Evaxion A/S (EVAX) 2025 Q2 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 Evaxion's second-quarter 2025 conference call. (Operator Instructions)

    您好,歡迎參加 Evaxion 2025 年第二季電話會議。 (操作員指示)

  • I would now like to turn the conference over to Birgitte Rono, Interim CEO and CSO. You may begin.

    現在,我想將會議交給臨時執行長兼首席策略長 Birgitte Rono。請您開始。

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Thank you for that. So first and foremost, welcome to our Q2 2025 business update and financial results. I am Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. And with me today, I have Thomas Schmidt, Chief Financial Officer, now permanent CFO as of August 1; and Mads Kronborg, VP of IR and Communications.

    謝謝。首先,歡迎大家收看我們2025年第二季的業務更新和財務業績報告。我是Evaxion首席科學官兼代理執行長Birgitte Rono。今天與我一同出席的還有財務長Thomas Schmidt(8月1日起正式擔任財務長),以及投資人關係與傳播副總裁Mads Kronborg。

  • Today, I will start with a short introduction, followed by an R&D update, and then Thomas will present our Q2 financial results. And lastly, we are, of course, as always, open for questions. So before we begin, please note that today's presentation contains forward-looking statements based on current expectations, and actual results may differ from this.

    今天,我將首先進行簡短的自我介紹,然後介紹一下研發情況,之後Thomas將報告我們第二季的財務表現。最後,我們一如既往地歡迎大家提問。因此,在開始之前,請注意,今天的演示包含基於當前預期的前瞻性陳述,實際結果可能與此有所不同。

  • So since last quarter, we have made significant achievements. And with the partnership with MSD, we are on track towards potential option exercise in the second half of 2025. Our business development pipeline remains solid and supports the FY target. However, we do see that the challenging financial markets and increased regulatory uncertainty is impacting deal execution in general.

    自上個季度以來,我們取得了顯著的成就。透過與默沙東的合作,我們預計在2025年下半年實現選擇權行使。我們的業務發展管道依然穩健,並支持實現財年目標。然而,我們確實看到,充滿挑戰的金融市場和日益加劇的監管不確定性正在影響整體交易的執行。

  • Key R&D events and progress include EVX-01 two-year clinical efficacy data accepted for an oral presentation at the ESMO Congress in 2025. And treatment in the main part of the EVX-01 Phase 2 trial is completed, and patients have been recruited for the one-year extension phase. We have also expanded our R&D pipeline with EVX-B4, and we will get back to the details around this.

    關鍵研發事件與進展包括:EVX-01 兩年臨床療效資料已獲准在 2025 年 ESMO 大會上進行口頭報告。 EVX-01 2 期臨床試驗的主要治療部分已完成,一年延長期的患者招募工作也已完成。我們也擴展了 EVX-B4 的研發管線,後續會詳細介紹。

  • Further, we have received a grant from the Gates Foundation, allowing for risk and cost-free application of the platform in yet another disease, polio. On the financial side, we have cash at hand until mid-2026 and we have converted our loan from the European Investment Bank to equity with an immediate increase in equity with USD4.1 million.

    此外,我們還獲得了蓋茲基金會的資助,使我們能夠將該平台無風險且無成本地應用於另一種疾病——脊髓灰質炎。在財務方面,我們擁有可維持至2026年中期的現金,並且已將歐洲投資銀行的貸款轉換為股權,股權立即增值410萬美元。

  • Since last quarter, we have achieved an additional milestone with the initiation of the EVX-B4 program, and we are well on track with the many exciting milestones coming up in the second half of '25. If we take a closer look at our R&D pipeline and recent progress, we have a very broad R&D pipeline of AI immunology-designed vaccine candidates spanning across two key disease areas, cancer and infectious diseases.

    自上個季度以來,隨著EVX-B4計畫的啟動,我們又取得了一個里程碑,並且我們正朝著2025年下半年即將實現的眾多令人興奮的里程碑邁進。如果我們仔細審視我們的研發管線和近期進展,就會發現我們擁有非常廣泛的AI免疫學設計候選疫苗研發管線,涵蓋癌症和傳染病這兩個關鍵疾病領域。

  • And today, I'll walk you through some of our latest progress in key R&D programs. I'll start with our lead asset, EVX-01, or personalized peptide-based cancer vaccine currently in Phase 2 clinical development. And then I would also, as mentioned before, point your attention to our recently added pipeline program, EVX-B4, a discovery program with the objective of developing a preventive vaccine against Group A Streptococcus. And lastly, I'll present our progress in our [CB] program that is EVX-V1.

    今天,我將向大家介紹我們一些關鍵研發專案的最新進展。首先,我將介紹我們的主要產品-EVX-01,即目前處於第二期臨床開發的個人化勝肽類癌症疫苗。然後,如同先前所提到的,我還想提請大家關注我們最近新增的研發管線計畫EVX-B4,這是一個旨在開發針對A組鏈球菌的預防性疫苗的發現計畫。最後,我將介紹我們[CB]計畫EVX-V1的進展。

  • So back to EVX-01, EVX-01 is, as mentioned, currently in Phase 2 and is being developed as a first-line treatment for advanced melanoma. As I mentioned earlier, our upcoming two-year data from the EVX-01 Phase 2 trial will be presented at the European Society for Medical Oncology, also called ESMO Congress in October.

    回到EVX-01。正如我之前提到的,EVX-01目前處於II期臨床試驗階段,並被開發為晚期黑色素瘤的第一線治療方案。正如我之前提到的,我們即將發表的EVX-01 II期臨床試驗的兩年數據將於10月在歐洲腫瘤內科學會(ESMO)大會上發表。

  • And the ESMO Congress is one of the most important and prestigious medical oncology congresses in the world. And we are very much looking forward to this as it gives us a great opportunity to interact with the global audience, including potential partners. And to this end, we are currently finalizing the two-year clinical outcome data for preparing it for the ESMO presentation and partner discussions.

    ESMO大會是世界上最重要、最負盛名的腫瘤內科學大會之一。我們非常期待此次大會,因為它為我們提供了與全球觀眾(包括潛在合作夥伴)互動的絕佳機會。為此,我們目前正在最終確定兩年臨床結果數據,以便為ESMO的演示和合作夥伴討論做好準備。

  • And as we talked about earlier, we have extended the EVX-01 Phase 2 study, allowing us to obtain three-year clinical outcome data. During this extension phase, EVX-01 will be administered as a monotherapy, allowing us better to understand the vaccine's standalone effect. The extension involves minimal additional costs as clinical trials remain active and vaccine production is already complete.

    正如我們之前提到的,我們延長了EVX-01的第二期研究,從而獲得了三年的臨床結果數據。在此延長階段,EVX-01將作為單一療法進行給藥,以便我們更了解該疫苗的獨立療效。由於臨床試驗仍在進行中,且疫苗生產已經完成,因此延長研究僅會產生少量額外成本。

  • Furthermore, we are planning to seek advice from FDA around the path to registration for this compound as we believe that this is important for any potential partners to understand this path. The strategy for the assets remains unchanged, and we are actively seeking partners that can take the compound through the last steps of clinical development towards registration.

    此外,我們計劃就該化合物的註冊流程向FDA尋求建議,因為我們認為這對於任何潛在合作夥伴了解該流程都至關重要。該資產的策略保持不變,我們正在積極尋找能夠帶領化合物完成臨床開發的最後階段並最終獲得註冊的合作夥伴。

  • Yes, another key recent achievement is the grant we received from the Gates Foundation. And in this collaboration, we are applying AI immunology to design a subunit vaccine against polio, and the project is progressing according to plan and in close dialogue with the Gates Foundation and the Polio Program Officer. So this initial grant could potentially lead to further projects and plans with the Gates Foundation or any other partner as we saw that the announcement of the grant gave or generated significant attention to our platform and pipeline.

    是的,我們近期的另一項重要成就是獲得了蓋茲基金會的資助。在此次合作中,我們正在應用人工智慧免疫學來設計一種針對脊髓灰質炎的次單位疫苗,該計畫正在按計劃推進,並與蓋茲基金會和脊髓灰質炎計畫官員保持密切溝通。因此,這筆首筆資助可能會促成我們與蓋茲基金會或其他合作夥伴開展進一步的專案和計劃,因為我們看到,這筆資助的宣布已經引起或引發了人們對我們平台和研發管線的極大關注。

  • Further, we are making strong progress in our infectious disease vaccine pipeline. And as mentioned, in June, we announced the expansion of the infectious disease R&D pipeline with the addition of the EVX-B4 program. And this program aims at developing a preventive vaccine against Group A Streptococcus, also called GAS. And development and testing of potential GAS vaccine has been traced back to 1923, yet no vaccine exists today.

    此外,我們的傳染病疫苗研發管線也取得了長足進展。如前文所述,我們在6月宣布擴大傳染病研發管線,新增EVX-B4計畫。該計畫旨在開發一種針對A組鏈球菌(也稱為GAS)的預防性疫苗。潛在GAS疫苗的研發和測試可以追溯到1923年,但至今尚無疫苗問世。

  • So we have conducted initial computational analysis, demonstrated that AI immunology can identify novel vaccine targets to combat the pathogen. We have ongoing and future planned activities that include identification and testing of novel antigens for immunogenicity, functionality, and protection in mouse models and in vitro assays.

    因此,我們進行了初步的計算分析,證明了人工智慧免疫學可以識別新的疫苗標靶來對抗病原體。我們正在進行和計劃進行的活動包括識別和測試新型抗原的免疫原性、功能性和在小鼠模型和體外試驗中的保護性。

  • So GAS infections can cause a broad spectrum of health issues, including severe invasive infections and also the development of immune-mediated life-threatening conditions. There is an increase in antibiotic resistance and therefore a great need for finding novel treatment solutions. And with EVX-B4, we are hopefully able to offer such a solution.

    因此,胃腸道感染可引發一系列健康問題,包括嚴重的侵襲性感染以及免疫介導的危及生命的疾病。抗生素抗藥性日益增加,因此迫切需要尋找新的治療方案。 EVX-B4 有望提供這樣的解決方案。

  • Lastly, I will briefly touch on our EVX-V1 program. And in this program, we are developing a multi-component vaccine for the prevention of CMV infections. We are in early preclinical development heading towards lead antigen selection in the second half of 2025. We believe that an efficacious vaccine should contain both B and T cell antigens and also glycoproteins that are known to be essential for viral entry. Despite many years of focus, no vaccine is approved for CMV, but with AI immunology, we believe that we can develop an efficacious vaccine that targets the virus from multiple angles.

    最後,我將簡單介紹一下我們的EVX-V1專案。在這個計畫中,我們正在開發一種用於預防CMV感染的多組分疫苗。我們目前處於早期臨床前開發階段,目標是在2025年下半年完成先導抗原的篩選。我們認為,有效的疫苗應該同時包含B細胞和T細胞抗原,以及已知對病毒入侵至關重要的醣蛋白。儘管我們關注多年,但目前還沒有針對CMV的疫苗獲得批准,但憑藉AI免疫學,我們相信能夠開發出一種從多個角度針對該病毒的有效疫苗。

  • This multi-target approach stands out from traditional methods that have been focused on a limited set of glycoproteins involved in viral entry. Combating the virus from numerous angles is expected to enhance the efficacy of future vaccines. And with our proprietary platform, AI immunology, we are uniquely positioned to optimize already no antigens and further to identify novel B and T cell targets.

    這種多靶點方法與傳統方法截然不同,傳統方法主要關注參與病毒入侵的有限醣蛋白。從多個角度對抗病毒有望增強未來疫苗的有效性。憑藉我們專有的AI免疫學平台,我們擁有獨特的優勢,可以優化現有抗原,並進一步識別新的B細胞和T細胞標靶。

  • And to give an initial insight into the data in this program, we have designed a proprietary glycoprotein B antigen, and that is one of the glycoproteins essential for viral entry that demonstrates superior ability to neutralize the virus. Further, we are currently pursuing top ranked B-cell antigens identified with AI immunology, and initial data demonstrate induction of the potent tumor or antibody immune response in immunized animals.

    為了初步了解該計畫的數據,我們設計了一種專有的糖蛋白B抗原,它是病毒入侵所必需的糖蛋白之一,並顯示出卓越的病毒中和能力。此外,我們目前正在研究利用AI免疫學鑑定出的頂級B細胞抗原,初步數據顯示,該抗原在免疫動物中可誘導強效的腫瘤或抗體免疫反應。

  • Several T cell epitope vaccine designs targeting multiple genes in the viral life cycle have been completed and they all induce a strong cellular immune response. So in summary, we do see significant progress across our pipeline in both our oncology and infectious disease programs, and we are well on track for our next milestones. And we look forward to updating you as our programs continue to advance.

    針對病毒生命週期中多個基因的多種T細胞抗原決定位疫苗設計已經完成,它們都能誘發強烈的細胞免疫反應。總而言之,我們在腫瘤學和傳染病領域的研發管線都取得了顯著進展,並且正朝著下一個里程碑邁進。隨著我們專案的不斷推進,我們期待與您分享最新進展。

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

    因此,我將委託托馬斯來報告財務結果。

  • Thomas Schmidt - Chief Financial Officer

    Thomas Schmidt - Chief Financial Officer

  • Yes. Thank you, Birgitte. And I will now, of course, go through the financial highlights. But we'll start, first and foremost, with a summary of the agreement that we have made with the European Investment Bank that really fundamentally helps our capital structure. So on July 11, we finalized the debt settlement agreement with the European Investment Bank where they converted EUR3.5 million of the total EUR7 million loan, and that was converted into equity via a purchase of ordinary Evaxion shares.

    是的,謝謝你,Birgitte。現在我當然會介紹一下財務重點。首先,我們先來概述我們與歐洲投資銀行達成的協議,這項協議對我們的資本結構有至關重要的幫助。 7月11日,我們與歐洲投資銀行最終達成了債務清償協議,他們將700萬歐元貸款中的350萬歐元轉換為股權,並透過購買Evaxion的普通股將其轉換為股權。

  • Our Evaxion shares and the purchase price was $4.87 per ADS, representing 89% premium versus the closing stock exchange on July 11. That immediately also in July then increased our equity by $4.1 million and also then, of course, both simplified our balance sheet and certainly reduced our overall liabilities.

    我們的 Evaxion 股票和購買價格為每股 ADS 4.87 美元,比 7 月 11 日收盤價高出 89%。這也使我們 7 月的股本立即增加了 410 萬美元,當然,這也簡化了我們的資產負債表,並且肯定減少了我們的整體負債。

  • Furthermore, and also looking forward, it improves our cash flow and certainly also the repayment of course that we need to do at the end of the loan agreement in 2028. So all in all, a very good agreement that we have reached with the European Investment Bank. And as mentioned, as the agreement was done in July, it is, of course, not included in our Q2 financials but will eventually be once we get into Q3.

    此外,展望未來,這不僅能改善我們的現金流,還能幫助我們在2028年貸款協議到期時償還貸款。總而言之,我們與歐洲投資銀行達成了非常好的協議。如前文所述,由於該協議是在7月份達成的,因此它當然不會計入我們第二季的財務報表,但進入第三季後就會納入其中。

  • Q2 financial highlights. First and foremost, our cash position is, at the end of June, $14.7 million. And with an operating cash burn that we still expect to be around $14 million, that also means we have cash in hand to fund operations until mid 2026. And important to note, that takes us past the potential option exercise by the MSD and also passed our two-year data readout on our EVX-01 study.

    第二季財務亮點。首先,截至6月底,我們的現金狀況為1,470萬美元。考慮到我們預計的營運現金消耗仍約為1400萬美元,這也意味著我們手頭上有足夠的現金來支援營運到2026年中期。值得注意的是,這不僅讓我們度過了默沙東(MSD)可能行使的選擇權,也讓我們度過了EVX-01研究的兩年資料讀取期。

  • Our overall spend was reduced in Q2 2025 compared to same period last year, which mainly reflects project timing. We still expect for the full year to be at a similar level versus last year from a spending perspective also. Total equity end of June of $6.2 million, obviously strengthened compared to end of last year due to the capital market activities we've done in the first half of the year. And again, this will further be strengthened in July as we -- the agreement registered with the European Investment Bank.

    與去年同期相比,我們在2025年第二季的總支出有所減少,這主要反映了專案時間表。我們預計全年支出水準仍將與去年持平。 6月底的總股本為620萬美元,由於我們上半年在資本市場的活動,與去年年底相比明顯增強。而且,隨著我們在歐洲投資銀行註冊協議,7月的股本總額將進一步增強。

  • Our Q2 profit and loss statement shows an operating loss of $4.3 million, which again compares to $4.6 million in the same period last year. R&D project costs are expected to increase in the second half year, so in the two coming quarters, while we still expect operating expenses in line with 2024. This also means that we expect, as mentioned already, the operational cash burn of approximately $14 million for the full-year 2025.

    我們第二季的損益表顯示,營運虧損為430萬美元,去年同期為460萬美元。預計下半年以及未來兩季的研發項目成本將有所增加,但我們預計營運支出仍將與2024年持平。如上文所述,這也意味著我們預計2025年全年的營運現金消耗約為1400萬美元。

  • Our net financial expenses of $0.7 million in the Q2 compared to $1.8 million net financial expenses in Q2 last year and in both years driven by reassessment of our derivative liability. Important to note is that the derivative liability in 2024 came from the February public offering in 2024, while this year, it comes from our January public offering, so two independent and different derivative liability. Our net loss for the quarter of $4.8 million compared to a net loss of $6.2 million same period last year. And the main difference is exactly the difference in net financial expenses. So that's the driver behind that difference.

    我們第二季的淨財務費用為70萬美元,而去年第二季的淨財務費用為180萬美元,這兩年的淨財務費用都是由於我們對衍生負債的重新評估而產生的。需要注意的是,2024年的衍生負債來自2024年2月的公開發行,而今年的衍生負債來自1月的公開發行,因此是兩項獨立且不同的衍生負債。本季我們的淨虧損為480萬美元,去年同期的淨虧損為620萬美元。主要的差異正是淨財務費用的差異。這就是造成這種差異的原因。

  • Turning to the balance sheet, our equity of USD6.2 million, certainly further will be strengthened in July or has been strengthened in July as we have booked the conversion into equity from the EIB. The derivative liability from the public offering, as mentioned in January 2025, net impacts our equity of USD0.4 million as of end of June.

    談到資產負債表,我們620萬美元的股東權益,肯定會在7月進一步增強,或者說,由於我們已將歐洲投資銀行的股權轉換為股權,7月已經增強。正如2025年1月所提到的,公開發行的衍生性商品負債截至6月底對我們的股東權益淨影響為40萬美元。

  • Cash at hand was $14.7 million. And again, really important to notice a note that this gives us a cash runway until mid-2026, so both past our potential MSD option exercise and past our EVX-01 two-year data. But also importantly, the cash runway projection into mid-2026 does not yet include the potential MSD expertise or any new business development deals. So both will net case further extend our cash runway.

    現金儲備為1470萬美元。再次強調,需要特別注意的是,這為我們提供了一份持續到2026年中期的現金儲備,既涵蓋了我們潛在的MSD選擇權行使,也涵蓋了我們EVX-01兩年期的數據。但同樣重要的是,到2026年中期的現金儲備預測尚未包含潛在的MSD專業知識或任何新的業務開發交易。因此,這兩項最終都將進一步延長我們的現金儲備。

  • And with that, I hand it back to Birgitte for some closing remarks.

    最後,我將發言權交還給 Birgitte,請她做最後的總結發言。

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Thank you, Thomas. So lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum, and we are tracking towards several potential value catalysts. Business development remains a key priority, and multiple parallel partnership discussions are currently ongoing. And as Thomas mentioned, we have cash at the hand until this 2026. And that takes us, as Thomas also explains, beyond the EVX-01 two-year data and the potential MSD option exercise.

    謝謝,托馬斯。最後,作為總結性發言,我想強調的是,我們確實擁有強勁的營運勢頭,並且正在追蹤幾個潛在的價值催化劑。業務發展仍然是我們的首要任務,目前正在進行多個並行的合作夥伴關係談判。正如湯瑪斯所提到的,我們手頭上有現金,可以維持到2026年。正如托馬斯所解釋的那樣,這讓我們能夠超越EVX-01兩年數據和潛在的默沙東選擇權行使。

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

    最後,我要感謝您的時間和關注,我們很樂意回答您的任何問題。

  • Operator

    Operator

  • (Operator Instructions) Thomas Flaten, Lake Street Capital Markets.

    (操作員指示)Thomas Flaten,Lake Street Capital Markets。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Good morning. Good afternoon. I appreciate taking the questions. Birgitte, I was curious if you could maybe detail for us what remaining steps are there in the process for Merck to make a decision on whether or not they want to option either or both of the programs.

    早安,下午好。很高興回答您的問題。 Birgitte,您能否詳細介紹一下,默克公司還有哪些步驟可以決定是否要選擇其中一個或兩個項目?

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Yes. Thank you for that question. So we have been running one of the collaborations, the B3, since September 2023. So we entered into this R&D collaboration. And there's been a lot of very exciting data generated under this collaboration. And we are currently according to the plan, timelines are kept, and we are heading towards the conclusion here in the second half of 2025.

    是的,謝謝你的提問。我們從2023年9月開始進行其中一項合作,B3。我們開始了這項研發合作。在這項合作下,我們已經產生了許多非常令人興奮的數據。目前,我們正按照計畫進行,時間表也已確定,預計在2025年下半年完成。

  • For B2, this is more a type of, I would say, evaluation collaboration. So MSD have been looking into our data and been conducting some studies on their side. Again, we are on track in terms of timelines and also, yes, heading towards this conclusion in the second half of 2025. So all in all, it looks very promising, and we are progressing according to the plan.

    對於B2來說,我想說這更像是一種評估合作。 MSD一直在研究我們的數據,並在他們那邊進行一些研究。同樣,我們的時間表進展順利,而且,是的,我們正朝著2025年下半年得出結論的方向前進。總而言之,前景非常光明,我們正在按照計劃前進。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Got it. I appreciate that. And then one final question, if you look at the business development conversations you're having, are they primarily on the infectious disease side? Is there some oncology interest? Can you maybe just give us a sense of what those discussions look like?

    明白了,我很感激。最後一個問題,您目前正在進行的業務拓展對話主要集中在傳染病方面嗎?腫瘤學方面也有一些合作嗎?能否簡單介紹一下這些討論的內容?

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Yes. No, it's across the R&D pipeline and assets across the two therapy areas and also centered around what we call target discovery collaboration, so where we apply AI immunology and find novel targets for a certain pathogen. So it's a mixed picture at the moment, but definitely, dialogues across -- some are more mature than others. And I think that's just the name of the game. And it's, of course -- I know there's a lot of curiosity around this. But as you know, we cannot say a lot about this until there is a signed contract. But we remain optimistic and do see also new dialogues starting.

    是的。不,它涵蓋了兩個治療領域的研發管線和資產,同時也圍繞著我們所謂的標靶發現合作,也就是我們應用人工智慧免疫學,為特定病原體尋找新的標靶。所以目前的情況好壞參半,但肯定的是,雙方的對話——有些比其他的更成熟。我認為這只是遊戲的名稱。當然——我知道大家對此有很多好奇心。但正如你所知,在簽署合約之前,我們不能透露太多。但我們仍然保持樂觀,也確實看到了新的對話正在開始。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Got it. I appreciate taking the questions. Thank you.

    明白了。感謝您的提問。謝謝。

  • Operator

    Operator

  • [Charles Wallace], H.C. Wainwright.

    [查爾斯華萊士],H.C.溫賴特。

  • Charles Wallace - Analyst

    Charles Wallace - Analyst

  • Hi. Thanks for taking my questions. This is Charles on for RK. I had a question about the data at ESMO coming up. So how will the two-year data, like the clinical outcomes compared to the one-year data that was presented -- and how many of the patients from year one will be seen in the two-year data? And then also, with the extension to the third year, how many patients will you enroll additionally? Thank you.

    你好。感謝您回答我的問題。我是 RK 的 Charles。我有一個關於即將公佈的 ESMO 數據的問題。那麼,兩年的數據,例如臨床結果與一年的數據相比如何?有多少第一年的患者會出現在兩年的數據中?此外,如果延長到第三年,你們還會額外招募多少患者?謝謝。

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Yes, hi, Charles. Thank you for those questions. So we have not yet disclosed the two-year data for EVX-01. So you have to be a bit patient here. We have -- of course, since our last update of the clinical data, the one-year data gathered additional information and scans, et cetera, of all the patients. We still have 18 -- no, sorry, 11 patients active in the trial. So a lot of the patients are faring extremely well. So more to come on this.

    是的,你好,查爾斯。謝謝你的提問。我們還沒有公佈EVX-01的兩年數據。所以你得耐心等待一下。當然,自從我們上次更新臨床數據以來,我們已經收集了所有患者的一年期數據、掃描結果等等。我們仍然有18位——不,抱歉,是11位——患者正在參與試驗。所以很多患者的狀況都非常好。接下來我們會公佈更多相關資訊。

  • For the extension phase, it's a subset of the patients that now have consented to participate in this additional year. They will receive two doses of EVX-01 and without concomitant pembrolizumab treatment. So this allows us to look further into the mode of action of EVX-01 without having this background of the checkpoint inhibitor. We have not yet said a lot about how many patients, et cetera, because there's still -- yes, we will come back with more information on this.

    延長期研究的對像是目前已同意參與延長一年研究的患者群體。他們將接受兩劑 EVX-01 治療,且不接受帕博利珠單抗合併治療。這使我們能夠在不了解檢查點抑制劑相關背景的情況下,進一步探討 EVX-01 的作用機制。我們目前尚未透露太多關於患者人數等信息,因為還有——是的,我們稍後會提供更多信息。

  • Charles Wallace - Analyst

    Charles Wallace - Analyst

  • Okay. Thank you for taking the questions.

    好的。感謝您回答這些問題。

  • Operator

    Operator

  • (Operator Instructions) I'm showing no further questions in the queue. I would now like to turn the call back over to Birgitte for closing remarks.

    (接線員指示)隊列中沒有其他問題了。現在我想將電話轉回Birgitte,請她做最後發言。

  • Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

    Birgitte Rono - Interim Chief Executive Officer and Chief Scientific Officer

  • Thank you for that. So finally, I would just like to say thank you for all of you participating in this business update and financial results. And we are, of course, as always, looking forward to update you on the further progress. Thank you.

    謝謝大家。最後,我想感謝大家參與本次業務更新和財務業績發布。當然,我們一如既往地期待著向大家報告進一步的進展。謝謝大家。

  • Thomas Schmidt - Chief Financial Officer

    Thomas Schmidt - Chief Financial Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's conference call. You may now disconnect.

    女士們,先生們,今天的電話會議到此結束。您可以掛斷電話了。