Nyxoah SA Ordinary Shares - NYXH STOCK NEWS

Nyxoah SA has announced the release of its financial results for the fourth quarter and full year 2022 on March 22, 2023, after market close. The company will host a conference call to discuss the results starting at 10:30pm CET / 4:30pm ET. Nyxoah is focused on developing solutions for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, holding a CE Mark since 2019. The product aims to offer innovative treatment for patients with OSA, having received CE approval for expanding its indications.

Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Oppenheimer 33rd Annual Healthcare Conference from March 13-15, 2023. CEO Olivier Taelman will present a corporate update on March 14 at 11:20 AM ET, with a webcast available on their Investor Relations website. The company aims to enhance treatment options with its Genio® system, which has received European CE Mark approval and is currently conducting the DREAM IDE pivotal study for FDA approval. This innovative therapy addresses OSA, a condition linked to serious health risks.

Nyxoah has completed the implantation of 115 patients in its DREAM U.S. pivotal study aimed at marketing authorization for the Genio® hypoglossal nerve stimulation system, targeting Obstructive Sleep Apnea (OSA). Additionally, the first PMA module was submitted, and the first patient has been implanted in the ACCCESS U.S. pivotal study, which will evaluate 106 Complete Concentric Collapse (CCC) patients. These studies aim for a 12-month assessment of key efficacy endpoints, providing a pathway to make the Genio solution available to all OSA patients in the U.S.

Nyxoah SA announces its inaugural Investor & Analyst Meeting scheduled for March 23, 2022, in New York City, where senior management will provide a business update followed by presentations from experts in obstructive sleep apnea (OSA). The meeting aims to enhance communication with investors and includes a Q&A session. Nyxoah is known for its innovative Genio® system, aimed at treating OSA. The company holds a European CE Mark for its system since 2019 and is currently pursuing FDA approval through its ongoing DREAM IDE pivotal study. Interested investors can register via the company’s website, with a webcast available post-event.

Nyxoah announced the appointment of Mr. Daniel Wildman as an Independent Director to its Board of Directors on January 9, 2023. Mr. Wildman brings over 40 years of experience in the medical device industry, holding significant positions at major companies like Johnson & Johnson and Boston Scientific. His expertise is expected to bolster Nyxoah's R&D and commercial strategies, particularly for the Genio® hypoglossal nerve stimulation system aimed at treating Obstructive Sleep Apnea (OSA). The appointment is effective immediately, pending shareholder confirmation.

Nyxoah SA has disclosed significant information regarding its share capital and voting rights, as mandated by Belgian law. As of December 29, 2022, the company's share capital stands at EUR 4,440,069.16, with a total of 25,846,279 securities carrying voting rights, comprising all ordinary shares. Additionally, Nyxoah has issued various employee stock option plan (ESOP) warrants, including 700,000 warrants in 2022, allowing subscribers to acquire 4,270,750 total shares. This announcement follows the issuance of new warrants and is essential for transparency with investors.

Nyxoah has filed a $200 million shelf registration statement with the SEC, allowing for the potential sale of various securities. This provides strategic flexibility for future capital access. Additionally, the company has initiated an at-the-market equity offering program, enabling the sale of up to $50 million worth of common shares, with no more than 6 million shares to be issued. The shares will be sold at current market prices on the Nasdaq. This initiative follows Nyxoah's recent progress and approvals in Obstructive Sleep Apnea treatments.

Nyxoah announced its participation in the Piper Sandler 34th Annual Healthcare Conference from November 29 to December 1, 2022, at the Lotte New York Palace hotel. Olivier Taelman, the CEO, will present a corporate update during a fireside chat on December 1 at 12:00 PM ET. A webcast will be available via the Investor Relations website. Nyxoah's lead product, the Genio® system, treats Obstructive Sleep Apnea (OSA) and attained the CE mark in 2019.

Nyxoah reported its financial results for Q3 2022, revealing €182,000 in revenue, a slight decline from €203,000 in the previous year. This drop was largely attributed to a supply disruption affecting €700,000 in orders in Germany. The company completed 110 out of 115 implants for the DREAM U.S. pivotal trial, with 12-month data expected in fall 2023. Operating loss increased to €8.8 million. Nyxoah's cash position stands at €115.4 million, with a monthly cash burn of approximately €3 million.