Nyxoah SA (NYXH) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Nyxoah first quarter 2025 earnings conference call. (Operator Instructions)

您好，感謝您的支持。歡迎參加 Nyxoah 2025 年第一季財報電話會議。（操作員指示）

I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.

現在，我想將會議交給今天的發言人、投資者關係助理 Pearson Dennis。請繼續。

Thank you. Good morning, everyone, and I welcome you to our first quarter of 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer.

謝謝。大家早安，歡迎參加我們 2025 年第一季的收益電話會議。今天參加會議的公司有執行長 Olivier Taelman 和財務長 John Landry。

During the call, we will discuss our operating activities and review our first quarter 2025 financial results released before US market opening 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 on the Investor Relations tab of our website.

在電話會議中，我們將討論我們的經營活動並回顧今天美國市場開盤前發布的 2025 年第一季財務業績，之後我們將舉辦問答環節。新聞稿可在我們網站的投資者關係部分找到。本次通話將會被錄音，並將存檔在我們網站「投資者關係」標籤的「活動」部分。

Before we begin, I'd 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.

在我們開始之前，我想提醒您，任何與未來事件、市場趨勢、結果或表現的預期或預測有關的陳述都是前瞻性陳述。所有前瞻性陳述均基於我們目前的估計和各種假設。

These forward-looking 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.

這些前瞻性陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。所有前瞻性陳述均基於目前可用的信息，本公司不承擔更新這些陳述的義務。

Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of these risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20 filed with the Securities and Exchange Commission on March 20, 2025.

因此，您不應過度依賴這些前瞻性陳述。有關與我們的業務相關的這些風險和不確定性的清單和說明，請參閱我們於 2025 年 3 月 20 日向美國證券交易委員會提交的 20 表中的風險因素部分。

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

說完這些，我現在將電話轉給奧利維爾。

Thank you, Pearson. Good day everyone and thank you for joining us for our first quarter of 2025 earnings call. Before we start, I'd like to welcome Pearson Dennis, who recently joined us as our Investor Relations Associate.

謝謝你，皮爾森。大家好，感謝您參加我們的 2025 年第一季財報電話會議。在我們開始之前，我想歡迎最近加入我們並擔任投資者關係助理的皮爾森丹尼斯 (Pearson Dennis)。

I'd like to focus today's discussion on our part to full PMA Approval in the United States. As we announced in March, the FDA issued an approvable letter for Genio® system, which confirms that our application substantially meets the requirements for marketing in the US.

今天的討論我想重點談談我們對美國 PMA 全面批准的部分。正如我們在三月宣布的那樣，FDA 為 Genio® 系統頒發了一封批准函，這封信確認我們的申請基本上符合在美國上市的要求。

Importantly, the FDA accepted our biocompatibility testing, usability studies, clinical data demonstrating safety and effectiveness of the Genio® system just to highlight a few components of our submission.

重要的是，FDA 接受了我們的生物相容性測試、可用性研究、證明 Genio® 系統安全性和有效性的臨床數據，這只是我們提交的幾個組成部分。

Following receipt of the approvable letter, the FDA will approve the application subject to satisfactory completion of manufacturing facilities, methods and control reviews. In that context, the FDA requested validation of one specific manufacturing process at the US contract manufacturing site.

收到批准函後，FDA 將批准該申請，前提是製造設施、方法和控制審查順利完成。在此背景下，FDA 要求對美國合約製造工廠的一項特定製造流程進行驗證。

I am pleased to report that our team has successfully completed this validation work and submitted the required documentation to the FDA. Have they reviewed this validation already and has confirmed they have no further questions regarding it.

我很高興地報告，我們的團隊已經成功完成了這項驗證工作，並向 FDA 提交了所需的文件。他們是否已經審查過此驗證並確認對此沒有其他疑問？

As a final step, the FDA is now conducting an on-site inspection of the US contract manufacturing facility, which we expect to be completed shortly. This site already successfully passed an FDA inspection as part of our DMA process with no deficiencies. We are confident in our ability to complete this final step in the process.

作為最後一步，FDA 目前正在對美國合約製造工廠進行現場檢查，我們預計很快就會完成。作為我們 DMA 流程的一部分，該網站已經成功通過 FDA 檢查，沒有任何缺陷。我們有信心完成這項流程的最後一步。

And based on this timeline, we continue to expect to receive PMA approval in the second quarter of 2025. In preparation of the US commercial launch, we have built a world class team in support of our US go to market strategy.

根據這個時間表，我們預計在 2025 年第二季獲得 PMA 批准。為了準備美國的商業發布，我們建立了一支世界一流的團隊來支持我們的美國市場策略。

In addition, we have put in place industry leading talents with a track record in neuromodulation and or Obstructive Sleep Apnea or OSA across our sales, marketing, reimbursement, and medical affairs teams in the US.

此外，我們在美國銷售、行銷、報銷和醫療事務團隊中配備了在神經調節和阻塞性睡眠呼吸中止症（OSA）方面具有豐富經驗的行業領先人才。

Our strategy for penetrating the US market is focused on a two-pronged approach. First, as a smart follower, we will target high volume hypoglossal nerve stimulation in planting centers where patients and physicians are actively seeking an alternative solution to current therapy.

我們進軍美國市場的策略是雙管齊下。首先，作為明智的追隨者，我們將在患者和醫生積極尋求當前療法替代解決方案的種植中心針對大容量舌下神經刺激進行研究。

Market research confirms significant demand from patients who are hesitant about receiving a pacemaker platform technology, including an implanted battery, which currently requires a subsequent surgery to replace it.

市場研究證實，那些對接受起搏器平台技術（包括植入式電池，目前需要後續手術進行更換）猶豫不決的患者的需求很大。

Research also indicates that physicians are eagerly awaiting a compelling alternative to further expand their OSA treatment options. This is consistent with feedback from the 75 US physicians that already have been trained on the Genio technology, giving their participation in our clinical trials and usability studies, and became familiar with the Genio unique features and patient outcomes.

研究還表明，醫生們正熱切期待一種令人信服的替代方案，以進一步擴大他們的 OSA 治療選擇。這與已經接受 Genio 技術培訓的 75 名美國醫生的回饋一致，他們參與了我們的臨床試驗和可用性研究，並熟悉了 Genio 的獨特功能和患者結果。

Second, we will develop strong networks with sleep physicians who manage large populations of moderate to severe OSA patients where hypoglossal nerve stimulation is not yet fully embedded as part of their treatment pathway.

其次，我們將與管理大量中度至重度 OSA 患者的睡眠醫生建立強大的網絡，這些患者尚未完全將舌下神經刺激納入治療途徑。

As a company that prioritized clinical evidence and patient outcome over simplified marketing messages, we believe in setting realistic patient expectations and partnering with physicians to find the optimal treatment for each patient as part of our mission in putting patients first.

作為一家優先考慮臨床證據和患者結果而非簡化行銷訊息的公司，我們相信設定切合實際的患者期望並與醫生合作為每位患者找到最佳治療方法，這是我們將患者放在第一位的使命的一部分。

We are ready to launch in the US with 50 commercial team members who are all hired and trained. This team is comprised of sales, marketing, market access professionals who will be supported by focused direct to consumers of DTC initiatives and dedicated reimbursement support.

我們已準備好在美國推出產品，擁有 50 名已聘用並經過培訓的商業團隊成員。該團隊由銷售、行銷、市場准入專業人員組成，他們將獲得直接面向消費者的 DTC 計劃和專門的報銷支援。

We plan to scale up US commercial team each quarter post FDA approval, hand in hand with the opening of new and blender curves. Regarding reimbursement, we are working closely with the [American Academy of Otolaryngology] and participating in the FDA's early payer feedback program to educate CMS and major commercial payers on the genial system and the clinical impact it can have on the OSA patient population.

我們計劃在獲得 FDA 批准後的每個季度擴大美國商業團隊的規模，並與新產品和攪拌機曲線的開放齊頭並進。關於報銷，我們正在與美國耳鼻喉科學會密切合作，並參與 FDA 的早期付款人反饋計劃，以教育 CMS 和主要商業付款人了解 Genial 系統及其對 OSA 患者群體的臨床影響。

We have identified and established CPT code that we plan to utilize at launch. The CPT code, to be very precise, is [64,568]. This CPT code has been recognized by commercial and government payers for OSA indications, and it is the same CPT code used for the current FDA approved AGNS technology.

我們已經確定並建立了計劃在發佈時使用的 CPT 代碼。準確地說，CPT 代碼是[64,568]該 CPT 代碼已被商業和政府付款人認可用於 OSA 適應症，並且與目前 FDA 批准的 AGNS 技術使用的 CPT 代碼相同。

We expect that our pricing will be similar to our AGNS competitors while we differentiate our styles via our unique technology benefits and clinical outcomes. Receiving FDA approval will represent the culmination of rigorous clinical research, technological innovation, and strategic preparation.

我們預計我們的定價將與 AGNS 競爭對手相似，同時我們透過獨特的技術優勢和臨床結果來區分我們的風格。獲得 FDA 批准將代表嚴格的臨床研究、技術創新和策略準備的頂峰。

We look forward to launching Genio in the US upon receipt of FDA approval, bringing a revolutionary or safe solution to patients who have been waiting for an alternative that can truly transform their quality of life and long-term health outcomes.

我們期待在獲得 FDA 批准後在美國推出 Genio，為一直在等待能夠真正改變其生活品質和長期健康狀況的替代方案的患者帶來革命性或安全的解決方案。

With that, I'll turn the call over to our CFO John Landry for the financial update.

說完這些，我將把電話轉給我們的財務長約翰·蘭德里 (John Landry) 來報告財務最新情況。

Thank you, Olivier. We recorded revenue of EUR1.1 million in the first quarter of 2025 compared to EUR1.2 million in the first quarter of 2024. The slight year over year revenue decrease was primarily due to temporary softness in the international AGNS market. We also launched our Genio® 2.1 patient software upgrade commercially via a phased approach which resulted in certain Genio sites deferring their purchase until the upgrade of patient software was available to them.

謝謝你，奧利維爾。2025 年第一季我們的營收為 110 萬歐元，而 2024 年第一季的營收為 120 萬歐元。營收較去年同期略有下降主要是由於國際 AGNS 市場暫時疲軟。我們也透過分階段的方式在商業上推出了 Genio® 2.1 患者軟體升級，這導致某些 Genio 站點推遲購買，直到患者軟體升級可用為止。

We expect these factors will normalize in the upcoming quarters. Total operating loss for the first quarter of 2025 was EUR20.6 million versus EUR12.2 million in the first quarter of 2024, driven by investments in the US commercial organization in preparation for FDA approval and subsequent commercial launch. Our cash position was EUR63 million at March 31, 2025, compared to EUR85.6 million at the end of 2024.

我們預計這些因素將在未來幾季內恢復正常。2025 年第一季的總營業虧損為 2,060 萬歐元，而 2024 年第一季為 1,220 萬歐元，這主要是由於對美國商業組織的投資，為獲得 FDA 批准和隨後的商業發布做準備。截至 2025 年 3 月 31 日，我們的現金狀況為 6,300 萬歐元，而 2024 年底為 8,560 萬歐元。

With that, I now like to hand the call back to Olivier to discuss his thoughts for the remainder of 2025. Olivier.

好了，現在我想把決定權交還給奧利維爾，讓他討論一下他對 2025 年剩餘時間的想法。奧利維爾。

Thank you, John. What sets next so apart in the OSA treatment landscape is our patients first approach and a unique therapy which mitigates the limitation of implantable pacemaker technologies. We have designed the Genio® system with patient comfort and convenience as priorities.

謝謝你，約翰。在 OSA 治療領域，Next 的與眾不同之處在於我們以患者為先的治療方法和獨特的療法，可減輕植入式心律調節器技術的限制。我們在設計 Genio® 系統時將患者的舒適度和便利性放在首位。

No implanted battery, bilateral stimulation for consistent therapy regardless of patient's sleep position, and the single incision procedure. All supported by strong clinical data demonstrating the safety and effectiveness.

無需植入電池，無論患者睡眠姿勢如何，均可進行雙側刺激以進行一致治療，並且僅需單切口手術。所有這些都有強有力的臨床數據支持，證明了其安全性和有效性。

Importantly, we are the only company with clinical data in positional OSA and supine sleep time. The US represents not just the largest market opportunity, but also the chance to meaningfully change the standard of care for millions struggling with moderate to severe OSA.

重要的是，我們是唯一一家擁有體位性 OSA 和仰臥睡眠時間臨床數據的公司。美國不僅代表著最大的市場機會，還有機會為數百萬患有中度至重度 OSA 的病人帶來顯著的護理標準改變。

With our commercial team in place or reimbursement pathway established, we are positioned at the starting line of what we believe will be a significant growth trajectory once we have FDA approval. The enthusiasm we have seen from the clinical community during our trials reflect what we have known all along.

隨著我們的商業團隊到位或報銷途徑建立，一旦獲得 FDA 批准，我們就處於起跑線上，我們相信這將是一個顯著的成長軌跡。我們在試驗期間看到的臨床界的熱情反映了我們一直以來所知道的事情。

Patients and physicians who are looking for meaningful innovation in OSA treatment options. Our approach addresses specific limitations that have affected patients adoption and treatment outcomes with existing therapies.

尋求 OSA 治療方案有意義的創新的患者和醫生。我們的方法解決了影響患者採用現有療法和治療結果的具體限制。

As we stand on the verge of FDA approval, we have never been more confident in Nyxoah's future and our ability to deliver value to patients, physicians, and shareholders alike. With that, I would not like to open the line for question and answers.

當我們即將獲得 FDA 批准時，我們對 Nyxoah 的未來以及我們為患者、醫生和股東創造價值的能力充滿信心。因此，我不想開通問答熱線。

(Operator Instructions)

（操作員指示）

Our first question comes from the line of Jon Block from Stifel.

我們的第一個問題來自 Stifel 的 Jon Block。

Thanks guys, good morning. Olivier, can you talk about what needs to get done? At this US inspection versus the initial one that took place, call it earlier in the FDA process.

謝謝大家，早安。奧利維爾，你能談談需要做什麼嗎？這次美國檢查與最初進行的檢查相比，可以說是 FDA 流程的早期階段。

Yes, hello, Jon. Thank you for the question. So, to be very precise, we were informed by FDA to do a validation of a specific manufacturing process at the contract manufacturers in the US.

是的，你好，喬恩。謝謝你的提問。因此，準確地說，FDA 通知我們對美國合約製造商的特定製造流程進行驗證。

You start by doing this administrative and also show protocols and how you validate certain processes that have been done, submitted and accepted by FDA so that part is off the table as part of the regulatory process, a site visit to confirm that this validation is standard practice after the first step of the validation and that is ongoing as we speak.

您首先要進行行政管理，同時還要展示協議以及如何驗證已經完成、提交並被 FDA 接受的某些流程，以便該部分作為監管流程的一部分不再被考慮，現場訪問是為了確認此驗證是驗證第一步之後的標準做法，並且正如我們所說的那樣，這正在進行中。

Okay, I think I got that just one follow up to my first question for clarification when you see the physical site inspection is ongoing, has that again it's a physical site inspection so has that occurred? Have they been out to the site? Is there a date for the site inspection? I'm just trying to get as granular as possible while still being sort of respectful to the process if you would.

好的，我想我明白了，對於我的第一個問題，我只需要澄清一下，當您看到現場實體檢查正在進行時，這是否又是一次現場實物檢查，是否已經發生了？他們去過現場嗎？現場檢查有具體日期嗎？如果您願意的話，我只是想盡可能詳細地講解，同時仍然尊重這個過程。

Yes, so definitely. So the site inspection is actively taking place as we speak. The normal process of site inspection is that it can last up to five days. We don't know. It's all in the hands of the inspector that is visiting or contract manufacturer. After this, he will finish his report.

是的，絕對是如此。我們現在正在積極進行現場檢查。現場檢查的正常流程最多可持續五天。我們不知道。一切都由來訪的檢查員或合約製造商負責。此後，他將完成他的報告。

He will submit a report to FDA to the PMA review committee, and then at that point they can issue us an approval. And that's also why we stay confident that we will obtain the approval by the end of [CO2].

他將向 FDA 的 PMA 審查委員會提交一份報告，然後他們就可以向我們頒發批准。這也是為什麼我們堅信我們將在年底前獲得批准。[二氧化碳]。

Okay, very helpful and then just for the second question to shift gears, as we think about the market launch and the commercialization, can you talk about the company's strategy, to have sort of outreach to the ENT where I'm guessing, if you get it on the label the no contraindication on CCC might mean a lot.

好的，非常有幫助，然後轉換一下話題，當我們考慮市場推出和商業化時，您能否談談公司的策略，對耳鼻喉科進行推廣，我猜，如果您在標籤上寫明 CCC 沒有禁忌症，這可能意味著很多。

Versus the outreach to the sleep doc where again I'm hypothesizing, but the supine data might resonate a little bit more because obviously the sleep is the one with the ongoing management of that of that patient. So two very different variables when we think about differentiation on the label that's possible. Can you talk about the outreach on one versus the other and how the company will tackle that? Thank you.

與我再次假設的睡眠醫生的關聯相比，仰臥數據可能引起更多的共鳴，因為顯然睡眠是對該患者持續管理的。因此，當我們考慮標籤上的區分時，兩個非常不同的變數是可能的。您能否談談這兩個方案的推廣情況以及公司將如何應對？謝謝。

Yes, okay. I will try because you're asking several questions at the same point, so let's talk with the clinical aspect. As I mentioned, I always, Genio was designed with the patient focus and something in mind. So there is one aspect of this. And therefore, we are extremely proud that we were able to demonstrate this in robust clinical data showing the differentiation compared to what composition competition is offered.

是的，好的。我會嘗試，因為您在同一時間問了幾個問題，所以讓我們從臨床方面來談談。正如我始終提到的，Genio 的設計以患者為中心，並考慮了一些因素。這是其中的一個面向。因此，我們非常自豪能夠透過可靠的臨床數據證明這一點，顯示出與競爭產品相比的差異化。

Today very concrete. We are the only company that can offer clinical data showing effectiveness in sleep position and also helping patients that are suffering from positional OSA. That's one clear differentiation point when it comes to patient-centric focus. So that's one aspect.

今天非常具體。我們是唯一一家能夠提供臨床數據證明睡眠姿勢有效性並幫助患有體位性 OSA 的患者的公司。當談到以患者為中心時，這是一個明顯的區別點。這是一個方面。

No linking this to the label, because that was the second part of your aspect. Of course, in our label submission to FDA, we are highlighting this, and I cannot jump to conclusions yet because we haven't seen the published label form from FDA because that goes hand in hand with an approval.

不要將其連結到標籤，因為那是您方面的第二部分。當然，在我們向 FDA 提交的標籤中，我們強調了這一點，但我還不能妄下結論，因為我們還沒有看到 FDA 發布的標籤表格，因為這與批准密切相關。

But it is clear that the discussions and the way we positioned the [Maro] case was clearly well perceived by FDA. So yes, we do expect that FDA will also build this in our labeling, so differentiating supine data positional OSA.

但很明顯，FDA 清楚地認識到了我們對 [Maro] 案的討論和定位方式。所以是的，我們確實希望 FDA 也能在我們的標籤中建立這一點，從而區分仰臥資料位置 OSA。

And then the last part of the question was CCC patients. As we already have CCC on label in our international markets. We are seeing great results in the markets where we are commercially available on CCC patients.

問題的最後一部分是CCC患者。因為我們在國際市場上已經貼有CCC標籤。我們在針對 CCC 患者的商業化市場上看到了巨大的成果。

We are conducting a specific study in the US called [ACAS treating] those CCC patients and also if we do think it will make sense that over time, we will add the CCC label in the US and to start with CCC would not be reflected as a contraindication in the label that will be issued in going forward. But again, we will have to wait upon the approval to have the final confirmation of all this.

我們正在美國進行一項名為 [ACAS 治療] 那些 CCC 患者的特定研究，而且如果我們確實認為隨著時間的推移這將是有意義的，我們將在美國添加 CCC 標籤，並且首先 CCC 不會在未來發布的標籤中反映為禁忌症。但我們必須等待批准才能最終確認這一切。

Understood. Thanks for the color, guys.

明白了。謝謝你們的顏色，夥伴們。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Adam Maeder from Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 Adam Maeder。

Hi, good morning, Olivier and John, thank you for taking the questions. The first one for me just on FDA approval process, great to hear you reiterate the Q2 FDA approval expectation and to hear that the final site inspection, it is ongoing. My question is I'm wondering if there's any kind of statutory response time from FDA.

嗨，早上好，奧利維爾和約翰，感謝你們回答問題。對我來說，第一個問題只是關於 FDA 批准流程，很高興聽到您重申第二季度 FDA 批准預期，並聽到最終現場檢查正在進行中。我的問題是，我想知道 FDA 是否有任何法定的回應時間。

Associated with this process and really, I'm just trying to kind of better understand what's informing the confidence that the US approval is going to come either later this month or next and then I had a follow up or two thanks.

與這個過程相關，實際上，我只是試圖更好地理解是什麼讓人們相信美國的批准將在本月晚些時候或下個月到來，然後我進行了一兩次跟進，謝謝。

Nice to hear you, Adam. So first of all, let me repeat the final steps. So there is currently an inspection that is taking place. Once the inspection is finished, then there will be a final report completed and submitted to the FDA PMA review committee, and at that point, FDA has all the information needed to also issue an approval.

很高興聽到你的聲音，亞當。首先，讓我重複最後的步驟。目前正在進行檢查。檢查完成後，將會有一份最終報告提交給 FDA PMA 審查委員會，此時 FDA 就擁有了頒發批准所需的所有資訊。

As I keep repeating what the previous timeline before the end of Q2, we are feeling confident that we will obtain the FDA approval. I'm just highlighting again the steps that we are facing that we are going through as we speak.

當我不斷重複第二季結束前的時間表時，我們有信心獲得 FDA 的批准。我只是再次強調我們正在面臨的、正在經歷的步驟。

Okay, understood, and then for the the next question, I just wanted to see if there was an update around timing for the the Dream Journal publication, just any visibility into when that could be published.

好的，明白了，然後對於下一個問題，我只是想看看是否有關於《夢想日記》出版時間的更新，只是想看看何時可以出版。

Definitely. So we submitted the publication to the leading industry Journal. Also here there is a clear review process. We have passed the first acceptance barriers as they like to refer too.

確實。因此我們將該出版物提交給了領先的行業期刊。這裡還有一個明確的審查流程。正如他們所提到的，我們已經突破了第一個接受障礙。

So now, we are in the second level of review. We got some questions already from the reviewers that we are answering and addressing. So if you add all this up, I do think that before summer starts, we should be able to have a publication out.

現在，我們處於第二級審查。我們已經從審閱者那裡得到了一些問題，我們正在回答和解決這些問題。所以，如果把所有這些加起來，我確實認為在夏天開始之前，我們應該能夠出版一本。

Okay fantastic and just one more for me if that's okay and then I'll hop back into the queue for John. I just wanted to ask about the pace of OpEx spending going forward, any qualitative or quantitative color that you're willing to share as we think about the next couple quarters as you guys, get ready to launch this in the US would be helpful. Thank you.

好的，太好了，如果可以的話，我再說一句，然後我就回到約翰的隊列。我只是想問一下未來營運支出的速度，當我們考慮接下來的幾個季度，當你們準備在美國推出這項服務時，您願意分享任何定性或定量的資訊嗎？謝謝。

Sure, yes, Adam, good to hear from you from an FDA timeline perspective, obviously we've taken steps to defer cost in the investments, until our FDA approval is achieved and received, so we've taken steps in terms of deferring commercial related investments that naturally go hand in hand with revenue, and we also have a number of other levers we've pulled in the P&L to extend our cash runway as well into, the second quarter of 2026.

當然，是的，亞當，很高興從 FDA 時間表的角度收到您的消息，顯然我們已經採取措施推遲投資成本，直到獲得 FDA 批准為止，因此我們已經採取措施推遲與收入自然相伴的商業相關投資，並且我們還在損益表中採用了許多其他槓桿，以將我們的現金流延長到 2026 年第二季度。

Okay, I, John, any just finer point, around kind of how we should think about. R&D and SGNA kind of going forward I guess you know the genesis of the question was that you know came in a little bit more heavy handed than we were modeling so just trying to kind of. Wondering if you can kind of orient us into a zip code for spend going forward thanks.

好的，約翰，我想問一下關於我們應該如何思考的更詳細的觀點。我想，研發和 SGNA 的進展是這樣的，問題的起源是，你知道，它比我們建模的要嚴厲一些，所以只是嘗試一下。想知道您是否可以為我們提供今後消費的郵遞區號，謝謝。

Sure, absolutely from an R&D perspective I'd expect, the full year to be probably in line with where we were from 2024 perspective, and then from a sales and marketing perspective, SGNA perspective overall I would expect that to be, a little bit more than double what we had incurred. In 2024, and then when you look at it, for the full year, will be from a timing perspective, the first couple quarters are probably going to be a little bit heavier than the the back quarters of the year.

當然，從研發的角度來看，我預計全年的支出可能與 2024 年的支出持平，然後從銷售和行銷的角度來看，從 SGNA 的角度來看，總體而言，我預計全年的支出將比我們之前支出的兩倍多一點。從時間角度來看，2024 年全年前幾季的業務量可能會比後幾季更大。

That's a really good color. Appreciate it. Thank you.

這顏色真好看。非常感謝。謝謝。

You're welcome.

不客氣。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Ross Osborne from Cantor Fitzgerald.

我們的下一個問題來自 Cantor Fitzgerald 的 Ross Osborne。

Hey guys, thanks for taking our questions. Starting off would be curious to hear how, the commercial launch of Genio in Dubai is progressing and how you're thinking about the allocation of resources, given the Middle East is obviously a large and underserved market, but focus is likely on the US in the near term.

嘿夥計們，感謝你們回答我們的問題。首先我很好奇地想聽聽 Genio 在杜拜的商業發布進展如何，以及您如何考慮資源分配，因為中東顯然是一個龐大且服務不足的市場，但短期內重點可能會放在美國。

Yeah, so thank you all for the question. So yes, it's great that with Genio, we are the first AGNS company that is implanted in the Middle East. Dubai was the first hospital in Dubai we had the first hospital where we had two successful implants to start with. We are opening a second hospital in Dubai and then we are also looking at Kuwait and Saudi Arabia to go further.

是的，謝謝大家的提問。所以是的，很高興與 Genio 合作，我們是第一家在中東落地的 AGNS 公司。杜拜是我們第一家成功實施兩例植入手術的醫院。我們正在杜拜開設第二家醫院，同時也考慮進一步拓展科威特和沙烏地阿拉伯市場。

So yes, I do think a great milestone entering the Middle East and offering also there as a solution for the patients. First, implants taking place, training and education put in place, and we are educating some very specific sites spread over the Middle East where we will be further implanting in quarter two, quarter three, and beyond.

所以是的，我確實認為進入中東並為那裡的患者提供解決方案是一個偉大的里程碑。首先，正在進行植入，開展培訓和教育，我們正在對中東地區的一些特定地點進行教育，我們將在第二季、第三季及以後進一步植入。

Great. And then apologies if I missed this. Any update on the access study in terms of where you stand with implants?

偉大的。如果我錯過了這一點，請原諒。就您對植入物的立場而言，有關進入研究有什麼最新進展嗎？

No, absolutely no problem, but on on as communicated, we keep making great progress in enrolling patients. So we were always talking about stopping the enrollment by summer, so that timeline hasn't changed. And once we have this, the next step will be 12 month data. Once we have those data submitted as a PMA supplement and then negotiating further or discussing further with FDA on how this can expand or label in the US, adding CCC patients.

不，絕對沒有問題，但正如溝通的那樣，我們在招募患者方面不斷取得巨大進展。因此，我們一直在談論在夏季停止招生，所以時間表沒有改變。一旦我們有了這些數據，下一步將是 12 個月的數據。一旦我們將這些數據作為 PMA 補充提交，然後與 FDA 進一步協商或討論如何在美國擴展或標記，並增加 CCC 患者。

Great thanks for taking our questions.

非常感謝您回答我們的問題。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of Suraj Kalia from Oppenheimer and Company.

我們的下一個問題來自奧本海默公司的蘇拉傑·卡利亞 (Suraj Kalia)。

Good morning, Olivier, John. Hey, Olivier, so thank you for providing a lot of details. You've consistently said that the initial target for Genio would be, 75 physicians have been trained, the 300 or so top at AGNS sites. My specific question, Olivier is, as we understand it, there are like 10 or so units, AGNS units already on the shelves for these top sites.

早安，奧利維爾，約翰。嘿，奧利維爾，非常感謝你提供這麼多細節。您一直說，Genio 的初始目標是培訓 75 名醫生，AGNS 站點的頂級醫生數量約為 300 名。奧利維爾，我的具體問題是，據我們了解，這些頂級站點上已經有大約 10 個 AGNS 單元。

How do you envision, would you also, I shouldn't say mandate, but require some of the sites to have a certain minimum unit upfront purchases? How are you going to do you think existing inventory would be an issue as you roll out into existing sites, the top sites?

您如何設想，您是否還會，我不應該說是強制要求，而是要求某些網站有一定的最低單位預付購買量？當您將產品推廣到現有站點（頂級站點）時，您認為現有庫存會成為一個問題嗎？

Yeah, Suraj, I nice hearing you and thank you for the commercial question if I can refer to this like this. So first of all, I would like to highlight that over 100,000 patients have received AGNS treatment. And why do I want to start with this in the US? It's just indicating that when you look at high volume sites, that 10 implants or having an inventory of 10 products, it will be easily absorbed in a couple a couple of weeks.

是的，蘇拉傑，我很高興聽到您的聲音，並感謝您提出商業問題，如果我可以這樣參考的話。首先，我想強調的是，已有超過 10 萬名患者接受了 AGNS 治療。我為什麼要從美國開始呢？這只是表明，當您查看高容量網站時，10 個植入物或 10 種產品的庫存將在幾週內輕鬆吸收。

So I don't see an issue of having current inventory of competition because that's the only company out there would be a hindering factor also in launching Genio and going forward. So that's the first answer.

因此，我認為現有的競爭對手庫存不會帶來問題，因為這是唯一會阻礙 Genio 上市和未來發展的公司。這是第一個答案。

The second answer to the question is that when working with the 75 surgeons and also with the hospitals, it's also clear that we will have to make sure that we are the committees. That when passing this, we also start planning off time and also scheduling real-time patients. And once we are doing this, we will make sure that we have available at the hospital to treat those patients.

這個問題的第二個答案是，在與 75 名外科醫生以及醫院合作時，很明顯我們必須確保我們是委員會。當透過這個時，我們也開始規劃休息時間並安排即時病人。一旦我們這樣做了，我們將確保醫院有足夠的資源來治療這些病人。

But it will not be a strategy where we are loading shelves even before we identify patients. I think the healthiest best to start is also you identify patients, you have your [AUD dates], and you make sure you have your products available, including some backups in case there would be a need for more than one product.

但我們不會採取在確定患者之前就將貨物裝上貨架的策略。我認為最健康的開始方式是確定患者，確定 [AUD 日期]，並確保有可用的產品，包括一些備份，以防需要多種產品。

Got it. Apologies for the (inaudible)

知道了。致歉（聽不清楚）

That's okay. I was, so Olivier, if I could send a couple of two-part questions your way quickly, so the regions where your sales force has been hired, how would you, any additional color you can give us there? And the second question, the second part of the question, Olivier, as you all roll out Genio commercially, what do you expect to do in terms of DTC? How are you expecting to be different than inspire? Thank you for taking my questions.

沒關係。是的，奧利維爾，如果我可以快速向您發送幾個分為兩部分的問題，那麼您在哪些地區僱用了銷售人員，您能給我們任何額外的信息嗎？第二個問題，問題的第二部分，奧利維爾，當你們將 Genio 商業化推出時，你希望在 DTC 方面做什麼？您期望與激勵有何不同？感謝您回答我的問題。

Yes, no, definitely. So, Suraj, we have been planning very carefully and studying the US market. It starts with heat maps. They they're called like where are the high volume sites. We have access to this. Based on this, we also combined with the surgeons that already are experienced with our product, and we did some further market research.

是的，不，絕對是。所以，蘇拉傑，我們一直在非常仔細地規劃和研究美國市場。它從熱圖開始。他們被稱為高流量網站。我們可以使用這個。基於此，我們也與已經熟悉我們產品的外科醫生聯合，做了進一步的市場研究。

So we mapped out to the entire AGNS market in the US using heat mapping, and then we started building and hiring our salesforce accordingly. So that's the answer to the first part of the question. The second one on.

因此，我們使用熱圖繪製了美國整個 AGNS 市場，然後我們開始據此建立和僱用我們的銷售人員。這就是問題第一部分的答案。第二個開啟。

And how are we different? We are different that we will not have Super Bowl commercials. I have to say something maybe a little bit funny, but we will not have this huge DTC outreach as known today by AGNS and as competitors. We will work very focused. We will work around sleep sites where they can also do DTC specifically address.

我們有何不同？我們與眾不同之處在於，我們不會播放超級盃廣告。我必須說一些可能有點好笑的事情，但我們不會像 AGNS 和競爭對手今天所知道的那樣擁有如此龐大的 DTC 外展規模。我們將非常專注地工作。我們將圍繞睡眠站點開展工作，他們也可以在那裡進行 DTC 專門處理。

Patients access to know what would be the best technology available to treat their OSA. Once we have identified these patients and those patients came forward with sleep doctors, then of course we will further invest in a very focused manner to drive these patients to the ENT surgeon where then they can further discuss and end up with a Genio.

患者可以了解治療 OSA 的最佳技術。一旦我們確定了這些患者，並且這些患者找到了睡眠醫生，那麼我們當然會進一步投入，以非常有針對性的方式將這些患者送到耳鼻喉外科醫生那裡，然後他們可以進一步討論並最終找到 Genio。

Got it thank you.

明白了，謝謝。

Thank you. One moment for our next question.

謝謝。請稍等片刻，回答我們的下一個問題。

Our next question comes from the line of David Rescott from Baird.

我們的下一個問題來自貝爾德的大衛雷斯科特 (David Rescott)。

Oh great, thanks for taking the questions, Olivier, I wanted to ask on Genio® 2.1. I think you called out that in in Europe with the roll out there, of the software that there was some delays in implants. So when you think about, I guess the first part of the question is going to be, curious on, Genio® 2.2 or kind of just future software upgrades as you come to the US.

哦，太好了，奧利維爾，謝謝你回答我的提問。我想問一下關於 Genio® 2.1 的問題。我記得你提到過，在歐洲推廣該軟體時，植入物出現了一些延遲。因此，當您考慮時，我想問題的第一部分將是好奇，Genio® 2.2 或您來到美國後的未來軟體升級。

But when you think about the roll out in the US and the potential for there to be, future maybe updates here I guess how do you, smooth out that kind of transition and so that you don't have, delays, or patient warehousing at all, on the implants when new system updates are ultimately rolled out in the next couple of years.

但是當您考慮在美國推出以及未來可能出現的更新時，我想您該如何平滑這種過渡，以便在未來幾年最終推出新的系統更新時，您不會在植入物上出現任何延遲或患者倉儲。

Yeah, no, thank you for this question, David, and it's a very important one, and I will start and then John will definitely step in on the second part of this question on roll out and how do we further scale up. But as I mentioned in the beginning, it is so important for Nyxoah to offer patient-centric solutions, and the Genio® 2.1 software upgrade is a clear example in how our therapy is different compared to a pacemaker platform technology.

是的，不，謝謝你提出這個問題，大衛，這是一個非常重要的問題，我將開始，然後約翰肯定會介入這個問題的第二部分，關於推出以及我們如何進一步擴大規模。但正如我在一開始提到的，對於 Nyxoah 來說，提供以患者為中心的解決方案非常重要，而 Genio® 2.1 軟體升級就是一個明顯的例子，表明我們的治療方法與起搏器平台技術有何不同。

No concrete, the software upgrade provides the opportunity for a patient to gradually increase stimulation, which will result in an improve an improvement of patient comfort. So it gives the patient the comfort and it gives the physician the option to gradually ramp up stimulation, enabling him also to treat patients that might be sensitive previously when treated with stimulation that now all of a sudden become eligible. So that is one aspect of the upgrade.

具體來說，軟體升級為患者提供了逐步增加刺激的機會，這將提高患者的舒適度。因此，它讓患者感到舒適，也讓醫生可以選擇逐漸增加刺激，使他能夠治療以前接受刺激治療時可能很敏感的患者，而這些患者現在突然變得適合接受刺激治療。這是升級的一個面向。

The second one is also providing the patient with autonomy to increase or decrease stimulation settings within predefined boundaries set by the physician. No, once you start providing a patient with that autonomy, it also increases the compliance of technology. Patients feel they're in control and they can find their optimal comfort.

第二個是也為病人提供自主權，在醫生設定的預定範圍內增加或減少刺激設定。不，一旦你開始為病人提供這種自主權，它也會增加技術的依從性。患者感覺一切盡在掌握，並能找到最佳舒適度。

So combining those two upgrades in one software upgrade is really contributing to our mission in having a patient centered solution. Now, how do you roll this out? I will hand it over to John because I know he's working very closely with our manufacturing team on this, and maybe you can provide some more call John.

因此，將這兩次升級結合在一次軟體升級中確實有助於我們實現以患者為中心的解決方案的使命。現在，您如何實現這一目標？我會把它交給約翰，因為我知道他正在與我們的製造團隊密切合作，也許你可以提供更多信息，請致電約翰。

Excellent, thank you, Olivier. Yes, so you to point, to your point, David, we had a few orders that we didn't ship out, this past quarter, because one of the customers and the customers want to have the latest upgraded activation chips for their customers.

太好了，謝謝你，奧利維爾。是的，正如您所指出的，大衛，上個季度我們有幾個訂單沒有發貨，因為其中一個客戶希望為他們的客戶獲得最新升級的激活晶片。

Had we shipped those, we were seeing, low double digit growth in the first quarter, of 2025 versus first quarter of 2024, what we're looking to do in the US we'll have our Genio® 2.1 available for all these customers. So as we enter the market, we won't have a switch from the Genio® 2.0 to the Genio® 2.1, so we'll be ready to roll, from that perspective as we enter into the US market.

如果我們出貨了這些產品，我們會看到，2025 年第一季與 2024 年第一季相比，將出現低兩位數成長，我們希望在美國為所有這些客戶提供 Genio® 2.1。因此，當我們進入市場時，我們不會從 Genio® 2.0 切換到 Genio® 2.1，所以從這個角度來看，當我們進入美國市場時，我們已經準備好了。

Okay thanks and then you know on the reimbursement front you know you you've been consistent on, you know the coach you're going to go after and so I'm curious what you're doing maybe on the back end to you know ensure that when the roll out happens that you definitively will be able to map to that or use that code.

好的，謝謝，然後您知道在報銷方面您一直保持一致，您知道您將要追求的教練，所以我很好奇您在後端做了什麼，以確保在推出時您能夠明確映射到該代碼或使用該代碼。

And if the case-by-case implants are maybe a little bit tougher than you anticipate, if you expect to have a, built out back-end kind of reimbursement team to really help streamline, pushing these patients through and getting coverage, when you also roll out, in the US.

如果逐案植入可能比您預期的要困難一些，如果您希望擁有一個完善的後端報銷團隊來真正幫助簡化流程，推動這些患者獲得保險，那麼當您在美國推出這項服務時。

Yeah, thanks for the question, David. Yes, so short answer we have a team, market access team that's dedicated to, helping us work through that process. They have a lot of experience, specifically in the neuromodulation space. So as we work through the roll out, we have a very specific, materials that we're utilizing to help our sales force, and then our market access teams navigate and work.

是的，謝謝你的提問，大衛。是的，簡而言之，我們有一個團隊，市場准入團隊，致力於幫助我們完成這個過程。他們擁有豐富的經驗，特別是在神經調節領域。因此，在我們進行推廣工作的過程中，我們會使用非常具體的材料來幫助我們的銷售人員，然後我們的市場准入團隊進行導航和工作。

Through the pre-authorization process for these particular patients as they make their way into the facility. So, again, we have a strong team in place that's growing, and we'll be well prepared to help with that process as we enter new accounts in the US.

當這些特定的病人進入醫療機構時，透過預先授權流程。因此，我們擁有一支正在不斷壯大的強大團隊，當我們在美國開設新帳戶時，我們將做好充分準備來幫助這一進程。

And maybe I just try to elaborate on this one. It's always nice to be second, meaning that there was a lot of heavy lifting done by competition. There is a code, the 64,568, that is a well established and recognized code by payers, both government and commercial payers, for the specific OSA indication where we also are oppositioned them. So yes, we do feel confident that this barrier or this world is also successfully taken and will result in a quick revenue generation.

也許我只是想詳細闡述這一點。獲得第二名總是令人高興的，這意味著競爭完成了許多繁重的工作。有一個代碼，64,568，這是付款人（包括政府和商業付款人）為特定 OSA 指徵建立並認可的代碼，我們也反對它們。所以是的，我們確實有信心，這個障礙或這個世界也會被成功攻克，並將迅速產生收入。

Okay, thank you.

好的，謝謝。

Thank you one moment for our next question.

感謝您的提問。

Our next question comes from the line of Michael Polark from Wolfe Research.

我們的下一個問題來自 Wolfe Research 的 Michael Polark。

Hey, good morning, I want to follow up on the CCC discussion and make sure I hear this clearly. It sounds like this initial FDA approval will not.

嘿，早上好，我想跟進 CCC 討論並確保我聽清楚了這一點。聽起來 FDA 的初步批准不會成功。

It sounds like it will have the CCC contraindication, and the FDA is not willing to not have that with your prelim access data and so we need to follow access through to completion to remove the contra indication is that, am I hearing the message, correct? Is that the current expectation?

聽起來它會有 CCC 禁忌症，而 FDA 不願意在您的初步訪問數據中沒有這一點，所以我們需要跟踪訪問直至完成以消除禁忌症，我聽到的消息對嗎？這是目前的預期嗎？

No, it is not. And let me be very precise on this, mic. So you know that there is off label, there is on label, but there are also steps in between and you like to be very precise. We don't expect to have CCC as on label for the simple reason that in the dream study, we did not implant the CCC patients.

不，不是。讓我非常精確地講一下這一點，麥克風。因此，您知道有標籤外的產品，標籤內的產品，但兩者之間還有步驟，您希望非常精確。我們不希望標籤上有 CCC，原因很簡單，在夢境研究中，我們沒有為 CCC 患者植入藥物。

So that's, I think, I hope this is very clear. Second thing is, When we look at the CCC that is ongoing in the US in ex access, but also the previous CCC and experience that we are having, there is no indication that Genio is not working for CCC patients and therefore there is also not one reason that would point in the direction that CCC should be a contraindication.

所以，我想，我希望這非常清楚。第二件事是，當我們查看美國正在進行的 CCC 以及先前的 CCC 和經驗時，沒有跡象表明 Genio 對 CCC 患者不起作用，因此也沒有任何理由表明 CCC 應該是禁忌症。

So what we do expect is we expect that in our label, we do not have it on label, but we also expect that we will not have it as a contraindication, but simply as an off-label indication that it is up to the physician's decision whether they would offer this to their patients, yes or no. I hope this is answering your question because I want to be on this yes.

因此，我們確實期望在我們的標籤上不寫明這一點，但我們也期望我們不會將其作為禁忌症，而只是將其作為標籤外適應症，由醫生決定是否向患者提供該藥物，是或否。我希望這能回答你的問題，因為我希望答案是肯定的。

Thank you, and so related. As you launch this, will you be an advocate for the dice procedure ahead of a Genio implant? How are you thinking about that given this, labeling expectation for CCC?

謝謝，如此相關。當您推出這項技術時，您會提倡在 Genio 植入之前進行骰子手術嗎？有鑑於此，您如何看待對 CCC 的標籤期望？

Yeah, so first of all, it's clear that we will never promote anything that is not on label or that is off label, and we will never do this. And if you then take it to the next port, how can a physician be certain that a patient is not having CCC? Yes, they will have to do the dice.

是的，首先，很明確的是，我們永遠不會推廣任何未列入標籤或未列入標籤的產品，我們永遠不會這樣做。如果您將其帶到下一個端口，醫生如何確定患者沒有患有 CCC？是的，他們必須擲骰子。

That is currently still the most traditional and accepted measurement to exclude CCC. I also know, and we also know that there is some work being done by others also in, for example, measuring the pharyngeal width.

這目前仍然是排除 CCC 最傳統和最被接受的測量方法。我也知道，我們也知道其他人也在做一些工作，例如測量咽部寬度。

The moment that would become accepted by patient to exclude CCC patients, it's clear that we will also adapt to this, but with our current data of dream, it is also obvious that we will have to exclude CCC and that we will not actively promote this when launching the product.

當排除CCC患者成為患者接受的那一刻起，我們顯然也會適應這一點，但以我們目前的夢想數據來看，顯然我們也必須排除CCC，而且我們不會在推出產品時積極推廣這一點。

Thank you Olivier.

謝謝你，奧利維爾。

Thank you, Mike.

謝謝你，麥克。

Thank you, one moment for our next question.

謝謝，請稍等片刻，回答我們的下一個問題。

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

我們的最後一個問題來自 Degroof Petercam 的 Laura Roba。

Good afternoon. Thank you for taking my question. First of all, I would like to come back on the previous question because you mentioned John of the other levers, to extend the cash 1 to Q2. So could you elaborate, on this? And then a second one on the temporary softness in the AGNS market, could you provide also a bit more information on this and also your expectations going forward? Thank you.

午安.感謝您回答我的問題。首先，我想回到上一個問題，因為您提到了其他槓桿的約翰，將現金 1 延長至 Q2。那您能詳細說明一下嗎？然後第二個問題是關於 AGNS 市場暫時疲軟，您能否提供更多有關此問題的資訊以及您對未來的預期？謝謝。

Sure, so let's start with the last piece, the temporary softness, in the market. We also saw our competitor in the first quarter also posted a single digits decline in the international market. We saw some, softness there, seasonality we expect it to be temporary in nature, and to recover over the course of the year.

當然，讓我們從最後一點開始，即市場暫時疲軟。我們也看到我們的競爭對手在第一季的國際市場上也出現了個位數的下滑。我們看到了一些疲軟的現象，季節性的現象，我們預期它本質上是暫時的，並會在一年內恢復。

With regard to some of the other, discretionary spending, when we build our P&L, we obviously have a number of fixed expenses, but we also have variable expenses, when we look at the variable expenses, they're discretionary in nature, whether they're projects or other commercial related items related to launch specifically.

至於其他一些可自由支配的支出，當我們建立損益表時，我們顯然有一些固定支出，但我們也有可變支出，當我們查看可變支出時，它們本質上是可自由支配的，無論它們是項目還是與發布具體相關的其他商業相關項目。

We've elected to defer those to be more in line obviously with an FDA approval timeline as well as to extend some of the other projects that that are ongoing that are not essential to either FDA approval status or immediate launch we'll be deferring those to a later date to extend that cash runway. So those are some of the nature of the items that we're deferring to extend the runway out.

我們選擇推遲這些項目，顯然是為了更符合 FDA 的批准時間表，同時也為了延長一些正在進行的其他項目，這些項目對於 FDA 的批准狀態或立即啟動並非至關重要，我們將推遲這些項目到以後的日期，以延長現金流。因此，這些是我們為了延長跑道而推遲的一些項目的性質。

Okay, thank you.

好的，謝謝。

Thank you. At this time, I would not like to turn the conference back over to Olivier Taelman, Chief Executive Officer for closing remarks.

謝謝。現在，我不想將會議交還給執行長奧利維爾·塔爾曼 (Olivier Taelman) 來致閉幕詞。

So first of all, I would like to thank everyone for attending the call. And as we stand on the verge of FDA approval, we have never been more confident in Nyxoah's future and our ability to deliver value to the patients, physicians, and also shareholders.

首先，我要感謝大家參加這次電話會議。當我們即將獲得 FDA 批准時，我們對 Nyxoah 的未來以及我們為患者、醫生和股東創造價值的能力充滿信心。

So thank you again for your time today and your continued support of Nyxoah, and we are really looking forward to updating you on our progress in the coming weeks slash months on FDA, to be very precise. Thank you all for joining.

因此，再次感謝您今天的時間和對 Nyxoah 的持續支持，我們非常期待在未來幾週甚至幾個月內向您通報我們在 FDA 方面取得的進展。感謝大家的加入。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。