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]

Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company anno ...

NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Nyxoah S.A. (“Nyxoah” or the “Company”) (NASDAQ: NYXH).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Nyxoah and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On March 25, 2025, N ...

LOS ANGELES, April 7, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nyxoah S.A. ("Nyxoah" or "the Company") (NASDAQ: NYXH) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Nyxoah issues a press release on March 25, 2025, "announcing that the U.S. Food and Dru ...

Investors can contact the law firm at no cost to learn more about recovering their losses The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing. The Firm's founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes. Lesley F. Portnoy, Esq. Admitted CA, NY and TX Bars lesley@portnoylaw.com 310-692-8883 www.portnoylaw.com Attorney Advertising Following the announcement, analysts a ...

The investigation concerns whether Nyxoah and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On March 25, 2025, Nyxoah issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system", which "means that Nyxoah's application for marketing the device ...

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 ...

Financial Data and Key Metrics Changes - The company recorded deferred revenue of €600,000 in Q4 2024, with recognized revenue of €1.3 million for the quarter and €4.5 million for the full year 2024 [27][28] - Total operating loss for Q4 2024 was €18.3 million, compared to €10.8 million in Q4 2023, driven by increased R&D spending and commercial investments in the U.S. [28] - Cash position improved to €85.6 million at the end of 2024, up from €57.7 million at the end of 2023 [28] Business Line Data and Key Metrics Changes - Revenue for Q4 2024 would have been €1.9 million excluding the impact of deferred revenue, representing a 46% sequential growth over Q3 2024 [23] - Full-year revenue increased by 18% to €5.1 million compared to 2023 [23] Market Data and Key Metrics Changes - The company launched Genio in the UK and UAE, with the UK expected to become one of the largest international markets due to NHS coverage [24][25] - The first successful implant in the UK generated excitement, and the company plans to expand into more hospitals [25] Company Strategy and Development Direction - The company aims to launch Genio in the U.S. by the end of March 2025, focusing on high-volume HGNS implanting centers and developing referral networks with sleep physicians [17][19] - A two-pronged strategy will be employed for market penetration, targeting both existing HGNS centers and sleep physicians managing OSA patients [17][19] - The company plans to utilize CPT code 64568 for reimbursement, which is recognized by commercial and government payers for OSA indications [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval by the end of March 2025, with ongoing discussions focused on labeling [31][50] - The company anticipates significant growth in 2025, with a focus on U.S. market entry and further international expansion [32][30] Other Important Information - The DREAM study demonstrated a strong AHI responder rate of 63.5% and an ODI responder rate of 71.3%, with a median AHI reduction of 70.8% [8][12] - Genio's safety profile showed an 8.7% severe adverse event rate, which is expected to positively influence therapy selection by physicians [14] Q&A Session Summary Question: Update on reimbursement and CPT code 64568 - Management acknowledged that while the reimbursement level may not be overly attractive, having a recognized CPT code is crucial for market entry [36][38] Question: Trajectory of U.S. launch and account openings - Management indicated that they are targeting approximately 300 to 350 high-volume HGNS sites for initial account openings, with plans to scale up quarterly [40][44] Question: Confidence in FDA approval timeline - Management remains confident in the March approval timeline, citing a 90-day review clock and positive interactions with the FDA [49][50] Question: Manufacturing and supply chain readiness - Management confirmed that they have sufficient manufacturing capacity and inventory for the U.S. market, with products being manufactured domestically [63][64] Question: Need for real-world data post-approval - Management plans to collect real-world data as part of their post-market study to support clinical and economic justification [70][71] Question: Key differentiators for Genio versus competitors - Management highlighted the benefits of bilateral stimulation and the ability to upgrade the system without additional surgery as key differentiators [78][80] Question: Timing of DREAM publication and ACCCESS enrollment - Management expects the DREAM study publication in a leading medical journal in the coming months and anticipates completing ACCCESS enrollment by mid-2025 [83][84]

Nyxoah SA (NYXH) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2%. A quarter ago, it was expected that this company would post a loss of $0.46 per share when it actually produced a loss of $0.55, delivering a surprise of -19.57%.Over the last four quarters, the company has surpassed consens ...