Nyxoah S.A. (NASDAQ:NYXH) Q4 2022 Earnings Call Transcript

Olivier Taelman: In total there are four modules. So the first one we have submitted. The next two modules, to your point, will be submitted before we have the 12-month DREAM safety and efficacy data. So they will be submitted this year. And our last module will be submitted, of course, upon 12-month DREAM data. To go a little bit more in depth is also what the module one we also — is containing product overview and preclinical data. In the second module, it’s the remaining preclinical data. In the third module, we have a manufacturing validation. So those three modules will take place in 2023 and then the last module or the final one is the clinical data review and the ISU mainly.

Jon Block: Okay. Great. Thanks for that color. And the last question, let me see if I can get your cost clearly on the phone, I think, it’s an important one and you had the helpful footnote in the release that says, for the trial to be successful, of the 115 patients, at least 63% of the patients need to be AHI and ODI responders at 12-month follow-up, okay? And then for the first 34 patients, it says, 65 % are an AHI responder and 76% are ODI responders and so I guess what I am trying to ask you, are those apples-to-apples? In other words, of the 65% that are an AHI responder for those first 34 patients, are all of those ODI responders, so that we could think about for the first 34 patients you hitting the threshold that seems to be necessary for the trial to be successful and let me know if that made sense, and hopefully, you did and you can give us some color? Thanks.

Olivier Taelman: Yeah. No. Definitely, Jon. And I hope to welcome you tomorrow as well during the Analyst Day, because I am sure that there we have more time to go more in depth on this with occupied kind of next clinical also growing more into depth than we abstract. But let me already start answering. So the AHI responders and the ODI responders do not need to be the same patients. So you can — we have to show all of the cohort of 115 patients that will at least showing 63% AHI response and then in the cohort of 115 we also have to show patients that are at least showing a 63% ODI response, but they don’t — it does not need to be the same patient. I hope this is answering your question.

Jon Block: It is. In other words got it. So you hit both criteria in the first 34. You are sort of well above on ODI and slightly north on AHI, but to your point, that is an apples-to-apples when we think about the 34 versus the 115, is that fair?

Olivier Taelman: That is completely correct.

Jon Block: Okay. I will see tomorrow and look forward to it. Thanks very much guys.

Olivier Taelman: Same likewise.

Operator: Thank you. One moment please. Our next question comes from the line of Suraj Kalia of Oppenheimer. Your line is open.

Suraj Kalia: Hi, Olivier, Loïc. Can you hear me all right?

Olivier Taelman: Clearly, Suraj.

Loïc Moreau: Hi.

Olivier Taelman: Hello. Good afternoon.

Suraj Kalia: Perfect. So, Olivier, congrats on DREAM enrollment, a few questions from my side, Olivier, when the final data set is presented next year, would there be cohorts or subgroups where the learning curve impact would also be assessed? Specifically, what I am trying to understand is, most physicians are pretty well versed with Inspire, right, and now this is something different. So is it a learning curve part of the equation that different subgroups of patients would need to go through that we can analyze the data?