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]

Core Points - Nyxoah SA announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs [3] - The total number of ordinary shares that can be sold and issued under the Company's ATM has increased to 5,662,694, which includes 662,694 shares remaining from a previous issuance decision made on December 22, 2022 [3][4] - The shares may be sold at prevailing USD market prices on the Nasdaq Global Market at the time of sale [4]

Core Viewpoint - Nyxoah is nearing full FDA approval for its Genio system, with expectations to meet final requirements in the second quarter of 2025 [1][4]. Group 1: FDA Approval Process - On March 26, 2025, the FDA issued an Approvable Letter for Nyxoah's Pre-Market Approval (PMA) application for the Genio system [2]. - The Approvable Letter indicates that the application substantially meets FDA requirements, pending satisfactory completion of a review of manufacturing facilities and methods [3]. - Nyxoah is addressing one remaining item related to the validation of a process at its U.S. manufacturing site, which is expected to be completed soon [4]. Group 2: Company Background and Product Information - Nyxoah specializes in developing innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation, with the Genio system being a leadless and battery-free hypoglossal neurostimulation therapy [6]. - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7]. - The company has conducted successful IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and has expanded its therapeutic indications based on positive study outcomes [7].

Core Viewpoint - The Schall Law Firm is investigating Nyxoah S.A. for potential violations of securities laws related to misleading statements and undisclosed information regarding the FDA's approval process for the Genio® system [1][2]. Group 1: Investigation Details - The investigation centers on whether Nyxoah issued false or misleading statements or failed to disclose critical information to investors [2]. - 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 [2]. - Analysts noted that this announcement may lead to a delay in the commercial launch of the Genio® system, resulting in a significant drop of over 21.3% in Nyxoah's share price the following day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who have suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

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].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Nyxoah S.A. and its officers or directors, following a significant stock price drop after the FDA's Approvable Letter regarding the Genio® system [1][2][3]. 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 [2]. - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [2]. - Following the announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [2]. 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 [3].

Core Insights - The FDA has issued an Approvable Letter for Nyxoah's Genio® system, indicating that the application substantially meets the necessary requirements for marketing in the U.S. [3][4] - The approval is contingent upon the satisfactory completion of a review of manufacturing facilities, methods, and controls [4][5] - Nyxoah's CEO expressed confidence in the approval process, noting that there were no further questions regarding clinical data or biocompatibility [5] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA) through neuromodulation [6] - The Genio® system is a leadless, battery-free hypoglossal neurostimulation therapy designed for OSA patients [6] - The company aims to improve the quality of life for OSA patients, who face increased mortality risk and cardiovascular issues [6] Regulatory and Market Position - The Genio® system received its European CE Mark in 2019 and has been approved for both Complete Concentric Collapse (CCC) and non-CCC patients [7] - Nyxoah has successfully completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [7] - The company has reported positive outcomes from clinical studies, including the BETTER SLEEP study and the DREAM IDE pivotal study [7]

Table of Contents As filed with the Securities and Exchange Commission on March 20, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPA ...