Nyxoah SA Ordinary Shares - NYXH STOCK NEWS

Nyxoah reports a strong start to 2022, achieving €660,000 in revenue, over three times growth year-over-year, primarily driven by its Genio® system in Germany. The company has expanded its active implant sites to 15, with plans for 10 more by Q3 2022. Monthly enrollment in the DREAM U.S. IDE study accelerated, expecting completion by Q2 2022. However, Nyxoah reported an operating loss of €7.3 million and a net loss of €6.7 million, with cash and financial assets totaling €127.8 million, down from €135.5 million at year-end.

Nyxoah has reported its financial and operating results for Q1 2022, achieving €660,000 in revenue from the commercialization of Genio®, a significant increase from €185,000 in Q1 2021. The number of active implant sites in Germany rose by 25%, reaching 15, with plans to expand to 25 by Q3 2022. R&D expenses increased to €3.6 million due to ongoing clinical studies. The net loss for the quarter was €6.7 million, compared to €5.7 million in Q1 2021. Nyxoah maintains a strong cash position of €127.8 million, providing liquidity for its U.S. commercialization in 2024.

Nyxoah has announced the nomination of Raymond Cohen and Virginia Kirby for its Board of Directors, pending approval at the Annual Shareholders' Meeting on June 8, 2022. This follows the resignations of Don Deyo and Jan Janssen, maintaining eight board members. Cohen brings extensive experience from leading Axonics and Cardiac Science, while Kirby offers significant expertise in clinical and regulatory affairs within the medical device industry. Nyxoah specializes in solutions for Obstructive Sleep Apnea, with its Genio® system already CE marked and undergoing further FDA studies.

On June 8, 2022, NYXOAH SA (Euronext Brussels: NYXH) will hold its annual and extraordinary shareholders' meetings at 2:00 PM CET. Shareholders are encouraged to register from 1:30 PM CET, with measures in place due to COVID-19. Key agenda items include the approval of statutory annual accounts for 2021, remuneration reports, and changes to the remuneration policy to introduce share-based compensation for non-executive directors. Shareholders can participate remotely via video conference. Further details are available on the Company’s website.

Nyxoah has announced the release of its Q1 2022 financial results, scheduled for May 9, 2022, after market close. A conference call will follow on May 10, 2022, at 2:00 PM CET / 8:00 AM ET, enabling investors to discuss these results. The call can be accessed through various dialing options for attendees from the U.S., Belgium, and international locations. Nyxoah focuses on treating Obstructive Sleep Apnea with its lead solution, the Genio® system, which has received CE Mark approval and is currently under review for FDA clearance.

Nyxoah reported significant growth in its full-year 2021 results, generating revenue of €852,000 from the Genio® system commercialization, up from €69,000 in 2020, achieving a gross margin of 64.4%. The company made strides in Germany with a DRG code and secured reimbursement in Spain, while expanding its addressable market by 30% after receiving expanded CE mark approval. Despite a net loss of €27.6 million, up from €12.2 million in 2020, Nyxoah's cash position improved to €135.5 million after a successful IPO, positioning the company for continued operational momentum in 2022.

Nyxoah announced that its BETTER SLEEP clinical trial met its primary endpoint, demonstrating the effectiveness of hypoglossal nerve stimulation (HGNS) for treating patients with Complete Concentric Collapse (CCC) of the soft palate. The trial involved 42 moderate-to-severe obstructive sleep apnea patients, with a statistically significant reduction in apnea-hypopnea index (AHI4) of 11 points at six months. Over 60% responder rates were achieved across patient cohorts. The company aims for expanded therapeutic indications and ongoing collaboration with the FDA for clinical trials in the U.S.

Nyxoah SA announced its participation in the Oppenheimer 32nd Annual Healthcare Conference, scheduled for March 15-17, 2022. The company will present virtually with CEO Olivier Taelman providing a corporate update on March 16 at 10:40 am EST. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA) treatment, notably through its lead product, the Genio® system. This system received its CE Mark in 2019 and is currently being studied for FDA approval. Investors can access the live webcast and updated presentations via the company's investor relations page.

Nyxoah announced its participation at the World Sleep Congress 2022 in Rome, Italy, from March 11-16, 2022. The company will present data from its BETTER SLEEP clinical trial on March 14 and hold several physician events. The Genio® system, a breakthrough treatment for Obstructive Sleep Apnea (OSA), was highlighted. Nyxoah aims to improve therapies for patients with Complete Concentric Collapse (CCC) and is working towards securing FDA approval for clinical trials for CCC patients in the U.S.