Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 1

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 1
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 with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

A copy of the press release is attached hereto
as Exhibit 99.1.

Preliminary, Unaudited Second Quarter 2025 Financial Results and Business Updates

On August 11, 2025, the Company announced certain preliminary, unaudited
financial results for the second quarter of 2025 and certain other business updates. For the second quarter of 2025: (i) revenue is anticipated
to be approximately €1.3 million, a 73% increase over the second quarter of 2024, and (ii) operating expenses are anticipated to
be approximately €20.7 million, a 50% increase over the second quarter of 2024. As of June 30, 2025, cash, cash equivalents and financial
assets are anticipated to be approximately €43.0 million.

The Company also announced that it expects to close patient enrollment
in its ACCCESS clinical trial prior to enrolling all 106 potential patients. The study will continue with the patients currently enrolled,
with the co-primary endpoints, Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates, assessed at 12 months post
implant and followed for five years. In addition, the Company announced that it has reorganized its global R&D function and expects
to transition all ongoing R&D activities from Israel to the United States and Belgium.

A copy of the press release is attached hereto as Exhibit 99.2.

The preliminary, unaudited financial results set forth herein, including preliminary revenue and operating expenses for the second quarter and preliminary cash, cash equivalents and financial assets as of June 30, 2025, are estimates only. This data 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 included in our Second Quarter 2025 Report, which we will file in our Report on Form 6-K.

Forward-Looking Statements

Certain statements, beliefs and opinions in this Report on Form 6-K (the “Report”) are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Company’s financial results for the second quarter ended June 30, 2025; the Company’s estimates