Evaxion A/S (EVAX) 2025 Q4 法說會逐字稿

完整原文

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  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Thank you for joining us for Evaxion's business update following the reporting of our 2025 full year financial results yesterday. And apologies that this call is 24 hours later than we anticipated for technical reasons.

    感謝您參加 Evaxion 繼昨日發布 2025 年全年財務業績報告後的最新業務更新會議。很抱歉,由於技術原因,這次通話比我們預期的晚了24小時。

  • We are delighted to be here today. My name is Helen Tayton-Martin, and I am honored to be leading this call for the first time as Evaxion's CEO.

    我們今天很高興來到這裡。我叫海倫泰頓-馬丁,很榮幸能以 Evaxion 執行長的身份首次主持這次電話會議。

  • We move to the first slide. Okay. So on today's call, we will review the achievements of 2025 and touch on the milestones we anticipate for 2026. Our Chief Scientific Officer, Birgitte Rono, will then walk through our key R&D updates for the year, including the latest innovations from our AI-Immunology platform, after which our CFO, Thomas Schmidt, will walk through our 2025 financial results before we close with a few concluding remarks and take questions.

    我們進入第一張投影片。好的。因此,在今天的電話會議上,我們將回顧 2025 年的成就,並展望 2026 年的里程碑。接下來,我們的首席科學官 Birgitte Rono 將介紹我們今年的主要研發進展,包括我們人工智慧免疫學平台的最新創新成果;之後,我們的財務長 Thomas Schmidt 將介紹我們 2025 年的財務業績;最後,我們將作總結發言並回答問題。

  • Right. Moving to the next slide. And of course, our comments and presentation today may contain forward-looking statements and all participants on today's call are referred to our filed SEC statements and specifically, our most recent 20th annual report for 2020 filed -- 2025 filed yesterday.

    正確的。進入下一張投影片。當然,我們今天的評論和演示可能包含前瞻性陳述,所有參加今天電話會議的人員都應參考我們向美國證券交易委員會提交的聲明,特別是我們昨天提交的最新 2020 年至 2025 年年度報告。

  • So moving to the next slide. I will start with our 2025 achievements and our 2026 milestones. In 2025, we were very pleased to report tremendous progress across all pillars of the company. First of all, in business development, we were delighted with the progress in our collaboration with MSD and our infectious disease portfolio, with the decision by Merck to exercise its option over our EVX-B3 program candidate.

    接下來是下一張投影片。我將首先介紹我們 2025 年所取得的成就和 2026 年的里程碑。2025年,我們非常高興地報告公司各個業務部門都取得了巨大的進步。首先,在業務發展方面,我們對與默沙東的合作以及我們的傳染病產品組合的進展感到非常高興,默克決定行使對我們 EVX-B3 項目候選藥物的選擇權。

  • Whilst the target for this program is not disclosed, we are very proud that this represents the first in-licensing, to our knowledge, of an infectious disease vaccine candidate identified and validated through an AI discovery platform. Whilst MSD chose not to exercise its option over our EVX-B2 candidate in gonorrhea, we remain very excited about the data and the prospects for this program, over which we have retained full rights and have seen significant interest.

    雖然該計劃的目標尚未公開,但我們非常自豪的是,據我們所知,這是首次透過人工智慧發現平台識別和驗證傳染病候選疫苗並進行許可引進。儘管默沙東選擇不行使對我們治療淋病的候選藥物 EVX-B2 的選擇權,但我們仍然對該計畫的數據和前景感到非常興奮,我們保留了該計畫的全部權利,並且已經看到了很大的興趣。

  • We were also pleased to enter into a collaboration with the Gates Foundation on the design of a new polio vaccine and are also seeing significant interest in our platform and pipeline programs more broadly from a number of parties.

    我們也很高興能與蓋茲基金會合作設計一種新的小兒麻痺疫苗,並且我們也看到許多方面對我們的平台和研發管線計畫表現出濃厚的興趣。

  • In R&D, we were very pleased to be able to present very positive two-year Phase 2 data at ESMO on our EVX-01 program with a personalized neoantigen-directed cancer vaccine in advanced melanoma patients.

    在研發方面,我們非常高興能夠在 ESMO 上展示我們 EVX-01 計畫在晚期黑色素瘤患者中應用個人化新抗原導向癌症疫苗的兩年期 2 期臨床試驗的積極數據。

  • We also presented preclinical data at ASH on our first cancer vaccine to a shared antigen -- sorry, antigen based directed to a conserved endogenous retroviral EVR elements that we have identified in AML patients with our EVX-04 program. In our infectious disease portfolio, we were also able to move forward a new program with candidates identified from our AI-Immunology platform against Group A Streptococcus.

    我們也在美國血液學會 (ASH) 上展示了我們第一個針對共享抗原的癌症疫苗的臨床前數據——抱歉,是基於抗原的,該疫苗針對的是我們透過 EVX-04 計畫在 AML 患者中發現的保守內源性逆轉錄病毒 EVR 元件。在我們的傳染病產品組合中,我們還能夠推進一項新計劃,該計劃利用我們的人工智慧免疫學平台識別出的針對 A 型鏈球菌的候選藥物。

  • On the platform itself, the team has continued to innovate and use platform to not only identify optimal vaccine candidates, but improve their design biology for product delivery for us in our new automated module. And Birgitte will touch on all of these achievements shortly.

    在平臺本身方面,團隊不斷創新,並利用該平台不僅識別出最佳候選疫苗,還改進了其設計生物學,以便在我們新的自動化模組中為我們交付產品。比爾吉特稍後將談到所有這些成就。

  • We were also honored by the recognition of our AI-Immunology platform by the Galien Foundation for AI advances in human health. And finally, we were very pleased to see the capital influx of the business last year through financing, business development and the use of our ATM, which now gives Evaxion a cash runway to the second half of 2027. And Thomas will talk more to this later.

    我們也很榮幸地獲得了蓋倫基金會的認可,表彰我們的人工智慧免疫學平台在人類健康領域的人工智慧進步。最後,我們非常高興地看到,去年公司透過融資、業務發展和使用我們的 ATM 獲得了大量資金,這使得 Evaxion 的現金流能夠維持到 2027 年下半年。湯瑪斯稍後會就此做更多闡述。

  • So moving to the next slide. Just as a reminder, Evaxion has built a broad novel product-focused pipeline of assets from its unique AI-Immunology platform clinically validated with the cancer vaccine space with our EVX-01 peptide-based vaccine in advanced melanoma that's supported by assets and data on DNA and RNA platforms and together with a preclinical pipeline of infectious disease vaccine candidate, focused on challenging targets remaining intractable with conventional approaches and subject to significant medical need.

    接下來進入下一張投影片。再次提醒,Evaxion 已建立了廣泛的以創新產品為中心的資產管線,該管線基於其獨特的 AI 免疫學平台,並在癌症疫苗領域進行了臨床驗證,例如我們用於治療晚期黑色素瘤的基於勝肽的 EVX-01 疫苗,該疫苗得到了 DNA 和 RNA 平台資產和研究數據的支持,以及具有重大醫療保健的臨床方法

  • On to the next slide. This unique capability with AI-Immunology is something that we have also begun to investigate within the autoimmune field, given a wider range of diseases driven by autoimmune attack and the direct applicability of our platform to focus on immune mechanisms in disease. Autoimmune diseases affected over 14 million patients annually in the US and are characterized by chronic debilitating conditions with treatment options focused primarily on the symptoms rather than the underlying cause of disease.

    進入下一張投影片。鑑於自體免疫攻擊導致的疾病範圍更廣,以及我們的平台可以直接應用於研究疾病中的免疫機制,我們也開始在自體免疫領域探索人工智慧免疫學的這種獨特能力。在美國,每年有超過 1,400 萬名患者受到自體免疫疾病的影響,這些疾病的特徵是慢性衰弱性疾病,治療方案主要集中在症狀上,而不是疾病的根本原因。

  • Moving on to the next slide. This is why we believe our AI-Immunology platform is strongly positioned to focus on underlying disease mechanisms with greater specificity to identify autoimmune disease targets, which can be approached in different ways. There will be more to come on this later in the year.

    接下來是下一張投影片。這就是為什麼我們相信我們的 AI 免疫學平台具有強大的優勢,能夠更精準地聚焦於潛在的疾病機制,從而識別自體免疫疾病靶點,並採用不同的方法進行治療。今年稍後還會有更多相關報導。

  • So finally, in the next slide, turning to our 2026 milestones. This year, we will be updating on our EVX-01 program with additional biomarkers and immunogenicity data, AACR and then the clinical data, three-year data towards the -- later towards the end of the year. Well, we will be talking more about the autoimmune applications of our AI-Immunology platform and bringing forward data on our new EVX-B4 candidate in Group B -- Group A Streptococcus in the second half of the year.

    最後,在下一張投影片中,我們將介紹我們 2026 年的里程碑。今年,我們將更新 EVX-01 項目,提供額外的生物標記和免疫原性數據、AACR 數據,然後是臨床數據,以及三年數據——預計在年底前發布。嗯,我們將在今年下半年更多地討論我們的 AI 免疫學平台在自身免疫方面的應用,並公佈我們針對 B 組至 A 組鏈球菌的新候選藥物 EVX-B4 的數據。

  • And finally, be ready to submit a regulatory application for our next EVX-04 candidate vaccine candidate for the shared ERV antigens in AML by the end of the year. And throughout, we remain committed to driving value from both our platform and our pipeline assets through partnership for our shareholders and patients.

    最後,請做好準備,在年底前提交我們下一個針對 AML 中共享 ERV 抗原的候選疫苗 EVX-04 的監管申請。我們始終致力於透過與股東和患者的合作,從我們的平台和在研產品中創造價值。

  • I'll now hand over to Birgitte to update you further on our R&D achievements.

    現在我將把發言權交給比爾吉特,讓她進一步向大家介紹我們的研發成果。

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • Thank you, Helen. So 2025 marked a turning point with significant advancement across our R&D pipeline and also -- and our AI platform. And additionally, as Helen alluded to, we also entered into the in-licensing agreement with MSD on the EVX-B3 program. So our 2025 focus has been on strengthening our platforms predictive power, maturing key R&D assets and on building the foundation for future partnerships.

    謝謝你,海倫。因此,2025 年是一個轉捩點,我們的研發流程以及人工智慧平台都取得了重大進展。此外,正如海倫所暗示的那樣,我們還與 MSD 就 EVX-B3 專案簽訂了引進許可協議。因此,我們 2025 年的重點是加強我們平台的預測能力,完善關鍵的研發資產,並為未來的合作奠定基礎。

  • So the 2025 achievements position us well as we move towards the data-rich milestones in 2026, that Helen just presented. So with that, I will begin by walking through individual key programs and platform development.

    因此,2025 年所取得的成就使我們在邁向 2026 年資料豐富的里程碑時處於有利地位,正如 Helen 剛才所介紹的。那麼,接下來我將逐一介紹各個關鍵項目和平台開發。

  • So next slide, please. EVX-01, our personalized peptide-based cancer vaccine in advanced melanoma continues to deliver strong clinical data. So our two-year Phase 2 data presented at an oral session at ESMO in October showed strong clinical outcomes, including a high objective response rate of 75% and complete response rate of 25%.

    那麼,請看下一張投影片。EVX-01 是我們針對晚期黑色素瘤開發的個人化勝肽類癌症疫苗,持續提供強而有力的臨床數據。因此,我們在 10 月 ESMO 的口頭會議上公佈的為期兩年的 2 期數據顯示出強勁的臨床結果,包括高達 75% 的客觀緩解率和 25% 的完全緩解率。

  • Notably, 92% of the responders remained in response at this two-year mark. Key biomarker data included the very high immunogenicity hit rate with 81% of all the individual new antigen administered across patients, giving rise to a specific T-cell response. So this very impressive hit rate outcompetes data from similar programs conducted by others.

    值得注意的是,兩年後仍有 92% 的受訪者保持回應。關鍵生物標記數據包括極高的免疫原性命中率,在所有接受治療的患者中,81% 的個體新抗原均能引起特異性 T 細胞反應。因此,這非常驚人的命中率優於其他類似項目的數據。

  • And this truly underlines the precision of our AI-Immunology platform, to identify relevant vaccine targets. Two key milestones are expected for this program, as Helen also alluded to, additional biomarker and immunogenicity data expected in the first half of '26, and we also plan to communicate the three-year data from a subset of patients that are currently in expansion part of the Phase 2 study, and that will be reported in the second half of '26.

    這充分體現了我們人工智慧免疫學平台的精準性,能夠辨識相關的疫苗標靶。正如海倫也提到的那樣,該計畫預計將有兩個關鍵里程碑:一是預計在 2026 年上半年獲得額外的生物標誌物和免疫原性數據;二是我們還計劃公佈目前正在進行 2 期研究擴展部分的部分患者的三年數據,這些數據將在 2026 年下半年公佈。

  • So importantly, we aim to conduct future trials in partnership ensuring the broadest possible impacts for patients.

    因此,我們的目標是與合作夥伴共同進行未來的試驗,以確保為患者帶來盡可能廣泛的影響。

  • So moving to the next slide and EVX-04, our off-the-shelf therapeutic vaccine for acute myeloid leukemia or AML, we have generated a compelling preclinical evidence supporting its development. In this program, we are focusing on a completely novel class of tumor antigens, so-called endogenous retroviruses or ERVs that are selectively and highly expressed in AML blast, making them attractive as therapeutic targets.

    接下來,我們來看下一張幻燈片,EVX-04,這是我們現成的用於治療急性髓系白血病(AML)的治療性疫苗,我們已經獲得了令人信服的臨床前證據來支持其開發。在這個計畫中,我們專注於一類全新的腫瘤抗原,即所謂的內源性逆轉錄病毒或ERV,它們在AML原始細胞中選擇性地、高度表達,因此具有作為治療標靶的吸引力。

  • So with AI-Immunology, we have identified millions of short ERV fragments from patient sequencing tumor data and designed the EVX-04 vaccines with 16 optimal ERV antigen fragments, selected based on cross-patient relevance and also on the immunological potential. So key data include in vitro vaccination studies, demonstrating that all of these 16 ERV fragments in the vaccine induced a strong specific immune response and further that EVX-04 prevents tumor growth in several mouse tumor models and induces strong T-cell responses.

    因此,透過人工智慧免疫學,我們從患者腫瘤定序數據中識別出數百萬個短的內源性逆轉錄病毒片段,並根據跨患者相關性和免疫學潛力,設計了包含 16 個最佳內源性逆轉錄病毒抗原片段的 EVX-04 疫苗。因此,關鍵數據包括體外疫苗接種研究,證明疫苗中的所有 16 個 ERV 片段均能誘發強烈的特異性免疫反應,而 EVX-04 還能在幾種小鼠腫瘤模型中阻止腫瘤生長並誘發強烈的 T 細胞反應。

  • So again, these findings reinforces the power of our platform. And here, we have expanded it to uncover unique tumor antigens that are not accessible through traditional discovery methods.

    所以,這些發現再次印證了我們平台的強大。在這裡,我們將其擴展到發現透過傳統發現方法無法獲得的獨特腫瘤抗原。

  • Next slide, please. As we progress towards clinical readiness for EVX-04, we have completed key steps, including antigen selection and lead development. We have conducted preclinical efficacy studies and are currently conducting further human cell-based translational assays. CMC work and GMP manufacturing are advancing according to plan. And the next major milestone for this program is the submission of the clinical trial application in the second half of '26, which enabled first-in-human testing.

    請看下一張投影片。隨著我們向 EVX-04 的臨床準備階段邁進,我們已經完成了關鍵步驟,包括抗原選擇和先導化合物開發。我們已經進行了臨床前療效研究,目前正在進行進一步的基於人類細胞的轉化試驗。CMC工作和GMP生產正在按計劃推進。該計劃的下一個重大里程碑是於 2026 年下半年提交臨床試驗申請,這將使首次人體試驗成為可能。

  • So this program is a prime example of how AI-Immunology accelerates vaccine design from concept to clinic.

    因此,該計畫是人工智慧免疫學如何加速疫苗設計從概念到臨床應用的絕佳例子。

  • So next slide, please. Now turning to our key infectious disease programs. So after retaining the full global rights to EVX-B2 late last year, we are now fully in control of the development of this highly differentiated vaccine candidate targeting Neisseria gonorrhoeae. So our preclinical data package is strong and comprehensive, demonstrating significant protection in a mouse infectious model.

    那麼,請看下一張投影片。現在讓我們來看看我們主要的傳染病防治項目。因此,在去年底保留了 EVX-B2 的全部全球權利之後,我們現在完全掌控了這種針對淋病奈瑟菌的高度差異化候選疫苗的開發。因此,我們的臨床前資料包強大而全面,在小鼠感染模型中表現出顯著的保護作用。

  • We have demonstrated broad efficacy against 50 clinically relevant isolates reflecting coverage across diverse strains and further induction of significant tumor and cellular responses in mice, and we have also demonstrated a well-established mechanism of action supported by potent antibody-dependent complement-mediated killing.

    我們已證明該藥物對 50 種臨床相關分離株具有廣泛的療效,反映了其對不同菌株的覆蓋範圍,並進一步在小鼠體內誘導了顯著的腫瘤和細胞反應,我們還證明了其作用機制已得到充分證實,該機制由強大的抗體依賴性補體介導的殺傷作用所支持。

  • So collectively, these results position EVX-B2 as one of the most advanced and differentiated infectious disease preclinical gonorrhea vaccine candidate in an area of high unmet need where no approved vaccine exists today. So given the strength of our data, we see a clear opportunity to engage with potential partners to progress the program towards clinical development.

    綜上所述,這些結果使 EVX-B2 成為目前尚未獲得批准的疫苗,且存在高度未滿足需求的傳染病臨床前淋病疫苗候選藥物中最先進、最具差異化的候選藥物之一。鑑於我們數據的強大實力,我們看到了一個與潛在合作夥伴合作,推進該計畫進入臨床開發階段的明確機會。

  • So next slide, please. So another of our key infectious disease vaccine program is EVX-B1. In this program, we are developing a multi-target vaccine against cytomegalovirus or CMV and instead of relying on a single glycoprotein or limited set of glycoproteins, the program integrates both these well-described glycoproteins and novel antigens to target the virus from multiple complementary angles.

    那麼,請看下一張投影片。因此,我們另一個重要的傳染病疫苗計劃是 EVX-B1。在這個計畫中,我們正在開發一種針對鉅細胞病毒(CMV)的多靶點疫苗,而該計畫不依賴單一糖蛋白或有限的糖蛋白集,而是整合了這些已充分描述的糖蛋白和新型抗原,從多個互補的角度靶向病毒。

  • So this broad multicomponent strategy is designed to enhance vaccine efficacy and also to reduce the risk of viral escape. So we have applied AI-Immunology for both antigen optimization of the known glycoproteins and for identification of truly novel antigens.

    因此,這種廣泛的多組分策略旨在提高疫苗效力,並降低病毒逃脫的風險。因此,我們應用人工智慧免疫學對已知糖蛋白進行抗原優化,並鑑定真正的新型抗原。

  • So first, we improved these established CMV antigens that are essential for virus neutralization. And as part of this, we have engineered the glycoprotein B antigen, by locking it in a prefusional state. And this AI-Immunology designed construct has demonstrated a superior neutralization capacity compared to the native protein.

    首先,我們改進了這些已知的 CMV 抗原,這些抗原對於病毒中和至關重要。作為其中的一部分,我們對糖蛋白 B 抗原進行了改造,將其鎖定在融合前狀態。這種由人工智慧免疫學設計的構建體已經證明其具有比天然蛋白質更優異的中和能力。

  • Secondly, we are identifying and validating entirely novel antigens and several of these -- they have already demonstrated the ability to inhibit viral entry and further, we are characterizing them at the moment. So supported by this strong preclinical data, EVX-B1 represents a highly promising program for continued development and for future partnership discussions.

    其次,我們正在鑑定和驗證全新的抗原,其中一些抗原已經證明能夠抑制病毒進入,目前我們正在對其進行表徵。因此,基於這些強有力的臨床前數據,EVX-B1 代表了一個非常有前景的項目,值得繼續開發並進行未來的合作洽談。

  • Next slide, please. So now turning to the recent development of our AI-Immunology platform. So our AI-Immunology platform continues to expand capability. So the platform integrates multiomic data sets to generate ranked antigen lists within 24 hours.

    請看下一張投影片。現在讓我們來談談我們人工智慧免疫學平台的最新進展。因此,我們的人工智慧免疫學平台的功能不斷擴展。因此,該平台整合多組學資料集,可在 24 小時內產生排名抗原清單。

  • So in October last year, we launched an automated vaccine design module enabling sequence and structural optimization directly from this short-listed antigens. At this end-to-end automation significantly reduced cost, development time and also risk.

    因此,去年十月,我們推出了一款自動化疫苗設計模組,可以直接從這些入圍抗原進行序列和結構優化。這種端到端的自動化顯著降低了成本、開發時間和風險。

  • So next slide, please. So more specifically, the automated module enhances design of soluble antigen constructs, enabling higher expression, better formulation and improved manufacturability. So this capability directs the design of soluble antigen constructs and also solubilizing antigens using inverse folding, producing more reliable antigen construct than the wild-type variant.

    那麼,請看下一張投影片。更具體地說,自動化模組增強了可溶性抗原構建體的設計,從而實現了更高的表達、更好的配方和更高的可製造性。因此,這種能力指導可溶性抗原構建體的設計,並利用反向折疊溶解抗原,從而產生比野生型變異體更可靠的抗原構建體。

  • The result is a faster and more cost-effective design cycle, fully integrated into our antigen discovery and vaccine optimization workflow. So this strengthens the foundation for all of our programs across oncology and infectious diseases.

    結果是設計週期更快、成本效益更高,並完全融入我們的抗原發現和疫苗優化工作流程中。因此,這將加強我們在腫瘤學和傳染病學領域所有計畫的基礎。

  • So in conclusion, we have seen strong progress across our platform and our R&D pipeline, and we are encouraged by the momentum and we look forward to keeping you updated as we advance through 2026.

    總而言之,我們在平台和研發管線方面都取得了顯著進展,我們對這一勢頭感到鼓舞,並期待在 2026 年繼續向您匯報最新情況。

  • And with that, I will now hand over to Thomas, who will walk us through our financial results.

    接下來,我將把發言權交給湯瑪斯,他將為我們介紹我們的財務表現。

  • Thomas Schmidt - Chief Financial Officer

    Thomas Schmidt - Chief Financial Officer

  • Yes. Thank you, Birgitte. And also a warm welcome from my side to our call today. And I will now walk you through the financial results for 2025. So turning to the next page.

    是的。謝謝你,比爾吉特。我非常歡迎您今天來電。接下來,我將帶大家了解2025年的財務表現。翻到下一頁。

  • We have, throughout 2025, been really successful in expanding on our cash runway and also strengthening on our equity side. This has happened throughout the year through public offering and the use of ATM we did in January, followed by the MSD exercise fee and the ATM used in September. And furthermore, the exercise of investor warrants from our January offering in October and November, all summing up to a cash inflow of USD32 million.

    2025 年全年,我們在擴大現金儲備和加強股權方面都取得了巨大成功。今年以來,我們透過公開發行和1月的ATM交易,以及9月的MSD行權費和ATM交易,都發生了這種情況。此外,我們在 10 月和 11 月行使了 1 月發行的投資者認股權證,總計帶來了 3,200 萬美元的現金流入。

  • Furthermore, as also shown on this slide, our EIB debt-to-equity conversion done in July of USD4.1 million. We've reduced certainly our cash -- future cash out and thereby certainly also expanding and extending our cash runway.

    此外,如本投影片所示,我們在 7 月完成了 410 萬美元的歐洲投資銀行債務轉股權交易。我們確實減少了現金儲備——未來的現金支出,也確實擴大並延長了我們的現金儲備。

  • And finally, with our filing in December of our prospectus supplement regarding our ATM. It has now created us with further flexibility and options as we move forward with expanding our pipeline and platform also. So really, really underlines the strong execution throughout the year.

    最後,我們在 12 月提交了關於我們 ATM 的招股說明書補充文件。現在,隨著我們不斷擴展產品線和平台,這為我們帶來了更大的靈活性和選擇。所以,這確實凸顯了全年優異的執行力。

  • And turning to the next slide that also leads into the highlights of 2025, where we really have delivered on all the targets that we set and we are progressing towards our aim of becoming a sustainable self-funding business. Both revenue and costs have improved while at the same time, we are continuing to invest in our platform and in our pipeline programs.

    接下來是下一張投影片,其中也提到了 2025 年的亮點,我們確實實現了我們設定的所有目標,並且正在朝著成為一家可持續的自籌資金企業的目標邁進。收入和成本均有所改善,同時,我們也持續投資於我們的平台和研發項目。

  • As just mentioned on the previous slide, activities and execution of the MSD deal, the EIB debt conversion, our ATM and capital market activities have not only improved our cash position and runway, but has also significantly strengthened our equity. And with improved cash runway and equity we have created more stability and certainly have also reduced uncertainty. So I think that is really, really also a highlight for '25.

    如上一張投影片中所提到的,MSD交易、EIB債務轉換、我們的ATM和資本市場活動及執行情況,不僅改善了我們的現金狀況和資金周轉能力,而且還顯著增強了我們的股權。隨著現金流量和權益的改善,我們創造了更大的穩定性,也降低了不確定性。所以我認為這真的是 2025 年的一大亮點。

  • And again, with the update of [F3] and ATM, we have removed the constraints of baby-shelf and also provides us far better flexibility and options in support of our long-term strategic initiatives and also the long-term plans we do have.

    此外,隨著 [F3] 和 ATM 的更新,我們取消了小型貨架的限制,也為我們提供了更大的靈活性和選擇,以支持我們的長期戰略舉措和我們現有的長期計劃。

  • Next slide is on our profit and loss statement. As I just mentioned, revenue has improved, but also we've improved on our operational costs. So we've actually been successful in lowering in our operational spend whilst at the same time delivering on the quality that we would want to do from a pipeline and platform perspective.

    下一張投影片是我們的損益表。正如我剛才提到的,收入有所提高,但我們的營運成本也有所降低。因此,我們實際上已經成功地降低了營運支出,同時從產品線和平台角度實現了我們想要達到的品質。

  • Revenue certainly stems from our MSD option exercises, but also important to mention, we also had a grant from the Gates Foundation that also has come in 2025 -- apologies.

    收入當然來自我們行使 MSD 選擇權,但同樣重要的是,我們還有來自蓋茲基金會的撥款,該撥款也將在 2025 年到達——對此我們深表歉意。

  • Net financial position of $0.6 million is driven by a premium that we received from -- our debt conversion -- debt-to-equity conversion from EIB and against that goes remeasurement of a derivative liability as some of our warrants or our warrants from the public offering in January were in a different exchange setting, so the USD versus our reporting of DKK.

    淨財務狀況為 0.6 億美元,主要原因是我們從歐洲投資銀行 (EIB) 的債務轉股權交易中獲得了一筆溢價。與之相對的是衍生性商品負債的重新計量,因為我們的一些認股權證或 1 月公開發行的認股權證處於不同的交易所環境,因此美元與我們報告的丹麥克朗有所不同。

  • Net loss for the year, $7.7 million, certainly a bettering compared to last year. And as I said before, also a good step on the way of becoming a self-funding and profitable business.

    本年度淨虧損770萬美元,當然比去年有所改善。正如我之前所說,這也是朝著成為自籌資金和獲利的企業邁出的重要一步。

  • Next slide, on the balance sheet items. We ended the year with a cash position of USD23 million with a runway that now is extended into half year two of 2027 certainly also a significant improvement compared to last year. And this, of course, will be used for operations expenses and investing into our platform and pipeline. We currently have an outstanding -- we have a total outstanding ADS of $8.3 million when assuming that all shares have been converted into ADSs.

    下一張投影片,關於資產負債表項目。年底時,我們的現金儲備為 2,300 萬美元,足以支撐到 2027 年下半年,這無疑也比去年有了顯著改善。當然,這些資金將用於營運支出以及對我們的平台和產品線的投資。我們目前有未償付的 ADS——假設所有股份都已轉換為 ADS,我們目前共有 830 萬美元的未償付 ADS。

  • We've also, through the investor warrants exercise has been reducing the outstanding warrants in terms of ADSs by $1 million. which leaves another 2.8 million warrants outstanding. So also an improvement in that and really drives in the right direction.

    我們也透過投資者認股權證行使方式,將未行使的美國存託憑證(ADS)數量減少了 100 萬美元,目前還剩下 280 萬張未行使的認股權證。所以這方面也有改進,確實朝著正確的方向發展。

  • So in summary, from a financial position, we have during 2025, established a far better foundation that really makes us -- puts us in a good position to continue our execution of strategy and business for '26 and the years beyond.

    總而言之,從財務狀況來看,我們在 2025 年已經建立了一個更好的基礎,這真正使我們處於有利地位,可以繼續執行 2026 年及以後的策略和業務。

  • With that, I hand it back to Helen for some final concluding remarks.

    說完這些,我把稿子交還給海倫,讓她做最後的總結發言。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Thanks, Thomas. And just moving to the last slide. In summary, 2025 was a year of strong operational momentum for Evaxion, in which we achieved several key milestones.

    謝謝你,托馬斯。現在進入最後一張投影片。總而言之,2025 年是 Evaxion 營運勢頭強勁的一年,我們實現了幾個關鍵里程碑。

  • Overall, we strengthened the business considerably to the validation of our strategy with our AI-Immunology platform, delivering on both data and partnerships. This, in turn, has enabled us to both strengthen our financial position and consolidate our position as a leader in AI-based drug discovery, design and early development.

    總體而言,我們透過人工智慧免疫學平台,在數據和合作夥伴關係方面都取得了顯著成果,從而大大增強了業務實力,驗證了我們的策略。反過來,這使我們能夠增強財務實力,並鞏固我們在人工智慧藥物發現、設計和早期開發領域的領導地位。

  • With a number of potential partnership discussions ongoing, we are already funded into the second half of 2027 through the financial milestones achieved in 2025. So we're in a good position to move forward through 2026.

    目前我們正在與一些潛在的合作夥伴進行討論,並且透過 2025 年實現的財務里程碑,我們已經獲得了 2027 年下半年的資金。因此,我們處於有利地位,可以順利推進到2026年。

  • With that, I'll hand over to the operator for questions.

    接下來,我將把麥克風交給接線員,回答大家的問題。

  • Operator

    Operator

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

    (操作員說明)托馬斯·弗萊頓,湖街資本市場。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Maybe to start broadly, Helen, you've been in the seat now for a few months. I'm just curious if you could provide some overarching commentary on what you have implemented or are going to implement -- any changes to strategy? And any bigger picture notes like that, that could help us with the context of your tenure?

    海倫,或許我們可以先從比較廣泛的角度談起,你擔任這個職位已經幾個月了。我只是好奇您能否就您已經實施或將要實施的內容提供一些總體性的評論——戰略方面是否有任何變化?還有其他類似這樣的大局性建議嗎?這些建議或許能幫助我們更了解您的任期背景。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Sure. Thanks. Thanks for the question. Yes, I joined at the end of November last year. So the last three months have flown by. But I already have a strong impression from my prior seat on the Evaxion Board.

    當然。謝謝。謝謝你的提問。是的,我是去年11月底加入的。時間過得真快,這三個月就這樣過去了。但我之前在 Evaxion 董事會任職期間,已經對該公司有了深刻的印象。

  • In terms of bigger picture changes. I think the fundamentals of Evaxion remained really strong. And in fact, I think they have only got stronger through 2025. So the ability to have an AI platform that is built up over many years, many iterations, grounded in data and testing for that data in the lab, and ultimately in the clinic has really strengthened the core offering. So I remain really excited about the power of the platform in the oncology space and also in the infectious disease space.

    從更宏觀的角度來看。我認為Evaxion的基本面依然非常強勁。事實上,我認為到 2025 年,他們的實力只會越來越強。因此,擁有一個經過多年、多次迭代、以數據為基礎,並在實驗室和最終在臨床上進行數據測試的人工智慧平台,確實增強了核心產品。因此,我對該平台在腫瘤學領域以及傳染病領域的潛力仍然感到非常興奮。

  • And I think we're sort of seeing a lot more traction around what we can do with the platform now from external engagement. So I think the fundamental strengths and core of what Evaxion has to offer is even stronger now than potentially before. And I think in a world of AI, everything, actually getting to products, actually producing candidates that can generate vaccines that generate a biological response and the clinical response is meaningful and is becoming recognized as meaningful, certainly in our partnering conversations, et cetera.

    我認為,透過外部參與,我們現在對利用平台所能做的事情有了更大的了解。所以我認為,Evaxion 的基本優勢和核心價值現在比以前可能更強大了。我認為在人工智慧的世界裡,一切,真正地研發出產品,真正地生產出能夠產生生物反應和臨床反應的候選疫苗,都是有意義的,而且也越來越被認為是有意義的,當然,在我們的合作對話中也是如此。

  • So I think that that is core. So clear observation I had before coming into the company and certainly strengthened by all my observations within it and even more impressed by the team that's in place that can deliver on this.

    所以我認為這就是核心所在。所以,我在加入公司之前就有了清晰的觀察,而我在公司裡的所有觀察也進一步強化了我的這種觀察,並且我對能夠實現這一目標的團隊印象深刻。

  • I think in terms of the overall strategy, what have Evaxion has done well is that early discovery, the early validation, that deep scientific and informatic embedded expertise, and we can certainly bring things forward into early clinical development, late preclinical, early clinical. And I think what we're going through at the moment is a process of really optimizing where we see the most value in the near term, both in terms of our oncology assets, but also within the infectious disease area.

    我認為就整體策略而言,Evaxion 做得好的地方在於早期發現、早期驗證,以及深厚的科學和資訊學專業知識,我們當然可以將產品推進到早期臨床開發、後期臨床前、早期臨床階段。我認為我們目前正在經歷的是一個真正優化過程,旨在確定在短期內最有價值的領域,包括我們的腫瘤資產以及傳染病領域。

  • I think we are not positioned to take too much further forward into the clinic. So we've been very cautious about that but we certainly see strength and getting interest from external parties around the assets that we've already got. And actually, the capability of the platform.

    我認為我們目前還沒有做好在臨床方面進行更多深入研究的準備。所以我們一直對此非常謹慎,但我們確實看到了我們現有資產的實力,也引起了外部各方的興趣。實際上,是平台的能力。

  • So no fundamental change to strategy, but I think a sharpening and the deepening of focus around the assets that will have the most value. I hope that's helpful.

    因此,策略不會發生根本性改變,但我認為會更明確和深入地關注那些最有價值的資產。希望這能幫到你。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Yes, that's great. And just keying off of your last comment there about taking products into the clinic. You mentioned with EVX-04 in Birgitte's presentation that you would be looking to submit regulatory paperwork. Is that a product that you think you have to take into Phase 1 given that ERVs are a bit new, a bit different in order to attract a partner interest?

    是的,那太好了。還有,我想就您剛才關於將產品帶入診所的評論做個補充。在 Birgitte 的演講中,你提到了 EVX-04,你會考慮提交監管文件。鑑於 ERV 是一種比較新的產品,與傳統產品略有不同,您認為為了吸引合作夥伴的興趣,是否必須將產品納入第一階段?

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • I think -- that's a very good question. We are certainly preparing to take it into the clinic, and we believe that we can do that to gain some initial proof of concept. There's a lot of interest around the platform, that particular set of candidate antigens in the vaccine. I think we're doing some further validation work, which I think will continue to strengthen it. So the answer in short is not necessarily, but clearly, the more critical validating data that we can add to the package.

    我覺得——這是一個很好的問題。我們當然正在準備將其引入臨床,我們相信我們可以透過這樣​​做來獲得一些初步的概念驗證。人們對這個平台,以及疫苗中的那組特定候選抗原非常感興趣。我認為我們正在進行一些進一步的驗證工作,我認為這將繼續加強它。所以簡而言之,答案不一定是,但顯然,我們可以在軟體包中添加更關鍵的驗證數據。

  • The stronger the value proposition to an external partner, and that's obviously what we're all about is maintaining the -- building the value for as long as we can to strengthen our position. And I think we're very confident about what we can do with it preclinically and potentially clinically.

    對外部合作夥伴而言,價值主張越強,我們就越能鞏固自身地位,而這顯然也是我們所追求的──盡可能長時間地維持價值,從而增強我們的地位。我認為我們對它在臨床前研究和潛在的臨床應用中所能取得的成果非常有信心。

  • Operator

    Operator

  • Michael Okunewitch, Maxim Group.

    Michael Okunewitch,Maxim集團。

  • Michael Okunewitch - Equity Analyst

    Michael Okunewitch - Equity Analyst

  • Congrats on all the great progress you made. I guess to start off, I'd just like to see if you could comment a little bit on the partnering efforts for EVX-01. And in particular, if there's anything that you've heard either in your feedback from partners that you think yourself would be particularly important for us to watch for from the upcoming data releases, whether that's the three-year data or the biomarker immunogenicity. Is there anything in particular you think is key for driving these partnering discussions?

    恭喜你所取得的巨大進步。首先,我想請您對 EVX-01 的合作努力發表一些看法。特別是,如果您從合作夥伴那裡聽到任何反饋,您認為在即將發布的數據中有什麼特別值得我們關注的內容,無論是三年數據還是生物標誌物免疫原性。您認為推動這些合作洽談的關鍵是什麼?

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • So that's a really good question. And I mean, clearly, the cancer vaccine space has had something of a checkered past -- way back, but more of renaissance, I think, in the checkpoint era. And I think our data is certainly resonating with companies who are interested in the cancer vaccine area, understand the nuances around getting, I think, strong cancer -- strong antigens, personalized cancer antigens for not just immune recognition, but for clinical benefit.

    這確實是個好問題。我的意思是,很顯然,癌症疫苗領域有著一段坎坷的歷史——可以追溯到很久以前,但我認為,在檢查點時代,癌症疫苗領域迎來了復興。我認為我們的數據肯定會引起對癌症疫苗領域感興趣的公司的共鳴,他們了解獲得強效癌症抗原(即個性化癌症抗原)的細微差別,這不僅是為了免疫識別,更是為了臨床獲益。

  • So it is a complex therapy to administer, but it is also potentially an effective therapy. And I think the sorts of things that gain interest of the -- not just the response rate that we've seen in two years, one year than two years at ESMO, but also the recognition of the antigens, the numbers that Birgitte spoke to, and I'll ask her to add comment to this as well. So I think the -- we're in a strong position with that updated clinical data package that we have.

    因此,這種療法實施起來很複雜,但它也可能是一種有效的療法。我認為引起人們興趣的事情,不僅是我們在過去兩年裡看到的ESMO(歐洲腫瘤內科學會)的回應率,還有抗原的識別,以及Birgitte提到的數字,我也會請她對此發表評論。所以我認為,憑藉我們掌握的最新臨床資料包,我們處於非常有利的地位。

  • The translational data, I think, it's going to be interesting. It continues to show why and how the immune response is happening in parallel to the clinical response. So that is, I think, a differentiator and also in the population, the advanced population rather than adjuvant melanoma population. And clearly, I think, we're also seeing interest in this whole approach in other high mutational burden cancers too.

    我認為,翻譯資料會很有意思。它繼續展示了免疫反應與臨床反應同步發生的原因和方法。所以我認為這是一種區別,而且在人群中,晚期黑色素瘤患者群體與輔助治療黑色素瘤患者群體之間存在區別。顯然,我認為,我們也看到人們對這種方法在其他高突變負荷癌症中也產生了興趣。

  • So beyond melanoma, I think those are the differentiators, thinking about where else this is applicable, acknowledging the different biological parameters, the translational insights that we're seeing that's somewhat different to how others have reported on this with similar approaches. So quite a bit of interest.

    所以除了黑色素瘤之外,我認為這些就是區別所在,思考它還適用於哪些其他領域,並認識到不同的生物學參數,我們看到的轉化見解與其他人使用類似方法報告的情況有所不同。所以大家對此相當感興趣。

  • I think the number -- to be honest, a number of companies are on the fence, but looking with interest and very interested in the shared approach -- the share antigen approach that our EVX-04 program offers. Birgitte, do you want to add some further comments?

    說實話,我認為很多公司都在猶豫不決,但他們對我們 EVX-04 計畫提供的共享抗原方法很感興趣,並且非常感興趣。比爾吉特,你還有什麼要補充的嗎?

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • So there's no doubt that the ability of our AI-Immunology platform to identify the relevant targets is getting a lot of interest from potential partners and also from the academic community. And with this 81% hit rate, as we call it, I think, this is very impressive. We have, of course, looked at other similar programs and seen that most of them are reporting hit rates way below 60%, meaning that the antigens that they are including in their vaccines are not all able to induce a specific T cell response.

    因此,毫無疑問,我們的 AI 免疫學平台識別相關標靶的能力引起了潛在合作夥伴和學術界的極大興趣。我認為,81% 的命中率非常令人印象深刻。當然,我們也檢視了其他類似的計劃,發現其中大多數計劃的命中率都遠低於 60%,這意味著他們疫苗中包含的抗原並非都能誘導特定的 T 細胞反應。

  • And this is, of course, a testament to the precision of our platform. So that's one of the key elements.

    這當然證明了我們平台的精準性。這是關鍵要素之一。

  • And another point that I would like to make is that we do see EVX-01 as not just a therapy for advanced melanoma. We believe that the same concept can be very useful in other indications where there are a high mutational burden, meaning that there are several antigens to choose from. That includes many of the high prevalent cancer indications. It could be non-small cell lung cancer and also some of the colorectal cancers.

    我想提出的另一點是,我們認為 EVX-01 不僅僅是晚期黑色素瘤的治療方法。我們認為,同樣的概念在其他具有高突變負荷的適應症中也很有用,這意味著有多種抗原可供選擇。這其中包括許多高發生性癌症適應症。可能是非小細胞肺癌,也可能是某些類型的大腸癌。

  • Michael Okunewitch - Equity Analyst

    Michael Okunewitch - Equity Analyst

  • Thank you. I appreciate that additional color on that. And then as a follow-up, I wanted to ask if you could provide a bit more color on how you're applying the AI-Immunology platform to autoimmune disease. You identified this as a new area of interest. And do you expect that this would be more focused on allergies? Or would you focus more on the major large autoimmune and inflammatory diseases. Any additional color you could provide on that would be helpful.

    謝謝。我喜歡上面添加的色彩。然後,作為後續問題,我想請您詳細介紹一下您是如何將 AI 免疫學平台應用於自體免疫疾病的。你將此確定為一個新的興趣領域。你認為這項研究會更著重於過敏症嗎?或者您會更關注主要的自體免疫疾病和發炎性疾病?如果您能提供更多顏色信息,那就太好了。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Sure. I think the first thing to say is it's early in terms of our prioritization of the indications, but we've certainly done some work around that based on parameters, which I'll -- Birgitte, if you're happy to comment on that, I think, high level in terms of what's guiding where we focus, that would be good.

    當然。我認為首先要說的是,就我們對這些適應症的優先排序而言,現在還處於早期階段,但我們確實已經根據一些參數做了一些相關工作,我會——Birgitte,如果你願意就此發表評論,我認為,從指導我們關注方向的高層次角度來看,這將很好。

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • Yes. So we have done a lot of analysis on most prevalent autoimmune diseases, and we do see a clear fit for our platform. I mean, we, of course, need to further improve it and build a few additional smaller unit that allows us to apply the immunology. But we do have many things in place that can be directly applied in this area.

    是的。因此,我們對最常見的自體免疫疾病進行了大量分析,我們發現我們的平台與這些疾病非常契合。我的意思是,我們當然需要進一步改進它,並建造一些額外的較小單元,以便應用免疫學。但我們確實有許多現成的資源可以直接應用於這個領域。

  • So we will, of course, share more when we have done both analysis on which key indications we will pursue and also when we have done a little bit more work on adjusting AI-Immunology, so it fits these diseases. But we should remember to say that there's a lot of these smaller units, we call them building blocks, that we can directly apply for these types of diseases.

    當然,當我們分析出我們將要研究的關鍵適應症,以及對人工智慧免疫學進行更多調整,使其適應這些疾病之後,我們會分享更多資訊。但我們應該記住,有很多這樣的小單元,我們稱之為構建模組,我們可以直接將它們應用於這些類型的疾病。

  • So not only for autoimmune diseases but also for other diseases where there is a strong immunological component. So of course, we need to build a little bit, but the majority is already in AI-Immunology.

    因此,不僅適用於自體免疫疾病,也適用於其他具有強烈免疫成分的疾病。所以當然,我們還需要做一些建設,但大部分已經屬於人工智慧免疫學領域。

  • Operator

    Operator

  • RK, H.C. Wainwright.

    RK,H.C. Wainwright。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you. This is RK from H.C. Wainwright. Just to start off, Helen, a quick question for you. You have basically been an architect in multibillion-dollar alliances at Adaptimmune, especially the large deal that was transacted with GSK. And also, you have had lot of experience in transactions. And while Evaxion is technically a very strong company, they have always had a difficulty in translating that language into meaningful transactions.

    謝謝。這是來自 H.C. Wainwright 的 RK。海倫,首先我想問你一個問題。您基本上是 Adaptimmune 數十億美元聯盟的架構師,尤其是與 GSK 達成的巨額交易。而且,您在交易方面也擁有豐富的經驗。雖然 Evaxion 從技術上講是一家非常強大的公司,但他們一直很難將這些技術轉化為有意義的交易。

  • Of course, Merck is a pretty strong partner. Based on your experiences, and how you have managed to translate that. What sort of discussions could you have at this point? Especially when talking with large-cap pharma, and convince them that an AI tools predictability is as good as a physical assay and get them to start looking into some of the products that Evaxion is generating.

    當然,默克公司是一個非常強大的合作夥伴。根據你的經驗,以及你如何將其轉化為現實。此時你們可以進行哪些方面的討論?尤其是在與大型製藥公司交談時,要讓他們相信人工智慧工具的預測能力與物理檢測一樣好,並讓他們開始關注 Evaxion 正在開發的一些產品。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • RK, thanks for the question. I think there are probably multiple dimensions to answer that question to the extent that it is possible to answer it at this point. One is that a lot of this is to do with timing. It's to do with data that validates that it's more than a sort of an AI platform. And I think actually, the fact that we have the scope to validate and iterate candidates -- target discovery with candidate development with candidate validation is something really novel that isn't sort of generally out there.

    RK,謝謝你的提問。我認為這個問題可能可以從多個角度來回答,但目前來看,這個問題或許無法回答。其一是,這很大程度上與時機有關。這是透過數據驗證的,這些數據表明它不僅僅是一個人工智慧平台。實際上,我認為我們能夠驗證和迭代候選藥物——目標發現、候選藥物開發和候選藥物驗證——這確實是一個非常新穎的做法,目前還沒有普遍採用。

  • And when I said timing -- there are obviously many of the large pharma, most of them will or all will have in-house AI platforms running in one form or another. But I don't think there are many that have got this sort of integrated long -- sort of longitudinal depth of expertise that Evaxion has. So really, this is about crystallizing the offering through the validation of the candidates we have and sort of being in dialogue with the right people.

    我說的是時機——顯然,很多大型製藥公司,其中大多數或全部都會以某種形式運行內部人工智慧平台。但我認為,像 Evaxion 這樣擁有如此深厚的、長期的、縱向專業知識的公司並不多。所以實際上,這關乎透過驗證我們現有的候選人,並與合適的人進行對話,來明確我們的方案。

  • And you mentioned my background was a long time, 17 years in my predecessor company, building relationships, establishing contacts, understanding and listening to strategy, looking at the wider picture. These are all things that are very much part of how deals get done. And ultimately, it's down to relationships and credibility and really having something that fits the need.

    您提到我的背景是,我在前一家公司工作了 17 年,累積了豐富的經驗,包括建立人脈、拓展關係、理解和傾聽策略、著眼於大局。這些都是交易達成過程中非常重要的環節。歸根結底,這取決於人際關係、信譽以及是否擁有真正符合需求的產品。

  • And all I can say at this point is we're working -- reworking up some of those approaches and some of those themes in terms of how we are approaching potential partnering interaction, I have to say that the Evaxion team is well known with quite a few of these groups, but we're building and expanding that profile.

    目前我只能說,我們正在努力——重新審視和調整一些方法和主題,以更好地處理潛在的合作夥伴互動。我必須說,Evaxion 團隊在許多這樣的團體中都頗有名氣,但我們正在努力提升和擴大我們的知名度。

  • And I think that's critical to the future success in partnering conversations. So it's being what you say you are in front of the right people.

    我認為這對於未來合作對話的成功至關重要。所以,關鍵在於在對的人面前展現你所說的自己。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Perfect. Then going into relationships with Merck, especially regarding EVX-B2, Merck decided to extend the evaluation of the molecule rather than exercise the option at this point. Is this a function of them trying to do additional experiments or functional assays? Or are they requesting from new additional work so that they can come to a conclusion?

    完美的。隨後,在與默克公司建立合作關係時,尤其是在 EVX-B2 方面,默克決定延長對該分子的評估,而不是在這個時候行使選擇權。這是因為他們想進行額外的實驗或功能性檢測嗎?或者他們是否要求增加新的工作量,以便得出結論?

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Sorry, are you referring to the extension that they had last year before the decision there?

    抱歉,您指的是去年他們做出決定之前獲得的延期嗎?

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Yes, yes.

    是的,是的。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • I mean, we can't really comment on, obviously, the combination nature of the interactions. All I can say is that sometimes is sort of R&D programs when they are back and forth and shared between organizations don't always run to plan. And so sometimes that requires looking at things again. But ultimately, then there are time frames around things, which have to follow through. So I think there are reasons for not taking, sort of obviously, their reasons are multidimensional.

    我的意思是,我們顯然無法對這些相互作用的組合性質發表評論。我只能說,有時研發專案在組織間來回交流和分享時,並不總是能按計畫進行。所以有時候需要重新檢視一些事情。但歸根究底,事情都有時間限制,必須遵守。所以我認為不接受是有原因的,很顯然,他們的理由是多方面的。

  • All I can say is that we remain really excited about the data. We actually continue to build data on the program internally throughout that period of time as well. So we feel very, very bullish and strong about the data package but how and why Merck wanted to do that work? Or -- is something we can't really add any more commentary on.

    我只能說,我們對這些數據仍然感到非常興奮。在此期間,我們實際上也在內部持續收集有關該項目的數據。所以我們對資料包感到非常非常樂觀和充滿信心,但是默克公司為什麼要做這項工作呢?或者──這是我們實在無法再多做評論的事情。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Okay. On the EVX-01 durability, Birgitte, so you have shown 92% of the responders showing sustainability, at 24 months. As we are looking forward today to the three-year durability. What sort of exhaustion markers are you going to be tracking so that we understand how well the durability is.

    好的。關於 EVX-01 的耐用性,Birgitte,您已經證明,92% 的受訪者表示該設備在 24 個月內具有可持續性。我們今天期待的是三年的耐用性。你們將追蹤哪些疲勞指標,以便我們了解其耐用性如何?

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • Yes. Thank you for that question, RK. So it's correct that 92% of the responders remained in response after this two-year mark. And I guess your question was related to the T-cell extortion -- yes, we do a deep T-cell profiling, looking at activation markers, exhaustion markers and also at different phenotypes of the T-cells, so including CD4, CD8, but also looking into whether there are regulatory T-cells coming up.

    是的。謝謝你的提問,RK。因此,92% 的受訪者在兩年後仍然保持回應,這是正確的。我猜你的問題與 T 細胞的消耗有關——是的,我們進行了深入的 T 細胞分析,研究了激活標誌物、耗竭標誌物以及 T 細胞的不同表型,包括 CD4、CD8,同時也研究了是否存在調節性 T 細胞。

  • And so far, we have demonstrated that the profile of the T-cells are very favorable. So in more of the activation or effector type of cells and not too many that are having exhaustion markers. We also see that there's like a dominance of CD4 T-cells with some patients also mounting a CD8 T-cell by time.

    到目前為止,我們已經證明T細胞的特性非常有利。因此,更多的是激活型或效應型細胞,而具有衰竭標誌的細胞並不多。我們也發現,CD4 T 細胞似乎占主導地位,但隨著時間的推移,有些患者也會出現 CD8 T 細胞。

  • So we have -- during this extension phase of the study, we have been collecting additional blood samples that are currently being analyzed in our lab. So more to come on that, but it's very exciting. And since EVX-01 is given as a monotherapy in this extension phase, we're also very curious of understanding what EVX-01 can drive on its own without having the background of the checkpoint inhibitors.

    因此,在研究的擴展階段,我們一直在收集額外的血液樣本,目前正在我們的實驗室進行分析。關於這一點,後續還會有更多消息,但非常令人興奮。由於 EVX-01 在此擴展階段是作為單藥療法給藥,我們也十分好奇 EVX-01 在沒有檢查點抑制劑的情況下,自身能發揮什麼作用。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Okay. One last question from me. This is on the EVX-04 --

    好的。我最後一個問題。這是關於 EVX-04 的——

  • Operator

    Operator

  • In the interest of time, we will move to our next question.

    為了節省時間,我們直接進入下一個問題。

  • Danya Ben-Hail, Jones.

    丹婭·本-海爾,瓊斯。

  • Danya Ben-Hail - Analyst

    Danya Ben-Hail - Analyst

  • On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates?

    關於自體免疫疾病項目,您能否詳細介紹您驗證早期候選人的策略?

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Thanks for the question. I mean, it's early, and we probably cannot provide more details. But, Birgitte, do you want to comment on how we think about it.

    謝謝你的提問。我的意思是,現在還早,我們可能無法提供更多細節。但是,比爾吉特,你想對我們的想法發表一下看法嗎?

  • Birgitte Rono - Chief Scientific Officer

    Birgitte Rono - Chief Scientific Officer

  • Yes. So the first step is to settle on an indication. So we have done landscaping. We've done dry analysis on looking at the top 10 most prevalent ultimate diseases, and we are now narrowing down which one could be the most, I would say, interesting from a -- from our perspective, where there is a nice fit for AI-Immunology. And so that work is ongoing.

    是的。所以第一步就是確定一個指標。我們已經完成了景觀美化工作。我們已經對十大最普遍的終極疾病進行了枯燥的分析,現在我們正在縮小範圍,從我們的角度來看,哪一種疾病最有趣,因為人工智慧免疫學與它非常契合。因此,這項工作仍在進行中。

  • We've almost completed it. And next step is to focus on building the additional smaller units that we will be needing in AI-Immunology to enable us to develop therapies for these diseases. And in parallel, we are also setting up mouse models in our lab, so ensuring that we can also test the candidates that AI-Immunology is designing.

    我們幾乎完成了。下一步是集中精力建立我們在人工智慧免疫學領域所需的其他小型單元,以便我們能夠開發治療這些疾病的方法。同時,我們也在實驗室建立了小鼠模型,以確保我們也能測試人工智慧免疫學正在設計的候選藥物。

  • So that is the current plan. So pretty traditional way of analyzing or testing the candidates that AI-Immunology is designing.

    這就是目前的計劃。所以,這是分析或測試人工智慧免疫學所設計的候選藥物的一種相當傳統的方法。

  • Operator

    Operator

  • Thank you. This concludes today's question-and-answer session. I will now hand the call back to Helen Tayton-Martin, CEO, for closing remarks.

    謝謝。今天的問答環節到此結束。現在我將把電話轉回給執行長海倫·泰頓-馬丁,請她作總結發言。

  • Helen Tayton-Martin - Chief Executive Officer

    Helen Tayton-Martin - Chief Executive Officer

  • Thank you very much for everyone participating on the call today. It's been a great year for 2025 of transforming the company, for Evaxion delivering on multiple milestones, leaving us in a stronger financial position than for some time, where we hope we can take the company forward and deliver on our 2026 milestones and continue to strengthen the value that comes from the platform and the assets.

    非常感謝今天所有參加電話會議的各位。對 Evaxion 而言,2025 年是公司轉型和實現多個里程碑的輝煌一年,使我們的財務狀況比以往任何時候都更加穩健。我們希望能夠帶領公司繼續前進,實現 2026 年的里程碑目標,並繼續增強平台和資產帶來的價值。

  • So thank you for your questions and your engagement, and we look forward to our next update. Thank you. Bye-bye.

    感謝大家的提問和參與,我們期待下次更新。謝謝。再見。