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]

Nyxoah (NYXH) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Pearson Dennis - Investor Relations AssociateOlivier Taelman - CEO & Executive DirectorJohn Landry - CFOJonathan Block - Managing DirectorSuraj Kalia - Managing Director Conference Call Participants Adam Maeder - Managing Director & Senior Research AnalystRoss Osborn - Director, Lead Research Analyst - MedTech and DiagnosticsDavid Rescott - Senior Research AnalystMike Polark - Senior Equity Research Analyst - Medical DevicesLa ...

Nyxoah (NYXH) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Speaker0 Good day and thank you for standing by. Welcome to the Nixoa First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ...

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]

Core Points - The company, NYXOAH SA, is inviting its securities holders to attend the annual and extraordinary shareholders' meetings scheduled for June 11, 2025 [2][3] - A video conference will be set up for remote participation, allowing registered securities holders to follow the meetings and ask questions [3][36] - The agenda includes the approval of statutory annual accounts for the financial year ended December 31, 2024, and the proposed allocation of results [6][7] - The shareholders will discuss the discharge of directors and the statutory auditor for their performance during the financial year ended December 31, 2024 [6][8] - Proposed amendments to the remuneration policy will be presented, including provisions for severance payments for executive management [8][10] - The reappointment of directors and the statutory auditor will be on the agenda, with specific remuneration details outlined [12][15][16] - An extraordinary shareholders' meeting will address amendments to the articles of association, including the right to nominate directors for shareholders holding at least 5% of shares [17][18] - Admission formalities for participation in the meetings are specified, including registration and voting procedures [22][26][29] Agenda Items - Approval of statutory annual accounts and allocation of results for the financial year ended December 31, 2024 [6] - Discharge of directors and statutory auditor for the financial year ended December 31, 2024 [8] - Acknowledgment and approval of the remuneration report and amended remuneration policy [8][9] - Reappointment of directors and statutory auditor, including remuneration details [12][15][16] - Extraordinary meeting agenda includes amendments to the articles of association regarding director nominations [17][18] Participation Details - Securities holders must register by May 28, 2025, to attend the meetings [26] - Voting can be conducted by mail or by proxy, with specific forms required [29][30] - Remote participation requires prior confirmation and communication of email addresses by June 5, 2025 [32][33]

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 first quarter of 2025 on May 14, 2025 [1] - A conference call to discuss these results will take place on the same day at 2:00 PM CET / 8:00 AM 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] Product Development and Regulatory 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, 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] - Positive outcomes were also announced from the DREAM IDE pivotal study [5]

Core Viewpoint - Pomerantz LLP is investigating 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 FDA announcement [4]