Evaxion A/S (EVAX) 2025 Q3 法說會逐字稿

完整原文

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

  • Hello and welcome to the Evaction Business update and 3rd quarter 2025 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a telephone question, please press 11 on your keypad to join the queue. To withdraw your question, press 11 again.

    大家好,歡迎收聽 Evaction Business 最新進展和 2025 年第三季財務業績報告。目前,所有參與者均處於唯讀模式。演講結束後,將進行問答環節。如需電話諮詢,請按鍵盤上的 11 加入隊列。若要撤回您的問題,請再按 11。

  • Please be advised that today's conference is being recorded.

    請注意,今天的會議正在錄影。

  • I would now like to hand over to Birgitte Rønø, interim CEO and CSO. Please go ahead.

    現在我想把麥克風交給臨時執行長兼首席策略長 Birgitte Rønø。請繼續。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Thank you. Good morning and good afternoon, and thank you all for joining our Q3 2025 business update and financial resource conference call.

    謝謝。各位早安、下午好,感謝各位參加我們2025年第三季業務更新和財務資源電話會議。

  • I'm Vigito Rohne, Chief Scientific Officer and interim CEO of Election.

    我是 Vigito Rohne,Election 的首席科學長兼臨時執行長。

  • I'm joined today by Summer Smith, Chief Financial Officer, and Ms. Kromborg, Vice President of Investor Relations and communications.

    今天與我一同出席的有財務長薩默·史密斯女士和投資者關係與傳播副總裁克羅姆博格女士。

  • I'll begin by walking through the agenda for today's presentation.

    我先來梳理一下今天演講的議程。

  • I'll start with a brief introduction followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, I will, we will open for questions.

    我將首先做一個簡短的介紹,然後報告研發進展,之後 Thomas 將介紹第三季財務表現。最後,在作了一些總結性發言後,我們將開放提問環節。

  • I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risk and uncertainties, and actual results may differ materially.

    我想提醒大家,今天的演講可能包含前瞻性陳述,這些陳述有風險和不確定性,實際結果可能與預期有重大差異。

  • First and foremost, I'm pleased to welcome Dr. Helen Taylor Martin as the new CEO of Election, effective November 24th.

    首先,我很高興地歡迎海倫泰勒馬丁博士擔任選舉公司的新任首席執行官,自 11 月 24 日起生效。

  • So Doctor Seyton Martin brings extensive biotech leadership, fundraising and partnership experience.

    塞頓馬丁博士擁有豐富的生物技術領導、籌款和合作經驗。

  • Helen co-founded Adapt Immune and has held several senior executive roles in Adapt Immune. Helen holds a PhD in molecular immunology and an MPDA.

    Helen 共同創立了 Adapt Immune 公司,並在 Adapt Immune 公司擔任多個高階管理職。海倫擁有分子免疫學博士學位和MPDA證書。

  • And with more than 30 years of experience in early research through product approval, Helen is an ideal candidate to lead the next stages of election strategy.

    海倫擁有超過 30 年的早期研究到產品審批經驗,是領導下一階段選舉策略的理想人選。

  • This also means that I will return to my previous role as CSO and with Helen's transition from director in the board to CEO, Jens Pit Nahe will join the board as an advisor and observer with the intention to seek election at the next ATM.

    這也意味著我將恢復擔任首席戰略官一職,隨著海倫從董事會董事過渡到首席執行官,延斯·皮特·納赫將作為顧問和觀察員加入董事會,併計劃在下屆ATM會議上競選。

  • Since the last business update, we have made several significant achievements.

    自上次業務更新以來,我們取得了一些重大成就。

  • And historic in licensing of EVXB3 by ESC providing significant cash and validation.

    ESC 對 EVXB3 的授權具有歷史意義,提供了可觀的資金和認可。

  • The extension evaluation period or the evaluation period for EDXB2 has been extended.

    EDXB2 的擴展評估期或評估期已延長。

  • We have several ongoing partnership discussions, though market uncertainty affects geo climate.

    我們目前正在進行多項合作洽談,但市場的不確定性會影響地理環境。

  • We have presented two-year clinical efficacy data for EVX01 at the ESMO Congress, and we have added EVX04, a novel therapeutic cancer vaccine for acute myeloid leukemia to our pipeline.

    我們在 ESMO 大會上公佈了 EVX01 的兩年臨床療效數據,並且我們還將 EVX04(一種用於治療急性髓性白血病的新型治療性癌症疫苗)添加到了我們的研發管線中。

  • We have expanded our AI immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time.

    我們擴展了人工智慧免疫學平台,增加了自動化疫苗設計模組,提高了疫苗品質並縮短了疫苗設計時間。

  • Lastly, we have strengthened our financial position, and we now have a cash runway extended to the second half of 2027.

    最後,我們加強了財務狀況,目前的現金流足以支撐到 2027 年下半年。

  • And this is based on a $7.5 million US dollar option exercise fee received from MSD and an additional capital market funding sources. And Thomas will share detail around this.

    這是基於從 MSD 收到的 750 萬美元選擇權行使費以及其他資本市場資金來源。托馬斯將分享更多細節。

  • So as mentioned, one of the main highlights of the quarter is the MSD transformative field.

    如同前面所提到的,本季的主要亮點之一是MSD的轉型領域。

  • So in September 25th.

    所以是在9月25日。

  • It was a historical moment for a vaccine with MSD or MERC exercising their option on EVXB3. So this was the first ever in licensing of an AI discovered vaccine candidate by a major pharma company.

    對於疫苗而言,這是一個歷史性的時刻,因為默沙東(MSD)或默克公司(MERC)行使了對EVXB3的選擇權。這是大型製藥公司首次獲得人工智慧發現的候選疫苗的授權許可。

  • And as mentioned, the $7.5 million dollar exercise fee extends our cash runway significantly.

    如同前面所提到的,750萬美元的行權費大大延長了我們的現金儲備。

  • This deal confirms our strategy of value creation through partnerships even with industry giants like MSD.

    這項交易證實了我們透過合作創造價值的策略,即使是與像默沙東這樣的產業巨頭合作也是如此。

  • It also validates our AI immunology and RD pipeline and further ensures the development of EVX3 without cost per election.

    它還驗證了我們的人工智慧免疫學和研發管線,並進一步確保了 EVX3 的開發無需每次選舉的成本。

  • And not related to the EVXD3 deal as such, the EVXP 2 evaluation period has been extended.

    與 EVXD3 交易本身無關,EVXP 2 的評估期間已延長。

  • So 2025 is shaping up to be a pivotal year for eviction.

    因此,2025年很可能成為驅逐案件的關鍵一年。

  • We've achieved several key milestones since the last business update. As mentioned, MSD exercised the option on EVXV3. We presented two-year clinical outcome data from our EVXO1 phase 2 study, and we have announced the addition of EVXO4 to our pipeline. And EVXO4 is the lead candidate for our persistent cancer vaccine.

    自上次業務更新以來,我們已經取得了幾個關鍵里程碑。如前所述,MSD 行使了 EVXV3 的選擇權。我們公佈了 EVXO1 2 期研究的兩年臨床結果數據,並宣布將 EVXO4 加入我們的產品線。EVXO4 是我們針對頑固性癌症研發的領先候選疫苗。

  • And looking ahead, we are expecting to provide further R&D and business development updates.

    展望未來,我們期待提供更多研發和業務發展的最新資訊。

  • So let's just focus to our recent R&D and AI immunology progress.

    那麼,我們就專注於我們近期在研發和人工智慧免疫學方面取得的進展。

  • PDXO-4 is our novel AI designed cancer vaccine candidate targeting non-conventional antigens from the dark genome, so-called endogenous retroviruses or herbs. And these herbs are specifically expressed in cancers but dormant in normal tissue, making them an attractive target for cancer vaccines.

    PDXO-4 是我們新設計的 AI 癌症疫苗候選藥物,針對來自暗基因組的非常規抗原,即所謂的內源性逆轉錄病毒或草藥。這些草藥在癌細胞中特異性表達,但在正常組織中處於休眠狀態,因此它們是癌症疫苗的理想標靶。

  • EVX 4 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia.

    EVX 4 是一種治療性癌症疫苗,旨在誘導急性髓系白血病的免疫控制。

  • Where we know relapses remain a major challenge.

    我們知道,復發仍然是一個重大挑戰。

  • The vaccine is based on our AI immunology platform leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that matches the herb expression profile and also the immune characteristics in patients.

    該疫苗基於我們的人工智慧免疫學平台,利用我們的發現引擎來識別多個最佳的腫瘤特異性表位,這些表位與草藥表達譜以及患者的免疫特徵相符。

  • And we have now designed the lead candidate and have conducted pre-clinical studies.

    我們現在已經設計出主要候選藥物,並進行了臨床前研究。

  • Next steps include GMP manufacturing and additional I&D enabling studies to prepare for a first in human study.

    下一步包括進行符合GMP標準的生產以及進行額外的研發支援研究,為首次人體試驗做好準備。

  • With the EVX1 lead vaccine candidates selected, the program has been added to our pipeline.

    EVX1 領先疫苗候選藥物已選定,該計畫已加入我們的研發管線。

  • Further changes include the removal of the EVXO2 program as we do not have any active development currently ongoing on this program. The EVXO 2 vaccine program serves as proof of concept for DNA delivery of new antigens and has informed on the design of both EVX 03 and 04.

    其他變更包括取消 EVXO2 計劃,因為我們目前沒有在該計劃上進行任何積極的開發工作。EVXO 2 疫苗計劃驗證了 DNA 遞送新抗原的概念,並為 EVX 03 和 04 的設計提供了資訊。

  • Our lead program EV X1.

    我們的主導項目 EV X1。

  • A personalized cancer vaccine that includes multiple patient-specific targets, so-called new antigens that we identify with our AI immunology platform from patient tumor material.

    一種個人化癌症疫苗,包含多個患者特異性靶點,即我們利用人工智慧免疫學平台從患者腫瘤材料中識別出的所謂新抗原。

  • EDXO1 is administered in combination with pembrolizumab and immune checkpoint inhibitor to enhance the clinical efficacy.

    EDXO1 與帕博利珠單抗和免疫檢查點抑制劑合併使用,以增強臨床療效。

  • So in October, we presented 2-year clinical outcome data from our phase 2 trial in an oral session at the ISO Congress.

    因此,在 10 月份,我們在 ISO 大會上以口頭報告的形式展示了我們 2 期試驗的 2 年臨床結果數據。

  • And the results are highly en encouraging and were received both by the scientific and medical community.

    研究結果令人鼓舞,受到了科學界和醫學界的一致好評。

  • So at the congress, we reported a 75% objective overall response. We also saw that 11 out of 12 patients that responded had a sustained response at 2 years mark.

    因此,在大會上,我們報告了75%的客觀整體回饋。我們也發現,12 名有反應的患者中有 11 名在 2 年時仍保持療效。

  • We also saw a 34% conversion rate, meaning that patients with stable disease or partial response deepened their response upon EVXO1 treatment.

    我們也觀察到 34% 的轉換率,這意味著病情穩定的患者或部分緩解的患者在接受 EVXO1 治療後病情加深。

  • So we find the clinical outcome data very encouraging, and further, we believe that they compare favorably to historical pimple monotherapy data.

    因此,我們發現臨床結果數據非常令人鼓舞,而且,我們認為它們與以往的痤瘡單一療法數據相比也具有優勢。

  • Equally encouraging is the strong immunological activity of EVX01, which is critical for long-term efficacy. So, in all patients treated with EVXO1, we saw a new antigen-specific T cell response.

    同樣令人鼓舞的是 EVX01 具有很強的免疫活性,這對於長期療效至關重要。因此,在所有接受 EVXO1 治療的患者中,我們都觀察到了新的抗原特異性 T 細胞反應。

  • Further, when assessing the individual new antigen immune responses, We demonstrated that 81% of the vaccine new antigens administered across patients were immogenic. So this high hit rate provides strong evidence of the predictive power of our AI immunology platform.

    此外,在評估個別新抗原免疫反應時,我們證明,在所有患者中接種的疫苗新抗原中有 81% 具有免疫原性。因此,如此高的命中率有力地證明了我們人工智慧免疫學平台的預測能力。

  • We also showed that the immune responses were sustained throughout the two-year trial period. Even after dosing, after the dosing period ended, T cell activity remained high, indicating lasting immune memory.

    我們也證明,在為期兩年的試驗期間,免疫反應一直持續存在。即使在給藥期結束後,T 細胞活性仍然很高,顯示免疫記憶持久存在。

  • And doable see cell responses are essential for preventing relapses and in achieving long-term control of melanoma.

    而且,細胞反應對於預防復發和實現黑色素瘤的長期控制至關重要。

  • So this reinforces the potential of EVX1 as a personalized immunotherapy that not only drives a tumor shrinkage in combination with a standard of care, but also builds on a robust immune defense.

    因此,這進一步證實了 EVX1 作為一種個人化免疫療法的潛力,它不僅可以與標準療法結合,縮小腫瘤,而且還能增強免疫防禦能力。

  • As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development timelines.

    如前所述,我們的人工智慧平台新增了自動化疫苗設計模組,顯著縮短了設計時間,並加快了研發進度。

  • It enables us to optimize vaccine candidates with high resistance both for new and approved vaccines.

    它使我們能夠優化具有高抗藥性的候選疫苗,包括新疫苗和已批准的疫苗。

  • So from data input to candidate generation, the process is now fully automated, ensuring optimal sequence and confirmation of vaccine targets.

    因此,從數據輸入到候選疫苗生成,整個過程現在完全自動化,確保了疫苗標靶的最佳序列和確認。

  • And as mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. And further, it seamlessly connects the down with downstreet processes supporting a smooth transition from design to production.

    如前所述,與傳統方法相比,新模組可以加快疫苗研發速度,同時降低成本。此外,它還能將底層流程與底層流程無縫連接,從而支援從設計到生產的平穩過渡。

  • And the design module has already been applied in some of our key R&D projects. First example is the use of the module to identify and select regions of an antigen that can be expressed. So we noticed that the full length of a particular antigen could not be expressed due to solubility constraints. But when we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen.

    此設計模組已應用於我們的一些重點研發專案。第一個例子是使用該模組來識別和選擇可以表達的抗原區域。因此我們注意到,由於溶解度的限制,特定抗原的全長無法表現。但是,當我們應用新模組時,我們發現了抗原的截短變體,這些變體可以表達,從而可以對該抗原進行臨床前評估。

  • Another example of the application is that we can with the module predict most optimal sequences of a vaccine target based on a given antigen protein structure.

    這個模組的另一個應用實例是,我們可以根據給定的抗原蛋白結構預測疫苗標靶的最佳序列。

  • And here we have also been able to rescue a how to express protein that would require labor-intensive and trial and error design approaches to find expressible constructs.

    而且,我們也成功地解決瞭如何表達蛋白質的問題,而這需要耗費大量人力和反覆試驗的設計方法才能找到可表達的結構。

  • So with this new design module, it positions us at the forefront of AI-driven vaccine innovation and further enables us to move fast from target discovery to final product candidate.

    因此,有了這個新的設計模組,我們便處於人工智慧驅動疫苗創新的前沿,並進一步使我們能夠快速從目標發現過渡到最終候選產品。

  • So in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. And we look forward to updating you as our programs continue to advance.

    總而言之,我們在研發流程和人工智慧平台方面取得了顯著進展,並且正朝著下一個里程碑穩步前進。我們將隨著專案的持續推進,及時向您報告最新進展。

  • So with that, I would like to give the word to Thomas to present the financial results.

    那麼,接下來我將交給湯瑪斯介紹財務績效。

  • Thomas Schmidt - Investor Relation

    Thomas Schmidt - Investor Relation

  • Yes, thank you, Pegile.

    是的,謝謝你,佩吉爾。

  • I am happy to present the financial results for the quarter and maybe let me just start with an overview of the achievements that we have done throughout the year up until now based on strong execution of our financial strategy. As we can see here on the slide also throughout the year, we have made a number of activities with capital market activities with of course also the agreement that we did with the European Investment Bank of debt conversion plus also MSD out licensing of the EVX.

    我很高興向大家介紹本季的財務業績,或許我可以先概述一下我們今年迄今在有效執行財務策略方面所取得的成就。正如我們在幻燈片中看到的那樣,在過去一年中,我們開展了許多資本市場活動,當然也包括我們與歐洲投資銀行達成的債務轉換協議,以及MSD對EVX的授權。

  • So throughout the year and up until the end of October, we have activities in the to the sound of $31.8 million US dollar, all which basically helps strengthening our equity and certainly also our runway which is now extended into the second half of 2027. So really good and strong achievement and following the financial strategy that we have laid out.

    因此,從今年到 10 月底,我們的活動總額將達到 3,180 萬美元,這基本上有助於增強我們的權益,當然也有助於延長我們的資金周轉期,現在已延長至 2027 年下半年。所以,這是一項非常好的、強勁的成就,也是我們依照既定財務策略執行的結果。

  • If we zoom in on the 3rd quarter and the highlights from the 3rd quarter, we certainly have had a strong financial quarterly performance.

    如果我們聚焦第三季及其亮點,我們無疑取得了強勁的季度財務表現。

  • As mentioned, the cash runway now has been extended into the second half of 2027.

    如前所述,現金儲備已延長至 2027 年下半年。

  • And we've also seen in the quarter the auction exercised by Merck or NSD, which not only provides cash income now but also has a future revenue income of potentially up to $592 million.

    我們還看到,本季度默克公司(NSD)行使了拍賣權,這不僅提供了當前的現金收入,而且未來還有可能帶來高達 5.92 億美元的收入。

  • We are well on track also in the 3rd quarter on delivering on our financial targets for the full year and throughout the quarter we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income, so really a good and strong quarter.

    第三季度,我們在實現全年財務目標方面也進展順利。本季度,我們透過歐洲投資銀行的債務轉換以及默沙東的收入,真正鞏固了我們的權益,因此這是一個非常好的強勁季度。

  • If we look a little bit closer on the profit and loss elements of it, clearly the revenue from NSD drives the first drives the quarterly operational gain, the first of its kind for action. But also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter. So also from earlier communications we expect from a cash flow perspective to still hit around about the 14 million operating cash flow level.

    如果我們更仔細地看一下損益表,很明顯,NSD 的收入是推動季度營運收益的主要因素,這是同類行動中的第一次。但同樣重要的是,我們的營運費用不僅控制得很好,而且實際上還略低於去年同期水平,與上一季基本持平。因此,根據先前的溝通,我們預計從現金流的角度來看,營運現金流仍將達到 1,400 萬美元左右。

  • Net financials in the quarter is to the sound of 1.3 million.

    本季淨財務數據約 130 萬。

  • Driven by the debt conversion that we did in July. The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10th. That premium has been recorded on the financial income for the quarter.

    受我們7月份進行的債務轉換的影響。7 月與歐洲投資銀行的債務轉換以 7 月 10 日收盤時 89% 的股價溢價完成。此筆溢價已計入本季財務收入。

  • And that then brings the income from the quarter to the $4.6 million US dollar.

    這樣一來,該季度的營收就達到了 460 萬美元。

  • Turning to the balance sheet, we certainly, as mentioned already, have continued the strong execution that also has improved our equity. The equity now stands at the end of the quarter at $16.6 million US dollars. Included in the equity is a derivative liability with the net impact of $1.5 million.

    就資產負債表而言,正如前面提到的,我們當然繼續保持了強勁的執行力,這也提高了我們的權益。截至本季末,公司淨資產為1660萬美元。權益中包含一項衍生負債,其淨影響為 150 萬美元。

  • The derivative stems from our public offering in January and the investor warrants that we had from from that date. However, in October we have seen.

    該衍生性商品源自於我們 1 月的公開發行以及我們自該日起持有的投資者認股權證。然而,我們在十月已經看到了。

  • We have seen, as mentioned already, warrant exercises of 2.7 million, which means that this net impact of the derivative will be at a minimum value at the end of the year.

    如前所述,我們已經看到 270 萬份認股權證被行使,這意味著到年底,該衍生品的淨影響將達到最低值。

  • So, also a good outcome.

    所以,這也是個好結果。

  • It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrants of 2.8 million.

    這也使我們未行使的認股權證減少了 100 萬份 ADS,目前我們還有 280 萬張未行使的認股權證。

  • Also important to note is that our cash balance end of June is at a sound and solid $10.6 million US dollar.

    另需注意的是,截至 6 月底,我們的現金餘額為穩健的 1,060 萬美元。

  • And we'll see further cash income as we cash flow in as we received in October the revenue income from MSD and also the cash from the sales of shares due to the investor point exercise.

    隨著 10 月收到來自 MSD 的收入以及投資者行使積分出售股票所得的現金,我們將看到更多的現金收入流入。

  • And last but not least, the debt conversion.

    最後,也是非常重要的一點,就是債務轉換。

  • To debt to equity conversion with the European Investment Bank, it really has strengthened our balance sheet, has improved our cash flow as we move forward, and has certainly also lowered our leverage. So really a great outcome from that event also.

    透過與歐洲投資銀行進行債務轉股權,我們確實加強了資產負債表,改善了現金流,並且肯定降低了槓桿率。所以那次活動也確實有了非常好的結果。

  • So a good solid quarter following along our financial strategy.

    所以,本季表現穩健,符合我們的財務策略。

  • And with that, I then hand it back to the Birgitte.

    然後,我把它還給了比爾吉特。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Thank you so much.

    太感謝了。

  • So lastly, as a conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority and multiple parallel partnership discussions are currently ongoing.

    最後,作為總結性發言,我想強調的是,我們目前擁有強勁的營運動能。我們已經實現了 2025 年的大部分里程碑,並且正朝著幾個潛在的價值催化劑穩步前進。業務拓展仍是重中之重,目前我們同時進行多項合作洽談。

  • Cash one ray is extended to the second half of 2027.

    現金第一線計畫延至 2027 年下半年。

  • And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. Please follow the operator's instructions.

    最後,感謝各位抽出寶貴時間關注,我們很樂意回答任何問題。請遵照操作員的指示。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you. As a reminder, if you wish to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, press 11 again.

    謝謝。再次提醒,如果您有任何問題想要提問,請按電話上的 11 鍵,然後等待播報您的名字。若要撤回您的問題,請再按 11。

  • Please stand by while we prepare the first question.

    請稍等,我們正在準備第一個問題。

  • First question comes from Soumit Roy at Jones Trading. Your line is open. Please go ahead.

    第一個問題來自 Jones Trading 的 Soumit Roy。您的線路已開通。請繼續。

  • Soumit Roy - Investor Relation

    Soumit Roy - Investor Relation

  • Good morning, everyone, and congratulations on all the progress this quarter. A quick question on the, yeah, EVXO1.

    各位早安,祝賀大家本季的所有進展。關於 EVXO1,我有個問題想問一下。

  • What are, if you can give us any color on the, Potential partnership deal like what seems, what is the key, question that you're getting there from a partner they want to wait for a much longer-term data or any other, key achievements you have to present for a successful deal.

    如果您能透露一些關於潛在合作交易的信息,例如您認為關鍵是什麼,或者您從合作夥伴那裡得到的問題是什麼,他們是否希望您提供更長期的數據或其他關鍵成果,以便達成成功的交易,請告訴我們。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yeah, thank you for that question. So we just presented the, as mentioned, the two-year clinical outcome data. And I would say that we have moved from Questions around quality of data, how does your platform work to more? How can we apply your technology within perhaps other types of cancer and cancer indication. So the data was received well and we have been discussing it with key opinion leaders. We have also been discussing it with potential partners. And the strate is that we will out license it at the current development stage, and then the partner can, of course, decide on potential next steps. If we continue on the track we are currently with advanced melanoma, the next, most likely step would be to conduct a larger randomized control study, comparing The combination of EVX01 plus standard of care to standard of care alone.

    是的,謝謝你的提問。如同前面提到的,我們剛才展示了兩年的臨床結果數據。我想說,我們已經從圍繞著數據品質、平台如何運作等問題,轉向了更多?我們如何將你們的技術應用於其他類型的癌症和癌症適應症?因此,這些數據得到了很好的迴響,我們一直在與關鍵意見領袖進行討論。我們也一直在與潛在合作夥伴討論此事。我們的策略是,在目前的開發階段,我們將對外授權,然後合作夥伴當然可以決定下一步的計畫。如果我們繼續沿著目前治療晚期黑色素瘤的道路前進,下一步最有可能的做法是進行更大規模的隨機對照研究,比較 EVX01 聯合標準治療與單獨使用標準治療的效果。

  • So that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a A high mutational burden, meaning that we can select a high-quality new antigens and formulate a vaccine that would benefit the patient. So multiple different discussions are ongoing and also different questions are coming our way. But generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward. Together and find solutions for manufacturing and also for for other indications.

    所以這至少是一種選擇,但我們也看到了將我們的技術應用於其他疾病或癌症適應症的潛力,在這些疾病或癌症適應症中,突變負荷較高,這意味著我們可以選擇高品質的新抗原並配製一種對患者有益的疫苗。因此,目前正在進行多場不同的討論,同時也有各種各樣的問題向我們提出。但總的來說,問題不在於數據的品質或數據的影響,而是我們如何才能推進這項工作。共同尋找製造方面的解決方案,以及其他適應症方面的解決方案。

  • Soumit Roy - Investor Relation

    Soumit Roy - Investor Relation

  • Got it.

    知道了。

  • Thank you.

    謝謝。

  • Thank you for that. One last question, congrats on unveiling the EVX04 in the AML program.

    謝謝。最後一個問題,恭喜你們在反洗錢計畫中推出 EVX04。

  • If you can give us a slight, understanding on the target or how is it expressed on, A stem cells, like, CD123 have been tried and trying to understand what the differentiation from this target is.

    如果您能稍微解釋一下靶點或它在幹細胞上的表達方式,例如 CD123,我們已經嘗試過,並試圖了解從該靶點分化出來的機制,那就太好了。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yeah, no, this is a very good question. So the way that we have, applied our AI immunology platform is that we look at, genomic and transcriptomic data and for this particular. Type of antigens, we mainly looked at transcriptomic data. So the, sequences that are being expressed as messenger RNA or RNA in general, in the tumors.

    是的,這確實是個好問題。因此,我們應用人工智慧免疫學平台的方式是,我們查看基因組和轉錄組數據,對於這個特定的例子來說。對於抗原類型,我們主要研究了轉錄組數據。因此,在腫瘤中以信使 RNA 或一般 RNA 形式表現的序列。

  • And then we have looked, we started out by actually analyzing several different types of novel classes of antigens. And we realized that in certain indications, and AML is one of them, there's a very high expression level of these endogenous retroviral sequences.

    然後我們進行了研究,我們首先分析了幾種不同類型的新型抗原。我們意識到,在某些疾病中(例如急性骨髓性白血病),這些內源性逆轉錄病毒序列的表達量非常高。

  • From the dark genome, meaning that we can across patients find, share sequences, and put them into a vaccine, and thereby, being able to Support several patients with one single vaccine. So this is an off the shelf approach where we will be able to use the same vaccine across the different tumor profiles and also the across the different immune characteristics of the patients.

    從暗基因組來看,這意味著我們可以跨患者尋找、共享序列,並將它們放入疫苗中,以便能夠用一種疫苗支持多名患者。所以這是一種現成的解決方案,我們可以將同一種疫苗用於不同的腫瘤類型以及患者不同的免疫特徵。

  • But we're still using AI immunology and our core technology to identify the most optimal antigens. Now, it's just coming from the dark genome.

    但我們仍然利用人工智慧免疫學和我們的核心技術來識別最佳抗原。現在,它完全來自黑暗基因組。

  • Soumit Roy - Investor Relation

    Soumit Roy - Investor Relation

  • Got it.

    知道了。

  • Thank you so much and congratulations again on the progress.

    非常感謝,再次恭喜你的進展。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Thank you.

    謝謝。

  • Soumit Roy - Investor Relation

    Soumit Roy - Investor Relation

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Please stand by for your next question.

    請稍等,您的下一個問題即將到來。

  • The next question comes from Nelson Cox at Lake Street Capital. Your line is open. Please go ahead.

    下一個問題來自 Lake Street Capital 的 Nelson Cox。您的線路已開通。請繼續。

  • Nelson Cox - Investor Relation

    Nelson Cox - Investor Relation

  • Hey, Nelson on for Thomas, congrats on all the progress here this quarter. I'll maybe ask my two upfront, and apologies if I've kind of missed some of this. I've had some technical issues, but a lot of updates here as of late, maybe at a high level. Can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? And then when you look at the proportion of your business development conversations you're having today. Can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline. Thanks.

    嘿,尼爾森替補托馬斯上場,祝賀你本季的所有進步。我可能會先問我那兩位,如果我漏掉了什麼,請見諒。我遇到了一些技術問題,但最近這裡有很多更新,可能是一些比較高層次的更新。請您談談您在整個銷售管道中開展的合作洽談的整體範圍,以及這些洽談在過去一年中是如何演變的?然後,當你檢視一下你目前進行的業務拓展對話的比例。您能否談談貴公司有多少專案專注於標靶發現,又有多少專案已經進入研發流程?謝謝。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yeah, hi, Thomas.

    嗨,托馬斯。

  • Thank you for that question. So, we do have multiple, dialogues ongoing, and I would say that they are, across, the interest is across our, R&D pipeline but also centered around our capabilities for identifying novel targets. So classical target discovery programs. There's interest in our oncology programs and there's also interest in our infectious disease program. So it's a little bit mixed, I would say. And some companies do have a Preferences in infectious disease. Some do have interest in both vaccine candidates that we have developed and in in target discovery collaborations. So a little bit of mix and that confirms, I would say our strategy is to monetize on both our own in-house developed vaccine candidates, but also to enter into infected or target discovery collaborations. I cannot comment so much on exactly where we are, as it's really difficult to speculate exactly on the timing, of when these different, Dialogues would move into a, a real deal. But a lot of activities and we can see that the interest is increasing when we have a major data readouts as we have had in this, last quarter with the EDX1 phase two data coming out.

    謝謝你的提問。所以,我們確實正在進行多項對話,我認為這些對話不僅涵蓋了我們的研發管線,而且還圍繞著我們識別新靶點的能力。所以,經典的標靶發現項目。人們對我們的腫瘤學課程很感興趣,對我們的傳染病計畫也很感興趣。所以我覺得情況有點複雜。有些公司確實對傳染病有特定的偏好。有些人對我們開發的候選疫苗和標靶發現合作都感興趣。所以,這其中也包含了一些混合因素,這也證實了我們的策略是,既要透過我們自己內部開發的候選疫苗來獲利,也要與感染源或標靶發現領域合作。我無法就我們目前所處的具體位置發表太多評論,因為很難準確推測這些不同的對話何時會發展成真正的行動。但是,我們有很多活動,我們可以看到,當有重大數據公佈時,人們的興趣會越來越高,就像上個季度 EDX1 第二階段數據公佈時一樣。

  • Nelson Cox - Investor Relation

    Nelson Cox - Investor Relation

  • Great, thanks for.

    太好了,謝謝。

  • Operator

    Operator

  • Taking questions.

    回答問題。

  • Please stand by for your next question.

    請稍等,您的下一個問題即將到來。

  • As a reminder, if you do have a question, please press 11 on your telephone.

    再次提醒,如果您有任何疑問,請按電話上的 11。

  • The next question comes from Ramakanth Swayampakula - H.C. Wainwright & Co., LLC. Your line is open, please go ahead.

    下一個問題來自 Ramakanth Swayampakula - H.C. Wainwright & Co., LLC。您的線路已開通,請繼續。

  • Ramakanth Swayampakula - Investor Relation

    Ramakanth Swayampakula - Investor Relation

  • Thank you. This is RK from Hetsy Wered, good afternoon, together and team.

    謝謝。我是來自 Hetsy Wered 的 RK,下午好,大家好。

  • So suddenly, there are very interesting developments going on, at the company. So, can we focus for a second on your automated design module, which is, yet another, interesting, AI design, drug design, module that you have.

    公司裡突然出現了一些非常有趣的新動向。那麼,我們能否花一點時間關註一下你們的自動化設計模組呢?這是你們另一個非常有趣的AI設計、藥物設計模組。

  • So how should we think about this, is this something, That can help your internal designing, I mean designing of your internal molecules only or or is this up for entering into partnerships or can you utilize this as a separate licensing.

    那我們該如何看待這個問題呢?這是否能幫助你進行內部設計,我的意思是僅用於設計你內部的分子,或者這是否可用於建立合作夥伴關係,或者你是否可以將其作為單獨的許可使用?

  • Situation where, any of your partners could take that into their own, computing systems and run on their own proprietary molecules, how, it looks like there's a lot of, places where this thing could go and what are your thoughts on that?

    如果你們的任何合作夥伴都可以將該技術應用到他們自己的電腦系統中,並在他們自己的專有分子上運行,這看起來有很多應用前景,你們對此有何看法?

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yes, you're absolutely right. It can go in multiple directions. So, In the past, we have used AI immunology to identify novel vaccine targets. And then, these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. And this process has been labor intensive. So the the ambition was to set up a, automated process for this, and, we have now, been able to launch a new module where several different AI tools are being integrating, enabling us to go from target discovery to a product candidate, selection very fast.

    是的,你說得完全正確。它可以朝多個方向發展。因此,過去我們曾利用人工智慧免疫學來辨識新的疫苗標靶。然後,這些目標經過人工處理,確保我們也能表達和製造它們。而且這個過程非常耗費人力。因此,我們的目標是建立一個自動化流程,現在我們已經能夠推出一個新模組,其中整合了幾個不同的 AI 工具,使我們能夠非常快速地從目標發現到產品候選選擇。

  • So that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that, what they select as their key antigens or in general, key targets, that, these, antigens or targets can also be produced in a cost-effective way.

    當然,這可以應用於我們自己的項目,但我們也看到,可以利用這種能力來支持其他公司,確保他們選擇的關鍵抗原或一般意義上的關鍵靶點,也能以經濟高效的方式生產出來。

  • So I do see multiple options for monetizing on on this new module.

    所以我認為這個新模組有很多種獲利方式。

  • Ramakanth Swayampakula - Investor Relation

    Ramakanth Swayampakula - Investor Relation

  • Okay, so, and then, coming into the real world, and talk about the EVX one for one more for another minute, at Citi, you're planning to present some Some additional data, from the, from the ongoing trial, what sort of data would come out from there and how would it strengthen your narrative on EVXO1, not only for yourselves but also for a potential partner whether it is just on the drug or on the platform just as you were talking about, with, when you're answering somiro.

    好的,那麼,回到現實世界,再花一分鐘談談 EVX 1,在花旗銀行,你們計劃展示一些來自正在進行的試驗的額外數據,這些數據會是什麼類型的,又將如何加強你們對 EVXO1 的論述,不僅對你們自己,而且對潛在的合作夥伴來說也是如此,無論是關於藥物本身還是關於平台,就像你剛才的問題 somiro 所說的那樣。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • So, at ESO, we presented the clinical outcome data and we are still in the process of, analyzing patient samples. So, we have collected, samples, blood samples, before therapy, during, vaccination, and then, also as follow-up samples. And all of these samples from the patients are currently being Assess in our own lab. So we do, course monitoring of the EVXO1 induced T cell responses, but we also do deeper phenotypic analysis.

    因此,在 ESO 會議上,我們展示了臨床結果數據,目前仍在分析病患樣本。因此,我們在治療前、治療期間、接種疫苗期間以及之後都採集了樣本(包括血液樣本)。目前,所有這些患者的樣本都在我們自己的實驗室進行評估。因此,我們不僅對 EVXO1 誘導的 T 細胞反應進行常規監測,還進行更深入的表型分析。

  • So some of this will go out, At CC we have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients. So more to come, and, more deep dives into the immune profiles.

    所以其中一些研究成果將會發表。在CC會議上,我們會以海報形式展示,但也會在未來的會議上發表,因為我們還沒有分析從患者身上收集的所有樣本。所以,敬請期待更多內容,以及對免疫特徵的更深入分析。

  • Of the sales.

    銷售額。

  • Collected from the patients. And then we also have the extension phase of the EXO1 trial where 6 patients are now receiving EVXO1 as a monotherapy. So more data will come from this subset of patients.

    從患者處收集。此外,EXO1 試驗也進入了擴展階段,目前有 6 名患者正在接受 EVXO1 單藥治療。因此,我們將從這部分患者中獲得更多數據。

  • Ramakanth Swayampakula - Investor Relation

    Ramakanth Swayampakula - Investor Relation

  • Perfect, thank you for that. And then the last question is on the MSD relationship.

    太好了,謝謝你。最後一個問題是關於MSD的關係。

  • I mean it's great to have the $7.5 million but you know how much more.

    我的意思是,擁有750萬美元固然很好,但你知道還需要多少嗎?

  • Do you still need to give any additional data for the second molecule, or is it, the merc still has to complete their due diligence, on that, on the data that you've given them, in terms of com running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million.

    對於第二個分子,您是否還需要提供任何額外的數據?或者,該製造商是否仍需對您提供的數據進行盡職調查,例如開展驗證性研究或數據分析,以決定是否要花費另外 250 萬美元?

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yeah, so for EDEXB2, MSD is currently evaluating the data that we have provided and further they are in the process of generating some confirmatory analysis. And that was also why the evaluation term was extended.

    是的,對於 EDEXB2,MSD 目前正在評估我們提供的數據,並且他們正在產生一些驗證性分析。這也是評估期延長的原因。

  • So, we expect that they will come back with an answer in the or in the first half of next year.

    因此,我們預計他們會在明年上半年給出答案。

  • Perfect. But the process is ongoing and and it's a cost.

    完美的。但這個過程仍在進行中,而且需要付出代價。

  • Very exciting and we would love to out license EX P2 to MC.

    非常令人興奮,我們很樂意將 EX P2 授權給 MC。

  • Ramakanth Swayampakula - Investor Relation

    Ramakanth Swayampakula - Investor Relation

  • Yeah, okay, great, thank you very much for taking all my questions.

    好的,太好了,非常感謝您回答我的所有問題。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Thank you. Thank.

    謝謝。感謝。

  • Operator

    Operator

  • You.

    你。

  • There are no further questions, so I shall hand back to you for final remarks.

    沒有其他問題了,我將把發言權交還給你們,請你們做最後的總結發言。

  • Birgitte Rønø - CEO

    Birgitte Rønø - CEO

  • Yes, and thank you for joining us today. And please do not hesitate to reach out should you have any additional questions.

    是的,感謝您今天加入我們。如有任何其他疑問,請隨時與我們聯繫。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • That concludes today's presentation.

    今天的演講到此結束。

  • Thank you for participating. You may now disconnect. Speakers, please stand by.

    感謝您的參與。您現在可以斷開連線了。發言人請稍候。