Immunic Inc (IMUX) 2024 Q3 法說會逐字稿

Good morning and welcome to Immunic third quarter, 2024 earnings call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic . I will also be the moderator today.

早安，歡迎參加 Immunic 2024 年第三季財報電話會議。我叫 Jessica Breu，Immunic 投資人關係與傳播副總裁。今天我也將擔任主持人。

Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer ; Glenn Whaley, our Chief Financial Officer, as well as Jason Tardio, our President and Chief Operating Officer. (Operator Instructions)

參加電話會議的有我們的執行長 Daniel Vitt 博士；我們的財務長 Glenn Whaley 以及我們的總裁兼營運長 Jason Tardio。（操作員指令）

Before we begin. I would like to remind you that this presentation may contain forward-looking statements. Such statements can be identified by words such as may will expect anticipate estimate or words with a similar meaning and such statements involve a number of risks and uncertainties that could cause Immunic actual results to differ materially from those discussed here.

在我們開始之前。我想提醒您，本簡報可能包含前瞻性陳述。此類陳述可透過諸如「可能、預期、預計」或具有類似含義的詞語來識別，並且此類陳述涉及許多風險和不確定性，可能導致 Immunic 的實際結果與此處討論的結果存在重大差異。

Please note that these forward-looking statements reflect in Immunic opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events.

請注意，這些前瞻性陳述僅反映截至本簡報發布之日的 Immunic 意見，並且不承擔根據新資訊或未來事件修改或公開發布對這些前瞻性陳述的任何修訂結果的義務。

Please refer to the Immunic sec filings for more detailed description of the risk factors that may affect the Immunic results and these forward-looking statements.

請參閱 Immunic 證券文件，以獲得可能影響 Immunic 結果和這些前瞻性陳述的風險因素的更詳細描述。

I would now like to turn the call over to our Chief Executive Office rDaniel Vitt to begin the presentation.

現在，我想將電話轉給我們的執行長 Daniel Vitt 開始演講。

Daniel.

丹尼爾。

Thank you, Jessica. I would also like to welcome everybody to today's Q3 2024 earnings call.

謝謝你，潔西卡。我也想歡迎大家參加今天的 2024 年第三季財報電話會議。

Earlier this morning, we announced our financial results for the third quarter and nine months ended, September 30 2024.

今天早些時候，我們公佈了截至 2024 年 9 月 30 日的第三季和九個月的財務表現。

During the call. Today, we will walk through our third quarter 2024 achievements and subsequent highlights financial and operating results as well as our clinical development programs including anticipated upcoming milestones.

通話過程中。今天，我們將回顧 2024 年第三季的成就，並重點介紹財務和營運績效以及我們的臨床開發計劃，包括預期的即將到來的里程碑。

As Jessica noted after the presentation, you will have the opportunity to ask questions.

正如傑西卡在演講結束後所說，您將有機會提問。

Let's start with the review of our third quarter 2024 and subsequent highlights in July, our management team was strengthened with the addition of Jason Tardio as President and Chief Operating Officer, bringing with him a wealth of experience launching and commercializing multiple sclerosis drugs for major biotechnology and pharmaceutical companies. Jason has already proven to be invaluable leading internal efforts to prepare for the potential commercialization of ous Calcium.

讓我們從回顧 2024 年第三季以及 7 月的後續亮點開始，我們的管理團隊因 Jason Tardio 的加入而得到加強，他擔任總裁兼首席營運官，為主要生物技術和製藥公司推出和商業化多發性硬化症藥物帶來了豐富的經驗。事實證明，Jason 在領導內部努力為我們鈣的潛在商業化做準備方面具有無價的價值。

Jason also has been collaborating closely with Patrick Walsh, our Chief Business Officer to prepare the company for a range of potential partnership outcomes for vous calcium, as well as our other drug candidates where we are leveraging his extensive partnering experience.

Jason 也一直與我們的商務長 Patrick Walsh 密切合作，為公司做好一系列潛在的合作成果的準備，這些合作成果涉及 vous calcium 以及我們的其他候選藥物，我們正在利用他豐富的合作經驗。

Additionally, Werner Gladdines was promoted to Chief Development Officer. Werner joined in Immunic in January of 2021 as head of IU 838 program and he has held positions of increasing responsibility since then. In his new role, he takes over additional strategic and operational responsibilities for I's overall clinical operations functions in July.

此外，Werner Gladdines 晉升為首席開發長。沃納於 2021 年 1 月加入 Immunic，擔任 IU 838 計畫負責人，自那時起，他所擔任的職位越來越重要。在他的新職位上，他將於7月接手I公司整體臨床營運職能的額外策略和營運職責。

We also strengthened our board of directors with the appointment of Simona Skerjanec a thought leader in brain health with decades of experience in drug development and commercialization over a 30 year career in the United States and internationally, Simona has led research and development efforts culminating in numerous regulatory drug approvals and successful commercial launches. Working with companies such as Ross, the Medicines Company, A Lily Pfizer and Johnson and Johnson.

我們還任命了西蒙娜·斯克賈內克 (Simona Skerjanec)，以加強我們的董事會。與 Ross、Medicines Company、A Lily Pfizer 和 Johnson and Johnson 等公司合作。

It is worth pointing out that Simona led business and global corporate strategy for our portfolio of neurological and rare diseases, achieving sustainable double digit growth in sales, including with creas, which remains one of the most successful medicines for the treatment of mass. Today.

值得指出的是，西蒙娜領導了我們神經疾病和罕見疾病產品組合的業務和全球公司策略，實現了銷售額可持續的兩位數增長，其中包括 creas，它仍然是治療大規模疾病最成功的藥物之一。今天。

Her success in this area really enhances our board as we work towards the potential commercial launch of Venus Calcium in September. We hosted an in-person MS R&D day which featured two world renowned industry experts, Doctor Francesca Montero, biologist and leading MS and no one target expert from the Neuroscience Institute Cavalieri Oen and University of Turin Italy, as well as Dr Ahmed Bor, clinician scientist and one of the leading neuroimmunologic in MS from the University of Pennsylvania.

我們正致力於在九月實現 Venus Calcium 的商業化上市，她在這一領域的成功確實增強了我們董事會的實力。我們舉辦了一次面對面的 MS 研發日活動，邀請了兩位世界知名的行業專家，來自義大利都靈大學神經科學研究所和卡瓦列裡·奧恩的生物學家和領先的 MS 專家 Francesca Montero 博士，以及來自賓夕法尼亞大學的臨床科學家和 MS 領域的領先神經免疫學家之一 Ahmed Bor 博士。

These distinguished key opinion leaders along with our management team provided an indepth overview of the MS landscape and our orally available lead acid vous calcium.

這些傑出的關鍵意見領袖與我們的管理團隊一起對 MS 領域和我們的口服鉛酸鈣進行了深入概述。

The presentation highlighted its dual mode of action which combines neuroprotective effects through its mechanism as a first class nuclear receptor related one or no one activator with antiinflammatory and antiviral effects via vho DH inhibition.

報告重點介紹了其雙重作用模式，即透過其作為一級核受體相關的一個或無一個活化劑的機制將神經保護作用與透過 vho DH 抑制發揮的抗發炎和抗病毒作用相結合。

During the event, he also shared insights on our ongoing ensure trials in relapsing MS.

活動期間，他也分享了我們在復發型多發性硬化症治療方面正在進行的試驗的見解。

Our ongoing p took caliber trial in progressive MS and highlighted the commercial opportunity for vlus calcium in the MS market.

我們正在進行的 p 在進行性 MS 中取得了良好的試驗效果，並強調了 vlus 鈣在 MS 市場的商業機會。

In particular, we discussed our strong belief in the potential of vif funam calcium and in the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with relapsing and progressive forms of MS where there are currently few options and there continues to be a huge unmet need.

具體來說，我們討論了我們對 vif funam calcium 的潛力的堅定信念，以及為復發性和進行性 MS 患者帶來這種突破性和急需的口服治療選擇的前景，目前此類患者的治療選擇很少，並且仍然存在巨大的未滿足需求。

We continue to believe that vous calcium has the potential to redefine the oral multiple sclerosis treatment landscape and elevate the standard of care for patients in September. We enrolled the first patient in an investigator sponsored phase two clinical trial of Fluidous calcium.

我們仍然相信，vous calcium 有潛力重新定義口腔多發性硬化症的治療格局，並在 9 月提高病患的照護標準。我們招募了第一位患者參與研究者發起的流體鈣第二階段臨床試驗。

The rapid revived trial in Postcovid Syndrome for which immunic is providing study medication. The trial is a randomized placebo controlled double blind parar trial led by Professor Maria Fedder and sponsored by the Goe University of Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research.

immunic 正在為 Postcovid 症候群提供研究藥物的快速復甦試驗。該試驗是由 Maria Fedder 教授領導、法蘭克福大學贊助的隨機安慰劑對照雙盲試驗，試驗資金來自德國聯邦教育和研究部。

We are honored to have the the council chosen for this investigator sponsored study run by such a highly regarded investigators and at esteemed institutions in Germany.

我們很榮幸能選出這個由德國備受推崇的研究人員資助的研究委員會，並在德國受人尊敬的機構進行這項研究。

We have already seen convincing data supporting VLU calciums antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase two calvi.

我們已經在臨床前和臨床研究中看到了令人信服的數據，支持 VLU 鈣的抗病毒作用以及它在第二階段研究中減輕患者疲勞的能力。

One importantly, third party research has identified Epstein Barr virus reactivation as a potential cause for fatigue. One of the most dominating symptoms for both post COVID syndrome and MS patients negatively impacting the quality of life and ability to participate in social activities.

重要的一點是，第三方研究發現愛潑斯坦巴爾病毒再活化是導致疲勞的潛在原因。這是新冠疫情後遺症和多發性硬化症患者最主要的症狀之一，對生活品質和參與社交活動的能力有負面影響。

We also aim to confirm the ability of eous calcium to influence fatigue and Epstein Barr virus reactivation of ongoing MS trials and look forward to receiving additional data from the rapid revive trial.

我們還旨在確認血鈣影響正在進行的 MS 試驗的疲勞和 Epstein Barr 病毒再活化的能力，並期待從快速復甦試驗中獲得更多數據。

It is our belief that this may create yet another differentiating feature for our drug candidate in September. We also had the opportunity to present four posters at the Prestigious Forth Congress of Acts showcasing data on key aspects of ero calciums profile, illustrating the strength of the data generated today and its potential to become a new treatment option for.

我們相信，這可能會為我們九月的候選藥物創造另一個差異化特徵。我們還有機會在享有盛譽的第四屆行為大會上展示四張海報，展示有關血液鈣化概況關鍵方面的數據，說明今天生成的數據的強度及其成為新治療選擇的潛力。

Jason. Do you want to add a few words on the Congress.

傑森。您想就大會補充幾句嗎？

Sure and thank you, Daniel.

當然，謝謝你，丹尼爾。

The Eams Congress is the premier meeting of the year in the field of multiple sclerosis and brings together over 9,000 of the world's top clinicians, researchers and health care professionals.

埃姆斯大會是多發性硬化症領域的年度首要會議，匯集了超過 9,000 名全球頂尖的臨床醫生、研究人員和醫療保健專業人士。

We are particularly excited to have had the opportunity to present data at this meeting to further support the differentiation of vita fluors, calcium as a potential treatment for both relapsing and progressive multiple sclerosis.

我們特別高興有機會在這次會議上展示數據，以進一步支持維生素氟鈣作為複發性和進行性多發性硬化症的潛在治療方法的區分。

More specifically, we shared additional data from the interim analysis of our ongoing phase two caliber trial in progressive multiple sclerosis that showed that beta fult calcium not only had a significant impact on reducing serum neuro film light chain levels across the total study population but also consistently reduces neuro film and light chain levels compared to baseline across different patient subgroups based on age and disability scores.

更具體地說，我們分享了我們正在進行的進行性多發性硬化症第二階段口徑​​試驗的中期分析的額外數據，這些數據表明，β-fult鈣不僅對降低整個研究人群的血清神經膜輕鍊水平有顯著影響，而且與基於年齡和殘疾評分的不同患者亞組的基線相比，持續降低神經膜和輕鏈水平。

These observations are important as neuroforamin proteins are a marker of neuronal degeneration and serve as an important biomarker of disease activity in multiple sclerosis. With recent data showing that lower neuroforamin light levels indicate a lower risk of future disability progression in progressive MS patients.

這些觀察結果很重要，因為神經孔蛋白是神經元退化的標誌，也是多發性硬化症疾病活動的重要生物標記。最近的數據顯示，神經孔光水平較低表明進行性多發性硬化症患者未來殘疾進展的風險較低。

We also prevented compelling data on fatigue from posthoc analysis of the COVID one trial which evaluated the safety and efficacy of vitali calcium. 45 mg in patients hospitalized for COVID 19.

我們也阻止了對 COVID 一項試驗的事後分析中獲得有關疲勞的令人信服的數據，該試驗評估了維生素鈣的安全性和有效性。因 COVID 19 住院的患者需服用 45 毫克。

As mentioned earlier, fatigue is the most frequent symptom reported by patients with multiple sclerosis and for many patients, it is the most disabling and chronic symptom, given the broad spectrum antiviral effects of optimus calcium and its potential to prevent reactivation of the Epstein Barr virus or EBV, which has been linked to fatigue in multiple sclerosis. We sought to understand the impact of optimus on fatigue in post COVID syndrome. Patients.

如前所述，疲勞是多發性硬化症患者報告最常見的症狀，對於許多患者來說，它是最致殘和慢性的症狀，因為 optimus calcium 具有廣譜抗病毒作用，並且具有預防愛潑斯坦-巴爾病毒 (Epstein Barr virus, EBV) 復發的潛力，而 EBV 與多發性硬化症中的疲勞有關。我們試著去了解 optimus 對 COVID 後症候群疲勞的影響。患者。

Results of this analysis showed that 80% of patients who received placebo reported fatigue compared to only 50% of patients who received belos calcium, fatigue was further decreased from weeks, 9 to 17 to 33% for patients on placebo and only 17% for patients on VEFL calcium thus supporting the antiviral effects of vitou and how it may contribute to lower fatigue levels.

該分析結果顯示，接受安慰劑的患者中有 80% 報告疲勞，而接受貝洛斯鈣的患者只有 50% 報告疲勞，並且從第 9 週到第 17 週，接受安慰劑的患者疲勞率進一步下降至 33%，而接受 VEFL 鈣的患者僅為 17%，從而支持了 vitou 的抗病毒作用以及它如何疲勞程度以及它如何疲勞的影響。

This hypothesis, we further assess by determining effects on fatigue using patient questionnaires as well as analysis of the anti EBV effect in our ongoing caliber and ensure trials.

我們透過使用患者問卷來確定對疲勞的影響以及在正在進行的口徑和確保試驗中分析抗 EBV 效果來進一步評估這一假設。

Lastly, we presented additional preclinical evidence supporting that vitaros calcium enhanced the expression of neurone target genes important for neuronal survival. Further suggesting neuro the neuroprotective benefit of this acid and also reduce infiltrating t helper cells in the spinal cord and the number of proinflammatory T helper cells in the periphery in marine eae models.

最後，我們提供了額外的臨床前證據，支持 vitaros 鈣增強了對神經元存活很重要的神經元標靶基因的表達。進一步顯示這種酸具有神經保護作用，並且可以減少海洋 eae 模型中脊髓中浸潤的 T 輔助細胞和周邊促炎 T 輔助細胞的數量。

In addition to these data presentations, I also feel an exhibitor booth for the first time at this important meeting. This served as a great opportunity to engage the MS community and further increase awareness of VEFL calcium as a potential treatment for MS back to Daniel.

除了這些數據展示之外，我還在這個重要的會議上第一次感受到了參展商的展位。這為丹尼爾提供了一個絕佳的機會，讓 MS 社區參與進來，進一步提高人們對 VEFL 鈣作為 MS 潛在治療方法的認識。

Thank you. Jason in October, we announced a positive outcome of the interim analysis of our phase three, ensure program of calcium in relapsing multiple sclerosis or R MS. An independent data monitoring committee IDMC reviewed unblinded data and based on this recommended that the trials are not futile and should continue as planned without any changes, marking the successful achievement of a critical milestone for the program.

謝謝。傑森在十月宣布了我們第三階段中期分析的積極成果，確保了鈣質治療復發性多發性硬化症（R MS）的計劃。獨立數據監測委員會IDMC審查了未盲數據，並據此建議試驗並非毫無意義，應按計劃繼續進行，不做任何更改，這標誌著該計劃成功實現了一個關鍵的里程碑。

While in Immunic remain blinded to our data. The DFC favorable recommendations corroborate our initial assumptions of design powering and relapse rate of the twin phase three trials and suggest that they are in line with the data observed. So far. In particular, the plant sample size seems appropriate to address the statistical assumptions for the primary endpoint of time to first relapse.

但在 Immunic 中，我們的數據仍然處於盲目狀態。DFC 的積極建議證實了我們對雙重三期試驗的設計動力和復發率的初步假設，並表明它們與觀察到的數據一致。迄今為止。特別是，植物樣本量似乎適合解決首次復發時間主要終點的統計假設。

We are confident in vlu calciums potential to transform the ore and market and continue to believe that the phase three program provides a clear and straightforward path towards seeking potential regulatory approval in armies that concludes our summary of the third quarter, 2024 and most recent highlights.

我們對 VLU 鈣質材料改變礦石和市場的潛力充滿信心，並繼續相信第三階段計劃為尋求軍隊潛在監管批准提供了一條清晰而直接的途徑，這總結了我們對 2024 年第三季度和最新亮點的總結。

I am very pleased with the scientific and clinical achievements we have made across our programs as it relates to the calcium. We continue to advance both our twin phase three insur trials in patients with relapsing, MS and our phase two caliber trial in progressive MS.

我對我們在與鈣相關的項目中所取得的科學和臨床成就感到非常高興。我們將繼續推進針對復發型 MS 患者的雙重三期臨床試驗以及針對進展型 MS 患者的二期試驗。

We are very excited to read out the top line data of the caliber trial in just a couple of months from now expected. In April 2025 based on the strong clinical evidence. Today, we continue to pursue partnering discussions with global and regional pharmaceutical companies.

我們非常興奮地在預計幾個月後讀出口徑試驗的最重要的數據。基於有力的臨床證據，將於2025年4月實施。今天，我們繼續與全球和地區製藥公司進行合作洽談。

Our team has also been busy advancing our M 856 program which has the potential to become a game changer for the treatment of a broad range of gastrointestinal disorders.

我們的團隊也一直在忙於推進我們的 M 856 計劃，該計劃有可能改變多種胃腸道疾病的治療格局。

I would now like to turn the call over to Glenn to provide a financial overview, Glen.

現在我想將電話轉給 Glenn，讓他提供財務概況，Glen。

Thank you, Daniel. I will now review the financial and operating results for the third quarter and nine months ended September 30th 2024.

謝謝你，丹尼爾。我現在將回顧截至 2024 年 9 月 30 日的第三季和九個月的財務和經營業績。

Let me start with a review of our cash position. We ended the third quarter of 2024 with $59.1 million in cash and cash equivalents which we expect to be able to fund our operations into the third quarter of 2025.

首先讓我回顧一下我們的現金狀況。截至 2024 年第三季度，我們的現金和現金等價物為 5,910 萬美元，預計這些資金將能夠為我們到 2025 年第三季度的營運提供資金。

Regarding the operating results, R&D expenses were $21.4 million for the three months ended September 30th 2024 as compared to $19.8 million for the three months ended September 30th 2023.

至於經營業績，截至 2024 年 9 月 30 日的三個月的研發費用為 2,140 萬美元，而截至 2023 年 9 月 30 日的三個月的研發費用為 1,980 萬美元。

The increase was mainly driven by increases in external development costs related to our clinical trials, which was partly offset by decrease in the deprioritization of the Zumar Organ program in psoriasis and castration resistant prostate cancer. Last year for the nine months ended September 30th 2024 R&D, expenses were$ 58.4 million as compared to $63.9 million. For the nine months ended September 30th 2023.

成長的主要原因是與我們的臨床試驗相關的外部開發成本的增加，但部分被 Zumar Organ 計畫在乾癬和去勢抵抗性前列腺癌領域的優先性降低所抵消。去年截至 2024 年 9 月 30 日的九個月研發費用為 5,840 萬美元，去年同期為 6,390 萬美元。截至 2023 年 9 月 30 日的九個月。

The decrease was mainly driven by the deprioritization of the Xumo Grant program in psoriasis and castration resistant prostate cancer. And the completion of the phase one clinical trial of Imu 856 in celiac disease last year, this was partially offset by an increase in external development costs related to the vita fluid of mesc calcium program, as well as an increase in personnel expenses.

下降的主要原因是 Xumo Grant 計畫在牛皮癬和去勢抵抗性前列腺癌的優先順序被降低。並且去年完成了Imu 856在乳糜瀉領域的一期臨床試驗，這部分被與mesc鈣計劃的維他命液相關的外部開發成本的增加，以及人員費用的增加所抵消。

G&A expenses were$ 4.4 million for the three months ended September 30th 2024. As compared to$ 3.8 million. The same period ended September 30th 2023. The increase was primarily related to personnel expenses.

截至 2024 年 9 月 30 日的三個月的 G&A 費用為 440 萬美元。相比之下，這一數字為 380 萬美元。同一時期截至 2023 年 9 月 30 日。成長主要與人事費用有關。

The nine months ended September 30th 2024 G&A expenses were$ 14 million as compared to $11.9 million for the same period ended September 30th 2023.

截至 2024 年 9 月 30 日的九個月的 G&A 費用為 1,400 萬美元，而截至 2023 年 9 月 30 日的同期為 1,190 萬美元。

The increase was primarily related to personnel expenses, legal and consultancy expenses and other costs across numerous categories.

成長主要與人事費用、法律和諮詢費用以及多個類別的其他成本有關。

Interest income remained unchanged at $0.8 million during the three months ended September 3,024 as compared to the three months ended September 30th 2023 for the nine months ended September 30th 2024 interest income was $3 million as compared to$ 2.5 million for the nine months ended September 30th 2023 the $0.5 million increase was due to higher interest rates.

截至 2024 年 9 月 30 日的三個月期間，利息收入保持不變，為 80 萬美元，而截至 2023 年 9 月 30 日的九個月期間，利息收入為 300 萬美元，而截至 2023 年 9 月 30 日的九個月期間的利息收入為 250 萬美元，由於利率上升。

We also reported a change in fair value of the tranche rights for the nine months ended September 30th 2024. The change of $4.8 million was a noncash charge related to the change in value of the tranche rights associated with the future tranches. Two and three of the January 2024 private placement.

我們也報告了截至 2024 年 9 月 30 日的九個月的分期權利公允價值變動。480 萬美元的變化是與未來分批相關的分批權利價值變化相關的非現金費用。2024年1月私募二、三期。

Other income was 600,000 for the three months ended September 30th 2024 as compared to 35,000 for the same period ended September 30th 2023.

截至 2024 年 9 月 30 日的三個月的其他收入為 600,000，而截至 2023 年 9 月 30 日的同期為 35,000。

The increase was primarily attributed to R&D tax incentives for the clinical trials in Australia for the nine months ended September 30th 2024. Other income was negative$ 1.1 million as compared to $1.3 million for the same period ended September 30th 2023.

成長主要歸因於截至 2024 年 9 月 30 日的九個月內澳洲臨床試驗的研發稅收優惠。其他收入為負 110 萬美元，而截至 2023 年 9 月 30 日的同期為 130 萬美元。

The decrease was primarily attributed to an expense related to the portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of tranche one.

下降主要歸因於與 2024 年 1 月融資中與第一批融資結束時確定的分期權利相關的成本部分相關的費用。

The timing of recognizing the German Federal Ministry of Finance Grant as well as a decrease in R&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country.

承認德國聯邦財政部撥款的時機以及由於澳洲臨床試驗支出減少而減少其臨床試驗研發稅收優惠。

The decrease was partially offset by an increase in foreign exchange gains.

外匯收益的增加部分抵銷了這一減少。

The net loss for the three months ended September 30th 2024 was approximately $24.4 million or 24¢ per basic and diluted share based on$ 101.3 million weighted average common shares outstanding compared to a net loss of approximately $22.8 million or 51¢ per basic and diluted share. Based on approximately $44.6 million weighted average common shares outstanding for the same period ended September 30th 2023 net loss for the nine months ended September 30th 2024 was approximately$ 75.3 million or 75¢ per basic and diluted share based on approximately$ 100 million weighted average common shares outstanding compared to a net loss of approximately $72 million or a dollar 63 per basic and diluted share based on $44.2 million weighted average common shares outstanding. The same period ended September 30th 2023.

截至 2024 年 9 月 30 日的三個月的淨虧損約為 2,440 萬美元或每股基本和稀釋虧損 24 美分，基於 1.013 億美元的加權平均流通股，而去年同期的淨虧損約為 2,280 萬美元或每股基本和稀釋虧損 51 美分。基於截至 2023 年 9 月 30 日的同一期間約 4,460 萬美元的加權平均流通在外普通股，截至 2024 年 9 月 30 日的九個月的淨虧損約為 7,530 萬美元或每股基本虧損和攤薄虧損 75 美分，基於約 1 億美元的平均流通股數美元或每股基本虧損和攤薄虧損 63 美元。同一時期截至 2023 年 9 月 30 日。

With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel.

說完這些，我將把電話轉回給丹尼爾，讓他回顧我們的開發流程和即將到來的里程碑。丹尼爾。

Thank you Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming milestones.

謝謝你，格倫。我現在想提供有關我們的臨床開發計劃的最新資訊以及預期即將到來的里程碑。

Our next important clinical readout which we are eagerly anticipating will be the topline data from our phase two trial of vous calcium in progressive MS in April of next year.

我們熱切期待的下一個重要臨床讀數將是明年 4 月我們對 vous 鈣治療進行性 MS 的第二階段試驗的頂線數據。

In addition to the overall P MS population, the data will also deliver insights on its sub forms including non relapsing, 2nd year progressive MS, a subtype with the highest unmet medical need.

除了整體 P MS 族群之外，數據還將提供有關其亞型的見解，包括非復發性、第 2 年進展性 MS，這是未滿足醫療需求最高的亞型。

Should the topline data continue to show a neuroprotective effect and the phase two trial meets its primary and key secondary end points. We may also be able to position the drug as the first oral treatment option for non relapsing secondary progressive MS.

頂線資料是否應繼續顯示神經保護作用，且第二階段試驗是否滿足其主要和關鍵次要終點。我們或許也可以將該藥物定位為非復發性繼發性進展型 MS 的首選口服治療選擇。

Additionally, we are progressing as planned with our phase three, ensure program of eous calcium in relapsing MS and expect to complete the first of our identical twin phase three insured trials in the second quarter of 2026.

此外，我們正在按計劃推進第三階段的治療復發性 MS 的鈣化計劃，並預計將在 2026 年第二季度完成第一項相同的第三階段保險試驗。

The completion of the second insur trial is expected in the second half of 2026 as it relates to our second clinical program. IHF six, we remain very enthusiastic and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders by targeting physiological intestinal epithelial regeneration resulting in gut wall healing with the absence of broad immunosuppression seen in many currently available gastrointestinal drugs in use.

第二次保險試驗預計將於 2026 年下半年完成，因為它與我們的第二個臨床項目有關。對於 IHF six，我們仍然非常熱情，並相信其創新的作用模式獨特地適用於治療廣泛的嚴重胃腸道疾病，透過針對生理性腸道上皮再生，導致腸壁癒合，並且不存在目前許多可用的胃腸道藥物中所見的廣泛免疫抑制。

Today, it bears repeating that data from our phase one B clinical proof of concept trial of I'm your A 56 in patients with celiac disease during periods of gluten free diet and gluten challenge demonstrated significant improvements over placebo in four key dimensions of clinical outcomes in celiac disease protection of the gut architecture, improvement of patient symptoms, enhancement of nutrient absorption and a strong biomarker response.

今天，值得重複的是，我們在第一階段 B 階段臨床概念驗證試驗中對患有乳糜瀉的患者進行了 I'm your A 56 試驗，在無麩質飲食和麩質挑戰期間，該試驗的數據顯示，在乳糜瀉臨床結果的四個關鍵維度上，與安慰劑相比有顯著改善：保護腸道結構、改善患者症狀、營養物質吸收和強烈的生物增強。

As previously reported, we have begun preparing for phase two clinical testing of Imu 856. And in addition to celiac disease. We are also exploring a number of other clinical applications for other gastrointestinal disorders where the renewal of the gut wall is important.

正如之前報導的那樣，我們已經開始為Imu 856的第二階段臨床試驗做準備。另外還有乳糜瀉。我們也正在探索其他胃腸道疾病的多種其他臨床應用，這些疾病中的腸壁更新非常重要。

We are currently exploring options to separately fund this unique asset and are openly considering different avenues.

我們目前正在探索為這獨特資產單獨提供資金的方案，並公開考慮不同的途徑。

Let me hand over to Jason at this point again, to emphasize Vris Calcium's unique profile.

現在，讓我再次將發言權交給 Jason，以強調 Vris Calcium 的獨特之處。

Thank you, Daniel. You know, part of the reason I joined Eminent just a few months ago, what was because of what I see as a tremendous opportunity and a tremendous potential for Vlus to transform the MS market and to potentially become the leading therapeutic within the oral disease modifying therapy segment.

謝謝你，丹尼爾。你知道，我幾個月前加入 Eminent 的部分原因是，我認為 Vlus 有巨大的機會和潛力，可以改變 MS 市場，並有可能成為口腔疾病治療領域的領先治療藥物。

The profile of this drug candidate is unique given its first in class dual mode of action approach designed to address the full spectrum of multiple sclerosis from stages of relapses and focal inflammation through the progressive stages where neurodegeneration takes hold as a first in class neurone activator vita misc calcium goes beyond inflammation, providing direct neuroprotective effects and thereby offering potential benefits for both relapsing progressive MS patients.

這種候選藥物的特徵是獨一無二的，因為它採用同類首創的雙重作用模式，旨在解決多發性硬化症的各個階段，從復發和局部炎症階段到神經退化性病變的進行階段，作為同類首創的神經元激活劑，維生素鈣不僅限於炎症，還提供直接的神經保護作用，從而為複發性進行性 MS 患者帶來潛在益處。

In addition, belos is also a highly selective DH O DH inhibitor associated with potent antiinflammatory effects, which we know plays a key part in the relapsing forms of multiple sclerosis.

此外，belos 也是一種高度選擇性 DH O DH 抑制劑，具有強大的抗發炎作用，我們知道它在多發性硬化症復發形式中起著關鍵作用。

We believe this mode of action combined with an exceptional safety and tolerability profile and the convenience of once daily oral administration gives vlu calcium a potentially best in class benefit risk profile within the oral class of medicines initially, it's worth to highlight that.

我們相信，這種作用方式，加上卓越的安全性和耐受性，以及每日一次口服給藥的便利性，使 vlu 鈣在口服藥物類別中具有潛在的最佳效益風險特徵，值得強調這一點。

We do not believe there is going to be any first dose or on treatment monitoring necessary, which means this will be an easy medicine to start newly diagnosed patients on and also a very easy medicine to switch patients to remembering that about 65% of the market today is a switch category.

我們認為不需要任何首劑或治療監測，這意味著這將是一種易於新診斷患者開始使用的藥物，也是一種非常容易讓患者轉換的藥物，請記住，目前約 65% 的市場屬於轉換類別。

We also do not anticipate any safety concerns or black box warnings specific to the vehicle or calcium given this profile and if approved across the vast indications of multiple sclerosis, we believe beta luum calcium has the potential to transform the oral disease modifying therapy market with expected peak sales of this product ranging from $2 to$ 6 billion US D.

有鑑於此，我們預計不會出現任何與載體或鈣相關的安全問題或黑框警告，如果獲得針對多發性硬化症廣泛適應症的批准，我們相信 β-鈣有可能改變口腔疾病改良治療市場，預計該產品的峰值銷售額在 20 億至 60 億美元之間。

This brings us to the end of our formal presentation, Jessica. Please open the call for the Q&A session.

我們的正式演講到此結束，傑西卡。請打開電話，進入問答環節。

Yes. Thank you, Jason and Daniel and Glenn for walking us through the third quarter and subsequent highlights as well as our clinical development pipeline and upcoming value inflection points.

是的。感謝 Jason、Daniel 和 Glenn 帶領我們了解第三季和後續亮點以及我們的臨床開發管道和即將到來的價值轉折點。

(Operator Instructions)

（操作員指令）

William Wood , B Riley. William. Welcome and please yourself.

威廉·伍德，B·萊利。威廉。歡迎大家的光臨並請隨意。

Thank you so much. We really appreciate you all to hear questions and congrats on another successful quarter. We, we have a couple of questions on our end. So the first is thinking, just thinking about your caliber study coming up read out in, in April you.

太感謝了。我們非常感謝大家回答我們提出的問題，並祝賀我們又一個季度取得成功。我們有幾個問題。因此，首先要思考的是，您要在四月讀出自己的能力研究報告。

This is in P MS. So SP MS including active and nonactive as well as PP MS. What level of detail should we expect a topline readout across these populations for both your primary, as well as your secondary endpoints presented, you know, possibly CD W NFL and or G FA essentially I'm trying to, are we going to just get an overall population data or should we expect some of these subpopulation data also? And then I have a follow up. Thank you.

這是在 P MS 中。因此，SP MS 包括活性和非活性以及 PP MS。我們應該期望這些人群的主要和次要終點的頂線讀數達到什麼詳細程度，您知道，可能是 CD W NFL 和/或 G FA，本質上我想知道，我們是否只是要獲得總體人群數據，還是我們也應該期望獲得其中一些亞群數據？然後我會進行後續跟進。謝謝。

Yeah, thank you, William for that wonderful question. And I have good news. So we, we plan to really come out with detailed data on the general and the sub forms tested during the study as we did for the interim analysis a year ago.

是的，謝謝威廉提出這個精彩的問題。我有個好消息。因此，我們計劃真正提供研究期間測試的一般形式和子形式的詳細數據，就像我們一年前進行的中期分析一樣。

And also we we really try to have everything possible available at the at the result, including the very important clinical endpoint.

而且我們也確實盡力在結果上提供一切可能的信息，包括非常重要的臨床終點。

So confirmed disability worsening the biomarker NFL, but also G fa given that the duration of the study allows to also evaluate that exploratory biomarker and also the, the brain atrophy data, of course. So it will be quite comprehensive data. We're expecting in April next year.

因此，證實殘疾惡化的生物標記 NFL，但同時 G fa 考慮到研究持續時間也允許評估探索性生物標誌物，當然還有腦萎縮數據。所以這將是相當全面的數據。我們預計明年四月。

Excellent. it's great to hear. And then just a quick second one. You also have, as you noted, you have your ongoing postcovid investigator led trial going on in Germany, you're looking to enroll, it looks like about 376 patients. It's got a 56 day timeline. And, and it's obviously evaluating fatigue, a key issue in, in multiple sclerosis.

出色的。很高興聽到這個消息。然後只是快速的第二個。正如您所說，您正在德國進行一項由研究者主導的新冠后試驗，您正在招募患者，看起來大約有 376 名患者。它有 56 天的時間表。而且，它顯然是在評估疲勞，這是多發性硬化症的關鍵問題。

Maybe you could remind me when we might expect the data here, possibly before insurers read out in 2026. And, and if so, how should we think about the results in this Post COVID trial?

也許您可以提醒我我們什麼時候可以在這裡看到這些數據，可能是在保險公司於 2026 年公佈數據之前。如果是這樣，我們應該如何看待這次 COVID 後試驗的結果？

How it might highlight your dual mo a and success in and and in inure and then remind me if there's any type of subtype analysis or earmarking of patients in either insure or caliper that are diagnosed with post COVID syndrome. Thank you. I'll hop back in the queue.

它如何突出顯示您的雙重 mo a 和在 inure 中的成功，然後提醒我是否存在任何類型的亞型分析或對被診斷為 COVID 後綜合症的患者的指定，無論是 insure 還是 caliper。謝謝。我將重新回到隊列中。

I hope I remember everything from the questions starting with the postcovid study. This is an investigator sponsored trial and therefore we really can't give any guidance on the speed of recruitment. I know that the study kicked off and they have patients in, but we are not a sponsor, we provide here the, the the drug and, but we are excited about the specific analysis here.

我希望我能記住從新冠疫情後研究開始提出的所有問題。這是一項研究者發起的試驗，因此我們無法就招募速度提供任何指導。我知道研究已經開始並且有患者參與，但我們不是贊助商，我們只是提供藥物，但我們對這裡的具體分析感到興奮。

The role of fatigue is, is super important in multiple sclerosis. And it's interesting to see the overlap and the role of EBV in expected in both in MS but also in in post COVID syndrome. And therefore, it could be scientifically and medically very meaningful thing even if it's an investigator sponsored trial.

疲勞在多發性硬化症中扮演極為重要的角色。有趣的是，EBV 在 MS 和 COVID 後綜合徵中都存在重疊，並且具有預期的作用。因此，即使這是一項研究者發起的試驗，它在科學和醫學上也可能是非常有意義的事情。

So we want to learn and we want to use that knowledge for the patients to have a better treatment option also to understand why and to what extent pus calcium can really make a difference here on preventing fatigue.

因此，我們希望學習並利用這些知識為患者提供更好的治療選擇，同時也希望了解膿鈣為什麼以及在多大程度上能夠真正發揮作用，防止疲勞。

And then there was the second part of the question, I forgot what that was.

然後是問題的第二部分，我忘了那是什麼。

Yeah, just if you're earmarking or, or making note of or any type of subanalysis going on insure or caliper for these post COVID syndrome patients just to sort of understand how that might translate their data might translate to these larger trials.

是的，如果你正在為這些 COVID 綜合症後患者進行指定或記錄或任何類型的子分析，只是為了了解如何將他們的數據轉化為這些更大規模的試驗。

Yeah, that's a good point. It's not predefined in the study as far as I know. And we will see if that shows up in the general safety monitoring of the study.

是的，觀點很好。據我所知，它在研究中並沒有預先定義。我們將觀察這是否會在研究的整體安全監測中反映出來。

And if we have data, we will likely also extract that. Maybe not at the top line data we are but maybe at a later time point.

如果我們有數據，我們可能會也提取它。也許不是我們現在的頂線數據，但也許是在稍後的時間點。

Right Makes sense. Thank you. And I'll hop back in the queue and congrats again on a very nice quarter. Thank you.

對的，有道理。謝謝。我將重新回到隊列，並再次祝賀這個非常美好的季度。謝謝。

William. Thank you, William.

威廉。謝謝你，威廉。

Yasmeen Rahimi , Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

Hey, good. Morning, this is Zhen on for Yz. Thanks for, thanks for taking our questions first to the extent you can. Can you comment on what do you see on a B basis for caliber in regards to safety and efficacy?

嘿，很好。早安，我是 Yz 的 Zhen。謝謝您，感謝您盡可能回答我們的問題。您能否評論一下您對 B 級口徑的安全性和有效性的看法？

And secondly, given that caliber has different P MS subpopulations for disability worsening. Can you detail which subgroup is most likely experienced the biggest treatment effect?

其次，鑑於不同口徑的 P MS 亞群存在不同的殘疾惡化情況。您能詳細說明哪個亞組最有可能獲得最大的治療效果嗎？

Thank you. It, let me start with the first thing. We, see blinded data. We can't conclude anything from that. So, and therefore we should not speculate on anything on the blinded data for caliber and so far what I hear from the clinical team, the study is progressing as expected. So that's all I can say on the subindications.

謝謝。那，讓我先說第一件事。我們看到的是盲數據。我們不能由此得出任何結論。因此，我們不應該對口徑的盲法數據進行任何猜測，到目前為止，根據我從臨床團隊聽到的消息，研究正在按預期進展。關於子指示我能說的就這麼多。

That's a good point. I think there is clearly there, there are three sub indications predefined in caliber, the active, secondary, progressive, nonactive, secondary, progressive and primary progressive and s and I think the nonactive, secondary progressive and primary progressive populations are kind of similar on the the issue that they don't have relapses that you don't measure lesions in the brain, no inflammatory lesions, but they still progress on this ability.

這是一個很好的觀點。我認為顯然存在三種預先定義的子適應症，即活動性、繼發性、進行性、非活動性、繼發性、進行性和原發性進行性，並且我認為非活動性、繼發性進行性和原發性進行性人群在以下問題上是相似的：他們沒有復發，沒有測量腦部病變，沒有炎症病變，但他們仍然在這種能力上取得進展。

And given that we, we have certain inclusion criteria for baseline E DS S score. And so we, we think those should be in the same ballpark of placebo disease activity in those patients. It's a little bit different. I think for the active SP MS patients given that there are still some inflammatory activity. And therefore we expect that to be a little bit.

有鑑於此，我們對基線 E DS S 分數有一定的納入標準。因此，我們認為這些患者的疾病活動應該與安慰劑大致相同。這有點不同。我認為對於活動性 SP MS 患者而言，仍然存在一些發炎活動性。因此我們預計會有一點。

Generally, I think a little bit higher, but also the number of those patients is a small, it's a smaller subgroup in the study. It's 9% of the patients in the study.

總的來說，我認為應該會高一些，但這些患者的數量很少，他們是研究中較小的亞群。這佔研究中患者的 9%。

Thank you.

謝謝。

Thank you, Jingle.

謝謝你，金格爾。

Faiza Kust from living partners._ Faiza, please AMM yourself and good morning.

來自生活伴侶的 Faiza Kust。Faiza，請 AMM 自己，早安。

Hey guys, good morning. This is Matt Calpar on for Felra. Thanks for taking my question a couple from me. What hazard ratio for disability worsening will you be looking for in caliber to feel good about the flu potential in P MS and then pending positive data in Caliper. Is there any opportunity for an accelerated registrational path in P MS or would you have to run a trial similar to what we see with the BT Ks and P MS? Thank you.

嘿，大家早安。這是 Felra 的 Matt Calpar。感謝您回答我的幾個問題。您將在 Caliper 中尋找什麼樣的殘疾惡化風險比來對 P MS 中的流感潛力感到滿意，然後在 Caliper 中等待陽性數據。P MS 中是否有機會加速註冊路徑，或者您是否必須進行類似於我們在 BT Ks 和 P MS 中看到的試驗？謝謝。

Yeah, thank you man. Hazard ratio assumptions. I think there is no, no predefined bar right now of what you need to show of course, but but there is a little of a perception of Kols what they perceive as medically meaningful. And we asked, we asked the questions of the medical team.

是的，謝謝你。風險比假設。我認為，目前對於你需要展示什麼並沒有預先定義的標準，但是 Kols 對他們認為具有醫學意義的東西有一點自己的看法。我們向醫療團隊詢問了問題。

There was a, we had a meeting with some, some of our KOL not too long ago and my colleague Andreas asked the team, what do you expect? And the discussion more or less came around. Okay? If it's a 15% benefit on disability protection, that is something at 20%. I think everybody agreed that that's a real signal. So we think that there is no hard line, but a 20% benefit would be a big win for the molecule and then the better, the higher the difference, the better for for the drug, of course.

不久前，我們與一些 KOL 舉行了一次會議，我的同事 Andreas 問團隊，你們有什麼期望？討論也差不多結束了。好的？如果殘障保障福利為 15%，那麼這個數字就達到了 20%。我想每個人都同意這是一個真實的信號。因此，我們認為沒有硬性界限，但 20% 的收益對於分子來說是一個巨大的勝利，當然，差異越大，對藥物就越好。

And on X rated approval, that's, that's definitely a opportunity. But again, it depends on on the data on the one hand and the distribution of the data.

就 X 級批准而言，這絕對是一個機會。但同樣，一方面這取決於數據，另一方面也取決於數據的分佈。

And there, for example, how similar are things between the subgroups and so forth and then, and the signal strength, for example, in the biggest population in the study and the nonactive secondary progressive patients.

例如，各亞組之間的相似度如何，以及研究中最大群體和非活動性繼發進展型患者的訊號強度。

And that may qualify for having a at least a discussion with the FT A on any kind of expedited way forward. However, we can't guarantee that this is a opportunity but definitely worth a try.

這可能有資格與 FT A 就任何形式的快速前進方式進行至少一次討論。然而，我們不能保證這是一個機會，但絕對值得一試。

Great. Thanks for the insight and taking my questions.

偉大的。感謝您的見解並回答我的問題。

Thank you. Thank you Matt. Just for full transparency here. We also had the question on accelerated or expedited, expedited approval two times in the in the chat. So I guess this is answered. Now, next one in the queue here is Matt Kaplan from Ladr Matt. Please unload yourself and go ahead.

謝謝。謝謝你，馬特。只是為了這裡的完全透明度。在聊天中，我們也兩次詢問了關於加速或加急、加急批准的問題。所以我想這個問題已經得到解答了。現在，下一位發言者是來自 Ladr Matt 的 Matt Kaplan。請放下負擔，繼續前進。

Hey Good morning guys. I just wanted to stay on the Caliper study a little bit in progressive MS. Can you talk a little bit about the unmet need in P MS and, and specifically also the subgroups of P MS as well?

嘿，大家早安。我只是想繼續對 Caliper 進行一些有關進行性 MS 的研究。您能否談談 P MS 中未滿足的需求，特別是 P MS 的子群體？

Oh Yeah, good that you asked, I think this is so super important. And then I think we can't say often enough that this is really one of the areas where there is the highest need and specifically for nonactive secondary progressive MS, there's currently not a single treatment approved.

哦，是的，你問得很好，我認為這非常重要。然後我認為我們不能經常說，這確實是需求最高的領域之一，特別是對於非活動性繼發性進展型 MS，目前還沒有一種治療方法獲得批准。

So that clearly is is a huge unmet need. Maybe Jason, you have a little bit of comments also on the number of patients affected there answering that question and just to complete that for the same, it's not the same but similar in primary progressive where you currently we only have re was approved as an infusion, there's no oral drug approved.

顯然這是一個巨大的未滿足的需求。也許 Jason，您對受影響的患者數量也有一些評論，請回答這個問題，只是為了完成同樣的問題，它是不一樣的，但在原發性進展性疾病中是相似的，目前我們只批准了輸液，沒有批准口服藥物。

And also I think on the effect size, it's good to have another option as well for PP MS patients. But maybe Jason you a little bit more color on that. They.

而且我認為，就效果而言，對於 PP MS 患者來說，有另一種選擇也是件好事。但也許傑森可以給你更多一些關於這一點的知識。他們。

Are happy to do so. Daniel and Matt, thank you for the question. So clearly, look, there's a huge unmet need in the progressive side of this disease specifically on the non relapsing, secondary progressive MS of phenotype or subtype. As Daniel mentioned, there's no currently approved medicines. We know that in across the seven major markets. There's approximately 175,000 patients diagnosed with non relapsing, secondary progressive MS.

很樂意這麼做。丹尼爾和馬特，感謝你們的提問。因此顯然，對於這種疾病的進展方面存在巨大的未滿足需求，特別是對於非復發性、繼發性進展型 MS 的表型或亞型。正如丹尼爾所提到的，目前還沒有批准的藥物。我們知道，這涉及七大主要市場。約有 175,000 名患者被診斷為非復發性繼發進展型 MS。

So it's a big opportunity represents about 15% of the total MS population. Also, on the primary progressive side, we know that there's approximately 120,000 or so patients diagnosed across the major markets representing about 10% of the total population.

所以這是一個巨大的機會，約佔總 MS 人口的 15%。此外，就原發性進展性疾病而言，我們知道主要市場約有 12 萬名患者被診斷出患有該疾病，約佔總人口的 10%。

There is only one treatment approved to date in primary progressive MS and that is Okouma or Ocrevus. But I I also think it's important to note that, you know, as patients progress as they, as they get into these, these, these more neurodegenerative forms of the disease, they're normally a little bit older in age, they normally have more accumulation of disability, both physical and cognitive disability.

迄今為止，只有一種藥物獲準用於治療原發性進展型 MS，即 Okouma 或 Ocrevus。但我認為也要注意的是，隨著患者的病情逐漸發展為神經退化性疾病，他們的年齡通常會稍微大一些，他們的殘疾程度通常會更加累積，包括身體殘疾和認知殘疾。

And just as patients age, you have a normal breakdown or wear down of of the of the body's natural immune system. And so in these primary progressive patients, though A Creus is currently approved, there is some reluctance about putting these type of patients on immunosuppressant, right?

隨著患者年齡的增長，身體的自然免疫系統會出現正常的崩潰或衰弱。因此，對於這些原發性進展型患者，儘管 A Creus 目前已獲批准，但人們對於讓這類患者使用免疫抑制劑還是有些猶豫，對嗎？

Broad B cell depleting therapies. And so again, the uniqueness of vioc calcium, given its dual mechanism of both the neuro activation and and highly selective innovation of DH O DH is that we think it's going to have a very strong neuroprotective play. It it's not immunosuppressed. So if approved and we show a good signal here, we believe it could become the gold standard of care in the progressive forms of the disease.

廣泛的 B 細胞耗竭療法。因此，鑑於其神經活化和 DH O DH 高度選擇性創新的雙重機制，vioc 鈣的獨特性在於我們認為它將具有非常強大的神經保護作用。它沒有受到免疫抑制。因此，如果獲得批准並且我們在此顯示出良好的信號，我們相信它可能成為治療這種疾病的漸進形式的黃金標準。

Thank you.

謝謝。

Thank you, Matt and maybe a follow up question for Jason here in the chat. Can you share more details on the calculation of the peak sales mentioned regarding market share?

謝謝馬特 (Matt)，也許在聊天中還有向傑森 (Jason) 提出的後續問題。您能否分享有關市場份額中提到的峰值銷售額計算的更多細節？

Yeah, I I mean I'm not going to get into the intricacies of total market capture. What I can tell you is that we've done a lot of work to understand both the bottoms up and a top down of a forecast and opportunity for this respective medicine.

是的，我的意思是我不會深入探討整個市場佔領的複雜細節。我可以告訴你的是，我們已經做了大量工作來自下而上和自上而下地了解該相應藥物的預測和機會。

It it's quite clear even with 20 approved 20 plus approved therapies in the relapsing forms of the disease, there continues to be a huge unmet need. A couple of data points that I think are worth mentioning of the roughly 900,000 patients that are currently diagnosed with relapsing forms of multiple sclerosis across the major markets today.

很明顯，即使已經有 20 多種針對復發型糖尿病的療法獲得批准，但仍有大量未滿足的醫療需求。我認為有幾個數據點值得一提，即目前主要市場上大約有 90 萬名被診斷出患有復發型多發性硬化症的患者。

Only about 525,000 of them are currently on a disease modifying therapy. So there's a huge delta between the number of patients diagnosed and those currently on therapy. And there's a lot of reasons as to why patients are not on therapy.

其中只有約 52.5 萬人目前正在接受疾病改良治療。因此，確診患者數量與目前接受治療的患者數量之間存在巨大差異。患者不接受治療的原因有很多。

But many of the most common reasons are our patients had a poor experience with an initial therapy, meaning that the tolerability associated with the medicine was worse than the disease itself. There are many patients especially early in their diagnosis that have concerns about some of the safety signals of the available therapies.

但最常見的原因是我們的患者對初始治療的體驗不佳，這意味著藥物的耐受性比疾病本身更糟糕。許多患者，特別是在診斷早期的患者，對現有療法的一些安全訊號感到擔憂。

And it's not surprising these are young people in the prime of their life, they have a long life ahead of them. And of course, if you have a medicine that potentially causes a severe and serious opportunistic infections or potentially increases the risk of blatant, that could certainly be a concern to many of these young patients. Again, there's also an unmet need for medicines that have a unique mechanism to stop this continued disability progression.

毫不奇怪的是，這些都是正值壯年的年輕人，他們的未來還很長。當然，如果某種藥物可能會導致嚴重的機會性感染，或者可能會增加明顯的風險，那麼這肯定會引起許多年輕患者的擔憂。此外，對於具有獨特機制來阻止這種持續殘疾進展的藥物，人們仍存在尚未滿足的需求。

Even in the relapsing forms of the disease, vitaflo calcium is going to address all these concerns. And so we believe that it is a wonderful option and we fill a need in the relapsing forms of of of the market. And therefore, all of the research that we've done to date supports significant uptake of this potential medicine, right? And I've discussed without, you know, without the nauseam here a little bit about that, the progressive side. But it goes without saying again, clearly, if this medicine shows signals in the progressive side, it ultimately becomes approved.

即使是復發型的疾病，vitaflo 鈣也能解決所有這些問題。因此，我們相信這是一個絕佳的選擇，而且我們滿足了市場復發形式的需求。因此，我們迄今為止所做的所有研究都支持大量採用這種潛在藥物，對嗎？我在這裡已經毫無厭煩地討論過這一點，關於進步的一面。但不言而喻，很明顯，如果這種藥物在進步方面顯示出信號，它最終會獲得批准。

We think that the efficacy, the uniqueness of this mechanism that the neurone activation that clearly provides neuroprotective benefits and the balance of all of this with a great safety and tolerability profile, really will differentiate this medicine. And again, we think it has the potential to disrupt the oral disease modifying therapy category. And that's why we're so hopeful.

我們認為，這種機制的有效性和獨特性，即神經元活化顯然提供了神經保護益處，並且所有這些與高​​度的安全性和耐受性之間的平衡，真正使這種藥物與眾不同。而且，我們認為它有可能顛覆口腔疾病改良治療類別。這就是我們如此充滿希望的原因。

Thank you, Jason. Again, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool. And we actually have one more on the Q&A tool is in Immunic in any negotiations to partner with Big Pharmaceutical at this moment, or are you still looking for a partner for nondilutive cash raises?

謝謝你，傑森。再次強調，如果您有任何問題，請使用 Zoom 入口網站或問答工具的舉手功能。實際上，我們還有一個關於問答工具的問題，那就是 Immunic 目前正在與大型製藥公司進行合作談判，或者您仍在尋找非稀釋性現金籌集的合作夥伴？

So, Daniel, why don't I take that? So, as you would imagine there is significant interest in vita funam calcium. There are very few late stage, there's little to no late stage therapies in development for multiple sclerosis and even in neuroscience in general.

那麼，丹尼爾，我為什麼不接受呢？因此，正如您所想像的，人們對 vita funam calcium 有濃厚的興趣。晚期患者很少，針對多發性硬化症甚至整個神經科學的晚期治療方法很少或根本沒有。

So certainly companies that have an existing interest in MS and companies that have an existing interest in neurology and Neuroscience, we are talking to just about every single one of them. I will not get into specifics around where we are at in those negotiations.

因此，我們正在與幾乎每一家對 MS 感興趣的公司以及對神經病學和神經科學感興趣的公司進行洽談。我不會詳細談論我們在談判中所處的階段。

But I can tell you that again, there's significant interest. I think the interest has has, has even increased over the course of the last couple of months. Given some of the market dynamics specific to the recent failures of, of the BTK inhibitors and the relapsing forms of the disease.

但我可以再告訴你，人們對此有濃厚的興趣。我認為過去幾個月人們的興趣增加。考慮到 BTK 抑制劑最近的失敗以及疾病的復發形式所特有的一些市場動態。

Again, I think that you have many companies taking a fresh and and different look at the potential for vorous calcium. So we're in ongoing discussions but but nothing more specific to provide at this point.

再次，我認為許多公司都以全新的、不同的視角來看待食用鈣的潛力。因此，我們正在進行討論，但目前還沒有更具體的內容可以提供。

Thank you, Jason and thank you. For all the questions. This concludes our question and answer session today. I would like to turn the conference back over to Daniel for any closing remarks.

謝謝你，傑森，謝謝你。對於所有問題。今天的問答環節到此結束。我想將會議交還給丹尼爾，請他作最後發言。

Yeah, thank you Jessica and thanks to everyone on the call today for your always insightful questions and good discussion here.

是的，謝謝傑西卡，也感謝今天電話會議上的每個人，感謝你們總是提出深刻的問題並進行良好的討論。

I would like to end the call by reiterating how excited we are about the potential for our advanced clinical programs, especially lead acid vous calcium, which is targeted to elevate the standard of care for the full spectrum of MS patients.

在結束本次通話之前，我想重申一下，我們對於先進的臨床項目，尤其是鉛酸鈣項目的潛力感到非常興奮，該項目旨在提高全系列 MS 患者的護理標準。

We are pleased with the milestones we have achieved with this program and look forward to reporting top line data from our phase two caliber trial as expected in April of next year while continuing the enrollment in our phase three ensure trials.

我們對透過該計劃取得的里程碑感到高興，並期待著按預期在明年 4 月報告第二階段口徑​​試驗的頂線數據，同時繼續進行第三階段確保試驗的招募。

Additionally, as progress is made, we expect to also provide an update in our preparations for phase two clinical trial of an HF six and its unique potential for the treatment of a broad array of serious gastrointestinal disorders. And beyond.

此外，隨著進展，我們還希望提供 HF 6 第二階段臨床試驗準備的最新進展，以及其在治療多種嚴重胃腸道疾病方面的獨特潛力。甚至更遠。

With that, I would like to close today's call. Thank you again for joining and we are very happy to answer any additional questions. One on one. So please do not hesitate to reach out.

今天的電話會議到此結束。再次感謝您的加入，我們非常樂意回答您的任何其他問題。一對一。因此，請不要猶豫地與我們聯繫。

Thank you for joining in Immunic third quarter, 2024 earnings call. The call has now concluded you may now disconnect.

感謝您參加 Immunic 2024 年第三季財報電話會議。通話已結束，您可以掛斷電話。