Nyxoah SA (NYXH) 2021 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Nyxoah First Half 2021 Earnings Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker for today, Vivian Cervantes, Investor Relations at Gilmartin Group. You may begin.

Thank you, Towanda. Good morning, and good afternoon, everyone. Welcome to our earnings call for the first half of 2021. Participating from the company today are Olivier Taelman, Chief Executive Officer; and Fabian Suarez, Chief Financial Officer.

During the call, we will offer commentary on our operating activities and review our first half financial results released after U.S. markets closed on August 31, after which we will host a question-and-answer session. The press release can be found in the Investor Relations section of our website. This call is being recorded and will be archived in the Investor Relations section of our website.

Before we begin, we'd like to remind you that any statements that relate to expectations or projections 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 list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our prospectus filed with the SEC on July 6, 2021, in connection with our initial public offering on NASDAQ.

With that, I will now turn the call over to Olivier.

Thank you, Vivian. So good morning and good afternoon, everyone. Thank you for joining us on our first earnings conference call as a publicly traded company on both NASDAQ and Euronext Brussels to discuss our first half of 2021 operating results.

Before I begin with my script, I'd like to thank our team at Nyxoah for their dedication and focused execution, resulting in a NASDAQ listing, during which we raised $97.8 million. Having completed 2 IPOs in less than 12 months puts the company in a strong financial position to achieve the vision to become a leading neuromodulation company in the field of obstructive sleep apnea. I also would like to welcome the new Nyxoah shareholders and thank them for their participating in our journey.

In the first half of 2021, we continued to execute on our programs, building further on key accomplishments made in 2020. This includes the first area of focus: the pivotal U.S. IDE trial called DREAM, for which we can report steady progress maintaining our target to complete enrollment in Q4 2021.

The second key area of focus being the commercial proof-of-concept in Germany, where I'm pleased to report that Nyxoah is now fully integrated into the German hospital system with a formal DRG reimbursement scheme, resulting in a strong therapy adoption in the top accounts. But I will come back to this later. Further, market expansion activities in Europe resulted in a formal DRG coding in Switzerland. It's the second DRG reimbursement scheme that we have in place in Europe, and we generated our first revenue in Spain and in Belgium.

Next area of focus is the therapy indication expansion for concentric collapse or complete concentric collapse, so-called CCC patients studied in the BETTER SLEEP trial. BETTER SLEEP top line results show that we reached primary safety and performance endpoint with a statistically significant mean reduction in AHI for both CCC and noncomplete concentric collapse patients, leading to a submission with the European notified body to expand our label to include those complete concentric collapse patients.

In the United States, Nyxoah plans on pursuing the FDA breakthrough device designation for the Genio system in order to shorten the approval part to treat CCC patients as well. We will submit full BETTER SLEEP study data to a medical journal for publication and announce results following further analysis.

Next, Nyxoah is strengthening its vision through our collaboration with the U.S. Vanderbilt University, supported by U.S. and German key opinion leaders in order to integrate a new ansa cervicalis stimulation technology into our scientific and technology department pipeline. Ansa cervicalis is a different nerve compared to hypoglossal nerve stimulation, and it's also located in the neck of the patient.

We also achieved further advancements in the tech transfer to our second manufacturing facility, the one in Belgium by successfully completing the first phase. So for the highlights, let me now move to a more detailed review of our activities.

Following our successful NASDAQ IPO, we strengthened our balance sheet, allowing us to continue to strategically deploy our resources to drive market penetration in Europe, steadily advance our clinical programs, scale up and build upon our IP, product and adjacent technologies with our focused R&D activities.

Now let me walk you through our priorities, and starting with the first one being the U.S. DREAM pivotal study. The U.S. DREAM study, our pivotal study in the U.S., aims to first confirm the safety and effectiveness of the Genio system and to support marketing authorization of the Genio system in the U.S.

The study plans to enroll 134 moderate-to-severe OSA patients who failed first-line CPAP therapy with 12-month effectiveness and safety primary endpoints. We continue to make progress enrolling patients into the trial. To date, we have identified 25 centers for the trial worldwide, of which 16 centers are currently active and enrolling patients in the United States. The other centers are in Australia, one in Germany and one in Belgium.

Based on the current enrollment rates, we continue to expect enrollment completion in the fourth quarter of 2021. We expect to obtain FDA approval and Genio system to be commercially available by the end of 2023.

Let me now discuss our commercial activities. We are committed to developing and then leveraging key center of excellence as we go deep versus go wide in driving market penetration of our Genio system. Our activities center on active engagement, education and market development across patients, physicians and hospitals with focus on high-volume ENT surgeons and sleep doctors who see, diagnose and treat patients with OSA.

We also tailor our programs to suit local and regional reimbursement needs, including the pursuit of a fast follow-up strategy in regions where there is already hypoglossal nerve stimulation therapy and establishing market leadership in new regions where we intend to develop coverage.

In the first half of 2021, in Germany, we successfully transferred our existing NUB coding into a dedicated diagnosis related group or DRG for hypoglossal nerve stimulation. This shift allowed us to ramp up our commercial activities with the German accounts. Nyxoah commercial proof-of-concept consists of a 2-step approach: Step 1, 12 months after DRG reimbursement, becoming German market leaders in these top accounts, Tier 1 accounts of center of excellence; and 24 months after DRG reimbursement becoming market leaders all over Germany for hypoglossal nerve stimulation.

In the first half of 2021, 20 Genio systems were implanted in these top accounts or Tier 1 accounts in Germany. During the first half of 2021, there was an increased commercial penetration with a 6x increase in accounts in Q2 versus Q1, resulting now in 12 active German accounts.

In addition, Nyxoah invested in building a German commercial organization by having 8 full-time employees in Germany led by a German Country Director. All these employees were trained and were operational by the end of June. The recruitment of 2 additional sleep experts, who will interact directly with sleep labs and patients and on top of that, a dedicated German marketing manager is ongoing. Simply put, we are strategically hiring personnel as we build out both our organization and infrastructure to grow our business.

We plan to drive further expansion by entering new markets. During the second quarter of 2021, we were able to generate revenue in Spain, which is a complete new market for hypoglossal nerve stimulation and in Belgium. In these 2 countries, several accounts were activated. And last but not least, Switzerland, reimbursement under an OSA specific DRG code obtained from the Federal Statistic Office was obtained. We also submitted a new reimbursement dossier for hypoglossal nerve stimulation in Belgium. Further, we are preparing market entry in the Nordic countries, Italy and Israel, by actively engaging centers of excellence.

Turning to our clinical program for international markets, where the focus is clearly on the BETTER SLEEP study. BETTER SLEEP, as a reminder, it's a multi-standard prospective open-label 2-group clinical study to evaluate the safety, efficacy and performance of the Genio system for the treatment of OSA in adult patients with and without complete concentric collapse of the soft palate.

This study is the first study of its kind to include those CCC patients. It was conducted in 9 medical centers in Australia and New Zealand. In June '21, we announced that the BETTER SLEEP trial reached its primary safety and performance 6-month endpoints in 42 implanted patients. Of these 42 implanted patients, 17 were complete concentric collapse patients.

And the data showed us a statistically significant mean reduction in the AHI score from baseline to 6 months post-implementation in the full analysis patient population, meaning both CCC and non-CCC patients, the same statistically significant mean reduction in AHI in the CCC patient subgroup only, and a statistically significant mean reduction in AHI from baseline in the non-CCC patient subgroup. To quote our principal investigator, Dr. Richard Lewis, the most impressive aspect of the result is the response rate of the complete concentric collapse patient subgroup.

In summary, we continue to build a body of clinical data in support of our bilateral hypoglossal nerve stimulation technology. We published the full data set of our BETTER SLEEP study and already have productively dialogued an interaction with the European notified body.

In the United States, Nyxoah plans on pursuing the FDA breakthrough device designation for the Genio system, which we hope will have a positive impact on shortening the approval path to also offer a treatment solution for complete concentric collapse patients.

Let me now turn to a discussion of our research and development activities. In the first half of 2022 -- or 2021, I apologize, we made important progress in our R&D programs. In January 2021, we received a CE Mark for an MRI conditional labeling, ensuring that patients implanted with a Genio system can now undergo a full body 1.5 tesla and 3 tesla MRI diagnostic scan within approved parameters.

We note that MRI compatibility aids in OSA patients quality of life with over 40 million MRI scans performed on OSA patients in 2020 alone, with 60% of MRI scans performed in the thorax or abdominal area and 40% of MRI scans in 3 Tesla. To date, we are the only company with an MRI compatibility label for 3 Tesla.

And in February 2021, we announced also our exclusive licensing agreement with the Vanderbilt University. This is allowing us to access the technologies and capabilities to build our pipeline. We have started development of this new technology in collaboration with U.S. key opinion leaders, but also with the help of some German key opinion leaders.

New treatment options will focus, amongst others, on stimulating the ansa cervicalis nerve. As previously noted, we developed our proprietary Genio system with the obstructive sleep apnea patient in mind. Our R&D initiatives maintain that focus.

Building on these accomplishments, we look forward to delivering on additional milestones ahead. Over the second half of 2021, we expect to begin marketing in Switzerland, Nordic countries and Italy with an increase in revenue generated in countries where we are already present with the key focus on Germany. We also look forward to opening our manufacturing facility in Belgium to further scale our production capacity. And finally, in the U.S., we continue to expect to complete enrollment in the DREAM IDE trial by the fourth quarter of 2021.

With this, let me now turn the call over to Fabian for financial discussion.

Thank you, Olivier. Good day to everyone. Thank you for joining us on our call. I will provide some highlights from our P&L and our balance sheet. For further details, please refer to our earnings press release issued yesterday and our half year report.

Revenue was EUR 355,000 for the 6 months ended June 30, 2021, compared to no revenue for the same period of 2020. The increase in revenue was attributable to the company's commercialization of the Genio system, mainly in Germany and with some contribution from Spain and Belgium.

Due to an administrative delay in one of our German hospital finance departments, EUR 100,000 of revenue generated during the second quarter will be recognized in the third quarter. The total cost of goods sold was EUR 150,000 with gross profit of EUR 240,000 or gross margins of 67.6%.

We realized a net loss of EUR 12 million point 6 -- EUR 12.6 million, sorry, for the 6 months ended June 30, 2021, compared to a net loss of EUR 4.3 million for the same period in 2020. General and administrative expenses increased by EUR 2.4 million or 99% from EUR 2.4 million for the 6 months ended June 30, 2020, to EUR 4.8 million for the same period of 2021 due to an increase in consulting and contractor spend.

Research and development expenses increased by 173% before capitalization of EUR 0.6 million for the 6 months ended June 30, 2021, and the same amount for the same period of 2020. Research and development expenses increased by EUR 1.1 million, sorry, from EUR 0.7 million to EUR 1.8 million due to an increase in staff and consulting costs to support our R&D activities.

Clinical expenses increased by 96% before capitalization of EUR 3.1 million for the 6 months ended June 30, 2021 and EUR 1.4 million for the same period of 2020. Clinical expenses increased by EUR 1.8 million from EUR 1.9 million to EUR 3.7 million. The increase in the expenses was mainly due to an increase in staff and consulting to support the completion of the BETTER SLEEP trial in clinics, continuous recruitment for the EliSA trial and the ongoing DREAM IDE trial in the United States.

On June 30, 2021, cash and cash equivalents totaled EUR 79.2 million compared to EUR 92.3 million on December 31, 2020. The decrease in cash and cash equivalents resulted mainly from net cash flows used in operating activities of EUR 8.4 million and net cash used in investing activities of EUR 4.5 million.

In July 2021, we completed our initial public offering in the United States with 3,260,250 ordinary shares including over-allotment at a price to the public of $30 per share for total gross proceeds of USD 97.8 million before deducting underwriting discounts and commissions and estimated offering expenses. Pro forma cash assuming the U.S. IPO was completed as of June 30, 2021, was EUR 154.7 million.

With that, I will turn the call back to Olivier.

Thank you, Fabian. We are now concluding the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session. Thank you.

(Operator Instructions) Our first question comes from the line of Adam Maeder with Piper Sandler.

Congrats on all the progress over the past 6 to 12 months. I wanted to start with one on U.S. path forward, regulatory path forward. It sounds like the DREAM study is tracking according to plan, which is great. I was wondering if you could give us some incremental details on things like number of patients implanted and consented? How are those metrics trending? And just talk a little bit more broadly about the level of confidence in delivering against that Q4 2021 enrollment completion guidepost that you've given us. And then I have a follow-up.

Thank you, Adam. Thank you for the question. So there were several questions in this one question. So let me try to answer as complete as I can at this moment. So first of all, I will start by saying what would the regulatory path look like in the U.S. and going forward.

As we already explained in the past, there will be 2 different routes that we can become eligible for. One will be the more traditional PMA, the other one will be the de novo group. Now in order to get more clarity on this from FDA, we will definitely need first preliminary DREAM study results around safety to get a further indication on FDA's thinking.

So what we expect to do on this one is after we reach 6 months endpoint, 6-month point already, to look at the safety results, but also how it was designed in the study and then for interacting with FDA to get more clarity. So that is maybe around to the first part on the regulatory path PMA or de novo.

Second part of the question, if I understood correctly, is where are we on the enrollment. And as mentioned already before, we are feeling very confident that we will close the enrollment by the end of this year, so by the end of Q4. To give you some more details on the enrollment, currently, we have 172 patients enrolled into the DREAM study.

You know that we have 16 sites active in the U.S. On top of that, we have our Australian, German and Belgium sites. What we also learned is that by working with a professional recruitment agency, Guillaume, that this is really impacting in a very positive way also the enrollment on patients. So in conclusion, regulatory path will become more and more clear when we have 6-month safety data coming from DREAM patients. And when it comes to the enrollment, we stick with our previous commitment ending this by Q4.

And when it comes to speeding up and also to manage current challenging situations in the market, mainly driven by COVID, not to call this an excuse because I think in business lines now, COVID has become part of it. But we also take some creative actions, like working with recruitment agency, like virtual talking, et cetera.

Got it. That's very helpful color. I appreciate that, Olivier. And maybe just for my follow-up, I wanted to hear a little bit more about the commercial progress you're making in Europe and in Germany in particular. I think you added a nice chunk of accounts in Q2. Maybe just talk about how quickly you anticipate those accounts will ramp? How do we think about the revenue contribution from these centers going forward?

And then just would love to hear how physicians are embracing Genio or utilizing Genio in their systems. Is it outright switching away from the incumbent product? Is it trialing? Is it splitting? Just any color there would be much appreciated.

Yes. So first of all, I'm very happy that you noticed also the strong uptake in opening new accounts. So today, we have 12 active accounts in Germany. And this is really exceeding our expectations, and let me explain why. And therefore, I would like to come back to our commercial proof-of-concept that we rolled out in Germany.

As you maybe still remember, we are talking about a 2-step approach. Step 1 would be to focus on the Tier 1 or the center of excellence or the top accounts in Germany, roughly 6 accounts. Step 2 or phase 2 would be following by other hypoglossal nerve experience account and also becoming the market leader 24 months or by the end of 2022 in Germany.

So what we see today is that the top 1 or the Tier 1 accounts that we have opened up this account that we are actively engaging with them and that these are the ones that are guiding our implant. That's already part of our strategy and also reaching our expectations in the first 6 months.

On top of this, we were solicitated by multiple what we call Tier 2 or accounts where there is hypoglossal nerve activity ongoing. And they're reaching out strongly to us. So therefore, we already are happy to communicate that we opened 7 more accounts of these Tier 2 accounts. So in total, 12 active accounts in Germany. They're all screening for patients, and we will expect in the second half to have all trials of these accounts actively implanting. That's the first step.

So next to this answering how physicians are responding or what their reaction is. Also here, I can say that the reactions are extremely positive. First of all, for a surgeon, the implant time is so important. And we are now having skin to skin time of 61 minutes, 62 minutes. So we already communicated that we see skin to skin around 60 minutes. Also this is confirmed by the German surgeons, who are actively implanting the Nyxoah technology. So that is already one positive sign.

The next positive comment that we get is on the results when the technology is activated. And there, ENT surgeons are mainly referring to the bilateral stimulation effect, that they really see very concentric pool on the upper airway, which they describe a link to bilateral stimulation and that patients are also extremely happy when technology is activated and that they are using this in a very compliant way. So that's the second key observation that we have.

Now in going forward, and I already touched on this, you have the patient group of complete concentric collapse patients that are currently contraindicated for hypoglossal nerve stimulation. So also on this patient group, physicians are really waiting for us to get this therapy indication expansion to have the warning that we have currently in the IFU listed, so that they can also implant these patients as well.

So overall, very, very positive reactions. And we also know and are focusing on having patients talking to each other and sharing also their personal experience.

Our next question comes from the line of Jon Block with Stifel.

Olivier, maybe for you to start. Can you just help us with maybe the timing or next updates for the pursuit of CCC in Europe when you'll hear from the regulators? And then maybe also the next step or timing on when you expect more color regarding the breakthrough designation in the U.S. for CCC as well? Just any color around the time line for both of those would be very helpful. And then I'll ask a follow-up.

Well, nice. Thank you for the question, Jonathan. So the first one, the notified body regarding seeing market expansion to include CCC patients. So we have submitted the file to notified body. And now there are 2 options based on the review criteria.

If they would use the latest MDR criteria, we would have the answer before the end of the year. If they would still use the existing review criteria, and we think we maybe have a good chance that, that can happen because we have submitted the file and engaged the interaction already before the transfer was taking place under the new MDR criteria, we could already have a -- next time, we could already have an answer by the end of October. So it will definitely be before the end of this year. Best case, it can also be before the end of October.

Okay, great. And then maybe just to pivot and go back to Adam's question on DREAM. I think I got the number right. I think you said 172 enrolled. Is there a raw sort of enrolled-to-implant ratio that you can provide? Is it 4:1? Is it 5:1? Maybe if you're willing to help us out with that? Or even better, just give us the outright number of implants to date for DREAM. Either one of those would be very beneficial.

Thank you, Adam. It's a little bit funny when you mentioned 4:1 or 5:1 because to be very precise, it's 4.5. That is the enrollment implant ratio that we are seeing today. So that is one thing.

The next thing is, at this moment, we have 22 patients that are -- of which 10 are already implanted, 12 more have an award date and will be implanted in the coming days. I'm also very pleased to announce that we will have Dr. Lewis from Australia now flying into the U.S. arriving on September 20 and stay there for 2 weeks with the key objective in having 4 U.S. ENT surgeons fully trained and certified to start educating their colleagues.

This is something that I would like to address of being creative based on the COVID restriction and travel that we are seeing. So I'm really pleased that we were able to overcome this and by having our PI present, our most experienced implanter. And so also we'll make sure that we have U.S. proctors in place to then train and educate other U.S. physicians, which definitely will help and drive further the implant ratio.

But from an enrollment perspective, it's going strong. We see that we are lining up patients. We are blocking the work time, and we are doing already our implants.

Okay, perfect. I'll follow-up offline.

Maybe I missed one question. I want to come back to Jonathan because there was also the question on the breakthrough designation time line, not only on the notified body for CCC but also breakthrough. This one, I would like to be very precise. As you know, FDA, they are communicated strict time lines. So 30 days review time. This has happened. They came back with very positive news to us already with one more question, which we answered.

So you know, we expect the final decision to be communicated in the middle of September, so second to third week of September. If they respect their 30-day time line, we should be able to give you also the final answer whether we have obtained the approval.

That's great. So a lot of news to come with the CCC side, I guess, both from U.S. and Europe in -- over the next couple of months.

Our next question comes from the line of Laura Roba with Degroof Petercam.

One question from my side. Could you provide some colors on the success rates that you get on approaching and convincing centers of excellence to adopt the Genio system?

Yes. So just that I understand the question precisely. So you're asking the success rate when approaching a center? Is this the question?

Yes, indeed.

So what we are seeing is because of our phased approach where we first focus on top centers or top experienced centers with hypoglossal nerve stimulation, we already see that there is a very strong pool of existing patients that is present. As you know, most of the patients, they are using CPAP. They need to be refractory to CPAP before they become eligible for hypoglossal nerve stimulation.

So this filtering already is done or has mostly been done before the patients reach those specialized top implant sites. So then at that moment, when the physician is approaching and offering the technology of -- our different technology options, meaning Nyxoah versus the one competitor that we are having, what we are hearing back is that patients are really focused on the fact to have a surgery that is as minimum invasive as possible. I think that is one key success ratio that I -- success factor what we're hearing back from patients and from physicians, so the minimal invasive surgery.

The next thing that we are hearing is that patients are also really interested in once they're implanted not have to come back too often to the hospital. With our technology, with the external software or the intelligence of the system, we can even push through software upgrades the moment the patient is just connecting the external component. And the physician is also logging into a platform and the software of it can be pushed through. So that's the second thing that we are hearing.

And last, we are also hearing that when patients, for example, are talking about recharging their device, about having no battery that can deplete, also this is the first high success factor that we are hearing. So in summary, minimum invasiveness of the surgery; next, software upgrades that can be pushed through without going to the hospital; and last, having no implantable battery so that if they need to replace the battery or if the battery will be depleting that they can simply charge it like they charge their phones currently. Those are the 3 success ratios, and that's what we are hearing back.

(Operator Instructions) Our next question comes from the line of Michael Polark with Baird.

I'm going to ask again on DREAM study. I just want to make sure I have the data straight. So 22 patients implanted so far, 12 -- an additional 12 to be implanted in coming days or weeks. So that's 34 total. The 170, 1-7-0, number enrolled, what does that number mean? Because that's higher than your target. So I'm just trying to true-up all these numbers.

Okay. No, no. And Mike, let me also share some more clarity because there was some things that I want to further clarify. So first of all, when you're mentioning on the implants and the patients that are pending an implant with an award date, so the number of implants that we have done is 10. And the number that is pending an implant with a fixed award date is 12. So in total, we are talking about 22.

Okay.

So just to clarify that. Now when we talked about an enrollment, the 172 patients, so what is this? So those are all patients that have been screened, that are fail -- that are CPAP failures or refractory to CPAP. So they are eligible, patients that are moderate-to-severe OSA. The only thing that still needs to happen is we still need to undergo a DISE because, as you know, in the DREAM study, patients suffering from complete concentric collapse needs to be excluded.

So when we say 172, the only thing that is missing to make them eligible is the screening of DISE and not being complete concentric collapse. And that's also why the ratio is higher than, of course, our implant target.

Now another comment to this to throw even a little bit more numbers at you, I mentioned the enrollment versus implant ratio being 4.5. So in fact, if we have patients that are enrolled, for every 4 patients, we have 1 patient that currently is being implanted. And that's why we still need to enroll roughly 400 patients more before the end of the year in order to make sure that we will hit our implant ratio. I hope that makes something -- clarify things.

Yes. So the 172, so the -- all that needs to be done is DISE. The rough data is 1/3 of patients have CCC, so they get kicked out, leaving 2/3. So is that what you're seeing in practice? So we take the 172, we multiply it by 0.67, and that's maybe a number that's closer to folks that you have enrolled that are going to be able to move to implant?

So at this moment, the number, in your calculation, it's a little bit lower, to be very precise and not growing too much into the details. But what we are seeing is that we will need to have roughly 600 patients that qualify to be enrolled in order to get 134 implants. That's how we do the calculation.

Okay. Okay. Yes. No, I appreciate that, and I don't -- look, it's -- I want to make sure we did as much clarification on this call as possible on that. Maybe if I can ask on BETTER SLEEP. So I appreciate all the data insights so far. My question is the investigator in that press release commented that the most impressive data in BETTER SLEEP was the responder rate for the CCC patients. You have not -- and correct me if I'm wrong, you have not disclosed what that responder rate is. So can you give us a flavor for what that is or what you see in the data?

Unfortunately, I cannot at this moment because, as you know, there is always this trade-off of making between a publication into a top medical journal, which we are still aiming for. So it would be wrong if I would comment on things like this because they are not public.

And when it comes to the statement of our PI, as you can understand, we are extremely happy that he makes those statements. And those statements are also driven by his own experience when participating in the study and what he sees with CCC. But I cannot comment more on this at this moment.

Okay. And what is updated timing for a potential publication or more data disclosure on BETTER SLEEP?

Yes. Also on this one, Mike, unfortunately, so what we are currently doing is we are exploring the trade-off to be made between submitting for a publication in a top medical journal versus disclosing study data in the most fast way. I know that everyone, including ourselves, we are really, really waiting to see the data and to show the data when it comes to Nyxoah. Currently, the database is still being analyzed, and the medical journal submission is being prepared.

Unfortunately, we do not control whether it will be accepted and in which time frame. But as you can understand and I keep coming back, we will have to take a strategic decision in order to make the trade-off between the top medical journal versus disclosing as fast as possible.

But we also are very well aware that the market and also physicians are waiting to see the analysis. And we do our utmost best to provide you with the full data set as soon as we can.

Yes. Perfect. And if I can sneak one more in. On the Vanderbilt collaboration, the new target, the ansa cervicalis, look, I understand this is really early stage work. But at a high level, what are believed to be the potential benefits of stimulating that target for OSA versus hypoglossal?

This is an excellent question. And the reaction and the feedback that we get from the researchers at Vanderbilt, but also supported by top KOLs in the U.S. and in Germany, as I mentioned, is the fact that today, hypoglossal nerve stimulation is really offering a strong solution for moderate to severe OSA patients. But there is still a percentage of nonresponders.

So the question will be, and that's where we will also be conducting further researches, how can ansa cervicalis provide an answer to those nonresponders? That's already one thing. Second thing that we are looking at as well is how will ansa cervicalis do as a stand-alone product? And how would ansa cervicalis do in combination with hypoglossal nerve stimulation? So all these paths are being examined, but it's clear that with what we can do today, hypoglossal nerve stim, we are focused on one dimension, the anterior posterior dimension of the upper airway.

With the ansa cervicalis, we will add a third dimension. And by having those third -- those 3 dimensions, we really believe and we are really proud that we can explore this and work with the research together because that is providing us a pipeline. And we are convinced that, that also will offer a neuromodulation solution for patients that currently have no solution. So we want to further expand, in fact, the market of the therapy access to patients that currently cannot benefit from hypoglossal nerve stim.

Thank you. I'm showing no further questions in the queue. I would now like to turn the call back over to Olivier for closing remarks.

Well, thank you. Thank you. In closing, I would like to close the call by reaffirming the large market opportunity for hypoglossal nerve stimulation. We really look forward to well addressing the unmet need of this market with our patient-centric Genio solution. So thank you for the questions. Thank you for calling in and listening. I'm happy I -- to continue interacting with all of you. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.