Evaxion Biotech A/S (EVAX) 2023 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Evaxion Biotech Q2 Results Call. (Operator Instructions)

美好的一天，感謝您的支持。歡迎參加 Evaxion Biotech 第二季度業績電話會議。 （操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Per Norlen. Please go ahead.

請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人佩爾·諾倫 (Per Norlen)。請繼續。

Thank you, operator. Good morning and good afternoon, everyone. I'm Per Norlen, Chief Executive Officer at Evaxion. And with me today is Jesper Nyegaard Nissen, Chief Operating Officer and Interim and Interim Chief Financial Officer at Evaxion since August 1.

謝謝你，接線員。大家早上好，下午好。我是 Per Norlen，Evaxion 首席執行官。今天和我在一起的是 Jesper Nyegaard Nissen，他自 8 月 1 日起擔任 Evaxion 首席運營官兼臨時和臨時首席財務官。

First, before we start, a note on forward-looking statements, let me remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's annual report Form 20-F and the company's current and future reports submitted to the Securities and Exchange Commission, SEC.

首先，在我們開始之前，關於前瞻性陳述的說明，讓我提醒您，以下討論包含某些被視為 1995 年《私人證券訴訟改革法案》中定義的前瞻性陳述的陳述。因為前瞻性陳述涉及風險和不確定性，它們不是對未來業績的保證，並且由於多種因素，包括公司年度報告20-F 表格中討論的風險因素，實際結果可能與這些前瞻性陳述明示或暗示的結果存在重大差異以及公司向美國證券交易委員會(SEC) 提交的當前和未來報告。

With that said, I'm pleased to welcome you to today's conference call. During the call, I will provide you with a brief overview of the excellent progress we made across our pipeline and on our core AI technologies over the past 6 months. I will then turn the call over to Jesper, who will review our financial report for the second quarter of 2023, and then we will open up the line for questions. We have a presentation which you can follow and this is Slide 1, and we will start by taking a quick look at today's agenda, which is on Slide 2.

話雖如此，我很高興歡迎您參加今天的電話會議。在電話會議期間，我將向您簡要概述過去 6 個月我們在整個流程和核心人工智能技術方面取得的出色進展。然後我會將電話轉給 Jesper，他將審查我們 2023 年第二季度的財務報告，然後我們將開通提問熱線。我們有一個演示文稿可供您觀看，這是幻燈片 1，我們將首先快速瀏覽一下今天的議程，即幻燈片 2。

So Slide 2. I will start with our recent communication on our staphylococcus aureus vaccine EVX-B1 where we were pleased to present preclinical proof-of-concept data showing that the vaccine candidate can clear staphylococcus infections. We will also show the early-stage clinical data reported on AACR 2023 and ASCO '23, indicating that patients treated with our vaccines, EVX-01 or EVX-02 in combination with the checkpoint inhibitor experienced a treatment benefit and with good overall tolerability.

所以幻燈片 2。我將從我們最近關於金黃色葡萄球菌疫苗 EVX-B1 的交流開始，我們很高興提供臨床前概念驗證數據，表明該候選疫苗可以清除葡萄球菌感染。我們還將展示AACR 2023 和ASCO '23 報告的早期臨床數據，表明使用我們的疫苗、EVX-01 或EVX-02 與檢查點抑製劑聯合治療的患者獲得了治療益處，並且具有良好的總體耐受性。

Further, I will provide an update on our next-generation personalized cancer vaccine candidate EVX-03, which is approaching the clinic as well as our novel AI technology observed, that's been used to identify a new source of antigens for personalized cancer vaccines. And that's planned for clinical validation through the EVX-03 program.

此外，我將提供有關我們的下一代個性化癌症候選疫苗EVX-03 的最新信息，該疫苗即將進入臨床，以及我們觀察到的新穎的人工智能技術，該技術已用於識別個性化癌症疫苗的新抗原來源。計劃通過 EVX-03 項目進行臨床驗證。

And of course, the financial update with second quarter financial results as presented by Jesper. So let's start with EVX-B1 on Slide 3. So move to Slide 3. In late July, we presented novel data on our vaccine candidate for prevention of staphylococcus aureus disease EVX-B1 at the Gordon Research Conference in New Hampshire, USA. The vaccine candidate has been generated using our AI technology.

當然，還有 Jesper 介紹的第二季度財務業績更新。讓我們從幻燈片3 上的EVX-B1 開始。轉到幻燈片3。7 月下旬，我們在美國新罕布什爾州舉行的戈登研究會議上展示了有關預防金黃色葡萄球菌病EVX-B1 的候選疫苗的新數據。候選疫苗是使用我們的人工智能技術生成的。

And apart from the protective effect demonstrated in the sepsis disease model, which we have shown previously and that you can see for reference on the left-hand side, we have now assessed the ability of EVX-B2 to clear bacteria from internal organs. And if you take a brief look at the graph on the right-hand side, the results are quite clear. No could be detected in any organs 4 weeks after a bacterial challenge. The program is currently in late preclinical development and we are in discussions with a potential partner on its future development and commercialization in accordance with our strategy.

除了我們之前在膿毒症模型中展示的保護作用（您可以在左側看到以供參考）之外，我們現在還評估了 EVX-B2 清除內臟器官細菌的能力。如果您簡單地看一下右側的圖表，結果就非常清楚了。細菌攻擊後 4 週，任何器官中均未檢測到任何物質。該項目目前正處於臨床前開發後期，我們正在與潛在合作夥伴根據我們的戰略就其未來的開發和商業化進行討論。

So now let's switch to oncology and our clinical programs for personalized cancer vaccines. That's Slide 4. So if you have the right slide in front of you, you should be able to read EVX-01 on the top, and it should show the readout of our clinical Phase I/II clinical trial in metastatic melanoma. EVX-01 is a personalized peptide-based cancer vaccine, where patient-specific tumor mutations, so-called neoantigens are identified using our AI technology pioneer. These neoantigens are ideal targets for cancer vaccine in that they derived from tumor mutations and therefore, only exists in tumor cells, which means that the treatment can become very specific for the tumor with less risk and negative effects on healthy tissue.

現在讓我們轉向腫瘤學和個性化癌症疫苗的臨床計劃。這是幻燈片 4。因此，如果您面前有正確的幻燈片，您應該能夠閱讀頂部的 EVX-01，並且它應該顯示我們針對轉移性黑色素瘤的臨床 I/II 期臨床試驗的讀數。 EVX-01 是一種基於肽的個性化癌症疫苗，使用我們的人工智能技術先鋒來識別患者特異性腫瘤突變，即所謂的新抗原。這些新抗原是癌症疫苗的理想靶標，因為它們源自腫瘤突變，因此僅存在於腫瘤細胞中，這意味著治療可以針對腫瘤變得非常特異性，而對健康組織的風險和負面影響較小。

In the first human trial, 6 biweekly doses of EVX-01 were given in combination with PD-1 therapy. The treatment was well tolerated. And of the 12 patients that completed the trial, 8 showed an objective response to the treatment. If you look on the graph on the right-hand side, you should see a horizontal black line indicating the tumor size at the start of treatment. You can see 12 bars, which represents the best objective responses for each patient in the trial. If the bar goes up, tumors increase in size and if the bar goes down, this means that the tumors decrease in size.

在第一項人體試驗中，每兩週服用 6 劑 EVX-01 與 PD-1 療法相結合。治療耐受性良好。在完成試驗的 12 名患者中，有 8 名患者對治療表現出客觀反應。如果您查看右側的圖表，您應該會看到一條水平黑線，指示治療開始時的腫瘤大小。您可以看到 12 個條形，代表試驗中每位患者的最佳客觀反應。如果條形上升，則腫瘤尺寸增大；如果條形減小，則意味著腫瘤尺寸減小。

And to our excitement, most bars do actually go down. And for 8 of the patients, the outcome fulfills the criteria of a treatment response. We're obviously really enthusiastic about these results. It's better than you would expect from PD-1 alone, and it speaks to the strength of our AI technology in selecting the right neoantigens for personalized cancer vaccine.

令我們興奮的是，大多數酒吧實際上都在下跌。其中 8 名患者的結果滿足治療反應標準。我們顯然對這些結果非常熱情。它比您對 PD-1 單獨的預期要好，它證明了我們的人工智能技術在為個性化癌症疫苗選擇正確的新抗原方面的實力。

This was EVX-01, but we have also reported data from our DNA-based cancer vaccine EVX-02. That's on the next slide, Slide 5. It just said, EVX-02 at the top. This is a clinical trial of EVX-02 in combination with nivolumab, a PD-1 blocker as adjuvant therapy to prevent cancer relapse after a complete surgical resection on malignant melanoma over 12 months. It's a DNA-based therapy. The image shows the DNA plasmid, carrying the genes for patient-specific neoantigens. So the vaccine is administered as DNA and then translated to neoantigens in the patients, and the results look very promising. All 10 patients that have completed the vaccination with EVX-02 were relapse free at the end of the trial. The vaccine was well tolerated in all patients and induce a new antigen-specific T cell immune response in all patients, which can be seen as a proof of mechanism for our DNA vaccine technology.

這是 EVX-01，但我們還報告了基於 DNA 的癌症疫苗 EVX-02 的數據。這是下一張幻燈片，即幻燈片 5。它剛剛說，EVX-02 在頂部。這是一項 EVX-02 與 PD-1 阻斷劑 nivolumab 聯合作為輔助治療的臨床試驗，用於預防惡性黑色素瘤完全手術切除後 12 個月內的癌症復發。這是一種基於 DNA 的療法。圖像顯示了 DNA 質粒，攜帶患者特異性新抗原的基因。因此，疫苗以 DNA 形式施用，然後在患者體內轉化為新抗原，結果看起來非常有希望。試驗結束時，完成 EVX-02 疫苗接種的所有 10 名患者均未出現復發。該疫苗在所有患者中均具有良好的耐受性，並在所有患者中誘導新的抗原特異性 T 細胞免疫反應，這可以被視為我們 DNA 疫苗技術機制的證明。

But we do not plan to develop this vaccine candidate further for the time being. And why? You may ask. Well, it's because we have already developed a next-generation vaccine based on EVX-02 and the [EVX] candidate is called EVX-03, and which we intend to prioritize. Let's move to Slide 6.

但我們暫時不打算進一步開發這種候選疫苗。為什麼？你可能會問。嗯，這是因為我們已經開發出了基於 EVX-02 的下一代疫苗，而 [EVX] 候選疫苗被稱為 EVX-03，我們打算優先考慮它。讓我們轉到幻燈片 6。

So EVX-03. EVX-03 is the first-ever personalized ERV cancer vaccine. It builds on EVX-02, meaning that it's a DNA-based personalized cancer vaccine but it has 2 major upgrades. One upgrade is the addition of a genetic immune adjuvant, which aims to boost the immune system risk, immune response to the vaccine. The other upgrade is the addition of a novel vaccine target, so-called ERVs, which I will come back to you in a minute.

所以EVX-03。 EVX-03 是有史以來第一個個性化 ERV 癌症疫苗。它以 EVX-02 為基礎，這意味著它是一種基於 DNA 的個性化癌症疫苗，但它有 2 個主要升級。其中一項升級是添加了基因免疫佐劑，旨在增強免疫系統風險、對疫苗的免疫反應。另一個升級是增加了一種新的疫苗靶點，即所謂的 ERV，我稍後會再給您講到。

Let's start with the genetic immune adjuvant. This is a chemoattractant molecule, which is incorporated into the DNA plasmid as shown for EVX-03 to the right of the picture. EVX-02 is a plasmid on the left-hand side, incorporating DNA coding for neoantigens, whereas EVX-03 on the right-hand side, in addition, incorporates the DNA sequence for the genetic immune adjuvant which is shown in green. The DNA plasmid is administered to the patient under adjuvant, a chemoattractant molecule called CCL19 is produced inside the cells of the patient at the injection site.

我們先從基因免疫佐劑說起。這是一種趨化分子，它被整合到 DNA 質粒中，如圖右側的 EVX-03 所示。 EVX-02 是左側的質粒，包含編碼新抗原的 DNA，而右側的 EVX-03 還包含遺傳免疫佐劑的 DNA 序列（以綠色顯示）。 DNA質粒在佐劑下注射到患者體內，注射部位的患者細胞內會產生一種稱為CCL19的化學引誘劑分子。

And the consequence of this is that the genetic adjuvant attracts immune cells to the vaccination site, which is thought to make the vaccine much more effective. Preclinical data supporting these claims were presented in detail at our R&D Day in May, and you are welcome to visit those presentations at our homepage. The second upgrade of EVX-03 is on the antigen side. Personalized cancer vaccines are usually dependent on neoantigens, which are created by mutations in the tumor.

這樣做的結果是，基因佐劑將免疫細胞吸引到疫苗接種部位，這被認為使疫苗更加有效。支持這些主張的臨床前數據已在我們五月份的研發日上詳細介紹，歡迎您在我們的主頁上訪問這些演示。 EVX-03的第二個升級是在抗原方面。個性化癌症疫苗通常依賴於腫瘤突變產生的新抗原。

This is how the immune system can identify and attack tumors. But it's not the only way for the immune system to identify tumor using artificial intelligence and specifically our novel AI technology observed, we have identified a novel source of tumor selective antigens, that can be used for personalized cancer vaccines, so-called ERVs, which stands for endogenous retroviruses and which are also included in EVX-03 as shown to the right.

這就是免疫系統識別和攻擊腫瘤的方式。但這並不是免疫系統使用人工智能識別腫瘤的唯一方法，特別是我們觀察到的新型人工智能技術，我們已經確定了腫瘤選擇性抗原的新來源，可用於個性化癌症疫苗，即所謂的 ERV，代表內源性逆轉錄病毒，也包含在EVX-03 中，如右圖所示。

Let's switch to Slide 7, and our novel AI platform or ObsERV. So Slide 7. ObsERV, it's our AI technology for identification of ERVs, and ERVs constitute a novel source of cancer vaccine antigens that may allow effective treatment also patients who are unresponsive to today's cancer immunotherapies. But what are ERVs? Well, ERVs are viral DNA leftovers from historical infections throughout human history. And we all have it. In fact, about 80% of our DNA has viral origin. But no need to worry, this DNA is resting and do no harm to us, at least not under normal conditions where ERVs are under tight control by our genetic machinery.

讓我們切換到 Slide 7，以及我們新穎的 AI 平台或 ObsERV。所以幻燈片 7。ObsERV，它是我們用於識別 ERV 的人工智能技術，ERV 構成了癌症疫苗抗原的新來源，可以為對當今癌症免疫療法無反應的患者提供有效的治療。但什麼是 ERV？嗯，ERV 是人類歷史上歷史感染留下的病毒 DNA。我們都擁有它。事實上，我們大約 80% 的 DNA 源自病毒。但無需擔心，這種 DNA 處於休眠狀態，不會對我們造成傷害，至少在 ERV 受到我們遺傳機制嚴格控制的正常情況下不會。

But in cancer cells, these control mechanisms often break down, leading to selective expression of ERVs on human cancer cells. And these ERVs, of course, ideal targets for the immune system. The cancer cell basically waits with a red flag saying, "I don't belong here. I'm infected by a virus and potentially leading to an immune attack. And that seems to happen quite regularly. We have recently shown that patients that produce ERVs in the tumors may survive longer. If you take a look on the left-hand side in this slide, you can see 2 survival curves in patients with low tumor mutational -- sorry, low tumor mutational burden, or TMB, which means that there are a few tumor mutations. The red line shows the survival in patients with few ERVs whereas the blue line shows the longer survival in patients with a lot of ERVs, presumably because such tumors with a lot of ERVs are more likely to be attacked by the immune system and hence, the better survival.

但在癌細胞中，這些控制機制經常崩潰，導致 ERV 在人類癌細胞上選擇性表達。當然，這些 ERV 是免疫系統的理想目標。癌細胞基本上是在等待，並發出危險信號，說：“我不屬於這裡。我被病毒感染了，可能會導致免疫攻擊。這種情況似乎經常發生。我們最近表明，產生腫瘤中的ERV 可能會存活更長時間。如果你看一下這張幻燈片的左側，你可以看到低腫瘤突變患者的2 條生存曲線——抱歉，低腫瘤突變負荷，或TMB，這意味著存在一些腫瘤突變。紅線顯示了ERV 較少的患者的生存期，而藍線顯示了ERV 較多的患者的生存期較長，大概是因為這種具有大量ERV 的腫瘤更容易受到免疫系統，因此，更好的生存。

And in preclinical models, we have shown that this can be used to make a personalized cancer vaccine that effectively combat tumors. So we believe that EVX-03 may be more effective than current vaccines that are based only on neoantigens. And notably, that it can be broadened -- we can broaden the target population quite significantly. So why is that? Why do we think we can broaden the target population? It's because today's immunotherapies are more or less restricted to patients with hot tumors, which are tumors where there are many tumor mutations called that tumors with high tumor mutational burden or high TMB. But ERVs seem to be equally highly expressed in tumors with [few] mutations or also called cold tumors.

在臨床前模型中，我們已經證明這可以用來製造有效對抗腫瘤的個性化癌症疫苗。因此，我們相信 EVX-03 可能比目前僅基於新抗原的疫苗更有效。值得注意的是，它可以擴大——我們可以相當大地擴大目標人群。那麼這是為什麼呢？為什麼我們認為可以擴大目標人群？這是因為今天的免疫療法或多或少地局限於熱腫瘤患者，這些腫瘤存在許多腫瘤突變，稱為高腫瘤突變負荷或高TMB的腫瘤。但 ERV 似乎在突變很少的腫瘤或也稱為冷腫瘤中同樣高表達。

And these actually make up the majority of all patients' tumors. So potentially a much larger target population, and we should remember that EVX-03 will contain both neoantigens and ERVs, and also our novel genetic adjuvant technology. And that's why we refer to EVX-03 as a next-generation (inaudible) cancer vaccines with potential for superior effect. So we plan to submit an application for start a Phase I clinical trial for EVX-03 in Q4 this year and expect to be first in the world with a (inaudible) ERVs vaccine in patients.

這些實際上構成了所有患者腫瘤的大部分。因此，潛在的目標人群可能更大，我們應該記住，EVX-03 將包含新抗原和 ERV，以及我們的新型遺傳佐劑技術。這就是為什麼我們將 EVX-03 稱為具有卓越效果潛力的下一代（聽不清）癌症疫苗。因此，我們計劃在今年第四季度提交啟動 EVX-03 一期臨床試驗的申請，並期望成為世界上第一個在患者中使用（聽不清）ERV 疫苗的公司。

So in addition to the operational progress, we have recently signed an agreement with the Global Growth Holding Limited, including financial commitments totaling up to USD 20 million available in tranches over the next 3 years, subject to SEC approval. The financing is intended to cover the company's working capital needs, including the advancement of EVX-03 to Phase I readiness, while the actual initiation of clinical activities for EVX-03 are subject to additional funding.

因此，除了運營進展之外，我們最近還與 Global Growth Holding Limited 簽署了一項協議，其中包括在未來 3 年內分批提供總額高達 2000 萬美元的財務承諾，但須經 SEC 批准。此次融資旨在滿足公司的營運資金需求，包括將 EVX-03 推進到 I 期準備工作，而 EVX-03 臨床活動的實際啟動則需要額外資金。

This was the updates from the operations. And now I would like to turn the call over to Jesper.

這是來自操作的更新。現在我想把電話轉給傑斯珀。

Thank you, Per. I will focus my comments on our financial results for Q2 '23 compared to Q2 2022. All of the numbers that I will review in this discussion will be approximate for easy sharing during the call. For additional information regarding our second quarter results and prior period comparisons, please refer to the business update and second quarter 2023 financial results press release and our Form 6-K both filed last week.

謝謝你，佩爾。我將重點評論我們 23 年第 2 季度與 2022 年第 2 季度相比的財務業績。我將在本次討論中查看的所有數字均為近似值，以便在電話會議期間輕鬆分享。有關我們第二季度業績和前期比較的更多信息，請參閱業務更新和 2023 年第二季度財務業績新聞稿以及我們上週提交的 6-K 表格。

Starting with our expenses. Research and development expenses for Q2 2023 amounted to USD 2.9 million, and general and administrative expenses to USD 2.7 million for the period. Research and development decreased by USD 1.2 million or about 29% compared to the same period last year. The decrease was primarily driven by a decrease in external development costs of USD 0.7 million related to clinical trial activities.

從我們的開支開始。 2023 年第二季度的研發費用為 290 萬美元，該期間的一般和管理費用為 270 萬美元。研究與開發費用比去年同期減少120萬美元，約29%。這一下降主要是由於與臨床試驗活動相關的外部開發成本減少了 70 萬美元。

Further, a decrease we've seen in employee-related costs of $0.5 million due to reduced headcount in personnel. General and administrative expenses increased by USD 0.6 million or 28% compared to the same period last year. The increase was primarily due to an increase of $0.3 million in external costs related to professional fees and overhead and an increase in employee-related costs of $0.2 million.

此外，由於人員數量減少，與員工相關的成本減少了 50 萬美元。管理費用比去年同期增加 60 萬美元，即 28%。這一增長主要是由於與專業費用和管理費用相關的外部成本增加了 30 萬美元，以及與員工相關的成本增加了 20 萬美元。

These increases are due to the timing of funding projects and business initiatives compared to 2022 and the expansion of the organization throughout 2022 to meet the requirements as a listed company. The net loss for Q2 2023 amounted to a loss of USD 5.7 million compared to a loss of USD 4.8 million for the same period last year. As of June 30, 2023, we have USD 7.1 million in cash and cash equivalents. We expect our cash balance to be sufficient to fund operations into December 2023.

這些增長是由於與 2022 年相比，資助項目和業務計劃的時間安排以及該組織在 2022 年全年的擴張以滿足上市公司的要求。 2023 年第二季度的淨虧損為虧損 570 萬美元，而去年同期為虧損 480 萬美元。截至2023年6月30日，我們擁有現金及現金等價物710萬美元。我們預計我們的現金餘額足以為 2023 年 12 月的運營提供資金。

Now I would like to turn the call back to you, Per, for a few closing remarks before Q&A.

現在我想把電話轉回給你，佩爾，在問答之前做一些結束語。

Thank you, Jesper. And now a brief look into the future. So looking into the rest of 2023, we expect to deliver on 2 important and near-term milestones. We plan to report interim results from the ongoing EVX-01 Phase II trial in patients with metastatic melanoma in Q4 this year. And also in Q4 to submit a clinical trial application to start a Phase I study for EVX-03, but as mentioned before, this is subject to additional funding in the range of $5 million to $10 million secured before initiation.

謝謝你，傑斯珀。現在簡要展望一下未來。因此，展望 2023 年剩餘時間，我們預計將實現 2 個重要的近期里程碑。我們計劃在今年第四季度報告正在進行的針對轉移性黑色素瘤患者的 EVX-01 II 期試驗的中期結果。還在第四季度提交臨床試驗申請，啟動 EVX-03 的 I 期研究，但如前所述，這需要在啟動前獲得 500 萬至 1000 萬美元的額外資金。

So in conclusion, I'm very happy about the progress and believe we have potential to develop vaccines that may truly improve the treatment of cancer as well as the prevention of infectious disease around the world. On behalf of everyone at Evaxion, I invite you to continue to stay in touch with the company and follow our progress in 2023 and beyond.

總之，我對這一進展感到非常高興，並相信我們有潛力開發出可以真正改善世界各地癌症治療以及傳染病預防的疫苗。我代表 Evaxion 的全體員工，邀請您繼續與公司保持聯繫，關注我們在 2023 年及以後的進展。

So operator, over to you for Q&A.

那麼接線員，請您進行問答。

(Operator Instructions) We will not take the first question from the line of Thomas Flaten.

（操作員說明）我們不會接受 Thomas Flaten 提出的第一個問題。

This is Thomas from Lake Street. A couple of quick questions. Per, you mentioned in your prepared remarks that you were discussing the staph aureus program with a partner. Has the deal been struck there? Or is this part of a partnership discussion for a deal we have to be announced?

這是來自湖街的托馬斯。幾個簡單的問題。 Per，您在準備好的發言中提到您正在與合作夥伴討論金黃色葡萄球菌計劃。那里達成協議了嗎？或者這是我們必須宣布的交易的合作夥伴關係討論的一部分？

So say that again, what was the question if we already have announced the partner or...

所以再說一遍，如果我們已經宣布了合作夥伴或者……還有什麼問題呢？

You mentioned that you were discussing with the partner of the future for the Staph aureus program. I was curious if there was a partnership that had already been struck? Or is this was a potential partner. .

您提到您正在與未來的合作夥伴討論金黃色葡萄球菌計劃。我很好奇是否已經達成了合作夥伴關係？或者這是一個潛在的合作夥伴。 。

No -- yes. Thank you for that question, Thomas. Yes. So sorry if that was confusing. Yes, I would refer to our strategy for these infectious disease programs, which is to find partnerships quite early. So we are in partnership discussions on some of our assets and including this product, and we have not yet announced a partnership. So that will be done in due time when a partnership is in place. But we do not have -- we have not signed a partnership yet.

不——是的。謝謝你提出這個問題，托馬斯。是的。很抱歉，如果這令人困惑。是的，我會提到我們針對這些傳染病項目的策略，即儘早尋找合作夥伴。因此，我們正在就我們的一些資產（包括該產品）進行合作夥伴討論，但我們尚未宣佈建立合作夥伴關係。因此，當建立夥伴關係後，這將在適當的時候完成。但我們還沒有——我們還沒有簽署合作夥伴關係。

Got it. And then for the EVX-01 readout in the fourth quarter, I believe last time -- last quarter, you thought that you might have up to 20 patients in that readout. Do you have any updates for us on how many patients you expect to have? And what format that release will come in press release versus scientific meeting? .

知道了。然後，對於第四季度的 EVX-01 讀數，我相信上一次 - 上個季度，您認為該讀數中可能有多達 20 名患者。您能向我們介紹一下您預計有多少患者的最新情況嗎？與科學會議相比，新聞稿將以什麼形式發布？ 。

Yes. We intend to present the interim data at the end of this year at one of the important -- well, cancer conferences and SITC could be one such conference, but it's yet to be finally determined. And we expect to present data from the first, say, handful of patients. But as you say, we have recruited patients, but we have also reduced the size of the trial. So currently, it looks to be slightly less than 20 patients, the exact number of patients to be determined. But as you say, we will report the first handful of patients towards end of the year at the conference.

是的。我們打算在今年年底在一個重要的會議上展示中期數據——嗯，癌症會議和 SITC 可能就是這樣的會議之一，但尚未最終確定。我們希望提供來自第一批（例如少數）患者的數據。但正如你所說，我們招募了患者，但我們也縮小了試驗規模。目前看來，患者人數略少於20人，具體患者人數有待確定。但正如你所說，我們將在今年年底在會議上報告第一批患者。

Excellent. And then just one final one. The cash runway into the fourth quarter, does that depend on additional use of the ATM or the Lincoln Park facility? Or can you get into December using the 7.1% that you had at the end of June. .

出色的。然後只有最後一件事。第四季度的現金跑道是否取決於 ATM 或林肯公園設施的額外使用？或者您可以使用 6 月底的 7.1% 進入 12 月嗎？ 。

Yes, that's correct. So that -- the runway is currently communicated with that assumption that we get additional funding.

對，那是正確的。因此，跑道目前已與我們獲得額外資金的假設進行了溝通。

We will now take the next question from the line of Ahu Demir.

現在我們將回答 Ahu Demir 提出的下一個問題。

I am Ahu Demir from Ladenburg Thalmann. Two questions from us. One follow-up to Thomas' question about EVX-01 Phase II study. How many of the patients are in the timing stage? Are all patients are in the timing stage versus boosting stage? And do you plan to follow up these patients and continue with the boosting stage as well? .

我是來自拉登堡塔爾曼的阿胡·德米爾。我們提出兩個問題。 Thomas 關於 EVX-01 II 期研究的問題的後續解答。有多少患者處於時機階段？是否所有患者都處於時機階段或加強階段？您是否計劃對這些患者進行隨訪並繼續加強階段？ 。

Yes. So to the trial, and as you referred --thank you, Ahu for the question. We have a -- this is a trial where we combined with PD-1 and we -- which is given to the patients the first 3 months, and then they continue and then we give the vaccine in combination. So we have initiated vaccine treatments with EVX-01 in a bit more than a dozen patients, and we are expecting to administer the vaccine to the last few patients quite soon. So it's all more or less closing in on the number of patients we'll have in the trial. So sure -- did that answer your question?

是的。因此，就審判而言，正如您所提到的，謝謝阿胡提出的問題。我們進行了一項試驗，將 PD-1 與 PD-1 結合起來，在前 3 個月給患者註射，然後他們繼續注射，然後我們聯合注射疫苗。因此，我們已經開始對十幾名患者使用 EVX-01 進行疫苗治療，我們預計很快就會為最後幾名患者註射疫苗。因此，這或多或少地接近了我們將參與試驗的患者數量。那麼確定——這回答了你的問題嗎？

So all the patients will actually have the boosting basically. So it will be, as I understand, between week 12 to 24, you have the timing section. So these are the patients you have a much longer follow-up. .

所以基本上所有的病人實際上都會得到加強。據我所知，在第 12 周到第 24 週之間，會有計時部分。因此，這些患者是您需要長期隨訪的患者。 。

Yes. Sorry. No, I understand. So yes, we do not know that yet, of course. So it's quite a lot of patients has been entering the trial during the spring. So we are not yet there where we will know if they will go into the next phase of boosting. But that is the plan for patients if they stay on the trial and if they're not progressing that they will be offer boosting.

是的。對不起。不，我明白。所以，是的，我們當然還不知道這一點。因此，春季有相當多的患者進入試驗。因此，我們還無法知道它們是否會進入下一階段的提升。但這是為患者制定的計劃，如果他們繼續參加試驗，如果沒有進展，他們將獲得加強治療。

I see. So all the patients will see end of this year would be at the timing stage basically. Is that...

我懂了。所以今年年底所有的患者基本上都會處於這個時機階段。就是它...

Yes. That will be the data we'll present at the end of this year, yes.

是的。是的，這將是我們將在今年年底提供的數據。

Okay. Helpful to know. And my second question is ERVs. This is something relatively new compared to new antigenal approach. So I am curious how do you select your ERVs, how specific are they patients or within indication. Just curious if you could elaborate on the ERV side. .

好的。了解很有幫助。我的第二個問題是 ERV。與新的抗原方法相比，這是相對較新的東西。所以我很好奇你們如何選擇 ERV，它們對患者的具體程度或適應症有多大。只是好奇您能否詳細說明 ERV 方面的情況。 。

Yes. I can give some more background. So there's a lot of ERV DNA in all humans. And as I said before, these are more or less randomly expressed in some cancers when the machine control machinery breaks down. That seem to be around, say, 10,000 or 20,000 different ERVs that can be expressed. So finding they are very different from each from patient to patient.

是的。我可以提供更多背景信息。因此，所有人體內都含有大量的 ERV DNA。正如我之前所說，當機器控制機制發生故障時，這些或多或少會在某些癌症中隨機表達。可以表達的 ERV 大約有 10,000 或 20,000 種左右。因此發現每個患者的情況都非常不同。

And that said, there are sometimes in some patients that could be overlapping ERVs. But we are in this trial looking for producing a fully personalized vaccine towards ERVs, and that's really where we are unique. So -- and these ERVs, they are selected based on likelihood to induce a strong immune response, given that they are relatively long foreign peptides that can be actually quite a large number of epitopes on each Europe.

也就是說，有時某些患者的 ERV 可能會重疊。但我們在這項試驗中尋求生產一種完全個性化的 ERV 疫苗，這確實是我們的獨特之處。因此，這些 ERV 是根據誘導強烈免疫反應的可能性來選擇的，因為它們是相對較長的外源肽，實際上每個歐洲可能有相當多的表位。

So we can find a very, say, high-quality antigens whenever we find a strong expression of these ERVs in patients. And it's based more or less in the same way as when you select the new antigens that you look for how well they match the immune system of that patient. So you need to predict the shape of the patients' immune receptors and also the shape of the epitopes on the ERV. And then how likely they are to adhere to one another. That is one of the key factors we look at, but there are many more aspects to it.

因此，每當我們在患者中發現這些 ERV 的強烈表達時，我們就可以找到非常高質量的抗原。它或多或少與您選擇新抗原時的方式相同，即您尋找它們與患者免疫系統的匹配程度。因此，您需要預測患者免疫受體的形狀以及 ERV 上表位的形狀。然後他們相互堅持的可能性有多大。這是我們關注的關鍵因素之一，但還有更多方面。

We will now take the next question, it comes from the line of Swayampakula Ramakanth.

我們現在將提出下一個問題，它來自斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth) 的傳承。

This is RK from H.C. Wainwright. So a quick question on EVX-01. So on the Phase I portion of that study, you had presented some interim data on the 9 patients. Is there going to be an additional data in the next update that you're going to be presenting at the end of this year? Or is it mostly going to be initial data from the trades 2 portion of the study?

我是 H.C. 的 RK。溫賴特。關於 EVX-01 的一個簡單問題。因此，在該研究的第一階段部分，您提供了 9 名患者的一些中期數據。你們將在今年年底發布的下一次更新中是否會提供額外的數據？或者它主要是來自研究的交易 2 部分的初始數據？

Yes. Thank you, RK, for that question. So at ASCO this year, we presented the full data set. So as you mentioned, we previously have shown interim data from 9 patients. But at ASCO in June, we presented -- and the slide that's in the presentation today is actually on 12 patients, which is a full patient set where we do have 8 responders. So there, we have already presented the data. We will likely publish the more scientific details later on, but we don't intend to present additional clinical outcome data on these programs.

是的。謝謝你，RK，提出這個問題。因此，在今年的 ASCO 上，我們展示了完整的數據集。正如您提到的，我們之前展示了 9 名患者的中期數據。但在 6 月份的 ASCO 上，我們展示了今天演示中的幻燈片實際上是針對 12 名患者的，這是一個完整的患者組，其中我們確實有 8 名響應者。所以，我們已經提供了數據。我們可能會稍後發布更多科學細節，但我們不打算提供有關這些項目的額外臨床結果數據。

So that's already a final. At the end of this year, we will focus on the interim data of the Phase II trial, which is a slightly different design, and it's then sites in Australia and in Europe. So it's a multicenter trial.

所以這已經是決賽了。今年年底，我們將重點關註二期試驗的中期數據，該試驗的設計略有不同，然後在澳大利亞和歐洲進行。所以這是一個多中心試驗。

Really good. And then on the ERVs. I'm just trying to understand a little bit more on the ERV. Are the ERVs expressed uniquely based on the patient or are they expressed uniquely based on the indication?

真的很好。然後是 ERV。我只是想更多地了解 ERV。 ERV 是根據患者獨特表達還是根據適應症獨特表達？

Yes. That question, I would say, is uniquely based on the patient. We think that could be some overlaps sometimes depending on the cancer. And maybe if you reason around how they're expressed if the sort of -- if there is a signal to express a certain part of the genes in a patient, then -- if that signal is common between patients, there may be an overlap between those ERVs.

是的。我想說，這個問題完全取決於患者。我們認為，根據癌症的不同，有時可能會有一些重疊。也許如果你推理它們是如何表達的——如果有一個信號表達患者體內基因的某一部分，那麼——如果該信號在患者之間很常見，那麼可能存在重疊這些 ERV 之間。

But usually, the expression of the is completely independent. So to answer your question a bit more simply, we think it's highly patient-specific but with the potential to find some overlap. We don't -- are not looking for overlap in the first trial. So there is fully personalized. But it's possible that you can find a subpopulation where there is a overlapping you can produce a common drive for several patients.

但通常情況下， the 的表達是完全獨立的。因此，為了更簡單地回答您的問題，我們認為它具有高度的患者特異性，但有可能發現一些重疊。我們不會在第一次審判中尋找重疊。所以說是完全個性化的。但您有可能找到一個存在重疊的亞群，您可以為多個患者產生共同的驅動器。

So one last question on the again. Do you need -- is there a certain threshold in terms of expression of the ERV for you to make a personalized vaccine against it? Or are you...

那麼最後一個問題又來了。您是否需要——ERV 的表達是否有一定的閾值，以便您製作針對它的個性化疫苗？或者你是...

That's a very good question, I think, because this is really the key challenge with neoantigens that you need a lot of mutations in order to find enough high-quality neoantigens to make a vaccine. And that's really why personalized cancer vaccines today are restricted to say melanoma, a few more indications, lung cancer and so on. And in other indications where there are a few mutations, maybe it's just a few percent of the patients where you can actually make a personal neoantigens vaccine With ERVs, we find a slightly different profile. It's not the same indications where they're highly expressed.

我認為這是一個非常好的問題，因為這確實是新抗原的關鍵挑戰，你需要大量突變才能找到足夠的高質量新抗原來製造疫苗。這就是為什麼今天的個性化癌症疫苗僅限於黑色素瘤、其他一些適應症、肺癌等。在存在一些突變的其他適應症中，也許只有少數患者可以真正使用 ERV 製造個人新抗原疫苗，我們發現情況略有不同。這與它們高度表達的跡像不同。

It's often expressed in patients with cold tumors. So it really allows for treating -- making a cancer vaccine for patients with a complete cold tumor without any neoantigens. And -- but in EVX-03, we actually plan to do both. We will sequence the tumor. And if they have good neoantigens, they will -- this will be included in the vaccine. And then it will be complemented by strong ERVs at the same time. So we try to pick the best from both worlds. And hopefully, we can also expand the target group quite significantly.

它通常在冷腫瘤患者中表達。因此，它確實可以用於治療——為患有完全冷腫瘤且沒有任何新抗原的患者製造癌症疫苗。而且 - 但在 EVX-03 中，我們實際上計劃兩者兼而有之。我們將對腫瘤進行測序。如果他們有好的新抗原，他們就會——這將包含在疫苗中。然後它會同時得到強大的 ERV 的補充。所以我們試圖從兩個世界中挑選最好的。希望我們也能顯著擴大目標群體。

(Operator Instructions) There are no further questions at this time. I would like to hand back over to Per for final remarks.

（操作員說明） 目前沒有其他問題。我想請佩爾發表最後的評論。

Okay. Thank you, everyone, for joining, and thank you for all the questions, and we look forward to stay in touch. Thank you, bye.

好的。感謝大家的加入，也感謝大家提出的所有問題，我們期待保持聯繫。謝謝你，再見。

Bye.

再見。

That does conclude our conference for today. Thank you for participating. You may now disconnect.

我們今天的會議到此結束。感謝您的參與。您現在可以斷開連接。