NRX Pharmaceuticals Inc (NRXP) 2025 Q2 法說會逐字稿

Good morning, ladies and gentlemen. Welcome to NRx Pharmaceuticals Q2 2025 earnings conference call. (Operator Instructions) This call is being recorded on Wednesday, August 20, 2025.

女士們、先生們，早安。歡迎參加 NRx Pharmaceuticals 2025 年第二季財報電話會議。（操作員指示）此通話於 2025 年 8 月 20 日星期三錄製。

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

現在我想將會議交給首席商務官馬修·達菲 (Matthew Duffy)。先生，請繼續。

Thank you, Ludy. 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 vary from statements made on this call is contained in our periodic reports filed with the SEC.

謝謝你，Ludy。歡迎大家。在我們繼續電話會議之前，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聲明屬於前瞻性聲明。這些聲明受風險和不確定性的影響，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陳述不同的因素的更多信息，包含在我們向美國證券交易委員會提交的定期報告中。

The forward-looking statements made during this call speak only as of the date here of, 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 Monday and in the company's Form 10-Q, which may be accessed from the investors page of the NRx Pharmaceuticals Inc. website.

本次電話會議中所做的前瞻性陳述僅代表截至本電話會議之日的觀點，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周一發布的新聞稿和公司的 10-Q 表中，可從 NRx Pharmaceuticals Inc. 網站的投資者頁面中存取。

Joining me today on the call are Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in Monday's 10-Q following which Mike will review the company's financial results. Following their prepared remarks, we will address investor questions.

今天參加電話會議的還有我們的創辦人、董事長兼執行長喬納森·賈維特 (Jonathan Javitt) 和財務長邁克爾·艾布拉姆斯 (Michael Abrams)。Javitt 博士將概述我們公司在周一 10-Q 報告中的進展情況，隨後 Mike 將回顧公司的財務表現。在他們發表準備好的發言之後，我們將回答投資人的問題。

I'll now turn it over to call to Jonathan. Jonathan?

我現在把它交給喬納森。喬納森？

Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exception for NRx. We've made vital advances across each of our programs with three drug approval applications in progress and our evolving network of interventional psychiatry clinics Hope Therapeutics taking place.

謝謝你，馬特。大家早安，感謝大家的收看。過去幾個月對 NRx 來說簡直就是例外。我們的每個計畫都取得了重要進展，其中三個藥物批准申請正在進行中，我們的介入精神科診所 Hope Therapeutics 網路也在不斷發展。

At the same time, as we position for near-term revenue, we've reduced our quarterly operating loss by approximately 50% year-over-year while filing more than 80,000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists.

同時，在我們為近期收入做好準備的同時，我們將季度營運虧損同比減少了約 50%，同時僅在上個季度，一支由專業科學家組成的小型團隊就提交了超過 80,000 頁的監管數據。

As we announced on Monday, we've strengthened our balance sheet and added long-term health care specialist investors with extensive experience in biotechnology as well as experience in managing multi-unit retail operations led by [Mr. Brandon Mall] and the B Group. These investors have demonstrated their long-term commitment to our success by way of their 1-year lockup agreement not to trade short or otherwise hypothecate our stock while also forgoing warrants and other dilutive features that are so obstructive to biotechnology stocks today.

正如我們週一宣布的那樣，我們加強了資產負債表，並增加了長期醫療保健專業投資者，他們在生物技術領域擁有豐富的經驗，並且在管理由 [Brandon Mall 先生] 和 B 集團領導的多單位零售業務方面擁有豐富的經驗。這些投資者透過一年鎖定協議表明了對我們成功的長期承諾，即不做空或以其他方式抵押我們的股票，同時放棄認股權證和其他目前對生物技術股票造成巨大阻礙的稀釋性特徵。

We at NRx look forward to their ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO in order to create a more straightforward growth path for long-term appreciation oriented investors.

NRx 期待他們繼續合作。從我們的資產負債表中可以看出，我們大幅減少了我重新擔任執行長時的可轉換債務負擔，以便為長期升值型投資者創造更直接的成長道路。

Let me start with a high-level overview for each program, starting with NRX-100. Our preservative-free intravenous ketamine is following two parallel approval processes. First, however, let me take a moment to explain how this came about. As many of you know, my original medical discipline is ophthalmology. And for 10-years, I cared for patients with chronic glaucoma first at Johns Hopkins and then at Georgetown Universities.

讓我先從每個程式的高層概述開始，從 NRX-100 開始。我們的無防腐劑靜脈注射氯胺酮正在遵循兩個平行的批准程序。不過，首先請容許我花點時間來解釋一下這是如何發生的。大家可能都知道，我原本的醫學專業是眼科。十年來，我先在約翰霍普金斯大學，然後在喬治城大學照顧患有慢性青光眼的病人。

Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients. The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. And the problem was compounded by the presence of benzalkonium chloride in the artificial tear drops that were used to try to help the dry eye that was caused by the glaucoma drops in the first place.

1995年左右，我的一位同事發現青光眼患者比大多數其他眼科患者更容易有乾眼症和淚膜缺陷。問題被追溯到苯扎氯銨，這是大多數青光眼藥物中都含有的一種防腐劑。而問題則因人工淚液中含有苯扎氯銨而變得更加嚴重，而人工淚液原本是用來治療由青光眼眼藥水引起的乾眼症的。

Clear evidence emerged that benzalkonium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea. That's why so many eye drops have gone preservative free over the years. Well, the first cousins of benzalkonium chloride, benzethonium chloride or BZT, is found in ketamine.

有明確的證據顯示苯扎氯銨對覆蓋眼睛的上皮細胞和角膜神經有毒性。這就是為什麼多年來許多眼藥水都不含防腐劑的原因。那麼，苯扎氯銨的近親，芐索氯銨或 BZT，存在於氯胺酮中。

BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70-years ago. So the same vial of drugs could be used for multiple doses of drug without contaminating the bottle. In today's hospital environment, multi-dose administration is increasingly infrequent. The BZT and ketamine may not pose much risk when Ketamine is used once in the operating room for anesthesia. The problem is patients who get ketamine for depression often get repeated administrations.

BZT 對上皮表面具有類似的毒性。70 年前首次配製氯胺酮時就已將其添加到其中。因此，同一瓶藥物可用於多劑量藥物而不會污染瓶子。在現今的醫院環境中，多劑量給藥的情況越來越少。當氯胺酮在手術室用於麻醉時，BZT 和氯胺酮可能不會帶來太大風險。問題在於，使用氯胺酮治療憂鬱症的患者經常需要重複服用。

As we have shown the FDA in our citizens petition, and as you can see from the scientific paper identified in the Q in the earnings release, multiple doses of ketamine with BZT preservative can approach toxic doses of BZT that's why we filed the citizens petition with FDA to have BZT removed from all forms of ketamine.

正如我們在公民請願書中向 FDA 展示的那樣，並且正如您在收益發布中 Q 中確定的科學論文中所看到的，多劑量的氯胺酮與 BZT 防腐劑可以接近 BZT 的毒性劑量，這就是為什麼我們向 FDA 提交了公民請願書，要求從所有形式的氯胺酮中去除 BZT。

Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe, is not on the list of preservatives generally recognized a safe, that's called the GRAS list by the FDA. Indeed, FDA's concern about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly.

我們提出此請願書的依據是專家毒理學分析，該分析證明 BZT 從未被證明是安全的，也不在通常認為安全的防腐劑名單上，即 FDA 所稱的 GRAS 名單。事實上，FDA 對 BZT 的擔憂非常高，以至於 FDA 不再允許用於洗手液和外用消毒劑。因此，我們認為 BZT 不適合作為重複給藥的腸外用藥。

As I said, we're following two regulatory paths for ketamine. The first 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 preservative-free ketamine available for ketamine's existing indications.

正如我所說，我們對氯胺酮採取了兩種監管​​路徑。第一個是針對憂鬱症（包括躁鬱症）患者自殺意念的 NRX-100 的新藥申請或 NDA。第二個是簡化新藥申請（ANDA），以使不含防腐劑的氯胺酮可用於氯胺酮現有的適應症。

Data are clear in our view that NRX-100 can offer effective and safe options for patients with suicidal depression whose only current treatment alternative is ECT or electroconvulsive therapy. Our corporate presentations highlight randomized controlled trials, demonstrating superiority of ketamine to placebo to active comparator along with demonstration of equivalents to ECT overall in more than 1,000 patients.

我們認為，數據清楚地表明，NRX-100 可以為有自殺傾向的憂鬱症患者提供有效且安全的選擇，目前這些患者的治療選擇只有 ECT 或電痙攣療法。我們的公司介紹重點介紹了隨機對照試驗，證明了氯胺酮相對於安慰劑和活性對照劑的優越性，並證明了其在 1,000 多名患者中與 ECT 的總體等效性。

We'll be presenting real-world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and SPRAVATO. We aim to submit these data in support of an application for accelerated approval and have already filed the module three manufacturing information and the draft proposed label.

我們將向 FDA 提供近 18 萬名接受氯胺酮和 SPRAVATO 治療的患者的真實世界數據供 FDA 審議。我們旨在提交這些數據以支持加速批准申請，並且已經提交了模組三製造資訊和擬議標籤草案。

You can read about accelerated approval on the FDA website. It represents an approval pathway for Fast Track and breakthrough drugs, whereby intermediate clinical data are presented in support of an initial approval with a concomitant commitment by the sponsor to present this positive clinical proof of efficacy within 5-years.

您可以在 FDA 網站上閱讀有關加速批准的資訊。它代表了快速通道和突破性藥物的審批途徑，透過該途徑，提交中期臨床數據以支持初步批准，同時由申辦方承諾在 5 年內提供積極的臨床療效證明。

Last week, FDA granted a major expansion of the Fast Track designation originally granted to NRX-100 in 2017 whereas the initial designation was related to bipolar depression. FDA has now broadened our Fast Track designation to encompass all patients with suicidal ideation in depression, including bipolar depression.

上週，FDA 批准了快速通道頭銜的重大擴展，該頭銜最初於 2017 年授予 NRX-100，而最初的頭銜與雙相憂鬱症有關。FDA 現已擴大我們的快速通道指定範圍，涵蓋所有有自殺意念的憂鬱症患者，包括雙極性憂鬱症患者。

The CDC estimates that 13 million Americans consider suicide each year and that an American dies from suicide every 11 minutes. Hence, FDA's broadened Fast Track designation offers NRx a tenfold greater opportunity to make a real difference in one of the largest public health crisis to face our nation.

美國疾病管制與預防中心估計，每年有 1,300 萬美國人考慮自殺，每 11 分鐘就有一名美國人死於自殺。因此，FDA 擴大的快速通道資格為 NRx 提供了十倍的機會，讓我們能夠在我國面臨的最大公共衛生危機之一中發揮真正的作用。

FDA under its new leadership and the MAHA program has dramatically focused on national public health crisis by creating the Commissioner's National Priority Voucher program that affords substantially faster review times of 1- to 2-months versus the standard 10- to 12-month review, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRX-100.

在新的領導下，FDA 和 MAHA 計劃重點關注國家公共衛生危機，制定了「專員國家優先憑證」計劃，將審查時間大幅縮短至 1 至 2 個月，而標準的審查時間為 10 至 12 個月，在整個審查過程中提供了加強溝通的能力，並為加速 NRX-100 的審批創造了潛力。

To receive a CNPV a product must meet at least one of the following criteria must address the US public health crisis and must deliver more innovative cures for the American people and must address a large unmet medical need, and this was noted in our Fast Track designation that we do, in fact, address a large unmet medical need and must onshore drug development and manufacturing to advance the health interest of Americans, strength in the US supply chain or increase affordability.

要獲得 CNPV，產品必須滿足以下標準中的至少一項：必須解決美國公共衛生危機；必須為美國人民提供更具創新性的治療方法；必須滿足大量未滿足的醫療需求，而這在我們的快速通道稱號中有所指出，我們確實解決了大量未滿足的醫療需求，並且必須在國內進行藥物開發和製造，以促進美國人的健康利益、增強美國鏈可提高可提高性。

Our team believes that NRX-100 meets all of CNPV's criteria. On the second approval path, we filed the ANDA in June of this year, utilizing existing manufacturing data found in module three of our suicidal depression NDA. We've since received comments from the FDA identifying only one scientific discrepancy, along with some easily remediated administrative deficiencies, specifically, FDA asked us to justify the level of a single inert ingredient in the formulation.

我們的團隊相信 NRX-100 符合 CNPV 的所有標準。在第二條審批路徑上，我們於今年 6 月提交了 ANDA，利用了自殺性憂鬱症 NDA 第三模組中的現有製造數據。此後，我們收到了 FDA 的評論，僅指出了一個科學差異，以及一些容易補救的行政缺陷，具體來說，FDA 要求我們證明配方中單一惰性成分的含量是合理的。

We're actively addressing this matter with FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year, and we believe NRX-100 made in the United States and offered without any toxic preservatives offers patients and clinicians a superior option.

我們正在積極與 FDA 討論此事，並且不認為這會導致審批流程過度延遲。目前，氯胺酮的市場規模預計約為每年 7.5 億美元，我們相信，在美國生產且不含任何有毒防腐劑的 NRX-100 為患者和臨床醫生提供了更好的選擇。

Approval of the citizens petition removing benzethonium chloride from the US ketamine supply would give NRx a substantial position in that existing $750 million generic ketamine market. We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public.

如果公民請願批准將芐索氯銨從美國氯胺酮供應中剔除，NRx 將在現有的 7.5 億美元仿製氯胺酮市場中佔據重要地位。我們將繼續與 FDA 密切合作，盡快推進我們的申請，並向美國公眾提供此關鍵產品的更安全版本。

NRX-101, our oral product for the treatment of suicidal bipolar depression recently achieved an important milestone that is the filing of the initial module known as module-3, the chemistry, manufacturing and control section or CMC with the US FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to NRX-101. And therefore, we anticipate rolling review of this application. We're working diligently to complete this filing and will request priority review, which, if granted, would confer a 6- month review period.

我們用於治療自殺性雙相憂鬱症的口服產品 NRX-101 最近取得了一個重要的里程碑，即上周向美國 FDA 提交了初始模組（稱為模組 3），即化學、製造和控制部分或 CMC。這是根據先前授予 NRX-101 的突破性療法認定提交的。因此，我們預計對該申請進行滾動審查。我們正在努力完成此申請，並將申請優先審查，如果獲得批准，將授予 6 個月的審查期。

There are more than 7 million patients suffering from bipolar depression in the US and many of these are at risk of akathisia, a terrible side effect related to serotonin active drugs that is closely related to suicide and can cause an irresistible need to move inability to sit still and all too often is associated with patients jumping off of roofs, jumping in front of trains and otherwise harming themselves in horrible ways.

美國有超過 700 萬雙相憂鬱症患者，其中許多人面臨靜坐不能的風險，這是與血清素活性藥物相關的一種可怕副作用，與自殺密切相關，會導致無法抗拒地想要活動，無法靜坐，而且常常與患者從屋頂跳下、跳到火車前以及其他可怕的自我傷害方式有關。

These patients are a tremendous risk of self-harm, and there are no current treatment options available that have been shown to reduce akathisia although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors. NRX-101 in our estimate offers the only current treatment option that both reduces depression, suicidality and akathisia in this patient group and as an oral treatment should generate widespread accessibility and benefit in these patients.

這些患者俱有極大的自我傷害風險，目前尚無可用的治療方案可以減少靜坐不能，儘管新一代非典型抗精神病藥物已比其前代藥物顯示出更少的靜坐不能症狀。我們估計，NRX-101 是目前唯一的治療選擇，既可以減少該患者群體的憂鬱、自殺傾向和靜坐不能，又可以作為一種口服治療方法，為這些患者帶來廣泛的可及性和益處。

We look forward to coming interactions with the FDA on this application. Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network. We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago, but needed to wait for a state regulatory approval to acquire Dura Medical that approval is now in hand as we announced last week.

我們期待與 FDA 就此申請進行互動。Hope Therapeutics 在開發我們相信將成為全國首屈一指的介入精神病學診所網絡方面繼續取得巨大進展。我們希望完成第一家診所的購買，並繼續評估該領域的新機會。幾個月前我們就計劃實現這一目標，但需要等待國家監管部門批准收購 Dura Medical，正如我們上周宣布的那樣，該批准現已到位。

With that milestone reached, we anticipate that you will shortly see closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive, high-quality care possible in each of our clinics continues to drive us, and we look forward to continuing to update you on the progress of our network. The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network.

隨著這一里程碑的達成，我們預計您很快就會看到收購融資的完成，而該過程目前進展順利。我們的目標是在每家診所提供盡可能最全面、最高品質的護理，這一目標始終激勵著我們，我們期待著繼續向您通報我們網路的進展。我們目前簽約的診所將為我們整個網路的成長提供強勁的收入和 EBITDA。

We've identified additional milestones reached in our 10-Q filing, including the FDA's grant of a PDUFA fee waiver, saving the company $4.3 million in filing fees. Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health. With the key milestones reached in Q2, and with the addition of a committed investor group based composed of experienced biotechnology investors we now have the balance sheet capacity to continue our quest to bring ope to life well into the coming year.

我們確定了在 10-Q 文件中達到的其他里程碑，包括 FDA 授予的 PDUFA 費用減免，為公司節省了 430 萬美元的申請費。FDA 可自行決定是否向小型企業實體和被認為對公眾健康必不可少的藥品授予豁免。隨著第二季度實現的關鍵里程碑，以及由經驗豐富的生物技術投資者組成的忠誠投資者集團的加入，我們現在擁有了資產負債表能力，可以繼續我們的追求，在來年實現運營。

I will now turn it over to Mr. Michael Abrams, our CFO, to review our financial results from the second quarter of 2025.

現在，我將把時間交給我們的財務長邁克爾·艾布拉姆斯先生，來回顧我們 2025 年第二季的財務表現。

Mike?

麥克風？

Thank you, Jonathan. For the first -- for the 3-months ended June 30, 2025, the company reported a net loss of $17.5 million versus a net loss of $7.9 million for the comparable quarter in 2024. The increase in the net loss was driven by an approximately $12 million charge in fair value accounting measurements related to previously issued convertible notes and warrants recorded in other expense, all of which is non-cash.

謝謝你，喬納森。首先，截至 2025 年 6 月 30 日的三個月，該公司報告淨虧損 1,750 萬美元，而 2024 年同期淨虧損為 790 萬美元。淨虧損增加是由於與先前發行的可轉換票據和認股權證相關的公允價值會計計量費用約為 1200 萬美元，這些費用記錄在其他費用中，且均為非現金。

For the 3-months ended June 30, 2025, the company reported a loss from operations, which excludes the non-cash impact of fair value accounting measurements of $3.7 million versus a loss from operations of $7.1 million for the comparable quarter in 2024. This marks an improvement of more than $3.3 million or 47% compared to the prior comparable quarter.

截至 2025 年 6 月 30 日的三個月，該公司報告營業虧損（不包括公允價值會計計量的非現金影響）為 370 萬美元，而 2024 年同期的營業虧損為 710 萬美元。與去年同期相比，這一數字成長了 330 多萬美元，增幅達 47%。

As of June 30, 2025, NRx had approximately $2.9 million in cash and cash equivalents. On August 18, 2025, the company closed a registered direct offering with a select group of experienced long-term health care and biotechnology investors, led by B Group Capital.

截至 2025 年 6 月 30 日，NRx 擁有約 290 萬美元的現金和現金等價物。2025 年 8 月 18 日，該公司與由 B Group Capital 領銜的一群經驗豐富的長期醫療保健和生物技術投資者完成了註冊直接發行。

In connection with that offering, the company issued approximately 3.9 million shares of common stock and received net proceeds of approximately $6.5 million. The shares issued in the offering are subject to a 1-year lockup and the terms of the offering did not include warrants, pricing resets or any other structured elements.

在此次發行中，該公司發行了約 390 萬股普通股，獲得淨收益約 650 萬美元。此次發行的股票有 1 年的鎖定期，發行條款不包括認股權證、價格重置或任何其他結構化要素。

The company did not use a broker or investment bank in connection with the offering. The company believes that its current cash position will support operations well into 2026 and provide sufficient capital to reach critical and anticipated regulatory inflection points and milestones. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders.

該公司在此次發行中沒有使用經紀人或投資銀行。該公司相信，其目前的現金狀況將支持其到 2026 年的良好運營，並提供足夠的資本以達到關鍵和預期的監管拐點和里程碑。我們唯一的重點仍然是推進我們的主要藥物開發計劃和計劃中的診所收購，以便為我們的股東創造長期價值。

With that, I turn the call back over to Jon.

說完，我把電話轉回給喬恩。

Jon?

喬恩？

Thank you, Mike. As you can see, the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors. Our goal of bringing hope to life is closer than ever. Our progress towards three potential drug approvals in the near-term and continuing the development of Hope Therapeutics national network for care delivery, our transformative steps for the company and for the treatment of mental health in the United States.

謝謝你，麥克。正如您所見，該公司已經取得了重大進展，並且正處於患者和投資者的巨大轉折點的邊緣。我們實現希望的目標比以往任何時候都更接近現實。我們近期在爭取三種潛在藥物批准方面取得了進展，並將繼續發展 Hope Therapeutics 全國醫療服務網絡，這是我們為公司和美國精神健康治療邁出的變革性步伐。

I would like to thank the NRx team, our long-time and new investors and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision.

我要感謝 NRx 團隊、我們的長期和新投資者，最重要的是，感謝參與我們臨床試驗的患者對我們追求這一願景的堅定支持。

Operator, we're ready to take questions from the audience.

接線員，我們準備好回答觀眾的提問了。

(Operator Instructions) Tom Shrader, BTIG.

（操作員指示）Tom Shrader，BTIG。

Good morning. And it really has been a lot of progress this quarter. I have a couple of quick ones. For 101, why is the pathway accelerated approval? It seems like you have very conventional clinical end points that you kind of argue you've hit and I think have accelerated approval for more biomarker-type trials. And a quick one on the new voucher. It looks like it's even more valuable than the older pediatric voucher. Is it clear it can be sold the way the other vouchers were? Has that been defined yet?

早安.本季確實取得了很大進展。我有幾個簡短的。對於 101，為什麼該途徑可以加速批准？看起來您有非常傳統的臨床終點，您認為您已經達到了這些終點，並且我認為已經加速了對更多生物標記類型試驗的批准。再簡單介紹一下新優惠券。它看起來比舊的兒科代金券更有價值。它是否能像其他代金券一樣出售？這已經定義好麼了？

Thank you.

謝謝。

Well, let me start with the second question first. I think the agency has been clear that the CNPV's are not to be sold. And certainly, we would have no interest in selling a Commissioner's National Priority Voucher where we -- to be awarded one. Our sole objective is to get this drug to patients as a life-saving drug for a critical unmet medical need as quickly as humanly possible.

好吧，我先從第二個問題開始。我認為該機構已經明確表示不會出售 CNPV。當然，我們不會有興趣出售我們能獲得的專員國家優先券。我們唯一的目標是盡快將這種藥物作為救命藥物提供給患者，滿足尚未滿足的關鍵醫療需求。

That's the objective of the commissioner's program, and that's the objective of NRx. As far as accelerated approval for NRX-101, as you recall, the primary endpoint of the clinical trial that we conducted was reduction in depression compared to lurasidone alone. And secondary endpoint was reduction in suicidality and akathisia as separate named endpoints.

這是專員計畫的目標，也是 NRx 的目標。就 NRX-101 的加速批准而言，您還記得，我們​​進行的臨床試驗的主要終點是與單獨使用魯拉西酮相比憂鬱症的減少。次要終點是自殺傾向和靜坐不能的減少，作為單獨的命名終點。

The clinical trial did not demonstrate that NRX-101 is a superior antidepressant to a very well-established antidepressant namely lurasidone, but did demonstrate reductions in akathisia and suicidality. And we believe that those are intermediate endpoints and that they haven't necessarily been demonstrated to be associated with long-term health benefits.

臨床試驗並未證明 NRX-101 是一種優於成熟抗憂鬱藥物魯拉西酮的抗憂鬱藥，但確實證明了其可以降低靜坐不能和自殺傾向。我們認為，這些只是中期終點，不一定被證明與長期健康益處有關。

So for that reason, we think the appropriate thing to do is ask for accelerated approval only for use in those patients who have demonstrated akathisia and suicidality despite best available medicine. In other words, for patients where there's truly an unmet medical need and an immediate risk of harm to the patient in the absence of treatment for those conditions and to ask FDA to give us 5-years in which to demonstrate that NRX-101 has a conventional long-term benefit compared to placebo.

因此，我們認為適當的做法是請求加速批准，僅用於那些儘管擁有最好的藥物但仍表現出靜坐不能和自殺傾向的患者。換句話說，對於確實存在未滿足的醫療需求並且在沒有治療的情況下對患者有直接傷害風險的患者，我們要求 FDA 給予我們 5 年的時間來證明 NRX-101 與安慰劑相比具有常規的長期益處。

Just to follow up, what would the second trial or the follow-up trial, confirmatory trial look like? Do you have any sense?

只是為了跟進，第二次試驗或後續試驗、確認性試驗是什麼樣的？你還有什麼感覺嗎？

Yeah. The confirmatory trial, if you look at the approval path of Auvelity, for instance, the confirmatory trial would be a very conventional randomized controlled trial of NRX-101 versus placebo with depression on the MADRS as primary endpoint because that's the endpoint that FDA has really set as the bar for all antidepressant drugs.

是的。例如，如果你看一下 Auvelity 的審批路徑，你會發現確認性試驗將是一項非常傳統的 NRX-101 與安慰劑的隨機對照試驗，以 MADRS 上的憂鬱症為主要終點，因為這是 FDA 為所有抗憂鬱藥物設定的標準終點。

Jason Kolbert, D. Boral Capital

Jason Kolbert，D. Boral Capital

Good morning again, congratulations on all the progress. Can we talk a little bit about some expense guidance. And I'm not really talking about third quarter or fourth quarter. But just from a big picture point of view, R&D is that likely to ramp up in the future? Should we see it at about the same level? And G&A, as you become a commercial entity, how do you envision G&A expanding? And I also have some questions about the acquisition pipeline associated with the clinics.

早上好，恭喜你取得的所有進展。我們可以談談一些費用指導嗎？我實際上並不是在談論第三季或第四季。但從宏觀角度來看，未來研發力道有可能增加嗎？我們是否應該將其視為大致相同的水平？那麼，當 G&A 成為商業實體時，您設想 G&A 將如何擴張？我對與診所相關的收購管道也有一些疑問。

Thanks.

謝謝。

Mike, please go ahead.

麥克，請繼續。

Okay. Sorry. So I'll -- from a financial perspective, Jason, thank you for your question. Obviously, as you know, we don't give guidance. So I think the best proxy for our financial statements and our trends and the expectations is what's reported in the 10-Q. And this is where it's very notable. We talked about we had approximately 50% reduction, 47%, almost 50% reduction in our loss of operations.

好的。對不起。所以我會——從財務角度來看，傑森，謝謝你的提問。顯然，如您所知，我們不提供指導。因此，我認為最能反映我們的財務報表、趨勢和預期的是 10-Q 報告中的內容。這是非常值得注意的地方。我們談到我們的營運損失減少了約 50%、47% 或幾乎 50%。

And so as a pre-revenue company, that is entirely made up of G&A expense and R&D expense. And so the decline from $7 million to $3 million change is as a direct result of internal budgeting and cost-saving measures that we continue to execute on.

因此，作為一家尚未獲利的公司，其收入完全由一般及行政費用和研發費用組成。因此，從 700 萬美元下降到 300 萬美元的變化是我們繼續執行的內部預算和成本節約措施的直接結果。

And again, not to get clouded with the net loss that was reported because that involves fair value accounting, which some people call derivative liability accounting, which could be quite counterintuitive in its impact on the income statement and the balance sheet, whereby an increase in our stock price makes it look like an increased liability, increased expense, but those are all non-cash.

再次強調，不要被報告的淨虧損所蒙蔽，因為這涉及公允價值會計，有些人稱之為衍生負債會計，它對損益表和資產負債表的影響可能相當違反直覺，即我們股價的上漲看起來像是負債增加、費用增加，但這些都是非現金的。

So really looking at loss from operations, I think, is the cleaner view into our financial picture. And the trends of reducing our overall operating costs comprised of G&A and R&D are evident, and we believe to be continued. Again, not prepared to give guidance on where that may go in the future. But we announced it and discussed it because we think it's a worthy note of our financial statements that investors can -- should take note of.

因此，我認為，真正看營業虧損才能更清楚地了解我們的財務狀況。降低包括一般行政費用和研發費用在內的整體營運成本的趨勢是顯而易見的，而且我們相信這種趨勢會持續下去。再次，我們還沒有準備好對未來可能的發展方向給予指導。但我們宣布並討論了這一點，因為我們認為這是我們財務報表中值得投資者註意的一點。

With that, I'll turn it back over to Jon.

說完這些，我會把話題交還給喬恩。

I can appreciate your comments, but the expectation is that we would see G&A ramping up as you become a commercial entity, but we'll I think what you're saying is tempor -- expense ramp up with the strength of the balance sheet so that kind of comes together and sync. That's how I interpret what you're saying.

我很欣賞您的評論，但我們預計，隨著您成為商業實體，G&A 費用會增加，但我認為您所說的是暫時的——費用會隨著資產負債表的強勁而增加，因此這種增加會結合在一起並同步。這就是我對你所說的話的理解。

Well, yeah, just a follow-up on that. The -- any increase in G&A that is sometimes seen in these situations as commercialization comes also comes in line with revenue, right? So we are -- we have been managing the business for what it is now.

嗯，是的，只是對此進行跟進。在這種情況下，隨著商業化的到來，G&A 的任何增加也與收入一致，對嗎？所以我們——我們一直在按照現在的狀況管理業務。

As Jonathan mentioned in his comments during the call, we believe we're relatively near-term commercialization and in advanced all of our drug programs as well as opportunities with Hope Therapeutics. So as revenue comes on, we -- management will continue to assess those and make decisions.

正如喬納森在電話會議中提到的那樣，我們相信我們處於相對近期的商業化階段，並且我們所有的藥物項目以及與 Hope Therapeutics 合作的機會都處於領先地位。因此，隨著收入的增加，我們—管理層將繼續評估並做出決策。

But the timing of which I don't want to provide forward-looking statements on or provide projections on what that revenue flow will look like. But any increase in expense related to commercialization will be taken part and parcel simultaneous with the revenue itself. So -- but your point is noted.

但我不想就具體時間提供前瞻性陳述，也不想對收入流的狀況提供預測。但任何與商業化相關的費用的增加都將與收入本身同時增加。所以——但我注意到了你的觀點。

Yeah, well. Typically, Jason, a question like that is going to get plugged into a model that ultimately projects a price per share for a company such as ours. And you're asking in a very legitimate way. Do we think our G&A may increase as we get forward to actually -- as we get closer to selling a drug.

嗯，嗯。通常情況下，傑森，這樣的問題會被納入一個模型中，最終預測出我們這樣的公司的每股價格。你問得非常合理。我們是否認為，隨著我們實際上越來越接近銷售藥品，我們的 G&A 可能會增加？

And although that answer might well be yes, by the time we do that, our probability of success in any such model will have substantially increased. So that the projected increased costs of G&A will be closely tied to an increased probability of corporate success.

儘管答案很可能是肯定的，但當我們這樣做時，我們在任何此類模型中取得成功的機率將大大增加。因此，預計的一般及行政費用的增加將與企業成功機率的增加密切相關。

And Jonathan, how about the acquisition pipeline in terms of clinics -- and can you give any kind of idea of what you might look at -- I mean, from a big picture point of view, 5-years from now, what do you think your footprint looks like?

喬納森，就診所而言，您的收購管道怎麼樣？您能否透露一下您可能會考慮哪些方面？我的意思是，從大局來看，五年後，您認為您的足跡會是什麼樣子？

Well, 5-years from now, if we're successful in what we aim to do with Hope Therapeutics, First of all, it will almost certainly be an independent company from NRx Pharmaceuticals. And the companies that we would hope people would look at are companies like DaVita and Fresenius that transformed the dialysis industry from disparate clinics where it was almost impossible for a consumer to know what kind of quality to expect to coherent networks of care delivery organizations where consumers had a reasonable expectation of consistent quality, consistent outcomes across the network. And investors enjoyed extraordinary financial success in the

好吧，五年後，如果我們成功實現了對 Hope Therapeutics 的目標，首先，它幾乎肯定會成為 NRx Pharmaceuticals 的獨立公司。我們希望人們關注的是像 DaVita 和 Fresenius 這樣的公司，它們將透析行業從分散的診所（消費者幾乎不可能知道期望什麼樣的品質）轉變為連貫的醫療服務提供組織網絡，消費者對整個網絡的一致品質和一致結果有合理的期望。投資者在

process. So our challenge is finding best-of-breed clinics that have really integrated the use of neuroplastic drugs, and this is a word you'll hear us using more and more. People talk about psychedelic therapy as if the hallucinations that are induced have something to do with the medical benefit. And they may.

過程。因此，我們的挑戰是找到真正整合使用神經可塑性藥物的最佳診所，您會越來越多地聽到我們使用這個詞。人們談論迷幻療法時，就好像所引起的幻覺與醫療效益有關。確實有可能。

But in our view, what's really going on is that this class of drugs causes the brain cells to form new connections to other brain cells. That's a process called neuroplasticity. If you want to make a computer chip, you take a piece of silicon and you etch it with a laser, you may use programming to turn circuits on and off, but the circuits on the chip will be there for the end of time. The brain works completely differently.

但我們認為，真正發生的情況是，這類藥物會導致腦細胞與其他腦細胞形成新的連結。這個過程被稱為神經可塑性。如果你想製造一個電腦晶片，你拿一塊矽片並用雷射蝕刻它，你可以使用程式來打開和關閉電路，但晶片上的電路將永遠存在。大腦的工作方式完全不同。

Brain cells are constantly branching, making new connections to other brain cells, pruning those connections and the evidence is that when that process of neuroplasticity stops, that's when you have severe depression, you have suicidality. And all of these drugs that are showing benefit are doing so in our view and in the evolving view of many of the scientists we talk to because they're causing neuroplasticity.

腦細胞不斷分支，與其他腦細胞建立新的連接，修剪這些連接，證據表明，當神經可塑性過程停止時，你就會患上嚴重的憂鬱症，產生自殺傾向。我們認為，以及根據我們交談過的許多科學家不斷發展的觀點，所有這些藥物之所以顯示出益處，是因為它們能夠引起神經可塑性。

So how do you do that? You can do it with ketamine and related drugs. There's evidence you can do it with the Psilocybin class of drugs, what people call the psychedelics. There are drugs over the horizon that achieved neuroplasticity without the hallucinations. You can achieve it with a treatment called transcranial magnetic stimulation, which is FDA approved, you put powerful electromagnets outside the head, and achieve profound changes on depression, on suicidality.

那麼該如何做呢？您可以使用氯胺酮和相關藥物來做到這一點。有證據表明，使用裸蓋菇素藥物（人們稱之為迷幻藥）可以達到這一目的。即將問世的藥物可以實現神經可塑性，且不會引起幻覺。你可以透過一種稱為經顱磁刺激的治療方法來實現這一目標，這種方法已經獲得 FDA 的批准，你可以在頭部外面放置強大的電磁鐵，從而對憂鬱症和自殺傾向做出深刻的改變。

There's emerging evidence that may work for autism for PTSD. And people are seeing benefits with hyperbaric oxygen therapy. I'm sure there will be other neuroplastic therapies coming down the pipe. Our objective with Hope Therapeutics is to identify best-in-class clinics that are already combining those treatments.

有新證據表明創傷後壓力症候群 (PTSD) 可能對自閉症有效。人們已經看到了高壓氧療法的益處。我確信還會有其他神經可塑性療法問世。我們與 Hope Therapeutics 的目標是找到已經結合這些治療方法的最佳診所。

The notion of a ketamine clinic where you can get IV ketamine on Mondays and peptides on Tuesdays and vitamins on Wednesdays, that's the opposite of what we think patients need. So we may be able to identify $100 million of acquisition of that kind of best-in- breed clinic.

在氯胺酮診所，你可以在星期一接受靜脈注射氯胺酮，週二接受勝肽注射，週三接受維生素注射，這與我們認為病人需要的恰恰相反。因此，我們可能能夠確定以 1 億美元收購這種一流診所的計劃。

But very quickly, you'll see Hope shifting to a model of building clinics from the ground up to extend those flagship clinics that we acquire on day 1 because we don't think we can grow beyond $100 million or so just by acquiring clinics that already exist. So it's hard enough to talk about what we'll do next year versus 5-years from now.

但很快你就會看到 Hope 轉向從頭開始建造診所的模式，以擴展我們在第一天收購的那些旗艦診所，因為我們認為僅透過收購已經存在的診所，我們的規模不可能超過 1 億美元左右。因此，談論明年和五年後我們要做什麼已經夠難的了。

But I think 5-years from now, you're going to see a national network in place such that patients and families who are suffering from these conditions know to pick up the phone, call Hope Therapeutics and expect to have a life-changing opportunity to get better.

但我認為五年後，你會看到一個全國性的網絡，讓遭受這些疾病困擾的患者和家屬知道拿起電話，撥打希望治療公司 (Hope Therapeutics) 的電話，並期待獲得改變生活、康復的機會。

Patrick Trucchio, HC Wainwright.

派崔克·特魯基奧、HC·溫賴特。

Thanks, good morning and congrats on all the progress advancing NRX-100, NRX-101 and the Hope platform. It's clear the team has made meaningful strides on both clinical and regulatory fronts. And we have a few follow-up questions. The first is just on the citizen petition impact. You've explained the scientific basis for the citizen petition on benzethonium chloride.

謝謝，早安，恭喜 NRX-100、NRX-101 和 Hope 平台取得的所有進展。顯然，該團隊在臨床和監管方面都取得了重大進展。我們還有一些後續問題。第一點是關於公民請願的影響。您解釋了有關芐索氯銨的公民請願的科學基礎。

I'm wondering if you can give us a sense of when you may expect an FDA response. And from a commercial perspective, if the FDA were to mandate preservative-free formulation across ketamine, how meaningful could that revenue uplift be for NRX-100? And how challenging might it be for existing suppliers to adjust?

我想知道您是否可以告訴我們何時可以期待 FDA 的回應。從商業角度來看，如果 FDA 強制要求氯胺酮配方中不得使用防腐劑，那麼 NRX-100 的收入成長會有多大意義？對現有供應商來說，調整有多困難？

Well, the FDA's requirement is to respond to a citizen's petition within 6-months of filing. And we hope that FDA will beat that requirement. Certainly, we have a Secretary of Health and Human Services. Mr. Kennedy, who has demonstrated a profound dislike for both artificial colors and preservatives in foods, in drugs, who clearly recognizes that many of the things we've assumed to be safe, unless proven safe may not be safe.

嗯，FDA 的要求是在公民提出請願後 6 個月內回應。我們希望 FDA 能夠滿足這項要求。當然，我們有一位衛生與公共服務部部長。甘迺迪先生對食品和藥品中的人工色素和防腐劑表現出了深深的厭惡，他清楚地認識到，許多我們認為安全的東西，除非被證明是安全的，否則可能並不安全。

And in this particular case, we're talking about a preservative that's toxic to the point where FDA won't even allow you to put it into a hand cleaner or topical antiseptic. So they know a lot about benzethonium chloride maybe even more than we do.

在這個特殊情況下，我們討論的防腐劑具有很強的毒性，FDA 甚至不允許將其放入洗手液或外用消毒劑中。所以他們對芐索氯銨的了解可能比我們還要多。

In terms of impact, right now, the generic ketamine market is $750 million a year. It's mostly foreign sourced goods. From what we've seen, and we haven't gotten other people's products into the laboratory measured ourselves, that level of BZT may not be entirely consistent from product to product. And if you read the toxicology paper that we posted last week for the public to read.

就影響而言，目前，仿製氯胺酮市場每年的規模為 7.5 億美元。大部分都是外國貨。據我們所知，而且我們自己也沒有將其他人的產品送入實驗室進行測量，不同產品的 BZT 水平可能並不完全一致。如果你讀過我們上週發布給大眾閱讀的毒理學論文。

As you have repeated doses of ketamine you start to get a cumulative impact of this, what's called a (inaudible) amine preservative. In fact, one thing you'll see if you poke around is that there's a known incidence of ulcerative cystitis that is an inflammatory and serious condition of the lining of the urinary bladder associated with repeated use of ketamine that's never been seen with repeated use of the J&J SPRAVATO product, which is a nasal form of a ketamine.

隨著你反覆服用氯胺酮，你會開始感受到這種累積效應，這就是所謂的（聽不清楚）胺類防腐劑。事實上，如果你四處打聽就會發現，潰瘍性膀胱炎是一種與反覆使用氯胺酮有關的膀胱內壁發炎和嚴重疾病，而強生公司的 SPRAVATO 產品（一種鼻腔形式的氯胺酮）的反覆使用從未出現過這種情況。

Well, if you ask what's different between the two products, certainly, intravenous ketamine is racemic, whereas the J&J product is the S enantiomer. And clearly, in one case, it's given by nasal administration versus IV administration but either way, once it's in the bloodstream, the residual product winds up being metabolized by the liver, excreted in the bladder. And the main difference or 8 main difference is that there's no benzethonium chloride in the J&J product.

好吧，如果你問這兩種產品有什麼不同，當然，靜脈注射氯胺酮是外消旋的，而強生產品是 S 對映體。顯然，在一種情況下，藥物是透過鼻腔給藥而不是靜脈給藥，但無論哪種方式，一旦進入血液，殘留物就會被肝臟代謝，並透過膀胱排泄。主要區別或第 8 個主要區別是強生產品不含芐索氯銨。

So it may be that we're already seeing an impact of repeated use of a BZT containing ketamine in real life without having to look too hard for other examples. In terms of what would be the impact of removing this toxic preservative from generic ketamine. It would, first of all, we think, benefit patients substantially that's the only reason it's in the bottle is so that a doctor can stick a needle into the same bottle more than once and administer drugs from that bottle either to the same patients or to multiple patients. So there's no real benefit to the patient associated with injecting BZT into the patient.

因此，我們可能已經在現實生活中看到了重複使用含有氯胺酮的 BZT 的影響，而無需費力尋找其他例子。從通用氯胺酮中去除這種有毒防腐劑會產生什麼影響？首先，我們認為，它將給患者帶來巨大的益處，它被放在瓶子裡的唯一原因是，這樣醫生就可以多次將針頭插入同一個瓶子，並將瓶子中的藥物注射給同一個患者或多個患者。因此，給患者註射 BZT 對患者沒有真正的好處。

What would be the impact? The impact could well be that rather than a normal share of the generic market that we would associate with an ANDA for a US manufactured safe and reliable form of ketamine, we might have a substantially larger share of that generic market while other suppliers readjust their formulations to take the toxic preservative out of those formulations.

這會有什麼影響？其影響很可能是，我們可能不但無法獲得與美國製造的安全可靠的氯胺酮 ANDANDA 相關的仿製藥市場的正常份額，而且在其他供應商重新調整其配方以從這些配方中去除有毒防腐劑的同時，我們可能擁有仿製藥市場的更大份額。

And since some of those current generic suppliers have pretty much left this product on the shelf. It's not even clear how many of them would readjust their formulations and reenter the marketplace versus simply go on to other things. So granted the citizens petition could really help us exceed people's financial expectations for us.

由於目前一些仿製藥供應商基本上已經將該產品擱置。目前甚至不清楚其中有多少公司會調整其配方並重新進入市場，而不是簡單地轉向其他業務。因此，公民請願確實可以幫助我們超越人們對我們的財務期望。

Right. That's really helpful. And just another follow-up on NRX-100. I think you mentioned plans to submit real-world data from nearly 180,000 patients treated with ketamine and SPRAVATO. I'm wondering how you expect the FDA to weigh this data set alongside the randomized controlled trials? And do you believe it could further strengthen the case for an accelerated approval?

正確的。這真的很有幫助。這只是 NRX-100 的另一個後續行動。我認為您曾提到提交近 180,000 名接受氯胺酮和 SPRAVATO 治療的患者的真實世界數據的計劃。我想知道您希望 FDA 如何權衡該數據集和隨機對照試驗？您是否認為這可以進一步加強加速核准的理由？

Well, we think real-world data in that quantity of patients certainly should motivate FDA to see the case has substantially strengthened the FDA guidance is that the agency really needs to pay attention to real-world data. And Commissioner Makary has said very clearly that he wants to move the agency solidly into the 21st century in terms of using real-world data.

嗯，我們認為，這麼多患者中的真實世界數據肯定會促使 FDA 看到這種情況，這大大加強了 FDA 的指導，即該機構確實需要關注真實世界的數據。馬卡里委員明確表示，他希望帶領該機構在使用真實世界數據方面穩步邁入 21 世紀。

So we hope this will be one of the first examples where real-world data supports an approval. It's very rare to have a drug approval coming down the pike where more than 200,000 people have already gotten the drug for this purpose. It just doesn't happen to be approved for this purpose yet. It's a unique circumstance.

因此，我們希望這將成為真實世界數據支援批准的首批例子之一。一種藥物在獲得批准後，已經有超過 20 萬人因此目的而獲得了該藥物，這種情況非常罕見。只是恰好它尚未被批准用於此目的。這是一個獨特的情況。

Yes. That's interesting. And then just on NRX-101, an interesting highlight of the potential synergy between NRX-101 and TMS. And I'm wondering if this combination could it accelerate adoption either within the Hope clinics or across interventional psychiatry more broadly? And is this something that you may seek a label expansion to more formally capture this potential.

是的。那很有意思。然後僅在 NRX-101 上，NRX-101 和 TMS 之間的潛在協同作用的一個有趣亮點。我想知道這種結合是否能夠加速希望診所或更廣泛的介入性精神病學領域的採用？您是否可以尋求標籤擴充來更正式地捕捉這種潛力？

Thank you. You're asking a fascinating question. And we've identified a very provocative -- in a good way, provocative scientific study that was performed out of Canada, where investigators showed that NRX-101, well, they specifically showed that D-cycloserine the main active ingredient in NRX-101 compared to placebo, enhanced the effect of transcranial magnetic stimulation or TMS in treating depression.

謝謝。你問了一個很有趣的問題。我們發現了一項非常具有啟發性——從好的方面來說，具有啟發性的科學研究，該研究是在加拿大進行的，研究人員表明，NRX-101，他們具體表明，與安慰劑相比，NRX-101 中的主要活性成分 D-環絲氨酸增強了經顱磁刺激或 TMS 在治療抑鬱症方面的效果。

And they didn't really give an antidepressant dose of D-cycloserine. They gave about 100 milligrams per patient per day which was a lower dose than would be needed to block the NMDA receptor. As you recall, my brother, Dan Javitt has done most of the work as supported by patents all over the world in demonstrating that you have to get to about 400- to 500-milligrams a day of D-cycloserine before the drug becomes a potent NMDA antagonist.

他們其實並沒有給予抗憂鬱劑量的 D-環絲胺酸。他們每天給每位患者註射約 100 毫克，低於阻斷 NMDA 受體所需的劑量。大家還記得，我的兄弟 Dan Javitt 已經完成了大部分工作，並得到了世界各地專利的支持，證明每天必須攝取約 400 至 500 毫克的 D-環絲氨酸，該藥物才會成為有效的 NMDA 拮抗劑。

So they used a much lower dose of D-cycloserine. They used 100 milligrams a day which is believed to be neuroplastic even if it's not a potent NMDA antagonist at those doses. And lo and behold showed a very potent improvement in the results achieved with transcranial magnetic stimulation.

因此他們使用了低得多的 D-環絲氨酸劑量。他們每天使用 100 毫克，即使在這種劑量下它不是有效的 NMDA 拮抗劑，也被認為具有神經可塑性。瞧，經顱磁刺激的結果顯示出了非常顯著的改善。

So we're in active discussion with US academic medical centers about mounting a confirmatory clinical trial in that area. It would be a very interesting label expansion for NRX-101, but more importantly, if that drug is able to potentiate the effect of TMS, it will bring TMS in our estimate, much more into the mainstream as maybe even a first-line treatment for depression rather than starting out with these old generic serotonin drugs that may or may not work depending on who you read.

因此，我們正與美國學術醫療中心積極討論在該領域進行確認性臨床試驗。對於 NRX-101 來說，這將是一次非常有趣的標籤擴展，但更重要的是，如果該藥物能夠增強 TMS 的效果，那麼在我們看來，它將使 TMS 更廣泛地進入主流，甚至可能成為抑鬱症的一線治療藥物，而不是從這些舊的通用血清素藥物開始，這些藥物可能有效，也可能是誰無效，這取決於你的是誰。

And certainly, every one of them has a label that says, caution, this drug may be associated with increased levels of suicidal ideation. So anything that leads to better outcomes from TMS, anything that makes that treatment more accessible and more potent for patients has the potential to really shift the whole paradigm of how we treat suicidal depression, even ordinary depression and PTSD.

當然，每種藥物上都貼有標籤，上面寫著：小心，這種藥物可能會增加自殺意念。因此，任何能夠改善 TMS 療效的方法，任何能夠使治療更容易獲得、對患者更有效的方法，都有可能真正改變我們治療自殺性憂鬱症、甚至普通憂鬱症和創傷後壓力症候群的整個模式。

Ed Woo, Ascendiant Capital.

Ed Woo，Ascendiant Capital。

Yeah. Congratulations on all the progress. What is your commercial strategy with NRX-100, now 101? Are you going to wait until closer to approval to actually expand and potentially get a sales force?

是的。祝賀你取得的所有進展。您對 NRX-100（現在為 101）的商業策略是什麼？您是否要等到接近批准時才真正擴大規模並可能獲得銷售團隊？

Yeah, it's a wonderful question. And Matt Duffy is on the phone with us. A lot of people know Matt in his role within our company as our Chief Business Officer. People have known Matt in his role at -- on Wall Street as a highly respected research analyst.

是的，這是一個非常好的問題。馬特達菲 (Matt Duffy) 正在和我們通電話。很多人都知道馬特，他在我們公司擔任首席商務官。人們知道馬特在華爾街是一位備受尊敬的研究分析師。

What fewer people know is that Matt got out of college, joined Pfizer, succeeded in a commercial role to the point where he actually wound up as the product manager for Viagra and went on to launch highly successful biologics at other companies. So Matt, why don't you walk Ed through what you'd be likely to do if we drop the drug approval in your lab?

很少有人知道，馬特大學畢業後加入了輝瑞公司，在商業領域取得了成功，最終成為威而鋼的產品經理，並在其他公司推出了非常成功的生物製劑。那麼馬特，你為什麼不向艾德介紹一下，如果我們取消你實驗室的藥物批准，你可能會怎麼做呢？

Sure. Thanks for the question, Ed. Good to hear from you. So we've done launches like this. I've done a few of them. The MedImmune is probably the most notable, but also at Lev Pharma, where it's a pretty focused launch for both of these drugs. It would be different with different targets. If you think of NRX-100, you think of the clinics like we have with Hope and other mental health facilities. There's probably 600 to 1,000 that are really solid places that will administer these medications.

當然。謝謝你的提問，Ed。很高興收到你的來信。所以我們進行了這樣的發布。我已經做過一些了。MedImmune 可能是最引人注目的，但 Lev Pharma 也非常重視這兩種藥物的推出。針對不同的目標，情況會有所不同。如果您想到 NRX-100，您會想到像 Hope 和其他精神衛生機構那樣的診所。大概有 600 到 1,000 個真正可靠的場所可以管理這些藥物。

At this point, that will grow once you have a reimbursed product. But when you start looking at those numbers and thinking about what a rep or an MSL or a business person and administrative person might be able to do. You probably can get away and really be successful with a small commercial force. I think at MedImmune, our initial group of reps and MSLs is about 20 people.

此時，一旦您擁有了報銷產品，這個數字就會成長。但是當您開始查看這些數字並思考代表或 MSL 或商務人員和行政人員可以做什麼時。您可能可以憑藉少量的商業力量獲得成功。我認為在 MedImmune，我們最初的代表和 MSL 團隊大約有 20 人。

And that was a very focused group of focusing about 500 hospitals. And then at Lev it was a similar situation with individual rheumatologists that we were targeting. And so for NRX-100 you probably launched with around 20 people, and you can do the math on what MSLs and reps cost these days and really do a good job really covering the key players in the market and really getting good coverage over a huge proportion of what we really think is the opportunity in the mental health side for ketamine and NRX-100.

這是一個非常專注的團體，重點關注約 500 家醫院。在 Lev，我們所針對的個別風濕病學家也遇到了類似的情況。因此，對於 NRX-100，你可能與大約 20 人一起推出，你可以計算一下現在的 MSL 和代表的成本，並真正做好覆蓋市場關鍵參與者的工作，並且真正獲得對很大一部分我們認為是氯胺酮和 NRX-100 在精神健康方面存在機會的良好報道。

It's going to be kind of similar with NRX-101, but look different. There are -- there is a very focused number of perhaps -- I think the number is about 1,500 to 1,600 maximum psychiatrists who treat bipolar patients. Those numbers are a little dated from market research we did a few years ago. But if you do the math backwards in terms of rep coverage and MSL coverage for that, it's a similar number of patients -- I'm sorry, of field personnel. Those folks may be a little bit more expensive because you may have a little bigger tilt towards MSLs.

它有點類似於 NRX-101，但看起來不同。有——可能有非常集中的——我認為治療躁鬱症患者的精神科醫生最多有 1,500 到 1,600 名。這些數據與我們幾年前所做的市場調查相比有些過時了。但是，如果你從代表覆蓋範圍和 MSL 覆蓋範圍的角度反向計算，你會發現患者數量——抱歉，是現場人員數量——是相似的。這些人的費用可能會稍微高一點，因為你可能會更傾向於 MSL。

But if you can cover 1,500 high-prescribing bipolar psychiatrists with not that many reps. And so those are pretty focused efforts and then the marketing behind it, therefore, is more focused as well. So I think these are two really focused launches. They can be synergistic because of the knowledge base of bipolar depression and major depression and suicidality for both will have a lot of overlap. But as you look at those, the company will obviously get smarter and smarter on the commercial side as we're getting closer and as we're launching the products.

但如果你能用沒有那麼多的代表來覆蓋 1,500 名開出大量處方的躁鬱症精神科醫生。因此，這些都是非常集中的努力，因此背後的行銷也更加集中。所以我認為這是兩次真正有重點的發布。它們可以發揮協同作用，因為雙相憂鬱症和重度憂鬱症的知識基礎以及兩者的自殺傾向會有很多重疊。但當你看到這些時，隨著我們越來越接近目標並推出產品，公司在商業方面顯然會變得越來越聰明。

But you're probably talking about two 20-, 25-person commercial organizations with the supporting infrastructure. It's really focused. We did it with not a lot of money at MedImmune, and they did it with not a lot of money at Lev and then when ViroPharma bought us shortly thereafter. And so it can really focused and it can be a very efficient launch. And the nice thing about that is you hit profitability much, much, much more quickly. And if you have a 500-person primary care sales force like Pfizer, we would launch with at Pfizer.

但您談論的可能是兩個擁有 20 到 25 名員工的商業組織及其支援基礎設施。確實很專注。我們在 MedImmune 用很少的錢做到了這一點，他們在 Lev 用很少的錢做到了這一點，而不久之後 ViroPharma 就收購了我們。因此它可以真正集中精力，並且可以實現非常有效率的啟動。這樣做的好處是，你可以更快地獲利。如果您擁有像輝瑞一樣的 500 人初級保健銷售隊伍，我們將從輝瑞開始。

And we have no further questions over the phone lines. I would like to turn it back to Matthew Duffy for closing remarks.

我們在電話裡沒有其他問題。我想請馬修·達菲 (Matthew Duffy) 作最後發言。

Well, thank you, everyone, for joining us this morning. We're extremely excited about the path ahead with three potential approvals and our Hope subsidiary targeting multiple profitable mental health clinics and interventional psychiatry centers. This concludes the NRx Pharmaceuticals second quarter 2025 results conference call.

好吧，謝謝大家今天早上加入我們。我們對未來的道路感到非常興奮，因為我們有三個潛在的批准，而我們的 Hope 子公司瞄準了多家盈利性的精神健康診所和介入精神病學中心。NRx Pharmaceuticals 2025 年第二季業績電話會議到此結束。

Thank you all for participating. You may disconnect.

感謝大家的參與。您可以斷開連線。