Nyxoah Sa · EURONEXT:NYXH
Nyxoah Sa — Investor Presentation (October 2024)
19 slides from Nyxoah Sa's investor presentation, October 2024
Slide 1: Nyxoah Company Overview
Nyxoah Company Overview October 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: Nyxoah's Blueprint for Success
Nyxoah’s Blueprint for Success • $10 Billion US HGNS Market Opportunity • 8% Market Penetration • Established HGNS Reimbursement Breakthrough Treatment For Obstructive Sleep Apnea With Unique Bilateral Mode of Action Compelling Clinical Evidence Through DREAM IDE Study Demonstrating Safety and Effic
Slide 4: The US Market Opportunity for Hypoglossal Nerve Stimulation
The US Market Opportunity for Hypoglossal Nerve Stimulation Currently, 97% of HGNS revenue is generated in the U.S. Many More OSA Patients Need Help HGNS Has Not Yet Focused Market Poised For Robust Growth On Where OSA Patients Are 1500 54MM OSA Patients Specialty # of US Current HGNS Clinicians Ind
Slide 5: Genio Therapy
Genio® Therapy A breakthrough solution with unique bilateral mode of action Implantable Stimulator • Lead-less, battery-free stimulator inserted through a single incision • Delivers bilateral hypoglossal nerve stimulation, which contracts the genioglossus muscle to maintain an open airway in any sle
Slide 6: 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 heal
Slide 7: Experienced Executive Leadership Team
Experienced Executive Leadership Team Bruno Onkelinx Dr. Maurits S. Boon Maggie McGowan Jey Subbaroyan Chief Technology Officer Chief Medical Officer Chief HR Officer Chief Clinical Officer • Has 25 years of experience in highly regulated • Has 24 years of academic and clinical career focused • Has
Slide 8: DREAM Results
DREAM Results Commercially confidential. Not for distribution.
Slide 9: 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 10: DREAM study achieved co-primary efficacy endpoints
DREAM Study DREAM study achieved co-primary efficacy endpoints Achieved Co-Primary Endpoints on an ITT basis Safety Set – ITT Responder Rate M12 p value • AHI Responder Rate – 63.5% (p=0.002) AHI4 63.5% (73/115) 0.002 • ODI Responder Rate – 71.3% (p<0.001) ODI4 71.3% (82/115) < 0.001 Full Analysis –
Slide 11: Safety endpoint
DREAM Study Safety endpoint Safety results compare favorably vs. standard of care* Serious Adverse Events & Most Common Adverse Events Related to Unrelated to Device SAE Related to Device Procedure and/or Procedure • Serious Adverse Events (SAEs) definition follows FDA Asthenia and Hypoesthesia 2 gu
Slide 12: Key Differentiating Data vs. Unilateral HNS
Key Differentiating Data vs. Unilateral HNS ean an e in ean an e in AHI improvements are independent from the sleep position e ian e u n e ian e u n 10 • Median AHI change of 71.0% in supine sleep 66 6 • Median AHI change of 66.6% in non supine sleep 12 • Median AHI change of 70.8% in all positions
Slide 13: Additional efficacy data
DREAM Study Additional efficacy data AHI Reduction • Clinically meaningful 70.8% median AHI reduction at 12 months compared with baseline ODI Reduction • Clinically meaningful 72.1% median ODI at 12 months compared with baseline 13
Slide 14: Quality-of-Life improved in correlation with efficacy outcomes
DREAM Study Quality-of-Life improved in correlation with efficacy outcomes FOSQ-10 total score by visit Clinically significant improvements in quality-of-life (mean ± Standard deviation) outcomes 25 17.9 18.2 20 15.9 15 Functional Outcomes of Sleep Questionnaire (FOSQ) • Significant mean increase of
Slide 15: US Launch
US Launch Commercially confidential. Not for distribution.
Slide 16: US Commercialization Strategy: Make Sleep Simple
US Commercialization Strategy Make Sleep Simple Smart Follower Patients at the Center Playbook for Scalability Break the HGNS monopoly ake Geni t e patient’s p efe en e Carve a fast track to profitability • Targeting the now firmly established • Bilateral stimulation to address both sides of • Focus
Slide 17: Genio US Launch Success Factors
Genio US Launch Success Factors Experienced talent with track records of success and the right mindset—with US-based leadership Commercial launch team focused on selected geographies, bolstered by market access, marketing, and commercial operations expertise Developing sustainable traction in the US
Slide 18: 2024-2025 Key Milestones
2024-2025 Key Milestones Q1 2024 Q2 2024 Q3 2024 Q4 2024 2025 CLINICAL DREAM EVIDENCE 12M data All PMA Expected FDA REGULATORY Modules Interactive Review with FDA Approval of Genio Submitted Planned Further Geographic COMMERCIAL US Commercial Launch Readiness US Launch Expansion LABEL Complete Conce
Slide 19: Solid Investor Base Provides Cash Runway Into Second Half 2026
Solid Investor Base Provides Cash Runway Into Second Half 2026 Cash Runway into H2 2026 Shareholders Base • Robert Taub € • Together Partnership • Jürgen Hambrecht €1 Early Investors €11 Institutional € Investors Strategic Investors Cash position EIB* ATM** Pro-forma cash As of June, 30 th (First tr