BioXcel Therapeutics Inc (BTAI) 2023 Q4 法說會逐字稿

Good morning, and welcome to the BioXcel Therapeutics conference call, which will include an update on the company's late-stage clinical programs and the discussion of financial results for the fourth quarter and full year 2023.

早安，歡迎參加 BioXcel Therapeutics 電話會議，會議將包括該公司後期臨床項目的最新情況以及對 2023 年第四季度和全年財務業績的討論。

(Operator Instructions)

（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 those forward-looking statements.

實際結果可能與這些前瞻性陳述中的預期有重大差異。

Risk factors that may affect future results are detailed in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2023, which can be found at www.BioXcelTherapeutics.com or on www.SEC.gov and which will be updated in its annual report on Form 10-K for the year ended December 31, 2023.

可能影響未來業績的風險因素詳見本公司截至 2023 年 9 月 30 日的季度 10-Q 表格季度報告，該報告可在 www.BioXcelTherapeutics.com 或 www.SEC.gov 上找到，並將更新截至2023 年12 月31 日止年度的10-K 表格年度報告。

As a reminder, today's call is being recorded.

提醒一下，今天的通話正在錄音。

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.

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。

Will be joined in the Q&A session by Dr. Frank Yocca, our Chief Scientific Officer; Matt Wiley, Chief Commercial Officer, and Dr. Rob Risinger, chief medical officer of neuroscience.

我們的首席科學官 Frank Yocca 博士將參加問答環節；商務長 Matt Wiley 和神經科學首席醫療官 Rob Risinger 博士。

It's now my pleasure to turn the call over to Dr. Mehta.

現在我很高興將電話轉給梅塔醫生。

Please go ahead.

請繼續。

Thank you, operator.

謝謝你，接線生。

Good morning and thank you for joining us.

早安，感謝您加入我們。

This is an exciting time for BioXcel Therapeutics.

對於 BioXcel Therapeutics 來說，這是一個令人興奮的時刻。

First, we are very pleased with the progress of our TRANQUILITY program.

首先，我們對 TRANQUILITY 計劃的進展感到非常滿意。

As I have communicated previously, this is a top priority for capital allocation.

正如我之前所傳達的，這是資本配置的重中之重。

Second, we are focused on advancing the SERENITY program.

其次，我們專注於推動 SERENITY 計劃。

Both programs provide significant opportunities for us to address the unmet need in treating patients struggling with episodes of acute agitation.

這兩個項目為我們提供了重要的機會來解決治療患有急性躁動發作的患者的未滿足的需求。

During today's call, we will dedicate our prepared remarks to update on TRANQUILITY and Serenity.

在今天的電話會議中，我們將用準備好的發言來介紹有關「寧靜」的最新情況。

These late-stage clinical program represent groundbreaking opportunities to advance our goal of bringing new treatment options to patients.

這些後期臨床計畫代表了突破性的機會，可以推進我們為患者提供新治療選擇的目標。

As a reminder, there are no currently approved acute treatment for agitation associated with Alzheimer's disease or for bipolar disorder or schizophrenia in the at-home setting.

提醒一下，目前還沒有批准的針對與阿茲海默症相關的躁動症或在家中治療雙相情感障礙或精神分裂症的急性治療方法。

This condition represents a large untapped markets.

這種情況代表了一個巨大的未開發市場。

All of us at BioXcel Therapeutics are motivated to develop new treatment options for the greater number of patients and caregivers.

BioXcel Therapeutics 的所有人都積極致力於為更多患者和照護者開發新的治療方案。

Vince will now provide a detailed update on tranquility and Serenity.

文斯現在將提供有關寧靜和寧靜的詳細更新。

After this, I will briefly discuss several corporate updates, which will then review our financial results before we open the call for Q&A.

之後，我將簡要討論幾項公司最新動態，然後在我們開始問答之前回顧我們的財務表現。

With that, I will turn the call over to Vince.

這樣，我會將電話轉給文斯。

Thank you, Vimal.

謝謝你，維馬爾。

So I appreciate the opportunity to speak with all of you this morning and provide an update on our two late-stage clinical programs with BioXcel Fiber One, let me begin with tranquility where we are evaluating Fiber One as an acute treatment for agitation associated with Alzheimer's dementia or for short AT as Bill said, tranquility remains a top priority to bring a novel treatment to this large underserved patient population.

因此，我很高興今天早上有機會與大家交談，並提供有關BioXcel Fiber One 的兩個後期臨床項目的最新信息，讓我先平靜地開始，我們正在評估Fiber One 作為與阿爾茨海默病相關的躁動的急性治療方法正如比爾所說，對於癡呆症或簡稱 AT，安寧仍然是為這一龐大的服務不足的患者群體提供新穎治療方法的首要任務。

Every year.

每年。

Estimates show that millions of Americans with Alzheimer's disease experience, agitation physicians often aim to address this with neuropsychiatric drugs used off label because there are no approved treatments specifically for acute agitation episodes.

據估計，數百萬患有阿茲海默症的美國人都經歷過，躁動症醫生通常會使用超說明書使用的神經精神藥物來解決這個問題，因為沒有專門針對急性躁動發作的批准治療方法。

This area of neuroscience drug development for an episodic treatment is novel and uncharted, and we believe we are uniquely positioned in this space at BioXcel Therapeutics.

用於間歇性治療的神經科學藥物開發領域是新穎且未知的，我們相信 BioXcel Therapeutics 在這一領域處於獨特的地位。

We have the gallery already on the US market as an acute approved acute treatment for bipolar disorder and schizophrenia related agitation.

我們的畫廊已經在美國市場上作為一種經批准的急性躁鬱症和精神分裂症相關躁動的急性治療藥物。

This provides us with a strong foundation from which we are expanding into development in AD. in our TRANQUILITY program.

這為我們拓展 AD 領域的發展奠定了堅實的基礎。在我們的寧靜計劃中。

And then to development in different settings in the bipolar and schizophrenia populations through the SERENITY program for TRANQUILITY, we have completed now a Type B breakthrough therapy designation meeting with the FDA on February 20th.

然後透過 TRANQUILITY 的 SERENITY 計劃在雙相情感障礙和精神分裂症人群的不同環境中進行開發，我們現已完成了 2 月 20 日與 FDA 舉行的 B 型突破性療法指定會議。

This meeting followed the one we had in October of last year.

這次會議是繼去年 10 月舉行的會議之後的一次。

Let me remind you that we are not in a position to provide detailed information about our overall program plans until after we receive and review the FDA's final meeting minutes.

讓我提醒您，在我們收到並審查 FDA 的最終會議記錄之前，我們無法提供有關我們總體計劃計劃的詳細資訊。

However, we can share and know that based on the FDA's feedback, we plan to generate additional Phase three efficacy and safety data in care facilities to expand the database beyond the 70 patients who have been treated with 60 micrograms of fiber, one in TRANQUILITY one and two to date, we plan to generate these data, including repeat efficacy data in a variety of relevant care settings and to use PEC as the primary efficacy measure as used in the prior TRANQUILITY two study.

然而，我們可以分享並知道，根據FDA 的回饋，我們計劃在護理機構中產生額外的第三階段療效和安全性數據，以將資料庫擴展到超過70 名接受60 微克纖維治療的患者，其中一名患者接受了TRANQUILITY 治療到目前為止，我們計劃產生這些數據，包括各種相關護理環境中的重複療效數據，並使用 PEC 作為主要療效指標，如先前 TRANQUILITY 兩項研究中使用的那樣。

To remind everyone, in November 23, we announced that we were planning to conduct a Phase three trial in the at-home setting with safety as the primary objective or otherwise known as TRANQUILITY trial.

提醒大家，11 月 23 日，我們宣布計劃在家庭環境中進行第三階段試驗，以安全為首要目標，也稱為 TRANQUILITY 試驗。

Given the priority to expand the database to generate additional efficacy data in care facilities, the Company is now reevaluating the timing for initiating TRANQUILITY at home.

鑑於優先擴大資料庫以產生護理機構的額外功效數據，該公司目前正在重新評估在家中啟動 TRANQUILITY 的時機。

Lastly, the FDA has indicated that we will need to generate long-term safety data.

最後，FDA 表示我們需要產生長期安全數據。

However, given the lack of any regulatory precedent for episodic treatment of MDD and patients, we plan to further engage with the FDA regarding this requirement.

然而，鑑於缺乏對重度憂鬱症和患者進行間歇性治療的任何監管先例，我們計劃就這項要求進一步與 FDA 合作。

We look forward to receiving final meeting minutes from the agency and sharing more details with you later this month.

我們期待收到該機構的最終會議紀要，並在本月稍後與您分享更多詳細資訊。

We're extremely motivated by this potential opportunity to bring a much needed acute treatment option to patients developing novel episodic treatments with no regulatory precedent comes with new learnings to create an optimal development path at this time, we believe we have a clear path forward to that point.

我們對這一潛在機會感到非常興奮，為正在開發新型偶發性治療且沒有監管先例的患者提供急需的急性治療選擇，並透過新的學習來創建此時的最佳開發路徑，我們相信我們有一條明確的前進道路那一點。

We've had multiple meetings with the FDA for this uncharted regulatory path and have greatly appreciated the agency's guidance as we move forward to advancing our clinical program.

我們已經與 FDA 就這一未知的監管路徑進行了多次會議，並且非常感謝該機構在我們推進臨床計劃時所提供的指導。

Let's now turn to SERENITY where we are evaluating the potential at-home use of fiber, one for agitation associated with bipolar disorders or script schizophrenia.

現在讓我們轉向 SERENITY，我們正在評估纖維在家庭中的潛在用途，一種用於治療與躁鬱症或精神分裂症相關的躁動的藥物。

On March the sixth, we completed a Type C meeting with the FDA this fall, the one we conducted last November.

3 月 6 日，我們完成了今年秋天與 FDA 的 C 類會議，也就是我們去年 11 月舉行的會議。

Based on FDA feedback, we plan to evaluate one 20 microgram dose of Fiber One.

根據 FDA 的回饋，我們計劃評估一劑 20 微克劑量的 Fiber One。

As a reminder, an approved dose of accounting in the at-home setting an amendment to our SERENITY three-part two protocol, which the company had voluntarily paused as we discuss the FDA's proposed changes to the protocol in light of the results of 3.23 Part one and our current plan is to move forward with this study as amended with safety as the primary objective and efficacy measures as exploratory endpoints.

提醒一下，在家庭環境中批准的會計劑量是對我們的 SERENITY 三部分兩部分協議的修正案，當我們根據 3.23 部分的結果討論 FDA 對協議的擬議變更時，該公司已自願暫停該協議我們目前的計劃是繼續推進這項修訂後的研究，以安全性為主要目標，以有效性措施為探索性終點。

Keep in mind, the label for Academy currently includes the limitation on use, noting the lack of efficacy or safety data beyond 24 hours.

請記住，Academy 的標籤目前包含使用限制，並指出缺乏 24 小時後的功效或安全性數據。

We believe that our ability to seek labeling without the current LOU will depend in part upon the number of agitation episodes we observed for the three month follow-up period to support our pivotal trial with the one 20 microgram dose.

我們相信，在沒有當前 LOU 的情況下尋求標籤的能力將部分取決於我們在三個月的隨訪期間觀察到的躁動發作次數，以支持我們使用 1 20 微克劑量的關鍵試驗。

We are also planning to conduct a small study, approximately 30 patients to evaluate the correlation between patient reported or informing reported efficacy with train greater reported efficacy using PEC scores.

我們也計劃進行一項約 30 名患者的小型研究，以評估患者報告或告知報告療效與使用 PEC 評分訓練更大報告療效之間的相關性。

We expect to provide additional information about the program plans after receiving and reviewing final meeting minutes from the FDA.

我們希望在收到並審查 FDA 的最終會議記錄後提供有關該計劃計劃的更多資訊。

And with that, I will turn the call back over to Vimal.

然後，我會將電話轉回給 Vimal。

Thank you, Vince.

謝謝你，文斯。

We are also pleased with progress in other areas of the business on January first, the permanent J-code for the government became effective and our commercial generation efforts continue to progress.

我們也對 1 月 1 日其他業務領域的進展感到高興，政府的永久 J 代碼生效，我們的商業發電工作繼續取得進展。

In addition, we continue building a robust intellectual property portfolio and strengthening our long-term patent protection.

此外，我們繼續建立強大的智慧財產權組合併加強我們的長期專利保護。

Finally, we are pleased to have received fast-track designation from the FDA for BXCL701.

最後，我們很高興 BXCL701 獲得 FDA 的快速通道指定。

I would like to end my remarks by emphasizing that we remain focused on strengthening the company's balance sheet.

我想在結束發言時強調，我們仍然專注於加強公司的資產負債表。

To this end, we are actively exploring multiple financial options to extend our cash runway and fund our key clinical program in order to create maximum value for our shareholders.

為此，我們正在積極探索多種財務選擇，以擴大我們的現金跑道並為我們的關鍵臨床項目提供資金，以便為股東創造最大價值。

I would now like to turn the call over to Rich, who will review our fourth quarter and full year 2023 financial results.

我現在想將電話轉給 Rich，他將審查我們第四季和 2023 年全年的財務表現。

Thank you, Vimal.

謝謝你，維馬爾。

Net revenue from IGALMI was $376,000 for the fourth quarter 2023 compared to $238,000 for the same period in 2022.

2023 年第四季 IGALMI 的淨收入為 376,000 美元，而 2022 年同期為 238,000 美元。

Net revenue was $1.4 million for the full year 2023 compared to $375,000 for 2022.

2023 年全年淨收入為 140 萬美元，而 2022 年為 375,000 美元。

Research and development expenses were $9.9 million for the fourth quarter of 2023 compared to $32.5 million for the same period in 2022.

2023 年第四季的研發費用為 990 萬美元，而 2022 年同期為 3,250 萬美元。

Research and development expenses were $84.3 million for the full year of 2023 compared to $91.2 million for 2022, decrease expenses for both fourth quarter and the full year for Paramount primarily attributed to decreased clinical trial activity associated with the wind-down of SERENITY three and TRANQUILITY two studies, a decrease in chemical manufacturing and control costs and a decrease in personnel related to the Company's reprioritization in August of 2023.

2023 年全年研發費用為 8,430 萬美元，而 2022 年為 9,120 萬美元，派拉蒙第四季和全年費用均減少，主要歸因於與 SERENITY 3 和 TRANQUILITY 的終止相關的臨床試驗活動減少兩項研究顯示，化學品製造和控製成本下降，以及與公司2023 年8 月重新調整優先順序相關的人員減少。

Selling, general and administrative expenses were $9.6 million for the fourth quarter of 2023 compared to $20.7 million for the same period in 2022.

2023 年第四季的銷售、一般和管理費用為 960 萬美元，而 2022 年同期為 2,070 萬美元。

SG&A expenses were $83.4 million for the full year 2023 compared to $68.8 million for 2022.

2023 年全年的銷售管理及行政費用為 8,340 萬美元，而 2022 年為 6,880 萬美元。

Increase costs for the full year, primarily attributable to an increase in legal and professional fees.

全年成本增加，主要歸因於法律和專業費用的增加。

Cost associated with personnel and related expenses to support the commercialization of Nozomi in the US prior to the Company's reprioritization.

在公司重新確定優先順序之前，支持 Nozomi 在美國商業化的人員成本和相關費用。

BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023 compared to a net loss of $54.8 million for the same period in 2022.

BioXcel Therapeutics 2023年第四季淨虧損2,230萬美元，而2022年同期淨虧損5,480萬美元。

In the same year for the full year 2023, the company reported a net loss of $179 million compared to a net loss of $165.8 million for the full year 2022.

同年，該公司報告 2023 年全年淨虧損為 1.79 億美元，而 2022 年全年淨虧損為 1.658 億美元。

Loss for 2023 includes approximately $18.6 million in noncash stock-based compensation.

2023 年的損失包括約 1,860 萬美元的非現金股票薪酬。

Total cash expenditures for 2023 totaled approximately $155 million.

2023 年現金支出總額約 1.55 億美元。

Cash and cash equivalents totaled $65.2 million as of December 31, 2023, compared to $193.7 million as of December 31, 2022.

截至2023年12月31日，現金及現金等價物總額為6,520萬美元，截至2022年12月31日為1.937億美元。

Company estimates says the current cash and cash equivalents will fund its operations through mid 2024.

公司估計，目前的現金和現金等價物將為其營運提供資金直至 2024 年中期。

The estimated cash runway does not include any potential financing activities being undertaken by the.

估計的現金跑道不包括該公司正在進行的任何潛在融資活動。

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.

謝謝你，里奇。

We would now like to open the call for questions.

我們現在要開始提問。

Operator?

操作員？

(Operator Instructions)

（操作員說明）

Greg Harrison, Bank of America.

格雷格·哈里森，美國銀行。

Hey, good morning, guys.

嘿，早上好，夥計們。

Thanks for taking my questions.

感謝您回答我的問題。

So after your recent FDA meetings, it seems you have more clarity for the TRANQUILITY programs.

因此，在最近的 FDA 會議之後，您似乎對 TRANQUILITY 計劃有了更清晰的認識。

Would you say now you have two separate path to NDA and Alzheimer's one in the CARE study and one at home?

您是否會說，現在您有兩種不同的 NDA 治療和阿茲海默症治療途徑，一種在 CARE 研究中，另一種在家裡？

And then how are you thinking about funding the program and the Company as a whole as you get closer to the end of your cash runway is, are there any specific avenues that you're exploring?

然後，當您接近現金跑道的盡頭時，您如何考慮為該計劃和整個公司提供資金，您是否正在探索任何具體途徑？

Good morning, Greg.

早安，格雷格。

This is Viance.

這是維安斯。

Thanks for the question.

謝謝你的提問。

And so to answer directly, yes, we believe so.

所以直接回答，是的，我們相信是這樣。

Obviously, the TRANQUILITY efficacy and pack primary study and also the safety home study would be run with registrational intent.

顯然，TRANQUILITY 功效和包裝初步研究以及安全之家研究將以註冊意圖進行。

So yes, in terms of funding, I would refer back to that.

所以，是的，在資金方面，我會回顧這一點。

So as I, Greg stated in my opening remarks, we are looking at multiple options to fund the company.

因此，正如我格雷格在開場白中所說，我們正在考慮多種選擇來為公司提供資金。

Now having a clarity, clarity from the FDA clearly tells us what other trials we need to do to capture these large market opportunities, both in the TRANQUILITY and SERENITY and as we speak, we are very actively working on those wells.

現在 FDA 的明確性明確地告訴我們，我們需要進行哪些其他試驗來抓住這些巨大的市場機會，無論是在 TRANQUILITY 還是 SERENITY 中，正如我們所說，我們正在非常積極地致力於這些油井。

Great.

偉大的。

Thanks again.

再次感謝。

Robyn Karnauskas, Truist Securities.

羅賓‧卡納斯卡斯 (Robyn Karnauskas)，Truist 證券公司。

Thank you for taking my questions.

感謝您回答我的問題。

So I have two to after the recent meetings with the FDA, you've chosen the 120 milligram dose that and does that mean that would allow for expansion and at-home setting as a follow for that?

因此，在最近與 FDA 舉行會議之後，我有兩個疑問，您選擇了 120 毫克劑量，這是否意味著可以進行擴展並在家中設置作為後續劑量？

Yes, morning, Robin.

是的，早安，羅賓。

And so I think the choice of 120 microgram dose and we believe is a good choice for the following reasons and efficacy it's fundamentally established for that does that's clearly an approved dose of economy, one of two approved doses of economy.

因此，我認為120 微克劑量的選擇是一個不錯的選擇，我們認為這是一個不錯的選擇，原因如下，它的功效從根本上是確定的，因為這顯然是經批准的經濟劑量，是經批准的兩個經濟劑量之一。

And so yes, we believe that with that, again, a registrational intended study with safety as a primary and is what we need to go back to the FDA with data in hand.

所以，是的，我們相信，有了這一點，我們需要將手頭上的資料回傳給 FDA，這是一項以安全性為主要目的的註冊研究。

And following up on that a little bit.

並對此進行了一些跟進。

So you'll give them a minute.

所以你給他們一分鐘時間。

Have you spoken to the FDA clearly about that dose and you'll give them a little later point.

您是否已經與 FDA 明確說明了該劑量，您稍後會向他們提供。

Yes.

是的。

Sorry to interrupt you.

抱歉打擾你了。

Absolutely.

絕對地。

We've spoken to the FDA.

我們已經與 FDA 進行了交談。

We have crystal clarity.

我們擁有水晶般的清晰度。

I think on the choice of dose.

我認為在劑量的選擇上。

Okay.

好的。

Then last question, sorry for three that's bad on like funding the program like Vimal, like how do you think about you have a lot going on you talked about like give a lot of options.

最後一個問題，對三個不好的人表示抱歉，例如資助像維馬爾這樣的項目，例如你如何看待你談到的很多事情，例如提供很多選擇。

How do we think about and this assay, you know, you have to find a lot of these programs are giving you feedback title How do investors think about the FastClick?

我們如何看待這個分析，你知道，你必須找到很多這些程式都給你回饋標題投資者如何看待 FastClick？

What actually how do you think about the options on the table for you?

您實際上如何看待擺在您面前的選項？

So Robin, good morning.

羅賓，早安。

In terms of the priority we will focus on TRANQUILITY trial that Vince has discussed because that's can help us on a path to a potential US NDA in the care setting.

就優先事項而言，我們將重點關注 Vince 討論過的 TRANQUILITY 試驗，因為這可以幫助我們在護理環境中走上潛在的美國 NDA 之路。

As discussed on this call, and also on the SERENITY program, we have a clarity what dose we can take it forward for a potential registration trial.

正如本次電話會議以及 SERENITY 計劃中所討論的那樣，我們清楚可以將其用於潛在的註冊試驗。

So our trial, we have a tremendous experience in the company.

所以我們的試用，我們在公司擁有豐富的經驗。

We have done more than 11 placebo-controlled double-blinded trials.

我們已經進行了超過 11 項安慰劑對照雙盲試驗。

These trials are capital efficient and the opportunity we have in front of us is very large, but we want to be very focused and as I mentioned, TRANQUILITY will be that our price priority followed by seasonality.

這些試驗具有資本效率，我們面前的機會非常大，但我們希望非常專注，正如我所提到的，「寧靜」將是我們的價格優先，其次是季節性。

Great.

偉大的。

Thank you.

謝謝。

Graig Suvannavejh from Mizuho Securities.

瑞穗證券 (Mizuho Securities) 的 Graig Suvannavejh。

Hey, good morning.

嗨，早安。

Thanks for taking my questions and for the clarity on two, please for me, I don't know if the first one was already asked.

感謝您提出我的問題並澄清兩個問題，請幫幫我，我不知道是否已經問過第一個問題。

My apologies just on the on TRANQUILITY at home or just the TRANQUILITY program overall that pivots to needing to collect and now efficacy data, can you tell us kind of what changed versus a previous plan just to focus on study on safety.

我對國內的 TRANQUILITY 或整個 TRANQUILITY 計劃表示歉意，該計劃的重點是需要收集現在的功效數據，您能否告訴我們與之前的計劃相比，只是專注於安全性研究，發生了什麼變化。

And then secondly, while I realize that you've got to figure out the financing for the Company on a go forward basis, I'm just trying to get a sense of whether you can provide us clarity around how much you think it might take to get to complete tranquility at home in order to be able to get it in a position to be able to file an SNDA.

其次，雖然我意識到你必須在未來的基礎上弄清楚公司的融資情況，但我只是想了解你是否可以向我們澄清你認為可能需要多少資金來讓家裡完全平靜，以便能夠提交 SNDA。

And similarly, what you think that total cost would be for completing the SERENITY program, it's just important just to in light of your current cash just to for investors to know what more funds you need to get to really the next revenue inflection point.

同樣，您認為完成 SERENITY 計劃的總成本是多少，重要的是要根據您當前的現金，讓投資者知道您需要多少資金才能真正實現下一個收入拐點。

Thank you.

謝謝。

Good morning, Graig.

早安，格雷格。

I'll take the first part of that question is obviously an important question.

我認為這個問題的第一部分顯然是一個重要的問題。

So after we met with FDA last year and we began to think about the design of the study in depth and in detail and begin to engage with our advisers and KOLs.

因此，去年我們與 FDA 會面後，我們開始深入、詳細地思考研究的設計，並開始與我們的顧問和 KOL 接觸。

It became clear that using non validated caregiver assessed instruments would be challenging and would frankly, carry risk.

很明顯，使用未經驗證的護理人員評估工具將具有挑戰性，並且坦率地說，會帶來風險。

So with that better understood, we went back to the FDA to rediscuss what additional court additional efficacy unquote meant AM And obviously, we've now agreed on formal efficacy analysis with PEC as a primary endpoint and clearly an endpoint we've used before with success.

因此，有了更好的理解，我們回到 FDA 重新討論額外的法院額外功效 unquote 意味著 AM 顯然，我們現在已經同意以 PEC 作為主要終點，並且顯然是我們之前使用過的終點成功。

So hopefully that provides clarity.

希望這能提供清晰的資訊。

And good morning, Greg.

早安，格雷格。

This is Vimal.

這是維馬爾。

Our financing solution is very relevant.

我們的融資解決方案非常相關。

Now having that clarity from the FDA was very important for us to know what financing we need to do.

現在，FDA 的澄清對於我們了解需要進行哪些融資非常重要。

So regarding the TRANQUILITY trial efficacy trial that Vince mentioned is under actively being designed and we will be able to share more details about it once we have received meeting minutes, which we expect after 30 days from our meeting on February 20.

因此，關於 Vince 提到的 TRANQUILITY 試驗療效試驗正在積極設計中，一旦我們收到會議記錄，我們將能夠分享更多細節，我們預計在 2 月 20 日會議後 30 天後收到會議記錄。

In terms of the synergy at home style, Tom, we have tremendous experience with SERENITY one, two and three and 83.

湯姆，就家居風格的協同作用而言，我們在 SERENITY 一號、二號、三號和 83 方面擁有豐富的經驗。

We have a very good idea in terms of the timing as well as capital requirement for that trial.

我們對該試驗的時間安排和資本要求有一個很好的想法。

And as I said in the beginning, for patient costs are low for these trials.

正如我一開始所說，這些試驗的病人成本很低。

And overall, these trials are capital efficient and they can be delivered in a reasonable time.

總的來說，這些試驗的資本效率很高，並且可以在合理的時間內交付。

So we are working on all of that and we will come back and lay out the plan for TRANQUILITY as well as SERENITY.

因此，我們正在努力解決所有這些問題，我們將回來制定安寧和寧靜的計劃。

And we will be having conversations what the capital requirements are based on our current cash position and how much cash than we need to extend using the means we have, which are equity investment versus monetization of any assets we have or flash partnering.

我們將討論基於我們當前現金狀況的資本要求，以及我們需要使用我們擁有的手段來擴展多少現金，這些手段是股權投資與我們擁有的任何資產的貨幣化或快速合作。

But all these things are being pursued in parallel, and we will be able to provide a clarity on the plan and financing as we progress.

但所有這些事情都在並行進行，隨著我們的進展，我們將能夠明確地規劃和融資。

Okay.

好的。

Thank you.

謝謝。

Sumant Kulkarni, Canaccord Genuity.

蘇曼特‧庫爾卡尼 (Sumant Kulkarni)，Canaccord Genuity。

Morning.

早晨。

Thanks for taking my question.

感謝您提出我的問題。

So you mentioned in your prepared remarks that for labeling purposes, the limitation of use is over a 24 to 48-hour period and you need to generate more data over three months.

因此，您在準備好的評論中提到，出於標籤目的，使用限制超過 24 至 48 小時，並且您需要在三個月內產生更多資料。

And when you're doing so what's the risk that you might find that agitation is not necessarily episodic?

當你這樣做時，你可能會發現躁動不一定是偶然的，這有什麼風險？

And in that case, you still think you might pursue Fiber One as a rescue therapy.

在這種情況下，您仍然認為您可能會尋求纖維一號作為救援療法。

So I think the first way to answer that is that's not our expectations, but I'm going to ask Dr. Risinger, our CMO to comment a little bit further on that?

因此，我認為回答這個問題的第一個方法是，這不是我們的期望，但我要請我們的行銷長 Risinger 博士對此進一步發表評論？

I mean, I guess it revolves around your expectations for frequency.

我的意思是，我想這取決於您對頻率的期望。

Yes.

是的。

I think I mean not to get into the weeds, but the CMAI as a tally of episodes Italia have on certain number of episodes plus severity.

我想我的意思不是要深入討論，而是 CMAI 作為義大利的劇集統計，包含一定數量的劇集以及嚴重程度。

The FDA has agreed to our pack as a pivotal endpoint for acute agitation.

FDA 已同意我們的包裝作為急性躁動的關鍵終點。

And we would all like to understand what the relationship is with a chronic condition with episodic episodic or episodes of acute agitation.

我們都想了解慢性疾病與偶發性或急性躁動發作之間的關係。

So we hope to be able to speak a little bit to that data.

因此，我們希望能夠對這些數據進行一些討論。

But the reality is these patients have acute episodes that need treatment even now and even with every treatment that is used, whether it's on-label or off-label.

但現實情況是，這些患者的急性發作需要治療，即使是現在，甚至使用每種治療方法，無論是標籤內或標籤外的治療。

And then my follow-up is a financial question, what do all the latest updates mean with respect to your ability to be in line with the covenants associated with the prior financing?

然後我的後續問題是一個財務問題，對於您遵守與先前融資相關的契約的能力而言，所有最新更新意味著什麼？

Or will you need to reverse those again?

或者你需要再次逆轉這些嗎？

Good question Kulkarni.

庫爾卡尼問得好。

We are always in discussion with our strategic partner and they are very supportive of facilitating and having company come be able to get financing because they really believe in this asset.

我們總是與我們的策略夥伴進行討論，他們非常支持促進和讓公司能夠獲得融資，因為他們真的相信這項資產。

And they see that this is a large market opportunity.

他們看到這是一個巨大的市場機會。

So it's a very good partnership and we work together to chart out the optimal path.

所以這是一個非常好的合作夥伴關係，我們共同努力製定最佳路徑。

I think most important from this call is that we have a clarity from a FDA perspective what we need to do in terms of our path forward for these two programs.

我認為這次電話會議最重要的是，從 FDA 的角度來看，我們清楚了在這兩個項目的前進道路上我們需要做什麼。

Thank you.

謝謝。

Ram Selvaraju, H.C. Wainwright.

塞爾瓦拉朱 (Ram Selvaraju)，H.C.溫賴特。

Thanks very much for taking my questions.

非常感謝您回答我的問題。

Can you hear me?

你聽得到我嗎？

We can.

我們可以。

Okay.

好的。

So I just wanted to see if you could offer some clarity whether quantitative or qualitative regarding the paused study and how much data from that study that was collected before it's paused.

因此，我只是想看看您是否可以就暫停的研究以及在暫停之前從該研究中收集了多少數據提供一些澄清，無論是定量還是定性。

You expect it to be usable in furtherance of the development plans for 501.

您期望它可用於推進 501 的開發計劃。

I'm going to ask Dr. Risinger, our CMO to comment on that as far as you can.

我將請我們的首席行銷長 Risinger 博士盡可能對此發表評論。

When you submit for an NDA, all data in all patients who were ever treated with the medication is use.

當您提交新藥申請時，所有曾接受過該藥物治療的患者的所有數據都會被使用。

And so to that extent, safety data from that trial is entirely submitted to the FDA.

因此，從這個意義上說，該試驗的安全數據已完全提交給 FDA。

With respect to whatever information was collected on the activity profile, is any of that information likely to be useful in potentially offsetting future development costs?

對於在活動概況中收集的任何信息，這些資訊是否可能有助於抵消未來的開發成本？

Or I'm just trying to ascertain to what extent you have to recapitulate anything if indeed you do.

或者我只是想確定如果你確實這樣做的話，你必須在多大程度上重述任何事情。

I think the pregnant pause here is we're trying to -- I think I captured the gist of your question in that.

我認為這裡有意義的停頓是我們正在努力——我想我抓住了你問題的要點。

Can that data be then sort of rolled into another study and typically you can't do that.

然後可以將這些數據匯總到另一項研究嗎？通常你不能這樣做。

It just has to be separate studies.

它只是必須是單獨的研究。

That doesn't mean it doesn't offset cost because in the end, FDA wants to see exposures and safety, safety safety.

這並不意味著它不能抵消成本，因為最終 FDA 希望看到暴露和安全、安全。

And that's what we have that safety data is probably is in the final analysis, a minor cost consideration.

這就是我們所掌握的安全數據，歸根究底可能是次要的成本考量。

Okay.

好的。

And then just really quickly, do you have any based on your plans for OncoSec Cellectis this time?

那麼很快，您這次對 OncoSec Cellectis 有什麼計劃嗎？

We have formally started the process to explore the opportunities, whether it's partnering or on monetization company was extremely focused right now on getting the plan for the neuroscience business, which is tranquility and Serenity.

我們已經正式開始探索機會的過程，無論是合作還是貨幣化，公司現在都非常專注於制定神經科學業務的計劃，即安寧和寧靜。

Having that clarity, we will have more time to dedicate to focus on oncology Actel because as you know, if we can monetize or partner that can help bring non-dilutive financing to company.

有了這個清晰的認識，我們將有更多的時間專注於腫瘤學 Actel，因為如你所知，如果我們能夠貨幣化或合作，可以幫助為公司帶來非稀釋性融資。

Thank you very much.

非常感謝。

Thank you.

謝謝。

Colin Bristow, UBS.

科林布里斯托，瑞銀集團。

Morning guys.

早安各位。

And thanks for the updates on where you put it sort of piggybacking on a few of the questions.

感謝您更新了一些問題的內容。

Bill, Rinat.

比爾、瑞納特.

Firstly, on the TRANQUILITY program, can you give us any indication on onset atrial size or perhaps what you see sort of timing.

首先，關於 TRANQUILITY 計劃，您能否向我們提供有關心房開始大小或您所看到的時間安排的任何指示。

It feels like this is now going to be a back half initiation.

感覺現在這將是後半場的啟動。

So is it reasonable for us to assume that we'll probably see data in the back half of '25.

那麼我們假設我們可能會在 25 年下半年看到數據是否合理？

And secondly, on the existing Academy launch, sales are down sequentially now acknowledging there's no sales effort to prove the surprised you can tell us why sales are not at least staying flat.

其次，在現有的學院推出時，銷售額連續下降，現在承認沒有銷售努力來證明令人驚訝的事情，您可以告訴我們為什麼銷售額至少沒有保持平穩。

And then just a point of clarification on the the credit agreement.

然後是對信貸協議的澄清。

Are you again acknowledging you didn't satisfy one of the requirements.

您是否再次承認您沒有滿足其中一項要求？

Is it reasonable to expect that we'll get an update shortly after you cement things with FDA?

在您與 FDA 達成協議後不久我們就會收到更新訊息，這是否合理？

Thank you.

謝謝。

Good morning Colin, so I'll take the first of your of your three-parter am in terms of timelines that we clearly want to have the meeting minutes in hand and digested before we make any definitive statements there and with that, I'll hand over to

早上好，科林，所以我將在您的三人上午中的第一個時間安排方面進行討論，我們顯然希望在我們做出任何明確的聲明之前掌握並消化會議紀要，因此，我將移交給

--.

--.

Good morning, this is Matt.

早安，我是馬特。

So to answer your question about Q4 versus Q3.

因此，回答您關於 Q4 與 Q3 的問題。

In Q3, remember that we had a fulsome commercial effort for most of that quarter.

請記住，在第三季度，我們在該季度的大部分時間都進行了豐富的商業工作。

In Q4, we saw revenues increased 10% versus Q3.

第四季度，我們的營收比第三季成長了 10%。

We saw our cartons shipped increased by about 8%.

我們看到我們的紙箱發貨量增加了約 8%。

That's a pretty tall order considering the fact that we have six corporate account directors in the field versus the 70 reps plus managers we had in the field previously in addition to the cats.

考慮到我們在該領域有 6 名公司客戶總監，而我們之前在該領域擁有 70 名代表和經理（除了貓之外），這是一個相當艱鉅的任務。

So the cat team is really punch above their weight to get to this revenue.

因此，貓團隊為了獲得這筆收入確實超出了他們的能力。

We've seen that occur on some of the contracting efforts in Q4 begin to matriculate.

我們已經看到第四季度的一些合約工作開始出現這種情況。

We're seeing more of that in Q1, and we expect to see continued growth.

我們在第一季看到更多這樣的情況，並且預計會持續成長。

Great.

偉大的。

Thanks.

謝謝。

And then on the credit.

然後是賒帳。

Hi, Colin.

嗨，科林。

This is Vimal.

這是維馬爾。

As I mentioned, that we are closely partnering with our strategic financing partners, portal, key and QA and any questions or any condition that needs to be met.

正如我所提到的，我們正在與我們的策略融資合作夥伴、入口網站、金鑰和品質保證以及需要滿足的任何問題或任何條件密切合作。

They're very collaborative with us and we update those amendments if needed.

他們與我們非常合作，如果需要，我們會更新這些修正案。

So if there is anything needed we will update you what is needed on the credit side.

因此，如果有任何需要，我們會向您更新信用方面的需要。

Thank you.

謝謝。

That's helpful.

這很有幫助。

Samir Devani, Rx Securities.

Samir Devani，Rx 證券。

Hi, guys.

嗨，大家好。

Thanks for taking my questions.

感謝您回答我的問題。

I've got just a couple and so I just want to make sure I understand the TRANQUILITY program strategy correctly for is it now the plan to do to get the label expanded further in care facilities and then do the subsequent OUTCOMES trial.

我只有幾個，所以我只是想確保我正確理解 TRANQUILITY 計劃策略，因為現在計劃在護理機構中進一步擴展該標籤，然後進行後續的 OUTCOMES 試驗。

And if that's the case, what's the marketing strategy in that scenario?

如果是這樣的話，這種情況下的行銷策略是什麼？

And then the second question is just on and maybe this is for Richard, as OpEx is significantly lower in the quarter than I had.

然後是第二個問題，也許這是理查德的問題，因為本季的營運支出明顯低於我的水平。

I'm just wondering if Q4 is a good run rate for Q1?

我只是想知道第四季是否比第一季有更好的運行率？

Thanks very much.

非常感謝。

Yes, hi, morning.

是的，嗨，早安。

This is Vince again.

這又是文斯。

I'll take the first part of your question.

我將回答你問題的第一部分。

So that is a good way to look at it, right.

所以這是一個很好的看待它的方式，對吧。

And I think it's also probably reasonable to say that in principle or in theory, we could run both studies together.

我認為原則上或理論上我們可以一起進行這兩項研究也可能是合理的。

I think your description is our the way we look at it, and I think that's a sensible way to approach it.

我認為你的描述是我們看待它的方式，我認為這是一種明智的處理方式。

Terms of the run rate, Samir, yes, it's probably a good marker of plus or minus a few dollars, but generally a pretty good marker.

就運行率而言，薩米爾，是的，這可能是一個很好的加減幾美元的標記，但總的來說是一個相當不錯的標記。

And it does, Matt, I'll just dovetail to what Vince outlined just now, market entry strategy in this market.

確實如此，馬特，我將與文斯剛才概述的內容相吻合，即該市場的市場進入策略。

Do you think about going into the care setting.

您是否考慮進入護理機構？

A lot of those are contracted through IDNs.

其中許多是透過 IDN 簽訂的。

So we're actively engaged with them now and it's going to take a much smaller footprint to engage with those those care facilities and snus versus the home setting.

因此，我們現在正在積極與他們接觸，與家庭環境相比，與那些護理機構和鼻煙接觸的足跡要小得多。

So we feel that building a beachhead there makes a really good commercial sense.

因此，我們認為在那裡建立灘頭陣地具有非常好的商業意義。

That's great.

那太棒了。

Thanks very much.

非常感謝。

Sumant Kulkarni, Canaccord Genuity.

蘇曼特‧庫爾卡尼 (Sumant Kulkarni)，Canaccord Genuity。

Thanks for taking the follow-up.

感謝您的關注。

So this might be somewhat of a premature question, but it's still an important one, I think both from a financial modeling perspective, what are your latest thoughts about eventual commercial pricing of Fiber One in the Alzheimer's agitation setting, as it appears that the product might be underpriced currently given the potential value intuitive?

因此，這可能是一個有點不成熟的問題，但它仍然是一個重要的問題，我認為從財務模型的角度來看，您對Fiber One 在阿茲海默症躁動環境中的最終商業定價的最新想法是什麼，因為該產品似乎考慮到直觀的潛在價值，目前的價格可能被低估？

Yes.

是的。

So that's a great question, and I appreciate it.

這是一個很好的問題，我很感激。

I mean, right now, when you look at the price point of Rexulti, it's just over $1,400 a month.

我的意思是，現在，當你查看 Rexulti 的價格時，你會發現它每月剛剛超過 1,400 美元。

So there does seem to be some pricing flexibility in that market and one that we continue to examine.

因此，該市場似乎確實存在一定的定價彈性，我們將繼續研究這一點。

Thank you.

謝謝。

We reached end of our question-and-answer session.

我們的問答環節結束了。

I'd like to turn the floor back over to management for any further or closing comments.

我想將發言權交還給管理階層，以徵求進一步的意見或結束意見。

Well, thank you, everyone, for joining us today and for your continued interest in BioXcel Therapeutics.

好的，謝謝大家今天加入我們並感謝你們對 BioXcel Therapeutics 的持續關注。

Have a great day.

祝你有美好的一天。

Thank you.

謝謝。

That does conclude today's teleconference and webcast.

今天的電話會議和網路廣播到此結束。

You may disconnect your line at this time and have a wonderful day.

此時您可以斷開線路並度過美好的一天。

We thank you for your participation today.

我們感謝您今天的參與。