NRX Pharmaceuticals Inc (NRXP) 2024 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and full year 2024 earnings call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question-and-answer session. (Operator Instructions)This call is being recorded on Monday, March 17, 2025.

女士們、先生們，早安，歡迎參加 NRx Pharmaceuticals 2024 年第四季和全年財報電話會議。此時，所有線路都處於只聽模式。演講結束後，我們將進行問答環節。(操作員指示)此通話於 2025 年 3 月 17 日星期一錄製。

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

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

Thank you, Joelle, and good morning, everyone. Welcome to our call. 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，喬爾，大家早安。歡迎來電洽詢。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。

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 Securities and Exchange Commission. The forward-looking statements made during this call speak only as of the day hereof, and the company undertakes no obligation to update or revise the forward looking statements.

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。本次電話會議中所做的前瞻性陳述僅代表當日的觀點，本公司不承擔更新或修改前瞻性陳述的義務。

Information presented on this call is contained in the press release issued this morning and the company's Form 10-K, which was filed on Friday and may be accessed from the Investor page of the NRx Pharmaceuticals, Inc. website.

本次電話會議中提供的資訊包含在今天早上發布的新聞稿和該公司週五提交的 10-K 表格中，可從 NRx Pharmaceuticals, Inc. 網站的投資者頁面訪問。

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 the 10-K and in the press release, following which Mike will review the company's financial results. Following our prepared remarks, we will address investor questions.

今天與我一起參加電話會議的還有我們的創始人、董事長兼首席執行官喬納森·賈維特 (Jonathan Javitt)；以及我們的首席財務官邁克爾·艾布拉姆斯（Michael Abrams）。Javitt 博士將概述我們公司在 10-K 報告和新聞稿中報告的進展情況，隨後 Mike 將回顧公司的財務表現。在我們準備好發言之後，我們將回答投資人的問題。

I will now turn the call over to Jonathan. Jonathan?

現在我將把電話轉給喬納森。喬納森？

Thank you, Matt. Good morning, everyone. Thank you for joining us. As you know, the Board asked me to assume leadership of NRx five months ago and to chart a path forward in the context of a capital market environment that's been less than supportive of pre revenue biotechnology company.

謝謝你，馬特。大家早安。感謝您加入我們。如你所知，董事會五個月前要求我擔任 NRx 的領導，並在資本市場環境對尚未盈利的生物技術公司支持力度不夠的情況下規劃前進的道路。

Over the past five months, we've raised new capital, retired toxic debt and begun executing on a path that leads our enterprise from a purely research and development focused company to a healthcare company that has potential to generate revenue and look forward to profit by the end of 2025. We believe that's rare among small cap biotech companies. At NRx, we continue to be driven by our mission to treat and prevent suicidality, depression, PTSD, and related disorders.

在過去的五個月裡，我們籌集了新的資本，償還了有毒債務，並開始走上一條道路，使我們的企業從一家純粹專注於研發的公司轉型為一家有潛力創造收入並有望在 2025 年底實現盈利的醫療保健公司。我們認為這在小型生技公司中很少見。在 NRx，我們繼續以治療和預防自殺傾向、憂鬱症、創傷後壓力症候群和相關疾病為己任。

While our mission has not changed, our path to revenue has advanced. Moreover, the US government and particularly the new administration has expressed increased commitment to the treatment of these lethal conditions with the class of medicines and clinical approaches that are central to our business. NRx Incorporated now owns two operating entities, the original NeuroRx business and the newly created HOPE Therapeutics.

雖然我們的使命沒有改變，但我們的創收之路已經進步了。此外，美國政府，特別是新政府，已表示將更加致力於利用對我們業務至關重要的藥物和臨床方法來治療這些致命疾病。NRx Incorporated 目前擁有兩個營運實體，即原 NeuroRx 業務和新成立的 HOPE Therapeutics。

All drugs under development are owned by NRx, while HOPE is focused on delivering clinical care. Under the original NeuroRx business, we've initiated filing of a New Drug Application or NDA for NRX-100, our preservative free intravenous ketamine based on stability data that support more than two years of room temperature shelf stability. We have proven manufacturing capacity to supply more than 1 million doses per month should we gain FDA approval.

所有正在研發的藥物均為 NRx 所有，而 HOPE 則專注於提供臨床護理。在原有的 NeuroRx 業務下，我們已經開始提交 NRX-100 的新藥申請或 NDA，NRX-100 是我們不含防腐劑的靜脈注射氯胺酮，其穩定性數據支持該產品在室溫下保質期超過兩年。一旦獲得 FDA 批准，我們已證明擁有每月供應超過 100 萬劑的生產能力。

We believe the strategic term sheet we have received to acquire this product for more than $300 million in total milestones and a double-digit royalty provides further validation of our drug development approach. NeuroRx is further preparing an accelerated NDA filing for NRX-101, a fixed dose combination of D-cycloserine and lurasidone with the anticipation that we will initiate an NDA filing in the coming quarter under accelerated approval.

我們相信，我們收到的以超過 3 億美元的總里程碑和兩位數特許權使用費收購該產品的策略條款清單進一步驗證了我們的藥物開發方法。NeuroRx 正在進一步準備 NRX-101（D-環絲氨酸和魯拉西酮的固定劑量組合）的加速 NDA 申請，預計我們將在下個季度根據加速批准啟動 NDA 申請。

Last year, we incorporated HOPE Therapeutics as a wholly owned subsidiary and began refining its mission. Simply put, NeuroRx will continue developing life-saving drugs, while HOPE will own clinics to treat patients with depression, PTSD and other life-saving -- life threatening brain diseases with a combination of drugs, medical devices, digital therapeutics and integrated psychiatric care.

去年，我們將 HOPE Therapeutics 合併為全資子公司，並開始完善其使命。簡而言之，NeuroRx 將繼續開發救命藥物，而 HOPE 將擁有診所，透過藥物、醫療設備、數位療法和綜合精神病護理相結合的方式治療患有憂鬱症、創傷後壓力症候群和其他救命 - 危及生命的腦部疾病的患者。

Those wishing to understand the mission of HOPE may gain insight from our presentation at the Sachs Biotechnology Innovation Forum cited in our annual report. In the past ten years, treatment of these diseases has transformed from a hopeless world in which psychiatric hospitalization, electroshock therapy and frequently ineffective drugs were the only alternatives for patients contemplating suicide to a world in which clinical success is being reported routinely in the public arena and being demonstrated in a number of well controlled clinical trials published in first tier journals.

那些希望了解 HOPE 使命的人可以從我們年度報告中引用的薩克斯生物技術創新論壇上的演講中獲得啟發。在過去十年中，這些疾病的治療已經發生了變化，不再是一個絕望的世界，曾經精神病住院治療、電擊療法和常常無效的藥物是考慮自殺的患者的唯一選擇，而現在，臨床成功的結果經常在公共場合報道，並在一些發表在一流期刊上的控制良好的臨床試驗中得到證明。

However, the totality of evidence as we see it suggests that no single treatment will yield the long term remission from the disease that Winston Churchill called his black dog, a disease that claims the life of well more than 500,000 Americans each year. The totality of evidence suggests that many patients require a combination of NMDA antagonist drugs or perhaps newer psychedelic therapies when they're approved, plus neuromodulatory therapies such as transcranial magnetic stimulation to achieve long term remission.

然而，我們所看到的所有證據表明，沒有一種單一的治療方法能夠長期緩解溫斯頓·邱吉爾稱之為「黑狗」的這種疾病，這種疾病每年奪走 50 多萬美國人的生命。全部證據表明，許多患者需要合併使用 NMDA 拮抗劑藥物或核准的較新的迷幻療法，再加上經顱磁刺激等神經調節療法，才能達到長期緩解。

All of these approaches are believed to work by a common pathway, namely raising the level of glutamate and other beneficial chemicals in the brain and causing the brain to form new healthy connections, otherwise known as synapses. HOPE has signed nonbinding letters of intent to acquire three already profitable interventional psychiatry clinics.

人們認為所有這些方法都透過一個共同的途徑起作用，即提高大腦中谷氨酸和其他有益化學物質的水平，並使大腦形成新的健康連接，即突觸。HOPE 已簽署不具約束力的意向書，將收購三家已經獲利的介入性精神病診所。

Our pipeline includes a number of additional clinics in Florida with whom we're in negotiation, as well as additional clinic groups in other geographies. We're in the process of drafting definitive acquisition documents and navigating the complexities of purchasing medical treatment facilities under state regulations. We're dedicated to building a company that will bring life-saving treatments to patients and financial returns to our investors.

我們的管道包括佛羅裡達州的多家診所（我們正在與其進行談判），以及其他地區的診所集團。我們正在起草最終收購文件，並根據國家法規處理購買醫療設施的複雜問題。我們致力於建立一家為患者帶來救命治療並為投資者帶來財務回報的公司。

Let's look at these programs in more detail. Suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC. An American dies from suicide every 11 minutes and worldwide, somebody dies from suicide every minute. Today, we are faced with a system where all patients who need life-saving precision psychiatry care with ketamine and other therapies are not routinely able to get it. Ketamine, for example, is available today almost exclusively to those who can afford to pay out of pocket and will remain so until FDA approval of ketamine for treating suicidal depression is obtained.

讓我們更詳細地了解這些程序。自殺傾向是一場全國性的流行病。根據美國疾病管制與預防中心的數據，每年約有 380 萬美國人積極制定自殺計畫。每 11 分鐘就有一名美國人死於自殺，而全世界每分鐘就有一人死於自殺。今天，我們面臨的系統是，所有需要使用氯胺酮和其他療法進行挽救生命的精準精神病治療的患者都無法定期獲得治療。例如，氯胺酮目前幾乎只提供給有能力自付費用的人，而且這種情況將持續到 FDA 批准氯胺酮用於治療自殺性憂鬱症。

We've initiated filing of our NDA for NRX-100, our intravenous preservative free ketamine in the treatment of suicidal depression, an indication with no approved pharmacotherapies. This NDA is supported with efficacy data from multiple well controlled trials. As identified in our 10-K, we've accepted nonbinding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 valued at potentially more than $300 million in milestones, plus a tiered double digit royalty.

我們已開始提交 NRX-100 的 NDA，這是我們的靜脈注射無防腐劑氯胺酮，用於治療自殺性憂鬱症，這是一種尚無核准藥物療法的適應症。該 NDA 得到了多項控制良好的試驗的功效數據的支持。正如我們在 10-K 報告中所述，我們已接受一家商業製藥公司的非約束性潛在條款，以授權和分銷價值可能超過 3 億美元的里程碑 NRX-100，外加分級兩位數的特許權使用費。

The issue of ketamine safety is one that will garner increased attention as the repeated use of ketamine becomes more widespread. Data from both primate and human studies show that repeated ketamine doses on the order of 60 doses or more of the currently available commercial intravenous ketamine may be toxic to the brain.

隨著氯胺酮的重複使用變得越來越普遍，氯胺酮的安全性問題將受到越來越多的關注。靈長類動物和人類研究的數據表明，重複注射 60 劑或更多劑量的目前市售靜脈注射氯胺酮可能會對大腦產生毒性。

The currently available ketamine preparation was designed for single use of the product in anesthesia. Ketamine is currently sold in a multi-dose vial where it was anticipated that doctors would draw from the same vial for multiple doses. Back in the 1960s when this preparation was formulated, it was manufactured with a potentially toxic preservative, benzethonium chloride.

目前可用的氯胺酮製劑設計為在麻醉中一次性使用。氯胺酮目前以多劑量小瓶形式出售，預計醫生將從同一小瓶中抽取多劑量。早在 20 世紀 60 年代，當這種製劑被配製時，它是用一種具有潛在毒性的防腐劑芐索氯銨製造的。

While there's no evidence that benzethonium chloride is toxic at its current concentration for the intended use in anesthesia, its safety has never been shown or even proposed for repeated use. The manufacturers of benzethonium chloride identify it as caustic, toxic, and capable of causing severe burns. This class of preservatives has increasingly been removed from eyedrops because of clear evidence of toxicity to the cornea and conjunctiva, even at the currently allowed levels.

雖然沒有證據表明芐索氯銨在目前的濃度下用於麻醉時會產生毒性，但其安全性從未得到證實，甚至從未被提議重複使用。芐索氯銨的製造商稱其具有腐蝕性、毒性，並能造成嚴重燒傷。由於有明顯證據表明，即使在目前允許的水平下，這類防腐劑也會對角膜和結膜產生毒性，因此越來越多地從眼藥水中去除此類防腐劑。

Chronic use of ketamine is associated in the literature with ulcerative cystitis, a dangerous bladder condition. This condition may be caused by the excretion of the preservative rather than by ketamine itself. Notably, there are no cases reported of interstitial cystitis following the use of SPRAVATO, a nasal form of S-ketamine that does not contain benzethonium chloride. Accordingly, we are filing a citizen's petition with the FDA to remove ketamine preparations with benzethonium chloride from the market until it can be shown safe for repeated use.

文獻通報，長期使用氯胺酮與潰瘍性膀胱炎（一種危險的膀胱疾病）有關。這種情況可能是由防腐劑的排泄而不是氯胺酮本身引起的。值得注意的是，目前尚未有使用 SPRAVATO（一種不含芐索氯銨的 S-氯胺酮鼻腔劑型）後出現間質性膀胱炎的病例報告。因此，我們正在向 FDA 提交一份公民請願書，要求將含有芐索氯銨的氯胺酮製劑從市場上撤出，直到能夠證明其可以安全地重複使用。

In light of our success in achieving long-term stability with preservative-free ketamine, the company is also filing an abbreviated NDA or ANDA for preservative free ketamine for all currently approved human and veterinary uses of intravenous ketamine. Hence, although we will never lose sight of our core mission to treat lethal CNS diseases, including suicidal depression and PTSD, the market for NRX-100 may be far larger than originally anticipated.

鑑於我們在無防腐劑氯胺酮方面取得的長期穩定性的成功，該公司還為所有目前批准的人類和獸醫靜脈注射氯胺酮申請了無防腐劑氯胺酮的簡化 NDA 或 ANDA。因此，儘管我們永遠不會忘記治療致命中樞神經系統疾病（包括自殺性憂鬱症和創傷後壓力症候群）的核心使命，但 NRX-100 的市場可能比最初預期的要大得多。

We have current manufacturing capability to supply 1 million vials of ketamine per month with the potential to scale up if needed. The toxic preservative is not the only challenge with the old Vietnam-era ketamine formulation. It's supplied at a pH of less than four, which can be administered intravenously, but cannot be injected subcutaneously because it causes pain and may cause skin ulcers.

我們目前的生產能力為每月供應 100 萬瓶氯胺酮，並且有需要時可以擴大生產規模。有毒防腐劑並不是越戰時期氯胺酮配方面臨的唯一挑戰。它的 pH 值低於 4，可以靜脈注射，但不能皮下注射，因為它會引起疼痛並可能導致皮膚潰瘍。

If you raise the pH, ketamine precipitates out of solution. Those who have tried to give ketamine by mouth have learned that the resulting blood levels can be highly inconsistent. Similar problems have occurred with ketamine nose spread. While intravenous administration is completely reliable in achieving intended blood levels, this mode of administration requires skilled nurses in clinic facilities.

如果提高 PH 值，氯胺酮就會從溶液中沉澱出來。嘗試過口服氯胺酮的人發現，其血液濃度可能會非常不一致。氯胺酮鼻腔擴散也出現了類似的問題。雖然靜脈注射能夠完全可靠地達到預期的血液水平，但這種給藥方式需要診所裡熟練的護理人員。

An attractive alternative is to give ketamine subcutaneously in the same way that insulin and newer obesity drugs are given. That route of administration is only enabled by a pH neutral form of ketamine. We've now developed a patentable version of pH neutral ketamine that remains stable at room temperature and are -- HTX-100 and we expect to begin human bioequivalence studies this year.

一個有吸引力的替代方法是皮下注射氯胺酮，就像注射胰島素和較新的減肥藥一樣。只有 pH 值中性的氯胺酮才能夠實現這種給藥途徑。我們現在已經開發出一種可獲得專利的 pH 中性氯胺酮，它在室溫下保持穩定，並且是 HTX-100，我們預計今年將開始人體生物等效性研究。

As is well known, bioequivalence is far simpler and less expensive to prove than safety and efficacy. If we are successful in gaining FDA approval for NRX-100, we have the potential to expand the number of patients who currently benefit from this form of care many-fold. The current off-label use of ketamine in brain disorders is generally only available to patients who can pay out of pocket.

眾所周知，生物等效性的證明比安全性和有效性的證明要簡單得多，而且成本也低得多。如果我們成功獲得 FDA 對 NRX-100 的批准，我們就有可能將目前受益於這種治療方式的患者數量增加數倍。目前，氯胺酮在治療腦部疾病的非說明書用途通常只適用於那些能夠自付費用的患者。

We expect NRX-100, once approved, to be widely reimbursed, thus providing access to the vast majority of people in need, not just those with the means to spend thousands of dollars in cash for treatment. NRX-100 represents a major opportunity for our company given the current market for intranasal S-ketamine, J&J's SPRAVATO, which is already approximately $1 billion. And the label states that it has not demonstrated anti-suicidal properties.

我們預計，NRX-100 一旦獲得批准，將得到廣泛的報銷，讓絕大多數有需要的人都能獲得治療，而不僅僅是那些有能力花費數千美元現金進行治療的人。鑑於目前鼻內 S-氯胺酮（強生公司的 SPRAVATO）的市場規模已達到約 10 億美元，NRX-100 對我們公司來說代表著一個重大機會。標籤上也指出，它並未顯示出抗自殺特性。

Now let's discuss NRX-101, our oral combination of cycloserine and NMDA receptor blocker and lurasidone, the standard of care in bipolar depression. Bipolar depression affects approximately 7 million people in the US. Current treatment options all carry the risk of suicide and akathisia, a side effect of serotonin active antidepressants, which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently.

現在讓我們討論 NRX-101，這是我們的環絲氨酸和 NMDA 受體阻斷劑與魯拉西酮的口服組合，是雙相憂鬱症的標準治療方法。雙極性憂鬱症影響著美國約 700 萬人。目前的治療方案都存在自殺和靜坐不能的風險，靜坐不能是血清素活性抗憂鬱藥物的副作用，與自殺密切相關。患有躁鬱症和靜坐不能或自殺傾向的人面臨著自我傷害的迫在眉睫的風險。這些患者迫切需要更好的治療選擇。

NRX-101 could represent a paradigm-changing breakthrough in the care of bipolar depression. In clinical trials, we've demonstrated comparable antidepressant effect to the leading antidepressant in this space with a statistically significant improvement in the safety of NRX-101 when compared to the standard of care, that is lurasidone.

NRX-101 可能代表雙極性憂鬱症治療領域的範式突破。在臨床試驗中，我們證明了 NRX-101 具有與該領域領先的抗憂鬱藥物相當的抗憂鬱效果，與標準治療藥物魯拉西酮相比，其安全性在統計上具有顯著提高。

In our recently completed clinical trial presented at the American Society of Clinical Psychopharmacology, NRX-101 demonstrated a comparable ability to reduce symptoms of depression when compared to lurasidone. Critically, NRX-101 demonstrated a reduction in symptoms of suicidality and is the first oral antidepressant to reduce symptoms of akathisia, a potentially lethal side effect of nearly all antidepressants. This could represent a new paradigm for treatment of bipolar depression.

在我們最近完成並提交給美國臨床精神藥理學會的臨床試驗中，NRX-101 表現出與魯拉西酮相當的減輕憂鬱症狀的能力。至關重要的是，NRX-101 顯示出了減輕自殺症狀的效果，並且是第一種減輕靜坐不能症狀的口服抗憂鬱藥，而靜坐不能是幾乎所有抗憂鬱藥物的潛在致命副作用。這可能代表了治療雙極性憂鬱症的新範例。

You may not have encountered the word akathisia before. However, key opinion leaders and patients who have suffered from akathisia regarded it as the worst side effect of antidepressants. Patients frequently describe it as a feeling of jumping out of their skin. Patients with akathisia are known to jump off roofs and in front of oncoming trains.

您可能以前沒有遇到過靜坐不能這個詞。然而，關鍵意見領袖和患有靜坐不能症的患者認為這是抗憂鬱藥物最嚴重的副作用。患者經常將其描述為一種從皮膚裡跳出來的感覺。患有靜坐不能症的患者會從屋頂跳下並跳到迎面駛來的火車前。

Recently, a patient petitioned the British Columbia Supreme Court for the right to end her life rather than continue to suffer from akathisia. Patients have simply had to endure this side effect in order to achieve the critical antidepressant effects that are needed to control bipolar depression. The data we presented at ASCP confirms data from our earlier STABIL-B trial demonstrating that NRX-101 is the first oral antidepressant to have effective antidepressant properties, while simultaneously decreasing akathisia in suicidality.

最近，一名患者向不列顛哥倫比亞省最高法院提出訴求，要求獲得結束生命的權利，而不是繼續遭受靜坐不能的折磨。為了達到控制雙極性憂鬱症所需的關鍵抗憂鬱效果，患者必須忍受這種副作用。我們在 ASCP 上展示的數據證實了我們早期 STABIL-B 試驗的數據，顯示 NRX-101 是第一種具有有效抗憂鬱特性的口服抗憂鬱藥，同時可降低自殺傾向的靜坐不能。

We believe this product profile could lead to NRX-101 becoming the drug of choice in bipolar depression. We're initiating the filing of an NDA for accelerated approval of NRX-101 for suicidal bipolar depression on patients at risk of akathisia. Given our strong data and the lack of treatment options for this group of people with bipolar depression, we and our regulatory council believe this to be a vital, unmet need and appropriate for consideration of accelerated approval. We plan to initiate filing in the early second quarter and anticipate a 2025 PDUFA date.

我們相信該產品特性可能使 NRX-101 成為治療雙相憂鬱症的首選藥物。我們正在啟動 NDA 申請，以加速批准 NRX-101 用於治療有靜坐不能風險的自殺性雙相憂鬱症患者。鑑於我們擁有的強大數據以及針對該組雙相憂鬱症患者的治療選擇不足，我們和我們的監管委員會認為，這是一個至關重要的、尚未滿足的需求，適合考慮加速批准。我們計劃在第二季初開始提交申請，預計 PDUFA 日期為 2025 年。

The company estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion. We've made substantial progress with HOPE Therapeutics in recent months. During the second half of 2024, we began outlining the plan for HOPE Therapeutics as a national and ultimately international network of interventional psychiatry centers that would combine neuroplastic treatments in an integrated and reproducible manner.

該公司估計，初步適應症的市場規模超過 20 億美元，而廣泛的雙相情感障礙市場規模可能超過 50 億美元。近幾個月來，我們與 HOPE Therapeutics 的合作取得了實質進展。2024 年下半年，我們開始概述 HOPE Therapeutics 的計劃，將其打造成為一個全國性的、並最終成為國際性的介入精神病學中心網絡，以綜合且可重複的方式結合神經可塑性治療。

The business model for HOPE Therapeutics is analogous to that of companies who have been instrumental in making kidney dialysis reliable and reproducible in a manner that transformed the industry. We've learned that ketamine alone is not sufficient to maintain remission from suicidality in many patients with depression and PTSD.

HOPE Therapeutics 的商業模式類似於那些在使腎臟透析可靠和可重複方面發揮重要作用並改變了整個行業的公司。我們了解到，單靠氯胺酮不足以維持許多憂鬱症和創傷後壓力症候群患者的自殺傾向緩解。

In clinical settings, ketamine has rapidly achieved a 50% reduction in suicidal ideation in numerous trials and real-world settings. This magnitude and rapidity of effect is a dramatic improvement from the prior 50 years of experience with SSRI and other serotonin-targeted antidepressants. The critical element is maintaining and enhancing the ketamine effect. This will, in our view, require a full range of additional therapies.

在臨床環境中，氯胺酮已在大量試驗和現實環境中迅速將自殺意念降低 50%。這種程度和快速的效果與過去 50 年使用 SSRI 和其他以血清素為標靶的抗憂鬱藥物的經驗相比有了顯著的改善。關鍵因素是維持和增強氯胺酮的作用。我們認為，這將需要全方位的額外治療。

In the fourth quarter, we announced our first major move to implement the HOPE business plan when we announced the signing of a non-binding letter of intent to acquire Kadima, LLC, a pioneering interventional psychiatry clinic in La Jolla, California. Kadima's founder, Dr. David Feifel, agreed to serve as HOPE's Chief Medical Innovation Officer post-acquisition and you heard his presentation with me at the SACS Forum.

第四季度，我們宣布了實施 HOPE 商業計劃的首個重大舉措，即宣布簽署一份非約束性意向書，收購位於加利福尼亞州拉霍亞的一家先驅介入精神病診所 Kadima, LLC。Kadima 的創辦人 David Feifel 博士同意在收購後擔任 HOPE 的首席醫療創新官，您在 SACS 論壇上和我一起聽到了他的演講。

He is one of the first academic psychiatrists to move ketamine and TMS therapy to the community care model and is frequently featured in the national media such as Rolling Stone and on Peacock as one of the most knowledgeable experts in the safe and appropriate use of ketamine and other advanced therapies in mental health treatment.

他是第一批將氯胺酮和 TMS 療法引入社區護理模式的學術精神病學家之一，並經常在《滾石》和《孔雀》等國家媒體上被報道，被認為是安全和適當使用氯胺酮和其他先進療法進行精神健康治療方面最有知識的專家之一。

Subsequent to the Kadima commitment, the company was poised to contract to acquire and partner with nine facilities in Florida, aiming for 15 to 20 facilities in Florida by year-end 2025. The clinical centers that are being incorporated in this acquisition program are revenue generating and EBITDA positive centers that the company believes can experience substantial revenue growth through the addition of a broader array of comprehensive services.

在做出 Kadima 承諾之後，該公司準備簽訂合同，收購佛羅裡達州的 9 家工廠並與其合作，目標是到 2025 年底在佛羅裡達州擁有 15 至 20 家工廠。此次收購計畫中納入的臨床中心均為創收中心，且 EBITDA 為正，公司相信透過增加更廣泛的綜合服務，這些中心的收入可以大幅成長。

Looking at the market, we estimate that the acquisition of 20 clinic networks, each with current revenue of approximately $5 million, will be required to meet the 2025 growth target. On the financial front, the best-in-class clinics currently generates operating margins of around 30%, with significant opportunities for further growth.

縱觀市場，我們估計，要實現 2025 年的成長目標，需要收購 20 個診所網絡，每個診所網路的當前收入約為 500 萬美元。在財務方面，一流的診所目前的營業利潤率約為 30%，並且具有巨大的進一步成長機會。

We expect funding for HOPE to be independent of and thus non-dilutive to NRx shareholders. However, we expect that a portion of the earnings generated through HOPE will support NRx's path to profitability and support our planned path to a spin-out of the company and subsequent listing on a national stock exchange.

我們預期 HOPE 的融資將獨立於 NRx 股東，因此不會稀釋 NRx 股東的權益。然而，我們預計透過 HOPE 產生的部分收益將支持 NRx 實現盈利，並支持我們計劃中的公司分拆以及隨後在國家證券交易所上市的道路。

Further, we recently announced the closing of our third tranche of funding from Anson Funds, an institutional investor bringing the total amount of financing to nearly $20 million. We anticipate that HOPE Clinics will be financed by traditional bank loans, supplemented by private equity and strategic lenders.

此外，我們最近宣布完成來自機構投資者 Anson Funds 的第三筆融資，使總融資額達到近 2,000 萬美元。我們預計 HOPE 診所的資金將來自傳統銀行貸款，並輔以私募股權和策略貸款。

We recently received a term sheet from a manufacturer of TMS technology to supplement funding from banks and similar financial institutions. As you've seen in our 10-K, we've substantially reduced operating expenses and are forecasting profitability on a going forward run rate basis by the end of 2025 with revenue and EBITDA from HOPE Therapeutics, along with projected sales of our medications.

我們最近收到了一份來自 TMS 技術製造商的條款清單，以補充銀行和類似金融機構的資金。正如您在我們的 10-K 報表中看到的，我們大幅削減了營運費用，並預測到 2025 年底，憑藉 HOPE Therapeutics 的收入和 EBITDA 以及我們藥品的預計銷售額，我們將在未來運行率基礎上實現盈利。

My first action when the board asked me to assume the leadership of NRx was to invite Mr. Michael Abrams to become our first full-time CFO. Mike has decades of experience as an investment banker, biotechnology executive, and Chief Financial Officer. He stepped into NRx just two months before the end of the fiscal year and achieved his first audit on time and with no material concerns raised by the auditors.

當董事會邀請我擔任 NRx 的領導時，我的第一個舉動就是邀請麥可‧艾布拉姆斯先生擔任我們的第一位全職財務長。麥克擁有數十年的投資銀行家、生技主管和財務長經驗。他在財政年度結束前兩個月加入 NRx，並按時完成了第一次審計，審計師沒有提出任何重大擔憂。

Now I would like Mike to review our financial results from 2024. Michael?

現在我想讓麥克回顧一下我們 2024 年的財務表現。麥可？

Thank you, Jonathan. For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million, and $27.8 million for the year ended December 31, 2023. This change was primarily driven by a decrease in research and development expense.

謝謝你，喬納森。截至 2024 年 12 月 31 日止年度，NRx Pharmaceuticals 的營業虧損減少了約 930 萬美元（即 33.5%）至 1,850 萬美元，截至 2023 年 12 月 31 日止年度的營業虧損為 2,780 萬美元。這項變更主要是由於研發費用的減少所致。

For the year ended December 31, 2024, research and development expense decreased by approximately $7.2 million or 53.6% to $6.2 million, as compared to $13.4 million for the year ended December 31, 2023. This change is primarily driven by a decrease in clinical trial and development expense due to the conclusion of the Phase 2b/3 study for NRX-101.

截至 2024 年 12 月 31 日止年度，研發費用減少約 720 萬美元（即 53.6%）至 620 萬美元，截至 2023 年 12 月 31 日止年度則為 1,340 萬美元。這項變更主要是由於 NRX-101 2b/3 期研究的結束導致臨床試驗和開發費用的減少。

Finally, general administrative expense for the year ended December 31, 2024, decreased by approximately $7.7 million to $13.5 million as compared to $14.2 million for the year ended December 31, 2023. This change was primarily driven by a reduction in insurance and employee costs and partially offset by the increase in consulting fees related to the potential acquisition of several psychiatry clinics in support of the growth model for HOPE Therapeutics.

最後，截至 2024 年 12 月 31 日止年度的一般行政費用為 1,350 萬美元，而截至 2023 年 12 月 31 日止年度的一般行政費用為 1,420 萬美元，減少了約 770 萬美元。這項變更主要是由於保險和員工成本的減少，但因 HOPE Therapeutics 為支持其成長模式而可能收購幾家精神病診所而導致的諮詢費增加，部分抵消了這一變化。

As of December 31, 2024, we had approximately $1.4 million in cash and cash equivalents. As noted above, in January 2025, the company completed two financings with aggregate gross proceeds of approximately $8.5 million. Management believes the current available cash resources will be sufficient to support ongoing operations through at least the end of 2025.

截至 2024 年 12 月 31 日，我們擁有約 140 萬美元的現金及現金等價物。如上所述，2025 年 1 月，該公司完成了兩筆融資，總收益約為 850 萬美元。管理層認為，目前可用的現金資源足以支持至少到 2025 年底的持續營運。

NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path of generating revenue and value for our shareholders. Please see detailed financials on our Form 10-K filed with Securities and Exchange Commission, which will also be available on our website.

NRx 繼續實施營運效率以延長現金流量並專注於為股東創造收入和價值。請參閱我們向美國證券交易委員會提交的 10-K 表格中的詳細財務信息，該表格也可在我們的網站上查閱。

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

說完，我把電話轉回喬納森。喬納森？

Thank you, Michael. The mission of NRx to prevent and treat suicidality in patients with depression and PTSD has continued to move forward. Over the last year, we've streamlined operations, we've retired toxic debt, we've capitalized the company to move forward. Planned 2025 PDUFA dates for our two NDAs and continuing the development of HOPE Therapeutics national network for care delivery are transformative steps for the company and for the treatment of mental health in the United States.

謝謝你，麥可。NRx 預防和治療憂鬱症和創傷後壓力症候群患者自殺傾向的使命一直在不斷推進。在過去的一年裡，我們精簡了運營，償還了不良債務，並為公司注入了資本，以推動公司向前發展。我們計劃於 2025 年完成兩項 NDA 的 PDUFA 日期，並繼續開發 HOPE Therapeutics 全國醫療服務網絡，這對於公司和美國的精神健康治療而言都是具有變革意義的一步。

I'd like to thank the NRx team, our 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、我們的投資者，最重要的是感謝參與我們臨床試驗的患者，感謝他們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。

Thank you. Ladies and gentlemen, we will begin the question-and-answer session. (Operator Instructions) Jason Kolbert, D. Boral Capital.

謝謝。女士們、先生們，我們開始問答環節。（操作員說明）Jason Kolbert，D. Boral Capital。

Good morning, guys. Congratulations on all the progress. Couple of questions. Jonathan, you made a good argument for removing the preservative from ketamine. If you remove the preservative for ketamine, how does that change the formulation? And for example, what do you do in its place?

大家早安。祝賀你取得的所有進展。幾個問題。喬納森，你提出了從氯胺酮中去除防腐劑的很好的理由。如果去除氯胺酮的防腐劑，配方會發生什麼樣的變化？舉例來說，您會做什麼呢？

When you say what do you do in its place, why do you need to do anything in its place?

當你說你要代替它做什麼時，為什麼你需要代替它做任何事？

Why is it there in the first place? Does ketamine degrade?

為什麼它會在那裡？氯胺酮會降解嗎？

Great question. So the preservative was stuck in ketamine way back when because an anesthesiologist would put it on the cart in the hospital and would draw out of the vial multiple times. So any time you stick more than one needle into a sterile vial, it's considered to be contaminated and to require a germicidal preservative in the bottle.

好問題。所以防腐劑很久以前就被卡在氯胺酮中了，因為麻醉師會把它放在醫院的推車上，並多次從小瓶中抽出。因此，任何時候將多根針頭插入無菌小瓶，都會被視為受到污染，需要在瓶中添加殺菌防腐劑。

Got you. Okay. Great.

明白了。好的。偉大的。

So as long as you have a single-use vial, by law you don't need a preservative. Now when we started this, people said, oh yes, but that preservative is critical to the stability and sterility of ketamine. Well, it turns out not to be true. That turns out to be a novel and surprising finding. And -- that's why we've pointed out that we've now got the ability to file for two-year shelf stability at room temperature for preservative-free ketamine.

因此，只要您有一次性使用的小瓶，根據法律規定您就不需要使用防腐劑。當我們開始這項工作時，人們說，哦，是的，但是防腐劑對於氯胺酮的穩定性和無菌性至關重要。但事實證明並非如此。這是一個新穎且令人驚訝的發現。並且—這就是為什麼我們指出我們現在有能力為不含防腐劑的氯胺酮申請在室溫下兩年的保質期。

And you've seen this happen in the ophthalmology industry, where it was assumed that glaucoma eyedrops and other eyedrops that people use on a long-term basis would always be in a big bottle with a preservative in it. The same was true for artificial tears that people were used to buying in the drugstore. And 15 or more years ago, I was involved in research that showed that those preservatives are actually quite toxic to the cornea and the conjunctiva.

你已經看到這種情況發生在眼科行業，人們認為青光眼眼藥水和人們長期使用的其他眼藥水總是裝在含有防腐劑的大瓶子裡。人們習慣在藥局購買的人工淚液也是如此。15 多年前，我參與的一項研究表明，這些防腐劑實際上對角膜和結膜具有相當大的毒性。

And that's why more often than not, people are buying artificial tears in single-dose preservative-free vials. And more and more of the prescription eye drops have been moved to single-dose preservative-free vials.

這就是為什麼人們經常購買不含防腐劑的單劑量小瓶裝人工淚液。越來越多的處方眼藥水已轉移到不含防腐劑的單劑量小瓶中。

If you read the material data sheet on benzethonium chloride, it's pretty frightening. The material data sheet says this product is caustic, it's toxic, it may cause severe burns. And clinical evidence is that it's anything but safe.

如果你讀過芐索氯銨的材料資料表，你會發現它相當可怕。材料資料表顯示產品具有腐蝕性、毒性，可能導致嚴重燒傷。臨床證據表明它根本不安全。

Perfect. Thank you. I just -- I didn't make the connection during the call, but I got it now, and it makes perfect sense. Can you talk a little bit about the acquisition strategy to add more clinics this year and without giving guidance, just give us some kind of rough idea on how that acquisition is going, what's the interest level, how many clinics out there, are there particular geographies that you'd like to focus on? Talk with us a little bit about what we should expect a year from now.

完美的。謝謝。我只是——我在通話期間沒有明白這一點，但我現在明白了，而且這完全說得通。您能否談談今年增加更多診所的收購策略？在不提供指導的情況下，請大致介紹一下收購的進展、興趣程度如何、有多少家診所，是否有您想要關注的特定地區？請與我們簡單談談我們對一年後的期望。

Well, Florida has become a geography of focus for us, partly because we've identified a group of clinics that, in our view, are already doing it right. Not to paint with too broader brush, but you can find a ketamine clinic on every other street corner in the United States today. But many of them are clinics that do ketamine on Mondays and vitamin drips on Tuesdays and God knows what on Wednesday.

嗯，佛羅裡達州已經成為我們關注的地區，部分原因是我們已經確定了一組在我們看來已經做得很好的診所。我不想太過於籠統，但如今在美國，你可以在每個街角找到一家氯胺酮診所。但其中許多診所週一進行氯胺酮注射，週二進行維生素滴注，週三則由天知道是什麼。

Organizations that know how to combine ketamine and in the future other psychedelic drugs with neuromodulatory technology like TMS are few and far between. These are tough patients to treat on a comprehensive basis, and anybody who says, come on in for your ketamine shot and go elsewhere for the rest of your care is not doing any patient any favors.

知道如何將氯胺酮以及未來的其他迷幻藥物與 TMS 等神經調節技術相結合的組織非常少。這些都是難以進行全面治療的病人，任何人說，來這裡注射氯胺酮，然後去其他地方接受其餘治療，對任何病人都沒有好處。

So that's why we retained BTIG and have partnered with BTIG to cast a broad net for clinics that we believe are doing it right and to use that platform of acquiring clinics as a basis for building out a nationwide network.

因此，我們保留了 BTIG，並與 BTIG 合作，廣泛尋找我們認為做得正確的診所，並利用收購診所的平台作為建立全國網路的基礎。

When we talk about the kinds of financing that's available, you're talking -- about a tiered risk financing. Our conversation so far suggests that commercial banks are prepared to finance up to 50% loan to value on fairly attractive commercial terms. Our conversation so far suggests that clinic owners are willing to take some piece of the acquisition in the form of HOPE Therapeutic shares. And that leaves financing in the middle, perhaps 20% to 30% of each acquisition that will come from investors who expect a higher rate of return, but a rate of return that HOPE can certainly afford to pay.

當我們談論可用的融資類型時，您談論的是分級風險融資。到目前為止，我們的對話表明，商業銀行準備以相當有吸引力的商業條款提供高達 50% 的貸款價值融資。到目前為止，我們的對話顯示診所老闆願意以 HOPE Therapeutic 股份的形式承擔部分收購責任。剩下的融資處於中間水平，每筆收購的 20% 到 30% 可能來自期望更高回報率的投資者，但 HOPE 肯定能夠支付這樣的回報率。

So the capital stack from our perspective is not a major impediment to getting our initial acquisitions done. The hard work is, the pile of legal documents that are required to acquire any healthcare facility in the United States, especially in states that have corporate practice of medicine laws, and the due diligence that we have to do, both on the financial front and on the regulatory front on each acquisition to make sure that these are acquisitions we can put on the balance sheet and offer to our shareholders.

因此，從我們的角度來看，資本結構並不是我們完成初始收購的主要障礙。困難之處在於，收購美國任何醫療機構都需要大量的法律文件，特別是在那些有公司行醫法律的州，而且我們必須在每次收購的財務和監管方面進行盡職調查，以確保這些收購可以列入資產負債表並提供給我們的股東。

Perfect. I completely understand. Thank you. One last question. In the press release, you talk a little bit about the potential for a ketamine deal, $300 million in milestones and tiered royalties, and the fact that you have -- you've received interest, non-binding term sheets. Can you expand a little bit about that because that certainly changes the company's future and creates kind of a very significant inflection point for investors?

完美的。我完全理解。謝謝。最後一個問題。在新聞稿中，您稍微談了一下氯胺酮交易的可能性、3 億美元的里程碑和分級特許權使用費，以及您已經收到利息和非約束性條款清單的事實。您能否對此進行一些詳細說明，因為這肯定會改變公司的未來，並為投資者創造一個非常重要的轉折點？

Yes, a deal is never done till it's done. But as we've moved closer to having a marketable drug, there's a real desire out there on the part of already commercial organizations to be able to offer such a drug to patients. I don't think anybody questions the size of the available market. And having a partner that already has a sales force in the field could be more attractive than raising the money to launch the drug ourselves. So we're gratified that commercial partners have started showing up. And we've told our investors what we can say today about what that might look like.

是的，交易不到最後完成就不算完成。但隨著我們越來越接近擁有一種可銷售藥物，一些已經商業化的組織確實希望能夠為患者提供這種藥物。我認為沒有人會質疑現有市場的規模。而且，擁有一個已經在該領域擁有銷售團隊的合作夥伴可能比我們自己籌集資金推出該藥物更有吸引力。因此，我們很高興看到商業夥伴開始出現。我們今天已經向我們的投資者透露了這一情況。

Thanks, Jonathan. Very exciting times.

謝謝，喬納森。非常激動人心的時刻。

Tom Shrader, BTIG.

BTIG 的湯姆·施拉德 (Tom Shrader)。

Good morning. Thanks for taking the question. Good luck on the busy year. A follow-up on the last line of questionings. The ketamine clinic landscape in Florida, is it chunky? So when you say you have nine facilities, is that one deal or is that nine independent negotiations? Should we look for this target to happen in big chunks?

早安.感謝您回答這個問題。祝您在忙碌的一年裡一切順利。最後一連串問題的後續跟進。佛羅裡達州的氯胺酮診所景觀是否崎嶇？那麼，當您說您有九個設施時，這是一項交易還是九個獨立的談判？我們是否應該期望這個目標能夠大規模實現？

And then maybe if you could give us a little bit of color on having an ANDA and an NDA in front of the FDA at the same time. How unusual is that? Is it the same people that deal with it? Is your manufacturing packet enough for both? Just it's unusual to me and I thought you could talk a little bit about what it would look like at the FDA. Thank you.

然後，也許您可以稍微介紹一下同時向 FDA 提交 ANDA 和 NDA 的情況。這有多不尋常？是同一群人來處理嗎？您的製造包是否足以滿足兩者需求？只是這對我來說很不尋常，我想你可以稍微談談它在 FDA 的情況是什麼樣的。謝謝。

So on the ketamine front, I think you should expect acquisitions to be chunky, your word, to represent more than, in general, more than one clinic at a time. In the case of Kadima, which is a one-site facility, we started there because we've been unable to identify another clinic that's doing so many things right all at the same time. But in general, the clinics that are doing it well are doing it at multiple locations. And we would expect that to be part of our acquisition path.

因此，在氯胺酮方面，我認為你應該預料到收購會很大規模，一般來說，收購會比同時收購多家診所要多。就 Kadima 而言，它是一個單一站點的醫療機構，我們從那裡開始，因為我們無法找到另一個能夠同時做好這麼多事情的診所。但總體來說，做得好的診所都是在多個地點開展這項業務。我們希望這成為我們收購之路的一部分。

With regard to an ANDA and an NDA. The NDA is specifically to ask the Division of Psychiatry products to add the depression and suicidality indications to the Ketamine label. And quite frankly, somebody probably could have come along and said, well, let's do that with the original formulation that has the preservative in it. But it's really a scientific exercise in attempting to prove safety and efficacy to the satisfaction of review division while also satisfying the manufacturing side of FDA.

關於ANDA和NDA。該 NDA 特別要求精神病學產品部門將憂鬱症和自殺傾向指徵添加到氯胺酮標籤中。坦白說，可能有人會說，好吧，讓我們用含有防腐劑的原始配方來做吧。但這實際上是一種科學實踐，試圖證明其安全性和有效性，以滿足審查部門的要求，同時也滿足 FDA 的生產方面。

Well, that same manufacturing package, that same Module 3 that we've already submitted, while it's necessary to the new drug approval application, While it's necessary to the psychiatry indications, it's both necessary and largely sufficient for an ANDA, because under the ANDA, we're not seeking to change the label of ketamine. We're seeking to offer a preservative-free version of a drug that's already generic.

嗯，同樣的製造包，同樣的我們已經提交的模組 3，雖然對於新藥批准申請是必要的，雖然對於精神病學適應症是必要的，但對於 ANDA 來說，它既是必要的，也是基本足夠的，因為根據 ANDA，我們並不尋求改變氯胺酮的標籤。我們正在尋求提供一種已經是仿製藥的無防腐劑版本。

So the ANDA would be for analgesia?

那麼 ANDA 是用於鎮痛的嗎？

The ANDA would have the same indications as the currently marketed forms of ketamine, but it wouldn't have the toxic preservative in it.

ANDA 的適應症與目前市面上銷售的氯胺酮相同，但不含有毒防腐劑。

Okay. Thanks for the color.

好的。謝謝你的顏色。

Vernon Bernardino, H.C. Wainwright.

弗農·貝納迪諾，H.C.溫賴特。

Hi, good morning, everyone. Thanks for taking my question and congrats on the progress. Looks like it will be a busy second quarter. Regarding the terms with the commercial pharmaceutical company for NRX-100, do you anticipate that will be a second quarter announcement as far as the finalization of the deal?

大家好，早安。感謝您回答我的問題，並祝賀您的進展。看起來第二季將會很忙。關於與商業製藥公司就 NRX-100 達成的條款，您是否預計該交易的最終確定將在第二季公佈？

Well, we hope it may be. And the deal is never done until it's done. On the other hand, we see the expression of interest as one that may even become broader. So we have the resources to continue to move these applications forward. We don't need a commercial deal right now, but we would certainly welcome the right partner.

嗯，我們希望如此。交易未完成就不算完成。另一方面，我們認為興趣的表達可能會變得更加廣泛。因此，我們有資源繼續推進這些應用。我們現在不需要商業交易，但我們當然歡迎合適的合作夥伴。

Great. Consider -- in terms of the ketamine intended for intravenous use and removing benzethonium chloride, so the idea there is single use. How easy would it be for a competitor to make their own single use presentations of ketamine for intravenous use?

偉大的。考慮一下—就用於靜脈注射的氯胺酮而言，去除芐索氯銨，因此其用途是一次性的。對於參賽者來說，製作一次性靜脈注射氯胺酮有多容易？

Well, there are a couple of challenges that anybody who wants to enter the market will have today. Certainly, the sponsor of ketamine, who owns the label, could certainly do it, if they wanted to. But if they don't already have a preservative-free formulation for stability, they've got a couple years of work before they can enter the market and file their ANDA.

嗯，如今任何想要進入市場的人都會面臨一些挑戰。當然，如果願意的話，擁有該品牌的氯胺酮贊助商當然可以這樣做。但如果他們還沒有不含防腐劑的穩定配方，他們還需要幾年的時間才能進入市場並提交 ANDA。

Do we expect that we'll long-term have the ketamine market to ourselves? I think that's too much for anybody to expect for a market that's quite that large. But for a period of time, we may well. And if some of the advice we've received that the preservative-free formulation we've engineered is surprising and ultimately stands up to patent review, we could have that marked to ourselves for longer than anticipated.

我們是否預期我們能夠長期獨佔氯胺酮市場？我認為，對於如此大的市場來說，任何人的期望都太高了。但在一段時間內，我們可能會這樣做。如果我們收到的一些建議是，我們所設計的無防腐劑配方令人驚訝，並最終通過了專利審查，那麼我們可能會比預期更長時間地記住這一點。

Thanks for that additional information. Then regarding the persistent psychiatry centers you intend to acquire; those are still projected to be ones you think will have run rates of about $5 million a year in revenue?

謝謝您提供的補充資料。然後關於您打算收購的持久精神病學中心；您認為這些業務的年收入預計仍將達到 500 萬美元左右嗎？

Or larger.

或更大。

Okay. And one of those you intend to acquire, you say three positions, one of those includes Kadima or these are in addition to Kadima?

好的。您打算爭取的其中一個席位是三個，其中一個包括前進黨，還是說這些是前進黨的補充？

That includes Kadima.

其中包括前進黨。

Okay. And then lastly for me, the term sheet with the publicly traded strategic investor that manufactures TMS devices, they manufacture their own or several devices or.

好的。最後，對我來說，這是與生產 TMS 設備的公開交易策略投資者簽訂的條款清單，他們生產自己的或多種設備。

Probably it wouldn't be appropriate for saying anything more at this time.

或許，此時再多說什麼都不合適。

Okay. Great. (multiple speakers) Thanks for taking my question.

好的。偉大的。（多位發言者）感謝您回答我的問題。

Ed Woo, Ascendiant Capital.

Ed Woo，Ascendiant Capital。

Yes, congratulations on the progress. As you may potentially have NRX-100 and NRX-101 approval this year with the FDA, have you thought about what you might do internationally with both of them?

是的，祝賀你取得進展。由於你們今年可能會獲得 FDA 的 NRX-100 和 NRX-101 批准，你們有沒有想過如何在國際上利用它們？

Well we've talked in previous calls and previous filings about relationships that we've developed in France, a European country that is highly focused on this disease. The French estimate that somebody becomes suicide in France every 45 seconds. And as you know, one of the clinical trials that we're citing to FDA is a French government funded study conducted at seven French hospitals. It could be the largest study ever attempted in patients with suicidal depression.

我們在先前的電話會議和文件中談到了我們在法國建立的關係，法國是一個高度關注這種疾病的歐洲國家。法國人估計，法國每45秒就有一人自殺。如您所知，我們向 FDA 提交的一項臨床試驗是由法國政府資助的，在七家法國醫院進行的研究。這可能是迄今為止針對有自殺傾向的憂鬱症患者進行的最大規模的研究。

So were that to continue to evolve and our relationship Foundation FundaMental result in a European filing, that would certainly have resonance throughout Europe. We've not considered going beyond US and Europe by ourselves. As you know, we've had relationships with Asia-Pacific entities. And as we gain momentum, we expect that interest to increase at the same time.

因此，如果這種關係繼續發展，並且我們與 Foundation FundaMental 的關係能夠在歐洲提交，那麼這肯定會在整個歐洲引起共鳴。我們還沒有考慮過走出美國和歐洲。如您所知，我們與亞太地區的實體建立了關係。隨著我們發展勢頭的增強，我們預期人們的興趣也會隨之增加。

Great. Well, thanks for answering my questions. I wish you guys good luck. Thank you.

偉大的。好吧，謝謝你回答我的問題。祝你們好運。謝謝。

Ladies and gentlemen, I will now turn the call over to Matt for other questions.

女士們、先生們，現在我將把電話交給馬特來回答其他問題。

Thank you, Joelle. Jonathan, we have one other question electronically that came in and that regard -- is regarding HOPE. And the question is that HOPE sounds very interesting, but how does it directly benefit NRx shareholders that NRx owns the equity in HOPE at this point?

謝謝你，喬爾。喬納森，我們透過電子管道收到了另一個問題，是關於「希望」的。問題是 HOPE 聽起來很有趣，但 NRx 目前擁有 HOPE 的股權對 NRx 股東有什麼直接好處？

Well, right now HOPE is an asset on the NRx balance sheet and to the extent that NRx continues to own shares of HOPE Therapeutics, if HOPE becomes profitable, those profits will roll up to the benefit of NRx. As other investors come into HOPE, those profits will devolve to the benefit of all investors in HOPE. But you But a prominent investor is likely to remain NRx.

嗯，現在 HOPE 是 NRx 資產負債表上的一項資產，並且只要 NRx 繼續持有 HOPE Therapeutics 的股份，如果 HOPE 盈利，這些利潤就會累積到 NRx 的利益中。隨著其他投資者加入 HOPE，這些利潤將轉移給 HOPE 的所有投資者。但你但一位傑出的投資者可能會繼續保持 NRx。

We've talked about our desire to spin out HOPE shares to those who own NRx stocks at the time of the spinout. Yes, it was disclosed last year. That was slowed down by a toxic lender who ultimately was guided by the court that they couldn't block the HOPR spinout.

我們已經談到了我們希望在分拆時將 HOPE 股票分拆給持有 NRx 股票的人。是的，去年就披露了。但這一進程因有毒貸款機構而放緩，最終法院裁定他們無法阻止 HOPR 分拆。

So we continue to be in a position to move forward towards spinning out some of those shares, need to make sure that we do it in a tax-free manner to NRx shareholders. But meanwhile, as long as NRx is on the -- as long as HOPE is on the NRx balance sheet, anything that HOPE does devolves to the benefit of NRx shareholdings.

因此，我們將繼續推進分拆部分股份，需要確保以免稅的方式向 NRx 股東進行分拆。但同時，只要 NRx 在 - 只要 HOPE 在 NRx 資產負債表上，HOPE 所做的任何事情都會歸於 NRx 股東的利益。

Okay, thank you very much. Everyone, that's all the time we have for questions today. Thank you, everyone, for joining us this morning. We're extremely excited about the year ahead and with our two potential drug approvals and a subsidiary targeting multiple profitable mental health clinics. This concludes the NRx Pharmaceuticals fourth quarter 2024 results conference call. Thank you all for participating and have a great day.

好的，非常感謝。各位朋友，今天我們的提問時間就到這裡了。感謝大家今天上午加入我們。我們對未來的一年感到非常興奮，我們即將獲得兩種藥物的批准，並且我們的子公司瞄準多家盈利性的精神健康診所。NRx Pharmaceuticals 2024 年第四季業績電話會議到此結束。感謝大家的參與並祝福大家有個愉快的一天。

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

女士們、先生們，今天的電話會議到此結束。感謝您的參與，並請您斷開線路。