BioXcel Therapeutics Inc (BTAI) 2023 Q2 法說會逐字稿

Good morning, and welcome to the BioXcel Therapeutics Second Quarter 2023 Financial Results Conference Call. (Operator Instructions)

早上好，歡迎參加 BioXcel Therapeutics 2023 年第二季度財務業績電話會議。 （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 that are subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. 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-Q] for the quarter ended March 31, 2023, which can be found at www.bioxceltherapeutics.com or on www.sec.gov and which will be updated in its quarterly report on Form 10-Q for the quarter ended June 30, 2023. As a reminder, today's conference is being recorded.

只是提醒大家，今天的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，這些陳述受到與未來事件和/或未來財務或業務績效相關的風險和不確定性的影響。公司。實際結果可能與這些前瞻性陳述中的預期存在重大差異。可能影響未來業績的風險因素詳見公司截至 2023 年 3 月 31 日的季度年度報告 [10-Q]，該報告可在 www.bioxceltherapeutics.com 或 www.sec.gov 上找到，將在截至2023 年6 月30 日的季度的10-Q 表格季度報告中進行更新。謹此提醒，我們正在錄製今天的會議。

Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer; Richard Steinhart, Chief Financial Officer; Matt Wiley, Chief Commercial Officer; Dr. Rob Risinger, Chief Medical Officer of Neuroscience; Dr. Vince O'Neill, Chief R&D Officer of OnkosXcel Therapeutics; and Dr. Frank Yocca, Chief Scientific Officer.

加入我們今天電話會議的還有首席執行官 Vimal Mehta 博士；理查德·斯坦哈特，首席財務官；馬特·威利 (Matt Wiley)，首席商務官； Rob Risinger 博士，神經科學首席醫學官； Vince O'Neill 博士，OnkosXcel Therapeutics 首席研發官；和首席科學官 Frank Yocca 博士。

It is now my pleasure to turn the call over to Dr. Mehta, the CEO and Founder of BioXcel Therapeutics. Please go ahead.

現在我很高興將電話轉給 BioXcel Therapeutics 的首席執行官兼創始人 Mehta 博士。請繼續。

Thank you, operator. Welcome, everyone, and thank you for joining our call today. Before we begin, I first want to say that the company was dismayed and frustrated by our recent discovery of certain investigator misconduct that occurred during our TRANQUILITY II trial. This summer has not progressed as we had anticipated, and we plan to make significant changes to our entire business structure. While I'm deeply disappointed, I'm more determined than ever to continue developing our drug candidates and put BioXcel Therapeutics back in a position to accomplish its core mission.

謝謝你，接線員。歡迎大家，感謝您今天加入我們的電話會議。在我們開始之前，我首先想說，公司對我們最近發現在 TRANQUILITY II 試驗期間發生的某些研究者不當行為感到沮喪和沮喪。今年夏天的進展並沒有像我們預期的那樣，我們計劃對整個業務結構進行重大改變。雖然我深感失望，但我比以往任何時候都更有決心繼續開發我們的候選藥物，並使 BioXcel Therapeutics 重新回到完成其核心使命的位置。

Now I will start by covering our strategic reprioritization and how it is designed to position us for success going forward. In addition, I will share as much information as I can about the status of our TRANQUILITY program in Alzheimer's associated agitation. Six years ago, we founded BioXcel Therapeutics with a clear mission to build a uniquely disruptive biopharmaceutical model using AI approaches to bring transformative medicines to patients. We believe we have fulfilled this mission with the approval and launch of IGALMI and with our programs in the late stage of clinical development.

現在，我將首先介紹我們的戰略優先順序調整以及它是如何為我們未來的成功定位的。此外，我將盡可能多地分享有關我們的 TRANQUILITY 項目在阿爾茨海默病相關躁動方面的狀況的信息。六年前，我們創立了 BioXcel Therapeutics，其明確的使命是利用人工智能方法構建獨特的顛覆性生物製藥模型，為患者帶來變革性藥物。我們相信，隨著 IGALMI 的批准和啟動以及我們的項目處於臨床開發的後期階段，我們已經完成了這一使命。

We are now taking the necessary steps across the business to strengthen our ability to advance our land and expense strategy. Specifically, we are taking clear, well-defined and decisive actions in 3 areas. First, let's discuss our commercial reprioritization. We landed with IGALMI's approval in the institutional setting. We are now shifting resources to the expand effect of our market strategy into what we believe is a potentially more promising retail pharmacy and outpatient setting. This shift is largely due to the fact that the hospital setting proved to be more difficult to penetrate than we originally anticipated, particularly in a challenging post-COVID environment.

我們現在正在整個業務範圍內採取必要的措施，以增強我們推進土地和費用戰略的能力。具體來說，我們在三個領域採取明確、明確和果斷的行動。首先，讓我們討論一下我們的商業優先順序。我們在機構設置方面獲得了 IGALMI 的批准。我們現在正在將資源轉移到我們認為更有潛力的零售藥房和門診環境中，以擴大我們的市場戰略的影響。這種轉變很大程度上是由於事實證明，醫院環境比我們最初預期的更難以滲透，特別是在充滿挑戰的新冠疫情后環境中。

Despite these challenges, however, we remain committed to making IGALMI available to patients in the institutional setting. We began deploying a contracting effort with large hospitals, health care systems and integrated delivery network prior to our reprioritization and have been pleased to see it achieved some initial success with increased demand from existing hospital customers and large health systems. In fact, our Q2 revenues doubled from Q1 largely due to this contracting strategy. Therefore, we will now broadly adopt it.

然而，儘管存在這些挑戰，我們仍然致力於為機構環境中的患者提供 IGALMI。在重新調整優先順序之前，我們開始與大型醫院、醫療保健系統和綜合交付網絡部署承包工作，並很高興地看到隨著現有醫院客戶和大型醫療系統需求的增加，它取得了一些初步成功。事實上，我們第二季度的收入比第一季度翻了一番，很大程度上歸功於這種承包策略。因此，我們現在將廣泛採用它。

As part of this action, we plan to reduce our total workforce from approximately 190 to 80 employees over the next several months. The majority of these reductions will be in the commercial organization to help us build towards potential label expansions and to support IGALMI, we will maintain a core 12 member team from market access, commercial operations, sales and trade functions. This decision to reduce our workforce was extremely difficult for the management team and the Board, but was necessitated by a variety of market and business factors. I'm grateful to all of our employees who made many contributions to our company. We are committed to providing support to those impacted as they transition from the company.

作為該行動的一部分，我們計劃在未來幾個月內將員工總數從約 190 人減少至 80 人。其中大部分削減將在商業組織中進行，以幫助我們實現潛在的標籤擴張並支持 IGALMI，我們將維持一個由 12 名成員組成的核心團隊，負責市場准入、商業運營、銷售和貿易職能。對於管理團隊和董事會來說，裁員的決定極其困難，但由於各種市場和業務因素，不得不做出這樣的決定。我感謝所有為我們公司做出貢獻的員工。我們致力於為受影響的人員從公司過渡時提供支持。

The second part of our business transformation involves shifting our development focus to high potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia and Alzheimer's dementia. We firmly believe this drug has the potential to have a positive impact on patients and caregivers, and address a significant unmet medically. For example, 23 million episodes of bipolar schizophrenia-related agitation occur annually in the U.S. in the at-home setting. In addition, 100 million Alzheimer's-related agitation episodes occur every year in the U.S. Importantly, more than 80% of these patients are in an agitation setting and episode here represent more than half of the total episode volume.

我們業務轉型的第二部分涉及將我們的開發重點轉向 BXCL501 在雙相情感障礙、精神分裂症和阿爾茨海默氏癡呆症方面的高潛力市場機會。我們堅信這種藥物有可能對患者和護理人員產生積極影響，並解決重大的未滿足的醫療問題。例如，在美國，每年在家中會發生 2300 萬起與雙相型精神分裂症相關的躁動發作。此外，美國每年發生 1 億例與阿爾茨海默病相關的躁動發作。重要的是，這些患者中超過 80% 處於躁動狀態，而此處的發作次數佔總發作次數的一半以上。

We are motivated to develop 501 to address the needs of these patients. We have developed a comprehensive plan for our TRANQUILITY program in Alzheimer's-associated agitation. In June, we announced positive top line data from TRANQUILITY II. This was a uniquely complex trial requiring mobilization of clinical team whenever an agitation episode occurred. We were pleased that our top line data showed that we met our primary endpoint with the 60-microgram dose, with 501 demonstrating a statistically significant 39% greater reduction in PEC score from baseline compared to placebo at 2 hours. We also met a key secondary endpoint with a statistically significant reduction in agitation symptoms versus placebo as measured by PEC score change from baseline at 1 hour with 60-microgram dose.

我們有動力開發 501 來滿足這些患者的需求。我們針對阿爾茨海默病相關躁動的 TRANQUILITY 計劃制定了全面的計劃。 6 月，我們公佈了 TRANQUILITY II 的積極頂線數據。這是一項獨特複雜的試驗，每當發生躁動事件時就需要動員臨床團隊。我們很高興我們的頂線數據顯示，60 微克劑量的我們達到了主要終點，501 表明與安慰劑相比，2 小時後 PEC 評分較基線降低了 39%，具有統計學意義。我們還達到了一個關鍵的次要終點，即與安慰劑相比，躁動症狀在統計學上顯著減少，這是通過 60 微克劑量 1 小時時 PEC 評分相對於基線的變化來衡量的。

501 was well tolerated with no drug-related serious adverse events over trial duration. As we disclosed in an 8-K filing, there were issues related to a principal investigator at a TRANQUILITY II clinical side. They conduct by this PI was unacceptable and extremely unfortunate. We are investigating the issue and, for example, have already initiated and audited by an independent third party of the data from the PI's clinical side.

501 的耐受性良好，在試驗期間未發生與藥物相關的嚴重不良事件。正如我們在 8-K 文件中披露的那樣，存在與 TRANQUILITY II 臨床方面的首席研究員相關的問題。該 PI 的行為是不可接受且極其不幸的。我們正在調查這個問題，例如，已經由獨立第三方啟動並審核了 PI 臨床方面的數據。

In addition, we have requested a meeting with the FDA to discuss our entire TRANQUILITY program. This will include both TRANQUILITY II, TRANQUILITY III clinical trials, the data audit and the data package that may be required to support submission of an sNDA seeking approval of 501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer's disease. We hope to have an update on the TRANQUILITY program, including the audit and FDA meeting by the end of the year.

此外，我們還要求與 FDA 召開會議，討論我們的整個 TRANQUILITY 計劃。這將包括TRANQUILITY II、TRANQUILITY III 臨床試驗、數據審核和數據包，這些數據審核和數據包可能需要支持提交sNDA，尋求批准501 用於急性治療患有可能患有阿爾茨海默病的輕度至中度癡呆患者的躁動。我們希望在年底前獲得 TRANQUILITY 計劃的最新情況，包括審計和 FDA 會議。

Regarding TRANQUILITY III, we paused enrollment after early trial data showed a much higher background frequency of agitation episode than originally expected. It appears that this patient population may be better suited for a chronic treatment of agitation, while our focus is on developing 501 as acute treatment of Alzheimer's agitation. As a reminder, we have breakthrough therapy designation for the acute treatment of agitation associated with dementia.

關於 TRANQUILITY III，我們在早期試驗數據顯示躁動發作的背景頻率比最初預期高得多後暫停了招募。看來該患者群體可能更適合長期治療躁動，而我們的重點是開發 501 作為阿爾茨海默氏症躁動的急性治療方法。提醒一下，我們已經獲得了針對癡呆症相關躁動的急性治療的突破性療法。

In parallel, we are advancing our SERENITY program for the at-home acute treatment of agitation associated with bipolar disorders or schizophrenia. In May, we reported top line results from SERENITY Part I. We evaluated patients in Part 1 in a monitored medical setting as surrogates for the at-home setting. The trial assessed the safety and efficacy of 60-microgram dose of BXCL501, which is half of the lowest approved dose of IGALMI using the same primary and secondary endpoint as in the SERENITY I and SERENITY II.

與此同時，我們正在推進 SERENITY 計劃，用於在家急性治療與雙相情感障礙或精神分裂症相關的躁動。五月，我們報告了 SERENITY 第 I 部分的主要結果。我們在受監控的醫療環境中評估了第 1 部分中的患者，作為家庭環境的替代者。該試驗使用與 SERENITY I 和 SERENITY II 相同的主要和次要終點評估了 60 微克劑量的 BXCL501 的安全性和有效性，該劑量是 IGALMI 最低批准劑量的一半。

While we believe the data suggests the potential for 501 to be effective in a monitored medical settling with 60-microgram dose, we did not meet the primary endpoint of mean change in PEC score at 2 hours. However, the 60-microgram dose was well tolerated and demonstrated favorable safety results, including proportionately fewer adverse events compared to those observed during SERENITY I and II, which evaluated the approved 120-microgram or 180-microgram doses. We believe these safety results support the potential for at-home use.

雖然我們相信數據表明 501 在 60 微克劑量的監測醫療解決中具有有效的潛力，但我們沒有達到 2 小時 PEC 評分平均變化的主要終點。然而，60 微克劑量具有良好的耐受性，並顯示出良好的安全性結果，包括與SERENITY I 和II 期間觀察到的不良事件相對較少，SERENITY I 和II 評估了已批准的120 微克或180微克劑量。我們相信這些安全結果支持了家庭使用的潛力。

We are now conducting SERENITY III Part 2. It is a 12-week study to evaluate the safety of a 60-microgram dose of BXCL501, with an optional 60-microgram dose. To identify a dose to potentially provide an optimal balance between the safety and efficacy in the at-home population, we performed pharmacokinetic and pharmacodynamic modeling that suggested that use of an 80-microgram dose of BXCL501 could provide this balance. We believe the evaluation of an 80-microgram dose is further supported by our previous clinical experience with this dose during our Phase Ib trial in schizophrenia patients with agitation.

我們現在正在進行 SERENITY III 第 2 部分。這是一項為期 12 週的研究，旨在評估 60 微克劑量的 BXCL501（以及可選的 60 微克劑量）的安全性。為了確定可能在家庭人群中提供安全性和有效性之間最佳平衡的劑量，我們進行了藥代動力學和藥效學建模，結果表明使用 80 微克劑量的 BXCL501 可以提供這種平衡。我們相信，80 微克劑量的評估得到了我們之前在患有躁動的精神分裂症患者的 Ib 期試驗中使用該劑量的臨床經驗的進一步支持。

We plan to meet with the FDA to discuss the 80-microgram dose and a protocol amendment to the ongoing SERENITY III Part II study. The primary objective of part 2 is to describe the incidence of treatment emergent adverse event, the primary endpoint is a comparison of serious adverse events and treatment emergent adverse events as compared to placebo, and the secondary endpoints include a number of efficacy assessments.

我們計劃與 FDA 會面，討論 80 微克劑量以及對正在進行的 SERENITY III 第 II 部分研究的方案修訂。第 2 部分的主要目標是描述治療中出現的不良事件的發生率，主要終點是與安慰劑相比，嚴重不良事件和治療中出現的不良事件的比較，次要終點包括一些療效評估。

Turning to our major depressive disorder program, we reported positive top line results from the Phase Ib multiple ascending dose trial in May. As part of our reprioritization effort, we will pause this program. To augment our clinical development team, Dr. Vince O'Neill, who is currently serving as Head of R&D for OnkosXcel, will play a broader role in our neuroscience development. Vince has been with the company since the IPO in 2018 and has been -- has extensive pharmaceutical clinical development experience. Vince played an instrumental role in SERENITY I and II trials, along with our Chief Medical Officer, Dr. Rob Risinger, that resulted in the approval of IGALMI and the successful human proof-of-concept trials for 701 in our oncology program.

談到我們的重度抑鬱症項目，我們報告了 5 月份 Ib 期多次劑量遞增試驗的積極頂線結果。作為重新調整優先級工作的一部分，我們將暫停該計劃。為了增強我們的臨床開發團隊，目前擔任 OnkosXcel 研發主管的 Vince O'Neill 博士將在我們的神經科學發展中發揮更廣泛的作用。 Vince 自 2018 年 IPO 以來一直在該公司工作，擁有豐富的藥物臨床開發經驗。 Vince 與我們的首席醫療官 Rob Risinger 博士一起在 SERENITY I 和 II 試驗中發揮了重要作用，最終導致了 IGALMI 的批准以及我們腫瘤學項目中 701 的成功人體概念驗證試驗。

Dusan Kostic, our Head of Medical Affairs, will play an important role in developing clinical and medical strategies of 501 to support commercialization of any potential indications. He has more than 2 decades of pharmaceutical industry experience in neuroscience. This includes clinical development and commercialization of leading drugs, such as Abilify, Invega, Abilify Maintena and Rexulti. We have also initiated a search to expand our Board of Directors to strengthen clinical development expertise.

我們的醫療事務主管 Dusan Kostic 將在製定 501 的臨床和醫療策略以支持任何潛在適應症的商業化方面發揮重要作用。他在神經科學領域擁有超過 20 年的製藥行業經驗。這包括領先藥物的臨床開發和商業化，例如 Abilify、Invega、Abilify Maintena 和 Rexulti。我們還開始尋求擴大董事會規模，以加強臨床開發專業知識。

The third part of our business transformation involves prioritizing AI-driven innovation to strengthen our neuroscience clinical development. Our unique integration of data science, clinical expertise and commercialization gives us a powerful and distinct competitive advantage in building a robust R&D pipeline. We are truly excited about our clinical initiatives and pipeline candidates, including BXCL502. We look forward to highlighting these developments at an R&D event we plan to host later this year. We also plan to spotlight our next-generation AI platform capabilities for identify and reinnovating late-stage truck candidates and introduce BXCL503 and 504.

我們業務轉型的第三部分涉及優先考慮人工智能驅動的創新，以加強我們的神經科學臨床開發。我們對數據科學、臨床專業知識和商業化的獨特整合使我們在建立強大的研發管道方面擁有強大而獨特的競爭優勢。我們對我們的臨床計劃和候選產品（包括 BXCL502）感到非常興奮。我們期待在計劃於今年晚些時候舉辦的研發活動中強調這些進展。我們還計劃重點展示我們的下一代人工智能平台功能，用於識別和重新創新後期卡車候選人，並推出 BXCL503 和 504。

In summary, this is a challenging yet transformative period for our company. We are taking swift and decisive steps with the goal of putting the company in the best possible position for future success. We have received interest from potential corporate partners. However, it is far too early to know what if any form such a transaction could take. We are passionate about our goals and remain committed to delivering long-term value to shareholders.

總而言之，對於我們公司來說，這是一個充滿挑戰但又充滿變革的時期。我們正在採取迅速而果斷的步驟，目標是使公司處於未來成功的最佳位置。我們已經收到了潛在企業合作夥伴的興趣。然而，現在判斷此類交易可能採取何種形式還為時過早。我們對我們的目標充滿熱情，並繼續致力於為股東提供長期價值。

Now I will turn the call over to Rich, who will discuss our second quarter financial results.

現在我將把電話轉給里奇，他將討論我們第二季度的財務業績。

Thank you, Vimal. Our second quarter 2023 financial results are as follows: Net revenue of IGALMI was approximately $457,000 for the quarter. Research and development expenses were $27 million for the second quarter of 2023, compared to $17.9 million for the same period in 2022. The increased expenses were primarily attributable to increased clinical trial expenses for SERENITY III and TRANQUILITY II.

謝謝你，維馬爾。我們的 2023 年第二季度財務業績如下： IGALMI 該季度的淨收入約為 457,000 美元。 2023年第二季度的研發費用為2700萬美元，而2022年同期為1790萬美元。費用增加主要歸因於SERENITY III和TRANQUILITY II的臨床試驗費用增加。

Selling, general and administrative expenses were $25.9 million for the second quarter of 2023, compared to $18.4 million for the same period in 2022. The increased expenses were primarily attributable to an increase in personnel and related costs to support the commercialization of IGALMI. BioXcel Therapeutics had a $53.5 million loss for the second quarter of 2023, compared to a net loss of $37.7 million for the same period in 2022. The loss for the quarter included approximately $6.1 million in non-cash stock-based compensation.

2023 年第二季度的銷售、一般和管理費用為 2590 萬美元，而 2022 年同期為 1840 萬美元。費用增加主要歸因於支持 IGALMI 商業化的人員和相關成本增加。 BioXcel Therapeutics 2023 年第二季度虧損 5350 萬美元，而 2022 年同期淨虧損為 3770 萬美元。該季度的虧損包括約 610 萬美元的非現金股票薪酬。

Cash and cash equivalents totaled $127.5 million as of June 30, 2023. As noted, the company is undertaking a strategic reprioritization that includes a reduction in the workforce of more than 50%, which is expected to reduce expenses significantly. In the absence of additional capital becoming available, the company under the strategic financing agreements or otherwise, the company estimates that its current cash and cash equivalents will last through mid-2024. The company's previously disclosed cash runway projection assumed a full utilization of its strategic financing agreements of $155 million with Oaktree Fund Administration and Qatar Investment Authority.

截至 2023 年 6 月 30 日，現金和現金等價物總額為 1.275 億美元。如上所述，該公司正在進行戰略優先順序調整，其中包括裁員 50% 以上，預計這將大幅減少開支。在沒有額外資本可用的情況下，根據戰略融資協議或其他方式，公司估計其當前的現金和現金等價物將持續到 2024 年中期。該公司此前披露的現金跑道預測假設充分利用其與橡樹基金管理局和卡塔爾投資局簽訂的 1.55 億美元戰略融資協議。

Based on recent events, the company is not likely to be in a position to meet the milestones required to access the additional capital under the financing agreements. The company is exploring multiple ways to extend its cash runway and is already in discussions with its strategic financing partners to amend the agreements. Successful modification of these agreements could extend the company's cash runway. Finally, with regards to OnkosXcel, we are currently examining strategic alternatives, including strategic partnerships or financing.

根據最近發生的事件，該公司不太可能達到根據融資協議獲得額外資本所需的里程碑。該公司正在探索多種方式來擴展其現金跑道，並已與戰略融資合作夥伴討論修改協議。這些協議的成功修改可以擴大公司的現金跑道。最後，關於 OnkosXcel，我們目前正在研究戰略替代方案，包括戰略合作夥伴關係或融資。

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. We would now like to open the call for questions. Operator?

謝謝你，里奇。我們現在要開始提問。操作員？

(Operator Instructions) Our first question today comes from Greg Harrison of Bank of America.

（操作員指令）我們今天的第一個問題來自美國銀行的格雷格·哈里森。

How are you thinking about the outlook for the company with this restructuring? And how do you think investors should think about the story at this point?

您如何看待此次重組後公司的前景？您認為投資者此時應該如何看待這個故事？

Greg, this is Vimal. I'm very excited about the outlook for our business. As I shared earlier, we are laser-focused on the at-home opportunities for BXCL501. Specifically, the 2 value drivers for 501 are SERENITY program for schizophrenia and bipolar associated agitation; and our TRANQUILITY program for Alzheimer's agitation. We landed with IGALMI in the institutional setting. We are now shifting resources to expand into a potentially more promising retail pharmacy and outpatient setting. We also look forward to highlighting our pipeline with BXCL502 update at R&D Day by the end of this year.

格雷格，這是維馬爾。我對我們業務的前景感到非常興奮。正如我之前分享的，我們非常關注 BXCL501 的家庭機會。具體來說，501 的兩個價值驅動因素是針對精神分裂症和雙相情感障礙的 SERENITY 計劃；以及針對阿爾茨海默氏症躁動的 TRANQUILITY 計劃。我們在機構環境中與 IGALMI 合作。我們現在正在轉移資源，以擴展到可能更有前景的零售藥房和門診環境。我們還期待在今年年底的研發日上通過 BXCL502 更新來強調我們的產品線。

Got it. That's helpful. And one more, if I can. Could you give us some more color on why you made the decision to shift focus to the at-home setting and away from institutional medical setting?

知道了。這很有幫助。如果可以的話，再來一張。您能否進一步說明一下您為何決定將重點從機構醫療環境轉移到家庭環境？

We are shifting our focus from the institutional setting to the retail/at-home market due to the market and business factors we shared in our call. The hospital setting was more difficult to penetrate than originally anticipated, particularly in a challenging post-COVID environment. It is important to note that we will continue to make IGALMI available to our hospital customers through a more targeted contracting effort and small core team. We are committed to bringing IGALMI to current and future patients and their families for current indication and for new indications.

由於我們在電話中分享的市場和業務因素，我們正在將重點從機構環境轉向零售/家庭市場。醫院環境比最初預期的更難滲透，尤其是在充滿挑戰的新冠疫情后環境中。值得注意的是，我們將繼續通過更有針對性的合同工作和小型核心團隊向我們的醫院客戶提供 IGALMI。我們致力於將 IGALMI 帶給當前和未來的患者及其家人，用於當前適應症和新適應症。

The next question is from Colin Bristow of UBS.

下一個問題是瑞銀集團 (UBS) 的科林·布里斯托 (Colin Bristow) 提出的。

I just wanted to pass on by well done on this reprioritization. You made tough decisions, but I think they had to be done. And maybe first question, and just kind of piggying back off of the (inaudible), could you outline how you see the market opportunity to make our for IGALMI now that you're shifting the focus to the at-home setting? And how should we think about that specifically from a market opportunity point of view?

我只是想傳達一下這次重新調整優先順序的出色表現。你做出了艱難的決定，但我認為它們必須完成。也許第一個問題，只是順便說一句（聽不清），您能否概述一下您如何看待為 IGALMI 製作我們的市場機會，因為您正在將重點轉移到家庭環境？我們應該如何從市場機會的角度具體考慮這一點？

And then secondly, I think this is the most common question we're getting from investors is just updates on the timing of first the external order. I think I heard you said by the end of the year, but any more color you can give with where you are in this process would be great.

其次，我認為這是我們從投資者那裡得到的最常見問題，這只是關於首次外部訂單時間的更新。我想我聽到你說過，到今年年底，但如果你能在這個過程中提供更多的色彩，那就太好了。

And then on the second part of that is just timing regarding feedback from FDA. I know you've requested a meeting, but when do you expect this to occur? And have you had any sort of interactions or feedback around this data issue?

第二部分是關於 FDA 反饋的時間安排。我知道您已要求會面，但您預計什麼時候會面？您是否就這個數據問題進行過任何形式的互動或反饋？

Colin, regarding your question about the TRANQUILITY program update, as I stated in my earlier remarks that we expect to have update -- our hope to have the update by the end of the year. Independent audit is in progress. We have requested a meeting. Once we have the meeting, we will have a clarity what is the data package required to file an sNDA and that will be a good time to provide an update on the TRANQUILITY program. I just would appreciate if you can come back to your first question that you had asked, so that we can address that.

Colin，關於您關於 TRANQUILITY 計劃更新的問題，正如我在之前的評論中所說，我們預計會進行更新——我們希望在今年年底之前進行更新。獨立審計正在進行中。我們已要求召開會議。一旦我們召開會議，我們將明確提交 sNDA 所需的數據包是什麼，這將是提供 TRANQUILITY 計劃更新的好時機。如果您能回到您提出的第一個問題，我將不勝感激，以便我們解決這個問題。

Yes. My first question was...

是的。我的第一個問題是...

Colin, it's Matt.

科林，是馬特。

I was just checking you heard it, right?

我只是想看看你是否聽到了，對吧？

I did. Yes. So the question about the market opportunity switching from the hospital setting to the at-home setting. Keep in mind that there are 23 million episodes in the at-home setting. One of the things that we accounted for in our models as well is that we would capture many of the patients that wind up in the emergency department in the at-home setting as well. And given the market research that we've conducted. We recognize the unmet need in the home setting is quite significant. It's underrecognized and underdiagnosed, but the patients certainly see value here. And they indicated that both they and their caregivers would use this product profile for BXCL501 in 80% of their episodes. So we feel that the market conditions for the at-home setting is quite favorable, and we look forward to bringing the drug to those patients.

我做到了。是的。因此，關於市場機會從醫院環境轉向家庭環境的問題。請記住，家庭場景中有 2300 萬集。我們在模型中考慮的事情之一是，我們也會在家庭環境中捕獲許多最終進入急診室的患者。鑑於我們進行的市場研究。我們認識到家庭環境中未滿足的需求非常重要。它未被充分認識和診斷，但患者肯定看到了這裡的價值。他們表示，他們和他們的護理人員將在 80% 的治療中使用 BXCL501 的產品簡介。因此，我們認為家庭環境的市場條件相當有利，我們期待著將這種藥物帶給這些患者。

The next question is from Sumant Kulkarni of Canaccord.

下一個問題來自 Canaccord 的 Sumant Kulkarni。

So for your Breakthrough Therapy designation status, how exactly does the FDA defined acute treatment of agitation in terms of number of episodes or instances of film usage per month? Along those lines, do you think the current pricing of $105 per film is appropriate on a strategic misstep for the convenience of at-home use? I'm asking because of 2 factors. First, even one were to hit the annual specialty tier of roughly $10,000 per year for pricing on a gross basis, that would translate to a patient using 100 films a year, and makers of chronic treatments of agitation enjoy significantly higher market caps or buyout values but pricing assumptions they were much higher as well.

那麼，對於您的突破性治療指定狀態，FDA 究竟如何根據每月的發作次數或膠片使用次數來定義躁動的急性治療？沿著這些思路，您認為目前每部電影 105 美元的定價是否合適，這是為了方便家庭使用而犯下的戰略失誤？我問是因為兩個因素。首先，即使是年度專業級別的總定價約為每年 10,000 美元，這也意味著患者每年使用 100 部膠片，而長期治療躁動症的製造商則享有明顯更高的市值或買斷價值但定價假設也高得多。

So let me -- I'll address the price question and the number of episodes. First and foremost, we did conduct research when we established our launch price in both bipolar, schizophrenia in the at-home setting and also in ADA. And what we found is that for episodic treatment, there was appetite in the market for that price point. Certainly, what we see is the volume of episodes in the mild Alzheimer's dementia patients is roughly 3 a month, and that can escalate further as they become more moderate. But we also recognize that 81% of the ADA patients are either in an at-home setting or an ALF setting, which is (inaudible) to an at-home setting, and represent over 50% of the total volume of agitation episodes. And that doesn't preclude 501 from being used in episodic breakthrough in other locations as well.

那麼讓我——我將解決價格問題和集數問題。首先也是最重要的是，當我們確定在家中治療雙相情感障礙、精神分裂症和 ADA 的上市價格時，我們確實進行了研究。我們發現，對於間歇性治療，市場對該價位有興趣。當然，我們看到的是，輕度阿爾茨海默病癡呆患者的發作次數約為每月 3 次，並且隨著病情變得更輕，發作次數可能會進一步增加。但我們也認識到，81% 的 ADA 患者要么處於家庭環境中，要么處於 ALF 環境中，這對於家庭環境來說是（聽不清）的，並且佔躁動發作總量的 50% 以上。這並不排除 501 也可以在其他地點用於情景突破。

Got it. And then does your new cash runway include the potential to redo TRANQUILITY II in case the FDA says you will not be able to file on just what you have currently?

知道了。那麼，您的新現金跑道是否包括重做 TRANQUILITY II 的可能性，以防 FDA 表示您無法僅提交當前擁有的內容？

Sumant, we are not speculating on that. We are doing an audit, and we want to meet with the FDA and get the feedback, then we will be able to comment on it.

Sumant，我們不是在猜測。我們正在進行審核，我們希望與 FDA 會面並獲得反饋，然後我們才能對此發表評論。

The next question comes from Ram Selvaraju of H.C. Wainwright.

下一個問題來自 H.C. 的 Ram Selvaraju。溫賴特。

I just wanted to revert back to the formulary wins that you had previously announced that you were previously engaged in pursuing in the institutional setting, and I wanted to ask how that is affected, if at all, by your reprioritization here into the at-home setting. To what extent could we potentially expect you to be able to capitalize on the formulary wins that have already happened in the institutional setting and along what trajectory? And also if you could comment at all on how you expect promotional activities to be different in the at-home context versus the institutional context?

我只是想回到您之前宣布的您之前在機構環境中追求的處方勝利，我想問一下，如果有的話，您將這裡的優先順序重新安排到家庭中會受到怎樣的影響？環境。我們可以在多大程度上期望您能夠利用機構環境中已經發生的處方勝利以及沿著什麼軌跡？另外，您是否可以評論一下您認為家庭環境下的促銷活動與機構環境下的促銷活動有何不同？

Sure. So first of all, we reported out that we had over 185 formulary wins, P&T wins to date. We're still accumulating those wins at a win rate of over 65%. In fact, we had 3 wins on Friday. And so we would expect that the 650-or-so hospitals that are still scheduled to vote will continue with that process. And assuming that we continue to accrue these hospitals, we will reach out to them through medical affairs activities, through market access activities, contracting and certainly support them of trade and distribution to ensure that they can access the drug and utilize it. The medical affairs support will obviously be really important in helping them determine how to develop protocols and pathways, so that planning is in place as well.

當然。首先，我們報告說，迄今為止，我們已取得超過 185 項處方勝利、P&T 勝利。我們仍在以超過 65% 的勝率積累這些勝利。事實上，我們週五取得了 3 場胜利。因此，我們預計仍計劃投票的 650 家左右醫院將繼續這一過程。假設我們繼續增加這些醫院，我們將通過醫療事務活動、市場准入活動、簽約以及當然支持他們的貿易和分銷來接觸他們，以確保他們能夠獲得藥物並使用它。醫療事務支持顯然對於幫助他們確定如何制定方案和途徑非常重要，以便規劃也到位。

The promotional activities for the at-home market is a little bit different because you are educating physicians and patients at the same time. As you know, patients can be motivated to ask for prescription drugs, so that would be part of the plan as well, and then through sampling and contracting with PBMs. And these are activities -- the contract with PBMs and state Medicaid, those are activities that may be accomplished prior to even FDA approval, considering we have a drug on the market today. So those are activities that we're planning out to get ahead of that potential approval, and more to come on the actual market entry strategy in months to come.

家庭市場的促銷活動有點不同，因為你同時在教育醫生和患者。如您所知，患者可能會主動索取處方藥，因此這也將成為計劃的一部分，然後通過抽樣並與 PBM 簽訂合同。這些都是活動——與 PBM 和州醫療補助的合同，考慮到我們今天在市場上有一種藥物，這些活動甚至可以在 FDA 批准之前完成。因此，這些是我們計劃在潛在批准之前開展的活動，並且在未來幾個月內將在實際市場進入策略中開展更多活動。

The next question is from Yatin Suneja of Guggenheim Partners.

下一個問題來自古根海姆合夥人公司的 Yatin Suneja。

Maybe first question is on the Alzheimer's disease agitation. I understand you will meet with the FDA and try to get their feedback on TRANQUILITY II and I. Can you just talk about what generally is the ICH guidelines for an indication like this? What sort of exposure, duration of exposure is needed from a regulatory perspective for a disease that affects millions of people? Because it seems like you were sort of stopping TRANQUILITY II. It's still not clear to me if TRANQUILITY I and II combined is enough for you to get an approval. So that's one. Basically just help me understand the path forward for Alzheimer's disease agitation as you understand.

也許第一個問題是關於阿爾茨海默病的躁動。我知道您將與 FDA 會面，並嘗試獲取他們對 TRANQUILITY II 和 I 的反饋。您能否談談針對此類適應症的 ICH 指南一般是什麼？從監管角度來看，對於影響數百萬人的疾病需要什麼樣的暴露、暴露持續時間？因為你似乎在某種程度上阻止了《寧靜 II》。我還不清楚 TRANQUILITY I 和 II 的結合是否足以讓您獲得批准。這就是其中之一。基本上只是幫助我了解阿爾茨海默病煽動的前進道路，正如您所理解的那樣。

The second is, it seems like on the R&D day, you're going to talk a little bit about the 502. Just curious, maybe if you can highlight a little bit there. And then in terms of the cash runway, maybe help us understand how should we model it going forward? Where exactly are you cutting cost? How many of the sales rep you're still going to have? So that's -- these 3 questions.

第二個是，看起來在研發日，您將談論一些有關 502 的事情。只是好奇，也許您可​​以在那裡強調一點。然後就現金跑道而言，也許可以幫助我們理解未來應該如何建模？您到底在哪裡削減成本？您還保留多少銷售代表？這就是——這三個問題。

Thank you, Yatin. First question regarding the TRANQUILITY program, Rob will answer like what our plans are.

謝謝你，亞汀。關於 TRANQUILITY 計劃的第一個問題，Rob 會回答我們的計劃。

Yes. So let me be clear that we paused the trial because the early data in TRANQUILITY III indicated that the patient population may be better suited for chronic as opposed to episodic therapy. And as you know, our focus is on the episodic treatment in line with our breakthrough therapy designation by FDA for episodic treatment. We have decided to pause the trial in order to discuss this issue with the FDA at an upcoming meeting, and we'll be able to provide more guidance on that once that meeting occurs.

是的。因此，我要澄清的是，我們暫停了試驗，因為 TRANQUILITY III 的早期數據表明，患者群體可能更適合慢性治療，而不是間歇性治療。如您所知，我們的重點是間歇性治療，符合 FDA 對偶發性治療的突破性治療指定。我們決定暫停試驗，以便在即將召開的會議上與 FDA 討論這個問題，一旦會議召開，我們將能夠就此提供更多指導。

We do expect at that meeting to discuss both the auditing and the TRANQUILITY II results. And at that point, we'll be able to provide more guidance at the end of the year with regard to what will be necessary for filing an sNDA package.

我們確實希望在那次會議上討論審計和 TRANQUILITY II 結果。到那時，我們將能夠在今年年底就提交 sNDA 包所需的內容提供更多指導。

Yatin, regarding your second question, I will pass it on to Rob -- pass it on to Frank for 502.

Yatin，關於你的第二個問題，我會轉給Rob——轉給502的Frank。

Yatin, this is Frank Yocca. I'm excited about our emerging pipeline development candidates, especially BXCL502. We really are looking forward to incoming R&D Day where we'll present our progress with this molecule, particularly its development, but also discuss some unique indications of interest.

雅汀，我是弗蘭克·約卡。我對我們新興的管道開發候選藥物感到興奮，尤其是 BXCL502。我們真的很期待即將到來的研發日，屆時我們將展示我們在該分子方面的進展，特別是其開發，但也會討論一些獨特的興趣跡象。

Secondly, we will discuss our next-generation AI platform. This has evolved considerably. From the first time we did our R&D Day 2 years ago, the capabilities are -- have been enhanced for identifying and reinnovating late-stage opportunities. And we'll also discuss some candidates for additional pipeline entries, such as BXCL503 and 504. So it will be a very interesting day.

其次，我們將討論我們的下一代人工智能平台。這已經發生了很大的變化。從兩年前我們第一次進行研發日起，我們識別和重新創新後期機會的能力就得到了增強。我們還將討論一些其他管道條目的候選者，例如 BXCL503 和 504。所以這將是非常有趣的一天。

So regarding your third question, Yatin, related to the cash runway, Richard will answer.

因此，關於你的第三個問題，Yatin，與現金跑道有關，理查德將回答。

Sure, Yatin. So the reprioritization that we're working on now will extend the cash runway by reducing our burn significantly. And we're also working on various other options to extend the cash runway, which includes working with our strategic partner. As we said, the goal is to get the company to about an $80 million go-forward annualized burn rate, and that's what we're working towards. In terms of the market, we'll reduce that, the market access team will be a core group of market access teams to work through the commercial sector.

當然，雅廷。因此，我們現在正在進行的優先順序調整將通過顯著減少我們的消耗來擴大現金跑道。我們還在研究各種其他選項來擴展現金跑道，其中包括與我們的戰略合作夥伴合作。正如我們所說，我們的目標是使公司的未來年化燒錢率達到約 8000 萬美元，這就是我們正在努力的目標。在市場方面，我們會減少這個，市場准入團隊將是市場准入團隊的核心團隊，通過商業部門開展工作。

The next question is from Greg Subazende of Mizuho Securities.

下一個問題來自瑞穗證券 (Mizuho Securities) 的格雷格·蘇巴贊德 (Greg Subazende)。

This is Richard on for Greg Subazende from Mizuho. So just 2 questions from me. One, just following up from the cash question, how do you expect the split between R&D and SG&A going forward? And then two, for the IGALMI opportunity and sales, how should we be moving that on a go-forward basis now that your primary focus is on the at-home setting?

我是理查德，代表來自瑞穗的格雷格·蘇巴贊德。我只有兩個問題。一，緊接著現金問題，您預計研發和銷售、一般管理費用之間的分配情況如何？其次，對於 IGALMI 的機會和銷售，既然您的主要關注點是家庭環境，那麼我們應該如何繼續推進呢？

So in terms of the commercialization, it's going to be a small core team of about a dozen people. So that will reduce our SG&A expenses pretty dramatically moving forward. Our R&D expenses should go down. Remember, in the first half of the year, we had SERENITY III and TRANQUILITY II fully implemented, and that's what caused the increase in expenses in the first half of 2023.

所以在商業化方面，將會是一個十幾人左右的小型核心團隊。因此，這將大大減少我們未來的銷售、管理和行政費用。我們的研發費用應該下降。請記住，今年上半年，我們全面實施了 SERENITY III 和 TRANQUILITY II，這就是導致 2023 年上半年費用增加的原因。

And Richard, regarding your second question on modeling. We've never provided guidance on IGALMI sales. And so I think the way to think about this is by reducing our headcount in commercial to 12, it limits our ability to go out and prospect the way that we had in targeting the 1,700 hospitals. However, we will continue to support through contracting efforts and through trade and distribution on both our existing customers and those that choose to come online and approve IGALMI through formulary, we will support them in the same way. So that may help you, but I can't give guidance beyond that.

理查德，關於你關於建模的第二個問題。我們從未提供過有關 IGALMI 銷售的指導。因此，我認為考慮這個問題的方法是將我們的商業員工人數減少到 12 人，這限制了我們像針對 1,700 家醫院那樣走出去並進行探索的能力。然而，我們將繼續通過合同努力以及貿易和分銷來支持我們的現有客戶以及那些選擇上線並通過處方批准 IGALMI 的客戶，我們將以同樣的方式支持他們。所以這可能對你有幫助，但我無法提供除此之外的指導。

The next question is from Robyn Karnauskas of Truist Securities.

下一個問題來自 Truist Securities 的 Robyn Karnauskas。

This is Alex on for Robyn. Can you remind us what the approximate market opportunity is, breakdown for dementia setting between assisted living facility versus nursing home? And what are the gating factors to IGALMI uptake on the assisted living facility?

這是亞歷克斯（Alex）替羅賓（Robyn）發言。您能否提醒我們大概的市場機會是什麼，輔助生活設施與療養院之間的癡呆症環境細分？輔助生活設施接受 IGALMI 的限制因素是什麼？

So as I think we've communicated previously with -- there are 100 million episodes total, about an 80% of the patients with Alzheimer's dementia, I mentioned this earlier in the call, are in either the at-home setting or the ALF setting. And I don't have a specific breakdown for you here, but certainly something I can communicate later as we get closer to market entry disclosure. Better than 50% of the episodes are in those settings. And we feel that, that allows us to price the drug as an episodic drug as opposed to pricing it as a chronic drug, and certainly can be used episodically in any setting. So we think that the TAM still holds at 100 million episodes.

因此，正如我認為我們之前溝通過的那樣，總共有1 億次發作，大約80% 的阿爾茨海默氏癡呆患者，我在電話中早些時候提到過，要么是在家環境中，要么是ALF 環境中。我在這裡沒有具體的細節，但當我們接近市場准入披露時，我當然可以稍後傳達一些信息。超過 50% 的劇集都是在這些背景下進行的。我們認為，這使我們能夠將藥物作為偶發性藥物定價，而不是作為慢性藥物定價，並且當然可以在任何情況下偶發性使用。所以我們認為 TAM 仍然保持在 1 億集。

The next question is from Corinne Jenkins of Goldman Sachs.

下一個問題來自高盛的科琳·詹金斯。

This is (inaudible) on for Corinne Jenkins. So first, what do you view as your best options to further extend runway beyond mid-2024? And then second question is, if the FDA requires an additional study, will they have to start -- to start it completely new trial with the same population in TRANQUILITY II?

這是科琳·詹金斯的（聽不清）。首先，您認為在 2024 年中期之後進一步延長跑道的最佳選擇是什麼？第二個問題是，如果 FDA 要求進行額外的研究，他們是否必須開始——在 TRANQUILITY II 中對相同人群進行全新的試驗？

This is Vimal. Regarding our cash runway expense, and as Richard has already outlined, our cash runway in mid of 2024. And that's obviously predicated on what clinical trials we will be executing on. In terms of our option to extend that cash runway, we have multiple opportunities. One is working with our strategic partner, which Richard has already outlined, who are our financing partners. There is a interest developing in these programs by other corporate partners. We are looking into that. And in addition, we have some core assets that we can monetize and capitalize to extend our cash runway. So good news is that we have multiple opportunities to extend our cash runway and achieve meaningful clinical milestones.

這是維馬爾。關於我們的現金跑道支出，正如理查德已經概述的那樣，我們在 2024 年中期的現金跑道。這顯然取決於我們將要執行的臨床試驗。就我們延長現金跑道的選擇而言，我們有很多機會。一是與我們的戰略合作夥伴合作，理查德已經概述了這一點，他們是我們的融資合作夥伴。其他企業合作夥伴也對這些計劃產生了興趣。我們正在調查此事。此外，我們還擁有一些可以貨幣化和資本化的核心資產，以擴大我們的現金跑道。好消息是，我們有多種機會來擴展我們的現金跑道並實現有意義的臨床里程碑。

So let me handle if the FDA has to do another study, at this point, it's premature to discuss whether another study is required. But in terms of whether that study would be ALF or just at-home, again, we certainly make that decision upon consultation with the FDA, and we'll be providing that update later this year.

因此，讓我來處理 FDA 是否必須進行另一項研究，目前討論是否需要另一項研究還為時過早。但就該研究是 ALF 還是在家進行而言，我們當然會在與 FDA 協商後做出決定，並且我們將在今年晚些時候提供更新。

I think I'd just like to add on top of what Rob said, we are a pioneer in developing episodic medication to treat agitation. We are learning from the data, from the science, from the clinical outcomes that we are observing. We never or FDA never expected that we will have so many episodes observed in the nursing homes setting. So we are taking that information back to the FDA and designing a program what makes most sense. Does it make sense to have ALF and home setting as an episodic, and whatever is needed to put together that package. And would it make sense to go back later on and evaluate the nursing home as a more chronic option?

我想我想在羅布所說的基礎上補充一點，我們是開發治療躁動的間歇性藥物的先驅。我們正在從數據、科學和我們觀察到的臨床結果中學習。我們或 FDA 從未預料到我們會在療養院環境中觀察到如此多的事件。因此，我們將這些信息帶回 FDA 並設計一個最有意義的計劃。將 ALF 和家庭環境作為一個片段是否有意義，以及將這個包組合在一起所需的一切。稍後再回去評估療養院作為一個更長期的選擇是否有意義？

Because I'd like to remind everyone our Breakthrough Therapy designation is in for acute treatment of agitation, and we believe mild-to-moderate probable Alzheimer's disease population is a relevant one so far what we have observed.

因為我想提醒大家，我們的突破性療法指定用於急性激越治療，並且我們相信，迄今為止我們所觀察到的輕度至中度可能的阿爾茨海默病人群是相關人群。

The next question is from Samir Devani of Rx Securities.

下一個問題來自 Rx Securities 的 Samir Devani。

It must have been asked already, but I've got a couple. I guess, the big question for me is it realistic for you guys to market directly to the generalist physicians for the at-home setting? Isn't that really more the domain of big pharma? And is it -- have you thought about just doing a partnership deal around IGALMI to address that and reduce the cash burn? And then I guess the second question is just really out of interest, how many agitation episodes were you seeing in TRANQUILITY III in the nursing home setting?

肯定已經有人問過了，但我有幾個。我想，對我來說最大的問題是你們直接向全科醫生推銷家庭環境是否現實？這難道不是大型製藥公司的領域嗎？您是否考慮過圍繞 IGALMI 達成合作協議來解決這個問題並減少現金消耗？然後我想第二個問題真的是出於興趣，你在《寧靜3》中在療養院環境中看到了多少次激動的情節？

I'll take the first question. So when we think about the at-home setting for bipolar and schizophrenia, there are roughly 7,000 to 8,000 psychiatrists that either diagnose or actively manage the therapeutic treatments for those patients. So we feel that we would be very well positioned to access that market. As it relates to Alzheimer's dementia agitation, these patients are managed from a top line perspective by about 65,000 physicians in the United States, about 30,000 of those would be of interest to us. Those 30,000 are additionally making the diagnosis and treatment evaluation for these patients.

我來回答第一個問題。因此，當我們考慮雙相情感障礙和精神分裂症的家庭環境時，大約有 7,000 至 8,000 名精神科醫生對這些患者進行診斷或積極管理治療。因此，我們認為我們處於進入該市場的有利位置。由於它與阿爾茨海默氏癡呆症躁動有關，這些患者由美國約 65,000 名醫生從一線角度進行管理，其中約 30,000 名醫生對我們感興趣。這3萬人還在為這些患者進行診斷和治療評估。

Now of those, there are somewhere between 3,000 to 4,000 that are specialists of interest. But the primary care opportunity or the generalist opportunity, as you described, we would either have to partner with a CSO, a potential partnership with a larger pharmaceutical company or permutations of all 3 of those. And so that market entry strategy has not yet clearly defined, but we're working through those problems for those potential opportunities, I guess, at this time.

其中，有 3,000 到 4,000 名是感興趣的專家。但是，正如您所描述的，初級保健機會或通才機會，我們要么必須與 CSO 合作，要么與更大的製藥公司建立潛在的合作夥伴關係，或者這三者的排列。因此，市場進入策略尚未明確定義，但我想，目前我們正在解決這些問題，尋找潛在的機會。

So Samir, regarding how many episodes we observed. I will let Rob answer that.

薩米爾，關於我們觀察到的劇集數量。我會讓羅布回答這個問題。

So there are patients continuing in the trial at this point, and they continue to have episodes. So the number is accruing. It's hard to say it on a given day. So I think the best way to describe it would be to say it's regular. And it is greater on an individual basis than what we reported in our TRANQUILITY II results. And this is exactly why we are discussing it with the FDA, so that we have a clear path forward for episodic treatment of acute episodes, and we'll have that guidance at the end of the year.

所以此時仍有患者繼續參加試驗，並且他們繼續出現發作。所以這個數字正在增加。很難在某一天說出來。所以我認為描述它的最好方式就是說它是有規律的。從個人角度來看，這個數字比我們在 TRANQUILITY II 結果中報告的要高。這正是我們與 FDA 討論的原因，以便我們為急性發作的偶發性治療制定明確的前進道路，並且我們將在今年年底獲得該指導。

The next question is from Kambiz Yazdi of Jefferies.

下一個問題來自 Jefferies 的 Kambiz Yazdi。

What are the proposed features that are going to be in the protocol amendment for SERENITY III Part 2? What are the kind of the key secondary efficacy assessments, that will be valuable? And then maybe on your strategic financing partnerships, what modifications to your credit agreement -- would enable you to access capital earlier and be attractive to your partners?

SERENITY III 第 2 部分的協議修正案中將包含哪些擬議功能？什麼樣的關鍵次要功效評估才是有價值的？然後，也許在您的戰略融資合作夥伴關係方面，對您的信貸協議進行哪些修改將使您能夠更早地獲得資本並對您的合作夥伴有吸引力？

So we are finalizing that amended protocol. The secondary measures have to do with a variety of different, we'll call them perspectives on efficacy. And once we have the meeting with the FDA, I think it will be much easier to describe the entire study and the details.

因此，我們正在最終確定修訂後的協議。次要衡量標準與各種不同的方面有關，我們將其稱為功效視角。一旦我們與 FDA 舉行會議，我認為描述整個研究和細節就會容易得多。

So Kambiz, did it answer your question? Because what we are saying is now we have selected dose 80 micrograms based on our pharmacokinetic/pharmacodynamic modeling as we were expecting. And now it's a matter of modifying protocol submitting to the FDA, and then we will be in a position to initiate the study. As Robert said, the primary is safety and then efficacy trends as we measure over a 12-week period. So that's what will be the outcome we will be looking from that time.

Kambiz，它回答了你的問題嗎？因為我們所說的是，我們現在根據我們預期的藥代動力學/藥效學模型選擇了 80 微克劑量。現在的問題是修改提交給 FDA 的方案，然後我們就可以啟動這項研究了。正如 Robert 所說，首要的是安全性，然後是我們在 12 週內衡量的療效趨勢。這就是我們從那時起所期待的結果。

Regarding your next question, modification on the credit agreement. As Richard has mentioned that we are in active discussions. And as we make progress, we'll provide an update.

關於你的下一個問題，關於信貸協議的修改。正如理查德所提到的，我們正在積極討論。隨著我們取得進展，我們將提供更新。

There are no additional questions at this time. I'd like to turn the call back over to Dr. Mehta for closing remarks.

目前沒有其他問題。我想將電話轉回給梅塔博士做總結髮言。

Thank you, everyone, for joining us today. We are excited about our path forward through this strategic reprioritization and look forward to sharing updates on our progress. Thank you for your continued interest in BioXcel Therapeutics, and have a great day.

謝謝大家今天加入我們。我們對這一戰略優先順序調整的前進道路感到興奮，並期待分享我們的最新進展。感謝您對 BioXcel Therapeutics 的持續關注，祝您度過愉快的一天。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。