Evaxion A/S (EVAX) 2025 Q1 法說會逐字稿

完整原文

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  • Christian Kanstrup - Chief Executive Officer

    Christian Kanstrup - Chief Executive Officer

  • Good morning and good afternoon, everyone. A very warm welcome to this Evaxon business update call on the back of our Q1 2025 results. I'm Christian Kanstrup, CEO of Evaxion. With me today, I have, as usual, Birgitte Rono, our Chief Scientific Officer; Thomas Schmidt, Chief Financial Officer; and Mads Kronborg, our VP of Investor Relations and Communications.

    大家早安,下午好。熱烈歡迎大家參加 Evaxon 2025 年第一季業績更新電話會議。我是 Christian Kanstrup,Evaxion 執行長。今天與我一起的,和往常一樣,有我們的首席科學官 Birgitte Rono、首席財務官 Thomas Schmidt 和我們的投資者關係和傳播副總裁 Mads Kronborg。

  • For the agenda today, I will do the introduction. Birgitte, she will be doing the R&D update. Thomas will take us through the numbers. And I will end up concluding before we again, as usual, will jump into the Q&A.

    對於今天的議程,我做一下介紹。Birgitte,她將負責研發更新。托馬斯將向我們介紹這些數字。最後,我將像往常一樣,在我們進入問答環節之前做出總結。

  • Before we get going, I will direct your attention to this slide. We will be talking about forward-looking statements. And as always, when you talk about the future, that is uncertain. Hence, I direct your attention to the slide here.

    在我們開始之前,我想請大家注意這張投影片。我們將討論前瞻性陳述。像往常一樣,當你談論未來時,它是不確定的。因此,我請大家注意這裡的幻燈片。

  • With that, let's get going and let's look at the introduction. I think it's fair to say that we have had a super busy couple of months since the last business update. We have seen a strong progress across all parts of the business and are continuing to execute well.

    好了,讓我們開始吧,先看一下介紹。我認為可以公平地說,自上次業務更新以來,我們已經度過了非常忙碌的幾個月。我們看到業務的各個部分都取得了強勁進展,並且繼續表現良好。

  • If we first look at business development, very pleased to say that the partnership with Merck is on track towards potential option exercise in the second half of the year. Needless to say, this is a key milestone for us. If Merck exercises the options to both compounds in the optional licensing agreement, we will be entitled to receive $10 million. Hence, a very important milestone, and I am pleased to see that we are tracking towards the decision point in the second half of the year.

    如果我們先看一下業務發展,我們非常高興地說,與默克的合作關係預計將在今年下半年實現潛在的選擇權行使。毋庸置疑,這對我們來說是一個重要的里程碑。如果默克公司在可選許可協議中行使兩種化合物的選擇權,我們將有權獲得 1000 萬美元。因此,這是一個非常重要的里程碑,我很高興看到我們正在朝著下半年的決策點邁進。

  • Also, super pleased to see that our business development pipeline remains solid and it supports our full-year target of at least two new business development deals. However, in that context, I also have to direct your attention to the fact that it is clear that the current turmoil in the financial markets, and I would say an increased regulatory uncertainty, is impacting deal execution. We have seen a potential partner, which we have been in discussions with, deciding to pause discussions and focus on internal data state assets in development. I think it's only natural that you would see decisions like that when there is turmoil in the financial markets and some uncertainty surrounding where we are.

    此外,我們非常高興地看到我們的業務發展管道依然穩固,並支持我們實現至少兩項新業務發展交易的全年目標。然而,在這種背景下,我還必須提請您注意這樣一個事實:當前金融市場的動盪以及監管不確定性的增加顯然正在影響交易的執行。我們看到一個潛在的合作夥伴,我們一直在與其進行討論,但該合作夥伴決定暫停討論,並專注於開發內部資料狀態資產。我認為,當金融市場動盪、我們所處位置存在一些不確定性時,做出這樣的決定是很自然的。

  • That being said, we are, of course, mitigating the risk of that by directing focus towards potential partners less impacted by the current macro environment. And as I said, we remain confident about our full-year target of completing at least two new business development deals. But its clear risk is increasing due to the macro environment.

    話雖如此,我們當然會透過將注意力轉向受當前宏觀環境影響較小的潛在合作夥伴來降低這種風險。正如我所說,我們對完成至少兩項新業務發展交易的全年目標仍然充滿信心。但由於宏觀環境的影響,其明顯風險正在增加。

  • From an R&D point of view, very pleased to see that EVX-01 is continuing to yield positive data. We just presented at the AACR in April another set of strong data and Birgitte will get back to those later on in the presentation here. On top of that, we are on track for the two-year readout in the second half of the year. And we have seen the first patient being dosed in the one-year trial extension.

    從研發的角度來看,很高興看到 EVX-01 繼續產生正面的數據。我們剛剛在 4 月的 AACR 上展示了另一組強有力的數據,Birgitte 稍後會在演示中再次討論這些數據。最重要的是,我們預計在今年下半年完成兩年期的業績報告。我們已經看到第一位患者在為期一年的延長試驗中接受治療。

  • Also important from an R&D point of view is to deploy our AI-Immunology platform to develop new pipeline candidates. Having a pipeline of novel candidates is crucial for our ability to continue our multi-partner approach and generate future business development income. Also here, I'm pleased to say that we are on track for selecting the new infectious disease pipeline candidate, which we will add to the pipeline here in the first half. Again, Birgitte will get back to that later on as well.

    從研發的角度來看,部署我們的 AI-Immunology 平台來開發新的候選藥物也很重要。擁有一群新的候選人對於我們繼續實行多合作夥伴模式並創造未來業務發展收入至關重要。另外,我很高興地說,我們正在按計劃選擇新的傳染病候選藥物,我們將在上半年將其添加到我們的藥物研發管線中。再次,Birgitte 稍後也會回到這個問題。

  • From a platform point of view, it's about the continued optimization and improvement of the platform. That is how we ensure that we have a leading AI platform for novel target discovery and development. Here, we have been spending the past time on curating a lot of data, aiming at optimizing the platform, being able to select the best possible lead candidate for our precision vaccine concept which is set to take place in the second half.

    從平台角度來說,就是平台的持續優化與完善。這就是我們確保擁有用於新目標發現和開發的領先 AI 平台的方式。在這裡,我們花了過去的時間來整理大量數據,旨在優化平台,以便能夠為我們定於下半年實施的精準疫苗概念選擇最佳的領先候選藥物。

  • From a financing point of view finally. Cash-at-hand until mid-2026. The EIB loan conversion we have talked about earlier is still expected to be completed in Q2. So all in all, busy couple of months, but also a couple of months where we continue to see solid traction across all parts of the business.

    最後從融資的角度來看。現金儲備至 2026 年中期。我們之前談到的歐洲投資銀行貸款轉換預計仍將在第二季完成。總而言之,這幾個月很忙碌,但同時也是我們業務各個部分繼續保持強勁成長勢頭的幾個月。

  • What we also have been doing during the past couple of months is we have been quite active at various scientific conferences AACR EVX-01 Phase 2 data. Here, we actually presented that 80% of the new antigens elicit an immune response, as you will see in Birgitte's presentation. Very strong data presented at that conference. We were at the World Vaccine Congress, had two presentations, had a manned booth. We were at the NextGen Biomed Conference also with two presentations.

    在過去的幾個月裡,我們也一直在積極參與各種科學會議 AACR EVX-01 第 2 階段數據。在這裡,我們實際上表明 80% 的新抗原會引發免疫反應,正如您在 Birgitte 的演講中看到的那樣。那次會議上公佈了非常有力的數據。我們參加了世界疫苗大會,做了兩場演講,並設立了一個有人值守的展位。我們也參加了 NextGen Biomed 會議並做了兩場演講。

  • These participations at scientific conferences are crucial both for our interaction with the scientific community in general, but also very much for the continued solid execution upon our multi-partner strategy because this allows us opportunities for engaging with possible partners at the various conferences. We will continue to have a very active presence at conferences throughout the year.

    參加這些科學會議對於我們與整個科學界的互動至關重要,而且對於我們繼續穩固執行多合作夥伴策略也至關重要,因為這使我們有機會在各種會議上與潛在的合作夥伴進行接觸。我們將繼續積極參與全年的會議。

  • Before handing over to Birgitte, just a quick look at our 2025 milestones. Here, pleased to say that we have delivered on the first two milestones for the year. We are on track with the first infectious disease pipeline candidate. And even though it has been a busy first half, it's very clear, the second half is going to be even busier. We have, as I already alluded to, key milestone in the Merck decision on option exercise coming up in the second half, EVX-01 Phase 2 two-year readout, also the selection of the lead candidate for our precision ERV cancer vaccine concept.

    在交給 Birgitte 之前,我們先來快速回顧一下我們的 2025 年里程碑。在此,我很高興地說,我們已經實現了今年的前兩個里程碑。我們正在順利研發首個傳染病候選藥物。儘管上半年已經很忙碌,但很顯然,下半年將會更加忙碌。正如我已經提到的,我們在默克公司下半年即將做出的期權行使決定、EVX-01 第 2 階段兩年讀數以及我們精準 ERV 癌症疫苗概念的主要候選藥物的選擇方面取得了關鍵里程碑。

  • On business development, continue strong focus on generating new partnerships, and we have our target of at least two new agreements in 2025 in addition to yet another infectious disease candidate in the second half of the year being entered into the pipeline. So while it was busy first half, it's going to be even more busy time ahead. We are looking very much forward to that.

    在業務發展方面,我們繼續高度重視建立新的合作關係,我們的目標是在 2025 年達成至少兩項新協議,此外,在下半年還將有另一種傳染病候選藥物進入研發線。因此,雖然上半年很忙,但未來會更加忙。我們對此非常期待。

  • With that, I will hand over to you, Birgitte, for an update on all the exciting things that have happened from an R&D point of view.

    接下來,我將把時間交給你,Birgitte,從研發的角度來介紹所有發生的令人興奮的事情。

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • Thank you, Christian. So we have a very broad R&D pipeline of AI-Immunology designed vaccines, spanning two key disease areas, cancer and infectious diseases. So today, I'll walk you through some of the latest progress in these key R&D programs. I'll start with EVX-01, our personalized peptide-based cancer vaccine currently in Phase 2. And then I will also touch on our advancement in our precision cancer vaccine program targeting this novel class of tumor antigens that are shared across patients. And then lastly, I will present our progress in expanding our infectious disease vaccine pipeline.

    謝謝你,克里斯蒂安。因此,我們擁有非常廣泛的人工智慧免疫學設計疫苗研發管道,涵蓋兩個關鍵疾病領域:癌症和傳染病。今天,我將向大家介紹這些關鍵研發專案的一些最新進展。我將從 EVX-01 開始,這是我們的個人化勝肽類癌症疫苗,目前處於第 2 階段。然後,我還將談談我們針對患者共有的新型腫瘤抗原的精準癌症疫苗計畫的進展。最後,我將介紹我們在擴大傳染病疫苗研發方面的進展。

  • So EVX-01, as mentioned, is currently in Phase 2, and it's being developed as a first-line treatment for advanced melanoma. The EVX-01 vaccine includes multiple patient-specific vaccine targets, so-called new antigens, that we have identified using our AI-Immunology platform by looking into the patient's tumor mutational profile and also feeding the immune system of the patients.

    如同所提到的,EVX-01 目前處於第 2 階段,並且正在開發作為晚期黑色素瘤的第一線治療藥物。EVX-01 疫苗包含多個針對特定患者的疫苗靶點,即所謂的新抗原,這些抗原是我們利用 AI-Immunology 平台透過研究患者的腫瘤突變情況並為患者的免疫系統提供營養而識別的。

  • It's being administered in combination with immune checkpoint inhibitors with the goal of enhancing clinical efficacy. And as Christian mentioned, we presented a biomarker and T cell immune data at the annual meeting in the American Association of Cancer Research. And at this meeting, we reported that EVX-01 induced a specific immune response in all the patients assessed so far. And that 80% of the vaccine target triggered a specific immune response. And that is a frequency that is substantially higher than what has been reported for other similar vaccine candidates. Furthermore, immunizations increased and maintained the broadness of the vaccine-induced T cell responses. And with this data, we are tracking towards the two-year clinical data that we will report in the second half of this year.

    它與免疫檢查點抑制劑合併使用,目的是提高臨床療效。正如克里斯蒂安所提到的,我們在美國癌症研究協會的年會上展示了生物標記和 T 細胞免疫數據。在這次會議上,我們報告稱,EVX-01 在迄今為止評估的所有患者中都引發了特定的免疫反應。而80%的疫苗目標引發了特定的免疫反應。這頻率遠高於其他類似候選疫苗的通報頻率。此外,免疫接種增加並維持了疫苗誘導的 T 細胞反應的廣度。利用這些數據,我們正在追蹤將在今年下半年報告的兩年臨床數據。

  • So building on this positive data and to further explore the durability of both the immune response and the clinical responses, we have, as Christian mentioned, extended this trial with one additional year and we now have dosed the first patient with this extra EVX-01. Notably, during this extension phase, EVX-01 will be administered as a monotherapy, allowing us to better understand the vaccine's standalone effect. Also, the extension involves minimal additional cost as clinical sites remain active and the vaccine production is already complete. So we're looking very much forward to sharing updates from this program in the second half of '25.

    因此,基於這些積極數據並進一步探索免疫反應和臨床反應的持久性,正如克里斯蒂安所提到的,我們將這項試驗延長了一年,現在我們已經為第一位患者註射了這種額外的 EVX-01。值得注意的是,在此擴展階段,EVX-01 將作為單一療法進行使用,以便我們更了解疫苗的獨立效果。此外,由於臨床站點仍在活躍且疫苗生產已完成,因此延期僅涉及極少的額外成本。因此,我們非常期待在 2025 年下半年分享該計劃的最新消息。

  • So let's turn our focus to our promising precision vaccine concept. So in this program, we're using AI-Immunology to design a precision cancer vaccine targeting this novel and non-conventional class of antigens, so-called ERV tumor antigens, that are shared across patients in select indication. And this approach could allow for broader use of cancer vaccines. Also for patients that are less likely to respond to conventional cancer immunotherapies.

    因此,讓我們把注意力轉向有前景的精準疫苗概念。因此,在這個計畫中,我們正在使用 AI-Immunology 設計一種精準癌症疫苗,針對這種新型、非傳統的抗原類別,即所謂的 ERV 腫瘤抗原,這些抗原在特定適應症的患者之間是共享的。這種方法可以擴大癌症疫苗的用途。也適用於不太可能對傳統癌症免疫療法產生反應的患者。

  • So in this program, we have obtained proof-of-concept, demonstrating that mice that are immunized with an ERV-based vaccine, they are protected from tumor. And also that we induced a specific T cell response in these mice. Further on, we have now curated transcriptomic and proteomic tumor data from more than 3,000 cancer patients. And additionally, to identify these ERV epitopes that are presented to the immune system, we have analyzed more than 1,000 immunopeptidomics data.

    因此,在這個計畫中,我們獲得了概念驗證,證明使用基於 ERV 的疫苗免疫的小鼠可以免受腫瘤的侵害。而我們也誘導了這些小鼠體內特定的 T 細胞反應。此外,我們現在已經從 3,000 多名癌症患者中整理了轉錄組和蛋白質組腫瘤數據。此外,為了識別呈現給免疫系統的這些 ERV 抗原決定位,我們分析了 1,000 多個免疫肽組學數據。

  • And with this data at hand, we have optimized AI-Immunology to allow for an improved version of a human-lead vaccine candidate containing multiple ERV epitopes that also has a broad HLA coverage. And we are on track for the final lead selection in the second half of this year. So in parallel with designing an optimal lead candidate, we are preparing for clinical entry and have initiated IND and CTA-enabling activities including CMC and clinical trial planning.

    利用這些數據,我們優化了 AI-Immunology,從而可以開發出一種改進版的人類主導疫苗候選物,該候選物包含多個 ERV 表位,並且具有廣泛的 HLA 覆蓋範圍。我們預計在今年下半年完成最終的領導遴選。因此,在設計最佳候選藥物的同時,我們正在為臨床進入做準備,並已啟動 IND 和 CTA 支持活動,包括 CMC 和臨床試驗規劃。

  • Lastly, we are making strong progress in expanding our infectious disease vaccine pipeline. The first of two planned new vaccine candidates is on track for launching in the first half of this year. And for this initial program, we have conducted a comprehensive assessment of several bacterial pathogen targets. And this evaluation included an analysis of medical needs, commercial potential, competitive landscape, platform applicability, and both clinical and preclinical feasibility. So based on this analysis, we now have shortlisted the most promising bacterial targets. And these have been reviewed and discussed with an expert advisory panel to guide the final selection. And more to come on on this in the near future.

    最後,我們在擴大傳染病疫苗研發管道方面取得了重大進展。計劃中的兩種新型候選疫苗中的第一種有望於今年上半年推出。對於這個初始計劃,我們對幾種細菌病原體目標進行了全面評估。該評估包括醫療需求、商業潛力、競爭格局、平台適用性以及臨床和臨床前可行性的分析。因此,基於這項分析,我們現在已經列出了最有希望的細菌標靶。這些都經過了專家顧問小組的審查和討論,以指導最終的選擇。不久的將來還會有更多相關內容。

  • So in summary, we have seen significant progress across our pipeline in both oncology and infectious diseases. And with the two major milestones completed in '25 and significant progress made across the program, we are well on track for our next milestones in the second half of this year. We are, of course, looking forward to updating you as our programs continue to advance.

    總而言之,我們在腫瘤學和傳染病領域的研發過程中都取得了重大進展。隨著 25 年兩個主要里程碑的完成以及整個計劃的重大進展,我們已順利實現今年下半年的下一個里程碑。當然,隨著我們的專案不斷進步,我們也期待向您通報最新進展。

  • Christian Kanstrup - Chief Executive Officer

    Christian Kanstrup - Chief Executive Officer

  • Thank you so much, Birgitte. I think it's fair to say, no doubt that AI-Immunology really holds the potential for developing truly novel precision medicines and it's great to see the progress in the pipeline.

    非常感謝,Birgitte。我認為可以公平地說,毫無疑問,AI-Immunology 確實具有開發真正新穎的精準藥物的潛力,很高興看到該領域的進展。

  • Let's turn to some progress in numbers. I then hand over to Thomas to take us through the Q1 results, please.

    讓我們來看看數字上的一些進展。然後我請湯瑪斯向我們介紹第一季的結果。

  • Thomas Schmidt - Chief Financial Officer

    Thomas Schmidt - Chief Financial Officer

  • Thank you, Christian. So moving into the financials from Q1 2025. Let me start with the key highlights that we have seen in Q1. First and foremost, our cash position, we have significantly improved in the first quarter due to our capital market activities in Q1 and mainly even in January. So we have a cash position of EUR17.8 million, up from EUR6 million by the end of the year 2024. And with our operational cash burn, which we estimate of $14 million for the year, this also means that we have cash runway until mid-2026, which really also means it's past potential exercise of options from MSD and also the EVX-01 two-year clinical data readout.

    謝謝你,克里斯蒂安。因此從 2025 年第一季開始進入財務狀況。讓我先從我們在第一季看到的關鍵亮點開始。首先,我們的現金狀況,由於我們在第一季以及主要是一月份的資本市場活動,我們在第一季有了顯著改善。因此,到 2024 年底,我們的現金狀況將從 600 萬歐元上升至 1,780 萬歐元。我們估計今年的營運現金消耗為 1,400 萬美元,這也意味著我們的現金流量可以維持到 2026 年中期,這實際上也意味著我們已經有可能行使 MSD 的選擇權以及 EVX-01 兩年臨床數據讀數。

  • In Q1, we've seen less spending if we compare it to Q1 2024 as most of our projects have higher spending planned in the upcoming quarters. Our equity has certainly also strengthened and benefited from our capital market activities. So end of Q1, we have total equity of $10.3 million which is again a significant strengthening versus the end of 2024.

    與 2024 年第一季相比,第一季的支出有所減少,因為我們的大多數項目都計劃在未來幾季增加支出。我們的股權當然也得到了加強,並受益於我們的資本市場活動。因此,第一季末,我們的總股本為 1,030 萬美元,與 2024 年底相比再次顯著增強。

  • If I dig a little bit further into the profit and loss statement of Q1, we have recorded an operating loss of EUR3.9 million which should be compared compared to EUR4.4 million last year. Again, the overall lower operating expenses in Q1 is really the result of this. But we do expect that the project cost will pick up and increase in the coming quarters, fully aligned with our planning.

    如果我進一步研究第一季的損益表,我們記錄的營業虧損為 390 萬歐元,與去年的 440 萬歐元相比。再一次,第一季整體營運費用的下降確實是由於這一點造成的。但我們確實預計,未來幾季專案成本將會回升並增加,這與我們的計劃完全一致。

  • As mentioned also already, similar cash burn we expect this year as we had last year, so approximately EUR14 million. And also important to point out here that that does not include any potential income from business development deals, so that will come in excess to that.

    如同前面提到的,我們預計今年的現金消耗與去年類似,約 1,400 萬歐元。這裡還需要指出的是,這還不包括來自業務發展交易的任何潛在收入,因此這將超出此範圍。

  • In the Q1, we also have financial income of $2.4 million and this has come mainly from a reassessment of a derivative liability. I will speak a little bit more about our derivative liability on the following slide. But the derivative liability has come from the capital market activity in Q1 and it impacts also the financial income. And we would expect to see further impact due to reassessment of our derivative liability in the upcoming quarter as we still have approximately 50% of the derivative remaining. That means that we've recorded a net loss of EUR1.6 million in Q1 which compares to an income of EUR1.2 million last year, but also due to that we last year had a significant financial income again also from a derivative liability and reassessment of EUR5.6 million last year. So at least, from an operating loss point of view, we are in a better position this year.

    在第一季度,我們還獲得了 240 萬美元的財務收入,這主要來自於衍生負債的重新評估。我將在下一張投影片中進一步談談我們的衍生責任。但衍生負債來自於第一季的資本市場活動,它也影響了財務收入。由於我們仍有大約 50% 的衍生性商品剩餘,我們預計下一季重新評估衍生性商品負債將產生進一步的影響。這意味著我們在第一季錄得 160 萬歐元的淨虧損,而去年的收入為 120 萬歐元,但也由於此,我們去年再次從衍生負債和重新評估中獲得了 560 萬歐元的可觀財務收入。因此,至少從經營虧損的角度來看,今年我們的狀況較好。

  • Moving then to the balance sheet items, as mentioned already, strengthening equity really has been a good step forward. and with the $10.3 million we have in net equity end of Q1, we are well above also on the Nasdaq listing requirements. Also, the Nasdaq listing requirements are completely withdrawn, so the determination issue.

    然後轉到資產負債表項目,正如前面提到的,加強股權確實是一個好的開始。並且,我們在第一季末的淨股權為 1,030 萬美元,這遠高於納斯達克的上市要求。此外,納斯達克的上市要求已完全取消,因此存在決心問題。

  • Investor warrants in our public offering have an exercise price denominated in U.S. dollar. We have a functional currency in Danish crowns which then also, according to international accounting and financial standards, means that we have recorded these investor warrants as a derivative liability. However, due to development in both the U.S. dollar exchange rates and also the share price, the net impact of this derivative liability on equity is only $20,000 in the first quarter. It is important to note that as we still have approximately 50% of our warrants still denominated in U.S. dollar, we will see reassessment and we'll need to do reassessment in the upcoming quarters. Again, net impact is limited, but this is expected in the upcoming quarters.

    我們公開發行的投資者認股權證的行使價格以美元計價。我們的功能貨幣是丹麥克朗,根據國際會計和財務標準,這意味著我們將這些投資者認股權證記錄為衍生性負債。然而,由於美元匯率和股價的發展,該衍生負債對第一季股權的淨影響僅為 20,000 美元。值得注意的是,由於我們仍有大約 50% 的認股權證以美元計價,我們將看到重新評估,並且我們需要在未來幾個季度進行重新評估。再次,淨影響是有限的,但預計在未來幾季就會出現。

  • Cash and cash equivalent, as mentioned, EUR17.8 million. So really, really nice to see also that we have cash until mid-2026 in the current runway setting.

    現金和現金等價物,如上所述,1780 萬歐元。因此,真的很高興看到,在目前的跑道設置下,我們還有現金可以使用到 2026 年中期。

  • And with that, I will then hand it back to Christian for concluding remarks.

    最後,我將把發言交還給克里斯蒂安,請他做總結發言。

  • Christian Kanstrup - Chief Executive Officer

    Christian Kanstrup - Chief Executive Officer

  • Thank you so much, Thomas, for taking us through the numbers. And let me just conclude before opening up the floor for Q&A. I do hope that you agree with me from the presentation here that we are maintaining the strong execution momentum. Also, our financial position will significantly increase in cash and equity, and has been clearly moving in the right direction.

    非常感謝托馬斯向我們介紹這些數字。在開始問答環節之前,請容許我先做個總結。我確實希望您能同意我在這裡的演講,即我們正在保持強勁的執行勢頭。此外,我們的財務狀況在現金和股權方面將大幅提升,並且顯然正朝著正確的方向發展。

  • Important though is that we are tracking towards several potential value catalysts coming up in the second half of the year which is derived from our clear strategy with a strong focus on value realization through our multi-partner approach. Also, when talking about cash, our runway into mid-2026 is beyond both the two-year readout on the EVX-01 and the potential option exercise from Merck which would bring us an additional $10 million if those options exercised for EVX-B2 and EVX-B3 which in turn will give us cash into 2027.

    但重要的是,我們正在追蹤下半年出現的幾個潛在的價值催化劑,這源自於我們明確的策略,重點是透過多合作夥伴方式實現價值。此外,談到現金,我們到 2026 年中期的跑道超出了 EVX-01 的兩年讀數和默克公司的潛在期權行使,如果這些期權對 EVX-B2 和 EVX-B3 行使,將為我們帶來額外的 1000 萬美元,這反過來又會給我們到 2027 年的現金。

  • So with that, I would like to open the floor for Q&A.

    因此,我想開始問答環節。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Thomas Flaten, Lake Street Capital Markets.

    托馬斯·弗拉頓(Thomas Flaten),湖街資本市場。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Good morning, good afternoon. Thanks for taking the questions. A few for Birgitte here. In the two-year EVX-01 data, was there a meaningful bias between CD4- and CD8-positive T cells?

    早安,下午好。感謝您回答這些問題。這裡有一些是給 Birgitte 的。在兩年的 EVX-01 數據中,CD4 和 CD8 陽性 T 細胞之間是否存在有意義的偏差?

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • We mainly see CD4 T cells. So in all the samples from the patients we have analyzed, so far, we have CD4 T cells. We also see CD8 in approximately half of the patients. And I think this bias is mainly driven by the fact that EVX-01 is a peptide-based vaccine. And we know that the way that the immune system is taking up these peptides and presenting them, that directs a strong CD4 T cell response.

    我們主要看到 CD4 T 細胞。因此,到目前為止,我們分析的所有患者樣本中都有 CD4 T 細胞。我們也發現大約一半的患者有 CD8。我認為這種偏見主要是因為 EVX-01 是一種基於勝肽的疫苗。我們知道,免疫系統吸收並呈現這些勝肽的方式會引發強烈的 CD4 T 細胞反應。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Excellent. That's very helpful. Thank you. And then on the lead ERV candidate that you have, is it the intention that that will be an ERV hotspot vaccine only or will you combine that with a personalized cancer (inaudible) antigens?

    出色的。這非常有幫助。謝謝。那麼,對於您擁有的主要 ERV 候選疫苗,您是否打算將其僅用作 ERV 熱點疫苗,還是將其與個人化癌症(聽不清楚)抗原結合?

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • So the idea with this precision concept is to do an off-the-shelf vaccine. So we basically are able to design a vaccine that has what we call, broad coverage, meaning that patients with a different immune system and also expression profiles of these tumor antigens would benefit from receiving this type of therapy. So it is a precision-based vaccine. And we will, at least not in the beginning, combine it with any other types of vaccines, including personalized approaches.

    因此,這種精準概念的想法是製造一種現成的疫苗。因此,我們基本上能夠設計出一種具有廣泛覆蓋範圍的疫苗,這意味著具有不同免疫系統以及這些腫瘤抗原表現譜的患者將受益於接受這種類型的治療。所以它是一種精準疫苗。而且我們不會將其與任何其他類型的疫苗結合使用,至少在開始時不會,包括個人化方法。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Understood. And then one final one for me. There was news last week out of the UK that they were going to repurpose a meningitis vaccine for gonorrhea. It looks like it provides limited protection. I was just curious if you had any thoughts on that or what maybe your partners at Merck might have said about that that roll out.

    明白了。對我來說還有最後一個。上週英國有消息稱,他們準備將腦膜炎疫苗改用於治療淋病。看起來它提供的保護有限。我只是好奇您對此有何想法,或者默克公司的合作夥伴對此有何看法。

  • Christian Kanstrup - Chief Executive Officer

    Christian Kanstrup - Chief Executive Officer

  • Before Birgitte speaks to the scientific content, I can just say, Thomas, I mean, of course, this just shows the level of desperation for having some effective therapy or a preventive therapy for gonorrhea, right? Looking at the numbers that also was disclosed for the number of cases in the UK, it's a pretty significant increase. So it's clear that something needs to be done. And of course, this gives us a lot of comfort with regards to the commercial potential for EVX-B2. And then, Birgitte, you can speak to the scientific rationale which of course is there.

    在 Birgitte 談到科學內容之前,我只能說,托馬斯,我的意思是,當然,這只是表明了人們對找到有效的治療方法或預防淋病療法的迫切程度,對嗎?從英國公佈的病例數來看,這是一個相當顯著的增長。因此顯然我們需要採取一些行動。當然,這讓我們對 EVX-B2 的商業潛力充滿信心。然後,Birgitte,你可以談談當然存在的科學原理。

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • The scientific rationale is there and it's also been known for a while that there is cross-protection to gonorrhea. But it's far from complete, meaning that there's definitely a need for more precision vaccine that would give a broader protection. We have not discussed it with our collaborators at MSD.

    有科學根據,人們也早就知道它對淋病有交叉保護作用。但它還遠未完成,這意味著肯定需要更精確的疫苗來提供更廣泛的保護。我們尚未與 MSD 的合作夥伴討論此事。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Got it. Thanks for taking the questions.

    知道了。感謝您回答這些問題。

  • Operator

    Operator

  • (Operator Instructions) Dear speakers, there are no further questions for today. I would now like to hand the conference over to your speaker, Christian Kanstrup, for any closing remarks.

    (操作員指示)尊敬的發言者,今天沒有其他問題了。現在,我想將會議交給發言人 Christian Kanstrup,請他做最後發言。

  • Christian Kanstrup - Chief Executive Officer

    Christian Kanstrup - Chief Executive Officer

  • I would just like to say thank you so much to everyone for listening in to our Q1 business update call. We are looking very much forward to the continued execution upon our strategy. And we'll, of course, keep you all informed when relevant news unfolds and I'm looking forward to staying in touch with all of you. So thank you so much to all of you for taking the time, for listening in. And I wish you all a good day.

    我只想對大家收聽我們的第一季業務更新電話會議表示衷心的感謝。我們非常期待我們的策略能夠繼續執行。當然,當相關消息公佈時,我們會及時向大家通報,我期待與大家保持聯繫。非常感謝大家抽空收聽。祝大家有個愉快的一天。