使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
Good morning, everyone, and welcome to the Anavex Life Sciences fiscal 2025 second-quarter conference call. My name is Clint Tomlinson, and I'll be your host for today's call. (Event Instructions) Please note, this conference is being recorded, and the call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer.
大家早安,歡迎參加 Anavex Life Sciences 2025 財年第二季電話會議。我叫克林特‧湯姆林森,我將擔任今天電話會議的主持人。(活動說明)請注意,本次會議將會被錄音,您可以在 Anavex 網站 www.anavex.com 上重播。今天與我們一起出席的嘉賓包括總裁兼執行長 Christopher Missling 博士和財務長 Sandra Boenisch。
Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on the current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC.
在我們開始之前,請注意,在本次電話會議期間,公司將做出一些預測和前瞻性陳述。這些聲明僅是基於當前資訊和預期的預測,涉及許多風險和不確定性。我們鼓勵您查看該公司向美國證券交易委員會提交的文件。
This includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital and maintenance of intellectual property rights.
這包括但不限於公司的 10-K 表格和 10-Q 表格,其中列出了可能導致實際結果或事件與這些前瞻性陳述中描述的結果或事件有重大差異的具體因素。這些因素可能包括但不限於潛在產品的開發和/或商業化固有的風險、臨床試驗或監管部門批准結果的不確定性、獲得未來資本的需要和能力以及智慧財產權的維護。
And with that, I would like to turn the call over to Dr. Missling.
現在,我想將電話轉給 Missling 博士。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update.
謝謝你,克林特,大家早安。感謝您今天與我們一起審查我們最近報告的財務結果並提供我們的季度業務更新。
Our portfolio of noninvasive targeted upstream precision compounds continues to advance with special focus on Alzheimer's disease and schizophrenia. We also continue to receive feedback from neurologists, preferring convenient, orally available and clinically meaningful Alzheimer's disease treatment options, which can be assessed without logistical restrictions.
我們的非侵入性靶向上游精準化合物組合持續發展,特別關注阿茲海默症和精神分裂症。我們也不斷收到神經科醫生的回饋,他們更傾向於方便、口服且具有臨床意義的阿茲海默症治療方案,並且可以在不受後勤限制的情況下進行評估。
In April, we were pleased to present open-label extension data of blarcamesine for Alzheimer's disease at the ADPD 2025 conference. The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once-daily oral blarcamesine demonstrated over three years of continuous treatment significant amelioration on clinical decline and shown continued clinically meaningful benefit for early Alzheimer's disease patients.
今年 4 月,我們很高興在 ADPD 2025 會議上展示了用於治療阿茲海默症的 blarcamesine 的開放標籤擴展數據。數據證實,早期阿茲海默症患者仍具有持續的臨床益處。每日一次口服 blarcamesine 經過三年的持續治療,臨床症狀明顯改善,並為早期阿茲海默症患者帶來持續的臨床益處。
Blarcamesine-treated patients continue to accrue benefit grew up to four years as measured by the clinical endpoints ADAS-Cog13 and ADCS-ADL. Last month, Marwan Sabbagh, Professor of Neurology at Barrow Neurological Institute and Chairman of Anavex Life Sciences Advisory Board, gave an oral presentation titled Oral Blarcamesine Novel Mechanism for Alzheimer's Disease: Autophagy Restoration through Upstream SIGMAR1 Activation, Clinical Efficacy Phase IIb/III Trial at the 9th International Conference on Alzheimer's Disease and Related Disorders in the Middle East.
透過臨床終點 ADAS-Cog13 和 ADCS-ADL 衡量,接受 Blarcamesine 治療的患者在長達四年的時間內持續獲得益處。上個月,巴羅神經學研究所神經學教授、Anavex 生命科學顧問委員會主席 Marwan Sabbagh 在第九屆中東阿茲海默症和相關疾病國際會議上做了題為「口服 Blarcamesine 治療阿茲海默症的新機制:透過上游 SIGMAR1 活化恢復自噬,臨床療效 IIb/III 期試驗」的口頭報告。
The meeting convened a wide range of health care professionals and community advocates from the Middle East and North Africa, USA, Europe and other countries with an interest in epidemiology, clinical research, medicine, basic science and health care advocacy related to Alzheimer's disease and related disorders in the region, specifically with an emphasis on region-specific health care delivery.
會議匯集了來自中東和北非、美國、歐洲和其他國家的眾多醫療保健專業人士和社區倡導者,他們對該地區阿茲海默症和相關疾病的流行病學、臨床研究、醫學、基礎科學和醫療保健倡導感興趣,特別強調特定地區的醫療保健服務。
With respect to schizophrenia, earlier this month, we announced the successful completion of enrollment in our Phase II clinical study of ANAVEX 3-71 for the treatment of schizophrenia. The study has enrolled a total of 71 participants with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses has been completed with encouraging preliminary safety and electroencephalography, EEG biomarker results previously reported.
關於精神分裂症,本月初,我們宣布成功完成 ANAVEX 3-71 治療精神分裂症的 II 期臨床研究的招募。研究共招募了 71 名參與者,其中 A 部分 16 名參與者,B 部分 55 名參與者。研究的 A 部分調查了多次遞增劑量,目前已完成,初步安全性令人鼓舞,並且先前已報告了腦電圖和腦電圖生物標記結果。
Part B, which includes more participants and with a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of ANAVEX 3-71 in individuals with schizophrenia. We expect to report top-line data from the study in the second half of this year. Since our last update, we also expanded our scientific advisory board.
B 部分涵蓋更多參與者且治療時間更長,將提供關於 ANAVEX 3-71 對精神分裂症患者的療效和安全性的更全面的臨床和生物標記數據。我們預計將在今年下半年報告該研究的主要數據。自上次更新以來,我們也擴大了科學顧問委員會。
In April, we announced the appointment of Professor Dr. Audrey Gabelle, a specialist of predictive, personalized medicine and digital health care in Alzheimer's disease and related disorders to the Anavex Scientific Advisory Board. Dr. Gabelle is a Professor of Neurology, neurologist and doctor neurosciences at the Memory Resources Research Center. The Rare and Early Dementia Reference Center and the European Neurodegenerative Excellence Center of Montpellier University, France. Dr. Gabelle is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer's disease Consortium.
今年 4 月,我們宣布任命 Audrey Gabelle 教授為 Anavex 科學顧問委員會成員,她是阿茲海默症及相關疾病領域的預測性、個人化醫療和數位醫療專家。Gabelle 博士是記憶資源研究中心的神經病學教授、神經病學家和神經科學博士。法國蒙彼利埃大學罕見及早期癡呆症參考中心及歐洲神經退化性疾病卓越中心。Gabelle 博士也是蒙彼利埃神經科學研究所的研究員和歐洲阿茲海默症聯盟的成員。
And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex for a financial summary of the recently reported quarter.
現在,我想請 Anavex 財務長 Sandra Boenisch 提供最近報告的季度財務摘要。
Sandra Boenisch - Principal Financial Officer, Treasurer
Sandra Boenisch - Principal Financial Officer, Treasurer
Thank you, Christopher. Good morning to everyone. I'm pleased to share with you today our second-quarter financial results for our 2025 fiscal year.
謝謝你,克里斯多福。大家早安。今天我很高興與大家分享我們 2025 財年第二季的財務表現。
Our cash position on March 31 was $115.8 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $5.9 million in operating activities after taking into account changes in noncash working capital accounts. As of quarter end, we anticipate at the current cash utilization rate and ranges, a runway of approximately four years.
截至 3 月 31 日,我們的現金狀況為 1.158 億美元,並且沒有債務。在本季度,考慮到非現金營運資本帳戶的變化後,我們在經營活動中使用了 590 萬美元的現金和現金等價物。截至季末,我們預計以目前的現金利用率和範圍,營運週期約為四年。
During our most recent quarter, general and administrative expenses were $2.6 million as compared to $2.9 million for the comparable quarter of last year. Our research and development expenses for the quarter were $9.9 million as compared to $9.7 million for the comparable quarter of last year. And lastly, we reported a net loss of $11.2 million for the quarter or $0.13 per share.
在我們最近一個季度,一般和行政費用為 260 萬美元,而去年同期為 290 萬美元。本季我們的研發費用為 990 萬美元,去年同期為 970 萬美元。最後,我們報告本季淨虧損 1,120 萬美元,即每股 0.13 美元。
Thank you, and now I will turn the call back over to Christopher.
謝謝,現在我將把電話轉回給克里斯多福。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Thank you, Sandra. In summary, we are focused on continuing to advance our precision medicine compounds with a special focus on Alzheimer's and schizophrenia. We are excited to be potentially making a difference for individuals suffering from these diseases by presenting a scalable treatment alternatives alongside the ease of oral administration.
謝謝你,桑德拉。總之,我們致力於繼續推進精準醫療化合物,特別關注阿茲海默症和精神分裂症。我們很高興能夠透過提供可擴展的治療方案以及便捷的口服給藥方式,為患有這些疾病的個人帶來改變。
I would now like to turn the call back to Clint for Q&A.
現在我想將電話轉回給克林特進行問答。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
(Event Instructions) Soumit Roy, Jones Research.
(活動說明)Soumit Roy,瓊斯研究公司。
Soumit Roy - Analyst
Soumit Roy - Analyst
Congrats on all the progress. A quick question on the Alzheimer's front. What can you tell us about the timeline around when you expect to hear back from EMA and if you already had some mid-cycle review comments received from the European agency?
祝賀你取得的所有進展。關於阿茲海默症的一個快速問題。您能否告訴我們您預計何時會收到 EMA 的回复,以及您是否已經收到了來自歐洲機構的一些中期審查意見?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
So we expect -- thank you for the question. So we expect to have from what we -- compared to other regulatory review cycles that it would probably take about 12 months. So we submitted in November last year, and it was accepted the submission in December last year.
所以我們期待——感謝您的提問。因此,我們預計與其他監管審查週期相比,這可能需要大約 12 個月的時間。所以我們在去年11月提交,去年12月被接受。
So it's probably prudent to estimate by the end of this year or early next quarter that we would get a feedback. And I also want to point out that we will not be able to give interim updates, but we will report the decision from the EMA in its final form.
因此,我們最好估計在今年年底或下個季度初我們會收到回饋。我還想指出,我們無法提供中期更新,但我們將以最終形式報告 EMA 的決定。
Soumit Roy - Analyst
Soumit Roy - Analyst
Got it. That's really helpful. Second one is for 2025, what do you see as the key inflection point? Is it schizophrenia data that's coming up in the second half? If you can give us a little bit more details on the trial, the patient characteristics and what will be the bar to beat in these patients?
知道了。這真的很有幫助。第二個問題是,您認為 2025 年的關鍵轉捩點是什麼?下半年會出現精神分裂症數據嗎?您能否向我們提供一些有關該試驗的更多細節,包括患者特徵以及這些患者的治療標準是什麼?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
So thank you for the question. I think the Phase II study in schizophrenia is the first efficacy study of 3-71. So it's a safety study preliminarily. And we also are focused in the study on the biomarker effect. So we would be very pleased to see a biomarker effect of the drug in these patients, which are very hard to treat patients.
謝謝你的提問。我認為精神分裂症的 II 期研究是 3-71 的首次療效研究。所以這是一項初步的安全性研究。我們也專注於生物標記效應的研究。因此,我們很高興看到該藥物對這些難以治療的患者產生的生物標記效應。
And there's a lot of unmet need out there still today, especially with the negative symptoms. So that will be the focus on the trial for the time being. We also included some clinical measures, but the focus is really on the safety for the longer duration as well as biomarker effect of the drug in the brain of patients by using EEG/ERP which has been now validated as a potential biomarker for schizophrenia in these patients.
時至今日,仍有許多需求尚未被滿足,尤其是負面症狀。因此這將是目前審判的重點。我們也納入了一些臨床措施,但重點實際上是透過使用 EEG/ERP 來關注藥物在患者大腦中的長期安全性和生物標記效應,EEG/ERP 現已被證實是這些患者精神分裂症的潛在生物標記。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
Tom Bishop, BI Research.
湯姆畢曉普 (Tom Bishop),BI 研究。
Tom Bishop - Analyst
Tom Bishop - Analyst
All right. Can you hear me now?
好的。現在你能聽到我說話嗎?
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
Yes, that's perfect. Thank you.
是的,太完美了。謝謝。
Tom Bishop - Analyst
Tom Bishop - Analyst
All right. Sticking with the schizophrenia trial. You mentioned the longer duration, but I didn't quite understand what that meant.
好的。堅持進行精神分裂症試驗。您提到了更長的持續時間,但我不太明白那是什麼意思。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
So the schizophrenia trial is separate in two parts. Part A was a short period of single ascending doses and Part B is a longer duration of 28 days. So it's almost a month. And that's what I was referring to that the Part B, which includes 55 patients randomized to placebo or active arm 1:1, will give us a probably more solid picture of the drug effect in these patients.
因此,精神分裂症試驗分為兩部分。A 部分是短暫的單次遞增劑量治療,B 部分持續時間較長,為 28 天。差不多一個月了。這就是我所指的 B 部分,其中包括 55 名患者,以 1:1 的比例隨機分配到安慰劑組或活性組,這將為我們提供更清晰的藥物對這些患者的作用圖景。
Tom Bishop - Analyst
Tom Bishop - Analyst
Well, I kind of meant how many weeks and months.
嗯,我的意思是多少週或幾個月。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
It's 4 weeks, 28 days.
已經4週28天了。
Tom Bishop - Analyst
Tom Bishop - Analyst
Okay. And can you go into a little more detail about what the company is doing pre possible launch of blarcamesine in Europe.
好的。您能否更詳細地介紹一下公司在歐洲推出 blarcamesine 之前所做的工作?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Right. So we have initiated in JPMorgan multiple discussions with potential partners in discussing, if so the drug is available to patients in Europe to move forward quickly with the distribution with the -- providing access to the drug in Europe. We also have discussions with CROs who also provide us as an alternative confidence in the ability to have sales force set up to move forward also in an independent way.
正確的。因此,我們已與摩根大通的潛在合作夥伴展開多次討論,討論如果歐洲患者能夠獲得該藥物,將如何快速推進藥物的分銷,從而為歐洲患者提供獲得該藥物的渠道。我們也與 CRO 進行了討論,他們也為我們提供了另一種信心,讓我們能夠以獨立的方式建立銷售團隊並向前發展。
This would be more advisable from a value creation point of view. So we like to maximize shareholder value. And the decision is, whatever maximizes the shareholder value will be a decision how to progress. But we are on these fronts active on being ready, so we need to be ready.
從價值創造的角度來看,這是更可取的。因此我們希望實現股東價值最大化。而決定就是,無論什麼都可以最大化股東價值,這將決定如何進步。但我們在這些方面已經積極做好準備,所以我們需要做好準備。
Tom Bishop - Analyst
Tom Bishop - Analyst
Okay. That's helpful. So basically, the choice is to partner with a major or somebody active in Europe or to go with a European-based clinical sales team.
好的。這很有幫助。因此,基本上,選擇是與歐洲的主要公司或活躍的公司合作,或與歐洲的臨床銷售團隊合作。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
These are the options. That's correct. If so, the drug was approved.
這些是選項。沒錯。如果確實如此,該藥物就獲得批准。
Tom Bishop - Analyst
Tom Bishop - Analyst
Okay. Now what's being used in the schizophrenia trial, that's A 3-71. So is that a -- I mean, that's different from blarcamesine, right?
好的。現在在精神分裂症試驗中所使用的是 A 3-71。那麼,這是——我的意思是,這與 blarcamesine 不同,對嗎?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
That's correct. So ANAVEX 3-71 is a completely different molecule. It comes from a different approach and has different affinities to Sigma One receptor. So that is completely independent on of blarcamesine, which is for ANAVEX 2-73, and it's the drug, which is called blarcamesine. So there are two different drugs.
沒錯。因此 ANAVEX 3-71 是一種完全不同的分子。它來自不同的方法並且與 Sigma One 受體具有不同的親和力。因此,這與用於 ANAVEX 2-73 的 blarcamesine 完全無關,這種藥物被稱為 blarcamesine。因此有兩種不同的藥物。
Tom Bishop - Analyst
Tom Bishop - Analyst
Okay. That's right. And what are the other countries that might piggyback on a European approval? And then secondly, how are you doing with the FDA, Canada or Australia? Could you cover that?
好的。這是正確的。還有哪些國家可能獲得歐洲的批准?其次,您與 FDA、加拿大或澳洲的合作情況如何?你能掩蓋這件事嗎?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Yes. Very good question. So the other countries who are piggybacking on approvals in regions like Europe, EMA would be, I think the entire rest of the world, South America. This would be Africa, this would be Middle East. This would be some countries, I think, also in the Asian region.
是的。非常好的問題。因此,我認為,搭上歐洲、EMA 等地區批准的其他國家包括整個世界其他地區和南美洲。這可能是非洲,這可能是中東。我認為,這也包括亞洲地區的一些國家。
So this would be a large number of population as well. Regarding U.K. and Canada, we also are planning to proceed in Australia. We're planning to proceed with starting the dialogue with the respective regulatory bodies in parallel this year.
因此這也將是一個龐大的人口數。除了英國和加拿大,我們還計劃在澳洲開展業務。我們計劃今年同時與相關監管機構展開對話。
Tom Bishop - Analyst
Tom Bishop - Analyst
But are you waiting for word from Europe first or -- because I know the FDA has been kind of possible to have a discussion with them.
但是您是否先在等待歐洲的消息,或者——因為我知道 FDA 有可能與他們進行討論。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
That's also the plan, correct. So we are planning to discuss with these authorities in parallel. So this is in parallel, I would say, is the best way to describe it.
這也是計劃,正確。因此,我們計劃同時與這些當局進行討論。所以我想說,這是平行的,這是描述它的最佳方式。
Tom Bishop - Analyst
Tom Bishop - Analyst
But we're not waiting for the results for Europe first, or are we?
但我們不會先等待歐洲的結果,不是嗎?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
We could wait, but it's probably also possible to work in parallel to prepare the discussion. So that does not mean it's a submission, but to initiate the discussions and to get the feedback on the respective authorities. And that's what we did with Europe as well. Remember, we had a first initial discussion with the European authorities and led to the feedback to submit.
我們可以等待,但也許也可以同時準備討論。所以這並不意味著這是一份提交,而是為了發起討論並獲得相關當局的回饋。我們也對歐洲採取了同樣的措施。請記住,我們與歐洲當局進行了初步討論,並提交了回饋意見。
Tom Bishop - Analyst
Tom Bishop - Analyst
Are any of those planned, though, yes, they're still working on that.
有這些計劃嗎?是的,他們仍在努力。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Pardon me?
對不起?
Tom Bishop - Analyst
Tom Bishop - Analyst
Are any of those planned yet or we plan to meet with Canada next month or anything like that?
這些計劃都已經制定了嗎?或者我們計劃下個月與加拿大會面,或類似的事情?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
We will update once when we get feedback. It's too early to provide details on the timing of those discussions. But once we have relevant outcome of this and meaningful outcome. We will update you.
一旦收到回饋,我們就會更新。現在提供有關這些討論時間的詳細資訊還為時過早。但是一旦我們有了相關的結果和有意義的結果。我們將向您更新最新情況。
Tom Bishop - Analyst
Tom Bishop - Analyst
Okay. And if Europe gave, say, an approval in November, just to pick a number, how long would it take for the company to see revenue? In other words, the launch process.
好的。如果歐洲在 11 月批准,只選擇一個數字,那麼該公司需要多長時間才能看到收入?換句話說,就是發射過程。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Yes. So in Europe, the approval is per all the entire European Union and the sales is done per country. Certain countries you're allowed to market the next day. In other countries, you need to first reach an agreement when to proceed on the timing of the first sale. So it varies. And so some countries, you can start right away.
是的。因此在歐洲,批准是整個歐盟的,銷售也是按國家進行的。某些國家允許您第二天進行行銷。在其他國家,您需要先就首次銷售的時間達成一致。所以它是多種多樣的。對於一些國家來說,你可以立即開始。
Tom Bishop - Analyst
Tom Bishop - Analyst
But you'd be in a position, I mean, to have revenue in the March quarter, are you saying or it takes six months to get going?
但是我的意思是,您能夠在三月這個季度獲得收入,還是說需要六個月的時間才能開始?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Yes, I cannot foresee right now there might be some logistical questions, but if we are getting close to this, we will be very likely prepared. That's our working assumption.
是的,我現在無法預見可能會出現一些後勤問題,但如果我們接近這一點,我們很可能會做好準備。這是我們的工作假設。
Tom Bishop - Analyst
Tom Bishop - Analyst
And my last question is, where is the drug being manufactured and do you have a launch inventory?
我的最後一個問題是,這種藥物在哪裡生產?你們有上市庫存嗎?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
We have a large inventory for a launch. That's correct. And the drug is manufactured by the largest US. manufacturer.
我們有大量庫存可供推出。沒錯。該藥物由美國最大的製造商生產。
Tom Bishop - Analyst
Tom Bishop - Analyst
And is there any tariff impact? It's crazy.
關稅方面有影響嗎?這太瘋狂了。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Right. We don't have any visibility on that right now.
正確的。目前我們還不清楚這一點。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
There's another question here, Dr. Missling. What would be the advantage of oral blarcamesine for patients.
這裡還有一個問題,米斯林博士。口服布拉卡美辛對病人有何益處?
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
I think the advantage for the patient for blarcamesine would be that they're being helped timely without delays and constraints by cumbersome or limiting inconvenient complex agnostic procedures, and it would allow for quicker time-sensitive access with continued focus on the individual patient. When we compare this to the antibodies, it takes up to sometimes six to nine months once they have been diagnosed and been seen by the doctor before they even get to the chance of getting the drug.
我認為,對於患者來說,使用 blarcamesine 的優勢在於,他們可以及時得到幫助,而不會受到繁瑣或限制性、不便、複雜且不可知程序的延誤和限制,並且可以更快地獲得時間敏感的治療,並持續關注個別患者。當我們將其與抗體進行比較時,從確診並接受醫生診治,有時需要六到九個月的時間才有機會獲得藥物。
And by then, they might move into a different bracket for a pathological severity point of view, it might not be even any more eligible to that drug. In our case, a patient could be visited by a physician and the patient would be identified as Alzheimer's patient right away, and the physician would prescribe him blarcamesine potentially, and he would leave with that prescription for three months and been told to come back three months later. So that's the difference, possibly.
到那時,從病理嚴重程度的角度來看,他們可能會進入不同的等級,甚至可能不再適合服用該藥物。在我們的案例中,醫生可以對患者進行檢查,並立即確定該患者為阿茲海默症患者,醫生可能會給他開出 Blarcamesine,他將帶著該處方離開三個月,並被告知三個月後再回來。所以這可能就是差別所在。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
And then there was a follow-up. Is there any difference -- I know you kind of touched on it, but the similar advantages to family members or physicians.
然後還有後續行動。有什麼區別嗎——我知道你已經提到了這一點,但對於家庭成員或醫生來說,優勢是類似的。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Yes. So the advantage for the family would be there's less caregiver stress and likely less financial strain. There is no need to arrange for constant transportation to hospital to measure MRI or better, PET scan. And also, there's no impact because of that on the family members' own work schedule, which is not to be underestimated. Some people cannot just take off work to bring grandmother or grandfather to the hospital every three weeks or every two weeks. And that's a big problem.
是的。因此,對於家庭來說,其好處是照顧者的壓力較小,經濟壓力也可能較小。無需安排經常前往醫院進行 MRI 或更好的 PET 掃描。而且,這對家庭成員自己的工作時間也不會造成影響,這一點不容小覷。有些人無法每三週或每兩週請假帶祖母或祖父去醫院一次。這是一個大問題。
Regarding the physicians, the advantage for the physicians would be that there's no logistical barrier for treatment and no need to arrange for complex invasive tax scans or lumber punter, which is spinal taps and -- or repeated MRIs. And so basically, everybody has less logistical challenges to overcome, and the patient is helped right away.
對於醫生來說,其優勢在於治療沒有後勤障礙,也不需要安排複雜的侵入性稅務掃描或木材探查,即脊椎穿刺和 - 或重複的核磁共振成像。因此基本上每個人需要克服的後勤挑戰都減少了,並且患者可以立即得到幫助。
And when you remember the outcome of the long-term extension study presented at AD/PD at the conference we demonstrated that if you delay the treatment of blarcamesine, you delay also the long-term benefit. So you basically prevent the patient to stay on a better quality of life level, which has implications for benefit for dealing with his own life and family interaction. And if you delay this, you basically are preventing this to happen. So it's important to give the drug to the patients once identified as Alzheimer's patient as soon as possible.
當您記得在 AD/PD 會議上提出的長期擴展研究的結果時,我們證明如果您延遲 blarcamesine 的治療,您也會延遲長期益處。因此,您基本上阻止了患者保持更好的生活品質水平,這對處理他自己的生活和家庭互動有好處。如果你推遲這件事,你基本上就是在阻止這件事發生。因此,一旦確診為阿茲海默症患者,盡快給予該藥物非常重要。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
Okay. Thank you very much. I think that's the end of the questions here. I'll turn it back over to you to close.
好的。非常感謝。我想這裡的問題到此為止。我會把它交還給你結束。
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Christopher Missling - Chairman of the Board, President, Chief Executive Officer, Company Secretary
Thank you. And in closing, we continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives, living with these devastating conditions. Thank you very much.
謝謝。最後,我們將繼續專注於執行和商業準備,推進我們的治療管道,以潛在地改善患者的生活,使他們能夠忍受這些毀滅性的疾病。非常感謝。
Clint Tomlinson - Vice President - Operations
Clint Tomlinson - Vice President - Operations
Thank you, ladies and gentlemen. That will conclude today's conference call. We appreciate your participation, and you may now disconnect.
謝謝各位,女士們、先生們。今天的電話會議到此結束。感謝您的參與,您現在可以斷開連接了。