NRX Pharmaceuticals Inc (NRXP) 2025 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Q3 2025 earnings conference call. (Operator Instructions) This call is being recorded on Monday, November 17, 2025.

各位女士、先生，早安，歡迎參加 NRx Pharmaceuticals 2025 年第三季財報電話會議。（操作員指示）本次通話於2025年11月17日星期一進行錄音。

I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

現在我將把會議交給首席商務官馬修·達菲。請繼續。

Thank you, Joelle, 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.

謝謝喬爾，也歡迎各位。在正式開始電話會議之前，我想提醒大家，本次電話會議中某些陳述屬於美國聯邦證券法意義上的前瞻性陳述。這些聲明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所作陳述存在差異的因素的更多信息，請參閱我們向美國證券交易委員會提交的定期報告。

The forward-looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise forward-looking statements. Information presented on this call is contained in the press release issued this morning and in the company's Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals, Inc website.

本次電話會議中所作出的前瞻性陳述僅代表截至本次會議之日的信息，本公司不承擔更新或修改前瞻性陳述的義務。本次電話會議提供的資訊包含在今天早上發布的新聞稿和公司 10-Q 表格中，可從 NRx Pharmaceuticals, Inc. 網站的投資者頁面中存取。

Joining me on the call today are Dr. Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. We'll provide an overview of our company's progress as reported in today's 10-Q, following which Mike will get to review the company's financials and results. Following their prepared results, we'll address investor questions. Jonathan's having a couple of technical issues this morning, so I'll start us off.

今天與我一起參加電話會議的有我們的創始人、董事長兼首席執行官喬納森·賈維特博士，以及我們的首席財務官邁克爾·艾布拉姆斯。我們將概述公司在今天發布的 10-Q 報告中披露的進展情況，之後 Mike 將審查公司的財務狀況和業績。在公佈結果後，我們將回答投資者提出的問題。喬納森今天早上遇到了一些技術問題，所以我先來吧。

Since the beginning of the third quarter, NRx has made transformative progress in developing our business. We have advanced each of our programs with drug approvals applications in process for KETAFREE, NRX-100 and NRX-101. It also expanded our NRX-101 pipeline and closed on multiple acquisition targets for a network of interventional psychiatric clinics HOPE Therapeutics.

自第三季開始以來，NRx 在業務發展方面取得了變革性進展。我們已推動各項研發項目，KETAFREE、NRX-100 和 NRX-101 的藥物審批申請正在辦理中。它還擴大了我們的 NRX-101 產品線，並為 HOPE Therapeutics 介入性精神病診所網絡完成了多項收購目標。

In conjunction with closing our first clinics, we now -- are now generating revenue and on a path to a highly promising company. The point of our call today is not three weeks of revenue from a single clinic just a few hundred thousand dollars that hit our third quarter income statement.

隨著我們關閉了第一批診所，我們現在開始產生收入，並走上了成為一家極具發展前景的公司的道路。我們今天打電話的重點不是一家診所三週的收入，而只是出現在我們第三季損益表上的幾十萬美元。

Rather, it's the revolutionary and generational shift that we see in the treatment of severe depression and PTSD today, along with the potential to use the same technologies to treat traumatic brain injury, autism spectrum disorder, Parkinson's and even cognitive decline in coming years.

更確切地說，我們今天看到的是重度憂鬱症和創傷後壓力症候群治療領域的革命性、世代轉變，以及在未來幾年內利用相同技術治療創傷性腦損傷、自閉症譜系障礙、帕金森氏症甚至認知衰退的潛力。

This past quarter has been a watershed moment in that generational shift from our perspective. Lastly, a group of highly respected scientists presented real-world data showing an 87% treatment response and 72% remission from severe depression following a single day of treatment with a newly developed TMS for transcranial magnetic stimulation coil and a low dose of D-cycloserine or DCS.

從我們的角度來看，過去這個季度是這一世代轉變的分水嶺時刻。最後，一群備受尊敬的科學家展示了真實世界的數據，顯示使用新開發的經顱磁刺激線圈 TMS 和低劑量 D-環絲氨酸或 DCS 進行一天治療後，重度憂鬱症的治療反應率為 87%，緩解率為 72%。

Note that the active ingredient in NRX-101 is also DCS. This allocation comes on the heels of a well-controlled clinical trial in which DCS was shown to more than double the effect of conventional TMS in treating both depression and suicidality. Rather than rely on this call, we urge you to read the underlying science, referenced on our website on the Publications page.

請注意，NRX-101 的活性成分也是 DCS。這項撥款是在一項控制良好的臨床試驗之後進行的，該試驗表明，DCS 在治療憂鬱症和自殺傾向方面比傳統的 TMS 效果高出一倍以上。我們建議您不要依賴此呼籲，而是閱讀我們網站「出版物」頁面上引用的相關科學文獻。

As we announced last week, our company HOPE Therapeutics is the first one to deploy this 1D protocol in Florida in partnership with Ampa Health and we're actively partnering with its established clinics and seeking to open new clinics in Florida and nationwide. The scientists involved in that trial will be the first to say that there is not the only TMS machine capable of affecting a one-day Theta-burst protocol. However, no drug other than DCS so far has demonstrated the augmentation of TMS in the literature.

正如我們上週宣布的那樣，我們公司 HOPE Therapeutics 是第一家與 Ampa Health 合作在佛羅裡達州部署這項 1D 方案的公司，我們正在積極與 Ampa Health 已建立的診所合作，並尋求在佛羅裡達州和全國範圍內開設新的診所。參與試驗的科學家會先指出，並非只有一台 TMS 機器能夠影響一日 Theta 脈衝方案。然而，迄今為止，除 DCS 外，還沒有其他藥物在文獻中被證實能增強 TMS 的效果。

Accordingly, this quarter's results should be viewed as seeing the first green shoots come out of the ground, not as an indication of whether these shoots will ultimately be a push or a giant treat. We anticipate that our growing enterprise will be far easier to discern by our next conference call.

因此，本季的業績應該被視為初露端倪，而不是表明這些萌芽最終會取得突破還是會帶來巨大成功。我們預計，到下次電話會議時，我們不斷成長的企業將會更容易被大家所了解。

As you know, we have been working with DCS since our founding in 2015, and our Co-Founder, Dr. Daniel Javed, began research with this class of compounds in 1987. NRx holds rights to more than 70 patents around the world that relate to the use of DCS in treating depression, PTSD and other life-changing brain disorders.

如您所知，自 2015 年公司成立以來，我們一直與 DCS 合作，而我們的共同創辦人 Daniel Javed 博士早在 1987 年就開始研究這類化合物。NRx 在全球擁有 70 多項與使用 DCS 治療憂鬱症、PTSD 和其他改變生命的腦部疾病相關的專利權。

We have extensive experience in the formulation and stabilization of this highly challenging and unstable molecule. A breakthrough therapy designation IND opened with the FDA and manufactured drug in our warehouse that is actively being deployed in an expanded access protocol to enable doctors to replicate last week's dramatic 1D findings.

我們在配製和穩定這種極具挑戰性和不穩定性分子方面擁有豐富的經驗。我們已向 FDA 申請了突破性療法認定 (IND)，並在倉庫中生產了藥物，目前正在積極實施擴大使用方案，以使醫生能夠重現上周令人矚目的 1D 研究結果。

Although a raft of compounding pharmacies are offering DCS for sale in response to these dramatic scientific results, we will be releasing chromatography and other foundational science demonstrating the need for manufacturing controls that are essential for preventing rapid degradation of DCS and the formation of various impurities, controls, and techniques that we have devised over nearly 10 years of active preclinical and clinical development.

儘管許多配藥藥房響應這些重大的科學成果而開始銷售 DCS，但我們將發布色譜法和其他基礎科學，證明生產控制對於防止 DCS 快速降解和各種雜質的形成至關重要，以及我們在近 10 年積極的臨床前和臨床開發過程中設計的控制和技術。

The reason to be excited about combining DCS, which is a highly neuroplastic drug along with TMS, which is also a neuroplastic therapy, is not the simple notion that two neuroplastic treatments may be better than one as in, one plus one equals two. Rather, the scientific legacy of leaders in the field increasingly proves the drugs such as DCS, make the brain cells far more receptive to TMS and other neuroplastic therapies, akin to fertilize in the field as you plant the seeds.

將 DCS（一種具有高度神經可塑性的藥物）與 TMS（也是一種神經可塑性療法）結合起來令人興奮的原因，並非簡單的「兩種神經可塑性療法可能比一種更好，即一加一等於二」這種概念。相反，該領域領導者的科學遺產日益證明，像 DCS 這樣的藥物，使腦細胞更容易接受 TMS 和其他神經可塑性療法，就像在播種時給田地施肥一樣。

For those who are new to this conversation, neuroplasticity is the process by which brain cells are constantly growing new connections to other brain cells. In a digital computer, transitors are always turning on and off under the control of software but the circuits stay the same. In the brain, those transistors are neurons, polarized and depolarizes, the cellular equivalent turning on and off, but also constantly form new connections and prune those connections to other cells. That's called neuroplasticity.

對於不熟悉這個主題的人來說，神經可塑性是指腦細胞不斷與其他腦細胞建立新的連結的過程。在數位計算機中，電晶體在軟體的控制下不斷地開和關，但電路保持不變。在大腦中，這些電晶體就是神經元，它們會極化和去極化，相當於細胞的開和關，但它們也會不斷地形成新的連接，並修剪與其他細胞的連接。這叫做神經可塑性。

Over the past 20 years, we have come to understand that the loss of neuroplasticity in different parts of the brain is at the root of depression, PTSD, autism spectrum disorder and other conditions that I've mentioned.

在過去的 20 年裡，我們逐漸認識到，大腦不同部位神經可塑性的喪失是憂鬱症、創傷後壓力症候群、自閉症譜系障礙以及我提到的其他疾病的根源。

And Dr. Javitt's 45 year medical and scientific career, predominantly focused on the visual access of the brain the last time he was involved in technological change this profound was the introduction of the first anti-VEGF drug to treat macular degeneration that led to a whole generation of injectable eye drugs that forever changed the potential for people to preserve their site in the face of previously hopeless and blinding conditions.

賈維特博士的 45 年醫學和科學生涯主要集中在大腦的視覺路徑上。他上一次參與如此深刻的技術變革，是推出了第一種用於治療黃斑部病變的抗 VEGF 藥物，這催生了一整代注射式眼藥，永遠改變了人們在面對以前絕望的致盲疾病時保住視力的可能性。

In our view, we are witnessing a similar totonic split shift in the neuroplastic drugs, devices and digital therapeutics are being combined to transform the treatment of severe depression of PTSD today and the brain diseases that affect more than 1 billion people on the planet tomorrow.

我們認為，我們正在目睹神經可塑性藥物、設備和數位療法之間類似的根本性轉變，它們結合起來，不僅改變了當今治療嚴重憂鬱症和創傷後壓力症候群的方式，也改變了未來影響全球超過 10 億人的腦部疾病的治療方式。

If those publishing this science are correct, it is likely that oral antidepressant drugs with their life-threatening complications, their effects on disfiguring weight gain and sexual dysfunction, their propensity to cause suicidal ideation and their dismal 30% success rate may lose their places first-line treatment for those with life-threatening brain diseases.

如果發表這些科學研究的人是正確的，那麼口服抗憂鬱藥物可能會失去其作為治療危及生命的腦部疾病的一線療法的地位，因為這些藥物會帶來危及生命的併發症，導致毀容性體重增加和性功能障礙，容易引起自殺念頭，而且成功率僅為 30%。

More importantly, this generational shift in our understanding will finally cause us to abandon the notion of brain diseases that result in behavioral symptoms such as discretion and anxiety are biologically different for brain diseases that cause Parkinson's or cognitive dysfunction and that the patients who suffered these supposedly behavioral health problems are somehow less deserving of medical care than those who suffer from other neurological or CNS diseases.

更重要的是，這種代際認知的轉變最終將使我們放棄這樣一種觀念：導致行為症狀（如謹慎和焦慮）的腦部疾病與導致帕金森氏症或認知功能障礙的腦部疾病在生物學上有所不同，並且遭受這些所謂的行為健康問題的患者在某種程度上不如遭受其他神經系統或中樞神經系統疾病的患者更值得獲得醫療保健。

One reason we founded HOPE Therapeutics was to have the ability to directly engage the payer community in this changing paradigm. That brings us to corporate and financial results achieved in the past quarter and the objectives we think are meaningful over the coming quarters.

我們創立 HOPE Therapeutics 的原因之一，就是為了能夠直接與支付方群體參與到這種不斷變化的模式中。這就引出了我們在上個季度取得的公司和財務業績，以及我們認為在未來幾季中具有重要意義的目標。

Our quarterly report reflects only the first three weeks of revenue from our first two clinics. By year-end, we anticipate growing from two clinics to six or more clinics within our current orbit, and we expect these revenues to demonstrate strong growth over the coming quarters as we integrate the clinics, help grow them and add to their numbers.

我們的季度報告僅反映了我們前兩家診所前三週的收入。到年底，我們預計診所數量將從目前的兩家增加到六家或更多，並且隨著我們整合這些診所、幫助它們發展壯大並增加它們的數量，我們預計這些收入將在未來幾季呈現強勁增長。

Most importantly, the historic revenue is based on ketamine treatment sessions and traditional TMS treatment sessions that are generally reimbursed at less than $500 a session. Much of our future growth is likely to be focused on day and shorter short-term multi-modality treatments with rapid clinical results that are already reimbursed by payers at higher levels.

最重要的是，歷史收入是基於氯胺酮治療療程和傳統 TMS 療程療程，而這些療程通常每次報銷金額不到 500 美元。我們未來的成長很可能主要集中在日間和更短時間的多模式治療上，這些治療能夠快速產生臨床效果，並且已經獲得支付方較高水平的報銷。

To give you just one of many real-life illustrations of why this is economically viable, considering the situation of a highly trained essential first responder, who is suffering from depression in PTSD. In many cases, antidepressants are incompatible with a return to duty.

舉一個現實生活中的例子來說明為什麼這樣做在經濟上是可行的，那就是考慮一位訓練有素的重要急救人員患有創傷後壓力症候群（PTSD）的情況。在許多情況下，服用抗憂鬱藥物與重返工作崗位是不相容的。

For many frontline roles, this is a disqualification. Hence, the desire of the patient and the family for relief from a debilitating and life-threatening condition aligns with the urgent need of military, law enforcement, emergency services and other organizations to maintain their force readiness.

對於許多一線崗位來說，這構成了一項不合格條件。因此，患者及其家人希望擺脫這種令人衰弱且危及生命的疾病的願望，與軍隊、執法部門、緊急服務部門和其他組織保持其部隊戰備狀態的迫切需求是一致的。

The financial and other resources -- financial and other resource costs of replacing frontline personnel is astronomical. While medical insurance decisions are often made by the executives who many Americans view as not caring enough about the individual, health insurance payment policies are increasingly dictated by the employers who pay the premiums and who care deeply about their ability to maintain a workforce in whom they have invested.

更換第一線人員所需的財務和其他資源成本是天文數字。雖然醫療保險的決定通常由高階主管做出，而許多美國人認為高階主管對個人不夠關心，但健康保險支付政策卻越來越受到支付保費的雇主的影響，這些雇主非常關心他們能否留住他們投資培養的員工隊伍。

Often the decision makers at that level are the military leaders, police and fire commissioners and others who have come up through the ranks and we think about their people first. When Dr. Javitt presented last month at Fort Belvoir room containing generals, Admiral and elected officials, he sat with a senior adviser to the Secretary of the Veteran Affairs Administration who reminded of the public statements from the VA that stopping veteran suicide is in their -- is their top priority. We hope to release a video of that briefing to you in the coming weeks.

通常情況下，那個層級的決策者是軍事領導人、警察和消防專員以及其他從基層一步步晉升上來的人員，我們首先考慮的是他們的人民。上個月，賈維特博士在貝爾沃堡的一間房間裡向將軍、海軍上將和民選官員發表演講時，與退伍軍人事務部部長的一位高級顧問坐在一起。這位顧問提醒他，退伍軍人事務部曾公開表示，阻止退伍軍人自殺是他們的首要任務。我們希望在未來幾週內向您發布該簡報會的影片。

Our balance sheet is considerably stronger than it was at the end of the second quarter, owing in part to the support of long-term health care specialist investors who joined us during the third quarter and purchased common stock with no warrant overhang, no pricing provisions, and no convertible debt feature. At this point, NRx has secured operating capital that is anticipated to be sufficient to fund drug development operations through 2026.

我們的資產負債表比第二季末強勁得多，部分原因是長期醫療保健專業投資者在第三季加入我們，購買了沒有認股權證懸而未決、沒有定價條款、也沒有可轉換債券特徵的普通股。目前，NRx 已獲得營運資金，預計足以支持其藥物研發業務運作至 2026 年。

Additionally, as just noted, we expect to continue to add revenue from the clinical operations and believe it is likely that we will see revenue from sales of ketamine under an ANDA in mid-2026. As you can see from our balance sheet, and as Mike Abrams will be discussing in greater detail later, we are well positioned to achieve numerous milestones on both sides of our business with existing cash. Our goal in doing so is to substantially enhance shareholder value while advancing our mission of bringing HOPE to life.

此外，正如剛才所提到的，我們預計臨床營運收入將繼續增加，並且相信我們很可能在 2026 年年中透過 ANDA 獲得氯胺酮的銷售收入。從我們的資產負債表中可以看出，而且麥克·艾布拉姆斯稍後將更詳細地討論，我們現有的現金儲備足以在業務的各個方面實現許多里程碑。我們這樣做的目標是在大幅提升股東價值的同時，推動我們「將希望變成現實」的使命。

Now let's review each program, starting with our preservative-free ketamine, which was previously required a toxic preservative, which is benzethonium chloride to maintain stability and sterility. Our stability data remains on track for a three-year room temperature shelf life.

現在讓我們逐一回顧每個項目，首先是我們的無防腐劑氯胺酮，它以前需要一種有毒的防腐劑——苯扎氯銨——來保持穩定性和無菌性。我們的穩定性數據仍符合三年室溫保存期限的要求。

We're pursuing two parallel approval processes, a generic pathway and an innovative pathway using two different formulations to prevent price confusion. As you saw in August, the FDA ruled that those two formulations create two different drug identities.

我們正在推進兩個並行的審批流程，一條是通用途徑，另一條是創新途徑，使用兩種不同的配方以防止價格混淆。正如您在 8 月看到的那樣，FDA 裁定這兩種配方構成了兩種不同的藥物。

The first pathway is a new drug application or NDA for NRX-100 in suicidal ideation for patients with depression, including bipolar depression. The second is an abbreviated new drug application or ANDA to make KETAFREE available for ketamine's existing generic indications. NDA preparation is nearly complete, and we anticipate transmitting the entire submission in the coming weeks.

第一條途徑是針對患有憂鬱症（包括躁鬱症）的患者，申請 NRX-100 的新藥上市許可，以治療其自殺意念。第二份是簡略新藥申請（ANDA），旨在使 KETAFREE 可用於氯胺酮現有的通用適應症。NDA（保密協議）準備工作已接近完成，我們預計在未來幾週內提交全部文件。

The key development is that we are adding more than 60,000 patient encounters of real-world efficacy data, which demonstrates statistically significant advantages of intravenous ketamine over nasal S-ketamine. Combined with the data from US and European trials in more than 1,000 patient participants, we believe this to be a compelling case for efficacy.

關鍵進展是，我們增加了超過 60,000 例真實世界療效患者就診數據，這些數據表明靜脈注射氯胺酮比鼻腔 S-氯胺酮具有統計學上的顯著優勢。結合美國和歐洲 1000 多名患者參與的試驗數據，我們認為這是療效的有力證明。

This will be an important step forward for both the company and for patients suffering from suicidal depression. There's currently no medication approved for treating suicidal ideation and the SPERVATO label clearly states that it has not been shown to be effective for reducing suicidality.

這對公司和患有自殺傾向憂鬱症的患者來說都是向前邁出的重要一步。目前尚無核准用於治療自殺意念的藥物，而SPERVATO的說明書也明確指出，尚未證實其能有效降低自殺傾向。

The only current alternative is for patients with suicidal ideation is ECT or electroconvulsive therapy. As you know, the PCORI trial, which is posted on our website, demonstrated a 30% incidence of memory loss with ECT and none with IV ketamine.

目前唯一可行的替代方案是，對於有自殺傾向的患者，電痙攣療法（ECT）是可行的治療方法。如您所知，PCORI 試驗（已發佈在我們的網站上）表明，電痙攣療法導致 30% 的人出現記憶喪失，而靜脈注射氯胺酮則沒有出現記憶喪失。

And what we feel is a strong validation the FDA granted us an expand Fast Track Designation in August to now include all patients with suicidal ideation and depression, including bipolar depression. Suicidality is a massive problem in the US. The fact -- in fact, the CDC estimates that nearly 13 million Americans seriously consider suicide each year, and this leads to an American dying from suicide every 11 minutes.

我們認為，FDA 在 8 月授予我們擴大快速通道資格，將所有有自殺意念和憂鬱症（包括躁鬱症）的患者納入其中，是對我們強有力的肯定。自殺傾向是美國一個非常嚴重的問題。事實上，根據美國疾病管制與預防中心估計，每年有近 1,300 萬美國人認真考慮自殺，這導致每 11 分鐘就有一名美國人死於自殺。

Our leadership team was invited to Fort Belvoir last month where we presented to senior military and veterans affairs leaders and will repeat and be repeating the briefing at VA headquarters and Nellis Air Force space to the Air Force leadership. As Secretary Collins has said publicly stopping veterans suicide is his top priority.

上個月，我們的領導團隊受邀前往貝爾沃堡，向高級軍事和退伍軍人事務領導人做了報告。我們將在退伍軍人事務部總部和內利斯空軍基地向空軍領導層重複報告。正如柯林斯部長公開表示的那樣，阻止退伍軍人自殺是他的首要任務。

In June, the FDA created the commissioner's national priority voucher program that affords substantially faster review times of one to two months versus the standard 10- to 12-month review, enhanced communication throughout the review process and creates potential for accelerated approval of NRX-100.

6 月，FDA 推出了專員國家優先代金券計劃，該計劃可將審查時間大幅縮短至一到兩個月，而標準的審查時間為 10 到 12 個月，同時加強了整個審查過程中的溝通，並有可能加速批准 NRX-100。

Commissioner Macri has publicly stated the safe and effective drugs to prevent suicide are a top priority for him. More importantly, after some publicly reported personnel changes, the FDA centers for drugs now as a leader has been long-term proponent of accelerated approval for life-saving drugs that meet an unmet medical need.

馬克里專員曾公開表示，安全有效的自殺防治藥物是他的首要任務。更重要的是，在經歷了一些公開報道的人事變動後，作為行業領導者的美國食品藥品監督管理局（FDA）藥物中心長期以來一直倡導加快審批那些能夠滿足未被滿足的醫療需求的救命藥物。

To receive a CNPV, a product must meet at least one of the following criteria: address the US public health crisis, address a large unmet medical need, deliver more innovative cures for the American people, reshore key strategic drugs to the US or reduce health care costs. NRx meets all of these criteria.

要獲得 CNPV，產品必須滿足以下至少一項標準：解決美國公共衛生危機、滿足大量未滿足的醫療需求、為美國人民提供更多創新療法、將關鍵策略藥物帶回美國或降低醫療成本。NRx 符合所有這些標準。

In Q3, we filed an abbreviated new drug application for ketamine with priority review requested. We call this product KETAFREE. After meeting with the FDA in August of 2025, we've refiled the ANDA following FDA notification of the suitability position for NRx's proposed strength of KETAFREE. Last week, we received a communication from FDA, noting no significant deficiencies in the revised KETAFREE filing, and we believe the filing is on track for second quarter PDUFA date or generic -- that's a generic drug equivalent of a PDUFA date.

第三季度，我們提交了氯胺酮的簡略新藥申請，並要求優先審查。我們將這款產品命名為KETAFREE。在 2025 年 8 月與 FDA 會面後，我們根據 FDA 對 NRx 提出的 KETAFREE 強度的適用性情況的通知，重新提交了 ANDA。上週，我們收到了 FDA 的來信，指出修訂後的 KETAFREE 申報文件沒有重大缺陷，我們相信該文件預計將在第二季度獲得 PDUFA 日期或仿製藥上市日期——這是 PDUFA 日期的仿製藥等效日期。

The company has additionally submitted a citizen petition seeking to have benzothonian chloride, a toxic preservative included in all currently approved ketamine products for antiquated reasons, removed from all presentations of ketamine. This preservative is the subject of a detailed toxicology report we have published, which details the concerns that led FDA to ban BCT from topical antiseptics and hand cleansers.

該公司還提交了一份公民請願書，要求從所有氯胺酮產品中去除苯並噻吩氯化物（一種有毒防腐劑，由於過時的原因，目前所有已批准的氯胺酮產品中都包含這種防腐劑）。我們已發表了一份關於這種防腐劑的詳細毒理學報告，其中詳細說明了導致 FDA 禁止在局部消毒劑和洗手液中使用 BCT 的原因。

Notably, benzethonium chloride does not categorized by FDA as grass or generally recognized as safe. This report has been submitted to the FDA in support of our citizen petition. As a preservative-free formulation of ketamine is an important invention, we have filed a patent application with the US patent in the Tradmark office to protect our intellectual properties surrounding this product.

值得注意的是，苯扎氯銨並未被美國食品藥物管理局 (FDA) 歸類為草類，也未被普遍認為是安全的。本報告已提交給美國食品藥物管理局，以支持我們的公民請願。由於不含防腐劑的氯胺酮配方是一項重要的發明，我們已向美國商標局提交了專利申請，以保護我們圍繞該產品的智慧財產權。

The existing generic market for ketamine has been projected at approximately $750 million. And we believe KETAFREE made in the US and often without any toxic preservatives offers patients and clinicians a superior option. We'll continue to work diligently with the FDA to move our application forward as rapidly as possible and provide a safer version of this critical product to the American public.

氯胺酮現有仿製藥市場規模預計約為 7.5 億美元。我們相信，美國製造且通常不含任何有毒防腐劑的 KETAFREE 為患者和臨床醫生提供了更優越的選擇。我們將繼續與美國食品藥物管理局 (FDA) 密切合作，盡快推進我們的申請，並為美國大眾提供更安全的這項關鍵產品。

Our program around NRX-101, our oral combination of D-Cycloserine and lurasidone took an extremely positive and unanticipated direction as outlined in the opening. As you know, we received breakthrough therapy designation for this drug in the treatment of suicidal bipolar depression and continue to advance that agenda.

如同開頭所述，我們圍繞 NRX-101（D-環絲氨酸和魯拉西酮的口服組合）開展的計畫取得了非常積極且出乎意料的進展。如您所知，我們的這種藥物在治療有自殺傾向的雙相憂鬱症方面獲得了突破性療法認定，我們將繼續推進這一目標。

Our manufacturing data is on file with stability trending towards five years, and we have 1 million doses in the warehouse. There are more than 7 million patients suffering from bipolar depression in the US, and many of these are at risk of acathesia, a terrible side effect caused by serotonin active or SSRI drugs that is closely related to suicide. These patients are a tremendous risk of self harm.

我們的生產資料已存檔，穩定性趨勢持續近五年，倉庫中備有100萬劑。美國有超過700萬雙相憂鬱症患者，其中許多人面臨自殺風險，自殺風險是血清素活性藥物或選擇性血清素再攝取抑制劑（SSRI）引起的嚴重副作用，與自殺密切相關。這些患者有極大的自殘風險。

We have demonstrated statistically significant superiority of NRX-101 over lurasidone is current standard of care in reducing suicidality and akathisia in two well-controlled trials. Both NRX-101 and Lurasidone are potent antidepressants and one of those trials also demonstrated superiority in reducing depression.

我們在兩項控制良好的試驗中證實，NRX-101 在降低自殺傾向和靜坐不能方面，具有統計學意義上的顯著優勢，優於目前作為標準治療藥物的魯拉西酮。 NRX-101 和魯拉西酮都是強效抗憂鬱藥，其中一項試驗也證實了 NRX-101 在緩解憂鬱症狀方面也具有優勢。

Remember that we are comparing to a known effective drug, not placebo. Because of the huge unmet need, we are optimistic that FDA will be receptive to an application for accelerated approval in the 600,000 patients who suffer from suicidal ideation in bipolar depression, despite treatment with a currently approved medication.

請記住，我們是在與已知有效的藥物進行比較，而不是與安慰劑進行比較。由於存在巨大的未滿足需求，我們樂觀地認為，FDA 將接受加速批准申請，以治療儘管接受目前已批准的藥物治療但仍患有雙相抑鬱症並伴有自殺意念的 60 萬名患者。

A few days ago, a new Director of the FDA Center for Drugs was appointed who pioneered the accelerated approval pathway and has been a staunch advocate for early approval of medicines for life-threatening conditions for which there is no currently available therapy.

幾天前，美國食品藥物管理局（FDA）藥物中心任命了一位新主任，他開創了加速審批途徑，並且一直堅定倡導儘早批准用於治療目前尚無有效療法的危及生命的疾病的藥物。

Last week, we saw a publication of the exciting and unanticipated finding that low-dose D-Cycloserine, again, the active ingredient in NRX-101, when combined with a one-day protocol of TMS. Recently, there's been exceptional interest in the use of DCS, the active component to enhance the efficacy in the treatment of depression. D-Cycloserine, like ketamine, blocks the NMDA receptor and enhances neuroplasticity.

上週，我們看到了一項令人興奮且出乎意料的發現，即低劑量 D-環絲氨酸（NRX-101 的活性成分）與 TMS 一日方案相結合。最近，人們對使用 DCS（一種活性成分）來增強憂鬱症治療效果表現出了極大的興趣。D-環絲胺酸與氯胺酮一樣，可以阻斷NMDA受體並增強神經可塑性。

Recently published real-world data provides confirmatory evidence seen in a prior randomized controlled trial that low-dose DCS more than doubles the antidepressant effect and anti-suicidl effect of TMS. Unfortunately, DCS alone is contraindicated in patients with depression, which may impact willingness of patients and practitioners to use this new protocol.

最近發表的真實世界數據證實了先前隨機對照試驗中發現的證據，即低劑量 DCS 可使 TMS 的抗憂鬱效果和抗自殺效果提高一倍以上。遺憾的是，對於憂鬱症患者，單獨使用 DCS 是禁忌的，這可能會影響患者和醫生使用這種新方案的意願。

Importantly, NRX-101 while including DCS in its formulation, does not carry this contraindication. As the addition to lurasidone blocks the effect of the NMDA inhibition in one key side effect. This creates a significant need for development of NRX-101 for the use of -- in conjunction with TMS to treat depression, PTSD and other options and other disorders.

重要的是，NRX-101 雖然其配方中含有 DCS，但並不具有此禁忌症。由於添加魯拉西酮會阻斷 NMDA 抑製作用的關鍵副作用。這產生了開發 NRX-101 的重大需求，以便與 TMS 聯合使用，用於治療憂鬱症、PTSD 和其他疾病。

We have more than 25,000 manufacturing doses of NRX-101 at the appropriate strength on hand and have launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under expanded access and federal right to try laws. A confirmatory Phase 3 trial of NRX-101 to augment the effects of TMS is planned for early 2026. The market estimate for this newly validated indication for NRX-101 is in excess of $1 billion.

我們手頭上有超過 25,000 劑適量的 NRX-101 生產劑量，並已啟動一項全國性的擴大使用計劃，使醫生能夠根據擴大使用和聯邦嘗試權法律免費為患者提供這種藥物。計劃於 2026 年初進行 NRX-101 增強 TMS 療效的 3 期驗證性試驗。NRX-101 這項新驗證適應症的市場估值超過 10 億美元。

On September 8, 2025, HOPE Therapeutics initiated revenue generation upon closing of its acquisition of Dura Medical to clinics located in Naples and Fort Myers, Florida. HOPE subsequently added Cohen and associates in Sarasota, Florida, another revenue-generating EBITDA positive clinic to the HOPE network. Dr. Rebecca Cohen, Founder of Cohen and Associates, has been appointed as HOPE's Medical Director.

2025 年 9 月 8 日，HOPE Therapeutics 完成了對 Dura Medical 的收購，開始向位於佛羅裡達州那不勒斯和邁爾斯堡的診所提供收入。HOPE 隨後將位於佛羅裡達州薩拉索塔的 Cohen 及其同事納入其 HOPE 網絡，這是另一家盈利 EBITDA 為正的診所。Cohen and Associates 的創辦人 Rebecca Cohen 博士已被任命為 HOPE 的醫療總監。

Last week, HOPE was the first organization in Florida to launch one-day TMS treatment for severe depression and 1D protocol using the NMDA TMS device. The 1D protocol has been reported in the peer-reviewed reliterature to achieve 87% response and 72% remission from severe depression at six weeks.

上週，HOPE 成為佛羅裡達州第一個使用 NMDA TMS 設備開展一日 TMS 治療重度憂鬱症和 1D 方案的組織。經過同儕審查的文獻報告，1D 方案在六週內可使重度憂鬱症患者的緩解率達到 87%，有效率達到 72%。

Following a single day of TMS treatment combined with D-Cycloserine, focus in the process of adding three more facilities this year and is in an active discussion with numerous acquisition opportunities around the country.

經過一天的 TMS 治療和 D-環絲氨酸治療後，重點是今年再增加三個設施，並且正在積極與全國各地的眾多收購機會進行洽談。

With our significant advances in the third quarter and a committed investor base, we believe we are better positioned than ever in our history to build shareholder value and to address the national crisis of suicide. We will do everything in our power to continue bringing HOPE to life.

憑藉第三季度取得的重大進展和堅定的投資者基礎，我們相信，我們比以往任何時候都更有能力創造股東價值並應對全國自殺危機。我們將竭盡全力，繼續為生活帶來希望。

With that, I'll turn it over to Michael Abrams, our CFO, to review our financial results for the third quarter. Mike?

接下來，我將把發言權交給我們的財務長麥可·艾布拉姆斯，讓他來回顧我們第三季的財務表現。麥克風？

Thank you, Matt. For the three months ended September 30, 2025, the company reported a loss of operations of $4 million versus a loss from operations of $3 million for the comparable quarter in 2024, the difference is primarily attributable to $800,000 of additional research and development expenses to support our FDA initiatives for NRX-100 and NRX-101, including the previously discussed and submission for preservative-free IV ketamine. And $400,000 of additional general and administrative expense which included our efforts to close, operate and identify clinic acquisition targets for HOPE.

謝謝你，馬特。截至2025年9月30日的三個月，公司報告營運虧損400萬美元，而2024年同期營運虧損為300萬美元。虧損額的差異主要歸因於80萬美元的額外研發支出，用於支持我們針對NRX-100和NRX-101的FDA審批項目，包括之前討論過的無防腐劑靜脈注射氯胺酮的申請。此外，還增加了40萬美元的額外一般及行政費用，其中包括我們為HOPE計畫尋找、營運和收購目標診所的相關工作。

As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents. Including approximately $3.1 million from a subscription receivable for which the company received the cash in early October, total cash as of September 30, 2025, would have been $10.3 million. For the third quarter ended September 30, 2025, the company reported revenue for the first time in its history, driven by the acquisition of Dura Medical, which closed September 8.

截至2025年9月30日，NRx Pharmaceuticals公司擁有約710萬美元的現金及現金等價物。若計入10月初收到的約310萬美元應收訂閱款，則截至2025年9月30日，公司現金總額應為1,030萬美元。截至 2025 年 9 月 30 日的第三季度，該公司歷史上首次實現營收，主要得益於 9 月 8 日完成的對 Dura Medical 的收購。

While revenue of approximately $240,000 was relatively modest, it reflects 22 days of the full quarter in a single clinic group. Management anticipates the ability to include results for the full period for during and future quarters closing anticipated additional acquisitions and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a noncontrolling interest are expected to improve our overall financial position, but not directly increase revenue.

雖然約 24 萬美元的收入相對較少，但這反映的是一個診所集團完整季度的 22 天的收入。管理層預計，隨著預期中的額外收購和先前收購的診所的內生增長，第四季度及到 2026 年，將推動收入實現顯著增長，從而能夠將本季度及未來幾季度的業績納入考慮。我們收購少數股東權益的交易預計會改善我們的整體財務狀況，但不會直接增加收入。

Finally, we remain in active discussions with several additional potential acquisition candidates and while no assurances can be given that we will close any or all of such opportunities, together, they represent total revenue of more than $20 million on an annual basis.

最後，我們仍在與幾家潛在的收購對象積極洽談，雖然不能保證我們會完成其中任何或所有收購，但這些收購加起來每年的總收入將超過 2000 萬美元。

The company believes that its current cash position will support operations at least through the second quarter of 2026 as well as provide sufficient capital to expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of HOPE clinics. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders.

該公司認為，其目前的現金狀況至少可以支持營運到 2026 年第二季度，並為預期的監管轉折點提供充足的資金，並完成潛在的其他精選收購機會，以擴大 HOPE 診所不斷增長的業務範圍。我們始終專注於推進主要藥物研發計劃和計劃中的診所收購，以創造股東的長期價值。

With that --

就這樣--

Thank you, Mike, and thank you guys for sparing my voice this morning. I look forward to taking questions.

謝謝你，麥克，也謝謝大家今天早上讓我免受嗓子痛的折磨。我期待回答問題。

Operator, I believe we can begin to take questions.

接線員，我想我們可以開始接受提問了。

(Operator Instructions) Tom Shrader, BTIG.

（操作說明）湯姆·施拉德，BTIG。

Good morning. Thanks for all the details. I have a couple of questions on this remarkable DCS result with TMS. Historically, is it clear that DCS is much better than ketamine in this position? Is this truly unique to the drug? Or is it a general combination effect.

早安.謝謝你提供的所有細節。關於TMS治療DCS的顯著成果，我有幾個問題。從歷史經驗來看，在這種情況下，DCS 是否明顯優於氯胺酮？這是這種藥物獨有的現象嗎？或者這是一種普遍的綜合效應？

And then can you give us a sense of how you would use 101 in this procedure? I assume it's not a hard co-formulation that your 101 is simply available. But how cumbersome is it to add a drug, your DCS -- and can you get paid for it? Just some logistics. I know you have a lot of drug. It looks like it's exciting. Can you guys run us through the steps to actually use it?

那麼，您能否簡要說明一下，在這個過程中您將如何使用 101？我猜想，你的 101 號配方應該很容易就能買到。但是，添加一種藥物（例如您的 DCS）有多麻煩？而且您能因此獲得報酬嗎？一些後勤方面的問題。我知道你有很多毒品。看起來很刺激。你們能給我們詳細講解一下使用步驟嗎？

Those are great questions. And a lot of this work, the basic science work has been done and published by Dr. Josh Brown at Harvard McLean with a number of others supporting the science. The most important thing to recognize is that DCS has to be used at a non NMDA antagonist dose. And I know this is a little more science than we sometimes do on a conference call.

這些都是很好的問題。這項工作中的許多基礎科學研究都是由哈佛大學麥克萊恩分校的喬許布朗博士完成並發表的，還有許多其他人為這項科學研究提供了支持。最重要的是要認識到，DCS 必須以非 NMDA 拮抗劑劑量使用。我知道這比我們有時在電話會議上討論的內容更偏向科學一些。

But in this case, it's critical. DCS is what's called a mixed agonist antagonist, unlike ketamine, unlike [phecycloserine], unlike all of the NMDA drugs that blocks the NMDA channel, DCS affects a side unit of NMDA called the glycine site and at low doses, it's actually an NMDA agonist, but much more importantly, it's a highly neuroplastic drug.

但在這種情況下，這一點至關重要。DCS 是一種混合激動劑拮抗劑，與氯胺酮、苯環絲氨酸以及所有阻斷 NMDA 通道的 NMDA 藥物不同，DCS 影響 NMDA 的一個側單元，稱為甘氨酸位點，在低劑量下，它實際上是一種 NMDA 激動劑，但更重要的是，它是一種高度神經可塑性的藥物。

There's evidence that ketamine plus TMS actually decreases the effectiveness of TMS, there are even people who believe that ketamine shouldn't be used in conjunction with electroshock therapy because it may decrease the effectiveness of electroshock therapy.

有證據表明，氯胺酮加TMS實際上會降低TMS的療效，甚至有人認為氯胺酮不應該與電擊療法一起使用，因為它可能會降低電擊療法的療效。

So all of the work that's been done is at low doses of D-Cycloserine, 150, 175-milligram dose and it just happens that when we formulated NRX-101, that was one of the strengths that we made. That's why we have it in the warehouse.

所以，所有已完成的工作都是在低劑量的 D-環絲氨酸（150、175 毫克劑量）下進行的，而恰好，當我們配製 NRX-101 時，這是我們取得的優勢之一。所以我們才把它存放在倉庫裡。

In fact, it was not made to be the main strength of NRX-101, it was manufactured to be a potential step-down strength in our clinical trial. So far, nobody else has identified a different neuroplastic drug that works in combination with TMS, the way D-Cycloserine does.

事實上，它並非NRX-101的主要優勢成分，而是為了在我們的臨床試驗中作為一種潛在的降級強度成分而製造的。到目前為止，還沒有人發現其他任何一種神經可塑性藥物能夠像 D-環絲胺酸一樣與 TMS 合併使用。

Do me a favor and repeat the second part of your question where you were asking just.

請幫我個忙，把你問題的第二部分再說一遍，就是你剛剛問的那部分。

Just the procedure to use your drug because it's in the works at the FDA, what would be -- how hard is it to just for somebody to get your drug if they want to add it to TMS in your clinic or anywhere else?

鑑於您的藥物正在 FDA 審批中，如果有人想在您的診所或其他任何地方將您的藥物添加到 TMS 治療中，那麼獲得該藥物的流程會有多難？

Well, we have an expanded access protocol for DCS under the laws than required to be made available for expanded access. So if somebody writes to us, we're happy to provide it for this purpose as long as they provide us with the data of what happened. ClinicalTrials.gov has been a little backed up because of the government shutdown. But as ClinicalTrials.gov catches up, you'll see those expanded access protocols for DCS and TMS showing up online.

嗯，根據法律規定，我們有針對 DCS 的擴展存取協議，以滿足擴展存取的要求。所以，如果有人寫信給我們，只要他們提供事件發生的數據，我們就很樂意為此目的提供服務。由於政府停擺，ClinicalTrials.gov 網站訪問量有所下降。但隨著 ClinicalTrials.gov 的更新，您將會在網路上看到 DCS 和 TMS 的這些擴展存取協定。

Okay, great, thanks for the details.

好的，太好了，謝謝你提供的詳細資訊。

Patrick Trucchio, HC Wainwright.

Patrick Trucchio，HC Wainwright。

NRX-100 and suicidal depression, the FDA has identified no significant deficiencies to date. I'm wondering, first, what feedback have you received on the accelerated approval strategy. Secondly, do you still anticipate a year-end PDUFA decision? And separately, when do you anticipate learning if the CNPV is granted and what impact that could have on the PDUFA?

關於 NRX-100 與自殺性憂鬱症的關係，FDA 迄今尚未發現任何重大缺陷。首先，我想知道你們收到了哪些關於加速審批策略的回饋意見。其次，您是否仍預期年底會推出 PDUFA 決定？另外，您預計何時得知 CNPV 是否獲得批准，以及這會對 PDUFA 產生什麼影響？

Well, as we've said, we're in the CNPV process, and therefore, the NDA under Fast Track Designation for NRX-101 has not been filed in its totality yet. We've said that several times, we're expecting to be heard about the CNPV this year.

正如我們所說，我們目前處於 CNPV 流程中，因此，NRX-101 的快速通道指定 NDA 尚未完全提交。我們已經多次說過，我們預計今年會聽到有關 CNPV 的消息。

And the main advances with that NDA are that we now have access to the real-world data that we believe massively augment the filing that we will make under accelerated approval once we learn whether we're doing it under CNPV or not, where we're expecting not only to file the original clinical trials that we've told people about, but more than 60,000 patients worth of real-world data as well that we believe provide a solid case for accelerated approval.

這項新藥申請的主要進展在於，我們現在可以獲得真實世界數據，我們相信這些數據將大大增強我們根據加速審批程序提交的申請。一旦我們確定是否要根據 CNPV 進行申請，我們不僅希望提交我們已經向人們透露的原始臨床試驗數據，還希望提交超過 60,000 名患者的真實世界數據，我們相信這些數據將為加速審批提供充分的理由。

Right. And with the Citizen Petition now filed to remove benzethonium chloride, can you discuss how this regulatory action could reshape the market for IV ketamine and how you would ensure adequate domestic supply if the FDA moves to ban this preservative-containing formulations?

正確的。鑑於目前已提交公民請願書要求移除苯扎氯銨，您能否討論一下這一監管行動將如何重塑靜脈注射氯胺酮市場，以及如果 FDA 採取行動禁止這種含有防腐劑的製劑，您將如何確保國內供應充足？

Yeah. This is actually the first ketamine that's packaged in what's called a Blow-Fill-Seal presentation where instead of a glass bottle. The machinery takes a drop of polyester resin heats it up, blows it into a container, fills it and puts it out at the back of the assembly line completely packaged and ready to ship.

是的。這其實是第一款採用吹塑-灌裝-密封包裝的氯胺酮，而不是玻璃瓶包裝。該機器取一滴聚酯樹脂，將其加熱，吹入容器中，灌滿後，將其從裝配線的末端取出，包裝完畢，即可發貨。

It takes your production capacity from a couple of hundred thousand bottles a month to 1 million or more bottles a month per assembly line, and therefore, if we had to, we could supply every vial that's required for ketamine in the United States at that kind of manufacturing capacity. Everything else that's coming in for ketamine is glass vials.

這樣一來，每條裝配線的月產量就從幾十萬瓶增加到一百萬瓶甚至更多，因此，如果需要的話，以這樣的生產能力，我們可以供應美國所需的所有氯胺酮藥瓶。其他所有運進來的氯胺酮都是玻璃瓶裝的。

Right. And just one maybe on HOPE. The ONE-D protocol combines TMS and DCS and it shows a rapid onset of antidepression effects. I'm just wondering how you'll be positioning HOPE to become an early adopter in data generator for that combined treatment pathways?

正確的。或許只有希望這一個。ONE-D 方案結合了 TMS 和 DCS，並顯示出快速起效的抗憂鬱效果。我只是想知道，您將如何定位 HOPE 項目，使其成為聯合治療路徑資料產生器的早期採用者？

And as well just separately, assuming the approval of NRX-100 and NRX-101, how will you integrate those treatments into the HOPE care model once they're approved, assuming they are approved?

另外，假設 NRX-100 和 NRX-101 獲得批准，一旦它們獲得批准，您將如何將這些療法整合到 HOPE 護理模式中？

Well, those are two fantastic questions. And the ONE-D protocol is legal under the medical device laws. The coil that was used was manufactured by a company called Ampa, which has some very exciting technology not only in terms of their pioneering of the ONE-D protocol, but in terms of having built the first portable TMS one that can be taken to nursing homes, extended living facilities, you could even do it in a firehouse because it fits in two Pelican cases.

這兩個問題都非常好。ONE-D 協議符合醫療器材法律的規定。所使用的線圈是由一家名為 Ampa 的公司製造的，該公司擁有一些非常令人興奮的技術，不僅體現在他們開創了 ONE-D 協議方面，還體現在他們製造了第一台便攜式 TMS，可以帶到養老院、長期居住設施，甚至可以在消防站使用，因為它能裝進兩個 Pelican 箱子裡。

We announced last week that we partnered with Ampa that we are the first site in Florida to be doing the ONE-D protocol, so it's readily deployable. Now it's not specific only to that machine, but all of the ONE-D results so far that have been reported on that machine.

我們上週宣布與 Ampa 合作，成為佛羅裡達州第一個採用 ONE-D 協議的站點，因此該協議可以隨時部署。現在，這不僅限於那台機器，而是迄今為止所有已報告的在該機器上運行的 ONE-D 結果都存在這個問題。

Great. Thanks so much.

偉大的。非常感謝。

(Operator Instructions) Ed Woo, Ascendiant Capital.

（操作說明）Ed Woo，Ascendiant Capital。

Yeah. Congratulations on all the progress. As NRX-100 and 101 have potential approval dates relative within the next year, hopefully, or much sooner than that? Have we talked about your clinical or commercialization strategy for both?

是的。祝賀你們取得的所有進展。NRX-100 和 101 的潛在批准日期都在未來一年內，希望如此，甚至可能更早？我們討論過你們針對這兩種情況的臨床或商業化策略嗎？

Ed I'd like to listen to that question again.

艾德，我想再聽一次這個問題。

Sure. Have you talked about your commercial strategy? Will you need to have a sales force to market NRX-100 and 101 when you get approval?

當然。你們談過商業策略嗎？獲得批准後，您是否需要組建銷售團隊來推廣 NRX-100 和 101？

Well, they're very different drugs and they will need different strategies. So NRX-100, we're talking about a drug that can only be deployed in a clinic setting by a physician who and we anticipate that there will be a REMS of some sort in the same way that there's a REMS for SPRAVATO.

嗯，它們是非常不同的藥物，需要不同的治療策略。所以，NRX-100 是一種只能由醫生在診所環境中使用的藥物，我們預期它會像 SPRAVATO 一樣，制定某種 REMS（風險評估和緩解策略）。

So the NRX-101, 100 project, the preservative-free ketamine project is very much something that a company of our size can undertake. You talking about much more of what's called a medical science liaison function than a sales function because physicians who are treating with ketamine in their office, know that they want to do that and what they need is medical liaison support. It's not traditional pharmaceutical detailing.

所以，NRX-101、100 項目，也就是不含防腐劑的氯胺酮項目，完全是我們這種規模的公司所能承擔的事情。你說的比較像是醫學聯絡職能，而不是銷售職能，因為在診間使用氯胺酮進行治療的醫師知道他們想這樣做，而他們需要的是醫學聯絡支援。這不是傳統的藥品推廣方式。

NRX-101 we're seeking an indication where we want to treat people with severe bipolar depression who have suicidal ideation despite having been treated with best available therapy. So if you take a look at the people who are currently prescribing drugs like lurasidone to treat bipolar depression, there are approximately 1,600 doctors like that in the United States.

NRX-101 我們正在尋求一種適應症，即治療儘管接受了最佳可用療法但仍有自殺意念的重度雙相抑鬱症患者。所以，如果你看看目前開立魯拉西酮等藥物治療雙相憂鬱症的醫生，你會發現美國大約有 1600 名這樣的醫生。

Many physicians don't want to be treating suicidal bipolar patients. So that's actually a sales force also that a company like ours could build, we anticipate it's a requirement of about 50 salespeople. We've talked to larger commercial partners in the past about NRX-101, and it's possible that we would partner with a larger commercial partner. But bottom line, NRX-100 is within our launch capabilities. NRX-101 is still within our launch capabilities, but we know that there is significant interest from larger partners.

許多醫生都不願意治療有自殺傾向的雙極性情感障礙患者。所以，像我們這樣的公司實際上也可以組建一支這樣的銷售團隊，我們預計大約需要 50 名銷售人員。我們過去曾與一些大型商業夥伴討論過 NRX-101，我們有可能與一家大型商業夥伴合作。但歸根究底，NRX-100 在我們的發射能力範圍內。NRX-101 仍在我們的發射能力範圍內，但我們知道一些大型合作夥伴對此表現出了濃厚的興趣。

Great. Thank you for that answer, and I wish you guys good luck. Thank you.

偉大的。謝謝你的解答，祝你們好運。謝謝。

There are no further questions at this time. I will now turn the call over to Matthew Duffy for closing remarks.

目前沒有其他問題了。現在我將把電話交給馬修·達菲，請他作總結發言。

Thank you, everyone, for joining us this morning. We're extremely excited about the path ahead with three potential drug approvals in the subsidiary targeting multiple profitable metal health clinics as well as our new indication with NRX-101. This concludes the NRx Pharmaceuticals third quarter 2025 results conference call. Thank you all for participating.

謝謝大家今天早上收看我們的節目。我們對未來的發展道路感到非常興奮，子公司有三款潛在的藥物獲得批准，目標客戶是多家盈利的心理健康診所，此外，我們的新適應症 NRX-101 也即將獲批。NRx Pharmaceuticals 2025 年第三季業績電話會議到此結束。感謝大家的參與。

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。感謝您的參與，請您斷開線路。