Immunic Inc (IMUX) 2023 Q4 法說會逐字稿

Good morning to everybody on the line. I would like to welcome you to the Immunic Inc Fourth Quarter and Year End 2023 earnings call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today.

在線的每個人都早上好。歡迎您參加 Immunic Inc 第四季和 2023 年底的財報電話會議。我叫 Jessica Breu，Immunic 投資人關係與傳播副總裁。今天我也擔任主持人。

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

我們的執行長兼總裁 Daniel Vitt 博士以及我們的財務長 Glenn Whaley 在電話會議上發言。（會議須知）

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 similar meaning and such statements involve a number of risks and uncertainties that could cause ImmunoGen actual results to differ materially from those discussed here. \

在開始之前，我想提醒您，本簡報可能包含前瞻性陳述。此類陳述可以透過「可能」、「將」、「期望」、「預期」、「估計」等詞語或具有類似含義的詞語來識別，此類陳述涉及許多風險和不確定性，可能導致ImmunoGen 的實際結果與此處討論的結果有重大差異。\

Please note that these forward-looking statements reflect Immunex opinions only as of the date of this presentation, and it undertakes no obligation to revise or publicly release the results of any revision to these forward-looking statements. In light of new information or future events, please refer to Immunex SEC filings for more detailed description of the risk factors that may affect Immunetics results and these forward-looking statements.

請注意，這些前瞻性聲明僅反映截至本簡報發布之日的 Immunex 意見，並且不承擔修訂或公開發布這些前瞻性陳述的任何修訂結果的義務。鑑於新資訊或未來事件，請參閱 Immunex SEC 文件，以了解可能影響 Immunetics 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 CEO and President, Dr. Daniel Vitt to begin the presentation. Daniel?

現在我想將電話轉給我們的執行長兼總裁 Daniel Vitt 博士來開始演講。丹尼爾？

Thank you, Jessica. I would also like to welcome everybody to today's earnings call. Earlier this morning, we announced our financial results for the fourth quarter and the year ended December 31, 2023, in our press release and Form 10-K.

謝謝你，潔西卡。我還要歡迎大家參加今天的財報電話會議。今天早些時候，我們在新聞稿和 10-K 表格中公佈了第四季度和截至 2023 年 12 月 31 日的年度財務業績。

During the call today, we will walk through our fourth quarter 2023 achievements and subsequent highlights year-end financial and operating results as well as anticipated upcoming milestones. As Jessica noted after the presentation, you will have the opportunity to ask questions. Let's start with a review of our fourth quarter 2023 and subsequent highlights.

在今天的電話會議中，我們將介紹 2023 年第四季的成就、隨後重點介紹的年終財務和營運業績以及預期即將實現的里程碑。正如傑西卡在演講後指出的那樣，您將有機會提問。讓我們先回顧一下 2023 年第四季及後續亮點。

Punctuating our remarkable progress throughout 2023, we announced a three tranche private placement of up to $240 million last month, at around led by media partners included participation from a group of top-tier new and existing investors, including MDC partner data centers and investors, Sergio's capital, RTW Investments and edge Capital Partners.

為了強調我們在2023 年取得的顯著進展，我們上個月宣布進行高達2.4 億美元的三期私募，大約由媒體合作夥伴牽頭，包括一群頂級新投資者和現有投資者的參與，其中包括MDC 合作夥伴資料中心和投資者， Sergio 的資本包括 RTW Investments 和 Edge Capital Partners。

We received a total of $75 million in net proceeds from the first tranche, which closed on January eighth, 2024, the second and third tranches of $80 million each are conditioned on the announcement of Phase 2b top-line data for our Caliper trial expected in April 2025. Volume weighted average share price levels and minimum trading volumes. Any of these conditions in the second or third month can be raised by holders of a majority of the outstanding securities, including the lead investor.

我們從第一筆付款中獲得了總計7500 萬美元的淨收益，該筆付款於2024 年1 月8 日結束，第二筆和第三筆各8000 萬美元的淨收益取決於預計於2024 年公佈的Caliper 試驗的2b 期頂線資料。成交量加權平均股價水準和最低交易量。大多數已發行證券的持有人（包括主要投資者）都可以在第二個月或第三個月提出任何這些條件。

This financing is completed in a challenging capital markets environment. And as such, a strong group of investors affirms the enormous value inherent in our two advanced clinical programs. In October, we have voted overwhelmingly positive interim data from the Phase two Telica trial of our potentially groundbreaking lead acid nuclear receptor related one and the one activator, we definitely was calcium in progressive multiple sclerosis of TNS.

本次融資是在充滿挑戰的資本市場環境下完成的。因此，一群強大的投資者肯定了我們兩個先進臨床項目固有的巨大價值。10 月，我們對Telica 潛在突破性的鉛酸核受體相關的一種和一種激活劑的第二階段試驗的中期數據進行了投票，結果是壓倒性積極的，我們肯定是鈣在TNS 進行性多發性硬化症中的作用。

In total, 203 patients were included in this analysis. The overall population, which includes all subtypes of our TMS saw a 22.4% improvement in general, large neurofilament light chain or NFL. So we did reduce calcium or placebo at week 24. We believe that this is a substantial and meaningful difference in favor of Pseudomonas calcium in this TMS population, even a statistically significant difference was found for arithmetic mean serum NFL levels at week 24 between because with MS calcium and placebo with a p-value of 0.01.

此次分析總共包括 203 名患者。整體人群（包括 TMS 的所有亞型）的一般大神經絲輕鍊或 NFL 改善了 22.4%。所以我們在第 24 週確實減少了鈣或安慰劑的攝取。我們認為，在該TMS 族群中，這是有利於假單胞菌鈣的顯著且有意義的差異，甚至在第24 週時，在MS 鈣和安慰劑之間發現算術平均血清NFL 水平存在統計學上顯著差異，因為MS 鈣和安慰劑的p 值為0.01 。

If you look at the subtypes of TMS to the right, you can appreciate that this difference in serum NfL at week 24 was consistently observed across all progressive MS subtypes. I would like to point out that we saw a 20.1% reduction of redefining this calcium versus placebo in advanced SPMS., meaning patients with no focus inflammatory activity, but continued disease progression. We believe the subtenants at this segment are very high unmet need in MS with no relevant FDA approved therapies available in the United States.

如果您查看右側的 TMS 亞型，您會發現在第 24 週時血清 NfL 的這種差異在所有進行性 MS 亞型中都一致觀察到。我想指出的是，在晚期 SPMS 中，與安慰劑相比，我們發現重新定義的鈣含量減少了 20.1%，這意味著患者沒有焦點發炎活動，但疾病持續進展。我們認為，由於美國沒有 FDA 批准的相關療法，該細分市場的多發性硬化症需求未滿足的比例非常高。

And then this next slide puts our Caliper interim data into this perspective on historical third-party studies and the same progressive MS subtypes. On the left, we display the data for PPMS. compared to our story was plenty for hopefully some up, which showed a spread of LBOs between active and placebo at 24 weeks or 12.4%. And the clinical trial, we observed an 18.8% improvement of active drug or placebo in TPMS at week 24.

然後下一張投影片將我們的 Caliper 中期數據納入歷史第三方研究和相同進展性 MS 亞型的觀點。在左側，我們顯示 PPMS 的數據。與我們的故事相比，我們的故事足以讓一些人樂觀，其中顯示活性藥物和安慰劑之間的槓桿收購差異為 24 週或 12.4%。在臨床試驗中，我們觀察到活性藥物或安慰劑在第 24 週時 TPMS 改善了 18.8%。

You may recall that the results of the arterial Phase three study, the debt to the approval of ocrelizumab for treatment of PPMS and percent of the slide, you see historical data for the secondary progressive MS. Both were inflammatory, not active and active SPMS in comparison with rhodium was calcium was able to show a substantial reduction in NFL in both subpopulations to our knowledge.

您可能還記得動脈三期研究的結果、批准 ocrelizumab 用於治療 PPMS 的債務以及幻燈片的百分比，您將看到繼發進展性 MS 的歷史數據。據我們所知，兩者都是發炎性的、非活性的，與銠鈣相比，活性 SPMS 能夠顯著減少兩個亞群中的 NFL。

This is the first time that such a substantial effect in and that has been shown in other active SPMS patients, again, which is the PMS. subtypes with the highest unmet medical need. The right-side of the slide shows the comparison between our Phase two emphasis data for the treatment of calcium in RMS versus historical relapsing MS studies to complete the picture.

這是第一次在其他活動性 SPMS 患者中顯示出如此顯著的效果，也就是經前症候群 (PMS)。未滿足醫療需求最高的亞型。幻燈片右側顯示了我們用於 RMS 鈣治療的第二階段重點數據與歷史復發 MS 研究之間的比較，以完成圖片。

In summary, we believe the clear separation of Swift in several minutes for FluMist calcium over placebo in this PMS patient population as well as its subtypes represent another significant step forward for what could potentially be a first in class and the one activator for MS Net's strong signal also points to a more likely positive outcome of the overall caliber trials as well as clinically relevant endpoints like prevention of disability worsening.

總之，我們相信，在該經前症候群患者群體及其亞型中，Swift 在幾分鐘內就可以將FluMist 鈣與安慰劑明確分離，這代表著又向前邁出了重要一步，可能是同類首創，也是MS Net 強效的唯一活化劑。

Also in October, we talked about flux from Cleveland Clinic with the coordinating investigator of our insured and Caliber programs presented data from our Phase two emphasis drive beautiful seamless calcium in on this in a poster at the joint actions actions meeting, it is important to reiterate that we fully host calcium shortly an improvement on serum NfL in both treatment arms of 30 and 45 milligram over placebo in November, we were granted two fundamental new patents, obviously for the most in the United States.

同樣在10 月，我們與我們的保險和Calibre 計劃的協調調查員討論了克利夫蘭診所的通量，在聯合行動會議的海報上提供了我們第二階段重點驅動美麗無縫鈣的數據，重要的是要重申11 月份，我們完全接受了鈣治療，兩個治療組的血清 NfL 比安慰劑分別提高了 30 毫克和 45 毫克，因此我們獲得了兩項基本的新專利，這顯然是美國最多的。

First coverage, a daily dose of about 10 to come to 45 milligrams of sodium and calcium and others to halt as well as three acid forms for the treatment of relapsing MS, including the 30 milligram dosage used in our ongoing twins Phase three in short trains. The second patent granted covers the dosing regimen associated with beautiful, seamless calcium and other thoughts as well as the free acid forms for the treatment of MS, including all regimens tested in our MS clinical program. As a result, our extensive patent portfolio now provides protection into 2041 or even beyond in United States.

首次覆蓋，每日劑量約10 至45 毫克鈉和鈣，其他藥物以及用於治療復發性多發性硬化症的三種酸形式，包括在我們正在進行的雙胞胎第三階段短期訓練中使用的30 毫克劑量。授予的第二項專利涵蓋了與美麗、無縫鈣和其他想法相關的劑量方案以及用於治療多發性硬化症的遊離酸形式，包括我們多發性硬化症臨床計畫中測試的所有方案。因此，我們廣泛的專利組合現在可以在美國提供直至 2041 年甚至更久的保護。

Turning to our second key program and 86, an orally available and systemically acting small molecule modulator that targets six protein. In October, we presented two abstracts at the United European Gastroenterology Week 2023 my colleague, Dr. Francisco embryonic, Senior Medical Director at Immunic, presented data from our Phase Ib clinical trial of a new 86 in patients with celiac disease during a moderated poster session.

轉向我們的第二個關鍵項目和 86，這是一種口服的、全身作用的小分子調節劑，針對六種蛋白質。10 月，我們在2023 年歐洲聯合胃腸病學週上展示了兩份摘要，我的同事、Immunic 高級醫療總監Francisco Emilyonic 博士在主持的海報會議上展示了我們對86 名乳糜瀉患者進行的新Ib 期臨床試驗的數據。

The trial results given during periods of gluten-free diet and gluten challenge demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology, histology disease symptoms, biomarkers at nutrient absorption and an 8.6 was also observed to be safe and well tolerated in this trial. Additionally, Dr. Eick, the empty homes from Amsterdam University Medical Center presented data from our Phase two capitals, one trial of three different image capture in ulcerative colitis or UC.

在無麩質飲食和麩質挑戰期間給出的試驗結果表明，在乳糜瀉病理生理學、組織學疾病症狀、營養吸收生物標記的四個關鍵維度上，與安慰劑相比，顯著改善，並且在該研究中也觀察到8.6 是安全且耐受性良好的審判。此外，來自阿姆斯特丹大學醫學中心的 Eick 博士介紹了我們第二階段首都的數據，這是對潰瘍性結腸炎或 UC 的三種不同影像捕獲的試驗。

As a reminder, the maintenance phase results from the ColorZ one trial demonstrated statistically significant activity of previous routing was calcium compared to placebo and reaffirmed the drug's favorable safety and tolerability profile. The data validated the potential of the different charts. I mean, you see and other inflammatory bowel disease indications. In November, we were pleased that Dr. bionic had another opportunity to present the data from our Phase Ib clinical trial of 106 in patients with celiac disease in a virtual poster at the Association of European celiac Society General Assembly conference in Athens, Greece.

提醒一下，ColorZ one 試驗的維持階段結果表明，與安慰劑相比，先前路線的鈣活性具有統計顯著性，並重申了該藥物良好的安全性和耐受性。數據驗證了不同圖表的潛力。我的意思是，你看到了其他發炎性腸道疾病的跡象。11 月，我們很高興 Bionic 博士再次有機會在希臘雅典舉行的歐洲乳糜瀉協會大會上以虛擬海報形式展示我們對 106 名乳糜瀉患者進行的 Ib 期臨床試驗的數據。

That concludes our summary of the fourth quarter 2023 and most recent highlights. I'm very pleased with the scientific and clinical advancements we have made across our different programs, and we are leveraging this momentum going forward. As an example, for the FluMist calcium. The release of our overwhelming positive biomarker NfL data has been an impetus for it, partnering discussions and global and regional pharmaceutical companies. There's also a lot going on with our I mean a five six program, which we will update you as progress is made this year.

我們對 2023 年第四季和最新亮點的總結到此結束。我對我們在不同項目中取得的科學和臨床進展感到非常滿意，我們正在利用這一勢頭繼續前進。以 FluMist 鈣為例。我們壓倒性的積極生物標記 NfL 數據的發布一直是其推動力，它與全球和區域製藥公司進行了合作討論。我們的「五六」計畫也正在進行許多工作，隨著今年的進展，我們將向您更新該計畫。

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

我現在想將電話轉給格倫，以提供財務概況和格倫。

Thank you, Daniel. I will now review the financial and operating results for the year ended December 31, 2023. Let me start with a review of our cash position. We ended the year with $46.7 million in cash, cash equivalents with these funds and the approximately $75 million in net proceeds raised in the first tranche of our January 2024 private placement. We expect to be able to fund operations into the third quarter of 2025.

謝謝你，丹尼爾。我現在將回顧截至 2023 年 12 月 31 日止年度的財務和經營業績。讓我先回顧一下我們的現金狀況。截至年底，我們擁有 4,670 萬美元的現金、這些資金的現金等價物以及在 2024 年 1 月第一筆私募中籌集的約 7,500 萬美元的淨收益。我們預計能夠為 2025 年第三季的營運提供資金。

Regarding the operating results, R&D expenses were $83.2 million for the 12 months ended December 31, 2023, as compared to $71.2 million for the 12 months ended December 31, 2022. These costs were mainly driven by external development costs related to the ongoing clinical trials of EDF, Luminus calcium and IMU. eight five six as well as personnel expenses. This was partially offset by a decrease in external development costs related to the deprioritization of the IMU. 95 program and a reduction in costs related to the data from the BMS calcium program in ulcerative colitis.

就營運績效而言，截至2023年12月31日止12個月的研發費用為8,320萬美元，而截至2022年12月31日止12個月的研發費用為7,120萬美元。這些成本主要是由與 EDF、Luminus 鈣和 IMU 正在進行的臨床試驗相關的外部開發成本所驅動的。八五六還有人員費用。這被與 IMU 優先順序降低相關的外部開發成本下降所部分抵消。 95 計劃以及與 BMS 鈣計劃治療潰瘍性結腸炎的數據相關的成本降低。

General and administrative expenses were $16 million for the 12 months ended December 31, 2023, as compared to $15.3 million for the same period ended December 31, 2022. The slight increase was spread across numerous categories and was partially offset by a decrease in personnel expense.

截至2023年12月31日的12個月，一般及行政費用為1,600萬美元，而截至2022年12月31日的同期，一般及行政費用為1,530萬美元。這一小幅成長分佈在多個類別中，但部分被人事費用的減少所抵消。

Other income was $5.6 million for the 12 months ended December 31, 2023, as compared to negative $0.9 million for the same period ended December 31, 2022. The increase was primarily attributable to a decrease in foreign exchange losses. Our research allowance material to the 2021 and 2022 tax years from the German Ministry of Finance and an increase in interest income as a result of higher interest rates. This was partially offset by a decrease in R&D tax incentives as a result of less spend for clinical trials in Australia.

截至2023年12月31日的12個月，其他收入為560萬美元，而截至2022年12月31日的同期其他收入為負90萬美元。增加的主要原因是外匯損失減少。我們的研究津貼資料來自德國財政部的 2021 和 2022 納稅年度，以及由於利率上升而增加的利息收入。由於澳洲臨床試驗支出減少，研發稅收優惠減少，部分抵銷了這項影響。

The net loss for the 12 months ended December 31, 2023, was approximately $93.6 million or $2.11 per basic and diluted share based on approximately $44.3 million weighted average common shares outstanding compared to a net loss of approximately $120.4 million or $3.78 per basic and diluted share based on approximately $31.8 million weighted average common shares outstanding for the same period ended December 31, 2022.

截至2023 年12 月31 日的12 個月淨虧損約為9,360 萬美元，或每股基本股和稀釋股2.11 美元（基於已發行普通股加權平均數約4,430 萬美元），而淨虧損約為1.204億美元，或每股基本股和稀釋股3.78 美元基於截至 2022 年 12 月 31 日止同期已發行普通股加權平均約 3,180 萬美元。

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

這樣，我會將電話轉回丹尼爾，以審查我們即將到來的臨床里程碑。丹尼爾？

Thank you and I would now like to provide an update and we anticipated upcoming milestones for our clinical development programs. We didn't really anticipate reporting top line data from our Phase two clinical trial of FluMist calcium in progressive MS in April 2025. Additionally, we expect to report an interim futility analysis of our Phase three into a program late this year. And to read out the first of our eight identical twin face reinsure trials in relapsing MS in the second quarter of 2026.

謝謝您，我現在想提供最新情況，我們預計我們的臨床開發項目即將到來的里程碑。我們並沒有真正預料到會在 2025 年 4 月報告 FluMist 鈣治療進展性多發性硬化症的第二期臨床試驗的主要數據。此外，我們預計將在今年稍後報告專案第三階段的中期無效分析。並宣讀 2026 年第二季我們針對複發性多發性硬化症進行的八項相同雙胞胎再保險試驗中的第一項試驗。

As stated before, based on the strong clinical activity observed thus far, and we just for the most calcium solidly established safety and tolerability profile. To date, we believe that the design of our Phase three NHL program will provide a straightforward path to potential regulatory approval in relapsing MS. If the top line clinical data continues to show a neuroprotective effect for PMS. patients, we may be able to position we do too much calcium as the first oral treatment for advanced secondary progressive MS as well.

如前所述，基於迄今為止觀察到的強大臨床活性，我們只是針對最牢固的鈣建立了安全性和耐受性概況。迄今為止，我們相信 NHL 第三階段計畫的設計將為復發性多發性硬化症的潛在監管批准提供一條簡單的途徑。如果最重要的臨床數據繼續顯示對經前症候群的神經保護作用。對於患者，我們也可以將服用過多的鈣作為晚期繼發性進展性多發性硬化症的第一種口服治療。

We also expect that the drug's potential first-in-class ability to activate no one will meaningfully benefit the ongoing clinical trials in multiple sclerosis. We are particularly excited about our MS program in light of the recent developments in the MS market. As we have noted before, if approved, we believe that to be different. And this customer has the potential to be a unique treatment option targeted to the complex path of physiology of multiple sclerosis based on combining neuroprotective, anti-inflammatory and anti-viral effects.

我們還預計，該藥物潛在的一流能力不會激活任何人，這將為正在進行的多發性硬化症臨床試驗帶來有意義的好處。鑑於 MS 市場的最新發展，我們對 MS 計劃感到特別興奮。正如我們之前指出的，如果獲得批准，我們相信情況會有所不同。該客戶有潛力成為一種獨特的治療選擇，針對多發性硬化症的複雜生理路徑，結合神經保護、抗發炎和抗病毒作用。

With regard to our annual 86 program, as previously reported, we have begun preparing for a Phase two clinical trial in ongoing active celiac disease patients at the same time based on the drug's broad therapeutic potential by targeting physiological epithelial regeneration. We are also considering additional clinical applications and other GI disorders. We are very excited about this program and believe our new 86 could present an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of all architecture without the serious consequences associated with immunosuppressive therapies.

關於我們的年度 86 計劃，正如之前報導的，我們已經開始準備在正在進行的活動性乳糜瀉患者中進行二期臨床試驗，同時基於該藥物通過針對生理上皮再生的廣泛治療潛力。我們也正在考慮其他臨床應用和其他胃腸道疾病。我們對這個計畫感到非常興奮，並相信我們的新 86 可以透過促進所有結構的再生，為胃腸道疾病提供一種全新的治療方法，而不會產生與免疫抑制療法相關的嚴重後果。

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

我們的正式演示到此結束。傑西卡，請打開問答環節的電話。

Thank you, Daniel, and also Glen for walking us through the fourth quarter 2023 and subsequent highlights as well as our upcoming value inflection points. (Operator Instructions)

感謝丹尼爾和格倫帶我們回顧了 2023 年第四季和隨後的亮點以及我們即將到來的價值轉折點。（操作員說明）

Caroline Pocher, Wedbush PacGrow.

卡洛琳波徹，韋德布希 PacGrow。

Hi, good morning. This is Caroline on for Andreas. On Just two questions from us. So if the data can tell positive, can you discuss what the regulatory path forward looks like in advanced SPMS. And then since the last quarterly update, it looks like the times were slightly shifted for the readout from the first ensure trial from the end of 2025 to Q2 '26. Just any clarity as to why the slight change arm and just enrollment progression in both of those trials?

早安.這是卡洛琳為安德烈亞斯配音。關於我們只有兩個問題。因此，如果數據顯示出正面的結果，您能否討論一下高階 SPMS 的監管路徑是什麼樣的。自從上次季度更新以來，從 2025 年底到 26 年第二季的第一次確保試驗的讀數時間似乎略有變化。是否清楚為什麼這兩項試驗中的手臂略有變化並且註冊進展順利？

Thank you, Caroline, for the question come? Let me start with Calibre. So I think it's a difficult question to answer. And I think the normal process in such an indication that let us pick non-active secondary progressive as the most likely indication where there is nothing approved, nothing available for patients that, of course, may offer an accelerated pathway forward towards approval. But that requires the discussion with the regulators and the different countries than what we know is that likely of the Phase three study would only require one study. So we think it will be a pretty lean and package. We expect after a positive readout of that study.

謝謝你，卡羅琳，提出這個問題？讓我從 Calibre 開始。所以我認為這是一個很難回答的問題。我認為這種適應症的正常過程是讓我們選擇非活性繼發進展作為最有可能的適應症，因為沒有任何批准，沒有任何可供患者使用的適應症，當然可以提供加速獲得批准的途徑。但這需要與監管機構和不同國家進行討論，據我們所知，第三階段研究可能只需要一項研究。所以我們認為這將是一個非常精簡的包。我們期待研究獲得正面的結果。

I'm going to ensure I think we didn't change the comments from our last projections, and I think this was already the update from some weeks ago, and that is reflecting the current speed of recruitment in our estimation, we always need to make and continues to explore how quick things are going forward and therefore, we meet and adapt to the and the time lines by real.

我將確保我認為我們沒有改變上次預測的評論，我認為這已經是幾週前的更新，這反映了我們估計的當前招聘速度，我們總是需要並繼續探索事情進展的速度有多快，因此，我們會真實地滿足並適應時間線。

Okay. We are on track them on the current recruitment right now.

好的。我們現在正在追蹤他們當前的招募。

Great. Thank you so much.

偉大的。太感謝了。

Thank you, Caroline.

謝謝你，卡洛琳。

Thanks, Caroline.

謝謝，卡洛琳。

[Netsolank from Leerink].

[來自 Leerink 的 Netsolank]。

My name is Nestor and so isotonics.

我的名字叫內斯特，所以是等滲的。

Yes. So congrats on all the progress. And we have couple of questions. The first one, like what are the biomarkers, we felt that we can expect from the interim futility analysis for the interim study expected in late '24. And what do you need to see to continue the development of different. We definitely mix calcium in RMS.

是的。所以要祝賀所有的進展。我們有幾個問題。第一個，就像生物標記是什麼一樣，我們認為我們可以從 24 年底預期的中期研究的中期無效性分析中得到預期。而你需要看到什麼才能繼續不同的發展。我們肯定會在 RMS 中混合鈣。

Well, just yes. Thank you, Matt, for the question. And it's good that you asked because I want to clarify that this is as we have written has will be tested futility analysis. Since this is a Phase three study.

嗯，只是是的。謝謝你，馬特，提出這個問題。您提出這個問題很好，因為我想澄清一下，這是我們所寫的，將進行無效分析測試。由於這是第三階段研究。

We can't read out biomarkers or other clinical data at this time points. It will just be a futility analysis and we would get some feedback from the Data Safety Monitoring Board about progression of the other study it may allow for sample size adjustment. So this is the only outcome which could happen either continued as planned for sample size adjustment recommendations from the Data Safety Monitoring Board.

目前我們無法讀取生物標記或其他臨床數據。這只是一個徒勞的分析，我們將從資料安全監測委員會得到一些關於其他研究進展的回饋，它可能允許樣本量調整。因此，這是唯一可能發生的結果，或按照資料安全監測委員會的樣本量調整建議的計劃繼續進行。

Got it. That's very helpful on. So the next one is like. So what are the gating factor to steady in ongoing asset discrepancies? Can you go over a potential trial design for a Phase two study? I think you plan to look into like additional doses other than the MACR. one 16, have you looked at in the Phase 1b study and what are the potential endpoints as well as exploratory biomarker, you plan to pretty steady.

知道了。這非常有幫助。那麼下一篇就是這樣的。那麼，穩定持續資產差異的控制因素是什麼？您能回顧一下第二階段研究的潛在試驗設計嗎？我認為您計劃研究除 MACR 之外的其他劑量。 16號，您是否看過1b期研究以及潛在的終點以及探索性生物標記是什麼，您計劃相當穩定。

And also quick question. As you know, we are heavily working in involved in celiac disease committee and the space, given our wonderful readout from the proof of concept study last year. And of course, that drove a lot of interest and that is influencing our very active preparation time of a potential Phase two study in celiac disease and also for potential other indications.

還有快速提問。如您所知，鑑於我們去年概念驗證研究的精彩結果，我們正在積極參與乳糜瀉委員會和該領域的工作。當然，這引起了極大的興趣，並且影響了我們對乳糜瀉以及潛在其他適應症的潛在二期研究的非常積極的準備時間。

As I said before, the more the proof of concept being achieved in the Phase one is not only limited to celiac disease because we have, for example, seen a very nice improvement of is of interest side function by increased uptake of nutrients like vitamin B12, for example. So that would also this is also more or less proving that the drug may work in other situations where you want to increase the viability and the functioning of those cells.

正如我之前所說，第一階段實現的概念驗證不僅限於乳糜瀉，因為我們已經看到，通過增加維生素 B12 等營養物質的攝取，我們感興趣的副功能得到了非常好的改善。因此，這也或多或少證明了該藥物可能在您想要增加這些細胞的活力和功能的其他情況下發揮作用。

With respect to Phase two, as we have said before, the Phase two study currently is not in our budget. So we and we are preparing a study. We have talks ongoing competition with potential partners and also looking for other ways to finance a full-blown Phase two study. And we will keep the market informed as we progress on these discussions and the way forward.

關於第二階段，正如我們之前所說，第二階段的研究目前不在我們的預算之內。所以我們正在準備一項研究。我們與潛在合作夥伴進行了持續的競爭談判，並尋找其他方式來資助全面的第二階段研究。隨著這些討論和前進方向的進展，我們將隨時向市場通報情況。

That may also mean that it's not finally limited to celiac disease. Maybe one thing I need to clearly state here. I could really go beyond and severe disease as indication in that context.

這也可能意味著它最終不僅限於乳糜瀉。也許我需要在這裡明確說明一件事。在這種情況下，我真的可以超越嚴重疾病作為指示。

That's very helpful. Thank you so much.

這非常有幫助。太感謝了。

Thanks Ned. We have a question that came in via the Q&A tool in writing and have nicely fits to annualized plus six. So I will read it can you provide any high-level description of how potential partners view the drug and its completion of Phase two is a prerequisite for them.

謝謝內德。我們有一個透過問答工具以書面形式提出的問題，並且非常適合年化加六。因此，我將閱讀它，您能否提供有關潛在合作夥伴如何看待該藥物的任何高級描述，以及完成第二階段是他們的先決條件。

As of May, it might have been subject to some conclusion on perception of the drug is that people really think it's because it's a new target. I think this has the potential really to address the GI disorders in a different way. So that key immunosuppressive effects is really a unique benefit we've since year end. And therefore, I think it is an attractive thing.

截至五月，人們對該藥物的看法可能已經得出一些結論，即人們確實認為它是因為它是一個新目標。我認為這確實有可能以不同的方式解決胃腸道疾病。因此，關鍵的免疫抑製作用確實是我們自年底以來的獨特優勢。因此，我認為這是一件有吸引力的事。

On the other hand, typically and new targets need to demonstrate that they work and to our favor. I think we have already achieved clinical proof of concept in the celiac disease patients. So I think generally the year. The perception is very positive and people are very excited about a completely new approach for those diseases.

另一方面，典型的新目標需要證明它們有效並且對我們有利。我認為我們已經在乳糜瀉患者中取得了臨床概念驗證。所以我一般認為是年份。人們的看法非常積極，人們對治療這些疾病的全新方法感到非常興奮。

Thank you, Daniel.

謝謝你，丹尼爾。

Matt Caplan, Landmark.

馬特·卡普蘭，地標。

Hi, good morning, guys. Can you hear me owning?

嗨，早上好，夥計們。你聽得到我擁有嗎？

Yes, morning.

是的，早上。

Great, great. Well, congrats on the progress. I mean, I just wanted to kind of I'm zeroing in on the data that you've gotten so far and with Vodafone us in terms of the impact and FX. And I guess what's the what's been the feedback so far you received from the MS community KOLs with that observed and a pronounced reduction in the Caliper and an emphasis study.

很棒很棒。嗯，恭喜你取得了進展。我的意思是，我只是想把注意力集中在您迄今為止獲得的數據以及沃達豐我們在影響和外匯方面的數據。我想到目前為止，您從 MS 社群 KOL 那裡收到的回饋是什麼，觀察到了 Caliper 的顯著降低以及重點研究。

Good morning, Matt, and thank you for that question. I think this is unique and people see that. And given that recently, if you look on a couple of key publications in that space, there are very nice data showing that NFL. It is in progressive MS, specifically in an isolated, if you will, separate the activity of NFL. from focal inflammation in relapses on what machines from the neurodegenerative contributions like you can do in progressive MS patients there.

早安，馬特，謝謝你提出這個問題。我認為這是獨一無二的，人們也看到了這一點。鑑於最近，如果您查看該領域的一些重要出版物，您會發現非常好的數據顯示 NFL。它是進行性多發性硬化症，特別是在孤立的（如果你願意的話）NFL 活動中。神經退化性病變的機器可以對進行性多發性硬化症患者進行治療，以防止局部發炎復發。

There's clearly a nice predictive power of NFL. for future disability. I was coming that was shown in a couple of a recent paper, specifically the second half of last year. There were some papers really pointed to that and that also drives excitement.

NFL 顯然具有很好的預測能力。為了將來的殘疾。最近的幾篇論文，特別是去年下半年的論文中都展示了我的到來。有一些論文確實指出了這一點，這也令人興奮。

But I think it's a scientific progress. Of course, at the end, we want to and we need to demonstrate clinical benefit as well, which is the goal of the Phase two study. And we're not too far from that, I think April 25. So too far from now and timing, given the two, as I said before, the huge unmet medical need in all forms of progress of progressive MS, namely the non-inflammatory advance secondary progressive MS population. We think that really for domestic customers really the opportunity to change the way we treat these diseases and that's helpful.

但我認為這是一個科學進步。當然，最後，我們希望也需要證明臨床益處，這是第二階段研究的目標。我認為 4 月 25 日，我們離這個目標已經不遠了。從現在到時機，考慮到兩者，正如我之前所說，進展性多發性硬化症所有形式的進展（即非發炎性進展繼發性進展性多發性硬化症人群）存在巨大的未滿足的醫療需求。我們認為，對於國內客戶來說，這確實是改變我們治療這些疾病的方式的機會，這很有幫助。

And then and then you mentioned the business development plans or partnering plans. What do you what are your plans for and the MS indications are for that approval in terms of partnering?

然後你又提到了業務發展計畫或合作計畫。您有什麼計劃以及 MS 的跡象表明您已批准合作？

Yes, I think given that some people we are talking to are mainly also on the line here. And I sometimes tend to be careful on projects and the status on BD discussions. But I think actually we do what we always do. We are we establish collaborations. We have established customer relationships to potential partners and progressing towards the readout I think clearly takes the way also for partnerships.

是的，我認為考慮到我們正在交談的一些人主要也是在線上的。有時我會對專案和 BD 討論的狀態持謹慎態度。但我認為實際上我們做了我們一直在做的事情。我們正在建立合作關係。我們已經與潛在合作夥伴建立了客戶關係，並且正在朝著我認為顯然也適合合作夥伴關係的方向邁進。

And if the Phase two PFS data was positive, this is certainly something which has a relevance for the whole treatment landscape of form of multiple sclerosis be even beyond PNH because and that may also be of benefit for and support from scientifically the issue of IMS. Phase three studies, which are ongoing as well. So I think this is something we have really some activity on we found, but we are not in a situation that we say we need to do something now I think we have the funding available to read out the Phase two study and in a good way and then to look what is the best way forward here.

如果第二階段的 PFS 數據是正面的，這肯定與多發性硬化症的整個治療格局相關，甚至超越 PNH，因為這也可能對 IMS 問題的科學有益和支持。第三階段研究也正在進行中。因此，我認為我們確實在這方面開展了一些活動，但我們現在還沒有處於需要採取行動的情況，我認為我們有足夠的資金以良好的方式宣讀第二階段研究然後看看什麼是最好的前進方向。

Great. Thanks for the added detail.

偉大的。感謝您添加的詳細資訊。

Yeah, thank you, Matt.

是的，謝謝你，馬特。

Thank you, Matt.

謝謝你，馬特。

(Conference Instructions)

（會議須知）

Younger Clark, Piper Sandler.

小克拉克，派珀·桑德勒。

Good morning, team, this is Jamilul on Riyas. Thanks for taking our questions. We have to for the futility analysis later this year venture, how should we think about implications upon Reto and what would be considered a win?

早安，團隊，我是 Riyas 的 Jamilul。感謝您回答我們的問題。我們必須在今年稍後進行徒勞分析，我們應該如何考慮對雷託的影響以及什麼會被視為勝利？

And second, for the Phase two celiac study where you were finalizing the design? And could you provide more color on your interactions with the regulatory agencies so far?

其次，對於第二階段乳糜瀉研究，您最終確定了設計？您能否提供更多有關迄今為止您與監管機構互動的資訊？

Thank you for the question to the first question, I think the the nature of futility analysis that you just want to get a proceed as planned. Audited from the committee, however, ended the bid model reason given that we have a event-driven endpoint, we would allow a reasonable sample size adjustment. That's all we can get. Maybe all we were down was implemented the further development on. So it's a more binary thing, honestly there. So we don't expect any surprises given based on the Phase two data we obtained from the emphasis studies in relapsing MS. We are very confident that this trial will also deliver comparable results. And I think all the calculations and assumptions are based on the Phase two emphasis data.

感謝您對第一個問題的提問，我認為無效分析的本質是您只想按計劃進行。然而，根據委員會的審計，鑑於我們有一個事件驅動的端點，結束了投標模型的原因，我們將允許合理的樣本量調整。這就是我們所能得到的一切。也許我們所關心的只是進一步的開發。所以說實話，這是一個更二元的事情。因此，根據我們從復發性多發性硬化症重點研究中獲得的第二階段數據，我們預計不會有任何意外。我們非常有信心這次試驗也會有可比較的結果。我認為所有的計算和假設都是基於第二階段重點資料。

And the second question, maybe you can repeat, I was under the regulatory interactions for pivot here at 50 billion expense work in progress right now. And also we are still working on the R&D on the project and the clinical Phase two study design. There are a couple of thoughts which are running through. So as soon as there's something to report on, we will disclose that.

第二個問題，也許你可以重複一遍，我正在接受監管互動，以 500 億美元的費用進行樞軸工作。我們也正在進行此計畫的研發和臨床二期研究設計。有幾個想法正在醞釀。因此，一旦有需要報告的事情，我們就會揭露。

Alright thank you so much.

好的，非常感謝。

Thank you.

謝謝。

Thank you.

謝謝。

William Wood, B. Riley.

威廉·伍德，B.萊利。

Yes, can you hear me?

是的，你聽得到我說話嗎？

Yes, hello.

是的你好。

Thanks very much and congratulations on the quarter and then you bring our questions on just thinking about your Phase three ensure When should we expect to see the baseline characteristics for that trial. And I'd just leave it there.

非常感謝並祝賀這個季度，然後您提出了我們的問題，只是考慮您的第三階段確保我們何時應該看到該試驗的基線特徵。我就把它留在那裡。

Good question, and I don't know exactly when we can disclose that and even we can get that because it's a Phase three study, I think likely we need to wait for the integrity of the study reasons until we unblind the study and '26. So that's the most likely case there because quality first, and you don't want to end up in difficult discussions with regulators and just because we want to know too early to kind of think. But I think we will we will be we'll have an eye on this and maybe, you know, more in the future if there is a way to get this information earlier.

好問題，我不知道我們什麼時候可以透露這一點，即使我們可以得到這一點，因為這是一項第三階段的研究，我認為我們可能需要等待研究原因的完整性，直到我們揭開研究的盲點並「26」 。所以這是最有可能的情況，因為品質第一，你不想最終與監管機構進行艱難的討論，只是因為我們想知道得太早而無法思考。但我認為我們會關注這一點，如果有辦法更早地獲取這些信息，也許將來會關注更多。

And actually I do have a two more on you also have two presentations at Accurin forms coming up next week. Should we should we be expecting any additional data on your on your emphasis interim results on which have already been presented? And how should we view sort of the blocking of that EBV reactivation as being an important strategy in improving patient symptomology overall and what that could mean for your Phase two study in PMS. and I have one more.

事實上，我確實還有另外兩場關於您的演講，下週我們還將在 Accurin 表格上進行兩場演講。我們是否應該期待您已經提交的中期結果的任何額外數據？我們應該如何看待阻止 EBV 重新活化作為改善患者整體症狀的重要策略，以及這對 PMS 的第二期研究意味著什麼。我還有一個。

Yes, I think the second one is we did a talking point from one of those parts of the EBV reactivation. This is something we will go to the client the last couple of months regarding that because we were so excited about this one but should that be a fruitless?

是的，我認為第二個問題是我們從 EBV 重新激活的其中一個部分做了一個談話要點。這是我們將在過去幾個月向客戶提出的問題，因為我們對此感到非常興奮，但這應該是徒勞無功的嗎？

Calcium is a blocker of the reactivation of EBV, and I think it's still not fully understood how that could have a positive impact.

鈣是 EBV 重新活化的阻斷劑，我認為目前尚未完全了解它如何產生積極影響。

And on our disability, for example, prevention of disability and how those fall indication disease progression is influenced by reactivation of EBV and patients. There are a lot of hints for is there's a lot of work done by really great scientists here and around the world, but also here on collaborators of ourselves. So I think that's an interesting scientific flashlight on on the third aspect of activity of video fitness consumer, the one poster and the second one is more dedicated to the caliber and the trial design and NFL.

例如，關於我們的殘疾，殘疾的預防以及 EB 病毒和患者的重新激活如何影響這些跌倒跡象的疾病進展。有很多跡象表明，這裡和世界各地真正偉大的科學家已經完成了很多工作，但也有我們自己的合作者完成的工作。所以我認為這是關於視頻健身消費者活動的第三個方面的有趣的科學手電筒，一張海報和第二張海報更致力於口徑和試驗設計以及 NFL。

And but no, no, really new data, but it's important to put that into context. We figured out that the market is maybe not fully up to speed on the link between NFL. and future disability progression. And we therefore think we want to come into this casual with doctors on this in more specifically and also talk about no one activation and the way this has the neuroprotective potential because this could really change the way we treat the disease and could be a major major impact for the whole MS market. And if the data reads out in a positive way next April.

但不，不，確實是新數據，但重要的是要把它放在上下文中。我們發現市場可能還沒有完全了解 NFL 之間的聯繫。以及未來的殘疾進展。因此，我們認為我們希望與醫生就這一問題進行更具體的討論，並討論無人激活以及它具有神經保護潛力的方式，因為這可能真正改變我們治療疾病的方式，並且可能成為一個重大的重大事件對整個微軟市場的影響。如果明年四月數據顯示正面的話。

And thank you for correcting me. There definitely is Calibre in term of results. And then lastly, just if I may, could you discuss how or possibly what the current learnings for FluMist County and the differentiated MOA position it in relation to and other anti-CD20 are actually just anti-CD20 antibodies and and even emerging excitement sort of in regards to the CD19 CAR T space, I think the biggest difference is that no one is not targeting focal classical inflammation signals, which are different from basically all of the other approaches.

謝謝你糾正我。就結果而言，肯定有口徑。最後，如果可以的話，您能否討論一下 FluMist 縣當前的知識和差異化 MOA 與其他抗 CD20 的關係如何或可能是什麼，實際上只是抗 CD20 抗體，甚至是新興的令人興奮的東西關於CD19 CAR T空間，我認為最大的區別是沒有人不針對局部經典發炎訊號，這與基本上所有其他方法不同。

And that makes us unique in a way that it may be. And we will see that in the Anatel data. But we may see also this in clinical outcomes starting with a candidate for study that would be different and the calcium can have a beneficial effect in patients which are not benefiting or not enough benefiting from immunosuppressive therapies like until 2019 or whatever you used there because it is just something different and AutoCAD or mode of action to the good thing about 40 minutes to step on the other hand, we also inhibit DHODH, which also and on top of this potential neuroprotective effect also is anti-inflammatory so that we if you focus on the key unmet medical need, which is really preventing and slowing down disability worsening in MS patients of our kind and that we target both eight mode. We know it's related endovenous, independent worsening of progression and the patients and that would be, I think the best differentiated you can have and also the best news for patients suffering from some of these indications like primary progressive secondary progressive MS, specifically.

這讓我們在某種程度上變得獨一無二。我們將在 Anatel 數據中看到這一點。但我們也可能在臨床結果中看到這一點，從一個不同的研究候選者開始，鈣可以對那些沒有從免疫抑制療法中受益或受益不足的患者產生有益的影響，例如直到2019 年或你在那裡使用的任何療法，因為它只是與AutoCAD 或作用方式不同，大約40 分鐘即可，另一方面，我們還抑制DHODH，除了這種潛在的神經保護作用之外，它還具有抗炎作用，因此如果您關注的話，我們會抑制DHODH。我們知道它與靜脈內、獨立的進展惡化和患者有關，我認為這將是最好的區分，對於患有某些適應症（例如原發性進展性繼發性進展性多發性硬化症）的患者來說也是最好的消息。

Very helpful, and thanks for taking my questions and congratulations again.

非常有幫助，感謝您再次提出我的問題並表示祝賀。

Thank you.

謝謝。

And thank you, William.

謝謝你，威廉。

I actually have another question here on the new one at target in the Q&A tool, in case of no one activation confirmation, do you see further benefits of feeder flooring was in the future or other neuromuscular disorders such as Parkinson's disease or even Alzheimer's and simple answer?

實際上，我還有另一個問題，關於問答工具中的新目標，如果沒有人激活確認，您是否認為饋線地板的進一步好處是未來或其他神經肌肉疾病，如帕金森病，甚至阿茲海默病和簡單的疾病回答？

Yeah. So very clear. This is something it was a breakthrough finding when we went and we together with our collaborators at University, giving unique around Daniel Merrick and how is that either should have most calcium is such a good activator of new ones. And most of the historic research on on used after the use of the one, it has been performed in the area of Parkinson's disease. So this was the original main focus of researchers in the world.

是的。非常清楚。這是一個突破性的發現，當我們和我們在大學的合作者一起去時，我們在丹尼爾·梅里克周圍提供了獨特的東西，以及為什麼其中任何一個應該含有最多的鈣，卻是新鈣的良好激活劑。大多數歷史研究都是在帕金森氏症領域進行的。所以這是世界上研究人員最初的主要關注點。

And I think still the ones still is on the top of the list of hope or potential targets for Parkinson's disease. Therefore, these programs, of course, on our on the meter floating was to be tested there. But we have mobilized since we have a bunch of derivatives. We have nine molecules that have different properties, maybe finding molecules for different, for example, CNS penetration and so forth.

我認為這些仍然是帕金森氏症的希望或潛在目標的首要目標。因此，這些方案當然要在我們的浮計上進行測試。但自從我們擁有大量衍生性商品以來，我們已經動員起來。我們有九種具有不同特性的分子，也許會找到不同特性的分子，例如中樞神經系統滲透等。

So there may be the potential to start other independent developments with our molecules in such indications with very specific target profiles. So we see a huge potential there. But once again, currently, the focus is delivering the formats and therefore, we will not use a huge amount of our budget for Ford used highly innovative new things. And but we are also considering collaborations there as well to boost things in parallel to our turning to MS activities.

因此，我們的分子可能有可能在具有非常特定目標特徵的適應症中開始其他獨立開發。所以我們看到了那裡巨大的潛力。但目前，重點還是交付格式，因此，我們不會為福特使用高度創新的新事物投入大量預算。但我們也在考慮在那裡合作，以在我們轉向 MS 活動的同時推動事情的發展。

I have another question in writing. Are there any plans for the video signals you'll see program given the stronger maintenance phase data?

我還有另一個書面問題。鑑於維護階段數據更強，您將看到的視訊訊號是否有任何計劃？

Yeah, some money for sure and our again. So I would love to continue with the Phase three directly net indications once again. And that was the reason why we kicked off a new program called climate-related one firm. We have of molecules which are maybe from their tissue sufficient profile, better suited for 4G penetration and by using our mode of action and our proof of concept data and from the year from Macondo studies. So yes, in principle, yes, but once again, something we would likely more likely separate in addition development track.

是的，肯定會有一些錢，我們再來一次。因此，我很樂意再次繼續第三階段的直接網路指示。這就是我們啟動一項名為「氣候相關公司」的新計畫的原因。我們擁有的分子可能來自其組織足夠的輪廓，更適合 4G 滲透，並透過使用我們的作用模式和我們的概念驗證數據以及來自馬孔多研究的一年。所以，是的，原則上是的，但再一次，我們更有可能將其與另外的開發軌道分開。

Final question. I currently have maybe a good chance for you to summarize the status quo and upcoming milestones for middle.

最後一個問題。我現在也許有一個很好的機會讓你總結一下中級的現狀和即將到來的里程碑。

What are the updates regarding annual plastics, annual hedge rate I'm sorry, were at a more at a summary of what we spoke about. I think we were intrigued by the data of last year, specifically in the time giving us a very nice signal on and on. We are increasing the likelihood of success for the clinical outcomes of the clinical study.

關於年度塑膠、年度對沖利率的最新情況是什麼，我很抱歉，更多的是我們所討論內容的總結。我認為我們對去年的數據很感興趣，特別是當時的數據不斷向我們發出非常好的訊號。我們正在增加臨床研究的臨床結果成功的可能性。

And it was agreed in April 25 days wouldn't make that drive huge commercial opportunity. I think this is the very huge potential for how the initial discussion that's that they're expecting new driving force here right now in parallel, we have that rock solid insured program in relapsing MS ongoing, which is more or less just based on our very good Phase two data for that molecule we obtained from the emphasis study, which allows us as low risk way forward and towards approval and data readout in 2026. So these are the key driving forces for the beautiful MS program.

4 月 25 日人們一致認為，這不會帶來巨大的商業機會。我認為這是非常巨大的潛力，因為最初的討論是他們現在期待新的驅動力，我們在復發性多發性硬化症方面擁有堅如磐石的保險計劃，這或多或少只是基於我們的非常我們從重點研究中獲得了該分子的良好第二階段數據，這使我們能夠以低風險的方式前進，並在2026 年獲得批准和數據讀出。因此，這些是美麗的 MS 項目的關鍵驅動力。

But to reiterate, I don't want to talk too long here, but to leave it at reiterate, we also had a positive readout on our on the IT on the GSE side, you have the maintenance data, which is more or less boosting the other molecule developments in that space and also the number one potential beyond just multiple sclerosis and other related neurological indications also something where we think this has another huge potential. And we will we will definitely also look into these things.

但重申一下，我不想在這裡講太長的時間，但要重申一下，我們在 GSE 方面的 IT 方面也有積極的讀數，你有維護數據，這或多或少地推動了該領域其他分子的發展，以及除了多發性硬化症和其他相關神經系統適應症之外的第一大潛力，我們認為這還有另一個巨大的潛力。我們一定也會研究這些事情。

And with that, this concludes our question and answer session today. I would like to turn the conference back over to Daniel for any closing remarks.

我們今天的問答環節到此結束。我想將會議轉交給丹尼爾發表閉幕詞。

Thanks, Jessica, and thank you to today's attendees for your insightful questions. To summarize with a positive interim data from our Phase two clinical trial as well as the continuation of enrollment of our Phase three issuer trials. We continue to make tangible progress on the clinical development of video truly multi-option as progress is made. We also expect to provide an update on our preparations for the Phase two clinical development of our new age plastics with our funds at the end of the fourth quarter and the recent closing of the first tranche of our three tranche private placement. We remain well funded, providing us runway through multiple clinical milestones into the third quarter of 2025.

謝謝傑西卡，也感謝今天的與會者提出富有洞察力的問題。總結我們的第二階段臨床試驗的積極中期數據以及我們第三階段發行人試驗的繼續招募。隨著進展，我們繼續在影片真正多選項的臨床開發方面取得實際進展。我們還預計在第四季度末提供新時代塑料第二階段臨床開發準備工作的最新信息，以及最近完成的三期私募第一期的最新情況。我們的資金仍然充足，為我們在 2025 年第三季實現多個臨床里程碑提供了道路。

With that, I would like to close today's call. Thank you very much for joining, and we are very happy to answer any additional questions one-on-one.

我想結束今天的電話會議。非常感謝您的加入，我們非常樂意一對一回答任何其他問題。

Thank you, Daniel, and thank you for joining Intuit Fourth Quarter and Year End 2023 earnings call, and the call has now concluded. You may now disconnect.

謝謝 Daniel，也謝謝您參加 Intuit 2023 年第四季和年終財報電話會議，電話會議現已結束。您現在可以斷開連線。