Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Investor Presentation (September 2025)
22 slides from Nyxoah Sa's investor presentation, September 2025
Slide 1: Company Overview
Company Overview September 2025 Commercially confidential. Not for distribution.
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 (“we,” “us” or the "Company"). It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, und
Slide 3: Our vision is to make sleep simple
Our vision is to make sleep simple. Nyxoah is a MedTech company with a unique neuromodulation solution for Obstructive Sleep Apnea, putting the patient first. Commercially confidential. Not for distribution.
Slide 4: Nyxoah's Blueprint for Success
Nyxoah’s Blueprint for Success Focused on Rapidly Growing, Underpenetrated estimated $10 Billion U.S. Obstructive Sleep Apnea (OSA) Annual Market Opportunity1 Breakthrough Treatment For OSA With Unique Bilateral Mode of Action Compelling Clinical Evidence Through DREAM IDE Study Demonstrating Safety
Slide 5: Obstructive Sleep Apnea is a Debilitating Chronic Condition
Obstructive Sleep Apnea is a Debilitating Chronic Condition Obstructive Sleep Apnea (OSA) is a common, chronic disorder where the upper airway repeatedly collapses during sleep, interru pting breathing. Beyond significant quality of life impacts, poorly treated OSA can lead to severe health complica
Slide 6: Existing Therapeutic OSA Solutions Have Significant Limitations
Existing Therapeutic OSA Solutions Have Significant Limitations Mandibular Advancement Devices Standard of Care First Line Therapy: • Only suitable for mild to moderate OSA Continuous Positive Airway Pressure (CPAP) • Non-predictive therapy efficacy • High out-of-pocket cost to patient Unilateral Hy
Slide 7: Rapidly Growing Estimated $10 Billion U.S. Market Opportunity with Limited Penetration
Rapidly Growing Estimated $10 Billion U.S. Market Opportunity with Limited Penetration Moderate to Severe OSA impacts approximately 23.7 million patients in the U.S. representing an estimated $10 billion annual market opportunity. Despite this, current HGNS therapies lack widespread adoption with le
Slide 8: Make Sleep Simple
Make Sleep Simple
Slide 9: 1.5T & 3T Full-body MRI compatible Battery-free implant
1.5T & 3T Full-body MRI compatible Battery-free implant Stimulator not visible After insertion
Slide 10: Sleep wearable
Sleep wearable Convenient, travel-friendly design Externally powers the system 10 Commercially confidential. Not for distribution.
Slide 11: Implant with bilateral mode of action
(Photo, then implant with bilateral MOA) Travel friendly Scalable platform Future ready 11 Commercially confidential. Not for distribution.
Slide 12: Intuitive app
mw Intuitive app • Track sleep progress • Adjust stimulation Empowers the Patient to Help Drive Compliance 12 Commercially confidential. Not for distribution.
Slide 13: DREAM Clinical Study
DREAM Clinical Study oO , a
Slide 14: Compelling Clinical Evidence
Compelling Clinical Evidence US Pivotal DREAM Study Achieved Safety and Efficacy Endpoints Achieved Co-Primary Endpoints Serious Adverse Events – 8.7% SAE Rate Unrelated to Related to Related to Serious Adverse Events Device and/or Device Implant 75% Implant 71.3% Asthenia and Hypoesthesia 2 Atrial
Slide 15: Additional DREAM Efficacy Endpoints
Additional DREAM Efficacy Endpoints Overall 70.8% Median AHI 66.6% Median AHI Reduction 82% of Patients with Reduction at 12 Months in Supine at 12 Months AHI Below 15 at 12 Months Change in AHI (4%)* Change in SUPINE AHI (4%)* (mean ± Standard deviation) (mean ± Standard deviation) AHI at 12-Month
Slide 16: Commercialization
Commercialization Confidential
Slide 17: Commercialization International Markets
Commercialization International Markets Germany – Commercial Proof of Concept Selective International Expansion Reimbursement National Coverage – Dedicated DRG • Germany • DRG code established in 2021, dedicated to Hypoglossal Nerve Stimulation • Switzerland • Both Genio and UHGNS use similar code –
Slide 18: US Commercialization
US Commercialization Reimbursement • Expect to use an established CPT code recognized by payers for the OSA indication at launch (64568) • Worked closely with the American Academy of Otolaryngology (AAO) on strategy • Participating in the FDA's Early Payor Feedback Program Smart Follower Strategy –
Slide 19: At U.S. Launch: Intend to Cover ~30% of Current U.S. HGNS Market
At U.S. Launch: Intend to Cover ~30% of Current U.S. HGNS Market With 25 Experienced Territory Managers Initial U.S. Launch Markets Territory Manager Profile • Seattle >10 Years Average Experience • Minneapolis • Upstate NY Grand Rapids ● Cedar Rapids ● •Chicago • Detroit • Newark • Philadelphia 44%
Slide 20: Nyxoah's Expected Growth Path Forward
Nyxoah’s Expected Growth Path Forward INNOVATION LEADERSHIP GEOGRAPHIC • Wearables and EXPANSION Internet of Things INDICATION • New stimulation • Additional EXPANSION targets international markets with US LAUNCH • Complete reimbursement Concentric COMMERCIAL Collapse PILOT • FDA approval Q3’25 CLIN
Slide 21: Nyxoah's Strategy for Anticipated Success
Nyxoah’s Strategy for Anticipated Success Business Poised for Scaled Execution • Proven clinical efficacy with DREAM study data • Successful commercial proof of concept in Germany • Establishing leadership in new markets (UK, Middle East) • Supply chain infrastructure in place Unlocking an estimated
Slide 22: References
References Sources DREAM Study Design Details 1. Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): DESIGN 1071–1078. • n=115 2. Al Lawati NM, Patel SR, Ayas NT. Epidemiology, risk factors, and consequences of ob