Core Viewpoint - Nyxoah has reported preliminary financial results for Q2 2025, indicating significant growth and successful commercial proof of concept in Germany, with plans to expand into the U.S. market following FDA approval of its Genio system [1][3]. Financial Results - Revenue for Q2 2025 is anticipated to be approximately €1.3 million, representing a 73% increase compared to Q2 2024 [4]. - Operating expenses for Q2 2025 are expected to be around €20.7 million, a 50% increase from Q2 2024 [4]. - Cash, cash equivalents, and financial assets are projected to be approximately €43.0 million as of June 30, 2025 [4]. Business Updates - The Genio system has received FDA approval for a subset of adult patients with moderate to severe Obstructive Sleep Apnea (OSA), specifically those with an Apnea-Hypopnea Index (AHI) between 15 and 65 [4][6]. - The company plans to close patient enrollment in its ACCCESS clinical trial, which aims to assess the safety and efficacy of Genio therapy for patients suffering from Complete Concentric Collapse (CCC) [4]. - Nyxoah has reorganized its global R&D function, transitioning ongoing activities from Israel to the U.S. and Belgium [4]. Legal Matters - Inspire Medical Systems, Inc. has filed a lawsuit against Nyxoah in the U.S. for alleged patent infringement, and the company intends to vigorously defend itself [4].

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]