Cognition Therapeutics Inc (CGTX) 2024 Q4 法說會逐字稿

Greetings and welcome to the Cognition Therapeutics' fourth-quarter and full-year 2024 earnings call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Mike Moyer with LifeSci Advisors. Thank you. You may begin.

問候並歡迎參加 Cognition Therapeutics 2024 年第四季和全年財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。現在，我想將會議交給主持人，LifeSci Advisors 的 Mike Moyer 先生。謝謝。你可以開始了。

Thank you, operator, and good morning, everyone. Welcome to Cognition Therapeutics' fourth-quarter and year-end 2024 results conference call.

謝謝接線員，大家早安。歡迎參加 Cognition Therapeutics 2024 年第四季和年終業績電話會議。

With me today are Lisa Ricciardi, President and Chief Executive Officer; John Doyle, Chief Financial Officer; and Dr. Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its 2024 fourth-quarter and year-end results. We encourage everyone to read this morning's press release, as well as Cognition's annual report and Form 10-K, which is now filed with the SEC and available on our website.

今天與我一起的有總裁兼執行長 Lisa Ricciardi、財務長 John Doyle 和首席醫療官 Tony Caggiano 博士。今天上午，該公司發布了一份新聞稿，詳細介紹了其2024年第四季和年終業績。我們鼓勵大家閱讀今天早上的新聞稿，以及 Cognition 的年度報告和 10-K 表格，該報告和表格現已提交給美國證券交易委員會 (SEC) 並可在我們的網站上查閱。

In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.

此外，本次電話會議將透過公司網站進行網路直播，並將存檔30天。請注意，今天電話會議上討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的涵蓋範圍。

We caution listeners that during this call, management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to the risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in cognition's press releases and SEC filings, including its annual report on Form 10-K and previous fillings.

我們提醒聽眾，在本次電話會議中，管理階層將做出前瞻性陳述。由於公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述所明示或暗示的結果有重大差異。這些前瞻性陳述受到 cognition 新聞稿和 SEC 文件（包括其 10-K 表格年度報告和先前的文件）中所含警示性聲明的限制。

This conference call contains time sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

本次電話會議包含時間敏感訊息，這些資訊僅在本次直播之日準確。Cognition 不承擔修改或更新任何前瞻性陳述以反映本次電話會議召開日期之後的事件或情況的義務。

With that, I would like to now hand the call over to Lisa Ricciardi.

說完這些，我現在想把電話交給 Lisa Ricciardi。

Mike, thank you, and good morning, everyone. Cognition Therapeutics' focus is the development of zervimesine for patients with Alzheimer's disease and dementia with Lewy bodies, which I'll refer to as DLB. For clarity, zervimesine is the USAN or the generic name for our lead candidate CT1812. Last year, we reported data from two studies in both patient populations, and the results showed strong efficacy signals, making it clear that zervimesine has the potential to bring great value to patients and their care partners, and we believe to investors as well.

麥克，謝謝你，大家早安。Cognition Therapeutics 的重點是開髮用於治療阿茲海默症和路易氏體失智症（我稱之為 DLB）患者的澤維美辛。為了清楚起見，zervimesine 是 USAN 或我們的主要候選藥物 CT1812 的通用名稱。去年，我們報告了針對兩種患者群體的兩項研究的數據，結果顯示出了強烈的療效信號，這清楚地表明澤維美辛有可能為患者及其護理夥伴帶來巨大的價值，我們相信，對投資者也是如此。

Many of you are wondering what are the next steps to advance the zervimesine into registrational trials. Our clinical operations and development teams are working to prepare final study documents from both trials.

你們中的許多人都想知道下一步該如何推進澤維美辛進入註冊試驗階段。我們的臨床營運和開發團隊正在努力準備兩項試驗的最終研究文件。

To be clear, these are very large dossiers. They need to be compiled, reviewed, and cross-checked. And when we're satisfied with these documents, we will submit them to the FDA along with requests for two different end of Phase 2 meetings, one for Alzheimer's and one for DLB. \At the same time, we're having discussions with advisers to ensure that we are as prepared as possible when approaching the FDA.

要先明確的是，這些都是非常大的檔案。它們需要被彙編、審查和交叉核對。當我們對這些文件感到滿意時，我們將把它們連同兩次不同的第 2 階段結束會議的請求一起提交給 FDA，一次針對阿茲海默症，一次針對 DLB。\與此同時，我們正在與顧問進行討論，以確保我們在與 FDA 聯繫時做好盡可能充分的準備。

Let's talk about capital allocation. We decided to conclude our dry AMD Phase 2 dry AMD study before its completion. The reduced expense extends our runway, and now 100% of our attention and resources are allocated to our Alzheimer's and DLB programs.

我們來談談資本配置。我們決定在乾性 AMD 第 2 階段乾性 AMD 研究完成之前結束它。減少的開支延長了我們的跑道，現在我們 100% 的注意力和資源都分配給了我們的阿茲海默症和 DLB 計畫。

Let me be clear, the decision to conclude the dry AMD study was not due to any safety concerns. Quite the contrary, our clinical research organization partner conducted an analysis of the masked data. This type of analysis is referred to as a futility study, and it is used to determine if an experimental drug has signals of efficacy during a clinical trial.

讓我明確一點，結束乾性 AMD 研究的決定並不是出於任何安全方面的考慮。恰恰相反，我們的臨床研究組織合作夥伴對屏蔽數據進行了分析。這種分析被稱為無效性研究，用於確定實驗藥物在臨床試驗期間是否具有療效訊號。

We reported that we had indeed passed the analysis which supports the potential of zervimesine in patients with dry AMD. However, we felt then, and we still believe, that the decision to conclude the dry AMD study was necessary for the success of our Alzheimer's and DLB programs.

我們報告說，我們確實通過了支持澤維美辛對乾性 AMD 患者潛力的分析。然而，我們當時認為，現在仍然相信，完成乾性 AMD 研究的決定對於我們的阿茲海默症和 DLB 計畫的成功是必要的。

Zervimesine has shown clear activity in these two large patient populations, and there is such a clear need for new, effective, convenient drugs in both Alzheimer's and Lewy body dementia. Therefore, we intend to discuss what the FDA plans to pursue each indication in separate studies.

Zervimesine 在這兩大患者群體中都表現出了明顯的活性，而阿茲海默症和路易氏體失智症患者顯然都需要新的、有效的、方便的藥物。因此，我們打算在單獨的研究中討論 FDA 計劃如何針對每種適應症進行研究。

Now, we are not naive about the significant capital needed to fund these studies. We have an active business development program ongoing. We've built strong relationships with biotech and pharma players in this space since we began as a company.

現在，我們對於資助這些研究所需的大量資金並不陌生。我們正在進行積極的業務發展計劃。自公司成立以來，我們就與該領域的生物技術和製藥公司建立了牢固的關係。

We have conducted a number of fruitful meetings since the beginning of the year, updating interested parties on the data from SHINE and SHIMMER. The ideal scenario would be to find a partner to work with on the development and registration program and, in the process, obtain non-diluted funding for one or both indications.

自今年年初以來，我們舉行了多次富有成果的會議，向相關人士通報了 SHINE 和 SHIMMER 的數據。理想的情況是找到一個合作夥伴共同開展開發和註冊計劃，並在此過程中獲得針對一種或兩種適應症的非稀釋資金。

There's nothing I can confirm today, and I have no guarantee that we're going to sign a deal, but I am confident we will find a path forward with funding. We are evaluating all our options to finance our clinical development efforts.

我今天無法確認任何事情，也無法保證我們一定會簽署協議，但我相信我們會找到解決資金問題的途徑。我們正在評估所有為臨床開發工作提供資金的選擇。

In addition, beyond securing capital, we're making strides to ensure we're Phase 3 ready. Our CMC team has developed a novel chemical process for the manufacture of zervimesine. Provisional patent applications covering this chemical process have been filed.

此外，除了確保資金之外，我們還在大力確保為第三階段做好準備。我們的 CMC 團隊開發了一種用於製造 zervimesine 的新型化學製程。涵蓋此化學過程的臨時專利申請已經提交。

We expect that this manufacturing process will produce materials sufficient for future clinical studies, and if zervimesine is approved, we expect it will support commercial manufacturing needs. On that same front, we're working with a domestic CMO or contract manufacturing organization that will be capable of producing commercial quantities of zervimesine.

我們預計該製造流程將生產足以滿足未來臨床研究需求的材料，如果 zervimesine 獲得批准，我們預計它將支援商業製造需求。在同一方面，我們正在與國內的 CMO 或合約製造組織合作，該組織將能夠生產商業數量的 zervimesine。

With that, John Doyle will review our financial results and provide color around our cash position and capital requirements. John.

約翰·道爾 (John Doyle) 將審查我們的財務結果並提供有關我們的現金狀況和資本需求的詳細資訊。約翰。

Thank you, Lisa. We made the strategic decision in January 2025 to voluntarily conclude our Phase 2 MAGNIFY study in dry AMD. This pipeline prioritization will result in cost savings that we expect will extend our cash runway into the fourth quarter of 2025. This allows us to focus our resources entirely on our Alzheimer's and DLB programs.

謝謝你，麗莎。我們在 2025 年 1 月做出策略決策，自願結束針對乾性 AMD 的 2 期 MAGNIFY 研究。這種管道優先排序將帶來成本節省，我們預計這將使我們的現金流延長至 2025 年第四季。這使我們能夠將資源完全集中在阿茲海默症和 DLB 專案上。

During 2024, we used one of the tools we have at our disposal, our aftermarket or ATM facility with B. Riley Securities. For the year ending December 31, 2024, we sold almost 20 million shares of our common stock for gross proceeds of approximately $12.8 million.

2024 年期間，我們使用了我們現有的工具之一，即與 B. Riley Securities 合作的售後市場或 ATM 設施。截至 2024 年 12 月 31 日的年度，我們出售了近 2,000 萬股普通股，總收益約為 1,280 萬美元。

Now, let's proceed to the financials for the fiscal year 2024. Cash and cash equivalents as of December 31, 2024, approximately $25 million in total obligated grant funds remaining from the NIA were $50 million. As indicated earlier, we estimate that we have sufficient cash to fund operations and capital expenditures into the fourth quarter of 2025.

現在，讓我們來看看2024財年的財務狀況。截至 2024 年 12 月 31 日的現金及現金等價物，NIA 剩餘的總義務補助金約為 2,500 萬美元，為 5,000 萬美元。如前所述，我們估計我們有足夠的現金來資助到 2025 年第四季的營運和資本支出。

Research and development expenses were $41.7 million for the year ended December 31, 2024, compared to $37.2 million for 2023. This increase was primarily related to higher costs associated with activities underway to complete two Phase 2 trials.

截至 2024 年 12 月 31 日止年度的研發費用為 4,170 萬美元，而 2023 年為 3,720 萬美元。這一增長主要與完成兩項第 2 階段試驗所進行的活動相關的成本增加有關。

General and administrative expenses were $12.3 million for the year ended December 31, 2024, compared to $13.5 million for 2023. The decrease was primarily related to lower equity-based compensation and professional fees.

截至 2024 年 12 月 31 日止年度的一般及行政開支為 1,230 萬美元，而 2023 年為 1,350 萬美元。下降主要與股權薪酬和專業費用下降有關。

The company reported a net loss of $34 million for $0.86 per basic and diluted share for the year ending December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023. Lisa.

該公司報告稱，截至 2024 年 12 月 31 日的年度淨虧損為 3,400 萬美元，即每股基本虧損和稀釋虧損均為 0.86 美元，而 2023 年淨虧損為 2,580 萬美元，即每股基本虧損和稀釋虧損均為 0.86 美元。麗莎。

Thank you, John. I want to take this opportunity to address the question of Nasdaq compliance. As many of you saw last week, we were granted a six-month grace period to come back into compliance with Nasdaq's minimum bid requirement. This means our stock has to close above $1 for 10 days consecutively before September 8, 2025. We are confident we will regain compliance during the allotted time.

謝謝你，約翰。我想藉此機會談談納斯達克合規性的問題。正如你們許多人上週所看到的，我們獲得了六個月的寬限期，以重新遵守納斯達克的最低出價要求。這意味著我們的股票必須在 2025 年 9 月 8 日之前連續 10 天收在 1 美元以上。我們有信心在規定時間內恢復合規。

We have multiple milestones coming up that we believe will drive value in the stock. We expect to hold two Phase 2 end of Phase 2 meetings with the FDA for Alzheimer's disease and Lewy body dementia, gaining clarity on our clinical programs going forward. And we anticipate having announcements about partnering or other sources of funding.

我們即將迎來多個里程碑，我們相信這些里程碑將推動股票價值的提升。我們預計將與 FDA 舉行兩次針對阿茲海默症和路易氏體失智症的 2 期 2 階段結束會議，以明確我們未來的臨床計劃。我們期待發布有關合作或其他資金來源的公告。

Now, I'll turn the call back to the operator who can open the call to questions. We'll begin with the sell side and then take questions from recent conferences.

現在，我將把電話轉回給接線員，接線員可以開始回答問題。我們將從賣方開始，然後回答最近會議中提出的問題。

(Operator Instructions) Mayank Mamtani, B. Riley Securities.

（操作員指示） Mayank Mamtani，B. Riley Securities。

As you prep for the end of Phase 2 FDA meeting, do you have any latest thoughts on the tau cutoff threshold that you might be thinking about based on the SHINE study learnings? And also, if you could comment on implications of that biomarker to the ongoing Phase 2 early AD study, and if there's any update on enrollment for that early AD study would be helpful too. And then I have a follow up.

在為第二階段 FDA 會議的結束做準備時，您是否根據 SHINE 研究成果對 tau 截止閾值有什麼最新想法？此外，如果您能評論該生物標記對正在進行的 2 期早期 AD 研究的影響，以及該早期 AD 研究的招募情況是否有任何更新，那也將很有幫助。然後我有一個後續行動。

Yeah, so we certainly are planning to do a enrichment of participants in the next study for those who have the lower tau. We haven't announced exactly what that level is going to be, but it'll be very similar to what we used in the SHINE study.

是的，所以我們確實計劃在下一項研究中為那些 tau 較低的人增加參與者。我們還沒有宣布具體水平，但它與我們在 SHINE 研究中使用的非常相似。

Now, we're looking at the data and we're looking at databases and our collaborators databases around what we would expect in the population, and then making cuts to see where the effects are most robust and where that best number would be. But we haven't landed on a specific number, but you can expect it to be very similar.

現在，我們正在查看數據，我們正在查看資料庫以及我們的合作者的資料庫，以了解我們對人口的預期，然後進行刪減，以查看哪裡的效果最強勁，以及最佳數字在哪裡。但我們還沒有確定一個具體的數字，但你可以預期它會非常相似。

So and then relating to the early AD study, we haven't made any announcements as to how we're progressing in that study. It is still continuing to recruit.

因此，關於早期的 AD 研究，我們還沒有宣布該研究的進展。目前仍在繼續招募。

Now, there you had asked about whether there is a particular cut around tau in that study. So in that study there is not.

現在，您問到該研究中是否有圍繞 tau 的特定剪切。所以在那項研究中沒有。

So understand this is a different population of people with Alzheimer's disease. These are folks at the early end of the spectrum. So inherently what's going to be enriched with those who have a slightly lower tau, anyway, but that's not part of that study.

因此要明白，這是一群不同的阿茲海默症患者。這些人處於早期階段。因此，從本質上來說，那些 tau 值稍低的人會得到豐富的營養，但這不是研究的一部分。

Thank you. And then on SHIMMER data that was presented at a recent conference, are you able to share any investigative physician feedback that that you came away with? And also, obviously, interested in what next steps in terms of publication strategy that you may have there in AMD because, obviously, not a lot going on there.

謝謝。那麼，根據最近一次會議上展示的 SHIMMER 數據，您能否分享您得到的任何調查醫生回饋？而且，顯然，我對您在 AMD 的出版策略方面的下一步舉措很感興趣，因為顯然，那裡沒有發生太多事情。

And if you're able to just maybe update us on how corporate development activity could look like if it's same-same partner interested in both indications, or do you think one indication could be more manageable by a company your size versus maybe another indication being pursued by a larger company?

而且，如果您能夠向我們介紹一下，如果同一個合作夥伴對兩種適應症都感興趣，企業開發活動會是怎樣的，或者您是否認為對於您這樣規模的公司來說，一種適應症可能比一家更大的公司追求的另一種適應症更容易管理？

We would love to hear your thoughts on that. And thanks again for taking the question.

我們很想聽聽您對此的想法。再次感謝您提出這個問題。

We don't have any updates on partnering. We have lots of interest in different forms. You alluded to several, one indication, both indications. So when the deal's concluded, we will make that announcement, and we're talking to all the interested parties.

我們沒有任何關於合作的最新消息。我們對不同的形式很感興趣。您提到了幾個，一個跡象，兩個跡象。因此，當交易完成時，我們將會宣布這一消息，並與所有相關方進行談判。

With regard to feedback, what I can tell you is we have excellent feedback from KOLs, from people we were with in the international conference in Amsterdam, from surveys we've done of neurologists and from payers. So as we are approaching the coming days, we'll make more of that information public in various ways.

關於回饋，我可以告訴你的是，我們從關鍵意見領袖、阿姆斯特丹國際會議上與我們一起參加的人、我們對神經病學家和付款人進行的調查中獲得了非常好的反饋。因此，隨著時間的推移，我們將透過各種方式公開更多資訊。

But I can tell you it is consistently strong feedback where KOLs and others, payers in particular, are identifying the fact there are great needs. This is a convenient drug. They appreciate the safety profile. Patients don't have many options out there. It's all the kind of feedback we would have hoped to receive, and it's very, very consistent.

但我可以告訴你，這是一個持續強烈的回饋，KOL 和其他人，特別是付款人，都認識到存在巨大的需求。這是一種方便的藥物。他們很欣賞其安全性。患者的選擇不多。這些都是我們希望收到的回饋，而且非常非常一致。

With regard to the publication. I'll turn that back to Tony.

關於出版。我會把這個問題轉回給托尼。

Sure, so the publication is already underway. Obviously, it's a long cycle, right? So the preparation will take a little bit. And then there's a submission review, revision, and publication. But it's underway and hopefully will be out in the next many months.

當然，出版已經在進行中了。顯然，這是一個很長的周期，對吧？所以準備工作需要一點時間。然後進行提交審核、修改和發布。但該項目已在進行中，預計在未來幾個月內完成。

Understood. Thanks again.

明白了。再次感謝。

Daniil Gataulin, Chardan Capital.

丹尼爾·加陶林，查丹資本。

I have one for DLB, specifically. Similar to the Alzheimer's program, are you looking at any biomarkers or any (inaudible) biomarkers to try to increase the probability of success of that program in the pivotal studies?

我有一個專門針對 DLB 的。與阿茲海默症計畫類似，您是否正在研究任何生物標記或任何（聽不清楚）生物標誌物，以嘗試增加該計畫在關鍵研究中成功的可能性？

Good question. Right now, we don't have any definitive enrichment strategy. The good news is we saw a really good robust response across all the people that we recruited, regardless of how we looked at it; whether it's age, gender, amyloid status, alpha-secretase status, whether they were on dopamine-related drugs, whether they were on acetylcholinesterase-related drugs. So the good news is we believe, across the spectrum of people with DLB, we expect to see a good response.

好問題。目前，我們還沒有任何明確的濃縮策略。好消息是，我們看到我們招募的所有人都表現出了非常好的強烈反應，無論我們如何看待它；無論是年齡、性別、澱粉樣蛋白狀態、α-分泌酶狀態，是否服用多巴胺相關藥物，是否服用乙醯膽鹼酯酶相關藥物。因此，好消息是，我們相信，對於患有 DLB 的所有人群，我們都有望看到良好的反應。

Got it. Thank you. And then, with respect to dosing, so when you reported the news about GA and I think you had a green light from DSMB, was that for 200 milligram dose? And thinking about the dose for pivotal studies for AD and DLB, what are your current thinking? Are you leaning towards 100 or 200?

知道了。謝謝。然後，關於劑量，當您報告有關 GA 的消息時，我認為您已經獲得了 DSMB 的批准，那是 200 毫克的劑量嗎？考慮到 AD 和 DLB 關鍵研究的劑量，您目前的想法是什麼？您傾向 100 還是 200？

We haven't selected an exact dose yet. Most likely we will be operating below 300 milligrams. And the reason for that is when you look at the data, you'll see we had a really nice robust response that's nearly identical for the 100- and 300-milligram dose group, which means we can get the full effect of the drug. And then, obviously, the less drug you're using, the fewer troublesome side effects you'll have.

我們尚未選定確切的劑量。我們很可能會在 300 毫克以下進行操作。原因是，當您查看數據時，您會發現我們獲得了非常好的強勁反應，100 毫克和 300 毫克劑量組的反應幾乎相同，這意味著我們可以獲得藥物的全部效果。顯然，使用的藥物越少，麻煩的副作用就越少。

So we'll be exploring doses below 300, but we haven't come to agreement exactly what that dose will be. Obviously, that'll be part of our end of Phase 2 meeting where you justify the dose and you propose how it'll be designed, physical analysis, and so forth. So we'll have an announcement once that meeting is done as to agreement on the exact plan.

因此，我們將探索低於 300 的劑量，但我們尚未就該劑量的具體數值達成一致。顯然，這將是我們第二階段會議結束的一部分，在該會議上您將證明劑量的合理性並提出如何設計、物理分析等。因此，會議結束後我們將發佈公告，宣布具體計劃的達成情況。

Got it. All right. Thank you, guys. I appreciate you taking the questions.

知道了。好的。謝謝你們。感謝您回答這些問題。

(Operator Instructions) Raghuram Selvaraju, H.C. Wainwright.

（操作員指示）Raghuram Selvaraju，H.C. Wainwright。

This is Dan on for Raghuram. Thanks for taking our questions. We were wondering what does the competitive landscape in DLB look like? And recognizing your plans to meet with the FDA regarding zervimesine, what are your thoughts around the potential provability of it and DLB based on neuropsychiatric parameters? And I'd like to ask a follow up if I could.

這是丹 (Dan) 為拉古拉姆 (Raghuram) 表演的。感謝您回答我們的問題。我們想知道 DLB 的競爭格局是什麼樣的？並且認識到您計劃與 FDA 會面討論澤維美辛，您對基於神經精神參數的澤維美辛和 DLB 的潛在可證明性有何看法？如果可以的話，我想問一下後續問題。

Yeah, the neuropsychiatric symptoms that you mentioned, a key or a core symptom of the disease. So, we're very confident that physicians and FDA will be interested in this. Unlike Alzheimer's disease where there's guidance on a cognitive outcome with a functional outcome; that doesn't exist for DLB.

是的，您提到的神經精神症狀是疾病的關鍵或核心症狀。因此，我們非常有信心醫生和 FDA 對此感興趣。與阿茲海默症不同，阿茲海默症有關於認知結果和功能結果的指導；而 DLB 則不存在這樣的指導。

So a strong emphasis of our FDA meeting will be around, which of the outcome measures we will propose, how they'll be ordered, whether they'll be stand-alone, or co-primary, or composite outcomes. So that's exactly what that meeting will be about. And again, once we have that meeting and have agreement and understand what that study will look like, there'll be an announcement.

因此，我們 FDA 會議的重點將圍繞在以下方面：我們將提出哪些結果衡量標準、如何對它們進行排序、它們是獨立的、共同主要的還是綜合的結果。這就是這次會議的議題。再說一次，一旦我們開會達成一致並了解研究內容，我們就會發佈公告。

Awesome. And then what are the outlooks in Europe versus the United States for accelerated approval of anti-Alzheimer's drugs and what are your thoughts for more near- or medium-term grant funding given the reported NIH cutbacks? Thank you.

驚人的。那麼，歐洲與美國在加速核准抗阿茲海默症藥物方面的前景如何？鑑於報告的 NIH 削減，您對更多短期或中期撥款有何看法？謝謝。

So right now, we are primarily pursuing a very traditional path, right, of Phase 3 studies that are adequately sized, well-controlled; either two studies, a supportive study and a single pivotal, or two parallel studies.

所以現在，我們主要採取一種非常傳統的路徑，對吧，即規模足夠、控制良好的第三階段研究；要么是兩項研究，一項支持性研究和一項關鍵性研究，要么是兩項平行研究。

The accelerated pathway in Alzheimer's disease, as you know, has been interesting, right? Following Biogen and then now with successes from [HI] and Lilly. And given our ability to clearly measure what a meaningful clinical outcomes, our path is to follow the traditional outcomes and seek a traditional approval.

如您所知，阿茲海默症的加速途徑很有趣，對嗎？繼 Biogen 之後，現在又有了 [HI] 和 Lilly 的成功。鑑於我們有能力清楚地衡量有意義的臨床結果，我們的途徑就是遵循傳統的結果並尋求傳統的批准。

Now, in Europe, we haven't seen that it's any easier to get an approval. So again, we plan to follow a very traditional pathway.

現在，在歐洲，我們還沒有看到獲得批准變得更加容易。因此，我們再次計劃遵循一條非常傳統的道路。

And then with regard to the NIH funding, John mentioned we have a $50 million dollar balance of funding and that supports our start trial in early-stage patients. All of our other trials were funded by the NIH or the NIA, with the iNDI NIH.

然後關於 NIH 的資助，約翰提到我們有 5000 萬美元的資金餘額，這支持我們在早期患者中進行試驗。我們所有其他試驗均由 NIH 或 NIA 以及 iNDI NIH 資助。

And those trials have completed and we're very confident that this final balance will be available to us. Like everyone else, we're watching what's going on. We're learning on a real-time basis, but we believe we'll have access to those funds to finish the trial.

這些試驗已經完成，我們非常有信心我們將獲得最終的平衡。和其他人一樣，我們也在關注著正在發生的事情。我們正在即時學習，但我們相信我們將能夠獲得這些資金來完成試驗。

As for your other question about new grants, it's our understanding that by the time you're into Phase 3 programs, you have the ability to reach other sources of funding the capital markets partnerships, et cetera. And that the funding vehicles we've seen so far are really geared toward earlier stage programs.

至於您關於新贈款的另一個問題，據我們了解，當您進入第三階段計劃時，您就有能力獲得其他資金來源，例如資本市場合作夥伴關係等。到目前為止，我們看到的融資工具其實都是針對早期階段的專案。

So I would say we don't anticipate more grant funding from the NIA. It's possible. We'll certainly try, but I think it's a lower probability now, than when we were in earlier stage company.

所以我想說，我們預計 NIA 不會提供更多的資助。這是有可能的。我們肯定會嘗試，但我認為現在成功的可能性比我們早期公司成立時要低。

Awesome. Thank you.

驚人的。謝謝。

Thank you. That concludes our questions over the phone. I'll turn the floor back to Ms. Ricciardi for any final comments.

謝謝。我們在電話中的問題到此結束。我將把發言權交還給 Ricciardi 女士，請她發表最後的評論。

Great. I'm just looking at some prior questions we were asked. John addressed the question about the ATM, how we have an ATM in place. We've addressed planning for Phase 3 trials in AD and DLB.

偉大的。我只是在看我們之前被問到的一些問題。約翰回答了有關 ATM 的問題，我們如何安裝 ATM。我們已經制定了 AD 和 DLB 的 3 期試驗計劃。

Someone had previously asked us why are you not starting your Phase 3 trials yet, and I think we've covered it on this call. You prepare an enormous dossier. You sit with the agency, you review your protocol. From there, by identifying your funding, you're good to go. You have a plan and a source of funding to complete it.

之前有人問過我們為什麼你們還沒開始第三階段試驗，我想我們在這次通話中已經討論過了。你準備了一份龐大的檔案。您與代理商坐在一起，審查您的協議。從那裡開始，透過確定您的資金，您就可以開始了。您有一個計劃和資金來源來完成它。

And last, with regard to partnerships, as we said earlier, we're very actively involved in that process and when we have something that we can announce we will.

最後，關於合作夥伴關係，正如我們之前所說，我們非常積極地參與這一進程，當我們有可以宣布的事情時，我們就會宣布。

What I would like to conclude with is saying we have FDA meetings coming this year. While there are challenges ahead in terms of financing our studies, we're committed to meeting these challenges. We're positioned to achieve and deliver on multiple clinical milestones, and we're focused on creating long-term value for our shareholders as we create important new medications.

最後我想說的是，今年我們將召開 FDA 會議。儘管我們在研究資金方面面臨挑戰，但我們致力於應對這些挑戰。我們致力於實現並交付多個臨床里程碑，並在創造重要新藥的同時，致力於為股東創造長期價值。

As always, we want to thank study participants and their caregivers, our investors, as well as supporters at the NIA, Michael J. Fox, the ADDF, our CRO partners, and our team. Without all of these groups, we'd not be where we are today, developing new medicines for neurodegenerative diseases. Thank you, operator. That concludes our call.

像往常一樣，我們要感謝研究參與者及其照顧者、我們的投資者以及 NIA、Michael J. Fox、ADDF、我們的 CRO 合作夥伴和我們的團隊的支持者。如果沒有這些團體，我們就不會擁有今天的成就，開發治療神經退化性疾病的新藥。謝謝您，接線生。我們的通話到此結束。

Thank you. Ladies and gentlemen, this concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。女士們、先生們，今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與。