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
Operator
Operator
Good morning, and welcome to the Molecular Partners fourth quarter and full year 2024 results call. (Operator Instructions). Please note this event is being recorded. I would now like to turn the conference over to Seth Lewis, Senior Vice President, Investor Relations and Strategy. Please go ahead.
早安,歡迎參加 Molecular Partners 第四季和 2024 年全年業績電話會議。(操作員指令)。請注意,此事件正在被記錄。現在,我想將會議交給投資者關係和策略高級副總裁 Seth Lewis。請繼續。
Seth Lewis - Senior Vice President - Investor Relations, Communications and Strategy
Seth Lewis - Senior Vice President - Investor Relations, Communications and Strategy
Thanks, Drew, and welcome, everybody, to the Molecular Partners year-end results in 2024 highlights call. My name is Seth Lewis, and I'm joined today by members of our senior leadership team, including Patrick Amstutz, Chief Executive Officer; Robert Hendriks, SVP of Finance; Philippe Legenne, Chief Medical Officer; and Michael Stumpp, Executive Vice President of Projects and Head of the DLL3 radio program. The team will make some prepared remarks, and then we will open the call for your questions. If you haven't had a chance to see the press release issued yesterday after market close, you can find it on our website. www.molecularpartners.com, where you can also access a copy of today's presentation.
謝謝,德魯,歡迎大家參加分子合作夥伴 2024 年年終業績亮點電話會議。我叫 Seth Lewis,今天與我一起出席的還有我們的高級領導團隊成員,包括首席執行官 Patrick Amstutz、財務高級副總裁 Robert Hendriks、首席醫療官 Philippe Legenne 和項目執行副總裁兼 DLL3 廣播節目負責人 Michael Stumpp。團隊將發表一些準備好的講話,然後我們將開始回答您的問題。如果您還沒有機會看到昨天收盤後發布的新聞稿,您可以在我們的網站 www.molecularpartners.com 上找到它,您還可以在那裡獲得今天的簡報的副本。
Today's call is being recorded and will be available for replay. Before we begin, I'd like to remind you that management will be making forward-looking statements about the future development of certain programs. These statements reflect the current estimates of Molecular Partners and are subject to change. For the most up-to-date information, please visit our website, www.molecularpartners.com.
今天的通話正在錄音,可供重播。在我們開始之前,我想提醒您,管理階層將對某些專案的未來發展做出前瞻性陳述。這些聲明反映了 Molecular Partners 的當前估計,可能會發生變化。如需了解最新信息,請訪問我們的網站 www.molecularpartners.com。
With that, I'll turn the call over to Patrick Amstutz. Patrick, please go ahead.
說完這些,我將把電話轉給帕特里克·阿姆斯圖茲 (Patrick Amstutz)。派崔克,請繼續。
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Thanks, Seth, for the intro and kicking off the call. And please, again, go to our website and wrap the presentation, and we will be referring to a slide number that we're on and the slide number that I will kick off with is slide number 5.
謝謝 Seth 的介紹和開始通話。請再次訪問我們的網站並結束演示,我們將參考我們正在使用的幻燈片編號,我將從幻燈片編號 5 開始。
Warm welcome from my side. Great to have you all on this call. Before diving into the highlights '24, we did put on the 20 years Molecular Partners logo because it is our 20 years anniversary and it coincides with being 10 years listed on the Swiss and then later on the US Stock Exchange. And it has been 20 years of a quest to -- (technical difficulty) make that matter for patients. And we have never gone away from that, and this has really brought us where we are.
我熱烈歡迎您。很高興大家能參加這次電話會議。在深入探討 24 年的亮點之前,我們確實貼上了 20 週年 Molecular Partners 標誌,因為這是我們成立 20 週年,而且恰逢我們在瑞士證券交易所上市 10 週年,隨後又在美國證券交易所上市 10 週年。我們花了 20 年的時間(克服技術困難)來尋求讓患者獲得這種治療。我們從未離開過這一點,這確實讓我們走到了今天。
And if we look back, it has not been a straight line. It is hard work for specific results. And twice, we actually reached clinical top with the wet AMD drug, abicipar, and with the COVID drug in (technical difficulty) and I think the call today is really to highlight where we are and how we're lining up our new programs to be in a position to have more of such readouts in the future.
如果我們回顧一下,就會發現這並不是一條直線。為了取得具體成果,需要付出艱苦的努力。實際上,我們兩次使用濕性 AMD 藥物 abicipar 和 COVID 藥物(存在技術困難)達到了臨床頂峰,我認為今天的電話會議實際上是為了強調我們目前的狀況以及我們如何安排我們的新項目,以便在未來獲得更多這樣的讀數。
So let's look at the highlights 2024. And what we have done, it was a year of execution to get our programs closer to that clinical readout. Let me start with the radio DARPin franchise, where we have DLL3 targeting 712. That is our lead compound passing all IND-enabling studies and ready to go into the clinics and Michael will be talking about that.
那麼讓我們來看看 2024 年的亮點。我們所做的是,透過一年的執行,使我們的專案更接近臨床讀數。讓我從無線電 DARPin 系列開始,其中我們的 DLL3 目標是 712。這是我們的先導化合物,它通過了所有 IND 支持研究,準備進入臨床階段,Michael 將會談論這一點。
We also selected a new target. And I mean, if we say selected the target, it also means that we have data. We now just took a target, and it is mesothelin, and we will touch on that, too. And maybe most importantly, the third bullet point is the expansion of our Oranomed collaboration. And as you know, in the radio field, we bring the vector, but we still need access to an isotope. And isotope supply is challenging. And with this collaboration, we have secured 10 slots of -- for products, real products, not just candidates, products for Lead-212, one of the most promising isotopes out there. So I think that is one of the possibly most important things of last year that we have secured that access to isotope.
我們也選定了一個新的目標。我的意思是,如果我們說選擇了目標,這也意味著我們有數據。我們現在剛剛確定了一個目標,那就是間皮素,我們也會談到它。也許最重要的是,第三點是擴大我們與 Oranomed 的合作。如你所知,在無線電領域,我們帶來了載體,但我們仍然需要同位素。同位素供應也充滿挑戰。透過此次合作,我們已獲得 10 個產品名額,是真正的產品,而不僅僅是候選產品,是鉛-212 的產品,鉛-212 是最有前途的同位素之一。所以我認為這可能是去年最重要的事情之一,我們確保了同位素的使用權。
On the T cell engager side, it is 533, where a year ago, we had mediocre or underwhelming results. And it was a year of understanding those working with our investigators and putting that back on track. And Philippe will talk about that, how we have tackled target mediated disrupted disposition problem and are very curious and of to see what the future will bring.
在 T 細胞接合劑方面,數量為 533,而一年前,我們的結果卻平庸或令人失望。這是我們了解與我們的調查人員一起工作的人並讓一切重回正軌的一年。菲利普將談論我們如何解決目標介導的破壞性處置問題,並且非常好奇並想知道未來會帶來什麼。
On the switch side, there was a bit of a change. A year ago, we were moving 6 1. That was the NK engager and switch. We have, call it, upgraded that to the T cell switch, and we will talk about that as we move.
在開關方面,有一些變化。一年前,我們搬家了 6 1。那是北韓的介入者和開關。我們稱之為將其升級為 T 細胞開關,我們將在後續討論中討論這一點。
There's another program, 317. It is less of strategic focus today, but still, we've finalized the Phase 1. We are very good. We saw biological activity. And we will be moving this one forward in combination with the PD-1 in investigator-initiated trial. We ourselves decided that we would not invest that much, but we still see a potential future for it. and there is support from the investigators to move it forward.
還有另一個程序,317。今天,它的戰略重點不再那麼重要,但我們仍然完成了第一階段。我們很好。我們看到了生物活動。我們將在研究者發起的試驗中將此藥物與 PD-1 結合起來。我們自己決定不投入那麼多,但我們仍然看到了它的潛在未來。並且有調查人員的支持推動它向前發展。
And last but not least, we did a small financing round late last year to bring in our friends from HPM, very strong repeatable Swiss investor and the round was also backed by exist things like [DBS and Subrata], adding CHF20 million to our treasure chest which makes us well capitalized with the runway into '27, also well beyond those inflection points that I was pointing out before.
最後但同樣重要的一點是,我們在去年年底進行了一輪小規模融資,引入了來自 HPM 的朋友,他們是非常強大的可重複的瑞士投資者,並且此輪融資還得到了 [DBS 和 Subrata] 等現有公司的支持,為我們的財富庫注入了 2000 萬瑞士法郎,這讓我們在 2027 年擁有了充足的資本資本,也超出我的資本。
So with that, let's move to the next slide. I'm now on slide number 6, -- the pipeline?
那麼,讓我們進入下一張投影片。我現在看到第 6 張投影片——管道?
Okay. Thanks for that. So on slide number 5. Let me quickly start with what is missing on this slide. and what is less important. The one line that is missing is the Novartis collaboration. So you remember, three years ago, we entered into a collaboration with Novartis on two targets. And we made DARPin against those two targets and moved them into research.
好的。謝謝。請參閱投影片 5。讓我快速介紹一下這張投影片上缺少的內容以及不太重要的內容。缺少的一個訊息是與諾華的合作。所以你記得,三年前,我們與諾華就兩個目標展開了合作。我們針對這兩個目標製作了 DARPin 並將其投入研究。
Over the years, they did not progress that fast. The results were there, but I think both Novartis and Molecular Partners and they not see the strategic interest in the target. This happens and maybe an explanation is all those research targets that we're moving. We never talk about before it is a candidate for exactly this reason because often, you don't move the target forward.
這些年來,他們的進步並沒有那麼快。結果已經存在,但我認為諾華和 Molecular Partners 都沒有看到該目標的戰略利益。發生這種情況,也許一個解釋就是我們正在轉移所有這些研究目標。正是出於這個原因,我們在成為候選人之前從不談論它,因為通常你不會將目標向前推進。
In this case, because it was the Novartis collaboration, they were there and Novartis now after three years, that was the research term decided not to move forward. We agree with that. We would also not move forward. So that line is missing. There is no technological setback. It was just not the right targets in the right time. They might come back. But as of now, this is not where we or Novartis would invest.
在這種情況下,因為這是與諾華的合作,他們已經在那裡了,但諾華現在已經過了三年,也就是研究期限,決定不再繼續前進。我們同意這一點。我們也不會前進。所以那條線就消失了。不存在技術挫折。這只是沒有在正確的時間實現正確的目標。他們可能會回來。但截至目前,這並不是我們或諾華公司會投資的地方。
The other one that we are not actively moving forward is 621, a nice molecule in HSCT. So stem cell transplant, he said that is not our focus interest success of 533 and also the success of the radio franchise is much more relevant and important. So that is one that we can sort of put on hold and up for partnering.
我們沒有積極推進的另一個藥物是 621,它是 HSCT 中的一種很好的分子。因此,他說,幹細胞移植不是我們關注的重點,533 的成功以及廣播特許經營的成功更為相關和重要。因此,我們可以暫時擱置這個問題,等待合作。
Now where are we focusing? This is 533 and the radio franchise. And I will hand over to Philippe later, our Chief Medic, to talk about 533 in AML and all the progress and Michael Stumpp will be walking you through the radio work on 712 and the latest from mesothelin and our collaboration with Orano Med. So before we go there, I'll hand over to Robert to give us the overview of the financial situation.
現在我們的重點在哪裡?這是 533 和廣播專營權。稍後,我將把時間交給我們的首席醫學官 Philippe,討論 AML 中的 533 及其所有進展,Michael Stumpp 將帶您了解 712 的無線電工作、間皮素的最新進展以及我們與 Orano Med 的合作。因此,在我們去那裡之前,我會先讓羅伯特向我們概述一下財務狀況。
Over to you, Robert.
交給你了,羅伯特。
Robert Hendriks - Senior Vice President, Finance
Robert Hendriks - Senior Vice President, Finance
Thank you, Patrick. I hope you can all hear you well. Good morning, good afternoon to everyone on the call. I'd like to run you briefly through the key figures of last year and the guidance for the year '25. My name is Robert Hendriks, I'm the SVP of Finance here at MP.
謝謝你,派崔克。希望大家能夠聽清楚。各位來賓,早安,下午好。我想向大家簡單介紹去年的關鍵數據和 25 年的指導方針。我叫羅伯特‧亨德里克斯 (Robert Hendriks),是 MP 的財務資深副總裁。
The numbers that I will present are stated in million Swiss Francs. More detail can be found in the press release as well as in the appendix to this presentation. Yesterday, we also published our full annual report in the 20-F. So plenty opportunity to dive into more detail. The entire presentation is also available on the website.
我將要展示的數字以百萬瑞士法郎為單位。更多詳細資訊請參閱新聞稿以及本簡報的附錄。昨天,我們也在 20-F 上發布了完整的年度報告。因此有足夠的機會深入了解更多細節。完整的簡報也可在網站上查閱。
Moving now to slide number 7 on the key figures. There are a few numbers that I'd like to highlight here. First of all, the revenue number 5 and 7. As Patrick has just mentioned, this is exclusively coming in both of these years from the Novartis collaboration. In '24, we recognized the last part of the upfront that we had received back to, and there is no more revenue to be coming from this collaboration. So that's on revenue, then the operating expenses at CHF66 million, well within the guidance that we gave, that was CHF65 million to CHF70 million. Just a high-level breakdown without too much detail around -- 74% of these costs are R&D-related. So pushing the products through the pipeline there. The overall costs have been fairly stable over the years.
現在轉到關鍵數據的第 7 張投影片。我想在這裡強調幾個數字。首先是收入數字5和7。正如派崔克剛才提到的,這是這兩年與諾華合作的獨家成果。在 24 年,我們確認已收回預付款的最後一部分,並且不再從這次合作中獲得收入。這是收入,然後是營運費用 6600 萬瑞士法郎,完全符合我們給出的指導,即 6500 萬至 7000 萬瑞士法郎。這只是高層次的細分,沒有太多細節——其中 74% 的成本與研發有關。因此將產品推向那裡的管道。多年來整體成本相當穩定。
The third number, just to highlight, if you look at the overview is the net financial result. Clearly, we benefited from high interest rates on our US dollar-denominated deposits. This number is clearly volatile by design. And this year, I think we, as I said, benefited from the FX rate, the interest rates, and through the small rate we did in October, we gained another $20 million. So that added to the dollar pool that we have.
第三個數字,只是為了強調,如果你看概覽,那就是淨財務結果。顯然,我們從美元存款的高利率中受益。這個數字顯然在設計上是不穩定的。今年,我認為,正如我所說,我們受益於外匯匯率和利率,透過 10 月的小幅調整,我們又獲得了 2000 萬美元。這樣就增加了我們的美元儲備。
With that, an interval strategic cash balance at the end of the year. ending with CHF149 million, down from CHF187 million at the end of last year, so resulting in a year-on-year cash investment of around CHF38 million taken into account the receipts from the capital raise in October. The cash burn, therefore, for the year is around CHF54 million. This December '24 balance of CHF149 million will carry us well into '27 and we consider this continues to put us in a privileged position in the industry. And also I'd like to remind here that the company has been and remains without debt.
這樣,年底的階段性戰略現金餘額為 1.49 億瑞士法郎,低於去年年底的 1.87 億瑞士法郎,因此,考慮到 10 月份的增資收入,同比現金投資約為 3800 萬瑞士法郎。因此,今年的現金消耗約為 5,400 萬瑞士法郎。24 年 12 月的 1.49 億瑞士法郎餘額將使我們順利度過 27 年,我們認為這將繼續使我們在該行業中處於有利地位。我還想在此提醒大家,公司過去一直沒有債務,現在仍然沒有債務。
All these numbers combined on this page, we feel these numbers tell that financial story of MP in '24 and so the continued solid financial state of the company. Then moving on to the next slide, just a few words on the guidance for '25.
我們認為,將本頁上的所有數字結合起來,可以說明 MP 在 24 年的財務狀況,從而說明該公司的財務狀況持續穩健。然後進入下一張投影片,簡單說幾句關於 25 年的指導。
We will not guide on revenue or any other metric. In terms of total operating expenses, we do guide for a total of CHF55 million to CHF65 million, of which around CHF7 million are expected to be noncash. And as always, this guidance is subject to the progress and changes in our pipeline and excludes any potential payments related to partnerships.
我們不會根據收入或任何其他指標提供指導。就總營運費用而言,我們預計總額為 5,500 萬至 6,500 萬瑞士法郎,其中預計約 700 萬瑞士法郎為非現金支出。與往常一樣,該指引取決於我們管道的進展和變化,並且不包括與合作夥伴關係相關的任何潛在付款。
So to summarize and conclude here, what is relevant to remember from these numbers, I would say, is the continued financial base -- solid financial base entering into '25 that will allow us to continue to invest in our pipeline and to bring drugs to patients.
因此,總結一下,我想說,從這些數字中需要記住的是持續的財務基礎——進入 25 年的堅實財務基礎將使我們能夠繼續投資於我們的產品線並將藥物帶給患者。
Thank you for your attention. I will be happy to take any questions during the Q&A later. And with that, I'd like to hand over to Michael Stumpp, who will talk about our radio DARPin programs. Over to you Micky?
感謝您的關注。我很樂意在稍後的問答環節回答任何問題。現在,我想把時間交給 Michael Stumpp,他將介紹我們的廣播 DARPin 節目。交給你了,米奇?
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Thanks very much, Robert. Good morning, good afternoon, everyone. I hope you can also hear me well. I'm really very happy and proud about the progress and all the achievements. The various teams have made in the year 2024. And let me, first of all, already acknowledge our collaboration partner, Orano Med, who is making all of this possible. I'll speak a bit more in detail later. And 2025 is really the year with the first clinical data from the radio DARPin and Lead. And that's why I'm so excited to be here. Things are moving forward. and that's quickly look back, but also then let's look a bit forward together.
非常感謝,羅伯特。大家早安,下午好。我希望你也能聽清楚我的話。我對所取得的進步和成就感到非常高興和自豪。各隊已於2024年達成目標。首先,我要感謝我們的合作夥伴 Orano Med,是他們讓這一切成為可能。稍後我會更詳細地講一下。2025 年才是真正獲得無線電 DARPin 和 Lead 臨床數據的一年。這就是我為什麼如此興奮來到這裡的原因。事情正在向前發展。快速回顧一下,然後讓我們一起展望未來。
So moving on to slide 10. I'm pretty sure you have heard about the DARPin before. So the big blue picture there, that's where we put a lot of effort into understanding what's the ideal properties of the radiopharmaceutical. It involves some protein engineering, but it also certainly involves the linker key later. And of course, we also explore half-life expanders.
請繼續看第 10 張投影片。我確信您之前聽過 DARPin。因此,在這張藍色的大圖中,我們投入了大量精力來了解放射性藥物的理想特性。它涉及一些蛋白質工程,但後來肯定也涉及連接鍵。當然,我們也探索半衰期擴展劑。
Most importantly, however, for the patient's benefit, is the alpha-emitting therapeutic isotopes. So that's the 212 version of Lead which has proven clinical efficacy, thanks to our collaborators from Orano Med gives release to a lot of high energy immediately within a very short time and sell the on-the-go double-strand DNA damage. And because it has a relatively short half-life, it also seems to have an ideal waste management and the safety profile so far. So good, of course, we need to explore further in patients.
然而,對於患者來說,最重要的是發射阿爾法射線的治療同位素。這就是 212 版的 Lead,它具有經過驗證的臨床療效,這要感謝我們的合作夥伴 Orano Med,它可以在很短的時間內立即釋放大量高能量,並消除雙股 DNA 損傷。而且由於它的半衰期相對較短,到目前為止,它似乎也具有理想的廢棄物管理和安全性。那麼好,當然,我們需要在患者身上進一步探索。
So all in all, we think that the DARPins are the ideal partner for Lead, and that's what we are going to establish in the future. So moving on to slide 11, let's quickly have a closer look at why Orano Med is really one of the leaders in the targeted alpha therapy field.
總而言之,我們認為 DARPins 是 Lead 的理想夥伴,這也是我們未來要建立的目標。請繼續看第 11 張投影片,讓我們快速仔細地了解為什麼 Orano Med 確實是標靶 α 療法領域的領導者之一。
They are one of the pioneers and I think the very, very big reason to mention here is they have the supply chain fully under control. with virtually unlimited starting material. You see a picture these 22,000 drums of 232 Thorium. That's where it's down to it. So there is really unlimited supply.
他們是先驅之一,我認為這裡要提到的非常非常重要的原因是他們完全控制了供應鏈,並且擁有幾乎無限的起始材料。你看這張照片,上面有 22,000 個裝有 232 釷的鼓。這就是事情的根源。因此,供應確實是無限的。
Orano Med also recently validated their approach by an agreement with Sanofi, which is, of course, one of the pharmaceutical players in the field. and that included their lead asset, the program, which has shown very nice clinical data presented last year at ASCO. And of course, there are a couple of technical advantage, that's how our teams chose to focus on that. Again, the short half-life, it makes it relatively easy for patient administration. They don't have to stay very long until they are so-called cleaned waste management is asset and the very high energy release from the Alpha meter with a clean decay chain. So lots of reasons to believe that this is the idea of isotope for us.
Orano Med 最近也透過與賽諾菲達成協議驗證了他們的方法,賽諾菲當然是該領域的製藥公司之一。其中包括他們的主要資產,即該項目,該項目在去年的 ASCO 上展示了非常好的臨床數據。當然,還有一些技術優勢,這就是我們的團隊選擇專注的重點。再次,由於半衰期較短,因此患者給藥相對容易。他們不需要停留很長時間,直到他們所謂的清潔廢物管理成為資產,並且從具有乾淨衰變鏈的 Alpha 計中釋放出非常高的能量。因此,有許多理由相信這就是同位素的概念。
We didn't stop there. This partnership was greatly expanded, and that's what really changed late last year. In the beginning of the year, we announced it around JPMorgan. So it's a global partnership expansion more and above and beyond what we had before. We are now basically together the owner of 10 products that are composed of lead and protein loyalty.
我們並沒有就此止步。這種合作關係得到了極大的擴展,而這正是去年年底真正發生的變化。今年年初,我們圍繞著摩根大通宣布了這一消息。因此,這是一次超越我們以前所擁有的全球合作夥伴關係的擴展。我們現在基本上共同擁有由鉛和蛋白質忠誠度組成的 10 種產品。
And the first one has been designated MPR712. I'll talk in more detail. That's our DLL3 program. And we also announced a mesothelin our second DARPin program, together with Orano Med 50-50 cost split. Beyond that, we have two NPL programs, number five and six here, where there is an opt-in and then we have another four MP program. So we have a very rich supply chain, so to say, now for lead-based programs.
第一個被指定為 MPR712。我會更詳細地講。這就是我們的 DLL3 程式。我們還宣布了我們的第二個 DARPin 項目,與 Orano Med 進行 50-50 成本分攤。除此之外,我們還有兩個 NPL 計劃,即這裡的第五個和第六個,可以選擇加入,然後我們還有另外四個 MP 計劃。因此,可以說,我們現在擁有非常豐富的基於鉛的專案供應鏈。
So let's go one step closer on that slide 13, our first program that we are really very, very actively involved in development right now. This the 712 program with a focus on DLL3 expressing tumors. Most patients initially, we will be treating our small cell lung cancer patients. They have a very high unmet medical need, relatively low five-year overall survival. And mostly what the target was validated last year by the approval of Amgen's tarlatamab in deltra, so we believe there is room to get results above and beyond tarlatamab, but it's also a proven pathway for approval.
那麼,讓我們在第 13 張投影片上更進一步,這是我們目前非常積極參與開發的第一個專案。這是 712 項目,重點關注 DLL3 表達腫瘤。大多數患者最初將接受小細胞肺癌患者的治療。他們有非常高的未滿足醫療需求,五年整體存活率相對較低。去年安進公司 Tarlatamab 在 Deltra 上的核准驗證了這個目標,因此我們相信 Tarlatamab 仍有取得更好療效的空間,但這也是一條行之有效的核准途徑。
If you look again at the right picture, 712, that's a DARPin that we added some albumin binding half-life extension too. So it's composed of three essential parts, the DARPin been binding (technical difficulty) albumin binding loyalty and the Lead-212 radio isotope.
如果您再次查看右側圖片 712,那就是我們也添加了一些白蛋白結合半衰期延長的 DARPin。因此,它由三個基本部分組成,即 DARPin 結合(技術難度)、白蛋白結合忠誠度和鉛-212 放射性同位素。
Been going to the preclinical results, just to be brief here, and please feel free to ask questions. This was presented late last year. We have a very potent molecule. And the potency is very important because the target is actually expressed at a relatively low level. You see the brownish stain at the left. So there are different tumors, but the human small cell lung cancer tumors we are staying came with a relatively fade ground color, which means you need molecule is a very, very potent see this in the middle, that's the biodistribution. We get exceptionally high values at the tumor, thanks to the design of the molecule and much above the kidney. So we also feel we have a good safety window. And very nice to see in this xenograft study on the right that we saw complete and durable regression in that very relevant model at a dose that is probably the right dose clinically.
一直在討論臨床前結果,這裡只是簡單介紹一下,請隨時提問。這是去年年底提出的。我們有一個非常有效的分子。效力非常重要,因為目標實際上是在相對較低的水平上表達的。您會看到左邊有褐色的污漬。因此存在不同的腫瘤,但是我們所研究的人類小細胞肺癌腫瘤具有相對褪色的底色,這意味著您需要的分子非常非常有效,請看中間的這個,這就是生物分佈。由於分子的設計,我們在腫瘤處獲得了極高的值,並且遠高於腎臟。因此我們也覺得我們有一個很好的安全視窗。很高興看到,在右側的異種移植研究中,我們看到在非常相關的模型中,以可能為臨床正確劑量的劑量出現了完全且持久的消退。
So with that, I think we can look at what the clinical program will be like. So there are many parts to the program. And as you can see, there is a green box, that's the Phase zero component, focused on imaging and from the imaging, you can calculate then the doses for the various organ. And this together should build the confidence that we reach relevant therapeutic levels in the tumor lesion called dosimetry. Probably about 10 patients in the use should be enough, and we anticipate these studies to start in the second half of the year.
因此,我認為我們可以看看臨床計劃會是什麼樣子。因此該計劃包含許多部分。如您所見,有一個綠色框,這是零階段組件,專注於成像,透過成像,您可以計算出各個器官的劑量。這些結合起來應該可以增強我們的信心,即達到腫瘤病變的相關治療水平(即劑量測定)。大約 10 名患者使用就足夠了,我們預計這些研究將於今年下半年開始。
The initial Phase 2, Phase 0 imaging will be complemented by a therapeutic part Phase 1/2a study in patients, the first part dose escalation with the main objective to establish the safety and the recommended Phase 2 dose, thinking of about 15 to 20 patients. Of course, we need to get the buy-in from the FDA.
初始第 2 階段、第 0 階段影像將輔以針對患者的治療部分第 1/2a 階段研究,第一部分劑量遞增,主要目的是確定安全性和建議的第 2 階段劑量,考慮約 15 至 20 名患者。當然,我們需要獲得 FDA 的支持。
And then the part two will be the dose expansion where we hopefully can also go a bit beyond the small cell lung cancer patients, so including neuroendocrine carcinoma and of course, looking then for response rate. which will lead them and we don't know exactly when in the future to a registration study. And of course, there could be more than one registration study depending on the integration and the line and other factors.
第二部分將是劑量擴展,我們希望可以擴展到小細胞肺癌患者之外,包括神經內分泌癌,當然,還要尋找反應率。這將引導他們,我們不知道未來何時進行註冊研究。當然,根據整合、線路和其他因素,可能會有多個註冊研究。
Moving on to now something completely different. Our second program, just in a nutshell, I'm very excited about this one because it has a true DARPin differentiation. We have found DARPin that are very specific for the membrane proximal abide shown here in pink, and therefore, not disturbed by a lot of very high levels of shed message in that has hampered previous approaches. So that's the unit power of DARPin that can discriminate very small differences.
現在繼續討論一些完全不同的事情。簡而言之,我對我們的第二個項目感到非常興奮,因為它具有真正的 DARPin 差異化。我們發現 DARPin 對此處以粉紅色顯示的膜近端黏附非常特異,因此不會受到大量非常高水平的脫落訊息的干擾,而這種幹擾會阻礙先前的方法。這就是 DARPin 的單位功率,可以區分出非常小的差異。
And again, it's the DARPin with a half-life extension and Lead-212. This will take some time to finish the preclinical development and the manufacturing. But hopefully, we can also report on that progress during the year. Note that there will be a poster at which is, I believe, late April with more preclinical data. And just to conclude my part, there is one important biochemical distinction. You see here a graph in the middle on slide 17, where we have added (technical difficulty) mesothelin in high concentrations and the distal DARPin, which binds an epitope don't like so much. So it's also been inhibited by Shed MSLN very different profile than the curve from the proximate that bind the membrane epitope, and that's totally maintained by shows totally maintained binding throughout the whole activity raise tested. (technical difficulty)
再次強調,它是半衰期延長的 DARPin 和 Lead-212。這將需要一些時間來完成臨床前開發和製造。但希望我們也可以在年內報告這項進展。請注意,我相信四月底將會有一張海報,上面有更多臨床前數據。最後,我要總結一下,有一個重要的生化差異。您可以看到幻燈片 17 中間的一張圖表,其中我們添加了(技術難題)高濃度的間皮素和遠端 DARPin,它與不太喜歡的表位結合。因此,它也被 Shed MSLN 抑制,其曲線與結合膜表位的近似曲線非常不同,並且透過在整個測試活動中完全維持結合來完全維持。(技術難度)
And again, this will be shown at AACR 2025 in late April. So again, very excited what the teams are doing together with Orano Med, fantastic collaboration partner. And very excited to look both back but especially forward throughout this year to have first patient results from these programs. (technical difficulty)
再次強調,這將在 4 月底的 AACR 2025 上展出。因此,我再次對團隊與 Orano Med 以及其他出色的合作夥伴共同開展的工作感到非常興奮。我非常高興回顧過去,尤其期待今年這些計畫能帶來第一批患者的結果。(技術難度)
Thank you very much. And with that, I hand over to my good colleague, Philippe who is running the hole from the medical side, and we'll talk today about the (technical difficulty) three program. Thank you (technical difficulty).
非常感謝。說完這些,我把時間交給我的好同事菲利普,他負責醫療方面的工作,今天我們將討論(技術難度)三號專案。謝謝(技術難度)。
Philippe Legenne - Chief Medical Office
Philippe Legenne - Chief Medical Office
So again, thanks, Micky first. And I am very happy to share an update on the progress of our 533-DARPIn, which we are developing in AML. On slide 19, basically, let's remember, it's important to remember that AML is a very challenging disease, because of the heterogeneity of the cell population as well as the difficulty to kill the leukemic stem cells, which tend to persist despite treatments and they drive the recurrence.
所以,再次感謝 Micky。我很高興與大家分享我們在 AML 領域開發的 533-DARPIn 的最新進展。在第 19 張投影片上,基本上,讓我們記住,重要的是要記住 AML 是一種非常具有挑戰性的疾病,因為細胞群體的異質性以及殺死白血病幹細胞的困難,這些細胞往往在治療後仍然存在並導致復發。
So we have designed 533 as the first TETRA specific T cell engager that recognizes AML blast and the LSC, leukemic stem cells through their co-expression of either CD33, CD123 or CD70 and cure them when they express at least two of the three TAA simultaneously. By doing that, this multi-specific approach has the potential to open the therapeutic index and particularly kills the leukemic stem cells more effectively than a single simple targeting -- single targeting agent would do.
因此,我們將 533 設計為第一個 TETRA 特異性 T 細胞接合器,它透過 CD33、CD123 或 CD70 的共表達來識別 AML 母細胞和 LSC、白血病幹細胞,並在它們同時表達三種 TAA 中的至少兩種時治癒它們。透過這樣做,這種多特異性方法有可能擴大治療指數,特別是比單一簡單靶向(單一靶向劑)更有效地殺死白血病幹細胞。
Moving to slide 20. So this slide describes the clinical journey that we have studied two years ago. When I reported last year, we were still in the blue left part of the schematic. We are now reporting on the orange middle one, and we will be initiating soon a new amendment corresponding to the green.
移至投影片 20。這張投影片描述了我們兩年前研究的臨床歷程。我去年報告的時候,我們還在示意圖左邊的藍色部分。我們現在正在報告中間的橙色部分,並且我們很快就會啟動與綠色部分相對應的新修正案。
In the initial dose escalation cohorts on the left blue we were able to understand the manageable safety profile of the drug up to cohort seven and obtain signals of efficacy, however, too low and not durable enough. Then what we did is we identified with a group of international experts that we had, in fact, too much loss of exposure likely due to the multi-target antigen sync. Let's remember, we are talking three antigens, two to three.
在左側藍色的初始劑量遞增隊列中,我們能夠了解直至第七個隊列的藥物可控安全性,並獲得療效信號,但是,療效信號太低且不夠持久。然後我們與一群國際專家確認,事實上,我們可能因為多目標抗原同步而失去了太多的曝光率。讓我們記住,我們談論的是三種抗原,二到三種。
And so at that time, we initiated the first amendment to accelerate the step-up dosing and densify the regimen by adding an additional dose during the first 15 days at day 12. And I'll show you the results of that. and basically that we have now significantly increased the efficacy, and we are now very encouraged to further accelerate that step-up dosing and have a more frequent administration, particularly during the first cycle. This new amendment corresponds to the green schematic and has been submitted to regulators.
因此,當時我們啟動了第一項修訂,透過在前 15 天的第 12 天增加額外劑量來加速遞增劑量並強化治療方案。我會向你們展示成果。基本上,我們現在已經顯著提高了療效,我們現在非常有信心進一步加快遞增劑量並更頻繁地給藥,特別是在第一個週期。這項新修正案與綠色示意圖相對應,並已提交給監管機構。
Moving to slide 21. You can see on the left, swimmer plot, corresponding to the blue part of the dose escalation, during which we saw some initial responses, however, not enough and not durable enough as I already said. On the right part, you can see that the outcome after the initial amendment and the initial step-up dosing and one level of densification. And you can see that this now appears to be very promising with three CRs out of eight patients that were treated past day 12.
移至第 21 張投影片。您可以在左側看到游泳者圖,對應於劑量遞增的藍色部分,在此期間我們看到了一些初步反應,但是,正如我已經說過的,這些反應還不夠,也不夠持久。在右側,您可以看到初始修正、初始逐步增加劑量和一個等級的緻密化之後的結果。您可以看到,現在看來,效果非常顯著,在接受治療超過 12 天的 8 名患者中,有 3 名達到了完全緩解 (CR)。
Moving to the next slide. which is wonderful, that slide in a way that visual adds one level of granularity to the document to open the blast reduction on top of the full ELN criteria. And we can see here that the drug had effect with approximately half of the patients having reduction in blast even during the dose escalation. However, the new amended cohort certainly has more. And also this helps understand that most of the patients that have blast reduction had a lower disease burden at baseline as is frequently seen for effect for T cell engagers.
轉到下一張投影片。這張投影片非常精彩,它以視覺方式為文件增加了一個粒度級別,以便在完整的 ELN 標準之上開啟爆炸減少功能。我們可以看到,該藥物確實有效,即使在劑量增加期間,大約一半的患者爆炸症狀也有所減少。然而,新修訂的隊列肯定還有更多內容。這也有助於理解大多數接受原始細胞減少治療的患者在基線時的疾病負擔較低,這在 T 細胞接合劑的作用中經常看到。
Moving to the next slide 23. It's a key slide because when we discussed the blue curve, representing Cohort six with our experts, they were even surprised that we had even responders and blast reduction because as you can see, there were only very few concentration peaks in the effective dose range on day 8, day 15 and 20.
移至下一張投影片 23。這是一張關鍵的幻燈片,因為當我們與專家討論代表第六組的藍色曲線時,他們甚至驚訝於我們有均勻的反應者和爆炸減少,因為正如你所看到的,在第 8 天、第 15 天和第 20 天的有效劑量範圍內只有很少的濃度峰值。
So very little stimulation or effective stimulation to generate that blast reduction or initial responses. And this is -- what is very interesting is that in the recent amendment, so corresponding to the orange curve, we see that there -- that in those orange curve, the concentration achieved effective ranges at the 8, 12 and 15 for significantly more time and we hypothesize that this component supports the higher activity that we see in this new cohort.
因此,很少的刺激或有效刺激就能產生爆炸減少或初始反應。這是 — — 非常有趣的是,在最近的修訂中,對應於橙色曲線,我們看到 — — 在那些橙色曲線中,濃度在 8、12 和 15 時達到有效範圍的時間明顯更長,我們假設這個成分支持我們在這個新群體中看到的更高活動。
So based on that learning -- on those earnings, we have now built on this lining and are further densifying the dose and also introduce a B-cell depletion premedication to also reduce the proportion of patients who were developing ADAs at the end of the first cycle. So we -- basically, it's a two-pronged approach. More densification to generate deeper response, more responses and T-cell devision to make sure that we have a maximum of patients that have long exposure beyond the first cycles.
因此,基於這些學習成果和效益,我們現在在此基礎上進一步提高了劑量,並引入了 B 細胞耗竭預用藥,以減少在第一個週期結束時出現 ADA 的患者比例。所以我們——基本上,這是一種雙管齊下的方法。更高的緻密化可以產生更深層的反應、更多的反應和 T 細胞分裂,以確保我們有最多的患者在第一個週期之後能夠長期暴露。
So slide 24, describe the further amendment, which is currently in review, and we anticipate to initiate it soon and communicate outcome of those new cohorts in -- by the end of the year coming.
第 24 張投影片描述了目前正在審查的進一步修正案,我們預計很快就會啟動該修正案,並在年底前公佈這些新修正案的結果。
Okay. So I'd like to expand a bit on this now, meaning that the first experience regard T cell engager has driven us to develop further the platform, and we have initiated programs in solid tumors, where it is key to manage the on target of tumor is toxicity. And you may know that there has been some good level of excitement recently on that topic with development from companies like GEnx.
好的。所以現在我想稍微擴展一下這一點,這意味著關於 T 細胞接合器的首次經驗促使我們進一步開發該平台,並且我們已經啟動了實體腫瘤項目,其中管理腫瘤靶標的關鍵是毒性。您可能知道,最近隨著 GEnx 等公司的開發,該主題引起了相當程度的關注。
So slide 26 is an example of how we are integrating the concept of masking the CD3 binders in absence of TAA, as well as the concept of coactivation to mitigate the risk of T cell absorption. So it's scientific concepts integrated.
因此,投影片 26 就是一個例子,說明我們如何整合在沒有 TAA 的情況下掩蓋 CD3 結合劑的概念,以及共同活化的概念以減輕 T 細胞吸收的風險。所以它是綜合的科學概念。
And more precisely, you can see on the left, schematic that the DARPin has the CD3 mask in circulation. And on the right that when engaged with the first TAA-like here mesothelin and secularly with a second TAA like EpCAM, this will free the snobinding to the T cell.
更準確地說,您可以在左側的示意圖中看到 DARPin 具有循環的 CD3 遮罩。右側顯示,當與第一個 TAA(類似於間皮素)結合,並與第二個 TAA(例如 EpCAM)結合時,這將釋放與 T 細胞的結合。
And the CD2 coactivation does potentially the immune mobilization. So this is a very sophisticated approach, highly relevant, we think. And again, some other analogy there's an age to what our doing, but we think that we are doing it in a very sophisticated manner. And I will share further detail on this interesting approach at the upcoming AACR. So on this, I want to thank you.
CD2 共活化可能起到免疫動員的作用。因此,我們認為這是一種非常複雜且高度相關的方法。再者,其他一些類比表明,我們所做的事情需要一定的時間,但我們認為我們正在以一種非常複雜的方式去做。我將在即將舉行的 AACR 會議上進一步分享這項有趣方法的細節。因此,我想就此向你表示感謝。
And I will pass again the phone to Patrick.
我會再次將電話轉給帕特里克。
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Thanks, Philippe, for these very nice explanations and also showing us how we have worked through some challenging settings and findings to give especially type 33, the best chance to succeed and help these patients. Let's have a look at what we can expect in '25. I will start on the radio side.
謝謝 Philippe 的精彩解釋,也向我們展示了我們如何克服一些具有挑戰性的環境和發現,從而為 33 型糖尿病患者提供成功治療的最佳機會並幫助他們。讓我們看看 25 年我們可以期待什麼。我先從廣播方面開始。
And I think there, as Michael pointed out, we are really excited by the perspective to share that the first clinical data of 712, the Radio DLL3 program. We do start with imaging, as he explained that it's a Phase 0 approach, and then we can do dosimetry and have them clinical results in efficacy and safety in 2026.
我認為,正如邁克爾指出的那樣,我們非常高興能夠分享 712 即 Radio DLL3 計劃的首批臨床數據。我們確實是從成像開始的,正如他所解釋的那樣,這是一種 0 階段方法,然後我們可以進行劑量測定,並在 2026 年獲得療效和安全性的臨床結果。
Let me just take a minute here because in most instances, your Phase 0 imaging is maybe not that relevant. This is different here. we will have the understanding of how much of the drug will be in the tumor and how much will be on the healthy organs.
讓我在這裡花一點時間,因為在大多數情況下,您的第 0 階段成像可能不那麼相關。這裡的情況有所不同。我們將了解有多少藥物會進入腫瘤,有多少藥物會進入健康器官。
And for those who are less familiar in the story, the one organ, we're really zooming into and excited to then see results is to keep me because most of these approaches have high kidney absorption. So we'll be, first and foremost, looking for a tumor to kidney ratio and should that be positive in the dose symmetry that is an exciting moment to move the program forward. the imaging holds real value for molecular partners and the whole radio DARPin pipeline.
對於那些不太熟悉這個故事的人來說,我們真正關注的一個器官是放大的,然後很高興看到結果,因為大多數這些方法都有很高的腎臟吸收率。因此,我們首先要尋找腫瘤與腎臟的比率,如果劑量對稱性為正,那麼這將是推動該計劃向前發展的令人興奮的時刻。成像對於分子合作夥伴和整個無線電 DARPin 管道具有真正的價值。
[Mazo] will go forward, and we will update that at AACR and we will definitely not stand still but add additional programs that are some fully owned by us, others likely also moved forward by Orano Med.
[Mazo] 將繼續前進,我們將在 AACR 更新這一點,我們絕對不會停滯不前,而是會增加一些完全由我們擁有的項目,其他一些也可能由 Orano Med 推進。
Moving to slide 33, as we just heard from Philippe, we are now at this moment where we can test maybe the optimized or even optimal dosing for this compound in a deadly disease. So that is a highly exciting moment for us. That's the reason we go to work to test our drug in the setting where it helps patients and we will be able to update with more data from cohort 1 in H1. And for sure, in H2, this new amendment that Philippe was talking about will be in place and be delivering results guiding us on response rate and especially also on duration of response.
轉到幻燈片 33,正如我們剛才從 Philippe 那裡聽到的,我們現在可以測試這種化合物在致命疾病中的最佳化甚至最佳劑量。所以這對我們來說是一個非常令人興奮的時刻。這就是我們在幫助患者的環境中測試我們的藥物的原因,我們將能夠在上半年使用更多來自第 1 組的數據進行更新。當然,在下半年,菲利普談到的這項新修正案將會實施,並產生指導我們提高回應率,特別是回應持續時間的效果。
On the switch side, as I said, we are here moving forward, hopefully, a first candidate, can well be the mesothelin or maybe another one. We're still looking at a few and we're also opening for partnering, be it 61 or also on the T cells because we will not have the bandwidth to move all options that these new platforms give a loan.
在開關方面,正如我所說,我們正在向前邁進,希望第一個候選藥物可能是間皮素,或者可能是另一種。我們仍在考慮一些合作,我們也在開放合作夥伴關係,無論是 61 還是 T 細胞,因為我們沒有足夠的頻寬來移動這些新平台提供貸款的所有選項。
Cash situation strong, almost boring for us. But I think boring in this market is a good thing. As many biotechs are struggling for funding, and we are in a position that we can execute our plans, move forward, bring value to patients that will then also move into value for shareholders.
現金狀況強勁,對我們來說幾乎無趣。但我認為,在這個市場上,無聊是件好事。許多生物技術公司都在為資金而苦苦掙扎,而我們卻能夠執行我們的計劃,向前邁進,為患者帶來價值,進而為股東帶來價值。
Now before opening for questions, this is a moment to also thank you for dialing in, thank the presenters that I had on the call. And they obviously just present the tip of the iceberg of the Molecular Partners team. And that team really makes all this work. All those hours, all those troubleshooting, all those coordination meetings, moving things forward, big thanks to everyone at Molecular Partners, highly and full of gratitude to be able to be part of that team.
現在,在開始提問之前,我也要感謝您撥入電話,感謝電話中的主持人。顯然,他們只展示了分子夥伴團隊的冰山一角。正是這個團隊讓這一切真正發揮作用。所有這些時間、所有這些故障排除、所有這些協調會議,推動事情向前發展,非常感謝 Molecular Partners 的每一個人,非常感激能夠成為這個團隊的一員。
We don't do this alone. We do this with partners. I think the name Orano Med was said many times, big thanks there, also to Novartis. Without Novartis, we would not be in this call, we would have not moved forward in radiotherapy. And it is maybe more on the personal side said that we're not continuing that one, but I'm sure there will be opportunities also with Novartis to move things forward in the future.
我們並不是單獨做這件事的。我們與合作夥伴一起這樣做。我認為 Orano Med 這個名字已經被提到過很多次了,非常感謝,也感謝諾華。如果沒有諾華,我們就不會參與這項呼籲,我們也不會在放射治療領域取得進展。也許從個人角度來說,我們不會繼續這樣做,但我相信未來還有機會與諾華合作推動事情向前發展。
The troubleshooting not only happens in our four walls. We are very closely with our investigators, KOLs, experts that know our drugs, big thanks to them. I do think the last and possibly most important things goes to the patients that are in our trial that are part of them and allow us actually to test these drugs early on to see if they actually do what we want them to do.
故障排除不僅發生在我們家。我們與研究人員、KOL、了解我們藥物的專家保持著非常密切的聯繫,非常感謝他們。我確實認為最後也是最重要的事情是針對參與我們試驗的患者,他們讓我們能夠儘早測試這些藥物,看看它們是否真的能達到我們想要的效果。
With that, thanks for everyone dialing in, especially also the analysts that cover us for these many years. Also for those 10 years, some of them have been doing it for 10 years, big thanks for that and looking for you to your questions.
最後,感謝大家的來電,特別是多年來通報我們的分析師。在這 10 年裡,他們中的一些人已經做了 10 年,非常感謝,並期待您回答您的問題。
Operator
Operator
We will now begin the question-and-answer session. (Operator Instructions) Jonathan Chang, Leerink Partners.
我們現在開始問答環節。(操作員指示)Jonathan Chang,Leerink Partners。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
First question on MP0712. Can you provide more color on where you are in the IND submission process and preparations for study initiation. And how should we be thinking about the initial clinical data by year-end? And then second question, can discuss why you think mesothelin is a good target for radio DARPin?
關於 MP0712 的第一個問題。您能否詳細介紹一下 IND 提交流程和研究啟動準備的進展?我們應該如何考慮年底的初步臨床數據?然後第二個問題,可以討論為什麼您認為間皮素是無線電 DARPin 的良好目標嗎?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Micky are you on because I think that goes directly to your area of expertise.
米奇,你上榜了嗎?因為我認為這直接涉及你的專業領域。
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Yes, I can start and then please continue. So thanks, Jonathan, for the question. I love to sit down with you in more detail and go over, but just give you the top line. So as I said, late last year, we started '25 with the GMP manufacturing that has moved forward really nicely. Of course, there are a lot of technical challenges to be overcome, including logistics. Q2 the next quarter will be the submission submissions, maybe there are several ones to the FDA. And that's where hopefully then in Q3, we can open the first part of the program, the imaging part. And in the net part of the year, so not exactly sure where we will be, we will then have the first therapeutic doses.
是的,我可以開始,然後請繼續。所以,喬納森,謝謝你提出這個問題。我很樂意和你坐下來更詳細地討論,但我只會給你最重要的一點。正如我所說,去年年底,我們開始了 25 年的 GMP 製造,並且進展非常順利。當然,還有很多技術挑戰需要克服,包括物流。Q2 下個季度將是提交申請的時間,可能有幾份要提交給 FDA。希望在第三季度,我們可以啟動該計劃的第一部分,即成像部分。在今年晚些時候,雖然還不確定我們會在哪裡,但我們將獲得第一批治療劑量。
If FDA agrees to our proposal to start close to therapeutic dose rates, we should see something made in the first two dose cohorts. And as you know, probably tumor shrinkage and then also the duration of it will probably take a bit of time. So early '26 will be then the clinical data on the therapeutic part submission in Q2 anticipated.
如果 FDA 同意我們的建議,從接近治療劑量開始,我們應該會看到前兩個劑量組取得一些進展。而且如您所知,腫瘤縮小以及持續時間可能都需要一些時間。因此,預計 26 年初將提交第二季治療部分的臨床數據。
Your -- I believe third question, mesothelin, why is it a good target? Excellent question. Of course, we are hoping it will be a good target. There is certainly a high medical need in the ovarian cancer patients and mesothelin expression is very high there. whether it will be perfect for an alpha emitter and our molecule, we need to establish. It looks good preclinically. But whether it will then work that depends to the on future data, there are a number of programs also using copper modalities. But I hope with the alpha radiation of that, we can tackle these to ourselves. Maybe over to you, Patrick, anything to add from your side?
您的-我相信第三個問題是間皮素,為什麼它是一個很好的目標?非常好的問題。當然,我們希望這是一個好的目標。卵巢癌患者肯定有很高的醫療需求,而且間皮素的表達在那裡非常高。我們需要確定它是否適合作為α發射體和我們的分子。臨床前看起來不錯。但它是否會起作用取決於未來的數據,有許多程式也使用銅模式。但我希望透過阿爾法輻射,我們可以自己解決這些問題。也許該輪到你了,派崔克,你還有什麼要補充的嗎?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Yes. No. And we often get the question on mesothelin because it let's say, in public, it's a bad target because others have failed on it and are not moving. I think as what we do is we go back and we triangulate the data and it's also in a phrase we use internally, we like to work on clinically validated problems. And in this case, as you said, Michael, ovarian is immune, more silent.
是的。不。我們經常被問到有關間皮素的問題,因為在公共場合,這是一個糟糕的目標,因為其他人在這方面失敗了,並且沒有採取行動。我認為我們所做的就是回顧並對數據進行三角測量,這也是我們內部使用的短語,我們喜歡研究經過臨床驗證的問題。在這種情況下,正如你所說,邁克爾,卵巢具有免疫力,更加沉默。
So you don't have that much effect you often have chemo resistance, so -- and also not the highest response rate for ADCs then meso was in principally a good target for the shedding and the high level of free target made it a very difficult approach for radiotherapy because you don't want to be binding share target being in the body everywhere and having an on target of tumor effect.
因此,您不會獲得太大的效果,因為您經常會對化療產生抗藥性,所以 - 而且 ADC 的反應率也不是最高的,因此中胚層在脫落方面主要是一個很好的目標,而高水平的自由目標使放射治療變得非常困難,因為您不想將共享目標綁定到身體的各個部位,並產生針對腫瘤的效果。
So this is the hypothesis that ovarian will be radio-sensitive when delivering an alpha via mesothelin the target very difficult for peptides to do, so we don't expect anyone from the peptide field to be able to crack that one. So it is DARPin unique and differentiated, and that's the thesis that we will have to prove. If it works, the good thing is I do think we are very differentiated versus other radio approaches.
因此,這是一個假設,即當透過間皮素傳遞 α 時,卵巢將對放射敏感,而勝肽很難做到這一點,所以我們不指望勝肽領域的任何人能夠破解這一點。因此,DARPin 是獨一無二的、具有差異性的,這是我們必須證明的論點。如果有效的話,我認為我們與其他無線電方法相比有很大差異,這是一件好事。
Operator
Operator
Richard Vosser,z JPMorgan.
Richard Vosser,摩根大通。
Richard Vosser - Analyst
Richard Vosser - Analyst
I wondered if could just explore learnings taken from the Novartis programs before they were discontinued, what you could take there? And also whether there were any issues with the DARPin hitting the target? Or was this as you said, just the targets don't work or they've been deemphasized.
我想知道,是否可以探索諾華計畫停止之前的經驗教訓,您可以從中得到什麼?還有 DARPin 擊中目標是否有問題?或者正如您所說,這些目標不起作用,或者它們被淡化了。
And then a second question just on -- you mentioned the key for 712 the kidney ratio to target ratio. So what could be -- if you could help us with a good level on that ratio that we should be looking for when we see the data? And you'll be looking for?
然後是第二個問題——您提到了 712 的關鍵是腎臟比率與目標比率。那麼,如果您能幫助我們確定我們在查看數據時應該尋找的比率的良好水平,那該怎麼辦?你會尋找什麼?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Thanks, Richard. I'll start off with the Novartis one and then I'll hand over to Michael. And I think when -- and we started this three years ago, and that was really our first step into radio. And we learned a lot by sharing and learning what profile makes good radio therapeutic. So tumor to kidney and Michael will come to that half-life. And this is all also gauge to which isotope you need and you apply. And there Novartis is obviously lutetium and more recently, Actinium, while we are going towards lead for different reasons.
謝謝,理查。我先從諾華公司開始,然後交給麥可。我認為,當我們三年前開始做這件事時,那確實是我們進軍廣播領域的第一步。透過分享和學習什麼樣的放射治療效果更好,我們學到了很多。因此腫瘤會轉移到腎臟,麥可也會到達那個半衰期。這也是衡量您需要哪種同位素以及您應用哪種同位素的標準。諾華公司顯然在研究镥,最近又研究了錒,而我們則因為不同的原因轉向了鉛。
The learnings, I mean, I can't be too detail oriented here. But -- the one thing we all agree in this field is you have to test many candidates meaning many different sequences to find the optimal tumor to kidney ratio. And you need to have the right models up and running and different models will give you different insights. And it was very helpful to compare notes on the models, how to run the models, how to use the models and at the same time, find what can you learn what can you not learn from these models. And I think you have to understand this field is still in the early days.
我的意思是,在這裡我不能太注重學習的細節。但是——我們在這個領域都同意的一件事是,你必須測試許多候選者,即許多不同的序列,以找到最佳的腫瘤與腎臟比例。您需要建立並運行正確的模型,不同的模型會給您不同的見解。比較模型的註解、如何運行模型、如何使用模型,以及同時發現從這些模型中可以學到什麼、不能學到什麼,這些都非常有幫助。我認為你必須明白這個領域仍處於早期階段。
And for the DLL3 molecule, I think we were in iteration 7 or 8. So that's the seventh generation that we have. With Novartis, just given the broad pipeline they have and the way they operate, we think never made it by on Level 3. So it was maybe not that fast cycling I do think and I'm fair to say, I've said that on stage that, that was also learning for Novartis, and that was one reason they acquired Mariana to have Poplabs faster to be able to cycle faster to test more in shorter time.
對於 DLL3 分子,我認為我們處於第 7 或第 8 次迭代中。這就是我們的第七代。對於諾華來說,考慮到他們擁有的廣泛產品線和營運方式,我們認為他們不可能在第 3 級取得成功。所以我認為循環速度可能沒有那麼快,公平地說,我在舞台上說過,這也是諾華公司的學習成果,這也是他們收購 Mariana 的原因之一,讓 Poplabs 速度更快,能夠更快地循環,在更短的時間內進行更多測試。
At the same time, the targets they picked, which were very reasonable three years ago, did not like have the data or the excitement building, like DLL3, when we started was also not present. And then with tarlatomab and all the excitement it validated itself. These targets are still as unknown, I would say, as they were three years ago, and nothing has built around them. So when you come to this moment. They should we invest in other three, four cycles, maybe it will yield, maybe not on a target that today, neither Novartis and us puts to the top of the list, we sort of together said, let's end it here, see how this goes on and then rather reengage when we actually have a candidate. I mean this is a research phase.
同時,他們選擇的目標在三年前是非常合理的,但卻沒有數據或令人興奮的東西,例如我們開始時沒有的 DLL3。然後,隨著 tarlatomab 和所有令人興奮的事情的發生,它得到了證實。我想說,這些目標仍然像三年前一樣不為人知,而且還沒有圍繞著它們建立任何目標。所以當你來到這一刻。他們是否應該投資其他三、四個週期,也許會產生收益,也許不是今天的目標,諾華和我們都沒有把它放在首位,我們一起說,讓我們在這裡結束它,看看情況如何,然後當我們真正有候選人時重新參與。我的意思是這是一個研究階段。
But the learning was really good. Collaboration is good scientifically speaking, I think both teams really liked that, and we'll see where it goes. I think I can also say that Novartis wants to see clinical data on lead, now we're talking about the isotope. They have obviously seen Orano Med. But for Novartis to add a third isotope to their war chest that would need clinical data. That's at least what they're saying publicly. Maybe Micky, could you be a bit -- or could you take 712 tumor kidney?
但學習效果確實很好。從科學角度來說,合作是件好事,我認為兩個團隊都非常喜歡這種合作,我們拭目以待。我想我還可以說諾華希望看到有關鉛的臨床數據,現在我們正在談論同位素。他們顯然已經見過 Orano Med。但對諾華來說,要將第三種同位素加入他們的戰爭基金中,就需要臨床數據。至少他們公開是這麼說的。也許米奇,你可以有點——或者你可以接受 712 腫瘤腎嗎?
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Yes. Thanks, Richard. And also here next time we meet, let's take the time and sit together, say, look at the piece of paper the laptop screen. I think the challenge is in animal is relatively perfect so you can control everything, you can give a number. And preclinically, you've probably seen this before, we like to go above one, so ideally 2:1, tumor to kidney. And then, of course, sometimes there is a question which time point do we integrate over many time points. So animal ones relatively easy. .
是的。謝謝,理查。下次我們見面時,讓我們花點時間坐在一起,看看筆記型電腦螢幕上的紙張。我認為挑戰在於動物是相對完美的,所以你可以控制一切,你可以給出一個數字。在臨床前階段,您可能已經見過這種情況,我們希望腫瘤與腎臟的比例超過 1,因此理想情況下是 2:1。當然,有時我們會問,我們應該在多個時間點中整合哪個時間點。所以動物的相對容易。。
In patients. We need to learn clinically whether there is exactly the same translation. In the end, it boils down to the therapeutic dose we can deliver. So ideally, we have, as Patrick said, more of the uptake in the tumors, but I'm pretty sure it depends on the tumor size, the blood profusion. Whereas the kidney will be probably relatively similar from patient to patient.
在患者中。我們需要臨床去了解是否有完全相同的翻譯。最終,它歸結為我們能夠提供的治療劑量。因此,理想情況下,正如帕特里克所說,腫瘤中的吸收量會更大,但我很確定這取決於腫瘤的大小和血液的充盈程度。而不同患者的腎臟可能相對相似。
So if we can deliver a therapeutically relevant dose to the tumors and we're speaking the old roof 100-megawatt carat per dose and the kidney stay below the safety line that is at the moment accepted, so several grades. But it's exactly one of the questions. We don't know for sure whether the nays for Alzheimer to like that have the same limit.
因此,如果我們能夠向腫瘤提供治療相關的劑量,我們所說的舊上限是每劑量 100 兆瓦克拉,而腎臟則保持在目前可接受的安全線以下,所以有幾個等級。但這只是問題之一。我們不確定阿茲海默症的盛行率是否也有同樣的限制。
So we will have the discussion with the FDA, will propose our dose escalation rationale and I'm pretty sure it will be similar to preclinical data, but I would not look for a specific number because two losing patients are very different. So on average, I hope it's above the kidney value. But maybe in the end, it's about therapeutically in -- .
因此,我們將與 FDA 進行討論,提出我們的劑量遞增原理,我非常確定它將與臨床前數據相似,但我不會尋找具體的數字,因為兩個失敗的患者非常不同。所以平均而言,我希望它高於腎臟值。但也許最終,它是為了治療-- 。
Operator
Operator
Mike Nedelcovych, TD Cowen.
邁克·內德爾科維奇 (Mike Nedelcovych),TD Cowen。
Michael Nedelcovych - Analyst
Michael Nedelcovych - Analyst
I have two. When it comes to DLL3 in radiotherapy, do you know you mentioned the kidneys, which I believe is nonspecific off tumor uptake. Do we know -- are there any on-target off-tumor DLL-3 expressing organs we should be concerned about when we see the first imaging or dosimetry data. That's my first question.
我有兩個。當涉及放射治療中的 DLL3 時,您是否知道您提到了腎臟,我認為這是非特異性的腫瘤攝取。我們是否知道——當我們看到第一個成像或劑量測定數據時,是否有任何我們應該關注的靶向非腫瘤 DLL-3 表達器官。這是我的第一個問題。
And then my second question is on the switch DARPin platform. This is very unique and very promising. How do you think about partnering in terms of the scope and scale? Would you be pursuing a partner for an individual molecule or more kind of platform-wide?
我的第二個問題是關於切換 DARPin 平台。這是非常獨特且非常有前景的。您如何看待合作的範圍和規模?您會尋找單一分子的合作夥伴還是更多類型的平台夥伴?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Maybe Philippe, take the first question on DLL3 and I'll be happy to talk a bit on the platform or candidate partnering.
也許 Philippe 可以回答有關 DLL3 的第一個問題,我很樂意就平台或候選人合作進行一些討論。
Philippe Legenne - Chief Medical Office
Philippe Legenne - Chief Medical Office
Yes. So thanks, Mike. I reason is a clean target. That's why there is so much excitement about it. I would want to say. And experts are very excited, in fact, based on the recent accumulation of experience which has conveyed on the antibody on the ADCs or on the radiopharma approaches. So there is a body of experience, which is still early, but rapidly shaping.
是的。所以謝謝你,麥克。我的理由是目標乾淨。這就是為什麼人們對此如此興奮。我想說的是。事實上,基於最近在 ADC 抗體或放射性藥物方法方面累積的經驗,專家們非常興奮。因此,我們累積了大量經驗,雖然這些經驗還處於早期階段,但正在迅速形成。
And I think for what we know from the programs is that we -- pituitary gland is the only place, which is -- has some level or many level of DLL3 expression. All the rest is clean. And when we looked at the tarlatamab experience, for example, they did not have any specific safety profile. And of course, we checked on the pituitary gland, and there hasn't been any adverse event that makes think that would be an issue.
我認為,根據我們從程序中了解到的情況,腦下垂體是唯一具有一定程度或多種程度的 DLL3 表達的地方。其餘一切都很乾淨。例如,當我們研究塔拉塔馬布的體驗時,我們發現它們並沒有任何特定的安全性。當然,我們檢查了腦下垂體,沒有任何不良事件,因此我們認為這是一個問題。
But of course, technically, if I could say there is a little expression there outside of the tumor. So that's really the one that will watch. Although, again, we are not very worried because if there hadn't been a problem, we would have seen it already. So that's a very clear target, and we are confident. Obviously, and as we're preparing our protocol, obviously, what are the adverse events of special interest, and that this is short for us, but also for the others.
但當然,從技術上講,如果我可以說腫瘤外面有一點表達。所以這才是真正值得關注的。不過,我們並不是很擔心,因為如果沒有問題,我們早就發現它了。這是一個非常明確的目標,我們有信心。顯然,當我們準備我們的協議時,顯然,特別令人感興趣的不良事件是什麼,這對我們來說很簡短,但對其他人來說也是如此。
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
And maybe just to add because there is a big hype on DLL3. So I think on the target, people totally agree that, that is call it validated and a very good target to go after. And we just had dinner with a PI that is in many trials. And for me, what was reassuring to here is that the different modalities, and we're talking T cell engagers, ADCs and radiotherapy that he also said there is a need for all of them. None of them will cure as of now. And the sequence and how we can actually develop them is was very excited for him, and he actually sees a big place for the radiotherapy there. Even a bit in an earlier line to help the others move forward.
也許只是補充一下,因為 DLL3 被大肆宣傳。因此我認為,就這個目標而言,人們完全同意這一點,這就是經過驗證的、值得追求的非常好的目標。我們剛與一位參加過多項試驗的 PI 共進晚餐。對我來說,讓我感到安心的是,這裡有不同的治療方式,我們正在討論 T 細胞接合劑、ADC 和放射療法,他也說所有這些都是必要的。到目前為止,這些方法都無法治癒。我們對這一序列以及我們如何真正發展它們感到非常興奮,他確實看到了放射療法的巨大應用前景。甚至在較早的路線上也能夠幫助其他人前進。
But thanks for the question. I'll take also the partnering one. And the question is great. I mean some partners like to work on a candidate. These are either companies that have a specific need, let's say, your -- just take this as an example, you are in breast cancer and then you want a breast cancer target and candidate for the pipeline and ideally then we have a candidate there. You sort of are the missing piece in the puzzle.
但感謝您的提問。我也會選擇合作的。這個問題問得非常好。我的意思是有些合夥人喜歡為候選人工作。這些公司要么有特定的需求,比如說,你的——就舉個例子,你患有乳腺癌,然後你想要一個乳腺癌目標和候選藥物,理想情況下,我們就有一個候選人。你就像是拼圖中缺少的一塊。
As you don't know and kind of in which part you fit well, that is sort of an opportunistic one. You obviously look what do we have, which candidates do we have and where would they fit? That is one part of the partnering versus the other. The big pharmaâs obviously take long shots. They see that they want to fill their pipeline over time.
因為你不知道自己適合哪個部分,所以這是一種機會主義的做法。您顯然會看我們有什麼,有哪些候選人以及他們適合什麼職位?這是合作的一部分與另一部分的差異。大藥廠顯然不敢冒險。他們意識到他們希望隨著時間的推移填補他們的管道。
And often, they say, okay, your targets are a nice showcase, but can you do these? And both discussions are valuable. Obviously, if you have to start from scratch, that's in 18 months, 30 yes. two to four years of research and development, as we just saw with the Novartis collaboration. Usually, they come with a good upfront because there is high risk, so you have to also commit something there. Versus a candidate that is ready to be in the clinic within the next 18 months that is exciting.
他們經常說,好吧,你的目標是一個很好的展示,但是你能做到嗎?這兩種討論都很有價值。顯然,如果必須從頭開始,那就需要 18 個月、30 個月、兩到四年的研究和開發時間,就像我們剛剛在與諾華的合作中看到的那樣。通常,它們會提供大量的預付款,因為風險很高,所以你也必須做出一些承諾。與準備在未來 18 個月內進入臨床的候選人相比,這是令人興奮的。
At the same time, it has that puzzle piece has to fit, and we don't know sometimes where it fits. So both we are looking at -- we're looking into both. Discussions are ongoing, and we will see how they develop from here.
同時,拼圖塊必須適合,但有時我們不知道它適合放在哪裡。所以,我們正在研究這兩者——我們正在調查這兩者。討論仍在進行中,我們將拭目以待後續進展。
Operator
Operator
[Kiara Montrone, Kempen].
[Kiara Montrone,肯彭]。
Unidentified Participant
Unidentified Participant
Hello team, this is Kiara from Kempen, congratulations with the update. On 712, I was wondering, the Phase 0 and 1, will not run in parallel right. So did I understood correctly that the Phase 1 start is contingent upon good imaging data or am I wrong?
大家好,我是來自 Kempen 的 Kiara,祝賀更新。在 712 上,我想知道,第 0 階段和第 1 階段不會並行運行吧。那麼,我是否正確了解第一階段的開始取決於良好的影像數據,還是我錯了?
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
Michael Stumpp - Executive Vice President - Projects, Member of the Management Board
-- Thanks a lot for the question. It's a really good one because we are proposing to the FDA that it should not depend on each other. We want to do them in parallel. We have the required animal data to argue for the parallel start.
-- 非常感謝您的提問。這是一個非常好的建議,因為我們向 FDA 建議,它們不應該相互依賴。我們希望同時進行這些工作。我們擁有所需的動物數據來支持平行啟動。
But in the end, of course, we will listen and have to live with what FDA decides. So stay a bit with us ideally in parallel, but it's a regulatory question. So -- and if that is, I think we will probably keep them together just a few months apart because patients like to be treated and not just image so also for the patient, we keep them closely staggered.
但最終,我們當然會聽從並接受 FDA 的決定。所以最好能和我們同時討論一下,但這是一個監管問題。所以 — — 如果是這樣的話,我想我們可能會讓他們的治療時間只相隔幾個月,因為患者喜歡接受治療,而不僅僅是想像,所以對於患者來說,我們也會讓他們的治療時間緊密錯開。
Operator
Operator
[Yuris Zimmerman], Octavian.
[尤里斯‧齊默曼],屋大維。
Unidentified Participant
Unidentified Participant
Thanks for the presentation and for the opportunity to ask questions. I have a short one, I guess, on just on the structure of your deal with Orano Med. If you could elaborate a little bit on how those different programs are split between the two companies? I mean you've nicely depicted that on slide 12, I guess. Just to understand, so the later programs will be fully owned by you, and then there is two with opt-in, but who will take the commercial lead for those? And then also for three and four, is it correct that this will be mainly led by Orano Med?
感謝您的演講和提問的機會。我想就您與 Orano Med 的交易結構做一個簡短的介紹。您能否詳細說明一下這兩家公司是如何劃分這些不同的項目?我想,您已經在幻燈片 12 上很好地描述了這一點。只是為了理解,所以後面的程序將完全由您擁有,然後有兩個可以選擇加入,但誰將負責這些程序的商業主導?那麼對於第三和第四點,主要由 Orano Med 主導,對嗎?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Thanks for the question, and this is a good opportunity to quickly explain how the deal works. And I'll do a sort of recap of how this all came about. So we started the collaboration on NTA with Orano Med on the DLLS DARPin. And so that was sort of, call it, the honeymoon. And we have made very good progress on it. And then we said, okay, let's move forward.
感謝您的提問,這是一個快速解釋該交易如何運作的好機會。我將對這一切的發生過程做一個回顧。因此,我們開始與 Orano Med 在 DLLS DARPin 上開展 NTA 合作。這就是所謂的蜜月。我們在這方面已經取得了非常好的進展。然後我們說,好吧,我們繼續前進。
At that point in time, we did a deal with actually three targets or three products these were both 50-50. We got the first. The idea was they would take the second. And then the third, we would see how that develops. And I think we have underestimated the speed and productivity of what we were doing. And so what had happened is that we took the first, but then [Mr. Selig] came about and we had to approach them and say, Actually, we have a second and then there was an imbalance, we said, okay, then let's add a four that we get one and two, and they can have three and four in the 50-50, but commercial lead for one and two are with us.
當時,我們實際上與三個目標或三種產品達成了交易,它們的份額都是 50-50。我們獲得了第一名。他們的想法是選擇第二名。然後第三,我們將觀察其如何發展。我認為我們低估了我們所做工作的速度和生產力。所以發生的事情是,我們拿下了第一個,但是後來 [塞利格先生] 出現了,我們不得不與他們接洽並說,實際上,我們還有第二個,然後出現了不平衡,我們說,好吧,那麼讓我們添加四個,這樣我們就得到第一個和第二個,他們可以在 50-50 的比例中獲得第三個和第四個,但是第一和第二個商業權在我們手中的領先。
In the meantime, they were successful in their Phase 2 and did a massive deal with Sanofi, bringing in CHF400 million for late-stage development and commercial supply -- so they have a clear mandate now to put that money to work, build the manufacturing site, build the last mile, built the logistics. So Sanofi is not doing that. That will be with Orano Med.
同時,他們在第二階段取得了成功,並與賽諾菲達成了一項大交易,為後期開發和商業供應帶來了 4 億瑞士法郎——因此他們現在有明確的任務,將這筆錢投入使用,建立生產基地,建設最後一英里,建立物流。所以賽諾菲沒有這樣做。這將是與 Orano Med 合作。
And sort of I would say it is clear where their focus is. And so we were like, okay, we have one and two. You have three and four and you're focused at late stage, let's sit together because we cannot wait until we move your programs. We want to do more.
我想說的是,他們的重點很明確。所以我們就像,好吧,我們有一和二。您有三和四,並且專注於後期階段,讓我們坐在一起,因為我們迫不及待地想移動您的程式。我們想做更多。
And then where this win-win situation happened where we said, okay, let's add six. Molecular Partners can move them forward and add early clinical phase zero-ish data or Orano Med can opt in into two, while four will remain with us. So I'm not going to go into all the details, but you see we are helping each other. They have high focused money to build the late-stage. We are working a bit more on the early stage, and they also get then with the opt-in, what they need to build their pipeline.
然後就出現了雙贏的局面,我們說,好吧,我們再加六個。Mocular Partners 可以推動它們向前發展並添加早期臨床階段零數據,或者 Orano Med 可以選擇加入其中兩個,而四個將保留在我們這裡。所以我不會講所有細節,但你看我們正在互相幫助。他們集中大量資金用於後期建設。我們在早期階段做了更多的工作,然後他們也可以透過選擇加入來獲得建造管道所需的東西。
So for me, it's a beautiful example of a win-win situation. And I do think on value, this has gone very much under the radar that we have products worth of lead supply with the most advanced and credible partner you can have. So big thanks to them. Indirectly, also big thanks to Sanofi for putting all that money to work. And we are ready.
所以對我來說,這是一個雙贏的美好例子。我確實認為,就價值而言,這一點已經非常不為人所知,我們擁有值得領先供應的產品,並且擁有最先進、最可靠的合作夥伴。非常感謝他們。間接地,也要感謝賽諾菲投入了這麼多資金。我們已經準備好了。
One point also, these are commercial products. So if number eight would fail in Phase 3, even then we can go back and replace it. So these slots are up to commercial stage. So if you want, this is a 30-40 target setting you can do. We don't have to -- we can also do other isotopes. But I would say for lead, we have access to whatever we need.
還有一點,這些都是商業產品。因此,如果第八個在第三階段失敗,我們仍然可以返回並替換它。因此這些時段已經進入商業階段。因此,如果您願意,您可以進行 30-40 的目標設定。我們不必這樣做——我們也可以做其他同位素。但我想說,對於鉛,我們可以獲得我們需要的一切。
Unidentified Participant
Unidentified Participant
That makes a lot of sense. Maybe a very quick follow-up. You mentioned the high productivity. So how should we think of time lines and frequency of you and Orano Med disclosing the additional programs?
這很有道理。也許是一個非常快速的後續行動。您提到了高生產力。那麼我們應該如何考慮您和 Orano Med 揭露附加方案的時間表和頻率?
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Yes, that's a good question and that is like you never communicate too much what you're doing in research because it is so risky. And if I will give you an update on our pipeline today in research and a year later, a lot has changed. That is always that we're careful.
是的,這是個好問題,就像你從不過度交流你在研究中所做的事情,因為這太冒險了。如果我今天向您介紹我們研究管道的最新進展,一年後,很多事情都改變了。那就是我們總是小心謹慎。
But I think it's fair to say that my guess is we'll have two new targets that we will be talking about this year and also new, call them, technologies that we're testing. So it's not that we are waiting in radio and sitting there, but we're also evolving our platform for a next generation as we go.
但我認為可以公平地說,我猜測我們今年將討論兩個新目標,同時也將測試一些新技術。因此,我們並不是在廣播領域坐等,而是在不斷發展我們的平台以適應下一代廣播。
So I think in all fairness, roughly two targets per year is likely a productivity that is fair. Pending the results of 712, obviously, we can ramp up more, their clinical data will be key. If that looks as we hope for, then let's move forward and do more.
因此,我認為平心而論,每年大約有兩個目標可能是一種公平的生產力。等待 712 的結果,顯然,我們可以進一步增加,他們的臨床數據將是關鍵。如果情況如我們所願,那麼讓我們繼續前進,做更多的事情。
Operator
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Patrick Amstutz, CEO for any closing remarks.
我們的問答環節到此結束。我想將會議交還給執行長 Patrick Amstutz 做閉幕發言。
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Patrick Amstutz - Chief Executive Officer, Executive Director, Member of the Management Board
Yes. No, thanks again, 20 years Molecular Partners, 20 years innovating and bringing drugs forward. I'm also proud on the timing. This is almost Swiss timing. We're right on the hour as we had planned. So also thanks and thanks for all the great questions. We're off to an exciting year. We'll keep you updated as we collect the data. We also work closely with you to give you the -- what you need to understand the data as we're doing that. And also I'll end with a big thanks to my team, treating physicians and especially the patients. See you all soon, and we're at many conferences going forward. So reach out and we'll be in contact.
是的。不,再次感謝,20 年來,Molecular Partners 一直致力於藥物的創新和發展。我也對時機感到自豪。這幾乎是瑞士計時。正如我們計劃的那樣,我們正好在那個時間到達。所以也感謝大家提出的所有精彩問題。我們即將迎來激動人心的一年。我們會在收集資料時及時向您通報最新情況。我們也與您密切合作,為您提供理解數據所需的資訊。最後,我還要向我的團隊、主治醫師以及特別是病人表達衷心的感謝。很快就會見到你們,我們將參加很多會議。請伸出援手,我們將會與您聯繫。
Operator
Operator
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。