Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Investor Presentation (March 2023)
22 slides from Nyxoah Sa's investor presentation, March 2023
Slide 1: Nyxoah March 2023
Nyxoah March 2023 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 Innova
Slide 4: Executing on Our Strategic Priorities
Executing on Our Strategic Priorities Euronext IPO – Present DREAM Implant FDA Breakthrough BETTER SLEEP Data Completion Designation for CCC Presented at World First DREAM Sleep Congress FDA Patient Implanted CE Mark Label First Approves Expansion for CCC ACCCESS IDE ACCCESS Clinical Implant 1.5T &
Slide 5: Experienced Board and Management Team
Experienced Board and Management Team Robert Taub Olivier Taelman Loïc Moreau Founder, Chairman Chief Executive Officer Chief Financial Officer • Serial entrepreneur in the pharmaceutical and • Experienced Medtech leader • Experienced Finance leader medical fields • 7 years in pharmaceutical healthc
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 OSA 1 • US: 510,000
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 2 E
Slide 10: The Genio System – Addressing Unmet Patient and Physician Needs
The Genio® System – Addressing Unmet Patient and Physician Needs Single incision procedure • Extended operative time is associated with increased risk of surgical site infection Leadless Implantable parts 1 – Genio® IS 3 – Pulse generator + 2 leads 2 – Pulse generator + lead • Up to 25% failure rate
Slide 11: 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 – Up to 110 patients • Long term safety and efficacy Ongoing • 5-year follow-up Expand Genio® therapeutic indications BETTER
Slide 12: BETTER SLEEP Study – Demonstrated Efficacy for Both Non-CCC and CCC Patients
BETTER SLEEP Study – Demonstrated Efficacy for Both Non-CCC and CCC Patients Population and key Multicenter, prospective, open-label, With and without complete concentric 22 < Age < 75 two group study collapse (CCC) inclusion criteria BMI < 32 kg / m2 Moderate to Severe OSA – AHI 15-65 Failed, did n
Slide 13: 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 criteria 22 (≥ 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 &
Slide 14: BETTER SLEEP Improvement in AHI4% 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 (n=23) 73.4%
Slide 15: BETTER SLEEP CCC Market Expansion Opportunities
BETTER SLEEP CCC Market Expansion Opportunities • CE Mark label expansion to include CCC patients in Europe Europe • CE-Mark Instructions for use: “The Genio® system is indicated to treat patients suffering from moderate to severe OSA with and without Complete Concentric Collapse (CCC) at the soft p
Slide 16: DREAM Study – IDE Pivotal Trial
DREAM Study – IDE Pivotal Trial Population and key 22 < Age < 75 Failed, did not tolerate, or refused PAP Combined central / mixed AHI>25% total inclusion criteria AHI excluded BMI < 32 kg / m2 Moderate to Severe OSA – AHI 15-65 CCC of soft palate excluded 115 patients Safety and Performance • Safet
Slide 17: ACCCESS Study – IDE Trial to Gain US Approval for CCC Patients
ACCCESS Study – IDE Trial to Gain US Approval for CCC Patients Population and key 22 < Age < 75 Failed, did not tolerate, or refused PAP Central / Mixed Events < 25% of Total inclusion criteria BMI < 32 kg / m2 Moderate to Severe OSA – AHI 15-65 Target: 106 patients Safety and Performance • Safety:
Slide 18: Commercial Leadership Through Focused Execution
Commercial Leadership Through Focused Execution Go Deep versus Go Wide EU Market Access Germany - Proof of concept GERMANY: 15 Headcount Nyxoah – EU reimbursed countries • Germany – 2021: Dedicated DRG • Switzerland – 2021: Dedicated DRG NORTH • Spain – 2021: Funding through hospital 6 active accoun
Slide 19: Acurable Home Sleep Test German Partnership
Acurable Home Sleep Test German Partnership AcuPebble Aligns with Nyxoah’s Patient-First Mission Statement A Next-Generation Home Sleep Test • CE Mark and FDA clearance • High specificity and sensitivity for AHI and ODI, which is validated by a randomized study published in the BMJ Open Patient-Cent
Slide 20: High Quality and Diverse International Shareholder Base
High Quality and Diverse International Shareholder Base Euronext IPO Current Shareholder Base (as of 6/30/22) • September 2020 • Robert Taub • Base offering & over-allotment: €85M ($100M) Historical Shareholders • Together Partnership • Jürgen Hambrecht International Strategics US Institutional Nasd
Slide 21: Strong Cash Position Supports Clinical and Commercial Priorities in 2023 and Beyond
Strong Cash Position Supports Clinical and Commercial Priorities in 2023 and Beyond Strong Cash Position - €115M H2 2021 • R&D/Clinical to represent >60% of Burn: €19M Raised in 2022 expenses driven by DREAM Nasdaq YTD 2022 IPO Burn €20M enrollment completion, EliSA study €75M SG&A, progress, and AC
Slide 22: 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,