NYXOAH S A Stock Price, News & Analysis

Nyxoah SA (NYSE: NYXH) announced on October 4, 2021, the CE-Mark indication approval from DEKRA for its Genio® system to treat Complete Concentric Collapse (CCC) patients. This approval expands their market by at least 30%. The decision is based on positive findings from the BETTER SLEEP study, confirming the effectiveness of the system for CCC patients without needing prior Drug-Induced Sleep Endoscopy. This marks a significant advancement for patients previously excluded from hypoglossal nerve stimulation therapies and boosts Nyxoah's growth prospects in Europe.

Nyxoah SA announces an increase in share capital following the issuance of 27,000 new shares on September 30, 2021, pursuant to subscription rights. The total share capital is now EUR 4,388,714.69, with a total of 25,547,359 voting rights related to ordinary shares. Additionally, the company discloses information regarding various ESOP warrants that allow holders to subscribe to over 2.2 million additional shares. This announcement aligns with regulations on large shareholdings as outlined in local law.

Nyxoah has received FDA Breakthrough Device Designation for its Genio® system, aimed at treating Obstructive Sleep Apnea (OSA) in adults with Complete Concentric Collapse (CCC). This designation facilitates quicker access to innovative therapies, offering priority review and interaction with FDA experts. The designation is supported by results from the BETTER SLEEP trial, which demonstrated safety and effectiveness in OSA patients. This advancement could significantly expand Nyxoah's market potential.

Nyxoah, a medical technology company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Cantor 2021 Global Healthcare Conference on September 28, 2021, at 4:00 pm CET/10:00 am ET. CEO Olivier Taelman will present virtually, and a live webcast will be available on the company’s investor relations website. Nyxoah is known for its lead product, the Genio® system, which received the European CE Mark in 2019 following the successful BLAST OSA study. The company is also conducting the DREAM IDE pivotal study for FDA approval.

On September 12, 2021, Nyxoah SA disclosed the issuance of 1,400,000 new warrants and 82,500 new shares. Following these events, the company's share capital has reached EUR 4,384,076.09 and the total number of securities carrying voting rights is now 25,520,359, all ordinary shares. The number of outstanding subscription rights includes various ESOP warrants issued between 2013 and 2021, entitling holders to subscribe to a total of 1,721,500 additional voting rights. This update is aligned with the Law of 2 May 2007 on large shareholdings.

Nyxoah SA (Nasdaq: NYXH) announced its participation in the Baird 2021 Global Healthcare Conference, scheduled for September 14, 2021. CEO Olivier Taelman and CFO Fabian Suarez will present virtually at 3:05 pm CET / 9:05 am ET. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA), with its leading product, the Genio® system, receiving CE Mark approval in 2019 following successful clinical trials. The company is currently conducting the DREAM IDE pivotal study for FDA approval and a European study to confirm the Genio® system's long-term effectiveness.

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announced on September 1, 2021, that it received transparency notifications from Robelga SRL and Together Partnership regarding their shareholdings. Robelga SRL's shareholding fell below 3%, holding 696,000 shares (2.78% of voting rights) as of July 7, 2021. Meanwhile, Together Partnership reported a downward crossing of the 10% threshold, holding 2,503,500 shares (9.84% of voting rights) as of July 9, 2021. The total voting rights for these entities combined represent 11.27% of all voting rights in Nyxoah.

Nyxoah reported its first half 2021 financial results, highlighting gross proceeds of $97.8 million from its Nasdaq IPO and €355 thousand in revenue, a notable increase from zero in the same period last year. The company is actively expanding its commercial presence in Germany, reporting 12 active accounts in Q2, up from 2 in Q1 2021. However, it recorded a net loss of €12.6 million compared to €4.3 million in the previous year, attributed mainly to heightened operational expenses across various departments. The cash position improved to €79.2 million.

Nyxoah has announced the appointment of Rita Johnson-Mills as an Independent Director to its Board, effective immediately. Her extensive background includes over 30 years in healthcare, notably as CEO of UnitedHealthcare Community Plan of Tennessee. The Chairman, Robert Taub, highlighted her experience and governance expertise as vital for Nyxoah's growth in the healthcare industry. Johnson-Mills aims to enhance Nyxoah's board diversity and strengthen its presence in the U.S. market, while the company focuses on innovative solutions for Obstructive Sleep Apnea treatment.