NRX Pharmaceuticals Inc (NRXP) 2022 Q2 法說會逐字稿

Good day, and welcome to the NRx Pharmaceuticals' second-quarter 2022 earnings conference call. All participants will be in a listen-only mode. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note, this event is being recorded.

美好的一天，歡迎參加 NRx Pharmaceuticals 的 2022 年第二季財報電話會議。所有參與者將處於僅聽模式。 （操作員說明）今天的演示結束後，將有機會提問。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Tom Johnson. Please, go ahead.

我現在想把會議交給湯姆·約翰遜。請繼續。

Thank you, operator. 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.

謝謝你，接線生。在我們進行電話會議之前，我想提醒大家，根據美國聯邦證券法，本次電話會議中所做的某些陳述屬於前瞻性陳述。這些陳述存在風險和不確定性，可能導致實際結果與歷史經驗或當前預期有重大差異。

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

有關可能導致實際結果與本次電話會議中的聲明不同的因素的更多資​​訊包含在我們向 SEC 提交的定期報告中。本次電話會議期間所做的前瞻性陳述僅以本新聞稿發布日期為準。本公司不承擔更新或修改這些前瞻性陳述的義務。本次電話會議中提供的資訊包含在今天稍早發布的新聞稿和我們今天提交的公司 10-Q 表格中，可以從 NRx Pharmaceuticals, Inc. 網站的投資者頁面存取該表格。

Joining me on today's call from NRx Pharmaceuticals are Stephen Willard, Chief Executive Officer; and Seth Van Voorhees, Chief Financial Officer and Treasurer. Stephen will provide a summary of the company's progress before turning it over to Seth for a review of the financial results. Following their prepared remarks, Stephen and Seth will be joined by Robert Besthof, Head of Operations and Chief Commercial Officer, to address investor questions.

參加今天 NRx Pharmaceuticals 電話會議的有執行長 Stephen Willard；以及財務長兼財務主管 Seth Van Voorhees。史蒂芬將提供公司進展的摘要，然後將其交給賽斯審查財務表現。在做好準備的演講後，營運主管兼首席商務官 Robert Besthof 將與 Stephen 和 Seth 一起回答投資者的問題。

I will now turn the call over to Stephen.

我現在將把電話轉給史蒂芬。

Thank you, Tom. Good morning, everyone, and thank you for joining us today. I'm excited to host my first quarterly results call as CEO of NRx Pharmaceuticals. I spent a large portion of my career in both private industry and public service, dedicated to advancing compelling science to benefit people and to build value for shareholders.

謝謝你，湯姆。大家早安，感謝您今天加入我們。我很高興能夠以 NRx Pharmaceuticals 執行長主持我的第一次季度業績電話會議。我職業生涯的大部分時間都在私人企業和公共服務領域度過，致力於推動引人注目的科學，造福人民並為股東創造價值。

When I decided to assume the leadership role at NRx, I saw an opportunity to do both. Joining me in this endeavor are Seth Van Voorhees, our new Chief Financial Officer; Jonathan Javitt, our Chief Scientific Officer; and Robert Besthof, Head of Operations and Chief Commercial Officer. We appreciate your attendance today and look forward to engaging with you on this and future calls as we work to realize the opportunities before us.

當我決定擔任 NRx 的領導職務時，我看到了兩全其美的機會。與我一起努力的還有我們新任財務長 Seth Van Voorhees；喬納森‧賈維特 (Jonathan Javitt)，我們的首席科學官；以及營運主管兼首席商務官 Robert Besthof。我們感謝您今天的出席，並期待在這次和未來的電話會議中與您互動，我們將努力實現擺在我們面前的機會。

Before discussing our second-quarter results and plans for the balance of this year, I wanted to take a few moments to highlight what attracted me to the opportunities at NRx. First, NRx has an extraordinary organization with a strong scientific and regulatory foundation and a unique and robust intellectual property portfolio. This fact is a point of differentiation between NRx and many of its competitors.

在討論我們第二季的業績和今年剩餘時間的計劃之前，我想花一些時間強調 NRx 的機會吸引我的原因。首先，NRx 擁有一個非凡的組織，擁有強大的科學和監管基礎以及獨特而強大的智慧財產權組合。這一事實是 NRx 與其許多競爭對手的區別點。

Second, our lead asset, NRX-101, forms the basis of a psychiatry franchise with potential applications in the array of mental health issues, such as PTSD and other major depressive disorders. And third, our renewed development program for NRX-101 seeks to address significant unmet medical needs in bipolar depression that also represent a significant commercial opportunity.

其次，我們的主要資產 NRX-101 構成了精神病學專營權的基礎，在一系列心理健康問題（例如 PTSD 和其他嚴重憂鬱症）方面具有潛在的應用前景。第三，我們對 NRX-101 的新開發計畫旨在解決雙相憂鬱症中未滿足的重大醫療需求，這也代表著重要的商業機會。

Together with a strong team that has a track record of rapidly developing and bringing life-saving medications to market, I am delighted to be leading the effort to change the treatment paradigm for those patients and deliver value to all of us.

我很高興能與一支在快速開發救生藥物並將其推向市場方面擁有良好記錄的強大團隊一起努力，努力改變這些患者的治療模式，並為我們所有人帶來價值。

So let's begin. NRX-101. To our knowledge, NRX-101 is the only oral antidepressant that targets patients with bipolar depression and active suicidality, which typically is an exclusion criteria in clinical studies of depression and PTSD. Data from one of our previously completed Phase 2 clinical trials shows a significant reduction in both depression and suicidality compared to standard therapy in patients with bipolar depression who were acutely suicidal and who were initially stabilized with ketamine.

那麼讓我們開始吧。 NRX-101。據我們所知，NRX-101 是唯一針對雙相憂鬱症和主動自殺患者的口服抗憂鬱藥，這通常是憂鬱症和 PTSD 臨床研究的排除標準。我們先前完成的一項 2 期臨床試驗的數據顯示，與標準治療相比，對於有急性自殺傾向且最初用氯胺酮穩定下來的雙相抑鬱患者，抑鬱症和自殺率均顯著降低。

We have also released preclinical findings demonstrating that unlike ketamine, the key component in NRX-101 is not addictive. Moreover, we have shared with you the peer-reviewed biomarker findings from Columbia University, showing that NRX-101 achieves the same chemical changes in the brain as are achieved by ketamine and that these changes are statistically correlated with improvement in depression. NRX-101 is the only psychiatry drug that has been granted the biomarker letter by FDA, which you may read on the FDA website.

我們也發布了臨床前研究結果，顯示與氯胺酮不同，NRX-101 中的關鍵成分不會成癮。此外，我們與您分享了哥倫比亞大學經過同行評審的生物標記研究結果，表明 NRX-101 在大腦中實現了與氯胺酮相同的化學變化，並且這些變化與憂鬱症的改善在統計上相關。 NRX-101 是唯一獲得 FDA 授予生物標記證書的精神科藥物，您可以在 FDA 網站上閱讀該證書。

The potential oral non-addictive nature of NRX-101 therapy combined with its potential therapeutic effects to reduce both depression and suicidality offer significant advantages over other commercial and developmental drugs as a new therapeutic option for bipolar patients.

NRX-101 療法潛在的口服非成癮性及其減少憂鬱和自殺的潛在治療效果，作為雙相情感障礙患者的新治療選擇，比其他商業和開發藥物具有顯著優勢。

During our second quarter, we met our stated milestones for advancing NRX-101 to commercialization. Let me share the catalysts we project for the rest of the year. We initiated enrollment in our new Phase 2 trial of NRX-101 patients and patients who have bipolar depression would sub-acute suicidal ideation and behavior and has activated 10 clinical sites, which represents about two-thirds of our intended sites. Additional sites are being activated soon and enrollment is ongoing.

在第二季度，我們實現了推動 NRX-101 商業化的既定里程碑。讓我分享一下我們預計今年剩餘時間的催化劑。我們開始招募 NRX-101 患者和患有亞急性自殺意念和行為的雙相憂鬱症患者，並已激活 10 個臨床中心，約占我們預期中心的三分之二。其他站點即將激活，註冊正在進行中。

This 70-patient study is targeted at patients with bipolar depression and suicidality that do not require hospitalization. We expect to upgrade this trial to a Phase 3 as soon as we release our newly manufactured Phase 3 drug supply and have received FDA's guidance on primary and secondary endpoints. This trial in sub-acute patients who are treated in the outpatient setting aims to achieve a substantial enlargement of our potential indication from the 150,000 patients to 180,000 patients with bipolar depression and acute suicidality to the significantly larger population of patients being treated in the ambulatory setting.

這項 70 名患者參與的研究針對的是不需要住院治療的雙相憂鬱症和自殺傾向患者。我們預計，一旦我們發布新生產的第 3 期藥物供應並收到 FDA 關於主要和次要終點的指導，我們就會將該試驗升級到第 3 期。這項針對在門診接受治療的亞急性患者的試驗旨在將我們的潛在適應症從 150,000 名雙相抑鬱症和急性自殺患者擴大到 180,000 名患者，擴大到在門診接受治療的更多患者群體。

As I mentioned at the annual meeting of shareholders, we view this as a $2 billion opportunity. The sub-acute trial also reflects the request of many of our study clinicians who voiced their desire to also treat patients who were on the verge of needing to be hospitalized due to their increased thoughts of suicide. NRX-101 is the first drug introduced for these patients that has shown potential to decrease rather than increase risk of suicide, unlike SSRI antidepressants and perhaps even reduce the need for hospitalizations. We project a readout of the data of this trial by the end of 2022 or in the first quarter of 2023 and look forward to adding it to our registration package.

正如我在股東年會上提到的，我們認為這是一個 20 億美元的機會。這項亞急性試驗也反映了我們許多研究臨床醫生的要求，他們表示希望也治療因自殺念頭增加而處於需要住院邊緣的患者。 NRX-101 是針對這些患者推出的第一種藥物，與 SSRI 抗憂鬱藥物不同，它顯示出有可能降低而不是增加自殺風險，甚至可能減少住院治療的需要。我們預計在 2022 年底或 2023 年第一季讀出該試驗的數據，並期待將其添加到我們的註冊包中。

During the second quarter, we also advanced preparations to restart our Phase 3 trial of NRX-101 in patients with acute suicidal ideation and behavior under a special protocol agreement awarded to us by FDA. This study will be conducted with commercial level material and if successful, could lead to a new drug application or NDA with the FDA for NRX-101 by late 2023 or the first half of 2024.

在第二季度，我們也根據 FDA 授予我們的特殊協議協議，推進了在有急性自殺意念和行為的患者中重啟 NRX-101 3 期試驗的準備工作。這項研究將使用商業級材料進行，如果成功，可能會在 2023 年末或 2024 年上半年向 FDA 提交 NRX-101 的新藥申請或 NDA。

Recall that as part of our special protocol agreement with the FDA, the agency advises in writing the successful completion of this trial would permit a regulatory filing for drug approval. Conducting this trial with commercial-level material is key to submitting clinical data on a rolling basis under our breakthrough designation by, as I said, mid-2023, the potential NDA filing by year-end 2023, and commercialization as early as 2024.

回想一下，作為我們與 FDA 的特別協議協議的一部分，該機構以書面形式建議，成功完成該試驗將允許向監管機構提交藥物批准申請。使用商業級材料進行這項試驗是在我們的突破性指定下滾動提交臨床數據的關鍵，正如我所說，在 2023 年中期提交潛在的新藥申請，並最早在 2024 年實現商業化。

During the first half of 2022, we transferred manufacturers of NRX-101 to Alcami Corporation in North Carolina in order to enable Phase 3 readiness and preparedness for commercial stage. We have recently manufactured our first batch of medicine. Manufacturing is a crucial element to achieving submission readiness and approval for a new drug. This investment is an important piece of our overall plan to initiate our Phase 2b/3 registrational study with commercial-level materials.

2022年上半年，我們將NRX-101的製造商轉移到北卡羅來納州的阿爾卡米公司，以便為第三階段做好準備並為商業階段做好準備。我們最近生產了第一批藥品。製造是實現新藥提交準備和批准的關鍵要素。這項投資是我們啟動商業級材料 2b/3 階段註冊研究總體計畫的重要組成部分。

The psychiatry franchise is the starting foundation of our company. And with our broad patent estate, we believe we are in a unique position to deliver a highly differentiated product, to help patients in this area of very high unmet medical need. We are also considering exploring other high unmet medical need indications such as PTSD with suicidality.

精神科專營權是我們公司的起步基礎。憑藉我們廣泛的專利資產，我們相信我們處於獨特的地位，可以提供高度差異化的產品，幫助該領域醫療需求未滿足的患者。我們也正在考慮探索其他高度未滿足的醫療需求適應症，例如伴隨自殺傾向的創傷後壓力症候群（PTSD）。

There are approximately 9 million individuals in our country that experience PTSD. One-third of them have severe PTSD. Between 17 and 22 members of our armed forces and veterans are lost every day to suicide. We view this as another very high unmet medical need.

我國約有 900 萬人患有 PTSD。其中三分之一患有嚴重的創傷後壓力症候群。每天有 17 至 22 名武裝部隊成員和退伍軍人因自殺身亡。我們認為這是另一個非常高的未滿足的醫療需求。

Our intellectual property estate offers a range of options to combine a variety of molecules and NMDA receptor antagonist, including D-cycloserine, a component of NRX-101.

我們的智慧財產權提供了一系列組合多種分子和 NMDA 受體拮抗劑的選擇，包括 NRX-101 的成分 D-環絲胺酸。

Turning to ZYESAMI. As we announced in May, the NIH ACTIV-3b TESICO trial was stopped for futility. COVID-19 continues to be an unpredictable and challenging area as evidenced by another clinical trial done recently for another company by the NIH that also did not read out with the desired efficacy. Our assessment of future options for ZYESAMI will be guided by independent analysis of the NIH data, along with data we received from an independent assessment of chest X-rays from a sub-study that include a subgroup of approximately 80 patients that had survived to day 10 during our Phase 2b/3 study.

轉向澤薩米。正如我們在 5 月宣布的那樣，NIH ACTIV-3b TESICO 試驗因無效而被停止。 COVID-19 仍然是一個不可預測且具有挑戰性的領域，NIH 最近為另一家公司進行的另一項臨床試驗也證明了這一點，該試驗也沒有達到預期的療效。我們對ZYESAMI 未來選擇的評估將以對NIH 數據的獨立分析為指導，以及我們從一項子研究中對胸部X 光檢查進行獨立評估獲得的數據，該子研究包括約80 名至今倖存的患者的亞組在我們的 2b/3 階段研究期間為 10。

This sub-study showed a statistically significant improvement in chest X-rays using rail scores in patients with COVID-19 respiratory failure, compared to a worsening in patients treated with placebo and that P was less than 0.05. We expect to receive the NIH data in the late third quarter or early fourth quarter, and we'll conduct an independent analysis at this time.

這項子研究顯示，與接受安慰劑治療的患者病情惡化相比，使用鐵路評分的 COVID-19 呼吸衰竭患者的胸部 X 光檢查結果有統計學上的顯著改善，且 P 值小於 0.05。我們預計在第三季末或第四季初收到 NIH 數據，此時我們將進行獨立分析。

Earlier this year, we completed manufacture of Phase 3 commercial-ready ZYESAMI. We are not funding additional trials of ZYESAMI at this time.

今年早些時候，我們完成了第三階段商用 ZYESAMI 的製造。目前我們不會資助 ZYESAMI 的額外試驗。

With that, I will turn it over to Seth for a brief overview of our financial results. Seth?

接下來，我將把它交給賽斯，讓他簡要概述我們的財務表現。賽斯？

Thank you, Stephen, and good morning, everyone. Like Stephen, I'm delighted to be part of the NRx leadership team, and I look forward to discussing our results and plans with you.

謝謝你，史蒂芬，大家早安。和 Stephen 一樣，我很高興成為 NRx 領導團隊的一員，我期待與您討論我們的結果和計劃。

First, I'd like to comment on our recent restatement of financial results for the second and third quarter of 2021. At the time of our merger in May of last year, warrants in the private company, NeuroRx, were exchanged for warrants in the public company, Big Rock Partners Acquisition Corp., which subsequently was renamed NRx Pharmaceuticals. These warrants were initially classified as equity in our financial reports.

首先，我想評論一下我們最近重述的 2021 年第二季度和第三季度的財務業績。去年 5 月我們合併時，私人公司 NeuroRx 的認股權證被交換為上市公司Big Rock Partners Acquisition Corp.，隨後更名為NRx Pharmaceuticals。這些認股權證最初在我們的財務報告中被歸類為股權。

However, in the process of preparing our financial statements for the second quarter of 2022, we concluded that the contingent features of these substitute warrants require that they be classified as a liability and not as equity. Last week, we detailed this issue in an 8-K and restated the second and third quarter reports for fiscal year 2021.

然而，在編制 2022 年第二季財務報表的過程中，我們得出的結論是，這些替代認股權證的或有特徵要求它們被歸類為負債而不是權益。上週，我們在 8-K 中詳細說明了這個問題，並重申了 2021 財年第二季和第三季報告。

The change resulted in a $15.9 million reduction in net loss from $16.1 million to $0.1 million for the three months ended June 30, 2021; and a comparable offsetting increase in the net loss during the third quarter of 2021, of $16.3 million from $20.8 million to $37.0 million for the three months ended September 30, 2021. The year had no impact on our cash balance and no impact on our operating cash flows and did not have a material impact on the company's consolidated financial statements for the full year.

這項變更導致截至 2021 年 6 月 30 日的三個月淨虧損從 1,610 萬美元減少到 10 萬美元；截至2021 年9 月30 日的三個月，2021 年第三季的淨虧損相應增加，從2,080 萬美元增至3,700 萬美元，增加了1,630 萬美元。這一年對我們的現金餘額沒有影響，對我們的營運也沒有影響現金流量，對公司全年合併財務報表沒有重大影響。

Now I'd like to discuss our financial results for the second quarter of 2022. Research and development expenses for the three months ended June 30, 2022, totaled $3.0 million, compared to $4.7 million for the same period in fiscal 2021. The decrease of $1.7 million related primarily to a decrease in clinical trial and developmental expenses related to ZYESAMI.

現在我想討論一下我們 2022 年第二季度的財務業績。截至 2022 年 6 月 30 日止三個月的研發費用總計 300 萬美元，而 2021 財年同期為 470 萬美元。170 萬美元主要與 ZYESAMI相關臨床試驗和開發費用的減少有關。

For the six-month period, R&D expenses totaled $8.4 million as compared to $7.6 million for the same period in fiscal year 2021. The increase of $0.9 million related primarily to an increase in regulatory and process development expenses.

在這六個月期間，研發費用總計 840 萬美元，而 2021 財年同期為 760 萬美元。增加 90 萬美元主要與監管和製程開發費用的增加有關。

General and administrative expenses for the three months ended June 30, 2022, totaled $6.6 million as compared to $12.5 million in the same period in fiscal year 2021. The decrease of $5.8 million was primarily related to a decrease in stock-based compensation and consulting fees, partially offset by an increase in higher insurance-related expenses.

截至 2022 年 6 月 30 日止三個月的一般及行政費用總計 660 萬美元，而 2021 財年同期為 1,250 萬美元。減少 580 萬美元主要與股票薪酬和諮詢費的減少有關，部分被保險相關費用增加所抵銷。

For the six-month period, G&A expenses totaled $16.9 million in fiscal year 2022, as compared to $14.6 million for the same period in fiscal year 2021. The increase of $2.3 million was primarily related to an increase in legal, professional, and insurance expenses, partially offset by a decrease in consulting fees and stock-based compensation expenses.

在這六個月期間，2022 財年的一般管理費用總計為 1,690 萬美元，而 2021 財年同期為 1,460 萬美元。增加 230 萬美元主要與法律、專業和保險費用的增加有關，部分被諮詢費和股票補償費用的減少所抵銷。

For the three-month period ended June 30, 2022, our net loss was $7 million as compared to a net loss of $0.1 million for the three months ended in June 30, 2021. For the six-month period, our net loss was $20.4 million as compared with a net loss of $25.6 million for the same period in 2021.

截至2022 年6 月30 日止的三個月期間，我們的淨虧損為700 萬美元，而截至2021 年6 月30 日止的三個月期間，我們的淨虧損為10 萬美元。在這六個月期間，我們的淨虧損為20.4 美元2021 年同期淨虧損為 2,560 萬美元。

Now I'd like to comment on our cash resources. As of June 30, 2022, we reported a cash balance of $24.5 million. We believe that we have sufficient funds and if necessary, the ability to reduce expenditures to support our operations through August 2023. We may consider raising capital during this year to further strengthen our balance sheet and to support our clinical trials and other operational activities.

現在我想談談我們的現金資源。截至 2022 年 6 月 30 日，我們報告的現金餘額為 2,450 萬美元。我們相信，我們有足夠的資金，如有必要，有能力減少支出來支持我們到2023 年8 月的營運。我們可能會考慮在今年籌集資金，以進一步加強我們的資產負債表並支持我們的臨床試驗和其他營運活動。

With that, I'll turn it back to Stephen for closing remarks. Stephen?

說到這裡，我將把它轉回給史蒂芬做結束語。斯蒂芬？

Thank you, Seth.

謝謝你，賽斯。

To conclude, we are excited about restarting development work in our psychiatry franchise. The unmet medical need in bipolar depression with suicidality are enormous. Today, we estimate that US annual peak sales potential for bipolar depression suicidality to be around $2 billion a year. There are only five drugs currently approved for bipolar depression and all of them carry the warning of increased suicidality.

總而言之，我們很高興能夠重新啟動我們精神病學專營權的開發工作。伴隨自殺傾向的雙極性憂鬱症未被滿足的醫療需求是巨大的。如今，我們估計美國雙極性憂鬱症自殺藥物的年高峰銷售潛力約為 20 億美元。目前只有五種藥物被批准用於治療雙相憂鬱症，並且所有這些藥物都帶有增加自殺傾向的警告。

Our Phase 2 study showed that NRX-101 has the potential to treat bipolar depression in patients with suicidality. That is why the FDA gave us breakthrough therapy designation and a special protocol agreement for registrational studies of less than 150 patients. If successful, this could lead to a commercialized product as early as 2024, and significant potential value.

我們的 2 期研究表明，NRX-101 有潛力治療有自殺傾向的雙相憂鬱症患者。這就是為什麼 FDA 給予我們突破性治療指定以及針對少於 150 名患者的註冊研究的特殊協議協議。如果成功，該產品最早可能在 2024 年實現商業化，並具有巨大的潛在價值。

We believe that NRX-101 is a potentially life-saving medicine that could change the treatment paradigm for individuals with bipolar depression that are also experiencing suicidality.

我們相信 NRX-101 是一種潛在的救命藥物，可以改變患有自殺傾向的雙極性憂鬱症患者的治療模式。

Tom, with that, we'll take some questions.

湯姆，接下來我們將回答一些問題。

Thank you. Operator, we --

謝謝。接線員，我們——

We will now begin the question-and-answer session. (Operator Instructions) Vernon Bernardino, HC Wainwright.

我們現在開始問答環節。 （操作員說明）Vernon Bernardino，HC Wainwright。

Hi. Thanks for taking my question. And Steve and Seth, welcome aboard. Looking forward to catching up to you in-person in the near future. Regarding the repatriated NRX-101 drug supply, just wondering if you could go to the mechanics or perhaps a history of that process, and what was the situation before that repatriation?

你好。感謝您提出我的問題。史蒂夫和賽斯，歡迎加入。期待在不久的將來與您見面。關於遣返的 NRX-101 藥物供應，只是想知道您是否可以了解機械師或該過程的歷史，以及遣返之前的情況如何？

Vernon, thank you very much for your call and your interest in us. Robert, would you like to handle that question?

弗農，非常感謝您的來電以及對我們的興趣。羅伯特，你願意回答這個問題嗎？

Yes. Hi. Good morning, Vernon. How are you? Thank you for your question.

是的。你好。早上好，佛農。你好嗎？謝謝你的問題。

Hi, Robert.

嗨，羅伯特。

Okay. So we had initially produced clinical material at Wuxi in China, and that is the material we've used to date in our clinical studies and also the material that is being used currently in the Phase 2 study.

好的。因此，我們最初在中國無錫生產了臨床材料，這是我們迄今為止在臨床研究中使用的材料，也是目前在第二期研究中使用的材料。

As you know, CMC is a crucial part of the regulatory submission process. And we felt it was appropriate to transfer that process, which we started late last year in this first half of the year to the US, to Alcami. And we've now started producing material, and we will be using that material in our Phase 3 study. So, we've successfully produced batches that will be released, and we expect to be using that material in our Phase 3 study later this year.

如您所知，CMC 是監管提交流程的重要組成部分。我們認為，將去年下半年開始的這項流程轉移到美國阿爾卡米是合適的。我們現在已經開始生產材料，我們將在第三階段研究中使用這些材料。因此，我們已經成功地生產了將要發布的批次，我們預計將在今年稍後的第三階段研究中使用該材料。

And as far as that was a desire to control the supply because of (inaudible) shipping --

就這而言，這是因為（聽不清楚）運輸而希望控制供應——

Exactly.

確切地。

Okay. (inaudible)

好的。 （聽不清）

Well not only with shipping, but it was our desire to have that in the US, closer to us at that time. Recall, we also had COVID at that time. We didn't know what things to deal, and we felt Alcami is an excellent partner to transfer the manufacturing to.

不僅是在運輸方面，我們也希望在美國擁有這種運輸，當時離我們更近。回想一下，我們當時也有新冠病毒。我們不知道要處理什麼事情，但我們覺得 Alcami 是一個將製造轉移到的優秀合作夥伴。

Okay. Maybe this is for Seth. Is there any accounting considerations as far as that supplies location that needs to be considered?

好的。也許這是為了賽斯。就供應地點而言，是否需要考慮任何會計事項？

No. I mean, there, obviously, will always be things in terms of exchange rate fluctuations, but nothing material that we anticipate.

不，我的意思是，很明顯，匯率波動總是會有一些事情，但我們預計不會有任何實質的事情。

Okay. One more question, and then I'll give -- one more question and then that's all I have, if I could. Regarding the supply of ZYESAMI, is there any accounting considerations that you're looking at there, considering there may, at least in my opinion, a possible impairment if future studies aren't pursued?

好的。如果可以的話，還有一個問題，然後我會再提出一個問題，然後這就是我所擁有的一切。關於 ZYESAMI 的供應，您是否考慮過任何會計考慮因素，至少在我看來，如果不進行未來的研究，可能會造成損害？

I'm sorry, could you repeat that question? You broke up in the middle, so I didn't quite catch it.

抱歉，您能重複這個問題嗎？你們中途分手了，所以我沒聽清楚。

Sorry, if I was just me-mumbling. But is there any accounting consideration as far as the supply of ZYESAMI that you may be considering, considering that -- in light that you may not pursue further future studies with ZYESAMI?

抱歉，如果我只是自言自語的話。但是，考慮到您未來可能不會繼續在 ZYESAMI 進行進一步的研究，您可能會考慮 ZYESAMI 的供應，是否有任何會計考慮？

Nothing that would be material.

沒有什麼是物質的。

Okay. Thanks for taking my question and congrats and looking forward to seeing the whole team in the near future.

好的。感謝您提出我的問題並表示祝賀，並期待在不久的將來見到整個團隊。

Thank you for your interest.

感謝您的關注。

Okay. We had two additional questions, Stephen, that were pre-submitted by investors.

好的。史蒂芬，我們還有兩個問題是投資者預先提交的。

Okay.

好的。

First question, there is a lot of business development going on in the pharmaceutical industry. Has NRx been a part of that in some way?

第一個問題，製藥業正在進行大量業務發展。 NRx 是否以某種方式參與其中？

Well, our technology includes components that have not shown addiction potential, which is an important differentiator. As a result of that, our technology, our IP portfolio have attracted strong interest, and we are in conversations with a number of potential partners.

嗯，我們的技術包括尚未表現出成癮潛力的組件，這是一個重要的區別因素。因此，我們的技術、我們的智慧財產權組合引起了人們的強烈興趣，我們正在與許多潛在的合作夥伴進行對話。

Thank you. Second question, how do you see NRX-101 in comparison to others in the industry, Axsome and Relmada compounds. I mean those are both in late Phase 3.

謝謝。第二個問題，與業界其他化合物（Axsome 和 Relmada 化合物）相比，您如何看待 NRX-101。我的意思是這些都處於第三階段後期。

Sure. I think they're interesting comparators to us. I believe that they do not study patients with suicidality. So in essence, they're seeking to develop an improved agent for major depressive treatment-resistant depression.

當然。我認為他們對我們來說是有趣的比較者。我相信他們不研究有自殺傾向的患者。因此，從本質上講，他們正在尋求開發一種改進的藥物來治療重度憂鬱症難治性憂鬱症。

We're focusing on a much higher unmet medical need in the bipolar segment with suicidality and up to 50% of bipolar people attempting suicide. Hence, we're working on an improved antidepressant that can be used in patients where the other two medicines cannot be used. And we think that while it's a comparator, it's a point of differentiation where we exceed the opportunities in a fairly significant $22 billion market.

我們專注於具有自殺傾向的雙相情感障礙患者以及高達 50% 的雙相情感障礙患者試圖自殺的未滿足醫療需求。因此，我們正在研究一種改良的抗憂鬱藥，可用於無法使用其他兩種藥物的患者。我們認為，雖然它是一個比較器，但它是一個差異點，我們在這個價值相當大的 220 億美元市場中超越了機會。

Okay. I believe those are the questions we had, operator.

好的。我相信這些就是我們的問題，操作員。

This concludes our question-and-answer session. I would like to turn the conference back over to Tom Johnson for any closing remarks. Please go ahead.

我們的問答環節到此結束。我想將會議轉回湯姆·約翰遜（Tom Johnson）發表閉幕詞。請繼續。

Well, thank you, everyone. That's all the time we have for questions today. I'm going to thank you for joining us this morning. This concludes NRx Pharmaceuticals' second-quarter 2020 results conference call. Thanks, everyone, for participating this morning.

嗯，謝謝大家。這就是我們今天提問的全部時間。我要感謝你今天早上加入我們。 NRx Pharmaceuticals 2020 年第二季業績電話會議至此結束。謝謝大家今天早上的參與。

Thank you.

謝謝。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。