Nyxoah S.A. (NASDAQ:NYXH) Q2 2024 Earnings Conference Call August 6, 2024 4:30 PM ET

Company Participants

Mikaela Kirkwood - Corporate Communications and Investor Relations Manager
Olivier Taelman - CEO
Loic Moreau - CFO

Conference Call Participants

Suraj Kalia - Oppenheimer
Edward White - H.C. Wainwright
Joseph Federico - Stifel
Ross Osborn - Cantor Fitzgerald
David Rescott - Baird

Operator

Good day, everyone, and thank you for standing by. Welcome to Nyxoah Second Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I will pass the call over to your first speaker today, Mikaela Kirkwood.

Mikaela Kirkwood

Thank you, and good afternoon and good evening, everyone, and welcome to our earnings call for the second quarter and first half of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loic Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter financial results released after U.S. market closed today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section of the Investor Relations tab of our website.

Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a listed description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2024. With that, I will now turn the call over to Olivier.

Olivier Taelman

Thank you, Mikaela. Good afternoon, and good evening, everyone, and thank you for joining us for our second quarter and first half of 2024 earnings call. 2024 is a pivotal year for Nyxoah with an increased focus on preparing for U.S. market entry. In March this year, we announced of DREAM U.S. pivotal study achieved its primary endpoints and demonstrated the Genio at the potential for best-in-class outcomes for OSA patients. Subsequently, our regulatory team filed in the fourth and final module in our model of PMA submission, which has set the stage for FDA approval as early as the end of 2024. We strengthened recently our balance sheet with over EUR 85 million in new capital raised, which extends our cash runway into mid-2026 and are actively building our U.S. commercialization organization led by our recently hired new Chief Commercial Officer, Scott Holstine.