Company: NYXH
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0001410578-25-000398
Chunk: 5

Company: Nyxoah SA
Filing Date: 2025-03-20
Form: 20-F
Item: Item 5
Chunk 5
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lossal nerve stimulation therapy coverage decisions, we continue to develop further clinical evidence demonstrating a long-term meaningful improvement in net health outcomes for patients meeting the specified criteria. We believe that establishing and maintaining reimbursement will be important in achieving broad acceptance of our system by healthcare providers in these markets. For our sales to grow, we will also need to receive FDA marketing authorization for the Genio system. We expect that the outcomes of the ongoing pivotal DREAM trial, if favorable, will support marketing approval and reimbursement in the United States.
Continuing to invest in innovation and growth
We continue to invest in, and innovate with respect to, our existing Genio system to further improve future generations, as well as clinical outcomes, enhance the patient and physician experience and broaden the patient population that can be treated. We are also investing in building our pipeline of new products through our partnership with Vanderbilt University to expand the current neurostimulation options to treat moderate to severe OSA. While developing new products and technologies can be time consuming and costly, we believe that a pipeline of new technologies and next generation products is important for supporting increased adoption of our products. In the short term, we expect these activities to increase our net losses, but in the longer term, we anticipate they will positively impact our business and results of operations.
Due to these and other factors and trends, we expect to experience meaningful variability in our financial performance for the foreseeable future, including, but not limited to: costs, benefits and timing of new product introductions; the availability and cost of components and raw materials; and fluctuations in foreign currency exchange rates. Additionally, we may experience quarters in which operating expenses, in particular research and development expenses, fluctuate depending on the stage and timing of product development.

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While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address. See the section titled “Risk Factors” for more information.
Need for additional capital
We expect to incur significant expenses and operating losses over the next few years, and we may need to raise additional capital in the future. We have so far been financed primarily by funds invested by our shareholders, including in connection with our initial public offering on Euronext Brussels in September 2020 and the listing of our ordinary shares on the Nasdaq Global Market in July 2021. Based on our current operating plan and our existing cash and cash equivalents of €34.2 million and financial assets of €51.4 million as of December 31,2024, we expect to be able to