Evaxion Biotech A/S (EVAX) 2022 Q4 法說會逐字稿

Greetings and welcome to the Evaxion Corporate Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎撥打 Evaxion 公司電話。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Corey Davis. Please go ahead, sir.

現在我很高興向大家介紹你們的主持人科里·戴維斯。請繼續，先生。

Thank you, operator. Good morning in the U.S. and good afternoon in Europe. Thank you for joining us today. With me on the line today are Per Norlen, Chief Executive Officer; Bo Karmark, Chief Financial Officer; and Birgitte Rønø, Chief Scientific Officer, who will join us for Q&A. Today's call will be available for replay as indicated in our press release.

謝謝你，接線員。美國早上好，歐洲下午好。感謝您今天加入我們。今天和我一起通話的是首席執行官 Per Norlen； Bo Karmark，首席財務官；首席科學官 Birgitte Rønø 將參加我們的問答活動。正如我們的新聞稿所示，今天的電話會議將可以重播。

Let me quickly 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're 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 on Form 20-F and other documents filed with the SEC.

讓我快速提醒您，以下討論包含某些被視為前瞻性陳述的陳述，如 1995 年《私人證券訴訟改革法案》中所定義。由於前瞻性陳述涉及風險和不確定性，因此它們並不是對未來業績的保證由於多種因素，包括公司 20-F 表格年度報告和向 SEC 提交的其他文件中討論的風險因素，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。

At this time, I'd like to turn the conference over to Per Norlen, the company's President and CEO. Go ahead, Per.

這次，我想將會議交給公司總裁兼首席執行官佩爾·諾倫 (Per Norlen)。繼續吧，佩爾。

Thank you, Corey, and good morning and good afternoon to everyone. 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 over -- across our pipeline and our core AI technologies over the last 15 months, and I'll share our outlook for 2023. I'll then turn the call over to Bo, who will review our 2022 financial report. Then we will open up the line for questions.

謝謝你，科里，祝大家早上好，下午好。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 15 個月我們在管道和核心人工智能技術方面取得的出色進展，並且我將分享我們對 2023 年的展望。電話轉給 Bo，他將審查我們 2022 年的財務報告。然後我們將開通提問熱線。

Before going into our programs, I'd like to spend a few moments on our strategy. I joined Evaxion in October 2022 based on my belief that the company's proprietary artificial intelligence, or AI technology, is world leading and has the potential to generate superior immunotherapies for cancer and infectious disease. This aligns perfectly with our strategic focus on our leading AI platforms for vaccine target discovery, on our excellence in target validation and on building a pipeline through partnerships. With increased focus and associated organizational changes we've made, we've been able to extend our cash runway into December of this year. And I want to start by recognizing the performance, dedication and commitment of the entire Evaxion team in setting up the company for success.

在開始討論我們的計劃之前，我想花一些時間介紹一下我們的策略。我於 2022 年 10 月加入 Evaxion，因為我相信該公司專有的人工智能或 AI 技術處於世界領先地位，並且有潛力為癌症和傳染病產生卓越的免疫療法。這與我們的戰略重點完全一致：我們致力於疫苗靶標發現的領先人工智能平台、我們在靶標驗證方面的卓越表現以及通過合作夥伴關係建立管道。隨著我們更加關注和進行相關的組織變革，我們已經能夠將現金跑道延長到今年 12 月。首先，我想表彰整個 Evaxion 團隊在建立公司取得成功方面的表現、奉獻和承諾。

Now I would like to take you through the recent progress in our product development portfolio, starting with oncology. Our program is focused on developing personalized cancer immunotherapies, aiming to substantially improve disease outcomes for patients with advanced cancers. The foundation of our oncology program is PIONEER, the PIONEER AI platform. PIONEER has enabled us to successfully identify patient-specific, tumor-specific mutations called neoantigens. These neoantigens can be incorporated into personalized drug and be delivered to produce an enhanced antitumor response. Clinical data from our clinical programs in EVX-01 and EVX-02 have provided important validation for our approach to developing personalized cancer vaccines.

現在我想向您介紹我們產品開發組合的最新進展，從腫瘤學開始。我們的項目專注於開發個性化癌症免疫療法，旨在大幅改善晚期癌症患者的疾病結果。我們腫瘤學項目的基礎是 PIONEER，即 PIONEER AI 平台。 PIONEER 使我們能夠成功識別患者特異性、腫瘤特異性突變，稱為新抗原。這些新抗原可以被納入個性化藥物中並被遞送以產生增強的抗腫瘤反應。我們的 EVX-01 和 EVX-02 臨床項目的臨床數據為我們開發個性化癌症疫苗的方法提供了重要驗證。

Building on those learnings, important technology advances and new discoveries have allowed us to advance a third-generation vaccine candidate, EVX-03, and towards the clinic. I'd like to start by highlighting the initial proof-of-concept clinical trials in melanoma for EVX-01 and EVX-02 and then provide a high-level overview of our newest oncology programs and technology collaborations.

在這些經驗的基礎上，重要的技術進步和新發現使我們能夠推進第三代候選疫苗 EVX-03 並走向臨床。我想首先重點介紹 EVX-01 和 EVX-02 黑色素瘤的初步概念驗證臨床試驗，然後對我們最新的腫瘤學項目和技術合作進行高級概述。

EVX-01 is our first-generation peptide-based vaccine. It's provided us with proof of concept, that our PIONEER technology can identify the right neoantigens and generate a potent antitumor immune response. We've been evaluating this vaccine in 2 early-stage studies in combination with checkpoint inhibitors in adults with metastatic melanoma. Results of the first trial, a Phase I/IIa study in 12 patients will be presented at the American Society of Clinical Oncology, or ASCO, in June in Chicago.

EVX-01 是我們的第一代肽疫苗。它為我們提供了概念證明，證明我們的 PIONEER 技術可以識別正確的新抗原並產生有效的抗腫瘤免疫反應。我們一直在兩項早期研究中評估這種疫苗與檢查點抑製劑聯合治療患有轉移性黑色素瘤的成人患者。第一項試驗（對 12 名患者進行的 I/IIa 期研究）的結果將於 6 月在芝加哥的美國臨床腫瘤學會 (ASCO) 上公佈。

Patients in this study are heavily pretreated, and many are nonresponsive to immune checkpoint inhibitors. As a result, a low treatment response would be expected with current standard treatments such as checkpoint inhibitors. Interim data reported last fall showed that we see high response rates. 6 out of the 9 first patients had an objective response, with 2 patients who actually demonstrated a complete response. These data compares very favorably to results from historical controls, and we are now eagerly looking forward to presenting the full study readout at ASCO in June.

這項研究中的患者接受了大量的預處理，許多患者對免疫檢查點抑製劑沒有反應。因此，目前的標準治療（例如檢查點抑製劑）預計治療反應較低。去年秋天報告的中期數據顯示，我們看到了很高的回應率。首批 9 名患者中有 6 名出現客觀緩解，其中 2 名患者實際上表現出完全緩解。這些數據與歷史對照的結果相比非常有利，我們現在熱切期待在 6 月份在 ASCO 上展示完整的研究結果。

EVX-01 progressed to clinical Phase IIb with dosing of the first patient in September last year. And with accelerated progress of our new generation DNA-based cancer immunotherapy EVX-03, we recently made a decision to enroll a smaller number of patients in the Phase IIb study of EVX-01, now we intended to enroll up to 20 patients. The study is conducted in collaboration with Merck, which provides KEYTRUDA, and the objective is still to confirm the results of the Phase I/IIa study. We expect to present interim results of this study in the fourth quarter of this year.

EVX-01已進入臨床IIb期，並於去年9月對第一位患者進行了給藥。隨著我們新一代基於DNA的癌症免疫療法EVX-03的加速進展，我們最近決定在EVX-01的IIb期研究中招募較少數量的患者，現在我們打算招募最多20名患者。該研究是與提供 KEYTRUDA 的默克公司合作進行的，目的仍然是確認 I/IIa 期研究的結果。我們預計將在今年第四季度公佈這項研究的中期結果。

Moving to EVX-02. We designed this vaccine as a DNA-based personalized cancer immunotherapy, building on our ability to select the right neoantigens, as demonstrated with EVX-01. Shifting from a peptide backbone to a DNA backbone we believe will allow us to shorten production time lines and manufacturing costs for this product. We were extremely happy to share the positive clinical data from our Phase I/IIa first-in-human study of EVX-02 during the late-breaking research session at AACR on April 18 this year. We evaluated EVX-02 in combination with a checkpoint inhibitor Opdivo or nivolumab in patients who had undergone a complete surgical resection of late-stage melanoma and were at high risk for recurrence.

轉向 EVX-02。我們將這種疫苗設計為基於 DNA 的個性化癌症免疫療法，建立在我們選擇正確新抗原的能力之上，正如 EVX-01 所證明的那樣。我們相信，從肽主鏈轉向 DNA 主鏈將使我們能夠縮短該產品的生產時間和製造成本。我們非常高興在今年 4 月 18 日 AACR 的最新研究會議上分享 EVX-02 I/IIa 期首次人體研究的積極臨床數據。我們在接受過晚期黑色素瘤完全手術切除且複發風險較高的患者中評估了 EVX-02 與檢查點抑製劑 Opdivo 或 nivolumab 的聯合治療。

The primary objective of the 12-month study were to assess the safety, tolerability and immunogenicity of the combination as well as to evaluate relapse-free survival. All 10 patients who received the full dose in schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment. Of those patients, 9 completely full study and were relapse-free at 12 months end of study visits. One patient discontinued the trial prior to the completion due to non-EVX-02 adverse events and was also relapse-free at the last visit, which was at 9 months.

這項為期 12 個月的研究的主要目的是評估該組合的安全性、耐受性和免疫原性，以及評估無復發生存率。所有 10 名按計劃接受 8 次 EVX-02 免疫接種的全部劑量的患者在最後一次評估時均未出現復發。在這些患者中，9 名患者完成了完整的研究，並且在研究訪視結束 12 個月時沒有復發。一名患者因非 EVX-02 不良事件在試驗完成前終止，並且在 9 個月的最後一次就診時也沒有復發。

From a study perspective, we showed that the combination of EVX-02 and nivolumab was well tolerated and only mild EVX-02-associated adverse events were observed. From an immunological perspective, robust and long-lasting neoantigen-specific T cell immune responses were confirmed in all patients who completed the full course of EVX-02 treatment.

從研究的角度來看，我們表明 EVX-02 和納武單抗的組合具有良好的耐受性，並且僅觀察到輕微的 EVX-02 相關不良事件。從免疫學角度來看，所有完成 EVX-02 治療全程的患者都證實了強勁且持久的新抗原特異性 T 細胞免疫反應。

In conclusion, we were pleased to report that we met both primary endpoints on safety, tolerability and immunogenicity and our secondary endpoint of clinical efficacy. With all 10 patients who completed the EVX-02 treatment being relapse-free during the trial and with robust and treatment-specific immune responses, we see clear signs of a treatment effect. The EVX-02 data further affirm our ability to select the right neoantigens, match to the cancer of each patient and demonstrates the value of our PIONEER platform.

總之，我們很高興地報告，我們達到了安全性、耐受性和免疫原性的主要終點以及臨床療效的次要終點。完成 EVX-02 治療的所有 10 名患者在試驗期間都沒有復發，並且具有強大的治療特異性免疫反應，我們看到了治療效果的明顯跡象。 EVX-02 數據進一步證實了我們選擇正確新抗原、與每位患者的癌症相匹配的能力，並證明了我們 PIONEER 平台的價值。

Now I'd like to highlight our newest oncology program, the third-generation cancer vaccine, EVX-03. We believe EVX-03 could be a game changer in personalized cancer immunotherapy. This vaccine is also a DNA-based vaccine and contains several exciting improvements. It was designed to incorporate novel targets based on our new AI platform ObsERV that identifies patient-specific endogenous retroviruses. It may sound surprising, but about 8% of our genes are in fact composed of DNA leftovers from viral infections that happened over the course of human history.

現在我想重點介紹我們最新的腫瘤學項目，第三代癌症疫苗 EVX-03。我們相信 EVX-03 可能會改變個性化癌症免疫治療的遊戲規則。該疫苗也是一種基於 DNA 的疫苗，包含多項令人興奮的改進。它旨在整合基於我們新的 AI 平台 ObsERV 的新靶標，該平台可識別患者特異性內源性逆轉錄病毒。這聽起來可能令人驚訝，但事實上，我們大約 8% 的基因是由人類歷史過程中發生的病毒感染留下的 DNA 組成的。

And such viral fragments or herbs are often expressed in cancer cells, which holds a lot of promise. We have, in fact, recently demonstrated in preclinical models that herbs can be used as highly effective targets for cancer immunotherapy. And we have shown that herbs are often expressed in patients with few tumor mutations. Based on this discovery, adding personalized herbs to the neoantigen therapy, that may help us to treat cancer patients who are today considered unresponsive to immunotherapy. This is, we believe, the first time that a personalized herb therapy will be assessed in a clinical trial.

此類病毒片段或草藥通常在癌細胞中表達，這具有很大的前景。事實上，我們最近在臨床前模型中證明，草藥可以用作癌症免疫治療的高效靶標。我們已經證明，草藥通常在腫瘤突變很少的患者中表達。基於這一發現，在新抗原療法中添加個性化草藥，可能有助於我們治療當今被認為對免疫療法無反應的癌症患者。我們相信，這是第一次在臨床試驗中評估個性化草藥療法。

In addition to adding herbs to the program, we have also boosted EVX-03 with a genetic immunostimulant that attracts antigen-presenting cells to the vaccination site and improves the immune activation. So collectively, we believe these technological improvements will enhance the efficacy of EVX-03 and supported by data from preclinical models showing superior potency compared to products based on standard DNA technologies. So subject to additional funding, we expect to file a clinical trial application, or CTA, in the third quarter to evaluate the combination of EVX-03 and an immune checkpoint inhibitor in patients with metastatic cancer. Patient recruitment is expected to begin in the fourth quarter of this year.

除了在該計劃中添加草藥之外，我們還使用基因免疫刺激劑增強了 EVX-03，該免疫刺激劑可將抗原呈遞細胞吸引到疫苗接種部位並提高免疫激活。因此，總的來說，我們相信這些技術改進將提高 EVX-03 的功效，並得到臨床前模型數據的支持，與基於標準 DNA 技術的產品相比，這些技術改進顯示出更優越的效力。因此，在獲得額外資金的情況下，我們預計將在第三季度提交臨床試驗申請（CTA），以評估 EVX-03 和免疫檢查點抑製劑聯合治療轉移性癌症患者的效果。患者招募預計將於今年第四季度開始。

Before we switch gears to infectious disease, I'd like to make a note regarding our collaboration with Pantherna. As mentioned before, Evaxion continues to explore technologies that will enhance and support the development and delivery of our product candidates. In February this year, we announced data from a preclinical study showing that the combination of tumor neoantigens identified by our PIONEER platform and Pantherna's mRNA vaccine delivery technology drove a strong immune response and led to the complete tumor growth inhibition. This data validated the combination of our vaccine candidates with mRNA platforms and they paveed the way for collaborations with other mRNA partners.

在我們轉向傳染病之前，我想先談談我們與 Pantherna 的合作。如前所述，Evaxion 繼續探索能夠增強和支持我們候選產品的開發和交付的技術。今年2月，我們公佈了一項臨床前研究的數據，顯示我們的PIONEER平台識別的腫瘤新抗原與Pantherna的mRNA疫苗遞送技術相結合，驅動了強烈的免疫反應，並導致腫瘤生長的完全抑制。這些數據驗證了我們的候選疫苗與 mRNA 平台的結合，並為與其他 mRNA 合作夥伴的合作鋪平了道路。

Turning to our infectious disease portfolio. We have 2 proprietary AI-driven technologies called EDEN and RAVEN to identify novel unique targets or antigens for the development of superior vaccines to prevent bacterial and viral infections. I'm very enthusiastic about our 3 infectious disease programs. Let's start with S. aureus. Our staphylococcus aureus program, EVX-B1, is a 4-component vaccine for prevention of skin and soft tissue infections and has shown significant protection in validated preclinical models of sepsis and of skin infections. The next step for this partnering-ready program is IND-enabling toxicology studies.

轉向我們的傳染病產品組合。我們擁有兩項人工智能驅動的專有技術，稱為 EDEN 和 RAVEN，用於識別新穎的獨特靶標或抗原，以開發預防細菌和病毒感染的優質疫苗。我對我們的 3 個傳染病項目非常熱情。讓我們從金黃色葡萄球菌開始。我們的金黃色葡萄球菌項目 EVX-B1 是一種用於預防皮膚和軟組織感染的 4 組分疫苗，在經過驗證的膿毒症和皮膚感染臨床前模型中顯示出顯著的保護作用。該合作準備計劃的下一步是支持 IND 的毒理學研究。

For our gonorrhea program, EVX-B2, we announced in the fall of 2022 that we, in collaboration with the University of Massachusetts Chan Medical School has received an NIH grant for the development of a lead vaccine candidate. We are currently developing a multicomponent vaccine candidate with broad efficacy in a panel of 50 gonorrhea strains, which has shown strong protection in preclinical models.

對於我們的淋病項目 EVX-B2，我們於 2022 年秋季宣布，我們與馬薩諸塞大學陳醫學院合作獲得了 NIH 撥款，用於開發主要候選疫苗。我們目前正在開發一種對 50 種淋病菌株具有廣泛功效的多組分候選疫苗，該疫苗在臨床前模型中顯示出強大的保護作用。

Finally, [pro vaccine] to cytomegalovirus or CMV, in December of 2022, we announced an exciting joint research collaboration with the company ExpreS2ion to develop the next-generation CMV vaccine candidate that elicits both cellular and humoral antibody responses. The initial phase of this collaboration will be jointly funded until 2025. After that, the parties could expand the research collaboration into development and commercialization agreement.

最後，針對鉅細胞病毒或 CMV 的[專業疫苗]，2022 年 12 月，我們宣布與 ExpreS2ion 公司開展令人興奮的聯合研究合作，開發下一代 CMV 候選疫苗，可引發細胞和體液抗體反應。該合作的初始階段將共同資助直至2025年。此後，雙方可以將研究合作擴大到開發和商業化協議。

Each of these infectious diseases represent a significant global health issue, affecting millions of people around the world and currently lacking effective vaccinations. And for staphylococcus and gonorrhea, antibiotic resistance is increasing fast, making this an extremely hot area. Our strong data, unique technology platform and market need form the basis of a very attractive preclinical partnering opportunity.

這些傳染病都是一個重大的全球健康問題，影響著世界各地數百萬人，但目前缺乏有效的疫苗接種。對於葡萄球菌和淋病來說，抗生素耐藥性正在迅速增加，使其成為一個極其熱門的領域。我們強大的數據、獨特的技術平台和市場需求構成了非常有吸引力的臨床前合作機會的基礎。

Now I'd like to turn the call over to Bo Karmark.

現在我想把電話轉給 Bo Karmark。

Thanks, Per. I will focus my comments on our financial results for 2022 compared to 2021. All the numbers will be approximate for easy sharing during the call. For additional information regarding our fourth quarter results and prior period comparisons, please refer to today's press release and our 20-F form, which we will file today.

謝謝，佩爾。我將重點評論我們 2022 年與 2021 年相比的財務業績。所有數字均為近似值，以便在通話期間輕鬆分享。有關我們第四季度業績和前期比較的更多信息，請參閱今天的新聞稿和我們今天將提交的 20-F 表格。

Starting with our expenses. Research and development expenses for 2022 amounted to USD 17.1 million. General and administrative expenses amounted to USD 8.2 million. Research and development expenses decreased by USD 2.5 million or about 30% compared to last year. The decrease was primarily driven by a decrease in external development costs related to EVX-01 and EVX-02. The decrease was partly offset by increase in personnel costs.

從我們的開支開始。 2022年研發費用達1710萬美元。一般及行政費用達 820 萬美元。研發費用比上年減少250萬美元，下降約30%。這一下降主要是由於與 EVX-01 和 EVX-02 相關的外部開發成本下降所致。這一下降被人事成本的增加部分抵消。

General and administrative expenses increased by USD 1.9 million or 31% compared to last year. This increase was primarily due to USD 1.8 million increase in professional fees and expansion of our corporate functions.

一般及管理費用比去年增加 190 萬美元，即 31%。這一增長主要是由於專業費用增加了 180 萬美元以及我們公司職能的擴展。

The net loss for 2022 amounted to a loss of USD 23.9 million (sic) [USD 23.2 million] compared to a loss of USD 24.7 million (sic) [USD 24.5 million] for 2021. As of December 31, 2022, we had USD 13.2 million in cash and cash equivalents. With the recent cost savings, we expect our cash balance to be sufficient to fund our operations into December 2023.

2022 年的淨虧損為 2,390 萬美元（原文如此）[2,320 萬美元]，而 2021 年的淨虧損為 2,470 萬美元（原文如此）[2,450 萬美元]。截至 2022 年 12 月 31 日，我們的淨虧損為1320萬現金及現金等價物。通過最近的成本節省，我們預計我們的現金餘額足以為我們的運營提供資金直至 2023 年 12 月。

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

現在我想把電話轉回給 Per，在問答之前做一些結束語。

Thank you, Bo. Looking out to the rest of 2023 and beyond, I'd like to highlight a few things. We will present the full readout of the EVX-01 Phase I/IIa study during the ASCO conference in June. We'll report interim results from the EVX-01 Phase II trial in patients with melanoma in Q4. Also in Q4, we will initiate patient recruitment in a Phase I study for EVX-03 in patients with solid tumors and then moving into non-small cell lung cancer.

謝謝你，博。展望 2023 年剩餘時間及以後，我想強調一些事情。我們將在 6 月的 ASCO 會議上公佈 EVX-01 I/IIa 期研究的完整結果。我們將在第四季度報告黑色素瘤患者的 EVX-01 II 期試驗的中期結果。同樣在第四季度，我們將在實體瘤患者中啟動 EVX-03 I 期研究的患者招募，然後轉向非小細胞肺癌患者。

In conclusion, I'm optimistic about the next year for Evaxion. I believe that Evaxion has the potential to develop immunotherapies to substantially improve the treatment of cancer and vaccines to prevent infections that impact the world. Over the last 7 months as we have refined our strategy and focus, we are invigorated by the data and the promise that our programs can make a difference. On behalf of everyone at Evaxion, I invite you to continue to keep in touch with the company and follow our progress in 2023 and beyond.

總之，我對 Evaxion 明年持樂觀態度。我相信 Evaxion 有潛力開發免疫療法，以大幅改善癌症治療和疫苗，以預防影響世界的感染。在過去的 7 個月裡，隨著我們完善了我們的戰略和重點，我們對數據和我們的計劃能夠帶來改變的承諾感到振奮。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。

Before I turn the call over to the operator for the Q&A, note that Birgitte Rønø, Chief Scientific Officer, will join us for the Q&A segment of today's call. Operator, over to you for Q&A.

在我將電話轉交給接線員進行問答之前，請注意，首席科學官 Birgitte Rønø 將加入我們今天電話的問答部分。接線員，請您進行問答。

(Operator Instructions) The first question we have is from Jeff Jones from Oppenheimer.

（操作員說明）我們的第一個問題來自奧本海默的傑夫瓊斯。

I guess 2 quick questions. With the reduced size of the EVX-01 study and the Phase II data -- I/II data that we reported out at ASCO, what are the next steps here? Would you proceed with another Phase II? Or could you move on to pivotal studies? And what are your plans? And then with respect to EVX-03 and you mentioned needing additional financing to kick those studies off, how much money would you be looking to raise to support that next clinical trial? Or how much money would you need to run the clinical trial?

我想有兩個簡單的問題。隨著 EVX-01 研究規模的縮小以及我們在 ASCO 報告的 II 期數據（I/II 數據），接下來的步驟是什麼？你會繼續進行另一個第二階段嗎？或者你可以繼續進行關鍵研究嗎？你的計劃是什麼？然後，關於 EVX-03，您提到需要額外的資金來啟動這些研究，您希望籌集多少錢來支持下一個臨床試驗？或者您需要多少錢來進行臨床試驗？

Yes. This is Per Norlen speaking. Basically, if we start with EVX-01, as you say, we will report the Phase I data in -- at ASCO in June and present the first interim data of the Phase II trial in Q4. And if I understand it correctly, you asked a bit of question for the clinical development plan beyond that trial, is that correct?

是的。這是佩爾·諾倫的發言。基本上，如果我們從 EV​​X-01 開始，正如您所說，我們將在 6 月份在 ASCO 報告第一階段數據，並在第四季度提供第二階段試驗的第一個中期數據。如果我理解正確的話，您對試驗之外的臨床開發計劃提出了一些問題，對嗎？

Yes.

是的。

Yes. So today, we have -- the focus of the strategy is actually to move more towards our most unique technology, which is in our EVX-03 program, where we have both the genetic immunoadjuvants and the DNA technology and including the herbs. So we will use this EVX-01 trial. It's basically to confirm the very promising data we had in the Phase I trial. And that was a relatively small trial run at 1 clinical sites. And now the Phase II trial is run at multiple sites in both Australia and Europe and confirming the data in a larger population, even if it's not very large. That's a major objective here since we do have strikingly good data in the Phase I trial. So just confirming it, it's a major importance. But to your question, it's more likely -- it, of course -- it's depending on emerging data, but EVX-03 is a primary focus, and that's the most likely where we will focus our resources after that Phase II trial.

是的。所以今天，我們戰略的重點實際上是更多地轉向我們最獨特的技術，這就是我們的 EVX-03 項目，我們擁有遺傳免疫佐劑和 DNA 技術，包括草藥。所以我們將使用這個 EVX-01 試用版。這基本上是為了確認我們在第一階段試驗中獲得的非常有希望的數據。這是在 1 個臨床中心進行的相對較小的試驗。現在，第二階段試驗正在澳大利亞和歐洲的多個地點進行，並在更大的人群中確認數據，即使人群不是很大。這是這裡的一個主要目標，因為我們在第一階段試驗中確實擁有非常好的數據。因此，確認這一點非常重要。但對於你的問題，更有可能的是——當然——這取決於新出現的數據，但 EVX-03 是主要焦點，也是我們在第二階段試驗後最有可能將資源集中的地方。

On EVX-03 then, I think your question was on the cost of that trial. And we are -- if you say the total -- it's a relatively small size trial, and we are in the range of -- maybe you can help me, is it -- $5 million to $8 million, and that will be distributed over, say, 2 years of time. So in fact, it's more -- we, of course, need to raise additional capital to start the trial, but we don't need to have the full cover for that trial upfront at the end of the year. So in that range, up to $8 million.

那麼關於 EVX-03，我認為你的問題是關於該試驗的成本。如果你說總額的話，我們是一個規模相對較小的試驗，我們的範圍是——也許你可以幫助我，是嗎——500萬到800萬美元，這將分配給，比如說，2年的時間。所以事實上，更重要的是——我們當然需要籌集額外的資金來啟動試驗，但我們不需要在年底預先獲得該試驗的全部費用。所以在這個範圍內，最多可達 800 萬美元。

(Operator Instructions) The next question we have is from Richard Ramanius from Redeye. Please go ahead.

（操作員說明）我們的下一個問題來自 Redeye 的 Richard Ramanius。請繼續。

My first question is, do you expect to reach a nondilutive funding during this year? Or for example, for an upfront payment?

我的第一個問題是，您預計今年會達到非稀釋性融資嗎？或者例如，預付款？

Yes. So I mean in terms of nondilutive funding, if we talk on the one hand on grants, we are applying for grants, and that is possible, but of course, not something we calculate on. We also have a very active business development discussions. And actually, there's a lot of interest in our early programs. So we have high hopes of getting additional funds into the company. But again, it's -- that's something we can't control, but it will be really a positive upside, of course.

是的。所以我的意思是，就非稀釋性資金而言，如果我們一方面談論贈款，我們正在申請贈款，這是可能的，但當然，這不是我們計算的東西。我們還進行了非常活躍的業務發展討論。事實上，人們對我們的早期項目很感興趣。因此，我們對獲得更多資金進入公司抱有很大希望。但同樣，這是我們無法控制的，但當然，這確實是一個積極的好處。

Okay. And just the last -- second to the last question. What kind of interest have you seen for the new EVX-03 ERV platform?

好的。還有最後一個問題——倒數第二個問題。您對新的 EVX-03 ERV 平台有何興趣？

Yes. Thank you, Richard. That's -- we get a lot of interest from that. As probably most of you know, we had a release recently, and we are first mover here with a personalized herb technology for personalized cancer immunotherapy. And we do get a lot of interest both from companies looking at neoantigen, that's all -- themselves and from other potential partners. So it's a very promising opportunity here. And of course, as you know, what we can do is expand the potential target population for immune -- cancer immunotherapy from patients with only hot tumors like melanoma, renal cell cancer and so on. Two is actually complete the other patient populations with much fewer cancer mutations that could potentially respond equally well to immunotherapy. So it's opening up the field tremendously if it works, and that's what we aim to show.

是的。謝謝你，理查德。那是——我們對此很感興趣。也許你們大多數人都知道，我們最近發布了一個版本，我們是個性化癌症免疫治療的個性化草藥技術的先行者。我們確實從研究新抗原的公司以及其他潛在合作夥伴那裡得到了很大的興趣。所以這是一個非常有前途的機會。當然，如您所知，我們能做的是擴大免疫——癌症免疫治療的潛在目標人群，從僅患有黑色素瘤、腎細胞癌等熱點腫瘤的患者中擴大。其中兩個實際上是完整的其他癌症突變較少的患者群體，這些患者群體可能對免疫療法有同樣良好的反應。因此，如果它有效的話，它將極大地開拓這個領域，這就是我們想要展示的。

Ladies and gentlemen, at this stage, there are no further questions. I would like to turn the floor back over to Per Norlen for closing comments. Please go ahead, sir.

女士們、先生們，現階段沒有其他問題了。我想把發言權交還給佩爾·諾倫（Per Norlen）以徵求結束意見。請繼續，先生。

Yes. So thank you so much for joining this call, and I hope to meet you again in the future. Thank you.

是的。非常感謝您參加本次電話會議，希望將來再次見到您。謝謝。

Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.

女士們、先生們，今天的會議到此結束。感謝您加入我們。您現在可以斷開線路。