Nyxoah SA Ordinary Shares - NYXH STOCK NEWS

Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced a proposed public offering of ordinary shares in the U.S. on May 22, 2024. This offering may also include private sales to institutional investors outside the U.S. All shares are offered by Nyxoah, with no selling stockholders involved. The underwriters may purchase up to an additional 15% of shares. Proceeds will support U.S. commercialization, clinical data collection, R&D for the Genio system, and general corporate purposes. The offering is subject to market conditions and may not be guaranteed. Cantor Fitzgerald & Co. and Degroof Petercam are managing the offering.

Nyxoah reported financial and operating results for Q1 2024 on May 14, 2024. Key highlights include the DREAM U.S. pivotal study achieving co-primary endpoints, with a median AHI reduction of 70.8% and a 12-month AHI responder rate of 63.5%. The company recorded €1.2 million in sales, a 170% increase from Q1 2023. However, the operating loss increased to €12.2 million from €11.4 million last year mainly due to higher R&D expenses. The cash position was €44.3 million, down from €57.7 million at the end of 2023. CEO Olivier Taelman emphasized the positive study results and the company's readiness for a U.S. launch by the end of 2024.

Nyxoah (Euronext Brussels/Nasdaq: NYXH), a medical technology company, will release its Q1 2024 financial results on May 14, 2024, after the market closes. The announcement will be followed by a conference call at 10:30pm CET / 4:30pm ET to discuss the results.

The webcast of the call can be accessed via the Nyxoah Investor Relations page. Pre-registration is required for those wishing to ask questions during the call, with an email providing dial-in details and a unique access code for the live call to follow. The webcast will be available for replay shortly after the event concludes.

The press release announces the invitation to attend the annual and extraordinary shareholders' meetings of NYXOAH SA, a company listed on Euronext Brussels under the symbol NYXH, to be held on June 12, 2024. The meetings will address various agenda items including approval of financial statements, discharge of directors and auditors, approval of remuneration report, and appointment of directors. Shareholders can participate in person or via video conference by following specified registration and voting procedures. The press release provides detailed information on formalities, participation requirements, voting procedures, and data processing related to the meetings.

Nyxoah appoints Dr. Maurits S. Boon, MD as Chief Medical Officer. Dr. Boon, a dual board-certified surgeon in otolaryngology and sleep medicine, brings extensive experience in hypoglossal nerve stimulation therapy. His appointment signifies Nyxoah's focus on revolutionizing obstructive sleep apnea treatment with Genio.

Nyxoah SA (NYSE: NYXH) discloses information on the total number of voting rights and shares following the issuance of new shares. The share capital stands at EUR 4,927,355.12 with a total of 28,682,635 securities carrying voting rights, all ordinary shares. Nyxoah also reveals the existence of rights to subscribe to additional securities carrying voting rights through various ESOP Warrants.

Nyxoah partners with AAO-HNSF to enhance patient access strategy, becoming the first medical device company at the ENTerprise Circle level. The collaboration aims to improve patient access to OSA treatments and navigate authorization requirements, FDA interactions, and clinical guidelines.

Nyxoah announces successful results from the DREAM U.S. pivotal study, showing a significant reduction in sleep apnea symptoms with high responder rates and promising safety profile. The study achieved a 70.8% median reduction in the Apnea-Hypopnea Index (AHI) and a 71.3% responder rate in the Oxygen Desaturation Index (ODI) on an intent to treat basis.

Nyxoah reported strong financial results for the fourth quarter and full year 2023, achieving record quarterly sales of €1.8 million. The company filed the third out of four modules in the U.S. modular PMA submission and ended the year with a total cash position of €57.7 million. Nyxoah plans to report DREAM U.S. pivotal study efficacy and safety data by early April and accelerate investments in the U.S. commercial organization for a late 2024 launch.