NRX Pharmaceuticals Inc (NRXP) 2024 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals third-quarter 2024 earnings conference call. (Operator Instructions) This call is being recorded on Monday, November 18, 2024. I would now like to turn the conference over to Mr. Matt Duffy, Chief Business Officer. Please go ahead.

女士們、先生們，下午好，歡迎參加 NRx Pharmaceuticals 2024 年第三季財報電話會議。（操作員說明）此通話錄音時間為 2024 年 11 月 18 日星期一。現在我想將會議交給首席商務官馬特·達菲先生。請繼續。

Thank you, Ina, and welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

謝謝你，伊娜，歡迎大家。在我們進行電話會議之前，我想提醒大家，根據美國聯邦證券法，本次電話會議中所做的某些陳述屬於前瞻性陳述。這些陳述存在風險和不確定性，可能導致實際結果與歷史經驗或當前預期有重大差異。有關可能導致實際結果與本次電話會議中的聲明不同的因素的更多資​​訊包含在我們向 SEC 提交的定期報告中。

The forward-looking statements that may be made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued last week as well as the Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals website. Joining me today on the call are Dr. Jonathan Javitt, our Founder, Chairman and CEO and Chief Scientist; as well as Richard Narido, our Interim Chief Financial Officer and Treasurer; and Michael Abrams, our incoming CFO.

本次電話會議期間可能做出的前瞻性陳述僅代表截至本新聞稿發布之日的情況，本公司不承擔更新或修改前瞻性陳述的義務。本次電話會議中提供的資訊包含在上週發布的新聞稿以及 10-Q 表格中，可以從 NRx Pharmaceuticals 網站的投資者頁面存取該表格。今天與我一起參加電話會議的還有我們的創辦人、董事長兼執行長兼首席科學家喬納森·賈維特 (Jonathan Javitt) 博士；以及我們的臨時財務長兼財務主管 Richard Narido；以及我們即將上任的財務長麥可‧艾布拉姆斯 (Michael Abrams)。

Jonathan will provide a summary of our company's progress, Rich will review the company's financial results, Mike will make some comments, and then Jonathan will review upcoming milestones before making closing comments. Following our prepared remarks, we will address investor questions. I'll now turn the call over to Jonathan.

喬納森將總結我們公司的進展，里奇將審查公司的財務業績，麥克將發表一些評論，然後喬納森將在發表結束評論之前審查即將到來的里程碑。在我們準備好的發言之後，我們將回答投資人的問題。我現在將把電話轉給喬納森。

Thank you, Matt. Good evening, everyone, and thank you for joining us. As you saw, we decided to do our conference call a day or two after our quarterly report in order to make our calls a bit more convenient for the increasing number of analysts who are covering our company and to encompass today's important news. The last few months have been incredibly productive for NRx and for Hope Therapeutics. In our view, they represent a positive point in our path to market entry and profitability.

謝謝你，馬特。大家晚上好，感謝您加入我們。正如您所看到的，我們決定在季度報告發布後一兩天召開電話會議，以便讓我們的電話會議對於越來越多報道我們公司的分析師來說更加方便，並涵蓋今天的重要新聞。過去幾個月對於 NRx 和 Hope Therapeutics 來說是非常富有成效的。我們認為，它們代表了我們進入市場和獲利之路上的積極點。

On the NRx side, we continue to advance our life-saving products and our NRX-100, that's our IV ketamine, and NRX-101, our oral treatment for suicidal bipolar depression for new drug application filings in 2024. Further, our wholly owned subsidiary, Hope Therapeutics, aims to be the business of delivering life-saving care to people with suicidal depression and PTSD by year-end, with its first revenues being generated. To that end, Hope has signed nonbinding letters of intent to acquire two foundational interventional psychiatry groups which are currently revenue generating and EBITDA positive. We have received initial nonbinding commitments from lenders for nondilutive acquisition financing of Hope Clinics and are in the final stages of the underwriting process for those acquisitions.

在 NRx 方面，我們繼續推進我們的救生產品和 NRX-100，即我們的靜脈注射氯胺酮，以及 NRX-101，我們用於治療自殺性雙相抑鬱症的口服藥物，將於 2024 年提交新藥申請。此外，我們的全資子公司 Hope Therapeutics 的目標是在年底之前成為一家為自殺憂鬱症和創傷後壓力症候群患者提供救生護理的企業，並產生第一筆收入。為此，Hope 簽署了不具約束力的意向書，收購兩個基礎介入精神病學集團，這兩個集團目前正在創造收入且 EBITDA 為正值。我們已收到貸款人對 Hope Clinics 的非稀釋性收購融資的初步非約束性承諾，而這些收購正處於承銷流程的最後階段。

This puts NRx in a unique position as the only company dedicated to developing a comprehensive care path for the prevention and treatment of suicidality. We recognize the need to augment drug development with a care delivery model because of the emerging evidence that ketamine may be essential but not sufficient to achieve a long-term benefit for people with suicidal depression. For at least some patients, our precision psychiatry approach is required. That includes ketamine, transcranial magnetic stimulation and other modalities.

這使得 NRx 處於獨特的地位，成為唯一一家致力於開發預防和治療自殺的全面護理途徑的公司。我們認識到需要透過照護服務模式來加強藥物開發，因為越來越多的證據表明氯胺酮可能是必不可少的，但不足以為自殺性憂鬱症患者帶來長期益處。至少對某些患者來說，我們需要精確的精神病學方法。這包括氯胺酮、經顱磁刺激和其他方式。

This model of care is difficult to access for many patients and is not available in a typical ketamine clinic as most people think of it. Only by building this comprehensive model and rolling it out nationwide can we fulfill our mission of bringing hope to life. At the same time, the Hope Clinics are able to generate revenues that support NRx in advance of FDA approval of our breakthrough medicines. Today, we have a key personnel appointment to announce. Mr. Michael Abrams will serve as our new Chief Financial Officer.

對於許多患者來說，這種護理模式很難獲得，並且不像大多數人想像的那樣在典型的氯胺酮診所中無法提供。只有建立起這個綜合模式並在全國推廣，我們才能完成為生活帶來希望的使命。同時，Hope Clinics 能夠在 FDA 批准我們的突破性藥物之前產生收入來支持 NRx。今天，我們要宣布一項關鍵人事任命。艾布拉姆斯 (Michael Abrams) 先生將擔任我們的新任財務長。

Mike is a senior finance professional with almost three decades of experience as an executive officer, investment banker, director and senior adviser, which includes serving as the Chief Financial Officer of Arch Therapeutics, RISE IT Solutions and Fit Life brands. Mr. Abrams has deep experience across multiple functional areas, including, but not limited to, financial operations, accounting, mergers and acquisition, financial engineering, capital raising and shareholder communications. Mike earned his MBA with honors from the Booth School of Business at the University of Chicago, and received his BVA with honors from the University of Massachusetts Amherst as a William F. Field alumni scholar. Rich Narido has been an inspiration as our interim CFO and a valued member of our team. He will continue to support our Hope Therapeutics acquisitions as he has so ably done.

Mike 是一位資深金融專業人士，擁有近三十年的執行長、投資銀行家、董事和高級顧問經驗，其中包括擔任 Arch Therapeutics、RISE IT Solutions 和 Fit Life 品牌的財務長。艾布拉姆斯先生在多個職能領域擁有豐富的經驗，包括但不限於財務營運、會計、併購、金融工程、融資和股東溝通。Mike 以優異的成績獲得了芝加哥大學布斯商學院的 MBA 學位，並以威廉·F·菲爾德校友學者的身份，以優異的成績獲得了馬薩諸塞大學阿默斯特分校的 BVA。作為我們的臨時財務長和我們團隊的重要成員，里奇·納裡多（Rich Narido）一直是我們的靈感來源。他將繼續支持我們對 Hope Therapeutics 的收購，就像他所做的那樣。

Pending finalization of those initial acquisitions, Dr. David Fifa, the Founder and President of Kadima Clinic in La Joya, California, has joined us as a key adviser. Dr. Fife is an internationally recognized expert in the use of precision psychiatry to treat suicidal depression and PTSD. He's believed to be the first to have taken ketamine outside the walls of university-based psychiatric clinics and demonstrated that it can safely be used in the outpatient setting. David will be working hand-in-hand with leading professors of psychiatry at Harvard, Yale, Colombia, Baylor Northwestern and the University of Neem and Inserm in France to advance our medicines through the FDA and the European Medicines Agency while bringing our network of Hope Clinics to life.

在這些初步收購完成之前，加州拉霍亞 Kadima Clinic 的創始人兼總裁 David Fifa 博士作為重要顧問加入了我們。法伊夫博士是國際公認的利用精準精神病學治療自殺憂鬱症和創傷後壓力症候群（PTSD）的專家。據信，他是第一個在大學精神科診所外服用氯胺酮的人，並證明它可以安全地在門診環境中使用。David 將與哈佛大學、耶魯大學、哥倫比亞、貝勒西北大學以及法國印楝大學和 Inserm 的精神病學頂尖教授攜手合作，透過 FDA 和歐洲藥品管理局推進我們的藥物，同時帶來我們的希望網路診所走向生活。

On the financial front, we are pleased to share that last quarter, we achieved a 74% reduction in net operating losses compared to third quarter 2023, and we're forecasting probability in 2025 with revenue and EBITDA from Hope Therapeutics, along with projected sales of our medications. Further, we recently announced the closing of our second tranche of funding from an institutional investor, bringing the total amount of funding to $10.8 million. In connection with this financing, we retired our prior and more expensive debt and settled outstanding litigation with Streeterville Capital. Collectively, these actions position us to enter the next business stage for the company in 2025, with two potential drug approvals to make us a revenue-generating biotechnology company as well as an EBITDA-positive care delivery company.

在財務方面，我們很高興與大家分享，上個季度，與2023 年第三季度相比，我們的淨營運虧損減少了74%，我們預測2025 年Hope Therapeutics 的收入和EBITDA 以及預計銷售額的可能性我們的藥物。此外，我們最近宣布完成機構投資者的第二筆融資，使融資總額達到 1,080 萬美元。透過此次融資，我們償還了先前更昂貴的債務，並解決了與 Streeterville Capital 的未決訴訟。總的來說，這些行動使我們能夠在 2025 年進入公司的下一個業務階段，兩項潛在的藥物獲得批准，使我們成為一家創收的生物技術公司以及一家 EBITDA 為正的護理服務公司。

In sum, we are building a company that is now poised to bring life-saving treatment to patients and financial returns to investors. What drives this mission for the NRx team is simple: suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC. An American dies from suicide every 11 minutes in the United States, and worldwide, someone dies of suicide every minute.

總之，我們正在建立一家公司，現在準備為患者帶來挽救生命的治療，並為投資者帶來財務回報。推動 NRx 團隊完成這項使命的原因很簡單：自殺是一種全國性的流行病。據 CDC 稱，每年約有 380 萬美國人制定積極的自殺計劃。在美國每 11 分鐘就有一名美國人死於自殺，而在全世界範圍內，每分鐘就有一人死於自殺。

Our overriding goal at NRx is to ensure that all patients who need life-saving precision psychiatry care with ketamine and other therapies are able to get it. That's not currently the case. For the most part, ketamine is available today only to those who can pay out of pocket and will remain so until FDA approval of ketamine for treating suicidal depression obtained. Our planned NDA, if approved, would bring NRX-100, clearly a life-saving product, to patients in a safe, accessible format as a preservative-free formulation that has insurance coverage.

我們 NRx 的首要目標是確保所有需要氯胺酮和其他療法來挽救生命的精準精神病學護理的患者都能獲得治療。目前情況並非如此。目前，大多數情況下，氯胺酮僅適用於那些能夠自費支付的人，並且在 FDA 批准氯胺酮用於治療自殺性憂鬱症之前，這種情況將一直存在。我們計劃的新藥申請（NDA）如果獲得批准，將以安全、易於使用的形式將 NRX-100（顯然是一種救生產品）作為一種具有保險範圍的無防腐劑配方帶給患者。

The current market for intranasal ketamine is already approximately $1 billion a year, and the label for intranasal ketamine states that it has not demonstrated anti-suicide properties. Let's talk specifically about what we need to do to bring the NRX-100 through the FDA. Originally, FDA granted us Fast Track designation for NRX-100 in 2017 for use in combination with NRX-101 to treat bipolar depression. We've now asked the FDA to expand that Fast Track designation and grant priority review to our NDA for use of NRX-100 in all forms of depression, including bipolar depression.

目前鼻內氯胺酮的市場規模已約為每年 10 億美元，而鼻內氯胺酮的標籤顯示其尚未表現出抗自殺特性。讓我們具體談談我們需要做什麼才能讓 NRX-100 通過 FDA。最初，FDA 於 2017 年授予我們 NRX-100 快速通道資格，用於與 NRX-101 聯合使用治療雙相憂鬱症。我們現在已要求 FDA 擴大快速通道資格，並對我們的 NDA 給予優先審查，以將 NRX-100 用於治療所有形式的憂鬱症，包括雙相憂鬱症。

To get a new drug approved, a manufacturer must demonstrate efficacy, safety and manufacturability. The slides on nrxpharma.com summarize the data we will be sharing with FDA that includes nearly 1,000 patients treated in randomized controlled trials against placebo, active comparator and electroshock therapy. In summary, intravenous ketamine is far more effective than both placebo and active comparator in treating suicidal depression. It is noninferior to and may, in fact, be superior to electroshock therapy without the memory loss caused by ECT.

為了使新藥獲得批准，製造商必須證明其有效性、安全性和可製造性。nrxpharma.com 上的投影片總結了我們將與 FDA 共享的數據，其中包括接受安慰劑、活性比較藥物和電擊療法隨機對照試驗的近 1,000 名患者。總之，靜脈注射氯胺酮在治療自殺性憂鬱症方面比安慰劑和活性對照劑更有效。它不劣於甚至可能優於電擊療法，也不會造成 ECT 造成的記憶喪失。

The patients treated in randomized trials are supplemented by data on more than 20,000 patients treated in the real-world setting, where a 50% reduction in depression scores is seen. Last June, the aggregator of those data reported results from intravenous ketamine were superior to those seen with intranasal esketamine, although that real-world comparison was not based on a randomized trial. A key component of any new drug application is a comprehensive chemistry manufacturing and control or CMC package, also known as module three. In our last conference call, we pointed to this requirement into our nine-month stability data.

隨機試驗中接受治療的患者得到了在現實世界中接受治療的 20,000 多名患者的數據的補充，其中憂鬱評分降低了 50%。去年六月，這些數據的總結者報告稱，靜脈注射氯胺酮的結果優於鼻內艾氯胺酮的結果，儘管現實世界的比較並非基於隨機試驗。任何新藥應用的關鍵組成部分是綜合化學製造和控製或 CMC 包，也稱為模組三。在上次電話會議中，我們在九個月的穩定性數據中指出了這項要求。

We've now completed this requirement with the 12-month stability data required to file an application for new drug approval. Another key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. As noted previously, we've reached this critical alignment with FDA, and I would like to commend the clinical regulatory team at NRx for achieving this milestone. Our development of a preservative pre ketamine may be surprising to some.

現在，我們已經完成了這項要求，並提供了提交新藥批准申請所需的 12 個月穩定性數據。FDA 提交 NDA 的另一個關鍵要求是按照法律要求調整兒科研究計劃。如前所述，我們已經與 FDA 達成了這一重要一致，我要讚揚 NRx 的臨床監管團隊實現了這一里程碑。我們開發的防腐劑前氯胺酮可能會讓一些人感到驚訝。

The basis for this development path is the result of data from both primate and human studies that show repeated doses on the order of 60 doses or more of the currently available commercial intravenous ketamine may be toxic to the brand. The currently available ketamine preparation was designed for use of the product in anesthesia. Ketamine is currently sold in a multi-dose vial, where it was anticipated that doctors would draw from the same vial for multiple patients. But of course, in anesthesia, it's expected that the patient will only get the medicine once.

這一開發路徑的基礎是靈長類動物和人類研究的數據結果，這些數據表明，重複服用 60 劑或更多劑量的當前市售靜脈注射氯胺酮可能對該品牌有毒。目前可用的氯胺酮製劑是專為在麻醉中使用該產品而設計的。氯胺酮目前以多劑量小瓶形式出售，預計醫生將從同一個小瓶中為多名患者抽取氯胺酮。但當然，在麻醉中，預計患者只會接受一次藥物。

Back in the 1960s, when this preparation was formulated, it was manufactured with a potentially toxic preservative benzanthonium chloride. While there is no evidence that benzanthonium chloride is toxic at its current concentration for the intended use in anesthesia, its safety has never been shown or even proposed for repeated use. Hence, we believe we are poised to file the first new drug application for a novel preparation of ketamine that will bring substantial value to patients and will be reimbursable by payers. Access to NRX-100 is a critical focus of our company.

早在 20 世紀 60 年代，當配製這種製劑時，它是用潛在有毒的防腐劑苯扎氯銨製造的。雖然沒有證據表明苯扎氯銨在其目前濃度下對於麻醉用途是有毒的，但其安全性從未證明，甚至沒有建議重複使用。因此，我們相信我們準備提交第一個氯胺酮新型製劑的新藥申請，該製劑將為患者帶來巨大價值，並將由付款人償還。獲得 NRX-100 是我們公司的一個重點關注點。

The current off-label use of ketamine in CNS disorders is generally only available to patients who can pay out of pocket. We expect NRX-101, once approved, to be widely reimbursed, thus providing access to the vast majority of people in need, not just to those with the means to spend thousands of dollars in cash for treatment. Let's turn to NRX-101, our oral combination of D-cycloserine, which is an NMDA blocker, and lurasidone, which is the standard of care in bipolar depression. We believe the product represents a paradigm-changing breakthrough in the care of bipolar depression.

目前氯胺酮在中樞神經系統疾病的超適應症用途通常僅適用於能夠自付費用的患者。我們預計 NRX-101 一旦獲得批准，將得到廣泛報銷，從而為絕大多數有需要的人提供服務，而不僅僅是那些有能力花費數千美元現金進行治療的人。讓我們來看看 NRX-101，這是我們的 D-環絲氨酸（一種 NMDA 阻斷劑）和魯拉西酮（雙相抑鬱症的標準治療方法）的口服組合。我們相信該產品代表了雙極性憂鬱症治療領域的典範突破。

This breakthrough is driven by a dramatic improvement in the safety of our medicine compared to the standard of care in bipolar depression in clinical trials. In our recently completed clinical trial, we demonstrated that NRX-101 is comparable in its ability to reduce symptoms of depression when compared to the market-leading drug, lurasidone. Critically, however, NRX-101 demonstrated that it's the first and only oral antidepressant to reduce symptoms of suicidality and the first oral antidepressant to reduce symptoms of akathisia, a highly dangerous side effect of nearly all antidepressants. The NRX-101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression.

與臨床試驗中雙相憂鬱症的護理標準相比，我們的藥物安全性有了顯著改善，從而推動了這一突破。在我們最近完成的臨床試驗中，我們證明，與市場領先的藥物魯拉西酮相比，NRX-101 減輕憂鬱症狀的能力相當。然而，重要的是，NRX-101 證明它是第一個也是唯一一個可以減少自殺症狀的口服抗憂鬱藥，也是第一個可以減少靜坐不能症狀的口服抗憂鬱藥，靜坐不能是幾乎所有抗憂鬱藥的一種非常危險的副作用。美國臨床精神藥理學會公佈的 NRX-101 數據展示了治療雙相憂鬱症的新範例。

Now akathisia is not a household term. However, key opinion leaders regard it as the worst side effect of any antidepressant. Akathisia is frequently described as an irresistible urge to move. Patients frequently describe it as a feeling of jumping out of their skins. Patients with akathisia are known to jump off of roofs and in front of oncoming trains.

現在，靜坐不能已不再是家喻戶曉的用語。然而，關鍵意見領袖認為這是所有抗憂鬱藥物中最嚴重的副作用。靜坐不能常被描述為一種不可抗拒的運動衝動。患者經常將其描述為一種從皮膚中跳出來的感覺。眾所周知，靜坐不能患者會從屋頂上或在迎面駛來的火車前跳下。

Currently, there is a petition before the Supreme Court of British Columbia regarding a Canadian citizen who has applied to enter life by medically assisted suicide because she cannot tolerate the akathisia caused by common antidepressant medication. Serotonin-targeted drugs for the treatment of depression are known to cause akathisia and suicidality. Doctors and patients have lived with those side effects in order to achieve the critical antidepressant effects that are needed to control life-threatening depression. The data we presented at ASCP, however, confirms data from our earlier STABIL-B trial, demonstrating that NRX-101 is the first oral antidepressant to have effective antidepressant properties while simultaneously decreasing akathisia and suicidality.

目前，不列顛哥倫比亞省最高法院收到一份請願書，涉及一名加拿大公民，由於無法忍受普通抗憂鬱藥物引起的靜坐不能，而申請透過醫療輔助自殺進入生命。已知用於治療憂鬱症的血清素標靶藥物會導致靜坐不能和自殺傾向。醫生和患者必須忍受這些副作用，才能達到控制危及生命的憂鬱症所需的關鍵抗憂鬱效果。然而，我們在 ASCP 上提供的數據證實了我們早期 STABIL-B 試驗的數據，證明 NRX-101 是第一種具有有效抗憂鬱特性，同時減少靜坐不能和自殺傾向的口服抗憂鬱藥物。

We believe this product profile could lead to NRX-101 becoming the drug of choice in bipolar depression. To that end, we're filing an NDA for accelerated approval of NRX-101 for suicidal bipolar depression with suicidality or akathisia. Given our strong data and the lack of treatment options for this segment of people with bipolar depression, we and our regulatory counsel believe this to be a vital unmet medical need and worthy of accelerated approval. Finally, let's turn to our progress with Hope Therapeutics. In the six months since hope was founded, we've considered nearly 100 potential flagship acquisitions.

我們相信該產品概況可能會導致 NRX-101 成為雙相憂鬱症的首選藥物。為此，我們正在提交一份 NDA，以加速批准 NRX-101 用於治療伴隨自殺傾向或靜坐不能的自殺性雙相憂鬱症。鑑於我們強有力的數據以及這部分雙相憂鬱症患者缺乏治療選擇，我們和我們的監管顧問認為這是一個至關重要的未滿足的醫療需求，值得加速批准。最後，讓我們來談談 Hope Therapeutics 的進展。自 Hope 成立以來的六個月裡，我們考慮了近 100 項潛在的旗艦收購。

If you Google ketamine clinics, you'll find many. However, they're known to come and go, and too many of them administer ketamine one day, vitamin drips another day and a variety of services that are colloquially known as mid-spa services throughout the week. Our objective is to build a national umbrella of precision psychiatric clinics that can safely treat the 3.8 million Americans who make a plan to kill themselves each year, prevent another death every 11 minutes and take the stigma out of suicidal depression.

如果你用谷歌搜尋氯胺酮診所，你會發現很多。然而，眾所周知，他們來來去去，其中有太多人一天注射氯胺酮，另一天注射維生素，並在一周內提供各種通俗稱為中期水療服務的服務。我們的目標是建立一個全國性的精準精神病診所，能夠安全地治療每年計劃自殺的 380 萬美國人，防止每 11 分鐘又發生一起死亡，並消除自殺抑鬱症的恥辱。

We've shared with investors that we aim to assemble an organization generating $25 million in revenue by the end of this year and an organization generating more than $100 million in revenue by the end of next year. Those who wish to gain insight into the market value of such an achievement might wish to look at the early development of similar entities such as DaVita for treating kidney failure. Although we and others have used the colloquial term ketamine clinic in association with Hope Therapeutics, you'll hear us increasingly use the term precision psychiatry. The data from the field demonstrate that ketamine alone is not sufficient to maintain remission from suicidality in many patients with depression and PTSD.

我們已與投資者透露，我們的目標是在今年年底前組建一個收入達到 2500 萬美元的組織，並在明年年底之前組建一個收入超過 1 億美元的組織。那些希望深入了解這項成就的市場價值的人可能希望了解類似實體的早期開發，例如用於治療腎衰竭的 DaVita。儘管我們和其他人在與 Hope Therapeutics 合作時使用了通俗術語“氯胺酮診所”，但您會聽到我們越來越多地使用“精準精神病學”一詞。現場數據表明，單獨使用氯胺酮不足以維持許多憂鬱症和創傷後壓力症候群患者自殺傾向的緩解。

There seems to be little question that ketamine has achieved a 50% reduction in suicidal ideation in numerous trials and real-world settings. This magnitude and repetitive effect is a dramatic change from the prior 50 years of experience with SSRI and lose serotonin-targeted antidepressants. However, maintaining that ketamine effect and enhancing it will, in our view, require additional therapies such as transcranial magnetic stimulation, an FDA-approved therapy, newly developed digital therapeutics and oral medicines, such as NRX-101. Our focus is built on building a comprehensive site of care that can achieve remission in 80% to 90% of patients, not just 50%.

毫無疑問，在眾多試驗和現實環境中，氯胺酮已經使自殺意念減少了 50%。與過去 50 年使用 SSRI 和失去血清素靶向抗憂鬱藥物的經驗相比，這種程度和重複性的效果是一個巨大的變化。然而，我們認為，維持並增強氯胺酮效應需要額外的療法，例如經顱磁刺激、FDA 批准的療法、新開發的數位療法和口服藥物，例如 NRX-101。我們的重點是建立一個全面的護理場所，可以使 80% 至 90% 的患者（而不僅僅是 50%）獲得緩解。

Over the past two quarters, we have obtained preliminary funding commitments from financial institutions and have identified several leading precision psychiatry organizations and signed nonbinding letters of intent to acquire key clinics on both the East and West Coast of our country. We've initially targeted these clinics because they'll serve as foundational elements of our network. From our perspective, they epitomize the compassionate, comprehensive and efficient operational structure that will serve as a model for additional facilities as we bring them into the Hope network. These are critical steps in our quest to make a range of life-saving treatments available to patients across the country.

在過去的兩個季度中，我們已獲得金融機構的初步資金承諾，並確定了幾個領先的精準精神病學組織，並簽署了收購我國東海岸和西海岸重點診所的不具約束力的意向書。我們最初瞄準這些診所是因為它們將成為我們網路的基礎要素。從我們的角度來看，它們體現了富有同情心、全面和高效的營運結構，當我們將它們納入希望網路時，它們將成為更多設施的典範。這些是我們為全國各地的患者提供一系列挽救生命的治療方法的關鍵步驟。

As of last week, our accounting teams have finished confirming the financial statements of these flagship acquisitions, and we've moved into the financial underwriting phase. Hope Therapeutics will offer a comprehensive menu of state-of-the-art precision psychiatry treatments, including IV ketamine, SPRAVATO, transcranial magnetic stimulation or TMS and medication management, together with planned digital therapeutics designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. On the financial front, the best-of-class clients we target are already generating profit margins of around 30%, with significant opportunities for growth. We expect funding for Hope to be independent and thus nondilutive to NRx and to its shareholders, however, we expect that a portion of the earnings generated through Hope will support NRx's path to profitability.

截至上週，我們的會計團隊已經完成了這些旗艦收購的財務報表確認，我們已進入財務承銷階段。Hope Therapeutics 將提供一系列最先進的精準精神病學治療，包括靜脈注射氯胺酮、SPRAVATO、經顱磁刺激或 TMS 和藥物管理，以及旨在增強和維持 NMDA 臨床益處的計劃數位療法。在財務方面，我們的目標客戶的一流客戶已經實現了 30% 左右的利潤率，並且具有巨大的成長機會。我們預期 Hope 的資金是獨立的，因此不會稀釋 NRx 及其股東的權益，但是，我們預期 Hope 產生的部分收益將支持 NRx 的獲利之路。

Now that the Streeterville litigation is settled, we continue to work toward a distribution of shares of Hope Therapeutics to existing shareholders, and we plan to seek a public listing for Hope on a national exchange. Our auditors have finalized the initial audit for Hope Therapeutics, and we're now able to draft and file the SEC forms to register the stock. I want once again thank Rich Narido for his exceptional service as our interim CFO over the past year as we financially reengineered our company and work to build what we hope will be a bright future. Rich will now review our third quarter financials.

現在 Streeterville 訴訟已經解決，我們將繼續努力向現有股東分配 Hope Therapeutics 的股票，並計劃尋求 Hope 在國家證券交易所公開上市。我們的審計員已經完成了 Hope Therapeutics 的初步審計，現在我們可以起草並提交 SEC 表格來註冊股票。我想再次感謝里奇·納裡多(Rich Narido) 作為我們的臨時財務長在過去一年中為我們提供的出色服務，幫助我們對公司進行了財務重組，並努力建立我們希望的光明未來。里奇現在將回顧我們第三季的財務狀況。

Thank you, Jonathan. For the three months ended September 30, 2024, NRx pharmaceuticals reduced its operating net loss by nearly 75% year-over-year from $6.1 million in the third quarter to $1.6 million in 2024. For that same period, research and development expenses decreased from $3.3 million in '23 to $0.6 million in 2024. The $2.7 million decrease is related primarily to the decrease of $2.1 million in clinical trial and development expenses due to the conclusion of the Phase 2b/3 study relating to NRX-101 and the company's cash conservation efforts. Also in that three-month period, NRx achieved a slight decrease in general and administrative expenses from $2.5 million in 2023 to $2.4 million in 2024.

謝謝你，喬納森。截至2024年9月30日的三個月，NRx Pharmaceuticals 的營運淨虧損年減近75%，從第三季的610萬美元減少到2024年的160萬美元。同期，研發費用從 2023 年的 330 萬美元減少到 2024 年的 60 萬美元。減少 270 萬美元主要與 NRX-101 相關 2b/3 期研究的結束以及公司的現金節約工作導致臨床試驗和開發費用減少 210 萬美元有關。同樣在這三個月期間，NRx 的一般和管理費用略有下降，從 2023 年的 250 萬美元減少到 2024 年的 240 萬美元。

For the nine months ended September 30, 2024, NRx Pharmaceuticals reduced its net loss to $16.1 million compared to $25.8 million in the prior year. These efficiencies represent an improvement in net loss of $9.7 million year-over-year and a $1.89 or 54% improvement in net loss per share year-over-year. Over that nine-month period, we recorded $5.2 million of research and development expenses compared to $10.8 million for the same period in 2023, representing a 52% decrease year-over-year. The decrease of $5.6 million is related primarily to the decrease of $6.1 million in clinical trial and development expenses due to the conclusion of the Phase 2b/3 study relating to 101, and offset by $1.3 million related to Alvogen warrants and $0.2 million related to fees paid to regulatory and development consultants.

截至 2024 年 9 月 30 日的九個月，NRx Pharmaceuticals 將淨虧損減少至 1,610 萬美元，而前一年為 2,580 萬美元。這些效率意味著淨虧損年減了 970 萬美元，每股淨虧損年減了 1.89 美元，即 54%。在這 9 個月期間，我們的研發費用為 520 萬美元，而 2023 年同期為 1,080 萬美元，年減 52%。減少 560 萬美元主要與 101 相關 2b/3 期研究結束導致臨床試驗和開發費用減少 610 萬美元有關，並被與 Alvogen 認股權證相關的 130 萬美元和與費用相關的 20 萬美元抵消支付給監管和開發顧問。

Also in that nine-month period, we decreased G&A by $1.4 million from $12.3 million in 2023 to $10.9 million in 2024, representing an 11% decrease year-over-year. As of September 30, 2024, we had $1.6 million in cash and cash equivalents. Subsequent to September 30, 2024, we added the cash by closing tranche two of the secured debt financing from funds in the amount of $5.4 million. This financing is expected to support filing of new drug applications for NRX-100, ketamine and NRX-101, general corporate purposes as well as the retired historical debt on more favorable terms and lower interest rates. NRx continues to implement operational efficiencies, to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders. With that, I will turn it back to Jonathan.

同樣在這 9 個月期間，我們將 G&A 減少了 140 萬美元，從 2023 年的 1,230 萬美元減少到 2024 年的 1,090 萬美元，年減 11%。截至 2024 年 9 月 30 日，我們擁有 160 萬美元的現金和現金等價物。2024 年 9 月 30 日之後，我們透過關閉資金中第二批擔保債務融資增加了現金，金額為 540 萬美元。這筆融資預計將支持 NRX-100、氯胺酮和 NRX-101 的新藥申請、一般企業用途以及以更優惠的條件和更低的利率償還歷史債務。NRx 繼續提高營運效率，擴大現金跑道，並繼續專注於為股東創造收入和價值的道路。這樣，我會將其轉回給喬納森。

Thank you, Rich. We look forward to your ongoing support as Hope takes shape, and we're able to bring life-saving therapies to patients across the world. Today, we announced that NRx has appointed Michael Abrams as our permanent CFO. Mike brings a wealth of experience both as a public company CFO and in the capital markets, a background well-suited to our long-term goals. Welcome, Mike. Please introduce yourself to our shareholders.

謝謝你，里奇。隨著「希望」的形成，我們期待您的持續支持，我們能夠為世界各地的患者提供挽救生命的治療方法。今天，我們宣布 NRx 已任命 Michael Abrams 為我們的永久財務長。麥克在擔任上市公司財務長和資本市場方面擁有豐富的經驗，這種背景非常適合我們的長期目標。歡迎，麥克。請向我們的股東介紹您自己。

Thank you, Jonathan. I'm excited to join the NRx team at such an important time for the company. In prior engagements, I've joined companies just as they were poised to transition to revenue generation, and look forward to shepherding NRx through that exciting phase. With major milestones expected in the near term, I see NRx as a unique opportunity and look forward to great things for the company and our shareholders. Jonathan?

謝謝你，喬納森。我很高興能在公司如此重要的時刻加入 NRx 團隊。在先前的工作中，我加入公司時正值他們準備過渡到創收階段，並期待帶領 NRx 度過這個令人興奮的階段。預計近期將實現重大里程碑，我認為 NRx 是一個獨特的機會，並期待為公司和股東帶來偉大的成就。喬納森？

Thank you, Mike. We're looking forward to working with you. NRx is dedicated to preventing and treating suicidality in patients with depression and PTSD. Filing our two NDAs in the near term and continuing the development of Hope Therapeutics national network for care delivery are transformative steps for the company and for the treatment of patients. I'd like to thank our team, our investors and most importantly, the patients who participated in our clinical trials for their steadfast support in pursuit of this station. Operator, we're ready to take questions from the audience.

謝謝你，麥克。我們期待與您合作。NRx 致力於預防和治療憂鬱症和創傷後壓力症候群 (PTSD) 患者的自殺傾向。近期提交兩項 NDA 並繼續發展 Hope Therapeutics 全國護理服務網絡對於公司和患者治療都是變革性的步驟。我要感謝我們的團隊、投資者，最重要的是，感謝參與我們臨床試驗的患者對這一站的堅定支持。接線員，我們準備好回答觀眾的問題了。

(Operator Instructions) Jason Kolbert, D. Boral Capital.

（操作員說明）Jason Kolbert，D. Boral Capital。

Thanks for the update. Jonathan, I'd like to zoom in a little bit on the accelerated approval, what you think is involved in that process? And if you get it, what does that mean in terms of a PDUFA data and the time line for both. And I know you're really talking about NRX-101, but kind of what is the PDUFA date do you think and the time line likely for NRX-100 as well?

感謝您的更新。喬納森，我想稍微關註一下加速審批，您認為該過程涉及什麼？如果您明白了，這對 PDUFA 數據和兩者的時間線意味著什麼。我知道您確實在談論 NRX-101，但您認為 PDUFA 日期是什麼以及 NRX-100 可能的時間表是什麼？

So in order to sort of unpack those questions, accelerated approval is a process, and people can look this up on the FDA website, where a sponsor has identified an important intermediate endpoint for a drug, but has not necessarily identified sufficient efficacy data for permanent approval of that drug. So in the case of NRX-101, what we've not yet done is 300 to 500 person clinical trial of NRX-101 against placebo to prove that it's better than placebo, although we know that its components have beaten placebo in multiple trials, especially lurasidone. On the other hand, we now have two clinical trials where NRX-101 has demonstrated reduction in suicidality and a akathisia compared to lurasidone. And we believe that akathisia and suicidality are critical intermediate endpoints.

因此，為了解決這些問題，加速批准是一個過程，人們可以在 FDA 網站上查找這一點，申辦者已經確定了藥物的重要中間終點，但不一定確定了足夠的永久療效數據。因此，就NRX-101 而言，我們還沒有進行300 至500 人的NRX-101 對照安慰劑臨床試驗，以證明它比安慰劑更好，儘管我們知道它的成分在多項試驗中擊敗了安慰劑，特別是魯拉西酮。另一方面，我們現在有兩項臨床試驗證明，與魯拉西酮相比，NRX-101 可減少自殺傾向和靜坐不能。我們認為靜坐不能和自殺是關鍵的中間終點。

We don't have proof that they're associated with long-term survival, but we certainly know that suicidality can be associated with short-term demise. So therefore, we intend to seek accelerated approval, which is a process by which the FDA grants five years of marketing rights to a drug, during which time, permanent data, permanent approval can be obtained. Now you may say, how are we ever going to get that long-term data? Well, there's a national study spinning up, where patients are being randomized to different currently marketed drugs for treating bipolar depression. And within that study, there is not yet any arm for drug therapy of patients who have suicidality and akathisia.

我們沒有證據表明它們與長期生存有關，但我們當然知道自殺可能與短期死亡有關。因此，我們打算尋求加速批准，這是FDA授予藥物五年行銷權的過程，在此期間可以獲得永久數據、永久批准。現在您可能會說，我們如何才能獲得長期數據？嗯，有一項全國性研究正在進行，患者被隨機分配到目前上市的不同藥物治療雙相憂鬱症。在這項研究中，還沒有任何方法可以對有自殺傾向和靜坐不能的患者進行藥物治療。

The only treatment that's approved for suicidality today is electric convulsive therapy. We've been in touch with the investigators of that study, and we think it's not unlikely that, that may be the place where patients in large numbers are randomized to NRX-101 over the next five years in a manner that gains permanent approval. We're not ruling out the possibility that a pharmaceutical company might step in and want to finance that definitive study as a traditional industry-sponsored study, but we believe that there's another path, one that's far less dilutive to our shareholders as well. Now you asked about NRX-100, and that's a situation where we now have randomized control data demonstrating that NRX-100, that is IV ketamine, reduces suicidality and depression compared not only to placebo, but to active comparator.

目前唯一被批准用於自殺的治療方法是電驚厥療法。我們一直在與該研究的研究人員保持聯繫，我們認為這不太可能是在未來五年內大量患者以獲得永久批准的方式隨機接受 NRX-101 的地方。我們並不排除一家製藥公司可能介入並希望為這項最終研究提供資金作為一項傳統的行業贊助研究的可能性，但我們相信還有另一條路，一條對我們股東的稀釋作用也小得多的路。現在您詢問了NRX-100，在這種情況下，我們現在擁有隨機對照數據，證明NRX-100（即靜脈注射氯胺酮）不僅與安慰劑相比，而且與活性比較劑相比，都能降低自殺率和憂鬱症。

And as you know, from the recent actions related to MDMA, FDA has been pretty clear that if you're studying a drug that can have psychedelic effects, and certainly, ketamine can have psychedelic effects, it's important to compare it not only to placebo, but to an active comparator that maybe less likely to tip the patients off to whether they got ketamine or got the comparator. Moreover, as people know from our slide deck, recent data show that ketamine is at least as good as electroshock therapy in treating depression. And although the design of that trial was a non-inferiority design, a post-hoc analysis shows that ketamine was superior to electroshock therapy in reducing symptoms of depression. So in terms of PDUFA dates, we expect to have PDUFA dates both on NRX-101 and NRX-100 during 2025. Does that answer the question, Jason?

如您所知，從最近與MDMA 相關的行動來看，FDA 已經非常清楚地表明，如果您正在研究一種可能具有迷幻作用的藥物，而且氯胺酮當然也可能具有迷幻作用，那麼重要的是不僅要將其與安慰劑進行比較，但對於一個活躍的比較器來說，它可能不太可能讓患者知道他們是否服用了氯胺酮或服用了比較器。此外，正如人們從我們的幻燈片中了解到的那樣，最近的數據表明，氯胺酮在治療憂鬱症方面至少與電擊療法一樣有效。儘管該試驗的設計是非劣效性設計，但事後分析顯示氯胺酮在減輕憂鬱症狀方面優於電擊療法。因此，就 PDUFA 日期而言，我們預計 2025 年 NRX-101 和 NRX-100 上都會有 PDUFA 日期。這能回答問題嗎，傑森？

It does. That's a great answer. Can I ask you to talk a little bit in switching gears and thinking about Hope? And you talked a little bit about the difference between kind of ketamine clinics that focus on doing various infusions for people and a real psychiatric center. And so my question is, are you finding motivated folks that really want to build that all-in-one comprehensive psychiatric center? And do you think you're going to be able to acquire them in a way that you really will develop a national footprint?

確實如此。這是一個很好的答案。我可以請你談談切換方式和思考希望嗎？您談到了專注於為人們進行各種輸液的氯胺酮診所與真正的精神病中心之間的區別。所以我的問題是，您是否找到了真正想要建立一體化綜合精神病學中心的積極主動的人？您認為您能夠以真正在全國範圍內發展的方式獲得它們嗎？

Well, I think what's fair to say is that having done a pretty broad canvassing of what's out there, we have identified some clinics that are doing it the right way, that are combining ketamine, TMS, good, psychiatric medical management and traditional therapy in an integrated model that best serves patients. We've been able to prove to ourselves that those clinics are able to operate at a healthy operating margin, somewhere in the neighborhood of 30%, and by virtue of the fact that some of those organizations have signed letters of intent to be acquired by us, we believe that our business model is a feasible one.

好吧，我認為公平地說，在對現有的情況進行了相當廣泛的調查之後，我們已經確定了一些正在以正確方式行事的診所，這些診所將氯胺酮、TMS、良好的精神科醫療管理和傳統療法結合起來最好地為患者服務的綜合模型。我們已經能夠向自己證明，這些診所能夠以健康的營業利潤率運營，大約在 30% 左右，並且由於其中一些組織已經簽署了收購意向書。

Are these clinics the minority of what's out there today? For sure. People have seen private equity acquisition models with clinics that have sort of come undone. Some have succeeded, some have not. We believe that, that integrated precision psychiatry model is what's needed to have both staying power in the marketplace and really to provide the maximum benefit to patients.

這些診所是當今診所中的少數嗎？一定。人們已經看到私募股權收購診所的模式已經失敗。有些成功了，有些則沒有。我們相信，這種整合的精準精神病學模型是在市場上保持持久力並真正為患者提供最大利益所需要的。

Perfect. And I just want to try to throw a question at Mike today. Mike, Jason Kolbert. Great to hear you again. We've known each other for a while. Great company. You should be excited to be there. I'm sure you are. In the press release of the third quarter, there was language talking about revenues this year and profitability next year. So can you talk a little bit about kind of what -- when you did your due diligence to join the firm, how you're looking at kind of the revenue build over the next year?

完美的。今天我只想嘗試向麥克提出一個問題。麥克，傑森·科爾伯特。很高興再次聽到你的聲音。我們認識有一段時間了。很棒的公司。你應該很高興能在那裡。我確信你是。在第三季的新聞稿中，有一些語言談論了今年的收入和明年的獲利能力。那麼，您能否談談當您為加入公司進行盡職調查時，您如何看待明年的收入成長？

So in full disclosure, thank you, Jason. In full disclosure, that's not my build, right? (inaudible)

完全公開，謝謝你，傑森。坦白說，這不是我的作品，對吧？（聽不清楚）

I know it's not a fair question, but I know you did due diligence.

我知道這不是一個公平的問題，但我知道你做了盡職調查。

Yes, but I did due diligence on it. So look, in a lot of respects, these things are a numbers game, right? There are a certain number of clinics that meet the model that Jonathan and his team have built. There's certain levels of profitability that can be expected from those.

是的，但我對此進行了盡職調查。所以看，在很多方面，這些事情都是數字遊戲，對吧？有一定數量的診所符合喬納森和他的團隊建立的模式。這些可以帶來一定程度的獲利能力。

So if you look at the clinics that they've already had discussions with in terms of LOIs and extrapolate the additional ones that can be added into the fold, it's not difficult to see, because they've already done and completed a good number of audits on those potential acquisitions. So it's just building a model from A plus B plus C plus D, and then the numbers kind of fall out of it. So while there's still a lot of work to be done, obviously, my results of my initial diligence were that the numbers are there and they can build on them. So I had a lot of confidence. Obviously, there's a lot of execution that needs to happen in that regard.

因此，如果你看看他們已經就意向書進行過討論的診所，並推斷出可以添加到其中的其他意向書，就不難看出，因為他們已經完成並完成了大量的工作。所以它只是根據 A 加 B 加 C 加 D 建立一個模型，然後數字就從模型中掉出來了。因此，雖然還有很多工作要做，但顯然，我最初的努力結果是，數字已經存在，並且可以在此基礎上繼續發展。所以我很有信心。顯然，在這方面需要進行大量的執行。

And secondly, on the larger one, now you start getting into factoring both NRX-100 and NRX-101 so you could start building the model by multiple sources there. And there, you just have to look at, what I did, look at the overall market opportunity. And when we talk about from the quotation from the CDC where, the United States of America, someone dies by their own hand once every 11 minutes and once every minute internationally, obviously, the demand is there.

其次，在更大的模型上，現在您開始考慮 NRX-100 和 NRX-101 的因素，這樣您就可以開始透過多個來源建立模型。在那裡，你只需要看看我做了什麼，看看整體市場機會。當我們引用 CDC 的話來談論時，美國每 11 分鐘就有一個人死於自己的手，國際上每分鐘就有一個人死於自己的手，顯然，需求是存在的。

So if we can truly prove this company can truly prove that it is a solution that provides better outcomes for patients, the market's there and then it's just about executing on it. So those are the things in my diligence that may be excited and very enthusiastic about joining the company. Does that answer your question?

因此，如果我們能夠真正證明這家公司能夠真正證明它是一種可以為患者提供更好結果的解決方案，那麼市場就在那裡，然後就是執行它。所以這些都是我勤奮中可能對加入公司感到興奮和非常熱衷的事情。這能回答你的問題嗎？

Yes, it does. And it sounds like you share the Jonathan's vision and what I see in the company, which is -- it's a fractured system with many different therapies, and nobody seems to be pulling it all together in one central place for patients, which is what has to be done to save lives. So I mean it's a noble cause. Thanks so much. Appreciate the update.

是的，確實如此。聽起來你同意喬納森的願景和我在公司看到的東西，那就是——這是一個支離破碎的系統，有許多不同的療法，似乎沒有人將所有這些都整合到一個中心位置為患者服務，這就是為拯救生命而採取的行動。所以我的意思是說這是一個崇高的事業。非常感謝。感謝更新。

Eddie Woo, Ascendiant Capital.

艾迪·吳（Eddie Woo），Ascendian Capital。

Yes. Congratulations on all the progress. In terms of the valuations for these precision psychiatry clinics, are there any issues in terms of finding enough of these clinics at a reasonable valuation? Or do the valuations really fluctuate wildly? And have you thought about possibly building as opposed to buying?

是的。祝賀所有的進展。就這些精準精神科診所的估值而言，以合理的估值找到足夠的此類診所是否存在任何問題？還是估值真的波動很大嗎？您是否考慮過建造而不是購買？

It's really a great question. And I think we're going into this knowing that there aren't nearly enough clinics that meet our model, the model that we've laid out in this call, to build a national network. So then our choices will be acquiring clinics that meet some piece of the model and enhancing their offering to where they're able to meet the whole model versus literally going and building out space and hiring caregivers, and building a clinic from the ground up.

這確實是一個很好的問題。我認為我們在進入這一領域時知道，沒有足夠的診所符合我們的模型，即我們在這次電話會議中提出的模型，無法建立全國網路。因此，我們的選擇將是收購滿足模型某些部分的診所，並增強他們的服務，使其能夠滿足整個模型，而不是直接建造空間和僱用護理人員，然後從頭開始建立診所。

And we know that capital is available for both of those, and we'll be opportunistic in terms of what we do. What you probably won't see us do is take over a mid-spa that's doing ketamine on Monday and vitamin drips on Tuesday and put our name on it.

我們知道這兩者都有資本，我們將在我們所做的事情上抓住機會。您可能不會看到我們做的是接管一家中型水療中心，週一提供氯胺酮，週二提供維生素點滴，並在上面寫上我們的名字。

Vernon Bernardino, HC Wainwright.

弗農·伯納迪諾，HC 溫賴特。

Congrats on the progress and the exciting changes in structure of the company to come. Just had a question as far as revenue recognition perhaps. You're pretty confident, Jonathan, about recognizing some form of revenue this quarter. Just wondering, that's contingent on all the things that are pointing to signing on the dotted line, right?

祝賀公司即將取得的進展和令人興奮的結構變化。只是有一個關於收入確認的問題。喬納森，您對本季確認某種形式的收入非常有信心。只是想知道，這取決於所有指向虛線上簽名的事情，對嗎？

And in that recognition and signing, is that something where the revenue generated from that day plus 1 is the revenue we'll be recognizing? Or will you also, as part of the acquisition, be recognizing the, let's say, historical for the beginning of this quarter when you have the structure in place?

在那個認可和簽字中，那天產生的收入加1就是我們要認可的收入嗎？或者，作為收購的一部分，當您建立適當的結構時，您是否也會認識到本季初的歷史？

Yes. That's really a Mike Abrams question, and it may even be one where he needs to come back to you in a note that we'll share with both you and the public. But what I said is that by the end of the year, we expect to have aggregated organizations that are generating revenue. I'm not an accountant, and I certainly am not an expert on U.S. GAAP as it relates to recognition of revenue for medical services.

是的。這確實是麥克艾布拉姆斯的一個問題，甚至可能是他需要在一份說明中回覆您的問題，我們將與您和公眾分享。但我所說的是，到今年年底，我們預計將擁有能夠產生收入的組織。我不是會計師，我當然也不是美國公認會計原則的專家，因為它涉及醫療服務收入的確認。

So if Mike's comfortable talking about our general approach to recognizing revenue, he's welcome to. But at the same time, he's now about to go into a series of conversations with our public auditors where we set some ground rules for how and when we're going to recognize revenue. So Mike, let me turn it over to you.

因此，如果麥克願意談論我們確認收入的一般方法，我們歡迎他。但同時，他現在即將與我們的公共審計師進行一系列對話，我們將就如何以及何時確認收入製定一些基本規則。麥克，讓我把它交給你。

Thank you, Jonathan. I don't have a lot to add besides that. I think you handled that very well, Jonathan. I mean revenue recognition, as everyone knows, is a very complicated subject, and that's gone through a lot of change with different ASC announcements, 606 notwithstanding, over the last couple of years. So that, I would much prefer to have had an opportunity to have detailed discussions with our auditors and work through it.

謝謝你，喬納森。除此之外我沒有太多要補充的。我認為你處理得很好，喬納森。我的意思是，眾所周知，收入確認是一個非常複雜的主題，並且在過去幾年中，隨著不同的 ASC 公告（儘管有 606），收入確認經歷了許多變化。因此，我更希望有機會與我們的審計師進行詳細討論並完成工作。

The one thing I can guarantee you is that this company, in concert with adherence to GAAP and working with our auditors, the revenue recognition policies will be defensible and compliant. But other than that, I really don't feel it's appropriate at this point to get into any more detail or specifics on the revenue recognition side.

我可以向您保證的一件事是，該公司在遵守公認會計原則並與我們的審計師合作的情況下，收入確認政策將是合理且合規的。但除此之外，我真的認為目前不適合深入了解收入確認方面的更多細節或細節。

Okay. As a follow-up to that, though, when you do perhaps give some kind of insight or maybe even some guidance, will you be providing some level of detail as far as how well are the level of business these entities actually realize?

好的。不過，作為後續行動，當您確實提供某種見解甚至一些指導時，您是否會提供一定程度的細節，說明這些實體實際實現的業務水平如何？

Yes. When we do discuss it publicly, the description and the disclosure will be complete and encompass all of the known facts at the time that we disclose it. But at that point -- we're not quite there yet.

是的。當我們公開討論時，描述和揭露將是完整的，並包含我們揭露時的所有已知事實。但在那一點上——我們還沒有完全做到這一點。

Okay. Congrats. Welcome aboard, Michael. Looking forward to working with you.

好的。恭喜。歡迎加入，麥可。期待與您合作。

Thanks, Jonathan.

謝謝，喬納森。

Thank you. There are no further questions at this time. I will now hand the call back to Mr. Matthew Duffy for any closing remarks.

謝謝。目前沒有其他問題。現在我將把電話轉回馬修·達菲先生以供結束發言。

Thank you, Ina, and thank you, everyone, for joining us this evening. We're extremely excited about the coming months and quarters and years, the 2 potential drug approvals and subsidiary targeting multiple profitable precision psychiatry clinics. This concludes the NRx Pharmaceuticals Third Quarter 2024 Results Conference call. Thank you for participating, and you may disconnect.

謝謝你，伊娜，也謝謝大家今晚加入我們。我們對未來幾個月、幾個季度和幾年感到非常興奮，這兩種潛在的藥物批准以及針對多個盈利的精準精神病學診所的子公司。NRx Pharmaceuticals 2024 年第三季業績電話會議到此結束。感謝您的參與，您可以斷開連線。