INSIDE INFORMATIONREGULATED INFORMATION Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2025 and Provides Revenue Guidance for the First Quarter of 2026 Strong Start in First Full Quarter of U.S. Commercialization Mont-Saint-Guibert, Belgium – January 12, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neu ...

Core Insights - Nyxoah reported strong initial results following the U.S. launch of its Genio system for treating Obstructive Sleep Apnea (OSA), achieving first revenue within a month post-FDA approval [2][4][5] Financial Highlights - Revenue for Q3 2025 was €2.0 million, a 56% increase year-over-year from €1.3 million in Q3 2024 [8][9] - The company reported a gross profit of €1.2 million with a gross margin of 60.5% for Q3 2025, compared to a gross margin of 62.0% in Q3 2024 [9][11] - Operating loss for Q3 2025 was €24.4 million, up from €15.0 million in Q3 2024, primarily due to increased selling, general, and administrative expenses [13][12] Market Launch and Strategy - The company executed a two-pronged launch strategy targeting high-volume hypoglossal nerve stimulation centers and building referral networks with sleep physicians [5][6] - As of October 31, 2025, 111 surgeons were trained on the Genio system, with 9 accounts having implanted the device [6] Reimbursement Progress - Significant progress was made in securing reimbursement coverage, with updates from major payors like Health Care Service Corporation and Blue Cross Blue Shield of Michigan, impacting over 26 million members [7][8] Cash Position - As of September 30, 2025, cash, cash equivalents, and financial assets totaled €22.5 million, down from €43.0 million at the end of June 30, 2025 [14]

Core Viewpoint - Nyxoah has received FDA approval for its Genio system, a novel treatment for obstructive sleep apnea (OSA), marking a significant advancement in the U.S. market for OSA therapies [2][4]. Company Overview - Nyxoah is a medical technology company focused on innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [7]. - The company aims to enhance the quality of life for OSA patients by providing effective treatment options [7]. Product Details - The Genio system utilizes bilateral stimulation and is designed to be MRI compatible, offering a non-implanted battery solution controlled by a wearable component [3]. - The wearable component is fully upgradable, allowing patients to access technological advancements without additional surgeries [3]. Clinical Data - The FDA approval was based on the DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index responder rate, with a median AHI reduction of 70.8% [4]. - Notably, 82.0% of subjects in the DREAM study achieved AHI scores below 15 [4]. - The study also showed efficacy across different sleeping positions, with a median AHI reduction of 66.6% in the supine position, which is significant given the increased airway obstruction risk in that position [5][6]. Market Impact - The approval of the Genio system expands treatment options for physicians managing OSA, particularly due to its consistent efficacy across various sleeping positions [6]. - The company is poised to execute its U.S. commercialization strategy following this approval [4].

Core Insights - Nyxoah is on track for anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements and currently undergoing final site inspection [2][4][17] - The company reported a revenue of €1.1 million for Q1 2025, a decrease from €1.2 million in Q1 2024, with a gross profit margin of 61.8% [5][10][11] - Significant increases in research and development expenses (€9.0 million) and selling, general and administrative expenses (€12.4 million) were noted, contributing to an operating loss of €20.6 million for Q1 2025 [12][13][14] Financial Performance - Revenue for Q1 2025 was €1.1 million, down from €1.2 million in Q1 2024 [10] - Cost of goods sold was €406,000, resulting in a gross profit of €658,000 [11] - Research and development expenses rose to €9.0 million from €7.2 million year-over-year [12] - Selling, general and administrative expenses increased to €12.4 million from €6.0 million year-over-year [13] - The operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024 [14] Cash Position - As of March 31, 2025, cash, cash equivalents, and financial assets totaled €63.0 million, down from €85.6 million at the end of 2024 [15] Regulatory Progress - The FDA issued an Approvable Letter for Nyxoah's PMA application for the Genio® system, indicating that the application meets the necessary requirements [6][17] - The final step before full PMA approval is an on-site inspection of the U.S. manufacturing site, which has already passed a previous inspection with no deficiencies [4][18] Company Overview - Nyxoah focuses on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, a hypoglossal neurostimulation therapy [21] - The company received its European CE Mark for the Genio® system in 2019 and has conducted successful IPOs on Euronext Brussels and NASDAQ [22]