NRX Pharmaceuticals Inc (NRXP) 2024 Q1 法說會逐字稿

Good afternoon, everyone, and welcome to the NRx Pharmaceuticals, Inc. first quarter of 2024 results conference call. Currently, all participants are on a listen-only mode. As a reminder, this conference call is being recorded. I will not turn the call over to Matthew Duffy, the company's Chief Business Officer. Please go ahead.

大家下午好，歡迎參加 NRx Pharmaceuticals, Inc. 2024 年第一季業績電話會議。目前，所有參加者都處於只聽模式。提醒一下，本次電話會議正在錄音。我不會將電話轉給公司首席商務官馬修·達菲 (Matthew Duffy)。請繼續。

Thank you, Jonah, and welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

謝謝你，喬納，歡迎大家。在我們繼續電話會議之前，我想提醒大家，根據美國聯邦證券法，本次電話會議中發表的某些聲明屬於前瞻性聲明。這些聲明受風險和不確定性的影響，可能導致實際結果與歷史經驗或當前預期有重大差異。有關可能導致實際結果與本次電話會議中的陳述不同的因素的其他資訊包含在我們向美國證券交易委員會提交的定期報告中。

The forward-looking statements made during this call speak only as of date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued earlier today and in the company's Form 10-Q filed today, which may be accessed from the investors page of the NRx Pharmaceuticals, Inc. website. Joining today on the call are Stephen Willard, our Chief Executive Officer; Dr. Jonathan Javitt, our Founder, Chairman, and Chief Scientist; and Richard Narido, our Chief Financial Officer and Treasurer.

本次電話會議中所做的前瞻性陳述僅代表截至本電話會議之日的觀點，本公司不承擔更新或修改前瞻性陳述的義務。本次電話會議中提供的資訊包含在今天稍早發布的新聞稿和公司今天提交的 10-Q 表中，可從 NRx Pharmaceuticals, Inc. 網站的投資者頁面存取。今天參加電話會議的有我們的執行長史蒂芬‧威拉德 (Stephen Willard)；我們的創辦人、董事長兼首席科學家 Jonathan Javitt 博士；以及我們的財務長兼財務主管 Richard Narido。

Steve and Jonathan will provide a summary of our company's progress, Richard will review the company's financial results, and then Steven will review upcoming milestones before making closing comments. Following their prepared remarks, we will address investor questions. Now, I'll turn the call over to Steve. Steve?

史蒂夫和喬納森將對我們公司的進展進行總結，理查德將審查公司的財務結果，然後史蒂文將回顧即將到來的里程碑，並做結束語。在他們發表準備好的發言後，我們將回答投資人的問題。現在，我將電話轉給史蒂夫。史蒂夫？

Thank you, Matt, and good afternoon, everyone, and thank you for joining us. NRx has had an incredibly productive and eventful start to 2024, with a great deal more to come through the remainder of the year. We are accelerating our work to bring hope to life. The past quarter, culminating with our clinical trial results last week, has been enormously productive.

謝謝你，馬特，大家下午好，謝謝你們加入我們。NRx 在 2024 年取得了令人難以置信的高效和多事之秋，並且在今年剩餘的時間裡還將發生更多的事情。我們正在加快工作，讓希望變成現實。隨著上週臨床試驗結果的公佈，過去一個季度的成果十分豐碩。

Jonathan will be discussing our scientific progress. Let me begin by addressing our progress as a company. You will notice that at the end of March, we had a lower cash balance than has been typical for us, because we used available cash to pay down debt to Streeterville LLC. During the quarter, we signed and announced a $5.1 million advance against milestones from Alvogen and Lotus Pharmaceuticals and have used those funds to support our clinical operations.

喬納森將討論我們的科學進展。首先我想談談我們公司所取得的進展。您會注意到，在三月底，我們的現金餘額低於正常水平，因為我們使用可用現金來償還對 Streeterville LLC 的債務。在本季度，我們簽署並宣布了來自 Alvogen 和 Lotus Pharmaceuticals 的 510 萬美元里程碑預付款，並已使用這些資金來支持我們的臨床運作。

Those funds do not appear on our balance sheet because they are paid directly to clinical trial partners. As you saw last week, our corporate debt was accelerated by Streeterville. This principle is publicly charged by the SEC on various matters. That development, combined with our recent clinical developments, generated enthusiasm from a number of well-regarded funding sources.

這些資金不會出現在我們的資產負債表上，因為它們直接支付給臨床試驗合作夥伴。正如您上週所看到的，我們的企業債務因 Streeterville 而加速成長。美國證券交易委員會在各種事項上都公開主張這項原則。這項進展，加上我們最近的臨床進展，引起了許多知名資金來源的熱情。

In addition to the support of the [heightened] on the equity side, we have now signed a $30 million nonbinding term sheet that will eliminate our current corporate debt and provide growth capital for revenue generating approved drugs to add to our pipeline, while substantially lowering our borrowing costs. We anticipate that separating ourselves completely from a lender who has not been supportive of our growth will be beneficial to shareholders and will substantially reduce our cost of debt service. Jonathan will talk more about the science behind an NRX-101 in a moment, but I'm also excited to point out that our new clinical data for NRX-101 support a product profile that could potentially be superior to the current standard of care in bipolar depression. We and our regulatory counsel believes that these data support the filing of a new drug application for NRX-101 in bipolar depression, a market of more than -- $20 billion rather.

除了股權方面的支持外，我們現在已經簽署了一份價值 3000 萬美元的非約束性條款清單，這將消除我們目前的公司債務，並為可產生收入的已獲批准藥物提供增長資本，以擴充我們的產品線，同時大幅降低我們的借貸成本。我們預計，徹底脫離不支持我們發展的貸款機構將有利於股東，並將大幅降低我們的債務償還成本。喬納森稍後將詳細介紹 NRX-101 背後的科學原理，但我也很高興地指出，我們關於 NRX-101 的新臨床數據支持該產品特性，該產品特性可能優於目前治療雙相抑鬱症的標準治療。我們和我們的監管顧問認為，這些數據支持提交 NRX-101 治療雙相憂鬱症的新藥申請，該市場的規模超過 200 億美元。

Other investors have approximately and appropriately asked us about the planned HOPE Therapeutics dividend that we anticipate achieving in March. We have been advised that the HOPEe shares are best distributed after they are already registered, in compliance with the 1934 Securities Act, and we are in the process of affecting that registration. The required audits on HOPE are near completion and we expect to file the required SEC registration this quarter. We appreciate our investors' patience as we work through these processes.

其他投資者也大致且恰當地詢問了我們有關我們預計在 3 月份實現的 HOPE Therapeutics 股息計劃。我們被告知，HOPEe 股票最好在註冊後再分發，以符合 1934 年《證券法》，我們正在進行該註冊。HOPE 所需的審計已接近完成，我們預計將於本季提交所需的 SEC 註冊。我們感謝投資者在我們完成這些流程過程中的耐心。

I'm incredibly proud of the progress our team has made this year, 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 delivering life-saving treatments to patients. Most importantly, we continue to believe that 2024 will represent our transition from a purely research and development company to a revenue-generating pharmaceutical company. Now, I would like to invite Dr. Jonathan Javitt, our Chief Scientist, to review our clinical development programs.

我為我們團隊今年的進步感到無比自豪，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。最重要的是，我們仍然相信 2024 年將代表我們從純粹的研發公司轉型為創收製藥公司的工作。現在，我想邀請我們的首席科學家 Jonathan Javitt 博士來回顧我們的臨床開發計劃。

Thank you, Steve. And as Steve noted, we've made important progress with our clinical development pipeline over the past few months. Our lead drug candidate, NRX-101, has delivered unprecedented data in suicidal bipolar depression. Based on these data, NRX-101 has demonstrated comparable antidepressant efficacy to the current standard of care lurasidone, while significantly reducing what is perhaps the most dangerous side effects of this class of drugs. Akathisia, a side effect considered by many to be a precursor to suicide. Indeed, reductions in suicidality and Akathisia have been seen previously with NRX-101 and our STABIL-B trial, which was published in the peer-reviewed literature.

謝謝你，史蒂夫。正如史蒂夫所說，過去幾個月我們在臨床開發方面取得了重要進展。我們的主要候選藥物 NRX-101 在治療自殺性雙相憂鬱症方面提供了前所未有的數據。根據這些數據，NRX-101 已證明具有與目前標準治療藥物魯拉西酮相當的抗憂鬱功效，同時顯著降低了此類藥物中最危險的副作用。靜坐不能症，許多人認為這是自殺的前兆。事實上，NRX-101 和我們的 STABIL-B 試驗先前已經觀察到自殺傾向和靜坐不能的減少，該研究已發表在同行評審的文獻中。

So this is the second time we've found this result. Akathisia is consistently seen in 10% to 15% of people who take the lurasidone class of drugs and no prior anti-depressant has ever demonstrated a reduction in Akathisia. Together, these studies, along with others in the literature, provides strong support for filing a new drug application with the FDA for patients with bipolar depression who are at risk of Akathisia. The FDA is well aware of the potential risks associated with today's antidepressants and currently requires that a suicide morning be placed on the label of all current antidepressants.

這是我們第二次發現這個結果。服用魯拉西酮類藥物的患者中，有 10% 至 15% 會出現靜坐不能症狀，且先前服用的抗憂鬱藥物從未證明可以減輕靜坐不能症狀。總之，這些研究以及文獻中的其他研究為向 FDA 提交針對有靜坐不能風險的躁鬱症患者的新藥申請提供了強有力的支持。FDA 非常清楚當今抗憂鬱藥物的潛在風險，目前要求在所有現有抗憂鬱藥物的標籤上標註「自殺早晨」字樣。

These existing FDA precedent for approval of novel antidepressants that have comparable antidepressant effects, combined with reduced side effect. So far, the key opinion leaders with whom we've spoken have been unambiguous in identifying Akathisia as the most troubling side effects of the lurasidone class of drugs, those are the drugs that are used to treat bipolar depression. And they've told us that they would welcome a new drug that reduces this potentially lethal side effect. We've been invited to present these data later this month at the American Society of Clinical Psychopharmacology meeting in Miami, together with Professor Andrew Nierenberg, the study's principal investigator and the head of bipolar research at Harvard Mass General Hospital.

這些現有的 FDA 先例批准了具有類似抗憂鬱效果且副作用較少的新型抗憂鬱藥物。到目前為止，我們採訪過的關鍵意見領袖都明確指出靜坐不能是魯拉西酮類藥物最令人不安的副作用，這類藥物是用來治療雙相憂鬱症的。他們告訴我們，他們歡迎一種可以減少這種潛在致命副作用的新藥。我們受邀於本月稍後在邁阿密舉行的美國臨床精神藥理學學會會議上與這項研究的首席研究員、哈佛大學麻省總醫院雙相情感障礙研究負責人安德魯·尼倫伯格教授一起展示這些數據。

We aim to host a key opinion leader discussion of Akathisia in bipolar depression at that conference, and please look for details. The second new drug application we're planning for HTX-100, our form of IV ketamine for the treatment of suicidal depression. The efficacy of this product is well established, but it's never been presented to the FDA in the data format and detail that's required for a drug approval. Therefore, we've licensed patient-level data from the government of France, from Columbia University and Harvard University, to support this application.

我們計劃在該會議上主辦一場關於躁鬱症靜坐不能症的關鍵意見領袖討論，敬請查看詳細資訊。我們計劃申請的第二個新藥是 HTX-100，它是我們用於治療自殺性憂鬱症的靜脈注射氯胺酮。該產品的功效已得到充分證實，但從未以藥品批准所需的數據格式和細節提交給 FDA。因此，我們從法國政府、哥倫比亞大學和哈佛大學獲得了患者級數據許可，以支持該應用。

The data are further supported by additional findings in the medical literature, including dose-ranging data, which is always important to the FDA. Now, a limitation of ketamine is that the old generic formulation dates back to the Korean War. It's highly acidic and it can be used for intravenous infusion, but not for subcutaneous treatments. It hurts, causes skin ulcers.

這些數據得到了醫學文獻中的其他發現的進一步支持，包括劑量範圍數據，這對 FDA 來說始終很重要。現在，氯胺酮的一個限制是舊的通用配方可以追溯到朝鮮戰爭。它的酸性很強，可以用於靜脈輸液，但不能用於皮下治療。它很疼痛，並會引起皮膚潰瘍。

Last month, we announced the formulation of a patentable pH neutral form of ketamine that we've designated HTX-100. We anticipate that this will be the commercial product we bring to market to support HOPE Therapeutics. While IV ketamine offers numerous benefits to patients, it's cumbersome for administration in the clinical setting. Intranasal ketamine, on the other hand, has failed to demonstrate anti-suicidal set of properties.

上個月，我們宣布了一種可獲得專利的 pH 中性氯胺酮的配方，我們將其命名為 HTX-100。我們預計這將是我們為支持 HOPE Therapeutics 而推向市場的商業產品。雖然靜脈注射氯胺酮為患者帶來了許多好處，但在臨床環境中使用起來卻很麻煩。另一方面，鼻內注射氯胺酮未能表現出抗自殺特性。

We are going to start with IV ketamine, but aim to augment it with a far more convenient form of administration that has equal efficacy. So the studies we've presented demonstrate an exceptional degree of efficacy, really, in a matter of hours in suicidality depressed patients when treated with ketamine. This is vitally important in our country where the only approved treatment for suicidality is electroconvulsive therapy. The CDC states had approximately 3.4 million Americans make an active plan to commit suicide each year.

我們將從靜脈注射氯胺酮開始，但目標是採用一種具有相同功效且更為方便的給藥方式來增強它。因此，我們所展示的研究表明，對於有自殺傾向的憂鬱症患者，使用氯胺酮治療確實在幾個小時內就達到了極高的療效。這在我們國家至關重要，因為唯一批准的治療自殺傾向的方法是電痙攣療法。疾病預防控制中心表示，每年約有 340 萬美國人積極制定自殺計畫。

By all measures, this is a national epidemic. We plan to bring this life-saving product to market as soon as possible. The current market for intranasal ketamine is already $750 million, and that's a product that doesn't have anti suicidal properties. We expect our market to be much larger.

無論從什麼標準來看，這都是一場全國性的流行病。我們計劃盡快將這種救生產品推向市場。目前鼻腔內氯胺酮的市場規模已達 7.5 億美元，且該產品不具備抗自殺特性。我們預計我們的市場將會更大。

To continue to build value for NRx shareholders, we intend to distribute shares of HOPE Therapeutics to existing shareholders in the near term and to seek a public listing for that company on a national exchange. We're actively building out our team, our partners, and our network with the goal of launching the product in early 2025. To augment and extend the efficacy of IV ketamine, we're planning the development of a companion digital therapeutic. I previously participated in developing new digital therapeutic for the US Navy to reduce combat stress and Special Forces operators.

為了繼續為 NRx 股東創造價值，我們打算在短期內向現有股東分配 HOPE Therapeutics 的股份，並尋求該公司在國家交易所公開上市。我們正在積極組建團隊、合作夥伴和網絡，目標是在 2025 年初推出產品。為了增強和擴大靜脈注射氯胺酮的功效，我們正在計劃開發一種配套的數位療法。我之前曾參與為美國海軍開發新的數位療法，以減輕戰鬥壓力和特種部隊的作戰壓力。

Our products in development was funded by the Defense Advanced Research Projects Agency known to many as DARPA and is still in use. Today, I'm delighted to announce that our former Chief Strategy Officer, Dennis McBride, who's just completed his tour of duty, will be leading this project on behalf of our company. You'll be hearing more from Dennis in coming weeks. His biography, which includes 20 years in the Navy, three tours of duty as a DAPRA program officer, and most recently, an appointee in the office of the Undersecretary of Defense, it's on our website.

我們正在開發的產品由國防高級研究計劃局（DARPA）資助，目前仍在使用中。今天，我很高興地宣布，剛結束任期的前首席策略長丹尼斯·麥克布萊德將代表我們公司領導這個計畫。您將在接下來的幾週內聽到更多來自丹尼斯的消息。他的簡歷包括在海軍服役 20 年、三次擔任 DAPRA 項目官員以及最近被任命為國防部副部長辦公室官員的經歷，這些都可以在我們的網站上找到。

Ultimately, we expect the digital therapeutics will be part of our FDA label, and that, it will further enhance our exclusivity. We'll build on these learnings and technologic advances to help suicidal patients stay on track. The addition of digital therapeutics for ketamine product is expected to extend this effect and to build our market exclusivity. Obtaining FDA approval will enhance our ability to approach insurers to cover the cost of ketamine therapy, which so many people need for the treatment of suicidal depression.

最終，我們預計數位療法將成為我們 FDA 標籤的一部分，並且它將進一步增強我們的獨佔性。我們將利用這些經驗和技術進步來幫助有自殺傾向的患者重回正軌。預計氯胺酮產品的數位療法的加入將擴大這種效果並建立我們的市場獨佔性。獲得 FDA 的批准將增強我們向保險公司索取氯胺酮療法費用的能力，許多人需要這種療法來治療自殺性憂鬱症。

Our discussions with clinics to date has indicated that the lack of reimbursement is one of the key impediments to patients being able to get the treatment that they need. We aim to solve this problem and to bring HOPE to life. In order to gain approval for a drug, you have to manufacture a drug to FDA standards. In other words, you can't get approval for a drug you haven't made.

我們迄今為止與診所的討論表明，缺乏報銷是患者無法獲得所需治療的主要障礙之一。我們的目標是解決這個問題並帶來希望。為了獲得藥品批准，您必須按照 FDA 標準生產藥品。換句話說，你還未生產的藥物就無法獲得批准。

This month, we are in the nine months stability endpoints in our manufacturing partnership with Nephron Pharmaceuticals. Ketamine is publicly identified by the FDA as being on drug shortage in the United States. And together with Nephron, we are already able to distribute ketamine under a five O3b pharmacy license. We anticipate reporting first commercial revenues in the near future.

本月，我們與 Nephron Pharmaceuticals 的生產合作關係已進入九個月的穩定性終點。氯胺酮被FDA公開認定為美國短缺藥物。並且我們與 Nephron 合作，已經能夠根據五個 O3b 藥房許可證分銷氯胺酮。我們預計在不久的將來報告第一筆商業收入。

We currently await the results of a 200 patient Department of Defense sponsored study in chronic pain being conducted at Northwestern University with D-cycloserine, the key component of NRX-101. We are as eager as you are to see those results. Our colleagues at Northwestern have advised us that the database is now locked and the Northwestern institutional review board, the IRB, has approved the statistical analysis plan and giving clearance for the data analysis. NRX-101 for chronic pain would offer a treatment beyond those treatments that are currently available to patients.

我們目前正在等待美國國防部資助的西北大學對 200 名慢性疼痛患者進行的研究的結果，該研究使用 D-環絲氨酸（NRX-101 的關鍵成分）。我們和您一樣渴望看到這些結果。西北大學的同事告訴我們，資料庫現在已被鎖定，西北大學的機構審查委員會 IRB 已經批准了統計分析計劃並批准進行數據分析。NRX-101 治療慢性疼痛將為患者提供超出目前可用治療方法的治療方法。

Of course, in today's world, you have a choice between tylenol, advil class of drugs that may lack efficacy and the opioid class of drugs that may be highly addictive, but not much in the middle. NRX-101 offers the possibility of a highly effective, but nonaddictive treatment options. As you know, in January, we opened an IND for NRX-101 in complicated urinary tract infection and pyelonephritis. Now, the reason this drug affects bacteria are completely different from the reasons it affects the brain, but in fact, the cycloserine began its life as an antibiotic.

當然，在今天的世界裡，你可以在泰諾、布洛芬類藥物（這些藥物可能缺乏療效）和鴉片類藥物（這些藥物可能會高度成癮）之間進行選擇，但介於兩者之間的藥物並不多。NRX-101 提供了一種高效但不成癮的治療選擇。如您所知，今年 1 月，我們啟動了 NRX-101 用於治療複雜性泌尿道感染和腎盂腎炎的 IND 申請。現在，這種藥物影響細菌的原因與影響大腦的原因完全不同，但事實上，環絲胺酸最初是一種抗生素。

So that IND was based on data from a study we recently sponsored a Charles River Labs, a highly respected contract research organization, that demonstrated significant anti-bacterial effective NRX-101 against the worst resistant urinary pathogens. The pathogens that are on the congressionally mandated list of dangerous pathogens and can qualify you for what's called QIBT or qualified infectious disease product status. And in fact, these data motivated the FDA to grant us QIDP status along with Fast Track and priority review designations. Several weeks ago, we reported data demonstrating that NRX-101 does not damage the normal bacteria in the intestine known as the microbiome.

因此，該 IND 是基於我們最近贊助的一項研究的數據，該研究由一家備受尊敬的合約研究機構 Charles River Labs 發起，證明了 NRX-101 對最嚴重的抗藥性尿路病原體具有顯著的抗菌效果。這些病原體均被列入國會規定的危險病原體名單，可使您獲得所謂的 QIBT 或合格傳染病產品資格。事實上，這些數據促使 FDA 授予我們 QIDP 地位以及快速通道和優先審查資格。幾週前，我們報告的數據證明 NRX-101 不會破壞腸道中的正常細菌（即微生物群）。

Well, the reason that's critically important is all other antibiotics for complicated UTI disrupt the intestinal microbiome, and they're well known to result in infection called C difficile; some people call it C diffs. Now, at best, C diffs causes several weeks of horrible intractable diarrhea. However, C diffs is lethal and 10% of those over the age of 65 who are infected. Therefore, an antibiotic for complicated UTI that does not cause C diffs is likely to have considerable market appeal.

嗯，至關重要的原因是，用於治療複雜性泌尿道感染的所有其他抗生素都會破壞腸道微生物群，眾所周知，它們會導致艱難梭菌感染；有些人稱之為 C diff。現在，艱難梭菌最多只會造成數週可怕的頑固性腹瀉。然而，艱難梭菌是致命的，65 歲以上的感染者中有 10% 會被感染。因此，一種用於治療複雜性泌尿道感染且不會引起艱難梭菌感染的抗生素可能具有相當大的市場吸引力。

Finally, we're working with our partners at the foundation fundamental in Paris, an early stage opportunity that may represent the world's first disease-modifying drug for schizophrenia. Everybody knows of the devastating effect of schizophrenia on patients and their families. 1% of the population has this lifelong debilitating disease. The medicines used to treat schizophrenia may diminish its symptoms, especially the hallucinations to varying degrees; however, there's never been a medicine that has potential to reverse the disease in some patients.

最後，我們正在與巴黎基礎科學基金會的合作夥伴合作，這是一個早期階段的機會，可能代表世界上第一個治療精神分裂症的疾病改良藥物。每個人都知道精神分裂症對患者及其家屬造成的毀滅性影響。 1% 的人口患有這種終身衰弱疾病。治療精神分裂症的藥物可能會不同程度地減輕其症狀，尤其是幻覺；然而，迄今為止還沒有一種藥物能夠逆轉某些患者的病情。

We anticipate providing our investors with a complete presentation on what may be the first disease-modifying that is the first potentially curative drug for schizophrenia by the end of this quarter. As you can see, we have a robust clinical development plan with multi-billion dollar potential. We work our hardest every day to bring this plan to reality and to bring HOPEe to life. I'll now ask Rich Narito, our CFO, to review first quarter financials. Rich?

我們預計將在本季末向投資者提供完整的介紹，介紹可能是第一種可以改善病情、具有潛在治療精神分裂症潛力的藥物。正如您所看到的，我們有一個強大的臨床開發計劃，具有數十億美元的潛力。我們每天都在盡最大努力將這個計劃變成現實，並讓 HOPEe 煥發生機。我現在將請我們的財務長 Rich Narito 審查第一季的財務狀況。富有的？

Thank you, Jonathan, and good afternoon, everyone. I will now review the highlights of our first quarter 2024 financial results. For the first three months ended March 31, 2024, we at NRx Pharmaceuticals, reduced our net loss from operations by 41% compared to the prior year, from $11 million in the first quarter of 2023 to $6.5 million in 2024. For that same period, we reduced research and development expenses were $3.7 million in 2023 to $1.7 million in 2024, as we finalize our clinical trial enrollment.

謝謝你，喬納森，大家下午好。現在，我將回顧我們 2024 年第一季財務表現的亮點。截至 2024 年 3 月 31 日的前三個月，NRx Pharmaceuticals 的營業淨虧損與上年相比減少了 41%，從 2023 年第一季的 1,100 萬美元減少到 2024 年的 650 萬美元。在同一時期，隨著我們完成臨床試驗報名，我們將研發費用從 2023 年的 370 萬美元減少到 2024 年的 170 萬美元。

The $2 million decrease is related primarily to a decrease of $1.6 million in clinical trial expenses, $0.2 million in regulatory and process development costs, and $0.1 million in stock-based compensation. Also in that three-month period, we recorded a 26% reduction in general and administrative expenses from $5.8 million in 2023 to $4.3 million in 2024. The decrease of $1.5 million is related primarily to a decrease of $1.2 million in insurance expenses, $0.4 million in employee expenses, slightly offset by other general administrative expenses. As of March 31, 2024, we had $1.3 million in cash and cash equivalents.

200 萬美元的減少主要與臨床試驗費用減少 160 萬美元、監管和流程開發成本減少 20 萬美元以及股票薪酬減少 10 萬美元有關。此外，在這三個月內，我們的一般和行政費用從 2023 年的 580 萬美元減少了 26% 至 2024 年的 430 萬美元。150 萬美元的減少主要由於保險費用減少 120 萬美元、員工費用減少 40 萬美元，其他一般行政費用略有減少。截至 2024 年 3 月 31 日，我們擁有 130 萬美元的現金和現金等價物。

However, this does not tell the whole story because of the clinical expenses that are now being paid directly by our partners. Over the first three months of 2024, we improved our access to working capital by $8 million in total, representing $2.9 million from equity sales and $5.1 million from the Alvogen milestone advance, while reducing our corporate indebtedness to Streeterville LLC by $2.2 million. Subsequent to March 31, 2024, we continue to increase our working capital by $3.3 million from equity sales. We continue to implement operational efficiencies to extend runway and focus on our path to generate revenue and value for our shareholders. With that, I will turn it back to Steve for closing remarks. Steve?

然而，這還不是全部，因為臨床費用現在由我們的合作夥伴直接支付。在 2024 年的前三個月，我們總共增加了 800 萬美元的營運資金，其中 290 萬美元來自股權銷售，510 萬美元來自 Alvogen 里程碑預付款，同時減少了我們對 Streeterville LLC 的公司債務 220 萬美元。2024 年 3 月 31 日之後，我們繼續透過股權出售增加 330 萬美元的營運資金。我們將繼續提高營運效率，延長營運時間，並專注於為股東創造收入和價值。最後，我將請史蒂夫作最後發言。史蒂夫？

Thanks, Rich. With two NDAs planned for the coming months, a HOPE shared distribution plan, two out-licensing opportunities, and an improved cash position, we are well positioned for the future. Addressing a range of unmet medical needs and suicidal bipolar depression, chronic pain suicidality, and complicated urinary tract infections, we have an opportunity to create a highly successful and vibrant biotechnology company. I'm incredibly proud of our team, our collaborators and partners, and most of all the patients who have made such an important contribution to these efforts. Together, we are pursuing NRx's goal of bringing hope to life on a daily basis.

謝謝，里奇。由於我們計劃在未來幾個月內簽署兩份保密協議、制定一份 HOPE 共享分銷計劃、獲得兩個對外授權的機會，並且現金狀況有所改善，我們已為未來做好了充分準備。透過解決一系列未滿足的醫療需求和自殺性躁鬱症、慢性疼痛自殺傾向以及複雜的泌尿道感染，我們有機會創建一家非常成功且充滿活力的生物技術公司。我為我們的團隊、合作者和合作夥伴以及為這些努力做出如此重要貢獻的患者感到無比自豪。我們共同追求 NRx 的目標，即每天為生活帶來希望。

We couldn't have gotten to this point without you, investors. If you would like to help spread the hope, please go to the contact us page on our website and asked us to send you a HOPE lapel pin. Operator, we are ready to take questions from the audience.

如果沒有你們，投資者，我們就不可能達到今天的水準。如果您想幫助傳播希望，請訪問我們網站的聯絡我們頁面，並要求我們向您發送希望翻領別針。接線員，我們已經準備好回答觀眾的提問。

(Operator Instructions) [Tim Warren].

（操作員指示）[蒂姆·沃倫]。

Thanks, and great update. For NRX-101, can you maybe just give us a rough timing frame on the 300 person registrational trial enrollment and the sites being lined up for that more statistical significant sample size?

謝謝，很棒的更新。對於 NRX-101，您能否給我們一個大致的時間框架，即 300 人註冊試驗的報名時間，以及為獲得更具統計意義的樣本量而安排的站點？

Well, yes, as you know, Tim, if that trial is needed, the trial is one that will be undertaken by our partner, Alvogen at their expense, and they'll be laying out a timeline. But we're also exploring whether the data that we already have in hand may give us a path to accelerated approval of NRX-101 for a narrower segment of patients. Those patients who can't tolerate the lurasidone class of drugs because of the Akathisia who are at risk of suicide and really who have no therapeutic alternative. So it's really a question of can we help some patients in urgent need right away, while Alvogen gears up to do the much larger trial.

嗯，是的，正如你所知，蒂姆，如果需要進行這項試驗，我們的合作夥伴 Alvogen 將自費進行試驗，他們會制定時間表。但我們也在探索我們手中已有的數據是否可以為加速批准 NRX-101 用於更窄範圍的患者提供途徑。那些因靜坐不能而無法耐受魯拉西酮類藥物的患者有自殺風險，並且確實沒有其他治療選擇。因此，真正的問題是，在 Alvogen 準備進行更大規模試驗的同時，我們能否立即幫助一些急需幫助的患者。

And that makes sense. That's really helpful. And, you know, I know that you've had what three manufacturing lots initiated from. So I know the press release, I think mentioned why is it still maybe a realistic goal for the NDA? That seems like it's still on track?

這是有道理的。這真的很有幫助。而且，您知道，我知道您已經啟動了三個製造批次。所以我知道新聞稿中提到了為什麼這對 NDA 來說仍然可能是一個現實的目標？看起來好像一切還在正軌上？

So as you as you pointed out, we've said in the past, there's 1 million pills of what's called GMP or good manufacturing practices drug in our warehouse at Alchemy in North Carolina. And really, by the end of the summer, we should be able to submit what's called the module three of our new drug application for NRX-101. It's a drug that's been granted breakthrough therapy designation by the FDA. And therefore, we're entitled to submit the NDA in part that's cold rolling review.

正如您所指出的，我們過去曾說過，北卡羅來納州 Alchemy 的倉庫裡有 100 萬粒所謂的 GMP 或良好生產規範藥物。事實上，到夏季末，我們應該能夠提交 NRX-101 新藥申請的第三模組。這是一種被 FDA 授予突破性治療藥物的藥物。因此，我們有權提交部分保密協議（即冷軋審查）。

So we expect to kick off that process in the fall. And at this point, we've got two years of real-time stability. We expect that this is a stable oral form drug that we'll have five years of room temperature, shelf stability.

因此我們預計將在秋季啟動這一進程。目前，我們已經擁有了兩年的即時穩定性。我們預計這是一種穩定的口服藥物，在室溫下可保存五年。

That's terrific. No, that's really good to hear. And then my last question is, you know, data is coming soon from that 200 person DOD funded trial or VCS on-prem? And what are you looking for to see the most in that data from Northwestern and without getting too specific, but just in general?

太棒了。不，聽到這個消息真是太好了。我的最後一個問題是，您知道嗎，由國防部資助的 200 人試驗或 VCS 內部部署的數據即將出來？您最想從西北大學的數據中看到什麼？

Well, yes, we knew the answer wouldn't be a trial, but what we do know is what they published in 2016. And in 2016, the way they reported the data, it was by week of treatment, but they did a trial where if we say the escalated the amount of these sites necessary and the patient was getting. And once they reach 400 milligrams a day of D-cycloserine, they saw an analgesic effect, which in plain English is a pain relieving effect. And that was really as good as the effect that you'd expect to see with an oral opioid.

嗯，是的，我們知道答案不會是一場審判，但我們確實知道他們在 2016 年發表了什麼。2016 年，他們報告數據的方式是按週計算，但他們進行了一項試驗，如果我們說必要的這些部位的數量不斷增加，患者就會得到治療。一旦他們每天攝取 400 毫克 D-環絲氨酸，就會看到鎮痛效果，用簡單的英語來說就是緩解疼痛的效果。這確實與口服鴉片類藥物所達到的效果一樣好。

But of course, D-cycloserine is completely non-addictive, it doesn't have any of the opioid side effects. Even if even if an LBO adjustment addicts you the constipation is intolerable to some people. The clouding of your mental judgment is intolerable to some people. D-cycloserine doesn't do any of that.

但當然，D-環絲胺酸完全不會上癮，它沒有任何鴉片類藥物的副作用。即便即使 LBO 調整讓你上癮，但便秘對某些人來說是無法忍受的。對某些人來說，精神判斷能力的模糊性是無法容忍的。D-環絲胺酸不發揮上述任何作用。

So our view, the 200 person trial simply replicate the findings of their 2016 Phase 2a trial. That's a that's an improbable kind of effect. That's the kind of effect that would make people want to use D-cycloserine in preference to the opioid drugs, and certainly, in preference to the tylenol, advil class of drugs. Now, 400 milligrams a day is really at the low end of the therapeutic range for D-cycloserine.

因此，我們的觀點是，這項 200 人的試驗只是複製了 2016 年第 2a 階段試驗的結果。這是一種不太可能發生的效果。這種效果會讓人們更願意使用 D-環絲胺酸，而不是鴉片類藥物，當然也比泰諾、布洛芬類藥物更願意使用。現在，每天 400 毫克確實處於 D-環絲氨酸治療範圍的低端。

The original of the patents that we stand on filed by [dianjabit] show that the SEC is saying doesn't even become an NMDA antagonist until you cross that 400 milligram a day threshold. But we can take this drug up to 1,000 milligrams a day. So there's ample reason to believe that, if the Northwestern trial shows your any meaningful benefit at the 400 milligram a day dosage, that there's room for substantially more efficacy, were we to take it to a higher doses. So we can't wait to see the data. And from talking to the investigators at Northwestern, they can't wait to see it either.

我們所依據的 [dianjabit] 提交的專利原件表明，美國證券交易委員會 (SEC) 表示，只有當每天的攝入量超過 400 毫克時，它才會成為 NMDA 拮抗劑。但我們每天最多可以服用 1,000 毫克這種藥物。因此，我們有充分的理由相信，如果西北大學的試驗表明，每天 400 毫克的劑量能帶來任何有意義的益處，那麼如果我們採取更高的劑量，那麼療效將有顯著的提升空間。所以我們迫不及待想看到數據。從與西北大學研究人員的交談中得知，他們也迫不及待地想看到它。

Good. That's really helpful color. I appreciate the elaboration on that, and I'll save my remaining questions for our conference tomorrow. Thanks a lot.

好的。這確實是很有用的顏色。我非常感謝您對此的詳細說明，我會將剩餘的問題留到明天的會議再回答。多謝。

Ed Woo.

艾德·吳。

Yeah, thank you for taking my question and congratulations on all the progress. My question is specifically on the UTI indication. You mentioned that you guys are looking for partnerships. What is the market like that? Is it pretty receptive as a slowdown? And how is there any timeline that you could possibly share with us? Thank you.

是的，感謝您回答我的問題，並祝賀您取得的所有進展。我的問題具體是關於泌尿道感染 (UTI) 指徵。您提到你們正在尋找合作夥伴。這樣的市場是什麼樣的呢？作為一種放緩，它是否很容易接受？能與我們分享一下時間表嗎？謝謝。

Well, in talking to investors, I have yet to be in a room full of investors where somebody doesn't have a friend or a relative who went to the doctor with a urinary tract infection, that first line drug, say bactrim, amoxicillin, those drugs didn't work, they wound up on an expense of antibiotics and an antibiotic that caused some problems and frequently they wind up on IV antibiotics. We have an investor whose wife started out with what should have been a fairly straightforward UTI. Went up in the hospital for three weeks with D-cycloserine. So there's enormous receptivity among urologistsm among gynecologists for antibiotics, it can treat these more aggressive urinary tract infections.

好吧，在與投資者交談時，我還沒有遇到過一個投資者房間，裡面有人沒有朋友或親戚因為泌尿道感染去看醫生，第一線藥物，比如複方新諾明、阿莫西林，這些藥物不起作用，他們最終花費大量金錢購買抗生素，而這種抗生素引起了一些問題，他們經常最終需要靜脈注射抗生素。我們有一位投資者，他的妻子一開始就得了本來應該很簡單的泌尿道感染。在醫院接受了三週的 D-環絲氨酸治療。因此，泌尿科醫生和婦科醫生對抗生素的接受度很高，它可以治療這些更嚴重的泌尿道感染。

And we're talking 3 million infectionsa. There's 15 million people each year get urinary tract infection. And at this point, one-fifth of those, 3 million a year, have these complicated UTI eyes that can go in some very ugly directions. I'd like to take a moment to acknowledge the really terrible loss who suffered last week. Professor Michael Manyak, who was the head of Urology at George Washington University, Head of urology for Glaxo Smith Kline, and became our guiding light on urology, passed away last week.

感染人數達300萬人。每年有1500萬人罹患泌尿道感染。目前，其中五分之一（每年有 300 萬人）的患者患有複雜的泌尿道感染，病情可能會非常嚴重。我想花一點時間來承認上周遭受的真正慘痛損失。麥可‧曼尼亞克教授曾任喬治華盛頓大學泌尿科主任、葛蘭素史克泌尿科主任，是我們泌尿科的引路人，他於上週去世。

But the people he brought to us on our urology advisory board are some of the top people in the country. And they all tell us there's is enormous need for a safe, oral antibiotic plus too many of the CTI drugs are intravenous, a safe oral antibiotics that patients can take for urinary infection without a likelihood of getting C. difficile, without a likelihood of getting conventional yeast infections, without that kind of unpleasant symptoms that these Ultra Strong antibiotics cause people that all of us know about. So that's what we're pointing to. But, at the same time, you're unlike suicidal depression, where there are really only 1,600 satiety areas in the United States who treat those patients and their people that we're increasingly getting to know and people whom we can reach out and talk to a much, much broader range of doctors treat patients with complicated UTI.

但他邀請我們加入泌尿科顧問委員會的人員都是國內頂尖人才。他們都告訴我們，我們急需一種安全的口服抗生素，而且太多的 CTI 藥物都是靜脈注射的，患者可以服用一種安全的口服抗生素來治療泌尿道感染，而且不會感染艱難梭菌，也不會感染傳統的酵母菌感染，也不會出現我們都知道的這些超強抗生素引起的那種令人不快的症狀。這就是我們所指出的。但同時，您與自殺性憂鬱症不同，美國實際上只有 1,600 個飽食區為這些患者提供治療，我們越來越了解這些患者和他們的家人，我們可以聯繫和交談的醫生範圍更加廣泛，可以治療患有複雜性尿路感染的患者。

And therefore, we really need a partner who already talks to those doctors. Because for a company, our size to staff the sales force and tried to address the 30,000 or 40,000 doctors or more wouldn't be feasible. So that's why we're actively looking for a partner who's already in that business, who already knows the doctors, because we know that the doctors and the patients are looking for the treatments.

因此，我們確實需要一個已經與這些醫生交談過的合作夥伴。因為對於一家公司來說，以我們的規模來配備銷售人員並試圖滿足 30,000 或 40,000 名甚至更多的醫生的需求是不可行的。因此，我們正在積極尋找已經從事該行業、了解醫生的合作夥伴，因為我們知道醫生和患者都在尋求治療方法。

Great. Thanks for answering my questions. And I wish you guys. Good luck. Thank you.

偉大的。感謝您回答我的問題。我也祝福你們。祝你好運。謝謝。

Thanks, Ed.

謝謝，埃德。

[David Bellinger].

[大衛貝林格]。

Hey, thanks for taking my question and congratulations on the remarkable progress. Back in November, you shared that you had a problem with substantial unreported naked short interest. The number you gave then was a minimum of 1 to 1.5 million shares you also described at the upcoming dividend as, among other things, one of the tools you'll be using to dislodge those naked short positions. And you recently announced that you have for SEC and enforcement leadership working to get the brokerages to first and when we close the positions. Can you give a current estimate of actual short interest and can you say anything about any progress you're having with the brokerages?

嘿，感謝您回答我的問題，並祝賀您取得了顯著的進步。早在 11 月，您就曾表示，您面臨大量未報告的裸賣空權益問題。您當時給出的數字是至少 100 萬到 150 萬股，您還描述了即將到來的股息，這是您將用來消除這些裸賣空頭寸的工具之一。您最近宣布，您已與美國證券交易委員會 (SEC) 和執法領導層合作，讓經紀公司首先平倉。您能否給出當前實際空頭利息的估計數，並能談談您與經紀公司合作的進展嗎？

So I'm going to ask Matt to present some of the numbers. But yeah, the thumbnail answer is your 1 to 1.5 million shares is really just the tip of the iceberg. Matt, why don't you talk about the research we've done?

所以我要請馬特提供一些數字。但是，簡而言之，您的 100 萬到 150 萬股實際上只是冰山一角。馬特，為什麼不談談我們所做的研究？

Sure. Thanks, Jonathan. So David, thanks for the questions, it's a very good one. So if you look at the Bear, you're asking about the bare minimum, the bare minimum would be with Nasdaq reports on a biweekly basis. And that's about 500,000 right now. That only was short through Nasdaq and reported appropriately. Some of the work we've done the sharing intel with others has indicated there is very likely perhaps even as much as an order of magnitude more short than -- multiples of that 500,000.

當然。謝謝，喬納森。所以 David，謝謝你的提問，這是一個非常好的問題。因此，如果您看一下貝爾斯達克，您會詢問最低限度，最低限度是每兩週發布一次納斯達克報告。目前這個數字大約是50萬。這只是透過納斯達克進行的簡短報道，並進行了適當的報道。我們與其他人共享情報所做的一些工作表明，這個數字很可能比 50 萬還要少一個數量級，甚至是 50 萬的倍數。

There's another set of data that are interesting as well, and that are available through certain channels. And that is the intraday shorting because every time a trader, whether they're a computer or a person enters a trade, they haven't entered whether it's a buy or sell or sell short or cover, there just the four categories. And a time ago, there were some lawsuits and some requests to the SEC to make the short sales information available for intraday trading. And we tracked that and gotten that from some folks that have attracted that have approached us and something in the vicinity of 46% of the time period they shared, which was, I think, the move March through the end of April or short sales intraday.

還有另一組數據也很有趣，可以透過某些管道獲得。這就是日內賣空，因為每次交易員（無論是電腦還是個人）進行交易時，他們都沒有輸入是買入還是賣出、賣空還是補倉，只有四種類別。前段時間，出現了一些訴訟，有人向美國證券交易委員會 (SEC) 提出了要求，要求其公開賣空資訊以供日內交易。我們對此進行了跟踪，並從一些吸引並與我們聯繫的人那裡獲得了一些信息，他們共享的時間段約為 46%，我認為，這是 3 月到 4 月底的舉動或盤中賣空交易。

Now market makers are allowed to do that as long as they cover during the day and not report it not borrow, but they have to cover by the end of the day, whether they do or not is a subject of a lot of speculation and that probably can fuel the deal of unreported short interest. I'll hand it back to Jonathan for comment.

現在，做市商可以這樣做，只要他們在日內補倉並且不報告借入情況，但他們必須在一天結束前補倉，至於他們是否這樣做是很多猜測的主題，這可能會助長未報告的空頭利息交易。我會將其交還給喬納森以供評論。

So the other question you asked, David, is important and the short interest is impressive. But it's important to recognize that somebody selling our stock short is essentially bidding that we're going to fail to get to data and go out of business, and therefore, they'll be able to up the buyback the short position for almost nothing. And the best way to really disappointed short-sellers to succeed. That's what we aim to do, and I think over the last quarter, we've turned some corners that may start to help our shareholders recognize that not only do we aim to succeed, but we're in the processes of succeeding. And if people want to invest their hard-earned money in betting against us and shorting our stock, we aim to help them lose their money.

所以，戴維，你問的另一個問題很重要，而且空頭利息令人印象深刻。但重要的是要認識到，賣空我們股票的人實際上是在競標我們無法獲得數據併破產，因此，他們幾乎可以不花任何錢就回購空頭部位。而真正讓賣空者失望的最好方法就是取得成功。這就是我們的目標，我認為在過去的一個季度裡，我們已經取得了一些進展，這可能開始幫助我們的股東認識到，我們不僅要取得成功，而且我們正在取得成功的過程中。如果有人想用自己辛苦賺來的錢做空我們的股票，我們就會幫助他們虧損。

Thanks for those answers.

謝謝這些回答。

There are no further questions at this time. I will turn the call back to you, Matt.

目前沒有其他問題。我會把電話轉給你，馬特。

Thank you. Joanna, and thank you, everyone, for joining us today for the current video conference call. And we appreciate your support your interest and are always interested in hearing your questions and feedback through our website as well. Have a good evening.

謝謝。喬安娜，感謝大家今天的視訊電話會議。我們感謝您的支持和關注，並且始終希望透過我們的網站聽取您的疑問和回饋。祝你晚上愉快。

Thank you, everyone, for participating. You may now disconnect.

感謝大家的參與。您現在可以斷開連線。