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].

Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [4] Financial Results Announcement - Nyxoah will release its financial results for the second quarter of 2025 on August 18, 2025 [1] - A conference call will be hosted by company management on the same day to discuss the financial results, starting at 10:30 PM CET / 4:30 PM ET [1] Webcast Information - A webcast of the earnings call will be available on the Investor Relations page of Nyxoah's website [2] - For participants wishing to ask questions, registration is required to receive dial-in details and a unique access code [3] Recent Developments - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5]

Core Insights - Nyxoah's DREAM pivotal study data has been published, demonstrating the safety and efficacy of the Genio® system for treating Obstructive Sleep Apnea (OSA) [1][2][4] Study Results - The DREAM study showed that over 70% of nights had device usage greater than 4 hours in 84.3% of participants, with 85.9% using the device over 70% of the nights [2] - Patient satisfaction with the therapy was reported at 90%, and snoring scores decreased from 83.5% at baseline to 30.4% at 12 months [3] - The study achieved co-primary endpoints with an AHI responder rate of 63.5% (p=0.002) and an ODI responder rate of 71.3% (p<0.001) [4][5] Device Performance - The Genio® system resulted in a median AHI reduction of 66.6% in supine positions and 70.8% across all sleeping positions at 12 months [5] - Quality of life improvements were noted, with a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire and a reduction of 3.4 points in the Epworth Sleepiness Score [6] Company Overview - Nyxoah focuses on innovative solutions for OSA, with the Genio® system being a leadless and battery-free hypoglossal neurostimulation therapy [7] - The company received its European CE Mark in 2019 and has completed successful IPOs on Euronext Brussels and NASDAQ [8]

Core Points - The Company is convening an extraordinary shareholders' meeting on July 2, 2025, at 2:00 p.m. CET, with an option for remote participation via video conference [2][3] - The agenda includes a proposal to amend the articles of association to allow shareholders holding at least 5% of outstanding shares for three years to nominate directors [5][6] - Shareholders must register by June 18, 2025, and notify the Company of their intention to participate by June 26, 2025 [13][14] Meeting Details - The meeting will be held at the Company's seat, with video conference facilities for remote attendees [2][3] - Attendance registration will begin at 1:45 p.m. CET on the day of the meeting [4] - Voting can be conducted by mail or by proxy, with specific forms required for these processes [17][18] Voting and Participation - Each share entitles the holder to one vote, and decisions require a 75% majority for certain agenda items [28][29] - Shareholders wishing to ask questions must submit them by June 26, 2025, and answers will be provided during the meeting [24] - Documentation related to the meeting is available on the Company's website and can be requested via email [25]

Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) [4] - The company's lead product is the Genio® system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA [4] Recent Developments - Nyxoah will participate in the Jefferies Global Healthcare Conference from June 3 to June 5, 2025, in New York [2] - CEO Olivier Taelman will present on June 4, 2025, at 4:55 PM ET, with a webcast available on the company's Investor Relations website [3] - The company will also hold one-on-one meetings with institutional investors during the conference [3] Product Milestones - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [5] - The company received CE mark approval for expanded therapeutic indications to treat Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have also been announced [5]

Financial Data and Key Metrics Changes - The company recorded revenue of €1.1 million in Q1 2025, a decrease from €1.2 million in Q1 2024, primarily due to temporary softness in the international HD and S market [16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization [17] - Cash position was €63 million as of March 31, 2025, down from €85.6 million at the end of 2024 [17] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade commercially via a phased approach, which led to certain Genio sites deferring their purchases until the upgrade was available [16] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch of the GENEOS system, with a focus on high-volume hypoglossal nerve stimulation implanting centers [11] - Market research indicates significant demand from patients and physicians for alternatives to current therapies, particularly in the OSA treatment landscape [11][12] Company Strategy and Development Direction - The company aims to penetrate the U.S. market as a smart follower, targeting high-volume centers and developing strong networks with sleep physicians [11][12] - The strategy includes a focus on clinical evidence and patient outcomes, differentiating itself from competitors through unique technology benefits [18] - The company plans to scale up its U.S. commercial team each quarter post-FDA approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving PMA approval in Q2 2025, following successful validation of a specific manufacturing process and ongoing site inspection by the FDA [9][20] - The company believes it is positioned for significant growth once FDA approval is obtained, with a strong commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for OSA indications, which is recognized by commercial and government payers [14][77] - The company is actively working with the American Academy of Otolaryngology to educate payers on the GENEOS system's clinical impact [13] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which has been completed and accepted [22][26] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][36] Question: What is the strategy for outreach to ENT and sleep doctors? - The company plans to differentiate its approach based on clinical data and patient-centric focus, targeting both ENT and sleep physicians [27][29] Question: Is there a statutory response time from the FDA? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [35][36] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [39] Question: What is the pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, with expectations for R&D and SG&A spending to increase [41][43] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted the GENEOS system in Dubai and is expanding into other Middle Eastern markets [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline for completion by summer [50] Question: Will there be a reimbursement team to streamline coverage? - The company has a dedicated market access team to assist with the reimbursement process as they enter new accounts in the U.S. [76] Question: Will CCC be a contraindication in the initial FDA approval? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [81] Question: How will the company promote the DICE procedure? - The company will not promote off-label uses and will rely on traditional methods to exclude CCC patients [84]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was €1.1 million, a decrease from €1.2 million in Q1 2024, attributed to temporary softness in the international HD and S market and a phased launch of the Genio 2.1 patient software upgrade [15][16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization in preparation for FDA approval and launch [16] - Cash position as of March 31, 2025, was €63 million, down from €85.6 million at the end of 2024 [16] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade, which led to some sites deferring purchases until the upgrade was available [15] - The U.S. market strategy includes targeting high-volume hypoglossal nerve stimulation implanting centers and developing networks with sleep physicians [10][11] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch, with a focus on addressing the needs of patients and physicians seeking alternatives to current therapies for obstructive sleep apnea (OSA) [10][11] - Market research indicates significant demand for alternatives to existing pacemaker technologies among patients and physicians [10] Company Strategy and Development Direction - The company aims to achieve full PMA approval in the U.S. by Q2 2025, with a focus on building a world-class team for the U.S. go-to-market strategy [6][8] - The strategy includes a two-pronged approach: targeting high-volume centers and developing strong networks with sleep physicians [10][11] - The company emphasizes a patient-first approach and aims to differentiate itself through unique technology benefits and clinical outcomes [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval and highlighted the enthusiasm from the clinical community regarding the innovative OSA treatment options [19][20] - The company believes it is positioned for significant growth following FDA approval, with a well-prepared commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for reimbursement, which is recognized by commercial and government payers for OSA indications [13] - The company is actively working with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program to educate payers on the GENEOS system [12] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which is currently ongoing [22][25] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][26] Question: What is the company's strategy for outreach to ENT and sleep doctors? - The company plans to highlight clinical data showing effectiveness in supine sleep position and positional OSA to differentiate its product [30][32] Question: Is there a statutory response time from the FDA for approval? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [36][38] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [40] Question: What is the expected pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, extending the cash runway into Q2 2026 [42][44] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted GENEOS in Dubai and is expanding to other locations in the Middle East [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline to stop enrollment by summer [50][51] Question: Will the initial FDA approval have a contraindication for CCC patients? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [80][82]

分组1 - Nyxoah SA reported a quarterly loss of $0.63 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.49, and compared to a loss of $0.45 per share a year ago, indicating an earnings surprise of -28.57% [1] - The company posted revenues of $1.12 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 29.71%, and this was a decline from year-ago revenues of $1.33 million [2] - Nyxoah shares have decreased by approximately 27.8% since the beginning of the year, contrasting with the S&P 500's gain of 0.1% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $2.12 million, and for the current fiscal year, it is -$2.25 on revenues of $15.16 million [7] - The Medical Info Systems industry, to which Nyxoah belongs, is currently ranked in the top 20% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Nyxoah S.A. and its officers or directors [1] Group 1: Company Developments - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [3] - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [3] - Following the announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [3] Group 2: Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the news [4]