 5, 2023 9 Sensorion KOL Webinar – July 5, 2023
Slide 10: Conflict of Interest
Conflict of Interest Laboratory and Medical department Research agreements: Oticon Medical, Cochlear, MEDEL Consultant: Collin Médical Sensorion Cilcare Principal investigator: Sensorion’s study of SENS-401 with cochlear implantation 10 Sensorion KOL Webinar – July 5, 2023
Slide 11: Cochlear Implantation: a Remarkable Technology to Rehabilitate Hearing Loss
Cochlear Implantation (CI): a Remarkable Technology to Rehabilitate Severe to Profound Hearing Loss External receiver Internal part Microphone Implant array Auditory nerve Apex RW Cochlea Base RW: ROUND WINDOW COCHLEAR CI 632 DEVICE ADAPTED FROM CÉLINE PIMBERT (INTERNAL PART) 11 Sensorion KOL Webina
Slide 12: Cochlear Implantation: a Remarkable Technology to Rehabilitate Hearing Loss
Cochlear Implantation (CI): a Remarkable Technology to Rehabilitate Severe to Profound Hearing Loss There are already one million patients in the world using cochlear implants but it would require many more to address the unmet medical need Example from France French population (2018): 65 millions B
Slide 13: Residual Preoperative Hearing Varies among CI Candidates
Residual Preoperative Hearing Varies among CI Candidates CI CANDIDATE WITH PROFOUND HEARING LOSS CI CANDIDATE WITH LOWER FREQUENCIES RESIDUAL HEARING 13 Sensorion KOL Webinar – July 5, 2023
Slide 14: Residual Preoperative Hearing Varies among CI Candidates
Residual Preoperative Hearing Varies among CI Candidates CI CANDIDATE WITH PROFOUND HEARING LOSS CI CANDIDATE WITH LOWER FREQUENCIES RESIDUAL HEARING 14 Sensorion KOL Webinar – July 5, 2023
Slide 15: Preserving Residual Hearing is Extremely Important
Preserving Residual Hearing is Extremely Important Conventionnal external processor (Cochlear®) Electric stimulation only • Electric for full tonotopy Loss of fine structrure preservation Adapted from Shannon R, Trend Cogn Sci, 2016 15 Sensorion KOL Webinar – July 5, 2023
Slide 16: Preserving Residual Hearing is Extremely Important
Preserving Residual Hearing is Extremely Important Acoustic stimulation Electric stimulation Hybrid electro-acoustic stimulator (Cochlear®) Hydrid Eleactro-acoustic • Acoustic for lower frequencies stimulation • Electric for higher frequencies Lower frequencies fine structure preservation Adapted fr
Slide 17: Preserving Residual Hearing is Extremely Important
Preserving Residual Hearing is Extremely Important Acoustic stimulation Electric stimulation Hydrid Eleactro-acoustic • Acoustic for lower frequencies stimulation • Electric for higher frequencies Lower frequencies • Better speech in noise fine structure preservation • Better music perception (Based
Slide 18: Various Mechanisms Result in Residual Hearing Loss
Various Mechanisms Result in Residual Hearing Loss • Mechanical disrupture of intracochlear structures (basilar membrane, spiral ligament, modiolar wall, spiral osseous lamina) • Inflammatory process (fibrosis in perilymphatic space) and secondary apoptosis • Disturbance of fluid balance (endolympha
Slide 19: Several Factors Influence Array Insertion Trauma: Cochlear Anatomy
Several Factors Influence Array Insertion Trauma Cochlear Anatomy • Cochlear anatomy • Array diameter • Array stiffness • Manual vs robot-based insertion • Drug administration AVCI, E. ET AL, EAR AND HEARING, 2017 19 Sensorion KOL Webinar – July 5, 2023
Slide 20: Several Factors Influence Array Insertion Trauma: Array Diameter
Several Factors Influence Array Insertion Trauma Array Diameter • Cochlear anatomy N=32 PATIENTS, EAS PRESERVATION TECHNIQUE • Array diameter • Array stiffness • Manual vs robot-based insertion • Drug administration NGUYEN ET AL, ACTA OTOLARYNGOL, 2013 20 Sensorion KOL Webinar – July 5, 2023
Slide 21: Several Factors Influence Array Insertion Trauma: Array Stiffness
Several Factors Influence Array Insertion Trauma Array Stiffness • Cochlear anatomy FRICTION FORCES WITH A 0.3, 0.4 SOFT, OR 0.4 HARD ARRAY DIAMETER • Array diameter • Array stiffness • Manual vs robot-based insertion • Drug administration DROUILLARD ET AL, PLOS ONE, 2017 21 Sensorion KOL Webinar –
Slide 22: Insertion Mechanism Influences Insertion Trauma
Insertion Mechanism Influences Insertion Trauma Robot cart Microscope • Cochlear anatomy • Array diameter Robot arm • Array stiffness CI array Driving interface • Manual vs robot-based insertion • Drug administration Patient supine position Head tilted opposite way 22 Sensorion KOL Webinar – July 5,
Slide 23: Corticosteroids Have a Limited Effect
Several Factors Influence Array Insertion Trauma Corticosteroids Have a Limited Effect • Cochlear anatomy • Array diameter • Array stiffness • Manual vs robot-based insertion • Drug administration “OVERALL, EVIDENCE OF ANTI-INFLAMMATORY EFFECTS IN HUMANS IS STILL SCARCE” Parys QA, et al. Inner Ear P
Slide 24: Cochlear Implant Surgical Standard Technique
Cochlear Implant Surgical Standard Technique • ECochG monitoring provides information on the chances of preserving residual hearing during the surgical procedure • The signal can be obtained if the hearing threshold < 80 dB at 500 Hz • It can guide the robot-based implant insertion to preserve resid
Slide 25: Cochlear Implant Surgical Standard Technique
Cochlear Implant Surgical Standard Technique 25 Sensorion KOL Webinar – July 5, 2023
Slide 26: Perilymph Sampling Protocol
Perilymph Sampling Protocol Cochlea Organ of Corti Hair cells With the courtesy of Prof Steven O’Leary 26 Sensorion KOL Webinar – July 5, 2023
Slide 27: Perilymph Sampling Protocol
Perilymph Sampling Protocol 27 Sensorion KOL Webinar – July 5, 2023
Slide 28: A New Drug for Hearing Preservation Could Be Extremely Valuable
A New Drug for Hearing Preservation during Cochlear Implantation Could Be Extremely Valuable 1. Residual hearing preservation in implanted patients improves hearing performance and quality of life 2. Cochlear implantation criteria could be further expanded if residual hearing preservation rate are h
Slide 29: Phase 2a Study Key Preliminary Results
PHASE 2A STUDY KEY PRELIMINARY RESULTS Dr. Géraldine Honnet Chief Medical Officer Sensorion July 5, 2023 29 Sensorion KOL Webinar – July 5, 2023
Slide 30: Study Design
Study Design A Phase 2a, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph after 7 days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation SCREENING PERIOD EVALUATION PERIOD W-6 W-1 W1 W2 W3 W4 W5 W6 W7
Slide 31: Baseline Characteristics & Safety
1 BASELINE CHARACTERISTICS & SAFETY 31
Slide 32: Patient Baseline Characteristics are Comparable between the Two Groups
Patient Baseline Characteristics are Comparable between the Two Groups Number of patients Control arm (N=4) SENS-401 arm (N=5) Total (N=9) Age (years) 72 66 69 Gender Female 2 4 6 Male 2 1 3 PTA (dB HL) 70 66 68 Mean of 250, 500 and 750 Hz 500 Hz 66 69 68 Cause of 1 1 Congenital non-inherited hearin
Slide 33: SENS-401 Confirms a Good Safety Profile
SENS- 401 Confirms a Good Safety Profile SEVERITY STUDY DRUG CAUSALITY Related Not related TOTAL Mild Constipation 3 Vomiting 1 Myalgia 1 Laryngitis 1 Dysgeusia 1 Hypokalemia 1 Nausea 1 Dizziness 1 Total 6 4 10 Moderate Left ear pain 1 Headache 1 Constipation 1 Total 0 3 3 Severe Acute Vertigo 1 Tot
Slide 34: Primary Objective
PRIMARY OBJECTIVE ~ . © Sensorion
Slide 35: SENS-401 is Detected in the Perilymph of the First Treated Patients
SENS- 401 is Detected in the Perilymph of the First 5 Treated Patients at Levels Consistent with Those Observed in Animals PERILYMPH CONCENTRATIONS DATA Minimal perilymph concentration in animals • Plasma concentrations of SENS-401 in humans at steady state: dosing of 43.5 mg b.i.d range from 20-90
Slide 36: Secondary Objectives
SECONDARY OBJECTIVES ~ . © Sensorjon
Slide 37: Residual Low Frequency Hearing Benefits for Cochlear Implant Users
Residual Low Frequency Hearing Benefits for Cochlear Implant Users • 80% of cochlear implant candidates now have bilateral low-frequency residual hearing before surgery.1 • Many cochlear implant candidates fear losing their residual hearing, as this may occur in as many as 50 - 70% of CI surgeries.2
Slide 38: Residual Low Frequency Hearing Benefits for Cochlear Implant Users
Residual Low Frequency Hearing Benefits for Cochlear Implant Users Initial shift* Second shift* (2-4 weeks postoperative) (3-6 months postoperative) between surgery and initial activation of the device • Attributed to perioperative factors • Attributed to intracochlear fibrosis, excitotoxic changes
Slide 39: SENS-401 Preserves Early Loss of Residual Hearing
SENS- 401 Preserves Early Loss of Residual Hearing - As Shown in all Five Patients Treated so far MEAN 3 FREQUENCY PTA CHANGE (250, 500 MEAN CHANGE FROM BASELINE AT 500 HZ, AND 750 HZ), IN THE IMPLANTED EAR, IN THE IMPLANTED EAR, FROM BASELINE TO 6 6 WEEKS AFTER IMPLANTATION WEEKS AFTER IMPLANTATION
Slide 40: SENS-401 Also Preserves Post-Operative Hearing
SENS- 401 Also Preserves Post-Operative Hearing - As Measured at the End of the Treatment Period CHANGE OF 500 HZ HEARING THRESHOLD MEAN 3-FREQUENCY PTA CHANGE (250, 500 AND 750 HZ) IN IN THE IMPLANTED EAR, FROM BASELINE TO 6 WEEKS THE IMPLANTED EAR, FROM BASELINE TO 6 WEEKS AFTER IMPLANTATION AFTER
Slide 41: Hearing Preservation Classification System
Hearing Preservation Classification System SKARZYNSKI ET AL. TOWARDS A CONSENSUS ON A HEARING PRESERVATION CLASSIFICATION SYSTEM. ACTA OTOLARYNGOL SUPPL 2013 Criteria • Classification independent from users’ initial hearing considers pre- and post PTA (Pure Tone Average) thresholds • Appropriate for
Slide 42: SENS-401 Completely Preserves Hearing in 40% of Patients Treated
SENS- 401 Completely Preserves Hearing in 40% of Patients Treated at the End of the Treatment Period HEARING PRESERVATION 6 WEEKS AFTER IMPLANTATION 25% 60% Legend 50% HP3 P to 25% HP2 P to >25% 75% 40% HP1 P to >75% 25% SENS-401 Arm Control Arm (N=5) (N=4) • Six weeks after surgery, partial (HP2) t
Slide 43: Conclusion
Conclusion Preliminary key results are promising and suggest that SENS-401 can cross the labyrinthine barrier to target cochlear hair cells. Six weeks post-cochlear implantation, the residual hearing loss whether assessed at 500 Hz or across an average of 3 consecutive frequencies exhibited a clinic
Slide 44: Q&A Session Closure
Q&A SESSION CLOSURE Nawal Ouzren CEO, Sensorion July 5, 2023 44 Sensorion KOL Webinar – July 5, 2023
Slide 45: Sensorion KOL Webinar
Sensorion KOL Webinar SENS-401 to Prevent Residual Hearing Loss after Cochlear Implantation July 5, 2023 45 Sensorion KOL Webinar – July 5, 2023