NRX Pharmaceuticals Inc (NRXP) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals first quarter 2026 earnings conference call. (Operator Instructions)

各位女士、先生，早安，歡迎參加 NRx Pharmaceuticals 2026 年第一季財報電話會議。(接線員指示)

I would now like to turn the conference call over to Brian Korb from astr partners. Please go ahead.

現在我想將電話會議交給 astr partners 的 Brian Korb。請開始。

Thank you, operator, 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 in this call is contained in our periodic reports filed with the SEC.

謝謝，接線員，也歡迎各位。在我們開始之前，我想提醒大家，本次電話會議中所作的某些陳述，依據美國聯邦證券法屬於前瞻性陳述。這些陳述受到風險與不確定性影響，可能導致實際結果與歷史經驗或目前預期存在重大差異。有關可能導致實際結果與本次電話會議陳述不同之因素的更多資訊，載於我們向 SEC 提交的定期報告中。

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 the forward-looking statements. Information presented on this call is contained in the press release issued today and in the company's Form 10-Q, which may be accessed from the Investor page of the NRx Pharmaceuticals website.

本次電話會議中的前瞻性陳述僅截至本日有效，公司不承擔更新或修訂前瞻性陳述之任何義務。本次電話會議所呈現的資訊載於今日發布的新聞稿以及公司 Form 10-Q 中，可於 NRx Pharmaceuticals 官網的投資人頁面查閱。

Joining me on today's call is Dr. Jonathan Javitt, our Founder, Chairman, and CEO; and Michael Abrams, our Chief Financial Officer; Dr. Javitt will provide an overview of the company's progress during the first quarter, following which Mike will review our financial results. Following our prepared remarks, we will address investor questions.

今天與我一同參與電話會議的有：我們的創辦人、董事長兼執行長 Jonathan Javitt 醫師，以及財務長 Michael Abrams。Javitt 醫師將先概述公司第一季的進展，隨後 Mike 將回顧我們的財務結果。

I will now turn the call over to Jonathan. Jonathan, please go ahead.

我現在把電話交給 Jonathan。Jonathan，請開始。

Thank you, Brian. Good morning, everyone. Thank you for joining us. The first quarter of 2026 was a productive one for NRx. We made progress on both regulatory pathways for preservative-free ketamine, initiated commercial manufacturing, advanced NRX-101 into a registrational trial, continued to grow the HOPE Therapeutics network, and acquired the Geneuro assets.

謝謝你，Brian。各位早安。感謝各位加入我們。2026 年第一季對 NRx 而言是富有成效的一季。我們在無防腐劑氯胺酮的兩條監管途徑上均取得進展，啟動商業化製造，推進 NRX-101 進入註冊性試驗，持續擴大 HOPE Therapeutics 網絡，並收購了 Geneuro 的資產。

A year ago, we had not yet filed for our first drug approval, and we were $8.7 million in debt. Now we are debt-free. We have sufficient cash for our immediate operating needs, and we've raised $7 million since the end of the quarter. We've reduced our financial statement loss by 74% year over year.

一年前，我們尚未申請第一項藥品核准，且負債 870 萬美元。如今我們已無負債。我們擁有足以支應近期營運需求的現金，並且在季末以來已募得 700 萬美元。我們的財務報表虧損較去年同期減少 74%。

Let me start with KETAFREE. As we reported in March, FDA notified us of a preliminary determination of bioequivalents to the reference branded drug, Ketalar. Since then, we've continued to clear the remaining review disciplines. In April, FDA issued a labeling letter requesting only minor formatting changes and a positive disciplined review letter on quality, requesting only administrative changes that FDA itself identified is minor.

我先從 KETAFREE 談起。如我們在 3 月所報告，FDA 通知我們初步判定與參考品牌藥 Ketalar 具生體相等性。此後，我們持續完成其餘審查領域的清關。4 月，FDA 發出標示函，僅要求些微格式調整，並就品質出具正面的分項審查函，僅要求行政性變更，且 FDA 自行指出該等變更屬輕微。

Leadership of the FDA Office of Generic Drugs expressed support for addressing the remaining items within the current review cycle, consistent with our summer 2026 goal. We are at the verge of entering a robust market where ketamine is in drug shortage at the exact moment when reliability matters most, and we're positioned to deliver it.

FDA 學名藥辦公室（Office of Generic Drugs）領導層表示支持在本次審查週期內處理剩餘事項，與我們 2026 年夏季的目標一致。我們正處於進入一個強勁市場的門檻：在氯胺酮正處於藥品短缺之際，供應可靠性最為關鍵，而我們已具備交付能力。

From our perspective, the market shortage of ketamine is larger than is apparent from hospital data because the rapidly growing ketamine clinic market segment is frequently unable to obtain ketamine through the commercial supply chain and must rely on compounding pharmacies. FDA has now reclassified our manufacturing site to VAI status, consistent with the launch of an ANDA drug.

在我們看來，氯胺酮的市場短缺程度比醫院數據所呈現的更為嚴重，因為快速成長的氯胺酮診所市場區隔經常無法透過商業供應鏈取得氯胺酮，而必須依賴配製藥局。FDA 現已將我們的製造場址重新分類為 VAI 狀態，與 ANDA 藥品上市相一致。

And on May 5, we transmitted our first commercial manufacturing order at the 1 million unit per batch scale. The blow-fill seal process we're using delivers more than tenfold throughput compared to traditional glass vial techniques and is readily scalable at substantially lower manufacturing cost.

並且在 5 月 5 日，我們以每批 100 萬單位的規模傳送了第一筆商業化製造訂單。我們採用的吹灌封（blow-fill seal）製程，相較於傳統玻璃小瓶技術可提供超過 10 倍的產能，且易於擴產，製造成本也顯著更低。

Simply put, the most expensive component in traditional manufactured ketamine is the glass vial. With blow-fill seal or BFS, there is no glass vial, no rubber stopper, and we calculate that we are capable of manufacturing 1 million units per week.

簡而言之，傳統製造氯胺酮中最昂貴的組成部分是玻璃小瓶。採用吹灌封（BFS）後，不需要玻璃小瓶，也不需要橡膠塞；我們估算可達到每週製造 100 萬單位的能力。

Timing matters here. As of April, sterile intravenous ketamine remains on the ASHP National Drug Shortage database. KETAFREE will be the first US manufactured preservative-free ketamine, free of benzethonium chloride, a preservative that is not generally recognized as safe and is no longer permitted even in hand cleansers and topical antiseptics.

時機在此至關重要。截至 4 月，無菌靜脈注射用氯胺酮仍列於 ASHP 全國藥品短缺資料庫。KETAFREE 將成為首款美國製造的無防腐劑氯胺酮，不含苯扎氯銨（benzethonium chloride）——這是一種通常不被認定為安全的防腐劑，甚至已不再允許用於洗手清潔劑與外用消毒劑。

To prepare for launch, in April, we appointed Glenn Tyson as our first Chief Commercial Officer. Glenn brings 25 years of commercial leadership in GSK and Indivior, where he led the successful launch of SUBLOCADE. Glenn is in the process of bringing on his launch team of accomplished pharmaceutical executives, and we look forward to introducing them to you in the near future.

為了準備上市，我們在 4 月任命 Glenn Tyson 為首任商務長（Chief Commercial Officer）。Glenn 擁有 25 年在 GSK 與 Indivior 的商業領導經驗，並曾主導 SUBLOCADE 的成功上市。Glenn 正在組建由資深製藥高階主管組成的上市團隊，我們期待在不久的將來向各位介紹他們。

As we prepare for anticipated approval of our preservative-free ketamine, we're entering a market that is already well established but structurally undersupplied. Sterile ketamine has remained on national drug shortage listings, as we mentioned, with intermittent back orders, product discontinuations, and inconsistent availability across hospital and outpatient settings.

在我們為預期的無防腐劑氯胺酮核准做準備之際，我們正進入一個已相當成熟但結構性供給不足的市場。正如我們提到的，無菌氯胺酮一直列於全國藥品短缺名單，並伴隨間歇性缺貨待交、產品停產，以及在醫院與門診場景中的供應不一致。

At the same time, clinical demand continues to expand across both anesthesia and psychiatric use, supported by widespread off-label adoption and established infusion infrastructure. It's important to recognize that ketamine is rapidly becoming a substitute for opioids in many pain control protocols and federal law is increasingly discouraging the use of opioids as a state law.

同時，在麻醉與精神科用途兩方面，臨床需求仍持續擴大，並受到廣泛的適應症外使用與既有輸注基礎設施的支持。必須認知到，氯胺酮正迅速在許多疼痛控制方案中成為鴉片類藥物的替代品，而聯邦法律也日益抑制鴉片類藥物的使用，並將其作為州法層面的要求。

We believe this creates a highly attractive initial commercial opportunity where reliability of supply and quality of manufacturing are as important as price. With US-based production, scalable manufacturing capability and a preservative-free profile, our goal is to provide a consistent and trusted source of ketamine at a time when clinicians are actively seeking alternatives to constrain supply on one hand and alternatives to using opioids on the other.

我們相信，這帶來一個極具吸引力的初期商業機會：供應可靠性與製造品質與價格同等重要。憑藉美國本土生產、可擴充的製造能力以及無防腐劑特性，我們的目標是在臨床醫師一方面積極尋求替代方案以因應供應受限、另一方面尋求替代方案以減少使用鴉片類藥物之際，提供穩定且可信賴的氯胺酮來源。

We believe our product represents the first domestically manufactured source of preservative-free ketamine. And we further reinforced this position through our previously filed citizen petition supporting standards for preservative-free formulations.

我們相信，我們的產品代表首個國內製造的無防腐劑氯胺酮來源。此外，我們先前提交的公民請願亦支持無防腐劑配方的相關標準，進一步強化了此一定位。

Turning to NRX-100. As we shared in March, our Type C meeting with the leadership of the FDA Division of Psychiatry Products and the Center for Drug Evaluation and Research confirmed FDA's willingness to review existing clinical trial data together with real-world evidence as potential basis for approval without a requirement for additional trials.

接著談 NRX-100。如我們在 3 月所分享，我們與 FDA 精神科產品處（Division of Psychiatry Products）及藥物評估與研究中心（Center for Drug Evaluation and Research）領導層召開的 Type C 會議，確認 FDA 願意審查既有臨床試驗數據以及真實世界證據，作為可能的核准基礎，而不要求額外試驗。

The NDA, which we expect to file in the second quarter, will be supported by clinical trial data on more than 1,000 patients and real-world evidence on more than 65,000 patients through our partnership with Osmind. FDA also guided us to seek the broader indication of depression in patients who may have suicidality rather than simply seeking an approval for patients who have suicidality, which applies to more than 10 million Americans.

我們預計於第二季提交的 NDA，將以超過 1,000 名病患的臨床試驗數據，以及透過與 Osmind 合作取得、超過 65,000 名病患的真實世界證據作為支持。FDA 亦指引我們尋求較廣泛的適應症：針對可能具有自殺意念的憂鬱症患者，而非僅針對具有自殺意念的患者；後者適用於超過 1,000 萬名美國人。

In April, the regulatory environment evolved further. On April 18, President Trump signed an executive order titled Accelerating Medical Treatment for Serious Mental Illness, directing acceleration of approval pathways for psychedelic medicines to treat depression, PTSD, and suicidality and directing FDA to award Commissioner's National Priority vouchers to qualifying drugs. The presidential order specifically directs the use of real-world evidence in the approval process for this class of drugs.

4 月，監管環境進一步演變。4 月 18 日，川普總統簽署名為《加速嚴重精神疾病的醫療治療》（Accelerating Medical Treatment for Serious Mental Illness）的行政命令，指示加速用於治療憂鬱症、PTSD 與自殺意念之迷幻藥物的核准途徑，並指示 FDA 向符合資格的藥物授予署長國家優先（Commissioner's National Priority）憑證。該總統命令特別指示在此類藥物的核准流程中使用真實世界證據。

Congressional appropriations language has similarly been filed, encouraging the use of real-world evidence in approval of drugs for suicidal depression and PTSD. We've applied for commission's national priority voucher in support of our NDA.

國會撥款相關文字亦已提交，鼓勵在針對自殺性憂鬱症與 PTSD 的藥物核准中使用真實世界證據。我們已申請委員會的國家優先審查憑證，以支持我們的 NDA。

For context, the current generic ketamine market exceeds $750 million per year, not counting the shadow market of ketamine that's being bought through compounding pharmacies, while SPRAVATO generates approximately $2 billion annually despite labeling that does not include reduction in suicidality.

作為背景，目前通用名氯胺酮（ketamine）市場每年超過 7.5 億美元，尚未計入透過配製藥局購買的氯胺酮灰色市場；而 SPRAVATO 儘管其標示適應症不包含降低自殺傾向，仍每年約創造 20 億美元營收。

Moving to NRX-101. When we advance two parallel tracks in our original indication of suicidal bipolar depression, we've initiated an NDA filing with submission of Module 3 manufacturing files, and we're requesting rolling review under our Breakthrough Therapy Designation.

接著談 NRX-101。在我們針對自殺性雙相憂鬱症的原始適應症推進兩條平行路徑之際，我們已啟動 NDA 申報，並提交第 3 模組（Module 3）製造文件，同時在我們的突破性療法認定（Breakthrough Therapy Designation）下申請滾動式審查。

Separately, however, on May 7, we received FDA clearance to proceed with the MIND1 trial, a Phase 2B/3 study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated one-day protocol. The trial is designed to enroll 400 participants across a leading academic teaching hospital, HOPE Therapeutics clinics, and US military treatment facilities with non-dilutive federal funding anticipated.

不過另外一方面，5 月 7 日我們獲得 FDA 核准可推進 MIND1 試驗，這是一項第 2B/3 期研究，比較 NRX-101 與安慰劑，作為機器人輔助 TMS 的加成治療，採用加速的一日療程方案。該試驗設計將在一所頂尖學術教學醫院、HOPE Therapeutics 診所，以及美國軍方醫療機構招募 400 名受試者，並預期取得非稀釋性的聯邦資金支持。

This use of NRX-101 was not anticipated until recent data have shown a doubling of clinical response and an eightfold increase in remission from depression when D-cycloserine is added to standard transcranial magnetic stimulation therapy. The market opportunity for this indication is in excess of $1 billion. We've also achieved non-clinical validation of a proprietary extended-release form of D-cycloserine designed to support TMS augmentation.

在近期數據顯示，於標準經顱磁刺激（TMS）治療中加入 D-環絲氨酸（D-cycloserine）可使臨床反應倍增，且憂鬱症緩解率提升八倍之前，NRX-101 的此一用途並未被預期。此適應症的市場機會超過 10 億美元。我們亦已完成一種專有 D-環絲氨酸緩釋劑型的非臨床驗證，旨在支援 TMS 加成治療。

The MIND1 trial will be conducted by NRx Defense Systems, a Florida-based R&D subsidiary we incorporated in April. NRx Defense Systems is led by Dr. Dennis McBride, retired Navy Captain, a former DARPA program manager. He served two terms as the DARPA program manager and former senior executive, both in the National Defense University and in the Office of the Secretary of Defense.

MIND1 試驗將由 NRx Defense Systems 執行，該公司為我們於 4 月成立、位於佛羅里達的研發子公司。NRx Defense Systems 由 Dennis McBride 醫師領導，他是退役海軍上校，曾任 DARPA 計畫經理。他曾兩度擔任 DARPA 計畫經理並出任資深主管，任職於國防大學以及國防部長辦公室。

The robotic-enabled TMS prototype is being developed in combination with Zeta Surgical, whose AI-powered neuro navigation platform has already received FDA 510 clearance for TMS navigation. We plan to unveil the prototype of Zeta at the Clinical TMS Society Annual Meeting in Boston in early June.

機器人輔助的 TMS 原型正與 Zeta Surgical 合作開發；其 AI 驅動的神經導航平台已取得 FDA 510 核准，可用於 TMS 導航。我們計畫於 6 月初在波士頓舉行的 Clinical TMS Society 年會上揭示 Zeta 的原型機。

Depression, if you want to see it, touch it, feel it first hand, please join us. Depression and PTSD carry a fivefold increased risk in frontline troops and first responders and personnel who are on standard antidepressants are not combat deployed. A short-term non-disqualifying treatment is both a healthcare imperative and a force readiness priority, not only in the military setting, but in the setting of firefighters, police officers, and other first responders.

憂鬱症——如果你想親眼看見、親手觸及、親身感受，歡迎加入我們。在第一線部隊與第一線應變人員中，憂鬱症與 PTSD 的風險增加五倍；而正在使用標準抗憂鬱藥的人員不會被派赴作戰部署。短期且不構成資格取消的治療，既是醫療照護的迫切需求，也是戰力整備的優先事項；不僅在軍方場域，在消防員、警察及其他第一線應變人員的場域亦然。

Turning to HOPE Therapeutics. We operated five Florida clinics during the quarter and expect eight or more locations by the end of the second quarter. In February, we appointed Professor Josh Brown of Harvard/McLean as Chief Medical Innovation Officer, joining Dr. Rebecca Cohen, our Medical Director. In March, HOPE announced a partnership with Emobot Health to deploy its AI-driven depression thermometer.

接著談 HOPE Therapeutics。本季我們在佛羅里達營運五家診所，並預期在第二季末達到八個或更多據點。2 月，我們任命哈佛／麥克林（Harvard/McLean）的 Josh Brown 教授為首席醫療創新長，與我們的醫療總監 Rebecca Cohen 醫師共同合作。3 月，HOPE 宣布與 Emobot Health 合作部署其 AI 驅動的「憂鬱溫度計」。

That's a cell phone app that can actually measure your level of depression at a very high correlation with standard depression measures. Emobot passively analyzes facial expressions, vocal tones, and actigraphy through a background smartphone application with clinical validation showing strong concordance against both MADRS and PHQ-9. This addresses a critical blind spot in the care of patients with depression suicidality.

那是一款手機 App，能以與標準憂鬱量表高度相關的方式，實際量測你的憂鬱程度。Emobot 透過背景執行的智慧型手機應用，被動分析臉部表情、聲音語調與活動記錄（actigraphy），其臨床驗證顯示與 MADRS 與 PHQ-9 皆具有高度一致性。這可補足在照護具有自殺傾向之憂鬱症患者時的一個關鍵盲點。

Approximately 50% of patients with treatment-resistant depression relapse within 6 to 12 months, and that relapse is often undetected between visits As I've said, we expect every patient in our network to be on EMOBOT. We continue to integrate our partnership with neurocare AG, which brings together the combined clinic base together with an installed base of more than 400 Apollo TMS machines across the US.

約有 50% 的治療抗性憂鬱症患者會在 6 至 12 個月內復發，而復發往往在回診間隔期間未被察覺。正如我所說，我們預期網絡中的每位患者都會使用 EMOBOT。我們也持續整合與 neurocare AG 的合作，該合作結合其診所網絡與在美國已安裝超過 400 台 Apollo TMS 設備的基礎。

Finally, an important pipeline expansion occurred just in the past few weeks. We, just last week, formed Geneuro, Inc., a Florida-based subsidiary built around a newly acquired portfolio targeting human endogenous retroviruses, or HERVs, which are implicated in schizophrenia, multiple sclerosis, ALS, autism, and optic neuritis. The portfolio was acquired through a Swiss Court Supervised liquidation sale of Geneuro SA, a Swiss company funded with existing cash and includes a broad patent portfolio, cell lines, antibodies, regulatory files, and data from pre-completed human clinical trials.

最後，在過去幾週我們完成了一項重要的產品線擴充。就在上週，我們成立了 Geneuro, Inc.，這是一家位於佛羅里達的子公司，核心為新近取得、針對人類內源性逆轉錄病毒（HERVs）的資產組合；HERVs 與思覺失調症、多發性硬化症、ALS（肌萎縮性側索硬化症）、自閉症及視神經炎相關。該資產組合係透過瑞士法院監督的 Geneuro SA（瑞士公司）清算拍賣取得，以現有現金支付，並包含廣泛的專利組合、細胞株、抗體、法規申報文件，以及已完成的人體臨床試驗數據。

Dr. Herve Perron, formerly Chief Scientist of Geneuro SA, has joined as our Chief Scientist; and Professor Marion Leboyer, who joined our Advisory Board several years ago, and whose intellectual property whose patents led us to this portfolio, will lead the anti-HERV-W program in schizophrenia. We anticipate supporting Geneuro through non-dilutive investment channels.

Geneuro SA 前首席科學家 Herve Perron 博士已加入並擔任我們的首席科學家；而 Marion Leboyer 教授數年前加入我們的顧問委員會，其智慧財產與專利引導我們取得此資產組合，將領導思覺失調症的抗 HERV-W 計畫。我們預期透過非稀釋性投資管道支持 Geneuro。

With that, I'll turn it over to Mike to review our financial results. Mr. Abrams?

接下來，我把時間交給 Mike 來回顧我們的財務結果。Abrams 先生？

Thank you, John. For the three months ended March 31, 2026, NRx Pharmaceuticals reported a net loss of approximately $1.4 million or $0.04 per share as compared to a net loss of approximately $5.5 million or $0.34 per share for the three months ended March 31, 2025, representing a 74% year-over-year reduction. This change is primarily related to the impact of certain fair value accounting measures and other non-recurring charges.

謝謝你，John。截至 2026 年 3 月 31 日止三個月，NRx Pharmaceuticals 報告淨損約 140 萬美元（每股 0.04 美元），相較於截至 2025 年 3 月 31 日止三個月淨損約 550 萬美元（每股 0.34 美元），年減 74%。此變動主要與若干公允價值會計衡量的影響及其他一次性費用有關。

For the three months ended March 31, 2026, NRx reported a loss from operations of $4.7 million versus a loss from operations of $3.8 million for the comparable quarter in 2025.

截至 2026 年 3 月 31 日止三個月，NRx 的營業損失為 470 萬美元，而 2025 年同季的營業損失為 380 萬美元。

The change is primarily driven by certain costs related to certain -- several targeted strategic initiatives advanced during the quarter ended March 31, 2026, which management believes will drive significant short- and long-term value for shareholders, including, but not limited to, progress toward the approval of our first drug product, aligning resources for an anticipated near-term commercial launch, augmenting and expanding profitable clinic operations, enhancing our overall intellectual property portfolio, and growing our development pipeline with new assets.

此變動主要由若干成本所驅動，這些成本與截至 2026 年 3 月 31 日止季度期間推進的多項聚焦之策略性計畫相關；管理層認為這些計畫將為股東帶來顯著的短期與長期價值，包括但不限於：推進我們首個藥品的核准、為預期近期的商業上市調整資源配置、強化並擴大具獲利性的診所營運、提升整體智慧財產權組合，以及以新資產擴充研發產品線。

For the three months ended March 31, 2026, research and development expense was approximately $1.3 million as compared to approximately $0.8 million for the three months ended March 31, 2025.

截至 2026 年 3 月 31 日止三個月，研發費用約為 130 萬美元，相較於截至 2025 年 3 月 31 日止三個月約為 80 萬美元。

General and administrative expense, which includes selling costs for the three months ended March 31, 2026, was approximately $3.8 million as compared to approximately $2.9 million for the three months ended March 31, 2025. The drivers of the changes of both research and development and G&A expense were both primarily driven, as mentioned above, certain costs related to our execution towards several targeted strategic initiatives advanced during the quarter ended March 31, 2026.

截至 2026 年 3 月 31 日止三個月，一般及行政費用（包含銷售成本）約為 380 萬美元，相較於截至 2025 年 3 月 31 日止三個月約為 290 萬美元。如前所述，研發費用與一般及行政費用變動的驅動因素，主要皆為我們在截至 2026 年 3 月 31 日止季度期間執行多項聚焦之策略性計畫所產生的若干成本。

As of March 31, 2026, the company had approximately $6.7 million in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic running, ongoing cost reduction initiatives, and continued availability of the company's active at-the-market offering will be sufficient to support operations through at least 2026. Subsequent to quarter end, the company generated approximately $7 million in gross proceeds from its at-the-market facility through the sale of common stock.

截至 2026 年 3 月 31 日，公司持有約 670 萬美元的現金及約當現金。管理層認為，目前現金資源、診所營運的預期成長、持續的成本降低措施，以及公司現行的「隨市發行」（at-the-market）計畫之持續可用性，將足以支持營運至少至 2026 年。在季度結束後，公司透過其隨市發行機制出售普通股，取得約 700 萬美元的總募集款。

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

那麼，我把電話交回給 Jon。Jonathan？

Thank you, Mike. We made meaningful progress on each of our programs in the first quarter. KETAFREE continues to advance through final FDA review. The NRX-100 NDA is on track for submission this quarter. The MIND1 trial has FDA clearance to proceed, and we expect non-dilutive funding to support it in partnership with the military sites that plan to deploy the trial.

謝謝你，Mike。我們在第一季於各項計畫上都取得了有意義的進展。KETAFREE 持續推進，正處於 FDA 最終審查階段。NRX-100 的 NDA 仍按計畫於本季提交。MIND1 試驗已獲 FDA 核准可繼續進行，我們預期將取得非稀釋性資金支持，並與計畫部署該試驗的軍方場址合作。

HOPE Therapeutics continues to add clinical sites and generate revenue. Geneuro adds a new platform for serious neurological and autoimmune disease supported through non-dilutive channels. Just to give you one example, the patent for treatment of endogenous retrovirus infection that is shown to be implicated in ALS is co-owned with the US National Institutes of Health and the prior company had a cooperative research and development agreement with the NIH.

HOPE Therapeutics 持續新增臨床據點並創造營收。Geneuro 新增了一個針對嚴重神經與自體免疫疾病的平台，並透過非稀釋性管道獲得支持。舉一個例子：針對內源性逆轉錄病毒感染的治療專利（已證實與 ALS 有關）由我們與美國國家衛生研究院（NIH）共同持有，而前一家公司曾與 NIH 簽有合作研究與開發協議。

We're deeply grateful to our team, to our patients, and their families, to our shareholders for the trust they place in us, our goal of bringing hope to life is closer than ever.

我們由衷感謝我們的團隊、我們的病患及其家屬，以及信任我們的股東；我們「讓希望成真」的目標比以往任何時候都更接近。

Operator, we're now ready to take questions.

接線員，我們現在準備開始回答問題。

(Operator Instructions) Tom Shrader, BTIG.

(接線員指示) Tom Shrader，BTIG。

A couple of operational ones for me. For KETAFREE, I understand there's need. What does the channel look like for distribution? How much do you have to build? Do you -- are the centers your customers? Or will this go through larger distributors? I'm just curious how much on the ground work is involved here? And then I have a real-world follow-up.

我有幾個營運面的問題。就 KETAFREE 而言，我理解市場有需求。在通路配送方面會是什麼樣子？你們需要建立多少能力？你們——這些中心會是你們的客戶嗎？還是會透過較大型的經銷商？我只是好奇這裡需要多少第一線的落地工作？另外我還有一個關於真實世界的追問。

Well, you're describing -- thank you, Tom. And as always, you get right to the heart of the matter. You're describing two different channels. There's the existing hospital channel for ketamine, the reference drug is Ketalar and given the drug shortages and what we believe will be a perception of not only of quality but US manufacturing and reliability.

嗯，你描述的是——謝謝你，Tom。而且一如既往，你直指問題核心。你描述的是兩種不同的通路。一個是既有的醫院端氯胺酮通路，參考藥是 Ketalar；在藥品短缺的情況下，加上我們相信市場會認為不僅品質更佳，且具備美國製造與供應可靠性。

We believe that with standard blocking and tackling for lack of a better word. And as you see the team that Glenn is bringing on to support that process in terms of payer outreach, in terms of major accounts at reach, part of our preservative-free ketamine strategy is that traditional market. But the other part is the clinic market that right now really doesn't have access to the wholesalers.

我們相信只要做一些基本功（沒有更好的說法）。而且如你所見，Glenn 正在組建團隊來支持該流程，包括與付款方的溝通、以及觸及主要客戶的關鍵客戶管理；我們無防腐劑氯胺酮策略的一部分就是這個傳統市場。但另一部分則是診所市場，而該市場目前其實無法取得批發商供貨。

And we've tested this. We've had our clinics call and try to buy from wholesalers. And so far, not a single one of our clinics has succeeded in obtaining a single vial of ketamine from any of the traditional wholesalers. The wholesalers really are uninterested in the most rapidly growing area of the clinic space. So those clinics are required to rely on a web of compounding pharmacies.

我們已經測試過這點。我們讓旗下診所打電話嘗試向批發商採購。到目前為止，我們沒有任何一家診所成功從任何傳統批發商取得哪怕一瓶氯胺酮。批發商對診所端這個成長最快的領域其實興趣不大。因此這些診所不得不依賴一張由配製藥局（compounding pharmacies）構成的網絡。

And we intend to displace that compounded product with reliably manufactured FDA-approved GMP product. So it's a two-pronged strategy at a time when not only is the psychiatry clinic market for ketamine rapidly growing, but as opioids are increasingly restricted in their availability and their prescribability, there is an increasing reliance on ketamine to treat pain syndromes as well.

我們打算以可靠製造、FDA 核准且符合 GMP 的產品，取代這些配製產品。因此這是一個雙軌策略；在精神科診所端的氯胺酮市場快速成長之際，隨著阿片類藥物的可取得性與可開立性日益受限，氯胺酮在疼痛症候群治療上的依賴度也在提高。

Got it. Okay. And then on the real-world ketamine data, I understand you have 65,000 records. What is the level of understanding with the FDA as to what they really want to see in those records? And is that all negotiated? We have 65,000 records that show the boxes you want to see filled? Or is that a negotiation that's ongoing?

了解。好。另外關於氯胺酮的真實世界數據，我理解你們有 65,000 筆紀錄。就這些紀錄，FDA 到底想看到什麼，你們目前理解到什麼程度？這些都已談妥了嗎？也就是說，我們有 65,000 筆紀錄，已經涵蓋你們希望看到的各項欄位？還是這仍是一個持續進行中的協商？

I mean, 65,000 is a lot. It's probably 60,000 more than you need if they like the record. So I'm just kind of curious where that process is in agreeing on what these records need to show.

我的意思是，65,000 很多。如果他們喜歡這些紀錄，可能比你們需要的多 60,000。只是我有點好奇，目前在就這些紀錄需要呈現什麼內容達成一致的進度到哪裡了。

And when we say records, we say record -- we mean records on 65,000 unique patients. At the risk of sounding humorous, everything with the FDA is a negotiation. But it's a negotiation that occurs through well-established channels. So what we agreed to in our meeting with FDA was we would -- they acknowledge that the preliminary cuts of the data looks promising.

我們說的 records（紀錄），是指 65,000 位不同病患的紀錄。冒著聽起來有點幽默的風險：跟 FDA 的一切都是協商。但這種協商是透過既定且成熟的管道進行。因此，我們在與 FDA 的會議中同意的是——他們承認初步切分的數據看起來很有希望。

Osmind has previously published data on about 20,000 patients, and that was part of our meeting package. So what we agreed is that we would submit a statistical analysis plan just in the same way that one submits a statistical analysis plan for a proposed clinical trial.

Osmind 先前已發表約 20,000 位病患的數據，那也是我們會議資料包的一部分。因此我們同意，我們會提交一份統計分析計畫（SAP），就像提交一項擬議臨床試驗的統計分析計畫一樣。

So that before we spin the data, before we do the first analysis, we will have agreed with FDA on what statistical tests will be used, which patients will be included and excluded, how they'll be categorized, so that when we do the analysis, we're not going to be in a position where we keep crunching the data over and over again, but sort of measured twice, cut once.

如此一來，在我們開始處理數據、進行第一次分析之前，我們會先與 FDA 就將使用哪些統計檢定、哪些病患納入與排除、如何分類等達成一致；這樣當我們做分析時，就不會陷入一再反覆重算數據的情況，而是「量兩次、剪一次」。

So right now, we're waiting for FDA's response to our statistical analysis plan. And as soon as we've agreed on exactly what tests will be used, we'll apply that and submit the data.

所以目前我們正在等待 FDA 對我們統計分析計畫的回覆。一旦就將使用的檢定方法完全達成一致，我們就會套用並提交數據。

And any time marks for any of that that you can share?

這些事項有沒有你能分享的任何時間點？

Well, there are some regulatory costs involved. So we're expecting FDA to come back to us approximately by the end of the month. I don't want to give you an exact date, but I don't have it at my fingertips, but that's about the time frame.

嗯，這裡面涉及一些法規相關成本。因此我們預期 FDA 大約會在月底前回覆我們。我不想給你一個確切日期，我手邊也沒有，但大概就是這個時間範圍。

Elemer Piros, Lucid Capital Markets.

Elemer Piros，Lucid Capital Markets。

Jonathan, I was wondering if you could help us understand the shortage, the ketamine shortage. What are the bottlenecks there, whether it's raw material or the scale of manufacturing? And how do you plan to overcome that shortage?

Jonathan，我想請你協助我們理解氯胺酮短缺的情況。瓶頸在哪裡，是原料問題還是製造規模問題？你們打算如何克服這個短缺？

Well, we're not in a very good position to understand other people's products. We know there is a shortage, whether it's a lack of glass vials, a lack of manufacturing capability for whatever reason that shortage exists. All we can really do is worry about our business and make sure we can address the shortage and do that by having a couple of years of ketamine drug ingredient in the warehouse by having high-volume assembly lines using blow-fill seal that are capable of making 1 million units in a single week if you run the line around the clock by having a manufacturing partner that literally has the loading dock capacity to get the raw materials in and the finished goods out the door. So we know how to address the shortage, but I'm not sure I can tell you exactly why the supply chain is undersupplied.

嗯，我們其實不太能掌握別人的產品狀況。我們知道確實有短缺；不論是玻璃小瓶短缺、或是因任何原因造成的製造能力不足。我們真正能做的就是專注於我們的業務，確保我們能因應短缺：在倉庫備有可供兩年的氯胺酮藥物原料；採用可高產量的 blow-fill-seal（吹灌封）組裝線，如果 24 小時運轉，一週可生產 100 萬個單位；並與一家製造夥伴合作，其裝卸碼頭能力足以讓原料進得來、成品出得去。所以我們知道如何因應短缺，但我不確定我能精確告訴你供應鏈為何供給不足。

Yeah. So raw material doesn't seem to be an issue?

了解。所以原料看起來不是問題？

It's not an issue for us. Availability of raw material is not a problem. I can't tell you the exact situation with pharmaceutical-grade glass today. I can tell you that during COVID, people were backed up a year. Pharmaceutical glass is kind of a problem worldwide.

對我們而言不是問題。原料供應不是問題。至於目前藥用級玻璃的確切情況，我無法告訴你。我可以告訴你的是，在 COVID 期間，大家的交期曾延宕到一年。藥用玻璃在全球範圍內算是一個問題。

Yeah. And somewhat related, if KETAFREE is approved, what do you anticipate the FDA's action would be towards a preservative-free ketamine as the solution across the industry?

是的。另外稍微相關的一點，如果 KETAFREE 獲得核准，您預期 FDA 對於「無防腐劑」氯胺酮作為全產業解決方案，會採取什麼行動？

Well, I would never want to predict what a regulatory agency will do. I can say that the current Secretary of Health has been quite vocal in his view of the need to remove toxic preservatives from -- certainly from foods and vaccines. He's certainly not been quiet about that throughout his career. The new acting commissioner of the FDA has been quite vocal about his view of safety and removal of toxic preservatives in various context.

嗯，我絕不想去預測監管機構會怎麼做。我可以說，現任衛生部部長一直相當直言不諱地表達他認為有必要移除有毒防腐劑——當然包括食品與疫苗中的。他在整個職涯中對此從未保持沉默。FDA 新任代理局長也在各種情境下相當直言不諱地表達他對安全性的看法，以及移除有毒防腐劑的立場。

And the law says that all ingredients in a drug should be safe. This particular preservative was put into ketamine back in the 1970s. And in general, nobody has really looked at the formulation until we got involved. Quite frankly, when we got involved, I asked, well, why is it there? And the answer was, oh, it's a necessary excipient, but ketamine will come out of solution without it. And I said, really?

而法律規定，藥品中的所有成分都應該是安全的。這種特定的防腐劑是在 1970 年代被加入氯胺酮中的。一般而言，在我們介入之前，幾乎沒有人真正檢視過這個配方。坦白說，當我們介入時，我問：嗯，為什麼要加它？得到的回答是：喔，它是必要的賦形劑，沒有它氯胺酮會從溶液中析出。我說：真的嗎？

And part of the reason that happened was I was involved back in the mid-1990s. We tried to figure out why does everybody with glaucoma have dry eye syndrome. And it turned out that it was the benzalkonium chloride in the eye drops that was killing the essential lipid component of human tears. So that's how I first learned about this class of preservatives. And that's why you see preservative-free eye drops on all the drug store shelves.

而我之所以會注意到這件事，部分原因是我在 1990 年代中期就曾參與相關工作。我們試著弄清楚為什麼每個青光眼患者都有乾眼症。結果發現，是眼藥水中的苯扎氯銨（benzalkonium chloride）正在破壞人類淚液中必需的脂質成分。這就是我第一次認識這一類防腐劑的原因。也因此你會在各大藥局貨架上看到無防腐劑的眼藥水。

So it will be interesting to see how the regulatory world ultimately reacts to this. But I think in general, the regulatory environment is pro-safety and anti-preservative.

所以，監管界最終會如何回應這件事，將會很有意思。但我認為整體而言，監管環境是偏向安全、反對防腐劑的。

Okay. And maybe one last question. Thank you. Once you file the NRX-100 NDA, how soon do you anticipate to learn whether you got the priority review, the voucher?

好的。也許最後一個問題，謝謝。一旦你們提交 NRX-100 的 NDA，你們預期多久會知道是否拿到優先審查（priority review）的資格、也就是那張憑證（voucher）？

Generally, that's a six-month process. But remember, we already have fast track approved for NRX-100. So we're already entitled to priority review.

一般來說，那是一個六個月的流程。但請記得，我們已經取得 NRX-100 的快速通道（fast track）資格。所以我們本來就已經有權享有優先審查。

(Operator Instructions) Patrick Trucchio, HC Wainwright.

（接線員指示）Patrick Trucchio，HC Wainwright。

Just first on KETAFREE. I thought you mentioned that the commercial manufacturing is now initiated a 1 million per dose month level. I'm wondering what inventory level do you expect to have available at the time of the launch?

先談 KETAFREE。我記得你提到商業化製造現在已啟動，規模是每月每劑 100 萬的水準。我想請問在上市時，你們預期可用的庫存水位會是多少？

At the time of the launch, we'll have at least 1 million units in the warehouse. And depending on what we see between now and then, we may take that up by 0.5 million or 1 million units.

在上市時，我們倉庫裡至少會有 100 萬個單位。並且視我們在那之前看到的情況，我們可能會再增加 50 萬或 100 萬個單位。

Got it. And for NRX-100, mentioned that have fast track review and that maybe hearing back on the CNPV could take six months. I guess, does this imply that you might be able to get a quicker review just with the standard fast track?

了解。那關於 NRX-100，你提到已經有快速通道，且可能要六個月才會收到 CNPV 的回覆。我想問，這是否意味著你們可能僅靠標準的快速通道就能獲得更快的審查？

Well, I don't know if anybody knows exactly how much a CNPV speeds up the process, but priority review is a pretty well-established pathway, and we know it does speed up the process. So could CNPV further speed the process? Could CNPV further increase the likelihood of an approval? I think those are all questions that remain to be seen.

嗯，我不確定是否有人確切知道 CNPV 能把流程加速多少，但優先審查是一條相當成熟的途徑，我們知道它確實能加快流程。所以 CNPV 是否能進一步加速？CNPV 是否能進一步提高核准的可能性？我認為這些都是仍有待觀察的問題。

I think the most important thing is to come to agreement with FDA on the real-world evidence and get that submitted. And in that regard, the President's executive order from April is enormously supportive and completely apart from the executive order from the White House.

我認為最重要的是與 FDA 就真實世界證據（real-world evidence）達成共識，並把資料提交上去。在這方面，總統四月的行政命令提供了極大的支持，而且這完全不同於白宮的那份行政命令。

If you look at the appropriations language in the FDA budget appropriation for this year, Congress has focused on the use of real-world evidence in the approval of drugs for depression and suicidality. So I think there's an increasing recognition that this is just something that's needed for the health of the American people, and it ought to get the most serious possible and expeditious possible review.

如果你看今年 FDA 預算撥款中的撥款文字（appropriations language），國會已聚焦於在憂鬱症與自殺傾向藥物核准中使用真實世界證據。所以我認為大家越來越認知到，這是為了美國人民健康所必需的事情，而且應該獲得最嚴肅、也最迅速的審查。

Yeah. That makes sense. And then just lastly, on the MIND1 trial for NRX-101 plus TMS. I'm wondering if you could talk a little bit more about this trial and including whether you would expect it to be registration-enabling if positive.

是的。這很合理。最後，關於 NRX-101 加上 TMS 的 MIND1 試驗。我想請你多談一點這個試驗，包括如果結果為正，你們是否預期它能成為支持註冊申請（registration-enabling）的試驗。

Well, it's certainly a large enough sample that if one had a dramatically positive result, and that wouldn't be P0.05, but P0.01 or better, given the priority that currently exists around treating depression and suicidality, again, back to the President's executive order, back to many things the Secretary said, back to things Congress is saying, a dramatic effect in this trial on par with previous results that have been seen where D-cycloserine doubled the effect of transcranial magnetic stimulation on depression, but increased that effect more than eightfold with respect to reducing suicidality.

嗯，樣本數確實夠大；如果出現非常顯著的正向結果——而且不只是 P<0.05，而是 P<0.01 或更好——考量到目前對治療憂鬱症與自殺傾向的優先性（回到總統的行政命令、回到部長說過的許多話、回到國會正在表達的立場），如果本試驗出現與先前結果相當的戲劇性效果：先前曾看到 D-環絲氨酸（D-cycloserine）使經顱磁刺激（TMS）對憂鬱症的效果加倍，但在降低自殺傾向方面，效果提升超過八倍。

I think if we saw something that was as dramatic as that, the possibility of seeking an approval based on one trial would be a very real possibility. But until the data is in hand, I'm not sure that our speculation matters. What matters is are getting this trial fielded in partnership with our military colleagues, with our academic colleagues.

我認為如果我們看到同樣戲劇性的結果，那麼基於單一試驗尋求核准的可能性會非常真實。但在資料到手之前，我不確定我們的推測是否重要。重要的是，我們正與軍方同仁、學術界同仁合作，把這個試驗真正推動並落地執行。

And if you take a look at the success that Professor Brown has had in this area over the last couple of years, we're extraordinarily excited to have him as the principal investigator for this work.

而如果你看看 Brown 教授過去幾年在這個領域取得的成果，我們非常興奮能由他擔任這項工作的主要研究者（principal investigator）。

Thank you. There are no further questions at this time. I will now hand the call back over to Jonathan Javitt for the closing remarks.

謝謝。目前沒有其他問題。我現在把電話交回 Jonathan Javitt 作結語。

Well, thank you. As I hope you can tell, this has been a quarter of heads down work. Our team has grown. Our proximity to market, we believe, has substantially increased or got shorter to be precise. And we're incredibly grateful to the investors who've come on board, who have lent their support, and given us their confidence. So thank you very much, and we look forward to seeing you soon.

好的，謝謝。如各位所見，這一季我們埋頭做了大量工作。我們的團隊已經擴大。我們與市場的距離，我們相信已大幅拉近——更精確地說，是縮短了。我們也非常感謝加入的投資人，給予支持並對我們投下信任票。非常感謝，也期待很快再與各位見面。

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.

謝謝。各位女士先生，本次電話會議到此結束。感謝各位參與。您現在可以掛斷電話。