Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Investor Presentation (May 2022)
27 slides from Nyxoah Sa's investor presentation, May 2022
Slide 1: Nyxoah
Nyxoah May 2022 Nyx
Slide 2: Forward-Looking Statements
Forward-Looking Statements Please read the following before continuing. This presentation has been prepared by the management of Nyxoah SA (the "Company"). It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or oth
Slide 3: Investment Highlights
Investment Highlights 425m moderate-to-severe OSA patients globally eligible for treatment Significant Underpenetrated >1m OSA patients eligible for HGNS treatment annually in US and Europe Global OSA Market Opportunity HGNS treatment solution now fully accepted by physicians and payors Mini
Slide 4: Experienced Board and Management Team
Experienced Board and Management Team Robert Taub Olivier Taelman Loïc Moreau Founder, Chairman CEO CFO • Serial entrepreneur in the pharmaceutical and • Experienced Medtech leader • Experienced Finance leader medical fields • 7 years in pharmaceutical healthcare at Eli Lilly and • 13 years in Pharm
Slide 5: Experienced Management Team
Experienced Management Team Bruno Onkelinx An Moonen Jey Subbaroyan Nathalie Gilat CTO General Counsel VP Clinical Affairs VP RA – GM Israel • Has 25 years of experience in highly regulated • Joined Nyxoah in December 2020 as General • Hs 14 years of experience in clinical and pre- • Has over 14 yea
Slide 6: Large and Underpenetrated Global OSA and HGNS Market Opportunity
Large and Underpenetrated Global OSA and HGNS Market Opportunity Worldwide Obstructive Sleep Apnea Prevalence Hypoglossal Nerve Stimulation Market Opportunity 936 Million >1 million eligible annually in key geographies • 936M individuals (30-69 year) are estimated to suffer from OSA1 • US: 510,000 e
Slide 7: A Disruptive Patient-Centric Solution TODAY…
A Disruptive Patient-Centric Solution TODAY… Single incision procedure Genio® Implantable Stimulator Leadless and 27.5 mm battery-free 21.3 mm Weight 2,96 grams Full-body 1.5T and 3T MRI 21.5 mm compatible Bilateral stimulation Genio® Activation Chip 31.7 mm CCC FDA breakthrough designation CCC indi
Slide 8: Our Vision: Improving Lives Through Restful Nights
Our Vision: Improving Lives Through Restful Nights Connectivity & Remote Care • Connectivity with remote smartphone application • Cloud based access for patients and physicians Patient Engagement • Feedback to / from the patient for optimized compliance & comfort Predictable Outcomes & Auto-Titratio
Slide 9: The Genio Duty Cycle Approach to Hypoglossal Nerve Stimulation
The Genio® Duty Cycle Approach to Hypoglossal Nerve Stimulation The Genio® proprietary Duty Cycle algorithm Genio® algorithm example Targeted stimulation window 1 Respects the patient physiological breathing • The patient breathing frequency is used as a reference to adjust the stimulation cycle Inh
Slide 10: Stimulation Parameters for Optimal Therapy Efficiency
Stimulation Parameters for Optimal Therapy Efficiency • Efficient therapy through patient customized parameters Parameter Description Ranges Pulse Amplitude (A) Stimulation amplitude 1-100 % • Optimal patient comfort: Pulse Duration (P) Duration of one stimulation pulse 50-250 µsec • Tolerable parae
Slide 11: The Genio System – Addressing Unmet Physician Needs
The Genio® System – Addressing Unmet Physician Needs Physician Single incision procedure • Extended operative time is associated with increased risk of surgical site infection13 Implantable parts 1 – Genio® IS 3 – Pulse generator + 2 leads 2 – Pulse generator + lead Leadless Number of incisions 1 in
Slide 12: The Genio System – Addressing Unmet Patient Needs
The Genio® System – Addressing Unmet Patient Needs Patient User-centric • No bulky pulse generator under the skin / Only one discreet scar in the chin fold Indicated for CCC and non-CCC patients Number of scars 1 – in the chin fold At least 2 scars 2 scars • CCC prevalence is up to 35% in OSA patien
Slide 13: 2021 Key Achievements – Focused on Execution
2021 Key Achievements – Focused on Execution Jan • MR Conditional Labeling – 1.5T & 3T / Full-Body • VANDERBILT University Exclusive Licensing (Ansa Feb Cervicalis) • BETTER SLEEP Study Achieves 6-Month Safety and May Performance Endpoints • Germany Commercial Proof of Concept – DRG / 12 June active
Slide 14: Clinical Strategy Building Robust Clinical Evidence
Clinical Strategy Building Robust Clinical Evidence CE-Mark BLAST OSA – 27 patients • 2 publications • CE mark approval in 2019 Demonstrate long-term safety and efficacy EliSA – At least 110 patients • Long term safety and efficacy Ongoing; Enrollment to be completed by mid 2023 • 5-year follow-up E
Slide 15: BETTER SLEEP Study Design & Endpoints
BETTER SLEEP Study Design & Endpoints Study Design Major Inclusion & Exclusion Criteria • Multicenter, prospective, open-label, two group study • Moderate-to-severe OSA • Safety and performance of bilateral HGNS system in adult • Body mass index ≤32 kg/m2 patients evaluated • Failed, refused or did
Slide 16: BETTER SLEEP Demographics & Safety Results
BETTER SLEEP Demographics & Safety Results Demographics Safety • Independent Clinical Events Committee: 3 device and/or procedure related SAEs in 2 subjects • Infection leading to explant • Device migration leading to replacement • Mild cellulitis secondary to folliculitis • All SAEs resolved withou
Slide 17: BETTER SLEEP Efficacy Endpoints
BETTER SLEEP Efficacy Endpoints Apnea Hypopnea Index – 4% Oxygen Desaturation Index – 4% Entire Cohort – n=42 CCC – n=18 Non-CCC –n=24 • Statistically significant reduction in AHI and ODI across Baseline Mean ± SD 27.54 ± 11.91 28.93 ± 11.86 26.49 ± 12.10 all cohorts Month 6 Mean ± SD 16.89 ± 16.00
Slide 18: BETTER SLEEP Responder Rate – Sher Criteria
BETTER SLEEP Responder Rate – Sher Criteria • 36 patients completed polysomnography at month 6 • Responder defined according to the Sher criteria22 (≥ 50 % reduction in AHI and AHI less than 20) • Strong responder rates help de-risk DREAM U.S. IDE study AHI4% Responder Rate – Sher Criteria – CCC & N
Slide 19: BETTER SLEEP Improvement in AHI 4% in Responders
BETTER SLEEP Improvement in AHI4% in Responders • >70% reduction in AHI4% in responders in both CCC and non-CCC population • Presence of “Super Responders” in both CCC and non-CCC cohorts provides additional validation – AHI4% – AHI responders Mean % reduction at 6 months Entire cohort 73.4% CCC coh
Slide 20: BETTER SLEEP Key Takeaways
BETTER SLEEP Key Takeaways Statistically significant AHI4% and ODI4% reduction in: Similar improvements in AHI4 and BETTER SLEEP study reached all • Full cohort ODI4% for both CCC and non-CCC efficacy endpoints • CCC cohort participants • Non-CCC cohort Europe • CCC patients are indicated for the Ge
Slide 21: DREAM Study – IDE Pivotal Trial
DREAM Study – IDE Pivotal Trial Combined central/mixed AHI>25% total AHI Population and key 22 < Age < 75 Failed, Failed, did Notnot tolerate Tolerated or or refused Refused PAP PAP inclusion criteria excluded BMI ≤ 32 kg/m2 Moderate to Moderate to severe Severe OSA OSA ––AHI AHI15-65 15-65 CCC of s
Slide 22: DREAM Study – US Active Sites
DREAM Study – US Active Sites Principal Investigator Institution & Location Kirk P. Withrow MD UAB, Birmingham, AL Samuel Mickelson MD, FACS Advanced ENT, Atlanta, GA Colin Huntley MD & Maurits S. Boon MD Thomas Jefferson Philadelphia, PA Tapan A. Padhya MD USF, Tampa General MC, Tampa, FL Marion Bo
Slide 23: DREAM Study – Status Update
DREAM Study – Status Update (Week of 2 May 2022) Enrolled consent 504 Failed screening Active screening OR scheduled / Implanted 345 93 66 • Status • Patient drop out (~60%) from Enrolled to Implant driven by DISE, PSG, BMI • US commercialization expected Q1 2024 • 12 months data on full study cohor
Slide 24: Commercial Leadership Through Focused Execution
Commercial Leadership Through Focused Execution Go Deep versus Go Wide EU Market Access Germany - Proof of concept Nyxoah – EU reimbursed countries GERMANY – 15 headcount • Germany – 2021: Dedicated DRG code NORTH • 2021: 2 CoEs • 2022: 3 new accounts • Switzerland – 2021: Dedicated DRG code • Spain
Slide 25: High Quality and Diverse International Shareholder Base
High Quality and Diverse International Shareholder Base Euronext IPO Current Shareholder Base (as of 12/31/21) • September 2020 • Robert Taub Historical Shareholders • Base offering & over-allotment: €85M ($100M) • Together Partnership • Jürgen Hambrecht International strategics US Institutional Nas
Slide 26: Strong Cash Position Supports Clinical and Commercial Priorities
Strong Cash Position Supports Clinical and Commercial Priorities in 2022 and Beyond Strong Cash Position - €128M Operating Expense Growth (in €) +20% H2 2021 • Operating expenses to increase by Raised in Burn: €19M ~19% in 2022 Nasdaq Q1 2022 IPO Burn €8M • R&D/Clinical to represent ~45% of €75M +15
Slide 27: Thank you Q&A
Thank you Q&A www.nyxoah.com All rights reserved © 2021 Nyxoah SA. All content on this presentation, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design etc., are the property of Nyxoah SA. Nyxoah SA owns all rights with respect to any of their trademarks,