Achieve Life Sciences Inc (ACHV) 2023 Q3 法說會逐字稿

Greetings and welcome to Achieve Life Sciences third quarter earnings conference call and webcast. (Operator Instructions). Please note this conference is being recorded. At this time, I'll turn the conference over to Nicole Jones with Investor Relations. Nicole, you may now begin.

您好，歡迎參加 Achieve Life Sciences 第三季財報電話會議和網路廣播。 （操作員說明）。請注意，本次會議正在錄製中。這次，我將把會議交給投資人關係部的妮可瓊斯 (Nicole Jones)。妮可，你現在可以開始了。

Thank you, operator, and thank you to everyone for joining the call today. Today from Achieve, we have John Bencich, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; and Jerry Wan, Principal Accounting Officer. Achieve's management will be available for Q&A after the prepared remark.

謝謝接線員，也謝謝大家今天加入通話。今天，我們有來自 Achieve 的執行長 John Bencich；辛蒂‧雅各布斯博士，總裁兼首席醫療官；和首席會計官 Jerry Wan。在準備好發言後，Achieve 的管理層將接受問答。

I'd like to remind everyone that today's conference call contains forward-looking statements based on current expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company.

我想提醒大家，今天的電話會議包含基於目前預期的前瞻性陳述。這些陳述僅是預測，實際結果可能與預測有重大差異。請參閱我們網站上提供的並向 SEC 提交的有關可能影響公司的因素的 Achieve 文件。

I'll now turn the call over to John.

我現在將把電話轉給約翰。

Thank you, Nicole. And thanks, everyone, for joining us today to review our third quarter highlights and the overall status of the cytisinicline program. Over the last quarter as well as throughout the entire year significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades.

謝謝你，妮可。感謝大家今天加入我們，回顧我們第三季的亮點和金雀花鹼計畫的整體狀況。在上個季度以及全年中，在為近二十年來第一個新型尼古丁依賴治療奠定基礎方面取得了重大進展。

So far this year with a small and efficient team of only 22 full-time employees Achieve accomplished many significant milestones, including the announcement of positive results from our second Phase 3 cytisinicline trial for smoking cessation.

今年到目前為止，Achieve 憑藉一支由 22 名全職員工組成的小而高效的團隊，實現了許多重要的里程碑，包括宣布我們的第二個 3 期金雀花鹼戒菸試驗取得了積極成果。

And published results from our first Phase 3 trial in JAMA reported a statistically significant efficacy benefit in the Phase 2 ORCA-V trial, the first ever randomized controlled trial for e-cigarette cessation.

我們在《美國醫學會雜誌》上發表的第一個 3 期試驗的結果報告了 2 期 ORCA-V 試驗具有統計學上顯著的療效益處，這是第一個戒菸電子煙的隨機對照試驗。

We've completed three additional clinical studies of over 100 subjects required for NDA submission, made significant progress on the compilation of the NDA, filed numerous interactions and conducted three formal meetings with the agency to prepare for filing and approval in the US, including most recently, a pre-NDA discussion that occurred at the end of October and increased outreach and further discussions with potential commercial organizations on the cytisinicline, US and global marketing opportunity.

我們已經完成了NDA 提交所需的100 多個受試者的另外三項臨床研究，在NDA 的編制方面取得了重大進展，提交了多次互動，並與FDA 進行了三次正式會議，為在美國的提交和批准做準備，其中包括大多數最近，10 月底進行了 NDA 前討論，並加強了與潛在商業組織就金雀花鹼、美國和全球營銷機會進行的外展和進一步討論。

We believe pending FDA approval, cytisinicline holds promise for providing a fresh start for the millions grappling with quitting smoking and vaping. There remain over 1 billion cigarette smokers around the globe. In the United States alone, over 28 million adults smoke combustible cigarettes and 11 million adult vape nicotine.

我們相信，在 FDA 批准之前，金雀花鹼有望為數百萬人努力戒菸和戒電子煙提供一個新的開始。全球仍有超過 10 億吸菸者。光是在美國，就有超過 2,800 萬成年人吸易燃香煙，1,100 萬成年人吸電子煙尼古丁。

The market potential for cytisinicline is substantial and its potential impact on global public health is unparalleled. We have strong confidence in cytisinicline effectiveness in assisting individuals who are motivated to quit smoking.

金雀花鹼的市場潛力巨大，其對全球公共衛生的潛在影響是無與倫比的。我們對金雀花鹼在幫助有戒菸動機的個人方面的有效性充滿信心。

Our Phase 3 clinical trial results demonstrate a significant advantage with smokers treated with cytisinicline being up to eight times more likely to successfully quit smoking compared to those receiving placebo. Notably, cytisinicline stands out from existing treatments due to its excellent tolerability with the most common adverse events affecting fewer than 10% of trial participants.

我們的 3 期臨床試驗結果表明，與接受安慰劑的吸菸者相比，接受金雀花鹼治療的吸菸者成功戒菸的可能性高出八倍。值得注意的是，金雀花鹼因其出色的耐受性而在現有治療中脫穎而出，最常見的不良事件影響不到 10% 的試驗參與者。

We perceive a distinct opportunity with cytisinicline to reinvigorate the nicotine de-addiction market and make a profound impact on public health. By introducing this new treatment option, we anticipate a higher number of individuals will be encouraged to embark on a new quit attempt.

我們認為金雀花鹼有一個獨特的機會，可以重振尼古丁戒癮市場並對公眾健康產生深遠影響。透過引入這種新的治療方案，我們預計將鼓勵更多的人開始新的戒菸嘗試。

With a product that is well-tolerated, we anticipate a high level of compliance and adherence to treatment, thereby enhancing their chances of successfully quitting. Our confidence in cytisinicline is reinforced by leaders in the smoking cessation community who have consistently shown their willingness to collaborate, express interest in new research and assist us in disseminating these crucial findings.

憑藉著耐受性良好的產品，我們預期患者對治療的依從性和堅持程度較高，從而提高他們成功戒菸的機會。戒菸界的領導者增強了我們對金雀花鹼的信心，他們始終表現出合作的意願，表達了對新研究的興趣，並幫助我們傳播這些重要的發現。

During our engagements with this influential community, they have expressed that the goal for a new therapy should be to double the likelihood of a successful quit compared to behavioral support alone. cytisinicline vastly exceeds the threshold, with subjects in our ORCA studies treated with cytisinicline having odds of quitting improved by upwards of six to eight times.

在我們與這個有影響力的社區接觸期間，他們表示，新療法的目標應該是與單獨的行為支持相比，將成功戒菸的可能性提高一倍。金雀花鹼大大超過了閾值，在我們的 ORCA 研究中，接受金雀花鹼治療的受試者戒菸的幾率提高了六到八倍。

This quarter, our research of the Optimized Dosing and Administration of cytisinicline in US subjects was published in the highly esteemed medical journal, Jama. This recognition has made a significant impact, garnering thousands of online views and being featured in more than 40 media outlets.

本季度，我們關於美國受試者金雀花鹼優化劑量和給藥的研究發表在備受推崇的醫學雜誌《Jama》上。這項認可產生了重大影響，獲得了數以千計的線上瀏覽量，並被 40 多家媒體報導。

Furthermore, during this quarter, Dr. Nancy Rigotti and ORCA primary investigator and Professor of Medicine at Harvard Medical School and the Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital presented for the first time data results from the Phase 2 ORCA-V1 trial of cytisinicline for e-cigarette cessation at the Society for Research on Nicotine and Tobacco Annual European meeting.

此外，在本季度，Nancy Rigotti 博士和 ORCA 首席研究員、哈佛醫學院醫學教授以及馬薩諸塞州總醫院煙草研究和治療中心主任首次介紹了 ORCA-V1 2 期數據結果在尼古丁和煙草研究學會歐洲年會上，金雀花鹼試驗用於戒菸電子菸。

ORCA-V1 evaluated the safety and efficacy of cytisinicline treatment for 12 weeks compared to placebo in 160 adults who use nicotine e-cigarettes. cytisinicline treated subjects experienced statistically significant cessation rate of approximately 32% compared to 15% in the placebo arm or 2.6 times higher odds of quitting vaping.

ORCA-V1 在 160 名使用尼古丁電子煙的成年人中評估了金雀花鹼治療 12 週與安慰劑相比的安全性和有效性。金雀花鹼治療組的戒菸率約為 32%，而安慰劑組為 15%，戒菸率高出 2.6 倍。

As seen across our development program cytisinicline was very well tolerated and no treatment-related serious adverse events were reported. Our endeavors to combat the vaping epidemic have been met with strong support from government agencies, clinicians and prospective commercial partners, highlighting the pressing unmet need in this area.

正如我們的開發計劃所見，金雀花鹼的耐受性非常好，沒有報告與治療相關的嚴重不良事件。我們對抗電子煙流行的努力得到了政府機構、臨床醫生和潛在商業合作夥伴的大力支持，凸顯了該領域尚未滿足的迫切需求。

ORCA-V1 was the first randomized placebo-controlled trial to achieve success in demonstrating the efficacy of a treatment for addressing this type of nicotine dependents. These results are highlighted as there are currently no approved treatments tailored specifically for vaping patients.

ORCA-V1 是第一個成功證明治療此類尼古丁依賴症的治療功效的隨機安慰劑對照試驗。這些結果之所以突出，是因為目前還沒有專門針對電子煙患者的核准治療方法。

The overall e-cigarette market continues to expand rapidly with the most recent prevalence rate in the US indicating a 20% annual increase of adult users. While e-cigarettes can serve as a helpful tool for some transitioning away from combustible cigarettes. The long-term effects remain unknown and many individuals aspire to quit nicotine altogether, which is precisely where cytisinicline can step in.

整個電子煙市場繼續快速擴張，美國最新的流行率表明，成人用戶每年增長 20%。雖然電子煙可以作為一些擺脫可燃香菸的有用工具。長期影響仍然未知，許多人渴望完全戒除尼古丁，而這正是金雀花鹼可以發揮作用的地方。

We are assessing our clinical development strategy to pursue an on-label indication for e-cigarettes decision and plan on holding an end-of-Phase 2 meeting with FDA in 2024 to discuss the requirements for approval. As there are no treatments approved for e-cigarettes cessation, this is a recognized area of high unmet need, and we will position it as such during our discussions with the FDA.

我們正在評估我們的臨床開發策略，以尋求電子煙的標籤適應症決策，並計劃於 2024 年與 FDA 舉行第二階段結束會議，討論批准要求。由於目前還沒有批准用於戒菸的治療方法，因此這是一個公認的需求未得到滿足的領域，我們將在與 FDA 的討論中對此進行定位。

Our goal is to expand the label of cytisinicline for specific promotions or e-cigarettes decision, even though many health care providers may consider cytisinicline a viable option for treating various forms of nicotine dependence.

我們的目標是擴大金雀花鹼的標籤以用於特定促銷或電子煙決策，儘管許多醫療保健提供者可能認為金雀花鹼是治療各種形式的尼古丁依賴的可行選擇。

As you may recall, ORCA-V1 was partially financed via non-dilutive grant funding from NIDA and NIH. We believe there may also be non-dilutive funding opportunities available to support a future basing study. Our aspirations of changing public health hinge on the regulatory filing and successful approval of cytisinicline .

您可能還記得，ORCA-V1 的部分資金來自 NIDA 和 NIH 的非稀釋性補助金。我們相信，也可能存在非稀釋性資助機會來支持未來的基礎研究。我們改變公共衛生的願望取決於金雀花鹼的監管備案和成功批准。

To that end, we have been focused on continuing the work needed to support a NDA filing, targeted in the first half of 2024. We are pleased to share that we have completed all of the in-clinic treatment portions of three NDA-enabling clinical trials that have been running over the course of this year.

為此，我們一直專注於繼續支持 NDA 備案所需的工作，目標是在 2024 年上半年完成。我們很高興地告訴大家，我們已經完成了三個 NDA 授權臨床的所有臨床治療部分今年以來一直在進行的試驗。

Specifically, these trials have been run to evaluate QT interval prolongation, steady-state pharmacokinetics in smokers and pharmacokinetic parameters in subjects with renal impairment. We expect final study reports from these trials to be available in early 2024.

具體來說，這些試驗的目的是評估 QT 間期延長、吸菸者的穩態藥物動力學以及腎功能不全受試者的藥物動力學參數。我們預計這些試驗的最終研究報告將於 2024 年初發布。

Additionally, last week, we held a pre-NDA meeting with the FDA. The FDA encourages this pre-submission engagement to solicit comments and clarification from the agency on the acceptability of key data, including information that might become available for submission during NDA review.

此外，上週，我們與 FDA 舉行了 NDA 前會議。 FDA 鼓勵這種提交前參與，以徵求該機構對關鍵數據可接受性的意見和澄清，包括在 NDA 審查期間可能可供提交的資訊。

This initial discussion was constructive, and agreement was reached on many of the submission requirements. Dialogue with the FDA is ongoing and because of this, we aren't able to provide additional details at this time.

初步討論具有建設性，並就許多提交要求達成了一致。與 FDA 的對話正在進行中，因此，我們目前無法提供更多詳細資訊。

We will be in a position to provide an overview once discussions are finalized. The output of the pre-NDA discussion is critical to clarifying the final regulatory path of cytisinicline in the US and will set the stage for how this product will progress through future market approvals around the globe.

一旦討論結束，我們將能夠提供概述。新藥申請前討論的結果對於澄清金雀花鹼在美國的最終監管路徑至關重要，並將為該產品如何在全球未來的市場審批中取得進展奠定基礎。

Additionally, these data points are important to furthering the discussions we are having with potential commercial organizations. Since ORCA-V1 and ORCA-3 have been released, and ORCA-2 was published in Jama. We have seen significant additional commercial interest in the cytisinicline program.

此外，這些數據點對於進一步推進我們與潛在商業組織的討論非常重要。自ORCA-V1和ORCA-3發布以來，ORCA-2在Jama上發布。我們已經看到金雀花鹼計畫產生了巨大的額外商業興趣。

As we have stated previously, we continue to believe that this asset in the hands of a larger organization will maximize the full commercial opportunity. What are we looking for exactly? Our ideal partner would have global capabilities with an established footprint and strong commercial capabilities and resources to maximize the global health impact that cytisinicline offers.

正如我們之前所說，我們仍然相信，這項資產掌握在更大的組織手中將最大限度地發揮全部商業機會。我們到底在找什麼？我們理想的合作夥伴應擁有全球能力、已建立的足跡以及強大的商業能力和資源，以最大限度地發揮金雀花鹼對全球健康的影響。

Given the substantial US market opportunity, strong US sales and marketing capabilities are an important attribute that we are seeking in our selection process. We are pleased with the dialogue and engagement with potential commercialization partners and are focused on continuing to move this process forward expeditiously.

鑑於美國市場機會龐大，強大的美國銷售和行銷能力是我們在選擇過程中尋求的重要屬性。我們對與潛在商業化合作夥伴的對話和接觸感到高興，並致力於繼續迅速推進這一進程。

At this time, I'll hand the call over to Jerry to review our financial highlights and results.

此時，我會將電話轉交給傑瑞，以審查我們的財務亮點和業績。

Thanks, John. I will be providing an update on our cash position as of September 30, 2023, and reviewing our operating expenses for the third quarter of 2023.

謝謝，約翰。我將提供截至 2023 年 9 月 30 日我們現金狀況的最新信息，並審查 2023 年第三季度的營運費用。

As of September 30, 2023, the company's cash, cash equivalents, short-term investments and restricted cash were $20 million compared to $24.8 million as of December 31, 2022. We believe our current cash balance is sufficient to provide us runway into the second half of 2024.

截至2023 年9 月30 日，公司的現金、現金等價物、短期投資和限制性現金為2,000 萬美元，而截至2022 年12 月31 日為2,480 萬美元。我們相信，我們目前的現金餘額足以為我們提供進入第二階段的跑道。2024 年 一半。

With respect to our statement of operations, net loss decreased to $7.1 million for the quarter ended September 30, 2023, compared to 1$3.1 billion for the same quarter of 2022. Net loss for the nine months ended September 30, 2023, decreased to $24.3 million compared to $31.1 million for the same period of 2022.

就我們的營運報表而言，截至2023 年9 月30 日的季度淨虧損降至710 萬美元，而2022 年同期為131 億美元。截至2023 年9 月30 日的九個月淨虧損降至24.3美元百萬美元，而 2022 年同期為 3,110 萬美元。

In line with expectations, operating expenses continued to decrease for the third quarter of 2023 with the completion and wind down of both the ORCA-3 Phase 3 trial and the ORCA-V1 Phase 2 trial. We expect our quarterly operating expenses to remain lower in the fourth quarter as compared to the first half of 2023.

與預期一致，隨著 ORCA-3 第 3 期試驗和 ORCA-V1 第 2 期試驗的完成和結束，2023 年第三季的營運費用繼續下降。我們預計第四季的季度營運費用將低於 2023 年上半年。

The decrease in costs will be partially offset by an associated increase in NDA supporting activities, including the finalization of three NDA supportive clinical trials and other NDA preparation activities.

成本的下降將被 NDA 支援活動的相關增加所部分抵消，包括完成三個 NDA 支持性臨床試驗和其他 NDA 準備活動。

That concludes my financial remarks, and I will now turn the call back over to John.

我的財務發言到此結束，現在我將把電話轉回給約翰。

Thanks, Jerry. As I stated at the beginning of the call, 2023 has been a remarkable year for Achieve and the cytisinicline development program. In the near term, we have three key priorities where we will focus our efforts.

謝謝，傑瑞。正如我在電話會議開始時所說，2023 年對於 Achieve 和金雀花鹼開發計劃來說是非凡的一年。短期內，我們將專注於三個關鍵優先事項。

First, finalize discussions with preferred strategic commercial organizations. Second, complete preparations to finalize the NDA submission. And third, define the regulatory pathway for cytisinicline label expansion in e-cigarette cessation.

首先，完成與首選策略商業組織的討論。二是做好NDA申報準備。第三，定義電子菸戒菸中金雀花鹼標籤擴展的監管途徑。

We maintain our confidence in cytisinicline ability to change the face of public health, and we appreciate your support as we work diligently to bring forward this important treatment.

我們對金雀花鹼改變公共衛生面貌的能力充滿信心，並感謝您在我們努力推進這項重要治療方法時的支持。

At this time. I'd now like to turn the call over to the operator for questions.

此時。我現在想將電話轉給接線員詢問問題。

Thank you. We'll now be conducting a question-and-answer session. (Operator Instructions)

謝謝。我們現在將進行問答環節。 （操作員說明）

Thomas Flaten, Lake Street.

托馬斯·弗拉頓，湖街。

Hey, guys. I appreciate you taking the question. John, with respect to timing of the NDA submission, given that the data from the three supportive studies will be out in the first quarter. Is second quarter, most likely? I know you're guiding to first half. Just some thoughts on that.

大家好。我很感謝你提出這個問題。約翰，關於 NDA 提交的時間，考慮到三項支持性研究的數據將在第一季公佈。第二季最有可能嗎？我知道你正在指導上半場。只是對此的一些想法。

Yeah, Thomas. Thanks for the question there. So given the discussions, they are ongoing with the agency that we conclude the pre-NDA meeting, and we look to get final agreement that netted out the other end. We're not able to refine anything further on that. Though, one of future update as we get through that final process and dialogue with the agency.

是的，托馬斯。謝謝你的提問。因此，考慮到討論，他們正在與我們完成 NDA 前會議的機構進行合作，我們希望達成最終協議，以消除另一端的問題。我們無法對此進行進一步完善。不過，當我們完成最後的流程並與該機構進行對話時，未來的更新之一是。

And coming out of that October meeting, was there anything surprising any incremental studies that they requested or was it pretty straightforward?

十月的會議結束後，他們要求的增量研究有什麼令人驚訝的嗎？還是不是非常簡單？

In terms of the output, I think as we mentioned, the discussion was constructive. We did get agreement on many of the items that we were looking for. But there's a few other pieces that we're looking to get finalized and written document [clarification] on. So we'll be able to provide a further update on that as we get through those final discussions.

就成果而言，我認為正如我們所提到的，討論是建設性的。我們確實就我們正在尋找的許多項目達成了一致。但我們也希望完成其他一些內容並形成書面文件[澄清]。因此，當我們完成這些最終討論時，我們將能夠提供進一步的更新。

And then just one final question from me. Could you give us maybe a little assistance in mapping up spending between today and the submission?

我還有最後一個問題。您能否為我們提供一些幫助來規劃從今天到提交之間的支出？

Yeah. So if you look at the third quarter in terms of the decrease in burn that we saw from the first half of this year, I think you can expect that will continue through the fourth quarter of this year as well. So we will see that decline carry forward. If you're looking at projecting that ahead, I think that be a good way to think about it at the moment.

是的。因此，如果你從今年上半年看到的燒錢減少的角度來看第三季度，我認為你可以預期這種情況也將持續到今年第四季。因此，我們將看到這種下降趨勢持續下去。如果你正在考慮未來的預測，我認為這是目前考慮的好方法。

Excellent. Appreciate taking the question. Thank you.

出色的。感謝接受這個問題。謝謝。

Yes, thanks, Thomas.

是的，謝謝，托馬斯。

Michael Higgins, Ladenburg Thalmann.

麥可希金斯，拉登堡塔爾曼。

Thanks, operator. Hi, John. Hi, guys. Congrats on the good news of progress on your own expenses. Notable here in Q3 results and thanks for taking some questions here. If I could ask a bit more and the feedback on your progress with potential commercialization partners, wondering how that's coming along and if you believe your discussions with the FDA will be wrapping up in the first part of 2024? Do you expect to have feedback from NIDA NIH regarding vaping before you complete those potential commercialization conversation?

謝謝，接線生。你好，約翰。嗨，大家好。恭喜您自費進展的好消息。在第三季的結果中值得注意，感謝您在這裡提出一些問題。我能否再問一些問題以及對您與潛在商業化合作夥伴的進展的反饋，想知道進展如何，以及您是否相信與 FDA 的討論將在 2024 年上半年結束？在完成這些潛在的商業化對話之前，您是否希望獲得 NIDA NIH 關於電子煙的回饋？

Hi, Michael, yeah, thanks for the question. So on the vaping indication, no -- what we've been guiding to, it's like an end of Phase 2 meeting next year. No further refining on timing on that, we can't really provide that at the moment. Our focus will continue to be on the smoking cessation NDA as kind of that initial priority to make sure that that moving forward expeditionally.

嗨，邁克爾，是的，謝謝你的提問。因此，就電子煙的跡象而言，不，我們一直在指導，這就像明年第二階段會議的結束。沒有進一步細化時間安排，我們目前無法真正提供。我們的重點將繼續放在戒菸 NDA 上，作為首要任務，以確保這一進程迅速推進。

Is it fair to say the partnering discussions would be separate for cigarettes versus vaping?

可以公平地說，香菸和電子煙的合作討論是分開的嗎？

On the partnering discussions, I think we have seen a fair amount of interest coming from the vaping side of the opportunity, smoking cessation will continue to be the core of that. And so I think in terms of the initial opportunity, that's going to be the first piece to launch. And so both are important, but I think the smoking given the near-term nature of it is going to be the majority of the (inaudible)

在合作討論中，我認為我們已經看到了來自電子煙的相當多的興趣，戒菸將繼續成為其中的核心。因此，我認為就最初的機會而言，這將是第一個推出的產品。所以兩者都很重要，但我認為考慮到吸煙的近期性質，吸煙將成為大多數（聽不清楚）

That's fair. Thanks. And then just to clarify for everyone on board here, the gating factors headed the NDA filing, obviously you have discussions with agency. You've got some three studies reading out early next year. Are those the two primary drivers, the obvious discussions with the agency, but anything else besides those three that you're waiting on?

這還算公平。謝謝。然後，為了向這裡的每個人澄清一下，NDA 備案中的限制因素，顯然你已經與機構進行了討論。明年初將會宣讀三項研究報告。這兩個主要驅動因素是與該機構的明顯討論嗎？除了您正在等待的這三個之外，還有其他什麼嗎？

Yeah. So the those three are obviously critical in terms of having those key components that we knew were going to be needed for the NDA. I think as we finalize the pre-NDA discussions and get those final minutes, we'll be able to clarify further timing on the NDA piece. I think the key piece of this is getting clarity going forward and that feeds back into the partnering discussions and making sure that the path towards approval is fully clarified, and that's exactly what we're getting out of the pre-NDA meeting.

是的。因此，就擁有我們知道 NDA 所需的關鍵組件而言，這三個顯然至關重要。我認為，當我們完成 NDA 前的討論並獲得最後幾分鐘時，我們將能夠進一步澄清 NDA 的時間表。我認為其中的關鍵部分是明確未來的方向，並將其反饋到合作討論中，並確保完全明確批准的路徑，而這正是我們從新藥申請前會議中得到的結果。

Makes sense. Appreciate it. Thanks, guys.

說得通。欣賞它。多謝你們。

Francois Brisebois, Oppenheimer.

弗朗索瓦·布里斯布瓦，奧本海默。

Hi, this is Dan on for Frank. Thanks for taking my questions. Firstly, congrats on JAMA publication. Also the ORCA-V2 presentation at the -- and the V1 presentation at the SRNT. Can you give us a sense of the KOL feedback that you're hearing from these conferences, anything in particular in terms of medicine claims features, tolerability, efficacy that is standing out, that is coming up? Any color there?

大家好，我是弗蘭克的丹。感謝您回答我的問題。首先，恭喜 JAMA 發表。還有 ORCA-V2 在 SRNT 上的演示以及 V1 演示。您能否向我們介紹一下您從這些會議上聽到的 KOL 回饋，特別是在即將出現的藥物聲明特徵、耐受性和功效方面的回饋？那裡有什麼顏色嗎？

Yeah. Thanks for the question. I'll hand this over to Cindy.

是的。謝謝你的提問。我會把這個交給辛蒂。

Yeah, well, it's Nancy Ragatti actually presenting and other KOLs were pretty excited as far as the efficacy that cytisinicline shows, but actually they're even more impressed by studied about the safety profile which allows them individuals to stay on treatment and get the benefit. So it's really a combination of the efficacy and safety profile that they are the most excited for smokers. And in the future, vapors too actually have a new therapy to help with their nicotine dependence.

是的，嗯，實際上是南希·拉加蒂（Nancy Ragatti）在演講，其他KOL 對金雀花鹼所顯示的功效感到非常興奮，但實際上，他們對安全性的研究印象更深刻，這使他們能夠繼續接受治療並從中受益。因此，真正讓吸煙者最興奮的是功效和安全性的結合。在未來，電子煙實際上也有一種新的療法來幫助他們緩解尼古丁依賴。

Great. And just any updates on the FDA inspection readiness on the Sopharma front? And also any updates regarding preparations for the larger supply chain, getting the registration batch? Are all those processes on track?

偉大的。 Sopharma 方面 FDA 檢查準備情況是否有更新？還有關於更大供應鏈的準備工作、獲得註冊批次的任何更新嗎？所有這些流程都步入正軌嗎？

Yeah. Thanks for the question there. So I think the Sopharma and CMC attributes are going to continue to be a focus as we move forward through NDA submission. As we've indicated historically, we've been working very closely with Sopharma in their readiness efforts, including numerous mock FDA inspection audits. So that work will continue as we progress. And Sopharma continues to be confident that they can be ready for a future inspection, but it will continue to be a high area of focus for us as we proceed.

是的。謝謝你的提問。因此，我認為，隨著我們提交 NDA，Sopharma 和 CMC 屬性將繼續成為焦點。正如我們過去所指出的，我們一直與 Sopharma 密切合作，做好準備工作，包括多次模擬 FDA 檢查審核。因此，隨著我們的進展，這項工作將繼續下去。 Sopharma 仍然相信他們可以為未來的檢查做好準備，但隨著我們的進展，這將繼續成為我們關注的重點領域。

Thank you. Thanks for taking my questions.

謝謝。感謝您回答我的問題。

(Operator Instructions) John Vandermosten, Zacks.

（操作員說明）John Vandermosten，Zacks。

All right. Thank you. Is there any reason to think that the potential vaping Phase 3 trial would be much different from ORCA3? Are there any considerations there? Might it be smaller or -- I know it's kind of early, but them just thinking ahead on that.

好的。謝謝。是否有任何理由認為潛在的電子煙三期試驗將與 ORCA3 有很大不同？這裡面有什麼注意事項嗎？可能會更小，或者——我知道現在有點早，但他們只是提前考慮這一點。

Yeah. So in terms of the overall sizing, I think looking back at ORCA-2 and ORCA-3 is probably a good proxy in terms of overall sample size. As we've indicated before, our belief is that a single Phase 3 trial is what would be required for approval in this indication but ultimately, we'll need to get guidance from FDA on that. But the ultimate design will still be working on that in terms of what that looks like. But yeah, that sort of size is what you should anticipate.

是的。因此，就總體規模而言，我認為回顧 ORCA-2 和 ORCA-3 可能是整體樣本規模的一個很好的代表。正如我們之前所指出的，我們相信，該適應症的批准需要進行一次 3 期試驗，但最終，我們需要獲得 FDA 的指導。但最終的設計仍將在外觀方面進行努力。但是，是的，這種尺寸是你應該預料到的。

Okay, great. And I was doing some reading on varenicline and there's thoughts that it could be used for other types of addiction, perhaps companion and things like that. Is that something that you might consider as well to pursue beyond nicotine addiction?

好的，太好了。我正在閱讀一些關於伐尼克蘭的文章，有人認為它可以用於其他類型的成癮，也許是伴侶之類的。除了尼古丁成癮之外，您是否也可以考慮追求這種東西？

It's Cindy. So we've had a lot of interest from our KOLs and other investigators pursuing that once obviously smoking cessation through grants. And so we're supportive and those types of investigative class trials to kind of look at the other areas of addiction that cytisinicline to be helpful. And with that then, watch and see what we should pursue as a company.

是辛蒂。因此，我們的 KOL 和其他調查人員對我們透過資助來追求一度明顯的戒菸有很大興趣。因此，我們支持這些類型的調查性試驗，以研究金雀花鹼對成癮的其他領域是否有幫助。然後，觀察並看看我們作為一家公司應該追求什麼。

Is that something that you've talked to with the potential buyers at this point? I think might get split off and you pursue that on your own and they lift out the nicotine addiction part or is that -- would that kind of all go together? Do you think I mean, again, I know it's early, but just I'm wondering kind of how the thought would be on that and maybe conversations that you've had?

您目前已經與潛在買家討論過這一點嗎？我認為可能會分開，你自己追求這一點，他們會解除尼古丁成癮的部分，或者是——這一切會在一起嗎？你認為我的意思是，我知道現在還為時過早，但我只是想知道對此的想法以及你們進行的對話會如何？

Yeah, I think in terms of your discussions with commercialization partners, I think this is really looking at the totality of this. We're not looking at splitting this apart in terms of multiple pieces, like as we indicated on a larger scale before -- we've had term sheets ex US front and from parties in particular a lot of interest coming out of Asia and our continued belief that knows that that belongs in the hands of a single global partner once it does have strong US capabilities to maximize the opportunity here in the US.

是的，我認為就您與商業化合作夥伴的討論而言，我認為這確實是在考慮整體。我們並不打算將其分成多個部分，就像我們之前在更大範圍內指出的那樣 - 我們已經在美國方面和各方特別是亞洲和我們的各方中獲得了條款清單。持續的信念是，一旦美國確實擁有強大的能力，可以最大限度地利用美國的機會，那麼這一切就屬於單一全球合作夥伴的手中。

And so that's what we're looking for. And we think that really resolves around the entirety of the asset, not carving it up into specific indications.

這就是我們正在尋找的。我們認為這真正解決了整個資產的問題，而不是將其分割成特定的指標。

Okay. And then looking at the potential sales force that might work the best for this after approval, are there any characteristics that you look for? And I'm sure you have a number of suitors that you're talking to. And obviously, you know, on your side, you want to see something that's attractive there to know if you can target and negotiate hardest with. What are some of those features that you look for in a sales force that would allow cytisinicline to layer on easily and have them be very effective?

好的。然後在獲得批准後查看可能最適合此目的的潛在銷售人員，您是否需要尋找任何特徵？我確信你正在和很多追求者交談。顯然，你知道，在你這邊，你想看到一些有吸引力的東西，看看你是否可以瞄準並與之進行最艱難的談判。您在銷售團隊中尋找哪些特徵，可以讓金雀花鹼輕鬆分層並使其非常有效？

Yeah, I think when we look at this overall indication, historically and where we see it moving forward and will continue to be a primary care call point. So from our perspective, having reps on the ground that can hit that whole point, this could be an asset that's basically plug-and-play into an existing sales force out there, and we think that's the easiest path forward. But there could be other opportunities when you look at more specialty companies that have either a CNS focus or addiction focus. So I think there's a number of angles, but I think a strong overlap with the call point is one of the key considerations for us.

是的，我認為當我們從歷史上看這個整體跡象時，我們看到它向前發展，並將繼續成為初級保健呼叫點。因此，從我們的角度來看，擁有能夠達到這一點的現場代表，這可能是一種基本上可以即插即用到現有銷售隊伍中的資產，我們認為這是最簡單的前進道路。但當你看看更多專注於中樞神經系統或成癮的專業公司時，可能還有其他機會。所以我認為有很多角度，但我認為與呼叫點的強烈重疊是我們的關鍵考慮因素之一。

Okay. And then any hints on a brand name that you guys might be working on or looking for?

好的。然後有關於你們可能正在研究或尋找的品牌名稱的任何提示嗎？

We do. Good question. Yes, something that we cleared with the agency already. Obviously, it's not a fully blessed until the NDA review I can get through the end, but that's one of the components we did pretty clear early just to make sure that we have that ready to roll.

我們的確是。好問題。是的，我們已經與該機構澄清了這一點。顯然，在我能夠完成 NDA 審查之前，這並不是一個完全的祝福，但這是我們很早就做的非常明確的組成部分之一，只是為了確保我們已經準備好推出。

Right. Thank you, John. Thank you, Cindy.

正確的。謝謝你，約翰。謝謝你，辛蒂。

Thank you. At this time, I'll turn the floor back to management for closing remarks.

謝謝。此時，我將請管理階層作結束語。

Yeah, thanks, operator. Thanks, everyone, for joining us today and appreciate all the continued interest. It's been a tremendous year with data coming out of not only our second confirmatory Phase 3 trial, but also the first-ever randomized placebo-controlled trial in vaping and publication of our first Phase 3 trial in JAMA. So really excited about where the program sits today and the interest that we continue to see from commercialization organization. And we look forward to driving this forward expeditiously and providing updates as we proceed.

是的，謝謝，接線生。感謝大家今天加入我們，並感謝大家的持續關注。這是重要的一年，我們的第二項驗證性3 期試驗數據不僅來自我們的第二個驗證性3 期試驗，而且還來自電子煙領域的第一個隨機安慰劑對照試驗，以及我們在《美國醫學會雜誌》上發表的第一個3 期試驗。對於該計劃今天所處的位置以及我們繼續從商業化組織中看到的興趣感到非常興奮。我們期待著迅速推動這一進程，並在進展過程中提供最新資訊。

So thanks, everyone, again for joining us today.

再次感謝大家今天加入我們。