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
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Thank you so much and good morning and good afternoon to all of you.
非常感謝大家,早安,午安。
And a very warm welcome to this Evaxion business update conference call on the back of our Q3 earnings release, which has been out earlier on today.
非常熱烈地歡迎在我們今天早些時候發布的第三季度收益報告之後參加這次 Evaxion 業務更新電話會議。
I'm Christian Kanstrup CEO of Evaxion with me today.
今天和我一起的是 Evaxion 執行長 Christian Kanstrup。
I have Birgitte Rønø my Chief Science Officer, I have Mads Kronborg, our head of relations also with me today for the first time.
我的首席科學官 Birgitte Ränä 和我們的關係主管 Mads Kronborg 今天也第一次與我會面。
I have our new CFO Thomas Schmidt who just joined us and I would actually like to start out by just handing over to Thomas for a very brief introduction of who you are.
我們的新任財務長 Thomas Schmidt 剛加入我們,實際上我想先將任務交給湯瑪斯,讓他簡單介紹一下您的身分。
Thomas.
托馬斯.
Thomas Schmidt - CFO
Thomas Schmidt - CFO
Thank you Christian and also from my side, good morning and good afternoon to everyone on the call.
謝謝克里斯蒂安,也謝謝我這邊,祝大家早安,下午好。
And as mentioned and as written here, my name is Thomas Schmidt and officially will be joining here 1st of November as the CFO of Evaxion having spent the last few days with a handover from YPA.
如前所述和此處所寫,我的名字是 Thomas Schmidt,我將於 11 月 1 日正式加入這裡,擔任 Evaxion 的首席財務官,過去幾天我從 YPA 移交了過來。
I'm an accountant, auditor by training and education and I've spent the past more than 25 years within the life science industry, many different roles within the company of Roche amongst other also financial officer in Germany and I've been groups here for also in Hamburg earlier.
我是一名會計師、審計師,接受過培訓和教育,過去 25 年我一直在生命科學行業工作,在羅氏公司擔任過許多不同的角色,其中包括德國的財務官員,我一直是這裡的團隊成員早些時候也在漢堡。
So I'm really looking forward to now joining this being my first business update conference call and excited to be working together with the team and also with the shareholders.
因此,我真的很期待現在參加這是我的第一次業務更新電話會議,並且很高興能與團隊和股東合作。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Great to have you on board.
很高興您加入。
Thomas, let's jump to the agenda which is very similar to what we normally do.
托馬斯,讓我們開始討論與我們通常所做的非常相似的議程。
I will start out with a brief introduction.
我先做一個簡單的介紹。
It will take an R&D business update.
這將需要研發業務更新。
We will have Thomas and go through the financial results.
我們將邀請托馬斯來檢查財務業績。
I will conclude before we jump into the Q&A but before we get going, let's also just direct your attention to this slide, the forward-looking statement slide as normal, we will be talking about the future.
在我們進入問答之前,我將得出結論,但在我們開始之前,讓我們也將您的注意力轉移到這張幻燈片上,像往常一樣,前瞻性聲明幻燈片,我們將討論未來。
Of course, when you talk about the future that does entail uncertainty.
當然,當你談論未來時,確實會帶來不確定性。
Hence, I carefully direct your attention to the forward-looking statement slide which speaks to the uncertainty about talking about the future with that.
因此,我小心地將您的注意力引向前瞻性聲明幻燈片,該幻燈片說明了談論未來的不確定性。
Let's get into the introduction.
讓我們進入介紹。
And look at the key achievements since last business update.
並查看自上次業務更新以來的主要成就。
I think it's fair to say that I am super proud of the team and proud of what we have achieved during the last quarter.
我認為可以公平地說,我為團隊感到非常自豪,並為我們在上季度取得的成就感到自豪。
It has been a very busy quarter and it has been a quarter with a lot of significant achievements and and we have seen a continued strong strategy execution.
這是一個非常繁忙的季度,取得了許多重大成就,我們看到了持續強勁的策略執行。
Several milestones have been achieved across the company if we start out with our multi partnering strategy here.
如果我們從這裡開始實行多重合作策略,整個公司已經實現了幾個里程碑。
Of course, in September, we signed a transformative deal with MSD, the European name for me around EVX-02 and P3.
當然,在 9 月份,我們與 MSD 簽署了一項變革性協議,MSD 是我在 EVX-02 和 P3 方面的歐洲名稱。
This is providing a significant financial and strategic value to action.
這為行動提供了重大的財務和策略價值。
Also, I'm proud to see that we see a continuously increasing external interest in both our pipeline and our platform and we have a number of ongoing partnership discussions.
此外,我很自豪地看到外部對我們的管道和平台的興趣不斷增加,並且我們正在進行許多合作夥伴關係討論。
We've also seen a very solid pipeline progress which beda also will get back to.
我們也看到了非常紮實的管道進展,beda 也將回歸。
We did release a very convincing one year clinical data from the phase two trial with EVX-01.
我們確實發布了 EVX-01 二期試驗的非常令人信服的一年臨床數據。
We did present the proof of concept for M&A based B two vaccine.
我們確實提出了基於併購的 B 2 疫苗的概念驗證。
We are also spending a lot of effort in in continuously strengthening the platform and the organization we launched an upgraded version of Eden will get back to that as well.
我們也花費了大量的精力來不斷加強平台,我們推出升級版Eden的組織也將回歸這一點。
And then as we just talked about Thomas has been appointed as a CFO so an exciting quarter, a busy quarter, but important a quarter with a lot of significant achievements.
然後,正如我們剛才談到的,托馬斯被任命為首席財務官,這是一個激動人心的季度,一個忙碌的季度,但也是一個重要的季度,取得了很多重大成就。
And let me just start out go a little bit of spend a few minutes on the MSD agreement, which is truly transformative for us.
首先讓我花幾分鐘時間討論默沙東協議,這對我們來說確實具有變革性。
Just to remind everyone it's an optional licensing agreement.
只是提醒大家這是一個可選的授權協議。
It's covering EVX-02 and B three and it is ensuring a fast and effective development of these two vaccines to address a serious unmet need.
它涵蓋 EVX-02 和 B 3,確保這兩種疫苗的快速有效開發,以滿足嚴重的未滿足需求。
Let's also remind all of you that no approved vaccines are available for the infectious diseases.
我們也提醒大家,目前還沒有針對傳染病的核准疫苗。
Those two vaccines are targeting, this does mean a significant financial and strategic value to us, not only for the short term but also very importantly.
這兩種疫苗的目標是,這對我們來說確實意味著重大的財務和策略價值,不僅是短期的,而且非常重要。
So for the long term, we have received the 3.2 million upfront payment in October, we are expecting up to 10 in million US dollars in 2025.
因此,從長遠來看,我們在 10 月收到了 320 萬美元的預付款,預計 2025 年將達到 10 萬美元。
Contingent upon MSD exercising the options to license either one or both candidates in terms of total financials milestone payments of up to 592 million per product plus royalties on sales.
視默沙東行使選擇權以每種產品高達 5.92 億美元的總財務里程碑付款加上銷售特許權使用費來許可一名或兩名候選人進行許可。
Needless to say this is providing a potential very important source of income and funding for the years ahead.
不用說,這為未來幾年提供了潛在的非常重要的收入和資金來源。
What's also important when we look beyond the may financials is this is an important validation of both our AI immunology platform, but also our pipeline from a world leader in vaccine development and commercialization.
當我們超越可能的財務狀況時,同樣重要的是,這是對我們的人工智慧免疫學平台的重要驗證,也是對我們來自疫苗開發和商業化領域世界領先者的管道的重要驗證。
And I think it's fair to say that that validation, we see that with a increasing interest in discussing potential partnerships with us from other companies.
我認為可以公平地說,經過驗證,我們看到其他公司越來越有興趣與我們討論潛在的合作關係。
So a very important element in our multipartner strategy that we have a strong validation from a world leader in science development and commercialization.
因此,我們的多合作夥伴策略中一個非常重要的因素是,我們得到了科學開發和商業化領域世界領導者的強有力的認可。
Then let's jump to the next slide and take a look at our milestone overview.
然後讓我們跳到下一張投影片,看看我們的里程碑概述。
As already said, a basic order we have achieved a number of important 24 milestones launched the upgraded EDEN, got the pre proof concept on EVX-02 for Mr and A presented the one year readout from the phase two with EVX-01 and we also have the milestone on the EVX-03 and conclusion of the partners or the target discovery and validation work with MSD.
正如已經說過的,我們已經實現了一系列重要的24 個里程碑,推出了升級版EDEN,為Mr 和A 提供了EVX-02 上的預證明概念,並展示了EVX-01 第二階段的一年讀數,我們也EVX-03 的里程碑以及合作夥伴的結論或與 MSD 的目標發現和驗證工作。
You can say that is now superseded by the option and licensing agreement because next step here will be the expected hopefully exercise of the option from MSD in 2025.
您可以說現在已被選擇權和授權協議所取代,因為下一步預計是默沙東 (MSD) 在 2025 年行使該選擇權。
We are on track for the preclinical proof of concept with our herb based prescient vaccine concept also expected in 2024.
我們的基於草藥的先見之明疫苗概念預計將於 2024 年進行臨床前概念驗證。
And then for the BD ambition of generating BD income or cash in equal to our annual cash flow.
然後,對於 BD 的目標,即產生相當於我們年度現金流量的 BD 收入或現金。
I'll have an update on that on the next slide for the business development ambition, we have as already mentioned, secure 3.2 million this year up to 10 million in 2025 contingent upon option exercise of course.
我將在下一張投影片上更新業務發展雄心,正如已經提到的,我們今年將獲得 320 萬美元,到 2025 年將獲得 1000 萬美元,當然這取決於選擇權的行使。
And we are seeing a solid and increasing interest in both pipeline and platform.
我們看到人們對管道和平台的興趣日益濃厚。
What can be said is that certain discussions are moving into 2025 and business development timing of that is uncertain.
可以說的是,某些討論正在進入 2025 年,而其業務發展時機尚不確定。
And we are seeing despite the strong interest that certain discussions are taking a longer time than anticipated or are being initiated later, meaning that certain things are moving into 2025 which does mean that we will not be meeting our 14 million and business development income or cash in 2024 ambition.
儘管人們對此很感興趣,但我們看到某些討論花費的時間比預期更長或啟動時間較晚,這意味著某些事情將進入2025 年,這確實意味著我們將無法實現1400 萬美元的業務發展收入或現金2024年的雄心。
What is important.
什麼是重要的。
However, this of course creates a solid basis for a business development income in 2025.
然而,這當然為2025年的業務發展收入奠定了堅實的基礎。
It's fair to say we are still having a number of discussions or we're having discussions which could potentially conclude in 2024 with additional business development income.
可以公平地說,我們仍在進行大量討論,或者我們正在進行的討論可能會在 2024 年結束,並帶來額外的業務開發收入。
But timing is of course uncertain given that we only have two months left of the year one final update I will give before handing over to GDA as also addressed in our release, we had out earlier on today is our, the situation around our Nasdaq deficiency letter we did in the may receive notification from Nasdaq that we do not need our minimum equity requirement.
但時間當然是不確定的,因為我們今年只剩下兩個月的時間了,在移交給GDA 之前,我將給出最後一次更新,正如我們的新聞稿中也提到的那樣,我們今天早一些時候發布的是我們的納斯達克缺陷的情況我們在五月份收到的信中收到了納斯達克的通知,稱我們不需要最低股本要求。
Actually, even though we did in fact meet it by the end of the, the first quarter, but we ended up not meeting it by the second quarter that resulted in a notification from Nasdaq based upon which we submitted a plan and got an exemption until November 4th.
事實上,儘管我們確實在第一季末達到了要求,但我們最終沒有在第二季度達到要求,導致納斯達克發出通知,根據該通知,我們提交了計劃並獲得了豁免,直到11 月4 日。
Our aim is to ensure compliance by a combination of business development, income and capital markets activities and we remain very committed to our NASA listing.
我們的目標是透過業務發展、收入和資本市場活動的結合來確保合規性,並且我們仍然非常致力於在 NASA 的上市。
But it's also clear that this will not be achieved by November 4th.
但同樣明確的是,這一目標在 11 月 4 日之前無法實現。
As a number of factors have impacted timing and we had to have certain things aligned.
由於許多因素都會影響時間安排,因此我們必須對某些事情進行協調。
We are however in a constructive manner with NASA or a constructive discussion with Nasdaq on on this matter.
然而,我們正在以建設性的方式與美國太空總署或納斯達克就此事進行建設性的討論。
And of course, we have a plan for how to, to ensure compliance.
當然,我們有一個計劃來確保合規性。
The way it works is when we're not meeting the the November 4th deadline for the extension, we will be receiving a notification or delisting notification from Nasdaq which we will be appealing and requesting a hearing at this hearing.
其運作方式是,當我們未能在11 月4 日的延期截止日期之前完成時,我們將收到納斯達克發出的通知或退市通知,我們將對此提出上訴並要求在本次聽證會上舉行聽證會。
We will be pursuing an additional 180 day exemption in order for us to be able to secure compliance in a balanced way.
我們將尋求額外的 180 天豁免,以便我們能夠以平衡的方式確保合規。
Of course, no guarantee of an additional 180 day extension can be given.
當然,不能保證額外延長 180 天。
But as mentioned, we are in a constructive dialogue with Nasdaq around this matter and and do have a plan in place for how to pursue compliance.
但如前所述,我們正在與納斯達克就此事進行建設性對話,並且確實制定瞭如何尋求合規的計劃。
As I said, we remain very committed to our NTIC listing.
正如我所說,我們仍然非常致力於 NTIC 的上市。
And then we'll pursue this very diligently.
然後我們將非常努力地追求這一點。
So with that, I will hand over to Birgitte for an R&D update.Birgitte?
那麼,我將把研發更新交給 Birgitte。
Birgitte Rønø - Chief Scientific Officer
Birgitte Rønø - Chief Scientific Officer
Thank you Christian.
謝謝克里斯蒂安。
It hasn't been in a very busy and exciting Q3.
第三季並不是非常繁忙和令人興奮的。
So besides the Transformative MSD Agreement, we have made a significant progress across our R&D pipeline.
因此,除了變革性默沙東協定之外,我們在研發管線上也取得了重大進展。
So next slide please.
請下一張投影片。
Today, I will be focusing on the milestones achieved in our EVX-01 program.
今天,我將重點介紹我們的 EVX-01 計劃中實現的里程碑。
And then I will present the preclinical proof of concept data we achieved in our Gonorrhea vaccine program with the Messenger RNA version of our EVX-02 vaccine candidate.
然後我將介紹我們在淋病疫苗計畫中使用 EVX-02 候選疫苗的 Messenger RNA 版本獲得的臨床前概念數據驗證。
And finally, I will present the outcome of our efforts in improving the EDEN model.
最後,我將介紹我們改進 EDEN 模型的努力成果。
So next slide please.
請下一張投影片。
So at the ESMO Congress in September, we presented the encouraging one year clinic with data from our ongoing phase two studies in the of our personalized cancer vaccine.
因此,在 9 月的 ESMO 大會上,我們展示了令人鼓舞的一年臨床試驗,其中包含我們正在進行的個人化癌症疫苗第二階段研究的數據。
So one in combination with anti PD one therapy in patients with advanced Melanoma.
因此,一種與抗 PD 一種療法聯合治療晚期黑色素瘤患者。
So we have treated 16 patients with EVX-01.
所以我們已經用 EVX-01 治療了 16 位患者。
And the current status is that we have 11 patients active in the trial with 10 patients having received ALL10 X or one doses and four patients having received the last dose of Tempur Isab.
目前的狀態是,我們有 11 名患者活躍在試驗中,其中 10 名患者接受了 ALL10 X 或一劑藥物,4 名患者接受了最後一劑 Tempur Isab。
This means that we are well on our way to the two year data readout plan for Q3 next year.
這意味著我們正在順利實現明年第三季的兩年數據讀出計畫。
So let's dive into the data we presented at next slide please.
因此,讓我們深入研究下一張投影片中提供的數據。
So for the primary analysis, we are looking at the clinical response improvement of patients that do have stable disease or partial response before dosing with EVX-01.
因此,對於初步分析,我們正在研究在服用 EVX-01 之前疾病穩定或部分緩解的患者的臨床反應改善。
So after this 12 week run in phase of PPO lium treatment, and currently we do have four patients out of the four patients out of the 14 patients included in this primary analysis that have had an improved clinical refund upon administration of EVX-01 therapy at week 12.
因此,經過 12 週的 PPO lium 治療階段後,目前我們在本次初步分析中納入的 14 名患者中,有 4 名患者在接受 EVX-01 治療後臨床退款有所改善。
So we saw that EVX-01 in combination with TBU Isab resulted in an overall response rate of 69% which we believe compares favorably to restore good data from tab monotherapy drive.
因此,我們看到 EVX-01 與 TBU Isab 組合的整體緩解率為 69%,我們認為這比恢復片劑單一療法驅動器的良好數據要有利。
So we are very encouraged with this early data.
因此,我們對這些早期數據感到非常鼓舞。
We also saw that three out of 16 patients achieved a complete remission of the tumor target lesion.
我們也看到 16 名患者中有 3 名實現了腫瘤標靶病灶的完全緩解。
Next slide please.
請下一張投影片。
If we look at the changes of the target lesions over time at the plot in the top, it is evident that the target lesions are reduced in the 1st 12 weeks.
如果我們在頂部的圖上觀察目標病灶隨時間的變化,很明顯目標病灶在第一個 12 週內有所減少。
So in this tempol isab running phase and then further reduced upon introduction of TVX one at week 12.
因此,在此 tempol isab 運行階段,然後在第 12 週引入 TVX 後進一步減少。
Also from the spider plot, it is clear the beautiful introduction in the of the lesions in five or 15 out of 16 patients.
同樣從蜘蛛圖上可以清楚看到 16 名患者中的 5 名或 15 名患者的病變情況。
If we look at the lower plus, we have zoomed in on the reduction of the tumor target lesions from week 12.
如果我們看一下較低的加號,我們就放大了從第 12 週開始腫瘤標靶病灶的減少。
So where we introduce EVX-01 and here we see that there is a clear further decline of the lesions upon this time point, we have not reached OS and PSF yet indicating a doable clinical response.
因此,在我們引入 EVX-01 的地方,我們看到在這個時間點病變明顯進一步下降,但我們尚未達到 OS 和 PSF,尚未表明可行的臨床反應。
So overall, we are very pleased with this interim data and we find it very promising and we are definitely looking forward to follow and then in the future, next slide please.
總的來說,我們對這個中期數據非常滿意,我們發現它非常有前途,我們絕對期待著後續,然後在未來,請看下一張投影片。
So the second of these three milestones achieved in September was our EVX-02 MRNA program.
因此,9 月實現的這三個里程碑中的第二個是我們的 EVX-02 mRNA 計劃。
So in September last year, we entered into an agreement with Egen biologics to develop an messenger two VAC or EVX-02.
所以去年9月,我們與Egenbiologics達成協議,開發信差二號VAC或EVX-02。
And in September, we presented the preclinical proof of concept of this messenger RNA vaccine candidate.
9 月,我們提出了這種信使 RNA 候選疫苗的臨床前概念證明。
We saw that the candidate triggered a targeted immune response in mice shown in the graft in the middle panel with the ability to eliminate several clinically relevant mRNA Gonorrhea.
我們看到,該候選藥物在小鼠體內觸發了標靶免疫反應,如中圖移植物所示,能夠消除幾種臨床相關的 mRNA 淋病。
The data provides strict clinical proof of concept for the messenger RNA based version of the EVX-02.
這些數據為基於信使 RNA 的 EVX-02 版本提供了嚴格的臨床概念證明。
And it also underlines that the targets that are identified by AI immunology are delivery modality agnostic as we have seen similar results with our PEP or protein based version of this vaccine candidate.
它還強調,人工智慧免疫學識別的目標與傳遞方式無關,因為我們已經看到了該候選疫苗的 PEP 或基於蛋白質的版本的類似結果。
So, next slide please.
那麼,請播放下一張投影片。
So the third major milestone achieved in September was the launch of a new version of our EDEN model.
因此,9 月實現的第三個重要里程碑是推出新版本的 EDEN 模式。
We use EDEN to identify protective fetal antigens that are included in our infectious disease vaccine.
我們使用 EDEN 來識別我們的傳染病疫苗中包含的保護性胎兒抗原。
So the upgraded Eden prediction model can now predict toxin antigen allowing for the development of improved bacterial vaccines.
因此,升級後的伊甸園預測模型現在可以預測毒素抗原,從而可以開發改進的細菌疫苗。
So as bacterial substant are often key con contributors to disease, their neutralization is essential for developing effective vaccines.
因此,由於細菌物質通常是疾病的關鍵因素,因此中和它們對於開發有效的疫苗至關重要。
And we strongly believe that this now adds to a more against various bacterial and also to some extent other infectious disease.
我們堅信,這現在可以更好地抵抗各種細菌,並且在某種程度上可以抵抗其他傳染病。
So overall very promising progress across the entire R&D pipeline in two weeks.
因此,總體而言,整個研發管道在兩週內取得了非常有希望的進展。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Thank you so much.
太感謝了。
Birgitte.
比吉特。
And now I will hand over to Thomas for his first quarterly business update and for Thomas to take you through the numbers.
現在我將向托馬斯報告他的第一個季度業務更新,並由托馬斯向您介紹這些數字。
Thomas will you take it from here?
湯瑪斯,你能把它從這裡拿走嗎?
Thomas Schmidt - CFO
Thomas Schmidt - CFO
Yes, certainly will do.
是的,當然會做。
And maybe let me jump straight into the Q3 financials.
也許讓我直接跳到第三季的財務狀況。
And let me start with the financial highlights.
讓我從財務亮點開始。
And in Q3, we've recorded a revenue of $3 million which again to what Christian mentioned earlier is primarily stemming from the new MSD agreement announced back in September 26 September 26.
在第三季度,我們錄得 300 萬美元的收入,這又是 Christian 先前提到的,主要源自於 9 月 26 日宣布的新默沙東協議。
The agreement obviously is well aligned with the financing strategy and the ambition and has also looking forward the potential to generate substantial future revenue.
該協議顯然與融資策略和雄心壯志高度契合,並有望在未來產生大量收入。
We've also been exec executing well on the earlier and ongoing cost reduction initiatives.
我們在早期和持續的成本削減計劃方面也表現出色。
And as a result of that, we are seeing lower spend compared to the same period in 2023 cash and cash equivalents were $4.6 million as of the end of September and the $3.2 million upfront payment from MSD agreement we have received in October, but is therefore not included in the September or Q3 figures, but obviously will be once we get to Q4 and we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into March 2025.
因此,與 2023 年同期相比,截至 9 月底的現金和現金等價物為 460 萬美元,以及我們 10 月份收到的 MSD 協議預付款 320 萬美元,但支出有所減少,但因此未包含在9 月或第三季的數據中,但顯然一旦進入第四季就會包含在內,我們預計現有的現金和現金等價物將足以滿足我們到2025 年3 月的營運費用和資本支出需求。
Turning to the profit and loss statement and net loss for the quarter was posted of $1.9 million compared to a loss in the same quarter last year of $5.7 million.
轉向損益表,該季度的淨虧損為 190 萬美元,而去年同期的淨虧損為 570 萬美元。
The improvement is as just mentioned, primarily driven by the rev recognized revenue but also reduced GNA spending.
正如剛才所提到的,這種改善主要是由轉速確認收入所推動的,但也減少了 GNA 支出。
There's a slight reduction in the R&D expenses versus the same quarter last year.
研發費用與去年同期相比略有下降。
And as the R&D expenses were 2.6 million this year versus $2.8 million last year.
今年的研發費用為 260 萬美元,去年為 280 萬美元。
The decrease is primarily related to head count.
減少主要與員工人數有關。
And on the mentioned G&A expenses, there's $800,000 lower expenditure in Q3 this year versus Q3 last year.
就上述 G&A 費用而言,今年第三季的支出比去年第三季減少了 80 萬美元。
And the decrease is mainly due to lower expenses following changes in the executive management team made in 2023 the balance sheet as end of September 30th shows that our that the due to capital increase in February 24 the equity has now improved by 4.8 million compared to the year end last year.
減少的主要原因是執行管理團隊在 2023 年做出的變動導致費用降低。年底。
While we at the same time, obviously are investing and continuing to invest into pipeline and platforms cash and cash equivalents as of September 30th of 4.6 million.
同時,截至 9 月 30 日,我們顯然正在並繼續投資管道和平台現金和現金等價物,投資金額為 460 萬美元。
As just mentioned again, I just want to stress that does not include the 3.2 million MSD Agreement payment.
正如剛才再次提到的,我只是想強調一下,這不包括320萬MSD協議付款。
But we expect that this cash will carry us forward from an expense operating expense and capital expenditures requirement into again, March 2025.
但我們預計這筆現金將使我們從支出營運費用和資本支出需求再次推遲到 2025 年 3 月。
Therefore of course, we will continue to work diligently to improve.
因此,我們當然會繼續努力改進。
As Christian mentioned earlier, cash flow through continued business development income and also capital market activities.
正如克里斯蒂安之前提到的,現金流透過持續的業務發展收入以及資本市場活動來實現。
And with that, I will hand it back over to you Christian for some conclusive remarks and following Q&A.
至此,我將把它交還給你克里斯蒂安,讓你做一些結論性的評論和隨後的問答。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Excellent.
出色的。
Thank you so much.
太感謝了。
Thomas And just to conclude, I think it's clear from the run through here that we are seeing a solid execution of OFG and, and plans and we had a strong quarter in terms of milestone achievements with a good mix of milestones across the different parts of the strategy.
湯瑪斯最後總結一下,我認為從這裡的運行可以清楚地看出,我們看到了OFG 和計劃的紮實執行,並且我們在里程碑成就方面取得了強勁的季度成績,各個部門的里程碑都很好地結合在一起策略。
What is also encouraging is the signing of the Transformative MSD Agreement and in general, a solid business development pipeline where we have full focus on continuing progressing those discussions and also initiating a new discussions with interested parties to continue being able to feed the business development pipeline.
同樣令人鼓舞的是簽署了《MSD 變革協議》,總體而言,我們有一個堅實的業務發展管道,我們將全力專注於繼續推進這些討論,並與感興趣的各方啟動新的討論,以繼續為業務發展管道提供支援。
All the top priorities are of course the continuation of the base of one phase two trial begin to mention we are on track for the two year readout in Q3 2025 which will be an important milestones for next year as well.
當然,所有首要任務都是繼續一期二期試驗的基礎,開始提到我們正朝著 2025 年第三季的兩年讀數邁進,這也將是明年的一個重要里程碑。
And then we have a number of no preclinical activities ongoing as a basis for expanding our pipeline.
然後,我們正在進行許多非臨床前活動,作為擴大我們的產品線的基礎。
So a full focus on executing upon the strategy and a strong delivery across all the different parts of the strategy.
因此,要完全專注於策略的執行,並在策略的所有不同部分進行強有力的交付。
So with that, I would like to open for Q&A and thank you all very much for listening to this first part.
因此,我想開始問答環節,非常感謝大家收聽第一部分。
Operator
Operator
Thank you.
謝謝。
If you would like to ask a question.
如果您想問問題。
You will need to press star one and one on your telephone and wait for your name to be announced to withdraw your question.
您需要在電話上按星號一和一,然後等待您的名字被宣布才能撤回您的問題。
Please press star 11 again.
請再按星號 11。
Thank you.
謝謝。
We will now take our first question.
我們現在回答第一個問題。
This is from the line of Thomas Flate from Lake Street Capital Markets.
這是來自 Lake Street Capital Markets 的 Thomas Flate 的文章。
Please go ahead.
請繼續。
Thomas Flate - Analyst
Thomas Flate - Analyst
Hey, Good Afternoon guys.
嘿,大家下午好。
I appreciate.
我很欣賞。
Hi, how are you?
你好你好嗎?
I appreciate you taking the questions.
感謝您提出問題。
Just a couple for me.
對我來說只是一對。
Can you walk us through the specific triggers that are required to generate the up to 10 million from Merck next year?
您能否向我們介紹明年從默克公司獲得高達 1000 萬美元所需的具體觸發因素?
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Yeah, I mean you can say the up to 10 is in case they license or exercise the option for both assets and then the for if we start with the simple one EVX-03, that's finalization of the work that we initiated in September, September last year.
是的,我的意思是,你可以說最多10 個是萬一他們許可或行使這兩種資產的選擇權,然後是如果我們從簡單的EVX-03 開始,這就是我們在9 月啟動的工作的最終確定去年。
You can say they'll be set out on the, on the target discovery and, and the validation of EVX-03, which is for an undisclosed target.
你可以說他們將著手目標發現和 EVX-03 的驗證,這是針對未公開的目標。
So that's finalization of that which is just execution of the plan that has been laid out.
這就是最終確定,只是執行已經制定的計劃。
For EVX-02, MSD is doing some confirmatory preclinical analysis on the ad So we, we are as such, not involved in the P two work and we are more or less wrapping up our involvement or participation in in the P three.
對於 EVX-02,默沙東正在對廣告進行一些驗證性臨床前分析,因此我們本身並沒有參與 P 2 工作,我們或多或少結束了對 P 3 的參與或參與。
What I can say also is that I mean this next part of the collaboration is well on track and everything is anchored in terms of plans.
我還可以說的是,我的意思是合作的下一部分進展順利,一切都按照計劃進行。
Thomas Flate - Analyst
Thomas Flate - Analyst
Got it and then from an ongoing business development perspective, do you, are you seeing more interest in on the oncology side of the business or more on the viral bacterial side or perhaps it's balanced across the.
明白了,然後從持續的業務發展角度來看,您是否看到對業務的腫瘤學方面更感興趣,或者對病毒細菌方面更感興趣,或者也許是平衡的。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Well, I would say over the past couple of past couple of months, we have definitely seen a pick up in the interest around the infectious disease side of the business.
嗯,我想說,在過去的幾個月裡,我們確實看到了人們對傳染病業務的興趣增加。
And which is also mentioned, our part is related to announcing the, the meg agreement but that pick up in interest actually started also before we announced that.
也提到,我們的部分與宣布 meg 協議有關,但興趣的增加實際上也在我們宣布之前就開始了。
So, that's where we are seeing the increase also around a new target discovery and validation partnerships.
因此,這就是我們看到圍繞新目標發現和驗證合作夥伴關係的成長。
So, it is tilted towards that, of course with the EVX-01 phase 21 year data out of course, that there's also been discussions around those data.
因此,當然,EVX-01 21 年階段的數據也傾向於這一點,圍繞著這些數據也進行了討論。
Thomas Flate - Analyst
Thomas Flate - Analyst
And then one final one, if I may in what format do you expect to release the proof of principle proof of concept data?
最後一個問題是,您希望以什麼格式發布概念證明資料的原理證明?
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Birgitte, Do you want to answer that?
比吉特,你想回答這個問題嗎?
Birgitte Rønø - Chief Scientific Officer
Birgitte Rønø - Chief Scientific Officer
So I can end up we are planning to present the data at a conference in December.
所以我可以得出結論,我們計劃在 12 月的會議上展示這些數據。
Thomas Flate - Analyst
Thomas Flate - Analyst
Got it.
知道了。
I appreciate it.
我很感激。
Thank you very much.
非常感謝。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Thanks so much.
非常感謝。
Operator
Operator
Thank you.
謝謝。
We'll now move to our next question.
現在我們將討論下一個問題。
This is from the line of Swayampakula Ramakanth from HCW.
這是來自 HCW 的 Swayampakula Ramakanth 的血統。
Please go ahead.
請繼續。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
Thank you.
謝謝。
Good afternoon folks about Thomas Schmidt.
托馬斯·施密特,大家下午好。
I have a few questions but let's start from the pipeline side of things.
我有幾個問題,但讓我們從管道方面開始。
Brigitte, you were stating that, you know, you would have some biomarker data in the first half of 25 from the EVX-01 phase two study.
Brigitte,您說,您知道,您將在 25 月 25 日上半年獲得 EVX-01 第二階段研究的一些生物標記數據。
Can you just highlight for us what additional biomarkers data would we be seeing that we have not yet seen?
您能否為我們強調我們將看到哪些我們尚未看到的額外生物標記數據?
Birgitte Rønø - Chief Scientific Officer
Birgitte Rønø - Chief Scientific Officer
Yes, thank you for that question.
是的,謝謝你提出這個問題。
So currently, we have not analyzed all samples that we have collected from the patients in the one phase two study.
因此,目前我們尚未分析在一項二期研究中從患者收集的所有樣本。
So it is additional T cell analysis that we will conduct.
因此,我們將進行額外的 T 細胞分析。
We will also do a little bit more on the like a general profiling of the immune cells in the patient.
我們也將做更多的事情,例如對患者免疫細胞進行一般分析。
So, looking for regulatory t of other immune suppressive immune components in the PB and C and we have also collected stem samples for soluble analytes.
因此,在 PB 和 C 中尋找其他免疫抑制性免疫成分的調節作用,我們也收集了可溶性分析物的莖樣本。
And we will of course, look at the some of the standard cancer related and inflammatory related soluble analysis.
當然,我們會查看一些標準的癌症相關和發炎相關的可溶性分析。
So an expenses biomark package is what we're working on at the moment.
因此,我們目前正在研究費用生物標記包。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
Thank, thank you for that.
謝謝,謝謝你。
And then one more question on the pipeline outside of the V data that we're expecting later this year.
然後還有一個關於我們預計今年稍後的 V 數據之外的管道問題。
What additional data set or data from your programs?
您的程式中還有哪些額外的資料集或資料?
Could we be seeing or say let's say over the next six months?
我們能否在接下來的六個月內看到或說?
Birgitte Rønø - Chief Scientific Officer
Birgitte Rønø - Chief Scientific Officer
Yeah, very good question.
是的,非常好的問題。
So we are currently looking at prioritizing the pipeline and also defining milestones for the coming year.
因此,我們目前正在考慮優先考慮管道,並確定來年的里程碑。
So I think we it might be a little bit too early to disclose exactly what we are thinking within the early part of our pipeline.
因此,我認為現在就透露我們在管道早期的想法可能有點為時過早。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
But we will when we are ready, of course, communicate the expected key milestones for 2025 and what you can expect both from a R&D but also of course from a general copyright point of view.
當然,當我們準備好時,我們會傳達 2025 年預期的關鍵里程碑,以及您對研發和一般版權角度的期望。
So that that is currently being discussed.
目前正在討論這一點。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
Thank you one last question for me and Christian.
謝謝你向我和克里斯蒂安提出最後一個問題。
You know it you we understand that, you know the 14 million or so that you are planning to raise through BD activities during 2024 and you know, it is not going to be done and some of it will be pushed into 25.
您知道,我們知道,您計劃在 2024 年期間透過 BD 活動籌集 1400 萬左右,但您知道,這不會完成,其中一些將被推至 25 個。
But is there any opportunity for you to close out the you know, some sort of a BD I transaction over the next two months or should we just assume all of it should be expected in 25?
但是,您是否有機會在接下來的兩個月內完成某種 BD I 交易,或者我們應該假設所有交易都應該在 25 年內完成?
Christian Kanstrup - CEO
Christian Kanstrup - CEO
No, I have a potential for closing an agreement, the additional agreement this year.
不,我有可能在今年達成一項附加協議。
But of course, two months left you have a Thanksgiving you have Christmas.
當然,還剩下兩個月,你就有感恩節、聖誕節了。
That's why I didn't include specific and I want to conclude another deal but it could be possible.
這就是為什麼我沒有具體說明,我想達成另一項協議,但這是可能的。
But of course that's the chance with BD Right.
但這當然是 BD Right 的機會。
It takes time and unfortunately most often it takes more time than you expect.
這需要時間,不幸的是,通常需要的時間比您預期的要多。
It's very rarely that it goes quicker than expected.
很少有事情進展得比預期更快的情況。
That did happen with the MSD deal.
與默沙東的交易確實發生了這種情況。
But that's also very rare.
但這也是非常罕見的。
So, there is potential, but then we also only have two months left of the year which is impacted by yeah you say various vacation and holidays.
所以,有潛力,但今年我們也只剩下兩個月了,這是受到各種假期和假期的影響。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
Got it, Thank you very much.
明白了,非常感謝。
Thanks for taking all my questions.
感謝您回答我所有的問題。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
You're welcome.
不客氣。
Operator
Operator
Thank you as a reminder.
謝謝你的提醒。
If you would like to ask a question, you can press star one and one on your keypad.
如果您想提問,可以按下鍵盤上的星號一和一。
Once again, that's star one and one for any further questions.
再說一次,對於任何進一步的問題,這是一等一的。
There are no further questions coming through.
沒有進一步的問題了。
So I will now hand back to the speakers for any closing remarks.
現在我將請發言者發表結束語。
Christian Kanstrup - CEO
Christian Kanstrup - CEO
Excellent.
出色的。
Thank you so much and I just want to thank everybody for listening in and for your questions and then we are truly excited about the quarter and are looking very much forward to the time ahead.
非常感謝你們,我只想感謝大家的傾聽和提問,我們對本季感到非常興奮,並對未來充滿期待。
So thank you so much for your time and we'll make sure to keep you updated on any developments.
非常感謝您抽出寶貴的時間,我們將確保向您通報任何最新進展。
Of course.
當然。
Thank you so much again for calling in.
再次非常感謝您的來電。