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]

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]

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Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Nyxoah S.A. and its officers or directors [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 this announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [3] 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 Viewpoint - Nyxoah S.A. is under investigation for possible securities fraud following a significant stock price decline after the FDA's Approvable Letter regarding its Genio® system [1][4]. Group 1: Company Announcement - 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 met regulatory requirements [3]. - Final approval from the FDA is pending a satisfactory review of Nyxoah's manufacturing facilities, methods, and controls [3]. Group 2: Market Reaction - Following the FDA announcement, analysts predicted a delay in the commercial launch of the Genio® system, leading to a stock price decline of $2.42 per share, or 21.36%, closing at $8.91 on March 26, 2025 [4]. Group 3: Legal Actions - The Portnoy Law Firm has initiated an investigation into Nyxoah for possible securities fraud and may file a class action on behalf of investors who incurred losses [1]. - Investors are encouraged to contact the law firm for a complimentary case evaluation and to discuss options for recovering their losses [2][5].

Nyxoah SA (NASDAQ:NYXH) Q4 2024 Earnings Conference Call March 13, 2025 8:00 AM ET Company Participants John Landry - Chief Financial Officer Olivier Taelman - CEO Conference Call Participants Adam Maeder - Piper Sandler Jon Block - Stifel Matthew Park - Cantor Fitzgerald Suraj Kalia - Oppenheimer & Co. David Rescott - Baird Paige Chamberlain - Wolfe Research Operator Hello, and welcome to Nyxoah Fourth Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After th ...