Nyxoah SA · EURONEXT:NYXH
Nyxoah SA — Investor Presentation (May 2024)
14 slides from Nyxoah SA's investor presentation, May 2024
Slide 1: Nyxoah Investor Presentation
Nyxoah Investor Presentation May 2024
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: 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 4: Nyxoah's Blueprint for Success
Nyxoah’s Blueprint for Success >$10bn US HGNS Market Opportunity with <5% Penetration and Established Reimbursement Genio® - A Breakthrough and Disruptive Hypoglossal Nerve Stimulation Solution Proof-of-Concept European Commercialization De-risked Pivotal Study with a US Launch in 2024 and CCC Label
Slide 5: 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 6: The Genio System: An innovative and unique solution
The Genio® System An innovative and unique solution • Mode of Action Hypoglossal nerve Genioglossus Maintaining Genio® system stimulation muscle contraction open airway • Genio System Components Implantable Stimulator Wearable Charging Unit 6 Commercially confidential. Not for distribution
Slide 7: Clinical Strategy Overview
Clinical Strategy Overview Growing Body of Clinical & Real-life Evidence AHI Responder Rates BLAST OSA CE Mark N=115 N=22 N=36 BLAST BETTER DREAM BETTER SLEEP CCC label – Europe OSA SLEEP ElISA Long term data – Europe @6 months @6 months @12 months DREAM IDE Pivotal Study – US 50% 64% 63.5% ACCCESS
Slide 8: DREAM U.S. Pivotal Study Study design & endpoints
DREAM U.S. Pivotal Study Study design & endpoints Design Baseline Characteristics • n=115 • Mean Baseline AHI: 28.0 events/h • Pivotal, multi-center, prospective, open-label study • Mean Baseline ODI: 27.0 events/h • Safety and performance of bilateral HGNS system in adult patients • Mean BMI: 28.5
Slide 9: DREAM – IDE Pivotal Study Achieved primary efficacy endpoints on ITT basis
DREAM – IDE Pivotal Study Achieved primary efficacy endpoints on ITT basis Efficacy Results Co-Primary Endpoints – Intent to Treat Key Takeaways • AHI Responder Rate – 63.5% (p=0.002) • Achieved co-primary endpoints on an Intent To Treat basis • ODI Responder Rate – 71.3% (p<0.001) • Results in-line
Slide 10: DREAM – IDE Pivotal Study Favorable safety results
DREAM – IDE Pivotal Study Favorable safety results Safety Results Serious Adverse Events – SAEs Key Takeaway • 11 SAEs in ten subjects resulting in an SAE rate of 8.7% • Safety results compare favorably to standard of care* • Out of the 11 SAEs • 3 device-related SAEs – Device-related SAE rate: 2.6%
Slide 11: US Commercialization Strategy
US Commercialization Strategy Smart Follower Patients At The Center Scalable Approach Smart follower strategy to leverage landscape Address unmet patient needs with a premium • Focus on top ENT accounts, which comprise established by monopoly player: choice for treatment of OSA: a majority of accoun
Slide 12: Genio Expected to Capture approx. 50% Market Share
Genio Expected to Capture approx. 50% Market Share Independent 25 Clinician Survey Guidepoint Survey • Sample size – 25 clinicians • Physician Profile • 12 US ENTs + 4 German ENTs • Clinicians at least “somewhat familiar” with Genio and Inspire systems • 9 US Sleep Specialists • ENTs/Sleep Specialis
Slide 13: 2024 – 2025 Key Anticipated Milestones
2024 – 2025 Key Anticipated Milestones Q1 2024 Q2 2024 Q3 2024 Q4 2024 2025 DREAM CLINICAL 12M data Module 4 – Potential Clinical Genio FDA REGULATORY PMA Approval Submission Commercial Team Potential COMMERCIAL Team buildout US Launch CCC LABEL ACCCESS ACCCESS Implant EXPANSION completion 12M data
Slide 14: Leading US and European Investor Base
Leading US and European Investor Base Cash of €44.3mm with a Runway into Late-2024 Current Shareholder Base Historical Shareholders International Strategics US Institutional EU Institutional • Robert Taub • Together Partnership • Jürgen Hambrecht 14