NRX Pharmaceuticals Inc (NRXP) 2024 Q2 法說會逐字稿

Good afternoon, everyone, and welcome to the NRx Pharmaceuticals, Inc., second-quarter of 2024 results conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

大家下午好，歡迎參加 NRx Pharmaceuticals, Inc. 2024 年第二季業績電話會議。（操作員說明）謹此提醒，本次電話會議正在錄音。

I will now turn the call over to Matthew Duffy, the company's Chief Business Officer. Please go ahead.

我現在將把電話轉給公司首席商務官馬修·達菲 (Matthew Duffy)。請繼續。

Thank you, Franzy, 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 law. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

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

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

本次電話會議期間所做的前瞻性陳述僅代表截至本新聞稿發布之日的情況，本公司不承擔更新或修改前瞻性陳述的義務。本次電話會議中提供的資訊包含在今天發布的新聞稿和公司的 10-Q 表格中，可以從 NRx Pharmaceuticals 網站的投資者頁面存取該表格。

Joining me today are Dr. Jonathan Javitt, our Founder, Chairman and Chief Scientist; Stephen Willard, our Chief Executive Officer; and Richard Narido, Chief Financial Officer and Treasurer. Stephen and Jonathan will provide a summary of our company's progress. Rich will review the company's financial results. Then Jonathan will review upcoming milestones before making closing comments. Following the prepared remarks, we will address investor questions.

今天和我一起的還有我們的創辦人、董事長兼首席科學家喬納森·賈維特 (Jonathan Javitt) 博士；史蒂芬·威拉德，我們的執行長；財務長兼財務主管理查德‧納裡多 (Richard Narido)。史蒂芬和喬納森將總結我們公司的進展。里奇將審查公司的財務表現。然後喬納森將在發表總結評論之前回顧即將到來的里程碑。在準備好的發言之後，我們將回答投資人的問題。

I'll now turn the call over to Jonathan.

我現在將把電話轉給喬納森。

Thank you, Matt. Good afternoon, everybody. Thank you for joining us. Steve, Matt, Rich, rest of the team have now reached a point where years of hard work are beginning to bear visible fruit. We've reached three key inflection points on scientific, business and financing fronts and advancing our business. First, on the scientific front, we're poised to file two NDAs for our product candidates in the current coming months. NRX-100 for clinic-based treatment of suicidal depression that is intravenous ketamine, and NRX-101 for home-based treatment of bipolar depression in patients with suicidality or akathisia. That's an oral combination of D-cycloserine and Lurasidone.

謝謝你，馬特。大家下午好。感謝您加入我們。史蒂夫、馬特、里奇和團隊的其他成員現在已經達到了多年的努力開始結出明顯成果的地步。我們在科學、商業和融資領域以及推進我們的業務方面已經達到了三個關鍵轉折點。首先，在科學方面，我們準備在未來幾個月內為我們的候選產品提交兩項新藥申請。NRX-100 用於臨床治療自殺性憂鬱症，即靜脈注射氯胺酮，NRX-101 用於家庭治療自殺性憂鬱症或靜坐不能患者的雙相憂鬱症。這是 D-環絲胺酸和 Lurasidone 的口服組合。

Second, on the business front, we've laid the foundation for a roll-up of state-of-the-art ketamine and interventional psychiatry clinics that will advance the treatment of patients with suicidal depression. In the process, as Rich will tell you, we've substantially reduced operating costs and cut our loss per share by nearly 50% compared to the prior year.

其次，在業務方面，我們為建立最先進的氯胺酮和介入性精神病學診所奠定了基礎，這將促進自殺性憂鬱症患者的治療。在此過程中，正如 Rich 將告訴您的那樣，與前一年相比，我們大幅降低了營運成本，並將每股虧損減少了近 50%。

Third, on the corporate financing front, we fundamentally stabilized our business from an economic perspective by attracting a fundamental investor with more than $1 billion under management while simultaneously eliminating toxic debt that was the subject of litigation from our balance sheet. That new investor Anson Partners committed between $10.5 million and $16 million in new funding as announced in last night's 8-K filing. Investors have expressed a repeated concern as to whether we can fund the activities required to get our drugs approved. As announced yesterday, this is no longer a concern.

第三，在企業融資方面，我們吸引了管理規模超過10億美元的基本面投資者，同時從資產負債表中消除了成為訴訟對象的有毒債務，從經濟角度從根本上穩定了我們的業務。正如昨晚的 8-K 文件中宣布的那樣，新投資者 Anson Partners 承諾提供 1,050 萬至 1,600 萬美元的新資金。投資者一再擔心我們是否能夠資助我們的藥物獲得批准所需的活動。正如昨天宣布的那樣，這不再是一個問題。

In announcing the funding transaction, the principal of Anson said, NRx Pharmaceuticals has a promising pipeline with the potential to transform the lives of patients and their loved ones. We are pleased to be working with NRx Pharmaceuticals team to support these drugs in their registration and hopefully, their approval phase. We intend to live up to those wishes.

Anson 負責人在宣布此次融資交易時表示，NRx Pharmaceuticals 擁有一條前景光明的產品線，有可能改變患者及其親人的生活。我們很高興與 NRx Pharmaceuticals 團隊合作，支持這些藥物的註冊並希望在批准階段。我們打算實現這些願望。

The funds from the Anson investment will both pay for our FDA submissions and will retire debt from our balance sheet that has impeded our forward progress. The Anson funding brings us a substantially lower interest rate, a substantially lower conversion discount on our stock. and reduced expense in its other key features. It frees NRx from extraordinary conversion demand that in the past led to significant erosion in shareholder value.

Anson 投資的資金將用於支付我們向 FDA 提交申請的費用，並將從我們的資產負債表中消除阻礙我們前進的債務。Anson 的資金為我們帶來了大幅降低的利率，以及我們股票的大幅降低的轉換折扣。並減少了其他關鍵功能的費用。它使 NRx 擺脫了過去導致股東價值大幅侵蝕的異常轉換需求。

Much of the stock we allocated for this transaction is in the form of currently unregistered shares demonstrating substantial faith on the part of the new investor that we can and will execute on our commitments to commercial success. These three inflection points scientific, business and finance related are near term in nature rather than far. We aim to receive drug approvals for NRX-101 and NRX-100 in 2025 and to make these drugs available to patients. Until then, we will do so through compounding pharmacy relationships.

我們為本次交易分配的大部分股票都是目前未註冊股票的形式，這表明新投資者對我們能夠並將履行我們對商業成功的承諾充滿信心。這三個與科學、商業和金融相關的轉折點本質上是近期而非遙遠的。我們的目標是在 2025 年獲得 NRX-101 和 NRX-100 的藥物批准，並將這些藥物提供給患者。在那之前，我們將透過複合藥房關係來實現這一目標。

The first Hope Therapeutics clinic has been identified, along with multiple follow-on acquisitions and the acquisition structure is currently in negotiation. One of the nation's leading psychiatrists who pioneer the use of ketamine more than 15 years ago, has agreed to serve as our Chief Medical Innovation Officer. These are critical steps in our quest to bring hope to life. Thus, from a scientific and financial perspective, we have a company that's now poised to bring life-saving drugs to patients and financial returns to its investors.

第一家 Hope Therapeutics 診所已經確定，還有多項後續收購，收購結構目前正在談判中。15 年前率先使用氯胺酮的美國頂尖精神科醫生之一已同意擔任我們的首席醫療創新官。這些都是我們為生活帶來希望的關鍵步驟。因此，從科學和財務的角度來看，我們的公司現在準備為患者提供救命藥物，並為投資者帶來財務回報。

On the scientific front, we believe that NRX-101 has demonstrated a paradigm-changing breakthrough in the care of bipolar depression. Unfortunately, that breakthrough may not be completely understood because advances in drugs are so often viewed as advances in efficacy rather than advances in safety. In our recently completed clinical trial, we did not demonstrate that NRX-101 is more effective in reducing symptoms of depression than the market-leading drug Lurasidone. It doesn't need to be in order to be an extremely effective drug. What we did demonstrate is that NRX-101 is the first oral antidepressant to reduce symptoms of suicidality and the first oral antidepressant to reduce symptoms of akathisia, a highly dangerous side effect of every known antidepressant.

在科學方面，我們相信 NRX-101 在雙極性憂鬱症的治療方面取得了突破性的進展。不幸的是，這一突破可能沒有被完全理解，因為藥物的進步通常被視為功效的進步，而不是安全性的進步。在我們最近完成的臨床試驗中，我們並未證明 NRX-101 在減輕憂鬱症狀方面比市場領先的藥物 Lurasidone 更有效。它不需要成為一種極為有效的藥物。我們所證明的是，NRX-101 是第一種減輕自殺症狀的口服抗憂鬱藥，也是第一種減輕靜坐不能症狀的口服抗憂鬱藥，靜坐不能是所有已知抗憂鬱藥的一種非常危險的副作用。

The NRX-101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression. From the start, seratonin targeted drugs for the treatment of depression, it was known that these drugs cause side effects such as akathisia that directly cause their propensity to trigger suicidality. Doctors and patients have lived with these side effects in order to achieve the critical antidepressant effects that are needed to control this life-threatening disease. The data we presented at ASCP confirms our earlier STABIL-B trial demonstrating that NRX-101 is the first oral antidepressant to have effective antidepressant properties while simultaneously decreasing akathisia and suicidality.

美國臨床精神藥理學會公佈的 NRX-101 數據展示了治療雙相憂鬱症的新範例。從一開始，血清素就是治療憂鬱症的標靶藥物，人們知道這些藥物會引起靜坐不能等副作用，直接導致其引發自殺傾向。醫生和患者必須忍受這些副作用，才能達到控制這種危及生命的疾病所需的關鍵抗憂鬱效果。我們在 ASCP 上提供的數據證實了我們先前的 STABIL-B 試驗，證明 NRX-101 是第一種具有有效抗憂鬱特性、同時減少靜坐不能和自殺傾向的口服抗憂鬱藥物。

On the NRX-100 or ketamine side, as our quarterly report was going to the printer, a major scientific breakthrough was published in the Journal of Translational Psychiatry, a retrospective cohort study that consider the electronic medical records data of more than 500,000 Americans with depression, demonstrated that those treated with ketamine were substantially and significantly less likely to have suicidal ideation for up to nine months post treatment versus those not treated with ketamine. Although FDA traditionally considers data from randomized controlled trials as its primary basis, for determining efficacy, real-world data such as this when it mirrors the findings have already demonstrated in randomized controlled trials as we have demonstrated can be important and persuasive.

在NRX-100 或氯胺酮方面，當我們的季度報告即將付印時，一項重大科學突破發表在《轉化精神病學雜誌》上，這是一項回顧性隊列研究，考慮了超過500,000 名患有抑鬱症的美國人的電子病歷數據證明，與未接受氯胺酮治療的患者相比，接受氯胺酮治療的患者在治療後長達九個月內出現自殺意念的可能性顯著降低。儘管FDA 傳統上將隨機對照試驗的數據視為確定療效的主要依據，但像這樣反映結果的真實世界數據已經在隨機對照試驗中得到了證明，正如我們所證明的那樣，它可能是重要且有說服力的。

As you know from our various scientific presentations, we aim to present the FDA with patient-level data on nearly 1,000 patients in which ketamine has been tested in a prospective randomized manner against placebo, active comparator and electroshock therapy. We thank our investors for their patience as our novel preservative-free presentation of ketamine matures and becomes ready for FDA filing. Unfortunately, many in the public don't know that in order to seek approval of a drug, you must actually hold a fully manufactured drug in your hands that's been stable on the shelf for a year or more. Without that, the FDA will refuse to file the new drug application. We anticipate reaching the critical point in our manufacturing stability program where FDA filing is possible for NRX-100 by the end of October.

正如您從我們的各種科學演示中了解到的，我們的目標是向FDA 提供近1,000 名患者的患者水平數據，其中氯胺酮已經以前瞻性隨機方式與安慰劑、活性比較劑和電擊療法進行了測試。我們感謝投資人的耐心等待，我們的新型無防腐劑氯胺酮產品已日趨成熟並準備向 FDA 備案。不幸的是，許多公眾不知道，為了尋求某種藥物的批准，您實際上必須手中持有一種已在貨架上穩定放置一年或更長時間的完全生產的藥物。否則，FDA 將拒絕提交新藥申請。我們預計我們的生產穩定性計畫將在 10 月底達到 FDA 備案 NRX-100 的關鍵點。

A second key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. Several weeks ago, we announced that we achieved this critical alignment with FDA. The notion of a preservative-free ketamine has been surprising to some in the public. However, data have emerged from both primate and human studies that repeated doses of the currently available commercial intravenous ketamine are toxic to the brain. The commercial preparation was designed for anesthesia in a multi-dose vial where it was anticipated that doctors would draw from the same vial for multiple patients. That's no longer allowed in hospitals today, but that's how it was designed.

FDA 提交 NDA 的第二個關鍵要求是按照法律要求調整兒科研究計劃。幾週前，我們宣布與 FDA 達成了這一重要一致。不含防腐劑的氯胺酮的概念令一些公眾感到驚訝。然而，靈長類動物和人類研究的數據表明，重複劑量目前市售的靜脈注射氯胺酮對大腦有毒。該商業製劑設計用於多劑量小瓶中的麻醉，預計醫生將從同一個小瓶中為多個患者抽取藥物。如今，醫院不再允許這樣做，但它就是這樣設計的。

Accordingly, commercial ketamine preparations are manufactured with a potentially toxic preservative benzethonium chloride. While there is no evidence that Benzethonium chloride is toxic at its current concentration for the intended use of anesthesia, its safety has never been shown or even proposed for chronic use. Hence, we believe we are poised to file the first new drug application for a novel preparation of ketamine in unpreserved form that will bring substantial value to patients and be reimbursable by payers. Whereas, the current off-label use of ketamine is available only to patients who can pay substantial amounts of money out of pocket.

因此，商業氯胺酮製劑是用潛在有毒的防腐劑芐索氯銨製造的。雖然沒有證據表明苯索氯銨在其目前濃度下對於麻醉的預期用途是有毒的，但其安全性從未證明，甚至從未提議長期使用。因此，我們相信我們準備提交第一個新藥申請，用於未防腐形式的氯胺酮新型製劑，這將為患者帶來巨大的價值，並可由付款人償還。然而，目前氯胺酮的超適應症用途僅適用於能夠自掏腰包支付大量費用的患者。

In introducing Steve, I'd like to thank him for his profound contribution to our company as its first non-founder CEO. Steve joined our company on the tail of the COVID pandemic, at a time when we were restarting our psychiatry program and recovering our equanimity in the wake of a world catastrophe that cost the lives of 1 million Americans and many millions more around the globe. He brought a methodical wisdom to our team. Steve has advised me that as we prepare for 2025 as our first year of commercial operations we should seek a CEO who has had commercial experience in marketing and successfully selling at least $1 billion in pharmaceutical products. We're starting that search today, and Steve will be a key part of that process. Through his poise and legal discipline, Steve has afforded me the opportunity to take bolder steps in advancing our scientific agenda and our commercial prospects. He'll continue to be a key member of our team and our family.

在介紹史蒂夫時，我要感謝他作為第一位非創辦人執行長對我們公司的深遠貢獻。史蒂夫在新冠疫情大流行結束時加入了我們公司，當時我們正在重新啟動精神病學項目，並在一場導致 100 萬美國人和全球數百萬人喪生的世界災難之後恢復平靜。他為我們的團隊帶來了有條不紊的智慧。史蒂夫建議我，當我們為 2025 年作為商業運營的第一年做準備時，我們應該尋找一位在營銷方面擁有商業經驗並成功銷售至少 10 億美元藥品的首席執行官。我們今天開始搜索，史蒂夫將成為這個過程的關鍵部分。憑藉他的冷靜和法律紀律，史蒂夫為我提供了採取更大膽步驟來推進我們的科學議程和商業前景的機會。他將繼續成為我們團隊和家庭的重要成員。

Steve?

史蒂夫？

Jonathan, thank you for those very gracious comments. The chance to lead NRx has one of been the great joys of my life, and I look forward to helping guide NRx to its success as a commercial enterprise. I'm incredibly proud to process and progress our team has made over the past months and I'm grateful to our partners and investors as well as to all of the patients who have participated in our clinical trials. We look forward to continuing to build value for our shareholders and deliver life-saving treatments to patients. Most importantly, we continue to believe that these steps represent the beginning of our transition from a purely research and development company to a revenue-generating pharmaceutical company.

喬納森，感謝您的友好評論。領導 NRx 的機會是我一生中最大的樂趣之一，我期待著幫助引導 NRx 作為商業企業取得成功。我對我們團隊在過去幾個月的進展感到無比自豪，我感謝我們的合作夥伴和投資者以及所有參與我們臨床試驗的患者。我們期待繼續為股東創造價值，並為患者提供挽救生命的治療方法。最重要的是，我們仍然相信這些步驟代表了我們從純粹的研發公司轉型為創收製藥公司的開始。

We have made important progress with our clinical development pipeline this year. Suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC. We plan to bring NRX-100, clearly a life-saving product to market as soon as possible. The current market for intranasal ketamine is already $800 million, which has not demonstrated antisuicidal properties. We expect our market to be much larger. We continue to work toward a distribution of shares in Hope Therapeutics to our existing shareholders. We plan to seek public listing for the company on a national exchange.

今年我們的臨床開發管線取得了重要進展。自殺是一種全國性的流行病。據 CDC 稱，每年約有 380 萬美國人制定積極的自殺計劃。我們計劃盡快將 NRX-100 這顯然是一款救生產品推向市場。目前鼻內氯胺酮的市場規模已達 8 億美元，但尚未證明其具有抗自殺作用。我們預計我們的市場會更大。我們將繼續努力向現有股東分配 Hope Therapeutics 的股份。我們計劃尋求該公司在國家交易所公開上市。

Hope is planned to be a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other life-saving therapies to patients with suicidal depression and related disorders, together with digital therapies designed to augment and preserve the clinical benefit of NMDA targeted drug therapy. We expect funding for Hope to be independent and most nondilutive to NRx. At the same time, we believe this will continue to build value for NRx shareholders with this important asset on its balance sheet.

Hope 計劃成為一家護理服務公司，開發一流的診所網絡，目前為患有自殺性抑鬱症和相關疾病的患者提供氯胺酮和其他救生療法，以及旨在增強和維持臨床益處的數位療法NMDA標靶藥物治療。我們預計 Hope 的資金是獨立的，不會稀釋 NRx。同時，我們相信這將繼續為 NRx 股東創造價值，並將這項重要資產納入其資產負債表。

I will now ask Rich Narido, our CFO, to review the first quarter financials. Rich?

我現在將請我們的財務長 Rich Narido 審查第一季的財務狀況。富有的？

Thanks, Steve. For the three months ended June 30, 2024, we at NRx Pharmaceuticals reduced our net loss from $8.7 million in the second quarter of 2023 to $7.9 million in 2024, representing nearly a 10% improvement year-over-year. For that same period, we reduced research and development expenses from $3.9 million in 2023 to $2.8 million in 2024. The $1.1 million decrease is related primarily to a decrease of $2.4 million in clinical trial and development expenses, offset by an increase of $1.3 million related to the Alvogen warrants.

謝謝，史蒂夫。截至 2024 年 6 月 30 日的三個月，NRx Pharmaceuticals 將淨虧損從 2023 年第二季的 870 萬美元減少到 2024 年的 790 萬美元，年減近 10%。同期，我們將研發費用從 2023 年的 390 萬美元減少到 2024 年的 280 萬美元。110 萬美元的減少主要與臨床試驗和開發費用減少 240 萬美元有關，但被與 Alvogen 認股權證相關的 130 萬美元增加所抵消。

Also in the three-month period, we recorded an increase in general and administrative expenses from $4.1 million in 2023 to $4.2 million in 2024. The increase of $0.1 million is related primarily to an increase in consultants and legal fees, partially offset by lower insurance expenses. For the six months ended June 30, 2024, NRx Pharmaceuticals reduced its net loss to $14.4 million compared to $19.8 million in the prior year. These efficiencies represent an improvement in net loss of $5.4 million year over year and a $1.32 or 47% improvement in net loss per share year over year.

同樣在這三個月期間，我們的一般和管理費用從 2023 年的 410 萬美元增加到 2024 年的 420 萬美元。增加 10 萬美元主要與顧問和法律費用的增加有關，但部分被保險費用的減少所抵消。截至 2024 年 6 月 30 日的六個月，NRx Pharmaceuticals 將淨虧損減少至 1,440 萬美元，而前一年為 1,980 萬美元。這些效率意味著淨虧損年減了 540 萬美元，每股淨虧損年減了 1.32 美元，即 47%。

Over that six-month period, we recorded $4.6 million of research and development expenses compared to $7.5 million for the same period in 2023, representing a 39% decrease year over year. The decrease of $2.9 million is related primarily to a decrease of $4.1 million in clinical trial and development expenses, $0.3 million related to fees paid to regulatory and process development consultants, while offset by $1.3 million related to the Alvogen warrants, and $0.4 million related to fees paid to regulatory development consultants. Also in that six-month period, we decreased G&A by $1.4 million from $9.9 million in 2023 to $8.5 million in 2024, nearly a 15% decrease year-over-year.

在這六個月期間，我們的研發費用為 460 萬美元，而 2023 年同期為 750 萬美元，年減 39%。減少290 萬美元主要與臨床試驗和開發費用減少410 萬美元、支付給監管和製程開發顧問費用相關的30 萬美元減少有關，同時被Alvogen 認股權證相關的130 萬美元和與Alvogen 認股權證相關的40 萬美元所抵銷。同樣在這六個月期間，我們將一般管理費用減少了 140 萬美元，從 2023 年的 990 萬美元減少到 2024 年的 850 萬美元，年減近 15%。

As of June 30, we had $1.9 million in cash and cash equivalents. As previously stated, we recently announced that we secured up to $16 million of senior secured debt financing from Anson Funds. This financing is expected to support 2024 filing of New Drug Applications for NRX-100 and NRX-101 and to support the launch of HOPE therapeutics as well as retire its historical debt with more favorable terms and a lower annual interest rate. NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.

截至 6 月 30 日，我們擁有 190 萬美元的現金和現金等價物。如前所述，我們最近宣布從 Anson Funds 獲得高達 1,600 萬美元的優先擔保債務融資。這筆融資預計將支持 NRX-100 和 NRX-101 於 2024 年提交新藥申請，支持 HOPE 療法的推出，並以更優惠的條款和更低的年利率償還其歷史債務。NRx 繼續提高營運效率，以擴大現金跑道，並繼續專注於為股東創造收入和價值的道路。

With that, I will turn it back to Jonathan for closing remarks. Jonathan.

至此，我將把它轉回喬納森做結束語。喬納森.

Thank you, Rich. With two NDAs planned for the current coming months, the initiation of HOPE's clinic acquisition program to be financed through a nondilutive mechanism, together with a stabilized cash position we're in a solid position to build shareholder value. Most importantly, we are poised to address critical unmet medical needs for patients suffering from suicidal bipolar depression, suicidal major depression and those with limited access to advanced psychiatric care. In other words, we intend to deliver on our promise to bring hope to life.

謝謝你，里奇。隨著未來幾個月計劃的兩項新藥開發協議、透過非稀釋機制融資的 HOPE 診所收購計劃的啟動，以及穩定的現金狀況，我們在建立股東價值方面處於有利地位。最重要的是，我們準備好解決患有自殺性雙相憂鬱症、自殺性重度憂鬱症和那些獲得高級精神科護理機會有限的患者未滿足的關鍵醫療需求。換句話說，我們打算兌現我們的承諾，為生活帶來希望。

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

接線員，我們準備好回答觀眾的問題了。

(Operator Instructions) Ed Woo, Ascendiant.

（操作員指令）Ed Woo，Ascendant。

Congratulations on all the progress. It seems like your initial focus will be on the U.S. market, but have you given thought about international opportunities for both NRX-100 and 101?

祝賀所有的進展。您最初的重點似乎是美國市場，但您是否考慮過 NRX-100 和 101 的國際機會？

Well, there's no question that the rest of the world is important to us, and we've consistently listed a large number of foreign patent approvals. As you know, we have Composition of Matter patent protection on NRX-101, and, so far, it's been approved in just about every jurisdiction where we've applied. So that rest of the world opportunity is something we're very much focused on. As you know, we've added Professor Marion Leboyer, who's one of the leading psychiatrists in France, the professor of psychiatry at INSERM in Paris to our advisory board, and it's something we think about on a regular basis. That said, we do anticipate that the initial launch will be in the United States.

毫無疑問，世界其他地區對我們很重要，我們一直列出大量外國專利批准情況。如您所知，我們對 NRX-101 擁有物質成分專利保護，到目前為止，它已在我們申請的幾乎每個司法管轄區獲得批准。因此，世界其他地區的機會是我們非常關注的。如你所知，我們已將法國頂尖精神科醫生之一、巴黎 INSERM 精神病學教授 Marion Leboyer 教授納入我們的顧問委員會，這是我們定期考慮的問題。也就是說，我們確實預計首次發布將在美國。

Operator, we've received some electronic questions as well. I think this is for Dr. Javitt. Would you please tell us more about the Hope business plan, how the funding is going to work, and what the benefits of our shareholders may be?

接線員，我們也收到了一些電子問題。我想這是給賈維特醫生的。您能否告訴我們更多有關 Hope 商業計劃、資金將如何運作以及我們的股東可能獲得哪些利益的資訊？

So one of the things we've realized is that while there is some outstanding ketamine clinics run by dedicated psychiatrists in the US many of the initial attempts to create ketamine clinic networks across the country have been private equity driven, focused on minimizing cost of care, but not necessarily maximizing quality and innovation of care. And what we intend to do through Hope Therapeutics is to bring together a best-of-breed ketamine and interventional psychiatric clinics, together with networks of clinics that want to learn from them, want to bring their standards up to the best possible standards. And we've seen a fair degree of investor enthusiasm for that structure. We'll certainly have more to say in the coming months, but I think you'll see Hope as a living, breathing entity in the coming quarter.

因此，我們意識到的一件事是，雖然美國有一些由專門的精神科醫生經營的優秀氯胺酮診所，但許多在全國範圍內創建氯胺酮診所網絡的初步嘗試都是由私募股權驅動的，重點是最大限度地降低護理成本，但不一定能最大限度地提高護理品質和創新。我們打算透過 Hope Therapeutics 做的事情是將最好的氯胺酮和介入精神科診所以及希望向他們學習、希望將其標準提高到最佳標準的診所網絡聚集在一起。我們已經看到投資者對這種結構有相當程度的熱情。在接下來的幾個月裡，我們肯定會有更多的話要說，但我認為在接下來的季度中，您會看到希望是一個活生生的、會呼吸的實體。

Another one came in, and the question is, how do you see NRX-101 fitting into the treatment paradigm for bipolar depression?

另一個進來了，問題是，您如何看待 NRX-101 適合雙相憂鬱症的治療範例？

If we're able to get accelerated approval for NRX-101 in patients who have akathisia and or suicidal ideation on the current generation of 5-HT2a antagonist drugs, you're talking about Lurasidone, olanzapine, cariprazine, that family of drugs, I think you'll see NRX-101 become a preferred drug in that category. Because akathisia is -- one leading psychiatrist put to me the worst side effect of every antidepressant. It can have lethal consequences. And until now, people didn't talk about it too much because there wasn't much to do about it. All of a sudden, there is something to do about it, and we hope to be that solution.

如果我們能夠在使用當前一代5-HT2a 拮抗劑藥物治療患有靜坐不能和/或有自殺意念的患者中獲得NRX-101 的加速批准，那麼您談論的是魯拉西酮、奧氮平、卡利拉嗪，這些藥物家族，我認為您會看到 NRX-101 成為該類別的首選藥物。因為靜坐不能是──一位領先的精神科醫生向我提出了所有抗憂鬱藥物中最嚴重的副作用。它可能會產生致命的後果。直到現在，人們還沒有過多談論它，因為對此沒什麼可做的。突然之間，我們需要採取一些措施來解決這個問題，我們希望成為這樣的解決方案。

Okay. The last electronic question that we've received is Steve mentioned that inhaled ketamine had not shown an improvement in suicidality. Why would IV be better than that?

好的。我們收到的最後一個電子問題是史蒂夫提到吸入氯胺酮並沒有顯示出自殺傾向的改善。為什麼 IV 會比那更好？

Well, and it's certainly possible that a future trial will show that intranasal ketamine has improved properties against suicidality compared to placebo, although that wasn't the case either with inhaled racemic ketamine or so far hasn't been shown with inhaled esketamine. It's possible that, and some doctors have hypothesized this, the steady-state nature of an intravenous administration is important compared to the more sort of wax and wane, the more of an acute blast of ketamine that you get when it's given intranasally. Rather than focus on other people's approaches, I think if we just focus on ours and say, we've seen an important decrease in suicidality in the clinical trials that we're presenting to the FDA. And that decrease has now been echoed in a 500,000-person cohort study, that's really the important message.

嗯，未來的試驗肯定有可能表明，與安慰劑相比，鼻內氯胺酮具有改善自殺的特性，儘管吸入外消旋氯胺酮的情況並非如此，或者到目前為止吸入艾氯胺酮的情況尚未顯示。一些醫生推測，與鼻內給藥時氯胺酮的劇烈爆發相比，靜脈注射的穩態性質可能很重要。我認為，與其關注其他人的方法，不如只關注我們自己的方法，在我們向 FDA 提交的臨床試驗中，我們已經看到自殺率顯著下降。一項 50 萬人的隊列研究也證實了這一下降，這確實是一個重要的訊息。

Okay. Thank you. Those are all our electronic questions. Ed Woo is, I believe, asked another. Operator, would you please take his question?

好的。謝謝。這些都是我們的電子問題。我相信，艾德吳是另一個人問的。接線員，請回答他的問題好嗎？

Ed Woo.

埃德吳.

As you guys are planning out so many NDAs this year, a possible approval for next year, have you thought about your commercial strategy, whether you will develop your own commercial team or whether you look for commercial partners?

今年你們計劃了這麼多的NDA，明年可能會批准，你們有沒有想過你們的商業策略，是要發展自己的商業團隊還是尋找商業夥伴？

Well, in the case of NRX-100, we already know who the customers are because it's a clinic-based drug and there's a limited number of clinics. So about 600 and it could grow to 1,000 by next year who are using the drug. And some of those clinics are going to be clinics that Hope Therapeutic zones. So there's no need for the overhead of a large commercial partner to reach customers who already want to talk to you. In the case of NRX-101, it's also a fairly compact footprint. There are approximately 1,600 psychiatrists in the United States who currently prescribe the Lurasidone class of drugs. And you can reach that number of doctors with a fairly compact sales force of about 50 people. Now I'm possibly the least qualified person in the company to talk about that. Matt Duffy started out doing that for living.

就 NRX-100 而言，我們已經知道客戶是誰，因為它是一種基於臨床的藥物，而且診所數量有限。大約有 600 人正在使用這種藥物，到明年可能會增加到 1,000 人。其中一些診所將成為希望治療區的診所。因此，無需花費大型商業合作夥伴的管理費用來吸引已經想與您交談的客戶。就 NRX-101 而言，它的佔地面積也相當緊湊。美國目前約有 1,600 名精神科醫生開魯拉西酮類藥物。您可以透過大約 50 人的相當緊湊的銷售隊伍來接觸到這個數量的醫生。現在我可能是公司裡最沒有資格談論這個問題的人了。馬特達菲 (Matt Duffy) 最初是為了謀生才這樣做的。

And Matt, why don't you comment?

馬特，為什麼不發表評論？

Thanks, Jonathan. Sure. You can look at a number of different parameters in terms of number of prescribers, in terms of geography and access to representatives. There's a number of ways to approach it, but you can very effectively get out with reps, reps in the 20 to 30 rep range or not necessarily reps, but field force and really plank at the key prescribers in actually, as Jonathan pointed out, with both of these drugs. And as you do so, really target the highest prescribing folks out there. I've done this before at Lev and Medimmune. And the targeted sales force is really a good way to go. It's very efficient, and you can really get the word out there very quickly. And those are I think the important parameters as we look into taking this really to the next level because there's just a tremendous amount of opportunity.

謝謝，喬納森。當然。您可以根據處方者的數量、地理位置和代表的獲取情況來查看許多不同的參數。有很多方法可以解決這個問題，但你可以非常有效地通過重複次數來擺脫，重複次數在20 到30 次範圍內，或者不一定是重複次數，但實際上，正如喬納森指出的那樣，現場力量和真正的關鍵處方者，與這兩種藥物一起。當你這樣做時，真正針對的是那裡最高處方的人。我以前在 Lev 和 Medimmune 做過這樣的事。有針對性的銷售團隊確實是個好方法。它非常高效，而且您確實可以很快地將消息傳出去。我認為這些是我們考慮將其真正提升到新水平時的重要參數，因為存在大量機會。

And speakers, we don't have any questions over the phone. Please continue. I would like to hand the call over to Mr. Matthew Duffy.

發言者，我們在電話中沒有任何問題。請繼續。我想把電話轉給馬修·達菲先生。

Thank you, Franzy, and thank you, everyone. That's all the time we have for questions and our time for our call. So thank you, everyone, for joining us this evening. And this concludes the NRx Pharmaceuticals second-quarter 2024 results conference call. Thank you for participating.

謝謝你，弗蘭齊，也謝謝大家。這就是我們提問和打電話的所有時間。謝謝大家今晚加入我們。NRx Pharmaceuticals 2024 年第二季業績電話會議到此結束。感謝您的參與。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。謝謝。