BioXcel Therapeutics Inc (BTAI) 2024 Q1 法說會逐字稿

Good morning and welcome to the BioXcel Therapeutics first quarter 2024 earnings conference call. (Operator Instructions)

早安，歡迎參加 BioXcel Therapeutics 2024 年第一季財報電話會議。 （操作員說明）

Just to remind everyone, certain matters discussed in today's conference call and or answers that may be given to questions asked are forward-looking statements subject to risks and uncertainties related to future events and or the future financial or business performance of the company.

只是提醒大家，今天電話會議中討論的某些事項和/或可能對提出的問題作出的回答屬於前瞻性陳述，受到與未來事件和/或公司未來財務或業務業績相關的風險和不確定性的影響。

Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect future results are detailed in the company's annual report on Form 10-K for the year ended December 31, 2024, which can be found at bioxceltherapeutics.com or on www.sec.gov and which will be updated in its quarterly report on Form 10-Q for the quarterly period ended March 31, 2024.

實際結果可能與這些前瞻性陳述中的預期有重大差異。可能影響未來績效的風險因素詳見該公司截至 2024 年 12 月 31 日的 10-K 表格年度報告，該報告可在 bioxceltherapeutics.com 或 www.sec.gov 上找到，並將在其報告中更新。截至2024 年3 月31 日的季度報告（表格10-Q）。

As a reminder, today's call is being recorded. Speaking on today's call are Dr. Vimal Mehta, Chief Executive Officer; Dr. Vince O'Neill, Chief of Product Development and Medical Officer; and Richard Steinhart, Chief Financial Officer. They will be joined in the Q&A session by Dr. Frank Yocca, Chief Scientific Officer; Matt Wiley, Chief Commercial Officer; and Dr. Rob Risinger, Chief Medical Officer of neuroscience.

提醒一下，今天的通話正在錄音。執行長 Vimal Mehta 博士在今天的電話會議上發言。 Vince O'Neill 博士，產品開發主管兼醫療官；和首席財務官理查德斯坦哈特。首席科學官 Frank Yocca 博士將參加問答環節；馬特威利 (Matt Wiley)，商務長； Rob Risinger 博士，神經科學首席醫學官。

It is now my pleasure to turn the call over to Dr. Mehta. Please go ahead.

現在我很高興將電話轉給梅塔醫生。請繼續。

Thank you, operator, and good morning, and thank you for joining us. 2024 has been an important period of progress for BioXcel Therapeutics, both at the program and corporate level. Starting with our neuroscience program, our journey with BXCL501 is well underway to expand the market potential for our agitation portfolio into the retail setting.

謝謝您，接線員，早安，謝謝您加入我們。 2024 年是 BioXcel Therapeutics 在專案和公司層面取得進展的重要時期。從我們的神經科學計畫開始，我們的 BXCL501 之旅正在順利進行，以將我們的令人興奮產品組合的市場潛力擴展到零售環境。

We are focused on potentially bringing this novel treatment option for bipolar and schizophrenia related agitation into the home setting. We are also dedicated to expanding into a much larger indication, alzheimer's related agitation, both in the in-care and home setting.

我們致力於將這種治療雙相情感障礙和精神分裂症相關躁動的新型治療方案帶入家庭環境。我們也致力於在照護和家庭環境中擴展到更大的適應症，即阿茲海默症相關的躁動症。

We believe these two opportunities are unique with no known FDA approved therapies and represent transformative value drivers for the company and our shareholders. We are pleased to be advancing their plans for both late-stage tranquility and synergy programs. While Vince will discuss the details of this program shortly.

我們相信，這兩個機會是獨一無二的，目前尚無 FDA 批准的療法，並且代表了公司和股東的變革性價值驅動因素。我們很高興能夠推進他們的後期安寧計劃和協同計劃。而文斯很快就會討論這個計畫的細節。

I want to point out that we believe SERENITY At-Home may provide us with a near-term opportunity to create shareholder value through a potential label expansion for the previously approved 120 microgram dose. The TRANQUILITY In-Care trial is similar in design to our positive Phase 3 TRANQUILITY II trial.

我想指出的是，我們相信 SERENITY At-Home 可能會為我們提供一個近期機會，透過先前批准的 120 微克劑量的潛在標籤擴展來創造股東價值。 TRANQUILITY In-Care 試驗的設計與我們積極的 3 期 TRANQUILITY II 試驗類似。

We see a larger long-term growth potential with this program. We believe there is a significant upside to be the first to enter this untapped market. In addition to progressing our clinical development programs, we have further expanded intellectual property for our neuroscience franchise.

我們看到該計劃具有更大的長期成長潛力。我們相信，率先進入這個尚未開發的市場將有巨大的優勢。除了推進我們的臨床開發項目外，我們還進一步擴大了神經科學特許經營權的智慧財產權。

We were recently granted two new patents in US and Japan. We believe this provides long-term protection for our assets and gives us a solid foundation from which to pursue further development of BXCL501 and potential partnership in key international markets.

我們最近在美國和日本獲得了兩項新專利。我們相信，這為我們的資產提供了長期保護，並為我們進一步開發 BXCL501 和在主要國際市場建立潛在合作夥伴關係奠定了堅實的基礎。

Our IP portfolio is substantial. As of April 2024, we have 30 granted or allowed patents and more than 140 additional patent applications in prosecution. We also have eight US patent for our approved drug regarding me, listed in the FDA's Orange Book with two additional recently allowed patents eligible for listing once issued by the US Patent and Trademark Office.

我們的智慧財產權組合非常豐富。截至 2024 年 4 月，我們已授予或允許專利 30 項，另有 140 多項專利申請正在審查中。我們還擁有與我有關的已批准藥物的八項美國專利，這些專利已列入 FDA 的橙皮書中，另外兩項最近允許的專利一旦由美國專利商標局頒發就有資格列入名單。

Turning to IGALMI commercialization traction, our revised and focus strategy is yielding results as we increase net revenue in that Q1 2024 by 55% over the Q4 2023. This growth is being primarily driven by volume contracting, new customer acquisitions, increased utilization from existing customers and the recently implemented permanent J-Code for IGALMI.

談到IGALMI 商業化牽引力，我們修訂後的重點策略正在取得成果，我們2024 年第一季的淨收入比2023 年第四季增加了55%。現有客戶利用率提高推動的以及最近為 IGALMI 實施的永久 J 代碼。

We are seeing this momentum carrying forward into the second quarter with carton volume already exceeding that of the first quarter this year. We are pleased that IGALMI is reaching a greater number of patients and health care providers and expect this momentum to continue.

我們看到這種勢頭延續到第二季​​度，今年的紙箱銷量已經超過第一季。我們很高興 IGALMI 正在覆蓋更多的患者和醫療保健提供者，並預計這種勢頭將持續下去。

Both institutional and home setting market for bipolar and schizophrenia related agitation are symbiotic and commercially strategic. We are excited about achieving an uptick in IGALMI utilization and having a clear development path for the [home setting].

雙相情感障礙和精神分裂症相關躁動的機構和家庭環境市場是共生的和商業策略性的。我們很高興能夠實現 IGALMI 使用率的上升，並為 [家庭環境] 提供清晰的發展路徑。

Turning now to the corporate front, we are pleased to have completed the $25 million registered direct offering we recently announced. This transaction provides an important bridge to continue advancing our business strategy and clinical trial plans.

現在轉向公司方面，我們很高興完成了最近宣布的 2500 萬美元的註冊直接發行。此次交易為繼續推進我們的業務策略和臨床試驗計劃提供了重要的橋樑。

We remain focused on further strengthening our balance sheet and exploring multiple financing options, including potential partnerships to extend our cash. We also continue to optimize operational efficiencies.

我們仍然專注於進一步加強我們的資產負債表並探索多種融資選擇，包括潛在的合作夥伴關係以擴大我們的現金。我們也持續優化營運效率。

So to wrap up, we believe our business fundamentals are strong. We are advancing to late-stage clinical programs, strengthening intellectual property and seeing progress with commercialization of IGALMI. These accomplishments are underpinned by a compelling value proposition for driving future growth for the company.

總而言之，我們相信我們的業務基礎很強大。我們正在推進後期臨床項目，加強智慧財產權並看到 IGALMI 商業化的進展。這些成就的基礎是推動公司未來成長的令人信服的價值主張。

With that, I will turn it over to Vince.

這樣，我就把它交給文斯了。

Thank you, Vimal. I appreciate the opportunity to review the progress we've made with our late-stage clinical development programs for [Fiber One]. Since speaking with you in March, we received the minutes from our meetings with FDA regarding the development plans for the TRANQUILITY and SERENITY programs.

謝謝你，維馬爾。我很高興有機會回顧我們在 [Fiber One] 後期臨床開發專案中取得的進展。自從三月與您交談以來，我們收到了與 FDA 就 TRANQUILITY 和 SERENITY 計劃的開發計劃舉行的會議記錄。

Based on that feedback, we have developed and unknowns the designs of both pivotal Phase 3 trials. We are pleased to have clarity on development path, which may lead to potential NDA submissions, both for Alzheimer's related agitation and bipolar and schizophrenia related agitation.

根據這些回饋，我們已經開發並未知了兩個關鍵 3 期試驗的設計。我們很高興能夠明確開發路徑，這可能會導致潛在的 NDA 提交，無論是針對阿茲海默症相關的躁動症還是躁鬱症和精神分裂症相關的躁動症。

As a reminder, in the TRANQUILITY program, we're evaluating Fiber One as an acute treatment for agitation associated with Alzheimer's dementia. Our TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of a 60 microgram dose of 501 over a 12 week period. The primary endpoint is change in PEC score at two hours post first dose.

提醒一下，在 TRANQUILITY 計劃中，我們正在評估 Fiber One 作為治療阿茲海默症相關躁動的急性療法。我們的 TRANQUILITY In-Care 試驗被設計為雙盲、安慰劑對照、多中心研究，旨在評估 60 微克劑量的 501 在 12 週內的有效性和安全性。主要終點是首次給藥後兩小時 PEC 評分的變化。

It's important to note that this is the same endpoint used in previous positive TRANQUILITY trials and in studies that supported the FDA approval IGALMI. In the SERENITY program, we're evaluating the potential at-home use of Fiber One for agitation associated with bipolar disorders or schizophrenia.

值得注意的是，這與先前的 TRANQUILITY 陽性試驗以及支持 FDA 批准 IGALMI 的研究中使用的終點相同。在 SERENITY 計劃中，我們正在評估家庭使用 Fiber One 治療與雙相情感障礙或精神分裂症相關的躁動的可能性。

Our SERENITY At-Home trial is designed to be a double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy, albeit 120 microgram dose of 501 over a 12 week period. The primary objective is safety with efficacy measures as exploratory endpoints.

我們的 SERENITY At-Home 試驗旨在成為一項雙盲、安慰劑對照、多中心研究，旨在評估 501 在 12 週內使用 120 微克劑量的安全性和有效性。主要目標是安全性和功效測量作為探索性終點。

Again, we've taken a thoughtful and deliberate approach to our trial designs with the ultimate goal of accessing the retail setting in mind, and we look forward to advancing our plans. The trial protocols have now been finalized and are being shared with the FDA and our CRO is for clinical site selection.

同樣，我們對試驗設計採取了深思熟慮和深思熟慮的方法，最終目標是進入零售環境，我們期待著推進我們的計劃。試驗方案現已最終確定，並正在與 FDA 共享，我們的 CRO 負責臨床地點選擇。

In our PMR study, we recently completed the enrollment of 22 patients with frequent episodes of agitation for bipolar disorders or schizophrenia in that open-label study. It's designed to evaluate whether tolerance, tachyphylaxis or withdrawal occur following repeat dosing of the one 80 microgram dose of IGALMI after seven days of repeated treatment.

在我們的 PMR 研究中，我們最近在該開放標籤研究中完成了 22 名因躁鬱症或精神分裂症頻繁發作的患者的入組。它的目的是評估在重複治療 7 天后，重複服用 1 個 80 微克劑量的 IGALMI 後是否會出現耐受性、快速耐受或戒斷反應。

These trial results can help address the language around limitations of use and warnings and precautions in IGALMI's current label. We are performing data cleaning currently and look forward to announcing results from this PMR study shortly.

這些試驗結果可以幫助解決 IGALMI 目前標籤中有關使用限制、警告和預防措施的語言問題。我們目前正在進行資料清理，並期待很快公佈這項 PMR 研究的結果。

I'd like to end my remarks with a few comments about our lead immuno-oncology asset 701. Earlier this year, we announced the completion of patient enrollment in the safety portion of the Phase 2 trial of 701 in combination with Keytruda in metastatic pancreatic ductal adenocarcinoma.

我想以一些關於我們領先的免疫腫瘤學資產 701 的評論來結束我的演講。

The trial is being led by Georgetown, Lombardi Comprehensive Cancer Center. We are pleased that a late-breaking abstract was selected for presentation at the Asc at the 2024 ASCO Annual Meeting and look forward to sharing the data on June 1 with you. We have formally initiated the process for monetization of this asset.

該試驗由喬治城隆巴迪綜合癌症中心領導。我們很高興在 2024 年 ASCO 年會上選擇了一份最新摘要在 ASC 上進行演示，並期待在 6 月 1 日與您分享這些數據。我們已正式啟動該資產的貨幣化流程。

I would now like to turn the call over to Rich, who will review our financial results for the first quarter of '24. Richard?

我現在想把電話轉給 Rich，他將審查我們 2024 年第一季的財務表現。理查德？

Thank you, Vince. Net revenue from IGALMI was $582,000 for the first quarter of 2024 compared to $206,000 for the same period in 2023, a 182% year-over-year increase. Sequential quarterly revenue increased 55% in the first quarter of 2024 from the fourth quarter of 2023.

謝謝你，文斯。 2024 年第一季 IGALMI 的淨收入為 582,000 美元，而 2023 年同期為 206,000 美元，年增 182%。 2024 年第一季環比季營收較 2023 年第四季成長 55%。

The increased revenue for both periods was primarily attributable to increasing demand with our existing customer base, the addition of new customer orders and volume-based contracting.

這兩個時期的收入增加主要歸因於我們現有客戶群的需求增加、新客戶訂單的增加和基於數量的合約。

Research and development expenses were $11.4 million for the first quarter of 2024 compared to $27.8 million for the same period in 2023. The decreased expenses were primarily attributable to the wind-down of the SERENITY III and the TRANQUILITY II and III trials as well as decreased professional fees, personnel and related costs.

2024 年第一季的研發費用為 1,140 萬美元，而 2023 年同期為 2,780 萬美元。 。

Selling, general and administrative expenses were $13.3 million for the first quarter of 2024 compared to $23.6 million for the same period in 2023. The reduced expenses were primarily attributable to a decrease in personnel and costs associated with the commercialization of IGALMI compared to the first quarter of 2023. The reduced expenses were partially offset by increased professional fees during the first quarter of 2024.

2024 年第一季的銷售、一般和管理費用為 1,330 萬美元，而 2023 年同期為 2,360 萬美元。年的費用減少被2024 年第一季專業費用的增加部分抵銷。

BioXcel Therapeutics had a net loss of $26.8 million for the first quarter of 2024 compared to a net loss of $52.8 million for the same period in 2023. The company used approximately $17.7 million in operating cash during the first quarter of 2024.

BioXcel Therapeutics 2024年第一季的淨虧損為2,680萬美元，而2023年同期的淨虧損為5,280萬美元。

Cash and cash equivalents totaled $74.1 million as of March 31, 2024. This includes the $25 million from the registered direct offering announced on March 25, 2024. This investment extends our cash runway beyond our previous guidance of mid-2024 into the second half of 2024.

截至2024 年3 月31 日，現金和現金等價物總計7,410 萬美元。指導延伸到了2024 年下半年。

For now, I'd like to turn the call back to Vimal.

現在，我想把電話轉回維馬爾。

Thank you, Rich. I like to add that in the coming weeks, we plan to attend several upcoming investor healthcare conferences and look forward to continuing our discussions. We would now like to open the call for questions. Operator?

謝謝你，里奇。我想補充一點，在未來幾週內，我們計劃參加幾場即將舉行的投資者醫療保健會議，並期待繼續我們的討論。我們現在要開始提問。操作員？

(Operator Instructions) Colin Bristow, UBS.

（操作員說明）Colin Bristow，UBS。

Hey, good morning and thanks for taking the questions. So I think the major question is investors are wrestling with what is the timeline date to approval in Alzheimer's agitation and what do you expect the cost of this program to be.

嘿，早上好，感謝您提出問題。因此，我認為主要問題是投資者正在思考阿茲海默症的批准時間表是什麼以及您預計該計劃的成本是多少。

And then just as a kind of follow on that, with regards to this path to approval in Alzheimer's agitation, can you say what FDA has specifically said regarding the need for the 12 month safety data. Thank you.

然後，作為一種後續，關於阿茲海默症治療的批准途徑，您能說說 FDA 對於 12 個月安全數據的需要具體說了些什麼嗎？謝謝。

Okay. So sorry, we had a technical glitch on this site. So Colin, thanks for the question. Just trying to answer that and sorry for the delay. We can't give specific dates today this morning. But what I can see in terms of the TRANQUILITY In-Care study and look to TRANQUILITY II, a very similar trials in design. So we would anticipate a timeline and a cost very similar and to the TRANQUILITY II system.

好的。非常抱歉，我們的網站出現了技術故障。科林，謝謝你的提問。只是想回答這個問題，抱歉耽擱了。今天早上我們無法給出具體日期。但我可以從 TRANQUILITY In-Care 研究中看到什麼，並期待 TRANQUILITY II，這是一項設計上非常相似的試驗。因此，我們預計時間表和成本與 TRANQUILITY II 系統非常相似。

Okay. And on the FDA requirement for 12 months safety?

好的。 FDA 是否要求 12 個月的安全性？

Yeah. So I think as we've said, we will reapproach the FDA to discuss specifically the details around the long-term safety trial, but the need for that trial is clearly not in doubt. That has to be done and that would form part of the package for the TRANQUILITY In-Care SNDA.

是的。因此，我認為正如我們所說，我們將重新與 FDA 聯繫，具體討論長期安全性試驗的細節，但該試驗的必要性顯然是毫無疑問的。這是必須要做的，這將成為 TRANQUILITY In-Care SNDA 套餐的一部分。

Ram Selvaraju, H.C. Wainwright.

塞爾瓦拉朱 (Ram Selvaraju)，H.C.溫賴特。

Thanks very much for taking my questions. Back to IGALMI, can you offer us some additional color regarding the status of the group contracting discussions? And when do you anticipate the impact to net revenue to manifest itself in the coming quarters? Are there any important GPO purchasing contracting decisions expected in the coming months for you?

非常感謝您回答我的問題。回到 IGALMI，您能否提供我們一些有關集團承包討論狀況的額外資訊？您預計對未來幾季淨收入的影響何時會顯現出來？您預計在未來幾個月內會做出任何重要的 GPO 採購合約決策嗎？

Yeah, good morning. This is Matt. So yes, the answer to question is we continue to matriculate contracts. We had multiple contracts in Q1. We continue to execute the plan. And over Q2, we've seen an increase in unit volume. In fact, as Vimal said in the prepared remarks, we've already seen unit volume increase more than what we posted in Q1 out so far in Q2.

是的，早安。這是馬特。所以是的，問題的答案是我們繼續簽約。我們在第一季簽訂了多份合約。我們繼續執行該計劃。在第二季度，我們看到單位數量增加。事實上，正如 Vimal 在準備好的評論中所說，我們已經看到第二季度迄今為止的單位銷售增長超過了第一季的增幅。

So the contracting strategy -- the volume contracting strategy is working. We see that existing customers continue to order, and we also see the acquisition of new accounts, which I think it's really important for continued growth throughout the year.

因此，承包策略－批量承包策略正在發揮作用。我們看到現有客戶繼續訂購，我們也看到新客戶的獲得，我認為這對於全年的持續成長非常重要。

And then secondly, with respect to the earlier stage, neuroscience asset, are you exploring strategic options for these or is to this effectively continue to develop them in-house? Thank you.

其次，關於早期階段的神經科學資產，您是否正在探索這些策略選擇，或者是否有效地繼續在內部開發它們？謝謝。

Ram, this is Vimal. Our focus, as I mentioned, is primarily on the two late-stage clinical program, SERENITY At-Home and TRANQUILITY In-Care. We are dedicating all our resources to those programs, but early program certainly will be explored if there is interest for potential partnership and that we plan to explore.

拉姆，這是維馬爾。正如我所提到的，我們的重點主要是兩個後期臨床項目：SERENITY At-Home 和 TRANQUILITY In-Care。我們將所有資源投入這些計劃中，但如果有興趣建立潛在合作夥伴關係並且我們計劃探索，那麼早期計劃肯定會被探索。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Hey, guys, good morning. Thanks for taking our question. Just two from us, maybe both on the metastatic [PDEC] data we should be expecting at ASCO. I guess maybe just a high-level walk us through how 701 is designed to treat these patients. And then as a follow-up, what would we typically expect with KEYTRUDA monotherapy in this line of treatment in these patients? Thanks.

嘿，夥計們，早安。感謝您提出我們的問題。我們只有兩個，也許都是關於我們應該在 ASCO 期待的轉移性 [PDEC] 數據。我想也許只是高層向我們介紹 701 是如何設計來治療這些患者的。然後作為後續行動，我們通常對 KEYTRUDA 單藥療法在這些患者的這一系列治療中的期望是什麼？謝謝。

Sure, morning, Alec. This is Vince. So I'll take your second part of your question first, KEYTRUDA is not active as a monotherapy. I think that's generally accepted, pancreatic cancer and is a very, very cold tumor, really the definition of a cold tumor. The only exception would be MSI high pancreatic cancer. KEYTRUDA has a separate label to cover tissue agnostic MSI high patients. So that's 1% approximately of pancreas.

當然，早上好，亞歷克。這是文斯。所以我先回答你問題的第二部分，KEYTRUDA 作為單一療法並不有效。我認為這是普遍接受的，胰臟癌是一種非常非常冷的腫瘤，確實是冷腫瘤的定義。唯一的例外是 MSI 高的胰臟癌。 KEYTRUDA 有一個單獨的標籤來覆蓋組織不可知的 MSI 高患者。這大約是胰臟的 1%。

So KEYTRUDA is not active there. Our approach is to combine with KEYTRUDA. So 701 plus KEYTRUDA in a combination at second line refractory pancreatic cancer, approximately 40 patients in total, Simon two-stage and Stage one, about 20 patients followed by another 20 patients.

所以 KEYTRUDA 在那裡並不活躍。我們的方法是與 KEYTRUDA 結合。所以701加KEYTRUDA合併治療二線難治性胰臟癌，總共大約40名患者，西蒙二期和一期，大約20名患者，隨後是另外20名患者。

So that's the general gist of the of the approach. The reason we're doing the study at all is because we have very strong and encouraging preclinical data for the combination which we've presented.

這就是該方法的總體要點。我們進行這項研究的原因是因為我們對我們所提供的組合擁有非常強大且令人鼓舞的臨床前數據。

And just lastly on the point in the pancreas is a cold tumor and it's also surrounded as you'll know by a fibrous layer, which again makes it very difficult to treat. We have no published data that show that 701 essentially makes that collagen disappear. So there's multiple reasons to anticipate encouraging results, you'll see those results in June.

最後，胰臟中的一個點是一個冷腫瘤，它也被纖維層包圍，這又使得治療變得非常困難。我們沒有公開的數據表明 701 本質上會使膠原蛋白消失。因此，有多種理由可以預期令人鼓舞的結果，您將在六月看到這些結果。

Avantika Joshi, Mizuho Securities.

Avantika Joshi，瑞穗證券。

Hi. This is Avantika on for Greg. Our question is up between TRANQUILITY In-Care and SERENITY At-Home, which trial would you say is the priority for you guys? And would you run these studies concurrently or would it make more sense to run them one after another? Thanks.

你好。這是 Greg 的 Avantika。我們的問題是在 TRANQUILITY In-Care 和 SERENITY At-Home 之間，你們認為哪一個試驗是你們優先考慮的？您會同時進行這些研究，還是依序進行這些研究更有意義？謝謝。

Thanks, Avantika. Strategically, we would prefer to run both trials in parallel. As I indicated, both are big value drivers for the company. There are no approved FDA therapies, and they represent a transformative value drivers.

謝謝，阿凡提卡。從戰略上講，我們更願意同時進行這兩項試驗。正如我所指出的，兩者都是公司的重要價值驅動因素。目前還沒有 FDA 批准的療法，它們代表了變革性的價值驅動因素。

SERENITY on one hand is a near term opportunity through label expansion for the 120 microgram approved dose. While TRANQUILITY is a much larger and longer-term opportunity with a significant upside and being first to market. So to answer your question, we prefer to run both. If we have to and then we will take the decision of prioritizing one over the other or a stepwise approach.

一方面，透過擴大 120 微克批准劑量的標籤範圍，SERENITY 是近期機會。而 TRANQUILITY 是一個更大、更長期的機會，具有顯著的上升空間，並且是第一個進入市場的。因此，為了回答您的問題，我們更願意同時運行兩者。如果必須的話，我們將決定優先考慮其中一項或採取逐步的方法。

(Operator Instructions) Sumant Kulkarni, Canaccord Genuity.

（操作員說明）Sumant Kulkarni，Canaccord Genuity。

Good morning. Thanks for taking my questions. I have three. So how would you frame the capital needs for running TRANQUILITY and SERENITY as they stand now relative to your current cash and the additional $25 million that you'll need to raise in November to conform to your financing agreement? That's the first.

早安.感謝您回答我的問題。我有三個。那麼，您將如何根據目前的現金以及 11 月份需要籌集的額外 2500 萬美元來確定營運 TRANQUILITY 和 SERENITY 的資本需求，以符合您的融資協議？這是第一個。

Hi, Sumant. This is Vimal. As Vince indicated TRANQUILITY In-Care trial is very similar to the TRANQUILITY II trial where we had the positive data. We are trying to have another well-controlled Phase 3 trial for confirmation of efficacy and safety. So we expect that trial cost to be very similar to the TRANQUILITY. So we have very good like an idea about what the per-patient cost is. And in terms of timelines, it will be pretty much similar.

嗨，蘇曼特。這是維馬爾。正如 Vince 所指出的，TRANQUILITY In-Care 試驗與我們獲得積極數據的 TRANQUILITY II 試驗非常相似。我們正在嘗試進行另一項控制良好的 3 期試驗，以確認有效性和安全性。因此，我們預計試用成本與 TRANQUILITY 非常相似。因此，我們非常了解每位患者的費用是多少。就時間表而言，它會非常相似。

While when we think of the SERENITY At-Home is much smaller number of patients, almost 100 patients. So that is recruitment is much faster than what we have observed in our previous three trials, SERENITY I, II and III and cost is much lower, almost 50% now what it would be in TRANQUILITY. So we are trying to look at both opportunity.

而當我們想到 SERENITY At-Home 時，患者數量要少得多，大約有 100 名患者。因此，招募速度比我們在先前的三項試驗（SERENITY I、II 和 III）中觀察到的要快得多，而且成本也低得多，幾乎是 TRANQUILITY 中的 50%。所以我們正在努力尋找這兩個機會。

And as you know, with SERENITY, we can be potentially if we can complete that trial file an NDA in 2025. So we are very synergistic because we already have a commercial partner. So I would say that we have very good handle and based on our current cash, which was reported $74 million, we are laying out what the trial cost is and what the capital requirement is and how to finance the trials. And previously answered, then we prioritize or we use a stepwise approach.

如您所知，透過 SERENITY，如果我們能夠在 2025 年完成試驗並提交 NDA，我們就有可能實現這一目標。因此，我想說，我們的處理能力非常好，根據我們目前的現金（據報告為 7400 萬美元），我們正在製定試驗成本、資本要求以及如何為試驗提供資金。之前已經回答過，然後我們會優先考慮或使用逐步的方法。

Got it. And then I'll ask the second and third questions in one shot here. So in TRANQUILITY In-Care, what's a general target percentage of patients you expect to enroll that might already be on [Rexulti] as a chronic treatment for agitation in Alzheimer's.

知道了。然後我會在這裡一次問第二個問題和第三個問題。因此，在 TRANQUILITY In-Care 中，您期望招募的患者的總體目標百分比是多少，這些患者可能已經在 [Rexulti] 上作為阿茲海默症躁動的慢性治療方法。

And going back to costs, do you think that the operating expense base at the company as it stands currently is optimized relative to the things you need to execute on.

回到成本問題，您認為公司目前的營運費用基礎相對於您需要執行的事項是否已優化？

So on the results, I'll ask my colleague, Dr. Risinger to come in here. I don't think we exclude or --

因此，關於結果，我會請我的同事 Risinger 博士過來。我不認為我們排除或——

We do not exclude patients who are on Rexulti or any other antipsychotic. And I'll point back to the TRANQUILITY II data, which demonstrated about 50% of patients are on concomitant antipsychotics.

我們不排除服用 Rexulti 或任何其他抗精神病藥物的患者。我將回顧 TRANQUILITY II 的數據，該數據顯示大約 50% 的患者同時服用抗精神病藥物。

And your last question, Sumant, I'm sorry, can I ask you to repeat it?

你的最後一個問題，Sumant，很抱歉，我可以請你再說一次嗎？

Yeah, sure. Do you have did you think the operating expense base at the company as it stands currently is optimized relative to all the things that you need to execute on in the near to midterm here?

好，當然。您是否認為公司目前的營運費用基礎相對於您在近期到中期需要執行的所有事情來說是優化的？

Yeah, thanks. It's Richard. How are you? The answer is we continually to evaluate. We continue to evaluate the operating overhead and we continue to look at ways to make it more efficient and optimize it. So that's an ongoing process here.

是的，謝謝。這是理查德。你好嗎？答案是我們不斷地評估。我們繼續評估營運開銷，並繼續尋找提高其效率和優化它的方法。所以這是一個持續的過程。

Samir Devani, Rx Securities.

Samir Devani，Rx 證券。

Hi, guys. Thanks for taking my question. I just wanted to come back to the comment about the 12 safety study that would be required as for the TRANQUILITY In-Care study. I just want to confirm that would be required before you make the SNDA. And also, now that you've essentially completed these discussions with the FDA, what's the trigger left now to initiate that trial?

嗨，大家好。感謝您提出我的問題。我只是想回到關於 TRANQUILITY In-Care 研究所需的 12 項安全研究的評論。我只是想確認您在製定 SNDA 之前需要這樣做。而且，既然您已經基本上完成了與 FDA 的這些討論，那麼現在啟動該試驗的觸發因素是什麼？

Good morning. This is Vince. So I think as we've said, we will go to the FDA and discuss not the need, of course, for long-term safety, that's clear. And for the details, and that will fundamentally be around the data that we collect in the study. So it's going to be a protocol discussion, which, of course, is typically why we go and discuss things with the FDA.

早安.這是文斯。所以我認為正如我們所說的，我們將去 FDA 討論當然不是為了長期安全的需要，這是明確的。至於細節，這基本上將圍繞我們在研究中收集的數據進行。所以這將是一個協議討論，當然，這通常就是我們去與 FDA 討論事情的原因。

In terms of the requirement, I think your question was when we ran the numbers and requirements, I mean those are obviously set by ICH guidelines, so 300 at six months and 100 at one year. We would need the long-term safety data outcome to support an SNDA submission.

就要求而言，我認為你的問題是我們何時運行數字和要求，我的意思是這些顯然是由 ICH 指南設定的，因此六個月為 300 個，一年為 100 個。我們需要長期安全數據結果來支持 SNDA 提交。

And Samir, to answer your question, when do we expect to initiate this study. As Vince mentioned, now we are sharing the protocol with the FDA and given it to the CROs for site selection. And once we have the financing in place up to the data readout, we will initiate the study. We are getting the technical readiness.

薩米爾，回答你的問題，我們預計什麼時候開始這項研究。正如 Vince 所提到的，現在我們正在與 FDA 共享該方案，並將其交給 CRO 進行地點選擇。一旦我們獲得數據讀取所需的資金，我們將啟動研究。我們正在做好技術準備。

Great. Thanks very much.

偉大的。非常感謝。

We have reached the end of our question-and-answer session. I would like to turn the call back over to management for closing remarks.

我們的問答環節已經結束。我想將電話轉回管理層以供結束語。

Thank you, everyone, for joining us today and for your continuing interest in BioXcel Therapeutics. Have a great day.

感謝大家今天加入我們並感謝您對 BioXcel Therapeutics 的持續關注。祝你有美好的一天。

Thank you. And this will conclude today's conference. You may disconnect your lines at this time. And thank you for your participation.

謝謝。今天的會議到此結束。此時您可以斷開線路。並感謝您的參與。