Nyxoah מודיעה על תוצאות ראשוניות לרבעון השני של 2025

מונט-סנט-גיברט, בלגיה, 11 באוגוסט 2025, (GLOBE NEWSWIRE) :

Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA) הודיעה היום על תוצאות כספיות ראשוניות ולא מבוקרות לרבעון השני של 2025 ועדכונים עסקיים אחרים.

Nyxoah Announces Preliminary Results for the Second Quarter of 2025

Mont-Saint-Guibert, Belgium – August 11, 2025, 7:00am CET / 1:00am ET -(GLOBE NEWSWIRE):

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited financial results for the second quarter of 2025 and other business updates.

Preliminary, Unaudited Second Quarter 2025 Financial Results and Business Updates

• Announced onAugust 8, 2025, that the U.S. Food and Drug Administration (FDA) hasapproved the Genio® system for a subset of adult patients with moderate tosevere OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to15 and less than or equal to 65. Press Releases | Nyxoah Investors
• Revenue for thesecond quarter of 2025 is anticipated to be approximately €1.3 million, a73% increase over the second quarter of 2024.
• Operating expensesfor the second quarter of 2025 are anticipated to be approximately €20.7million, a 50% increase over the second quarter of 2024.
• Cash, cashequivalents and financial assets are anticipated to be approximately €43.0million at June 30, 2025. The Company also has a term debt facility with€27.5 million of remaining availability which can be drawn down in twoequal tranches subject to revenue and other financial milestones.
• The Companyexpects to close patient enrollment in its ACCCESS clinical trial prior toenrolling all 106 potential patients. The study will continue, with thepatients currently enrolled, with the co-primary endpoints, Apnea-HypopneaIndex (AHI) and Oxygen Desaturation Index (ODI) responder rates, assessedat 12 months post implant and followed for five years.
• The Companyreorganized its global R&D function and expects to transition all ongoingR&D activities from Israel to the U.S. and Belgium.
• The Companyreceived notice that Inspire Medical Systems, Inc. (“Inspire”) filed alawsuit against the Company in the United States alleging infringement ofcertain patents owned by Inspire. The Company is well prepared, has themeans and intends to vigorously defend itself in this matter.

“We are pleased with the growth we saw in the second quarter, which provides further evidence that our commercial proof of concept in Germany has been successful,” commented Olivier Taelman, Chief Executive Officer. “With FDA approval in hand, we expect to take the lessons learned from Germany and apply them to the U.S. as we bring our unique Genio system to the U.S. In addition, we believe that the patient population currently enrolled in the ACCCESS study will provide statistically significant results, which along with the outcomes from prior clinical evidence, will provide meaningful data with respect to the safety and efficacy of using Genio therapy in the patient population suffering from Complete Concentric Collapse (“CCC”). Patients with CCC represent a significant unmet need in the treatment of OSA as no FDA approved treatment currently exists.”

The preliminary, unaudited financial results described in this press release, including preliminary revenue and operating expenses for the second quarter of 2025 and preliminary cash, cash equivalents and financial assets as of June 30, 2025, are estimates only. These financial results could change as a result of further review. Accordingly, you should not place undue reliance on this information. Complete financial results for the second quarter of 2025 will be announced and issued on Monday, August 18, 2025 after NASDAQ market close. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2 2025 Earnings Call Webcast.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the U.S. Food and Drug Administration (FDA) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Contacts: Nyxoah
John Landry, CFO
[email protected]

For Media
In United States
FINN Partners – Alyssa Paldo [email protected]

In International/Germany
MC Services – Anne Hennecke [email protected]

In Belgium/France
Backstage Communication – Gunther De Backer [email protected]

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Attachment

• Preliminary Results 2Q and 1stHalf 25 PR-531708903-v5

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