Altimmune Inc (ALT) 2025 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Altimmune year-end 2025 financial results conference call. (Operator Instructions). As a reminder, this call is being recorded.

各位女士、先生，早安，歡迎參加 Altimmune 2025 年度年終財務業績電話會議。（接線員指示）。提醒各位，本次電話會議將被錄音。

I'll now introduce your host for today's conference call, Lee Roth, President of Burns McClellan, Investor Relations Adviser to Altimmune. Lee, you may begin.

現在我來介紹今天電話會議的主持人：Burns McClellan 總裁、Altimmune 投資人關係顧問 Lee Roth。Lee，您可以開始了。

Thanks, Gigi, and good morning, everyone. Thank you for joining us for Altimmune's Fourth Quarter 2020 Financial Results and Business Update Conference Call. On today's call, you'll hear from Jerry Durso, our Chief Executive Officer; Dr. Christophe Arbet-Engels, Chief Medical Officer; Linda Richardson, Chief Commercial Officer; and Greg Weaver, Chief Financial Officer.

謝謝你，Gigi，各位早安。感謝各位參加 Altimmune 2020 年第四季財務業績與業務更新電話會議。今天的電話會議中，您將聽到我們的執行長 Jerry Durso；首席醫務長 Christophe Arbet-Engels 醫師；首席商務長 Linda Richardson；以及財務長 Greg Weaver 的發言。

Following management's prepared remarks, we'll open the line for the Q&A session. Our fourth quarter and full year 2025, earnings release was issued this morning and can be found on the Investor Relations section of the Altimmune website.

管理團隊的準備發言結束後，我們將開放問答環節。我們 2025 年第四季及全年財報新聞稿已於今早發布，可於 Altimmune 官網的投資人關係專區查閱。

Before we begin, I'd like to remind everyone that remarks made about future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

在開始之前，我想提醒各位，關於未來預期、計畫與前景的評論，依據 1995 年《私人證券訴訟改革法》之安全港條款，構成前瞻性陳述。

Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated. For a review of the risk factors that could affect the company's future results and operations, we refer you to our filings with the SEC.

Altimmune 提醒各位，這些前瞻性陳述受風險與不確定性影響，可能導致實際結果與所述內容存在重大差異。關於可能影響公司未來業績與營運的風險因素之說明，請參閱我們向美國證券交易委員會（SEC）提交的文件。

I'd also direct you to read the forward-looking statements disclaimer in our press release issued this morning, which is now available on our website. Any statements made on this call speak only as of today's date, March 5, 2026, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date.

我也請各位閱讀我們今早發布之新聞稿中的前瞻性陳述免責聲明，該新聞稿現已於我們網站提供。本次電話會議中的任何陳述僅截至今日（2026 年 3 月 5 日）為準，公司不承擔任何義務更新任何前瞻性陳述，以反映今日或今日之後發生的事件或情況。

As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website. With that, it's now my pleasure to turn the call over to Mr. Jerry Durso, President and CEO of Altimmune. Jerry?

再次提醒，本次電話會議將被錄音，並將於 Altimmune 官網提供音訊重播。接下來，我很榮幸把電話交給 Altimmune 總裁兼執行長 Jerry Durso 先生。Jerry？

Good morning, everyone, and thank you for joining us today for our fourth quarter financial results and corporate update. This is my first earnings call since joining Altimmune as CEO in January. I'd like to start with some comments to reinforce why I'm excited about the opportunities ahead of us with pemvidutide.

各位早安，感謝各位今天參加我們的第四季財務業績與公司最新進展說明。這是我在 1 月加入 Altimmune 擔任執行長以來的第一次法說電話會議。我想先談幾點，強調為何我對 pemvidutide 未來的機會感到振奮。

Altimmune's exclusively focused on liver disease, an area where I've spent a good part of my career. Despite a number of therapeutic breakthroughs in the past several years, there remains significant unmet need and treatment gaps among patients living with serious liver diseases like MASH.

Altimmune 專注於肝臟疾病領域，而這也是我職涯投入相當多時間的領域。儘管過去幾年已有多項治療突破，但對於罹患 MASH 等嚴重肝病的患者而言，仍存在顯著未被滿足的需求與治療缺口。

We believe that pemvidutide has the potential to bring meaningful benefit to people affected by a variety of hepatic diseases. The balance one-to-one agonism of glucagon and GLP-1 in a single molecule achieved with pemvi makes it potentially well suited for the conditions we're targeting.

我們相信，pemvidutide 有潛力為受多種肝臟疾病影響的人帶來具意義的效益。pemvi 在單一分子中實現胰高血糖素（glucagon）與 GLP-1 的 1:1 平衡致效作用，使其可能非常適合我們鎖定的適應症。

Glucagon's direct effect on the liver can drive reductions in liver fat inflammation and fibrotic activity, while GLP-1 can mediate weight loss and appetite suppression and may contribute to anti-inflammatory effects.

胰高血糖素對肝臟的直接作用可促進肝脂肪、發炎與纖維化活性下降；而 GLP-1 可介導體重下降與食慾抑制，並可能有助於抗發炎效果。

Additionally, pemvi incorporates our proprietary U-port structure, which slows absorption and is believed to drive improved tolerability, potentially reducing GI and other side effects, which can lead to greater treatment adherence.

此外，pemvi 採用我們專有的 U-port 結構，可減緩吸收，並被認為可提升耐受性，可能降低腸胃道（GI）及其他副作用，進而提高治療依從性。

Importantly, keeping patients on therapy at the right dose is crucial to the management of chronic diseases such as MASH. The data we've generated to date across multiple preclinical and clinical trials, including our Phase IIb MASH study reinforce our belief in the strong therapeutic potential of pemvidutide as well as its ability to stand out among competing therapeutic options, if approved in MASH.

重要的是，讓患者以適當劑量持續接受治療，對於如 MASH 這類慢性疾病的管理至關重要。迄今我們在多項臨床前與臨床試驗（包括第二期 b MASH 研究）所產生的數據，強化了我們對 pemvidutide 強大治療潛力的信心，以及其在 MASH 適應症若獲核准後，有能力在競爭療法中脫穎而出。

As we evolve the pemvi plan, we're focused not only on advancing into Phase 3 but also ensuring that the potentially unique benefits of pemvi for patients, payers and physicians are addressed in our program with a keen eye to competitive advantages in pemvidutide's targeted product profile.

在我們逐步完善 pemvi 的計畫時，我們不僅專注於推進至第三期，也確保 pemvi 對患者、支付方與醫師可能具備的獨特效益，能在我們的研發計畫中被充分體現；同時，我們也將敏銳聚焦於 pemvidutide 目標產品特性（targeted product profile）中的競爭優勢。

Based on our ongoing discussions with hepatology KOLs and other practitioners, it's clear that clinical practice in MASH is evolving and will continue to evolve as new therapies become available. The prevailing sentiment is that no single therapy will be able to effectively address the needs of all patients.

根據我們與肝病學關鍵意見領袖（KOL）及其他臨床醫師的持續討論，MASH 的臨床實務顯然正在演變，且隨著新療法問世將持續演變。主流觀點是，沒有任何單一療法能有效滿足所有患者的需求。

This is already being acknowledged by the industry as a number of companies are pursuing combination strategies to meet the needs of broader segments of the patient population.

業界已開始認同這一點，因為多家公司正採取聯合治療策略，以滿足更廣泛患者族群的需求。

With pemvi's dual mechanism, we have a combination therapy in a single molecule with the potential to address both the hepatic and metabolic drivers of disease at once, which could differentiate pemvidutide from these multidrug approaches that aim to achieve the same benefits we're providing with a single compound.

憑藉 pemvi 的雙重機制，我們在單一分子中提供了「組合療法」，有潛力同時處理疾病的肝臟與代謝驅動因素；這可能使 pemvidutide 有別於那些以多藥併用方式、試圖達成與我們單一化合物相同效益的策略。

In our Phase 2 MASH study, pemvi showed strong and early MASH resolution at just 24 weeks and clear antifibrotic activity at 48 weeks. The key measures were consistently moving in the right direction with important noninvasive markers of fibrosis and inflammation improving as therapy progressed in the trial.

在我們的第二期 MASH 研究中，pemvi 在僅 24 週時即展現強勁且早期的 MASH 緩解（resolution），並在 48 週時呈現明確的抗纖維化活性。隨著試驗治療推進，關鍵指標持續朝正向發展，多項重要的非侵入性纖維化與發炎標記亦有所改善。

In addition to efficacy, patients need a therapeutic regimen that they can adhere to in order to realize the full benefit of treatment.

除了療效之外，患者還需要一套他們能夠遵循的治療方案，才能充分實現治療的全部效益。

As we've shared the favorable tolerability leading to low discontinuations due to adverse events that we saw in our Phase 2 MASH trial can be a key differentiator that pemvi may deliver. Likewise, for patients and physicians, the simple dosing aspect of pemvidutide could play an important role.

如我們先前分享的，在第二期 MASH 試驗中，我們觀察到良好的耐受性，且因不良事件而停藥的比例偏低；這可能是 pemvi 能帶來的關鍵差異化因素。同樣地，對患者與醫師而言，pemvidutide 的簡化給藥方式也可能扮演重要角色。

The one- or two-step titration scheme will be incorporating into the pemvidutide Phase 3 trial could prove to be key when compared to the much more complex dosing of other injectable compounds.

將納入 pemvidutide 第三期試驗的一步或兩步劑量遞增（titration）方案，與其他注射型化合物更為複雜的給藥方式相比，可能成為關鍵優勢。

The potential of pemvi was recently recognized with FDA Breakthrough Therapy designation and MASH. Breakthrough is granted to medicines that are intended to treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on a clinically significant endpoint.

pemvi 的潛力近期已獲 FDA 認可，並在 MASH 適應症上授予「突破性療法」（Breakthrough Therapy）資格。突破性療法資格授予用於治療嚴重或危及生命疾病、且初步臨床證據顯示其在具臨床意義的終點上，相較現有療法可能帶來顯著改善的藥物。

We look forward to proving this out in our opening Phase 3 trial. I hope this gives you some additional perspective into why we're so encouraged about the future of pemvidutide and excited for what's to come.

我們期待在即將啟動的第三期試驗中加以驗證。希望以上能讓各位更了解，為何我們對 pemvidutide 的未來如此受到鼓舞，並對接下來的進展充滿期待。

Now as to how we're preparing to deliver on this potential, one of my top priorities since becoming CEO is strengthening Altimmune's foundation to equip us for the continued successful advancement of pemvi and support our strength as a late-stage development company.

至於我們如何為實現這項潛力做準備，自我擔任執行長以來的首要任務之一，就是強化 Altimmune 的基礎，以使我們具備持續成功推進 pemvi 的能力，並支撐我們作為後期研發公司（late-stage development company）的實力。

I'm pleased to report that over the last several months, we've enhanced our team with the addition of new leaders to bring expertise in liver disease, late-stage clinical development, commercial strategy and other key areas.

我很高興報告，在過去幾個月中，我們透過延攬新領導人才強化了團隊，帶來肝臟疾病、後期臨床開發、商業策略及其他關鍵領域的專業能力。

We'll continue to build on to the strong Altimmune team strategically to make sure we're able to deliver. We've also remained focused on strengthening our financial position. The $75 million capital raise completed in January was an important step in our ongoing efforts to prepare for the planned initiation of our Phase 3 this year. We remain committed to securing access to the capital required to successfully drive our clinical programs and create long-term value.

我們將持續在策略上進一步打造強大的 Altimmune 團隊，以確保我們具備交付成果的能力。我們也持續專注於強化我們的財務狀況。1 月完成的 7,500 萬美元募資，是我們為今年計畫啟動第 3 期試驗所做持續準備工作中的重要一步。我們仍致力於確保取得成功推進臨床計畫並創造長期價值所需的資金。

At the end of Phase 2 meeting with the FDA, which was held in the fourth quarter based on 24-week data from our Phase 2 MASH study, we received valuable guidance on the Phase 3 trial and we made excellent progress on the in-depth planning of a major global mass trial like this.

在與 FDA 舉行的第 2 期結束會議（End of Phase 2 meeting）中，該會議於第四季召開，並以我們第 2 期 MASH 研究的 24 週數據為基礎；我們獲得了關於第 3 期試驗的寶貴指導，並在此類大型全球 MASH 試驗的深入規劃上取得了極佳進展。

We are clear on the overall design elements and the endpoints, and we're now in the process of making the final detailed decisions on the protocol and the full operational plan. Christophe will share more on the trial with you this morning.

我們已明確整體設計要素與終點指標，目前正進行方案（protocol）與完整營運計畫的最終細節決策。Christophe 今天上午會與各位分享更多關於該試驗的內容。

While we have significant focus on our MASH program, we're also executing well on our other Phase 2 trials. As a reminder, last fall, we completed enrollment of the Phase 2 AUD trial ahead of schedule, and we're now on track to report top line data from this study in the third quarter of this year.

在我們高度聚焦於 MASH 計畫的同時，我們也在其他第 2 期試驗上執行良好。提醒各位，去年秋天我們提前完成第 2 期 AUD 試驗的受試者招募，目前仍按計畫於今年第三季公布該研究的主要（top line）數據。

We're also expecting the complete enrollment of our Phase 2 trial assessing pemvi and ALD in 2026. Pemvidutide represents a unique and compelling opportunity to improve the lives of people with MASH and other liver conditions.

我們也預期將於 2026 年完成評估 pemvi 與 ALD 的第 2 期試驗之全部受試者招募。Pemvidutide 代表一個獨特且具吸引力的機會，可改善 MASH 與其他肝臟疾病患者的生活。

It has the potential to become an important tool for physicians as they look to improve upon the current treatment paradigm. This is a very exciting time for the team at Altimmune.

它有潛力成為醫師在改善現行治療模式時的重要工具。對 Altimmune 團隊而言，這是一個非常令人振奮的時刻。

We're moving quickly with intent and focus on bringing pemvidutide to patients and creating long-term value for our shareholders with that, I'll now turn the call over to Christophe for a clinical update.

我們正以明確意圖與專注快速推進，將 pemvidutide 帶給患者，並為股東創造長期價值；接下來我把電話會議交給 Christophe，請他提供臨床更新。

Thank you, Jerry. As we shared on our conference call in December, the 48-week data from the IMPACT trials of pemvidutide and MASH which evaluated the 1.2 and 1.8 milligram doses was very encouraging.

謝謝你，Jerry。如同我們在 12 月的電話會議中分享的，針對 pemvidutide 與 MASH 的 IMPACT 試驗之 48 週數據（評估 1.2 與 1.8 毫克劑量）非常令人鼓舞。

The 48-week data set, including key noninvasive markers of liver inflammation and fibrosis weight class and tolerability and showed strong evidence of anti-fibrotic effect at week 48 following the early MASH resolution shown already at week 24.

這份 48 週數據集涵蓋關鍵的非侵入性肝臟發炎與纖維化指標、體重分級與耐受性，並在第 24 週已顯示早期 MASH 緩解的基礎上，於第 48 週呈現強而有力的抗纖維化效果證據。

The 48-week data established a clear dose response that supports our plan to focus on the 1.8 milligram dose in the Phase 3 trial, while also evaluating the 2.4 milligram dose which could provide additional benefits on both weight loss and most importantly, liver efficacy.

48 週數據建立了明確的劑量反應關係，支持我們在第 3 期試驗中聚焦 1.8 毫克劑量的計畫，同時也評估 2.4 毫克劑量；後者可能在減重以及更重要的肝臟療效方面帶來額外益處。

We saw substantial improvement both from baseline and from week 24 to week 48 in health liver stiffness with the results achieved at the 1.8 million dose being particularly clinically relevant and comparable to or greater than that observed with the approved MASH product.

我們觀察到肝臟硬度（liver stiffness）從基線以及從第 24 週到第 48 週皆有顯著改善，其中 1.8 毫克劑量所達成的結果在臨床上尤其具有意義，且與已核准的 MASH 產品相比相當或更佳。

These measures are clear indicators of antifibrotic activity, and we believe that they will translate into measurable histologic improvement, the 52-week time point in Phase 3, which, along with MASH resolution, will be the basis for a potential accelerated approval.

這些量測是抗纖維化活性的明確指標，我們相信它們將在第 3 期的 52 週時間點轉化為可量測的組織學改善；該時間點將與 MASH 緩解一起，作為潛在加速核准（accelerated approval）的基礎。

In addition to the strong benefit in health and vetiveness results, treatment with pemvidutide demonstrated statistically significant improvement in liver content, liver health as measured by ALT and CET1 imaging with particularly impressive results observed in the 1.8 milligram treatment arm.

除了在肝臟硬度結果上展現強勁效益外，pemvidutide 治療亦在肝脂含量、以 ALT 衡量的肝臟健康，以及 CET1 影像評估方面呈現具統計顯著性的改善，其中 1.8 毫克治療組的結果尤其亮眼。

While these net tells the story of pemvidutide's robust direct beneficial effect on the liver, the 48-week data also provided evidence of the ability to address metabolic drivers of mass with patients receiving 1.8 milligram pemvi, achieving 7.5% weight loss at 48 weeks with no plateauing.

雖然這些結果已說明 pemvidutide 對肝臟具有強健且直接的有益作用，但 48 週數據也提供了其可處理 MASH 代謝驅動因子的證據：接受 1.8 毫克 pemvi 的患者在 48 週達到 7.5% 的體重下降，且未出現平台期。

As noted, the inclusion of a 2.4 milligram dose could result in greater weight loss in the upcoming Phase 3 trial and be an opportunity for additional efficacy on match endpoints for accelerated approval. As Jerry pointed out, alert treatment in this chronic disease is currently a substantial challenge.

如前所述，在即將進行的第 3 期試驗中納入 2.4 毫克劑量，可能帶來更大的減重幅度，並有機會在用於加速核准的 MASH 終點上提供額外療效。正如 Jerry 指出的，在這種慢性疾病中，警覺性治療目前仍是一項重大挑戰。

Long-term treatment is key to demonstrating clinical outcomes as well as delivering benefits to patients in the real world.

長期治療是證明臨床結局、並在真實世界中為患者帶來效益的關鍵。

Therefore, safety and tolerability of parent importance in addition to demonstrating efficacy in MASH. I am very pleased to say that the low treatment discontinuation rate in the 48-week Phase 2 study were maintained in patients taking EMV.

因此，除了證明在 MASH 的療效之外，安全性與耐受性也至關重要。我非常高興地表示，在 48 週第 2 期研究中，服用 EMV 的患者仍維持了較低的治療中止率。

We attribute these key benefits to the favorable safety and tolerability profile of pemvi with limited GI adverse events despite the absence of titration. The timing of the GI-related adverse events in the IMPACT trial which were predominantly occurring in the first or two months of treatment helped inform our plan to introduce a simple one or two step titration depending on the dose in the Phase 3 program. We expect this to further improve the tolerability profile of what we observed in Phase 2 study.

我們將這些關鍵優勢歸因於 pemvi 良好的安全性與耐受性特徵，即使未進行劑量遞增（titration），胃腸道（GI）不良事件仍相對有限。IMPACT 試驗中與 GI 相關的不良事件多發生於治療的前一到兩個月，這有助於我們制定在第 3 期計畫中，依劑量採用簡單的一或兩步遞增方案。我們預期這將進一步改善相較於第 2 期研究所觀察到的耐受性表現。

On the regulatory side, the minutes from our end of Phase 2 meeting with the FDA which we received in January confirmed our takeaways from the meeting. We are aligned with the agency, all key aspects of the design for the pivotal Phase 3 study, which will assess pemvidutide patients with moderate to advanced fibrosis. Participants in the pemvi arms will start at 1.2 milligram and follow a one- or two-step monthly titration to either 1.8 or 2.4 milligram dose.

在法規面，我們於 1 月收到與 FDA 之第 2 期結束會議紀要，確認了我們從會議中得到的重點結論。我們與主管機關在關鍵設計面向上已達成一致：關於關鍵性（pivotal）第 3 期研究的設計，該研究將評估 pemvidutide 用於中度至重度纖維化患者。pemvi 組的受試者將以 1.2 毫克起始，並按月進行一或兩步遞增至 1.8 或 2.4 毫克劑量。

The trial's primary population will enroll 990 patients with biopsy-confirmed F2 or F3 MASH, evenly split between placebo emitted 1.8 milligram and MVG 2.4 milligram and major improvement in either of two primary endpoints, match resolution of fibrosis improvement at 52 weeks with AMS assessed used to add the histologic assessment.

本試驗的主要族群將招募 990 名經活檢確認為 F2 或 F3 的 MASH 患者，並平均分配至安慰劑、emitted 1.8 毫克與 MVG 2.4 毫克；兩個主要終點之一達到顯著改善：在 52 週時達成 MASH 緩解或纖維化改善，並以 AMS 評估用於補充組織學評估。

The 52-week endpoint is designed to support potential accelerated approval with 5-year clinical outcomes data on the liver-related events needed for an eventual final approval.

52 週終點的設計旨在支持潛在加速核准；而最終核准則需要 5 年的臨床結局數據，涵蓋與肝臟相關事件。

A second cohort following the same dosing and titration parameter will enroll approximately 800 patients with NET assessed F2 and F3 MASH and measure changes in these noninvasive tests over the same treatment period. This population will support safety and long-term clinical outcome evaluations. In total, we will enroll approximately 1,800 patients in this pivotal study.

第二個隊列將沿用相同的給藥與遞增參數，預計招募約 800 名以 NET 評估為 F2 與 F3 的 MASH 患者，並在相同治療期間量測這些非侵入性檢測指標的變化。此族群將支持安全性與長期臨床結局評估。總計而言，我們將在此關鍵性研究中招募約 1,800 名患者。

Other key endpoints in the program will include safety, weight loss and additional potential differentiation attributes such as body composition, quality of weight loss and patient reported outcome. This will be a global trial with sites in North and South America, Europe and Asia.

本計畫的其他關鍵終點將包括安全性、減重，以及其他潛在差異化屬性，例如身體組成、減重品質與患者回報結果（patient reported outcome）。這將是一項全球性試驗，設點涵蓋北美、南美、歐洲與亞洲。

In addition to the alignment with the FDA, we have submitted rector scientific advice to both the European Medicines Agency and the MHRA. We have incorporated learnings from previous programs and believe that our Phase 3 design is well positioned for these regulatory agencies.

除與 FDA 的一致性之外，我們也已向歐洲藥品管理局（EMA）與英國藥品與醫療產品管理局（MHRA）提交監管科學諮詢（regulatory scientific advice）申請。我們已納入先前計畫的經驗學習，並相信我們的第 3 期設計已為這些監管機關做好良好定位。

Overall, we've made great strides towards preparing to initiate our Phase 3 trial this year. We are finalizing our protocol and we have aligned with the FDA on the trial design. We have incorporated feedback from key opinion leaders and we look forward to execution of the Phase 3 study.

總體而言，我們在為今年啟動第三期試驗的準備工作方面已取得重大進展。我們正在完成試驗方案（protocol）的定稿，並已就試驗設計與 FDA 達成一致。我們已納入關鍵意見領袖的回饋，並期待推進第三期研究的執行。

We will be providing updates on our progress as appropriate now looking beyond MASH, pemvi has the potential to address major unmet medical needs in both AUD and ALD because of a similar lever physiopathology to MASH in this indication.

我們將在適當時機提供進展更新。展望 MASH 以外的領域，由於在此適應症中與 MASH 具有相似的生理病理學驅動因素，pemvi 也有潛力滿足 AUD 與 ALD 兩大領域的重大未被滿足醫療需求。

And both of those Phase 2 trials are progressing well. First, reclaim our AUD trial completed enrollment in the fourth quarter of 2025 and we look forward to reporting the top line data in Q3 of this year.

而這兩項第二期試驗的進展都很順利。首先，我們的 Reclaim AUD 試驗已於 2025 年第四季完成受試者入組，我們期待在今年第三季公布主要（top-line）數據。

In addition to patients reported measures of alcohol consumption, the trial will also assess an objective biomarker associated with alcohol intake, pemvi's effect on body weight and safety in this population.

除受試者回報的酒精攝取量量測外，該試驗也將評估與酒精攝取相關的客觀生物標記、pemvi 對體重的影響，以及其在此族群中的安全性。

For the restore trial in ALD, which will evaluate avidities effect on liver-related noninvasive tests markets of alcohol consumption and body weight is continuing to enroll, and we expect to complete enrollment later this year. Both trials will further expand the already robust party evidence for pemvidutide in seriously deviated. And with that, I will turn the call to Linda for a commercial perspective on pemvidutide.

至於 ALD 的 Restore 試驗，將評估 avidities 對肝臟相關非侵入性檢測、酒精攝取標記以及體重的影響；目前仍在持續入組，預期將於今年稍晚完成入組。這兩項試驗都將進一步擴充 pemvidutide 在嚴重偏離（seriously deviated）方面既有且強健的整體證據。接下來，我將把電話交給 Linda，請她從商業角度談談 pemvidutide。

Thanks, Christophe, and good morning, everyone. As we move toward Phase 3 initiation, establishing the future commercial competitiveness of pemvidutide in MASH remains a primary focus, both of them design of our trial, as Christophe described, and in identifying and addressing unmet needs in the marketplace.

謝謝你，Christophe，各位早安。隨著我們邁向第三期啟動，建立 pemvidutide 在 MASH 領域未來的商業競爭力仍是首要重點，這包括我們試驗的設計（如 Christophe 所述），以及在市場中辨識並解決未被滿足的需求。

Despite early excitement with the first two classes of approved therapies for MASH, it is clear there is significant room for new therapies to address treating gaps and needs. We recently conducted market research with 75 US health care professionals who treat mesh patients to assess unmet needs in the market and satisfaction levels with current and future therapies. I'll share some key insights now.

儘管對前兩類已核准的 MASH 治療早期充滿期待，但很明顯仍有相當大的空間需要新療法來補足治療缺口與需求。我們近期對 75 位治療 MASH 病患的美國醫療專業人員進行市場調查，以評估市場中的未被滿足需求，以及對現有與未來療法的滿意度。我現在分享幾項關鍵洞見。

First, we learned that physicians are identifying emerging needs in patient subgroups. This includes options for MASH patients who have discontinued semaglutide for either tolerability or efficacy reasons and now need alternatives.

首先，我們了解到醫師正在辨識特定病患亞群的新興需求。其中包括：對於因耐受性或療效因素而停止使用 semaglutide 的 MASH 病患，現在需要替代選項。

Tolerability failure was seen as an area of high or very high unmet need by the majority of the respondents. Half of all physicians surveyed agreed that there is a higher -- very high unmet need for therapies appropriate for MASH patients at risk for loss of muscle mass.

多數受訪者認為「耐受性失敗」是高度或非常高度未被滿足需求的領域。受訪醫師中有一半同意：對於有肌肉量流失風險的 MASH 病患，適用的治療存在較高—非常高的未被滿足需求。

A recent view of the literature shows that nearly one in four patients with [MazeD] is at risk for additional muscle loss for sarcopenia. And this rate is higher in more advanced MASH patients. In addition, health care professionals in our research see several fundamental limitations with currently approved and potential future therapies, setting up a clear need for potential novel options like pemvidutide.

近期文獻回顧顯示，近四分之一的 [MazeD] 病患有額外肌肉流失與肌少症（sarcopenia）的風險。而在更晚期的 MASH 病患中，這個比例更高。此外，我們研究中的醫療專業人員也看到目前已核准與潛在未來療法存在若干根本限制，凸顯對 pemvidutide 這類潛在新穎選項的明確需求。

Many physicians acknowledge that the lack of weight loss with FGF21s and Resmetirom are limitations of these options. And 44% agree that the tolerability profile of GLP-1 and GLP-1-based therapies cause many patients to drop off.

許多醫師認為，FGF21 類與 Resmetirom 缺乏減重效果，是這些選項的限制。且有 44% 的受訪者同意：GLP-1 與以 GLP-1 為基礎的療法之耐受性特徵，會導致許多病患中途停用。

Over one third believe that lengthy titration schemes to improve the tolerability of these drugs create adherence challenges. A similar number agreed that the loss of lean muscle mass is a concern when initiating GLP-1 or GLP-1 gift therapy, echoing the concerns regarding sarcopenic patients I mentioned earlier.

超過三分之一的人認為，為改善這些藥物耐受性而採用的冗長滴定（titration）方案，會造成用藥依從性挑戰。相近比例的受訪者同意：在開始使用 GLP-1 或 GLP-1 gift 治療時，瘦體重（lean muscle mass）流失是一項疑慮，呼應我先前提到對肌少症病患的擔憂。

From our Phase 2 data seen to date, we believe that pemvidutide and a dual mechanism of action may address many of these unmet needs. Our existing clinical program already shows that pemvi has a favorable tolerability profile relative to current and investigational therapies.

根據目前已見的第二期數據，我們相信 pemvidutide 及其雙重作用機制可能可滿足上述多項未被滿足需求。我們既有的臨床計畫已顯示，pemvi 相較於現有與研發中療法具有較佳的耐受性特徵。

This may be highly differentiating and is clearly important in this market where patients must remain on drug therapy to achieve efficacy and weight loss benefits.

這可能具有高度差異化，且在此市場中尤為重要，因為病患必須持續用藥才能達到療效與減重效益。

Furthermore, other MASH therapies have trial designs with long titration schedules using multiple subtherapeutic doses to try to mitigate side effects. As Christophe highlighted, our Phase 3 trial will start with an active 1.2 milligram dose in each arm and have only one or at most two titration steps to possibly further improve our favorable tolerability profile.

此外，其他 MASH 療法的試驗設計常包含較長的滴定時程，使用多個低於治療劑量（subtherapeutic）的劑量以試圖降低副作用。如 Christophe 所強調，我們的第三期試驗將在每個治療組別以 1.2 毫克的有效起始劑量開始，且僅有一步或至多兩步滴定，以期進一步改善我們良好的耐受性特徵。

The inclusion of a 2.4 milligram dose with a two-step titration over only eight weeks should help maintain tolerability and allow us to evaluate potential further increases in efficacy and weight loss.

納入 2.4 毫克劑量，並在僅八週內以兩步滴定完成，應有助於維持耐受性，並讓我們評估療效與減重是否可能進一步提升。

Light loss is an important element of managing MASH, and it's clear that lean muscle preservation is a growing concern among HCPs.

體重減輕是 MASH 管理的重要要素，而很明顯地，瘦肌肉保留正成為醫療專業人員日益關注的議題。

This is an unmet need that we may be able to address as we've seen lean mass preservation in our pemvidutide obesity trial, then we'll be generating additional data on this element and are further studies with pemvi and MASH patients.

這是一項未被滿足需求；我們或許能加以因應，因為在 pemvidutide 的肥胖試驗中我們已觀察到瘦體重保留。接下來我們將針對此要素產出更多數據，並在 pemvi 與 MASH 病患中進行進一步研究。

Now I'll share how physicians reacted to our trended product profile in this market research. We developed our projected product profile based on our current DataCo impact, showing early and significant mass resolution anti-inflammatory and fibrosis effects from kits and included data we anticipate seeing in our Phase 3 program, such as quality weight loss in the 8% to 10% ranges with lean muscle preservation.

接著我將分享在本次市場調查中，醫師對我們趨勢化產品特徵（trended product profile）的反應。我們根據目前的 DataCo 影響建立了預期產品特徵，顯示早期且顯著的 MASH 緩解、抗發炎與抗纖維化效果，並納入我們預期在第三期計畫中看到的數據，例如 8% 至 10% 區間的高品質減重並保留瘦肌肉。

HCP surveyed recognized significant promise in our efficacy, including direct action in the liver with our glucagon agonym, metabolic improvements, straightforward titration, quality weight loss that preserves lean muscle mass and pemvi safety and favorable tolerability.

受訪的醫療專業人員認為我們的療效具有顯著潛力，包括：透過我們的胰高血糖素促效劑（glucagon agonism）在肝臟的直接作用、代謝改善、簡明的滴定方式、可保留瘦肌肉的高品質減重，以及 pemvi 的安全性與良好耐受性。

In fact, in this market research setting, over 70% reported a very high or high likelihood to prescribe pemvi. Physicians projected using pemvi in 43% of their F2 patients and 51% of the three patients. Over 80% of pemvi at both first- and second-line option.

事實上，在此市場調查情境下，超過 70% 的受訪者表示「非常高」或「高」的處方 pemvi 可能性。醫師預估會在其 F2 病患中有 43% 使用 pemvi，在其 F3 病患中有 51% 使用 pemvi。超過 80% 將 pemvi 視為第一線與第二線選項。

Pemvidutide's potential efficacy, safety and tolerability profile may allow for use in patients requiring greater efficacy than a GLP-1 alone or providing quality weight loss not seen to certain other classes of drugs like FGF21s and resmetirom.

Pemvidutide 潛在的療效、安全性與耐受性特徵，可能使其可用於需要比單用 GLP-1 更高療效的病患，或提供某些其他藥物類別（如 FGF21 類與 resmetirom）所未見的高品質減重。

As we add to our understanding of pemvi's clinical performance and data, amplify our storyline regarding our unique combination of attributes, we believe we will be well positioned to enter the MASH marketplace.

隨著我們對 pemvi 臨床表現與數據的理解持續加深，並強化我們關於其獨特屬性組合的敘事，我們相信將能以良好態勢進入 MASH 市場。

We see today and continue to hear from health care professionals certainly signaled strong interest in pemvidutide. It is not enough to be differentiated. You must have meaningful differentiation than pemvi's projected profile provides that. I'll now turn it over to Greg to review our financial results.

我們目前看到、也持續從醫療專業人員那裡聽到，對 pemvidutide 的強烈興趣訊號。僅僅做到差異化還不夠。你必須具備有意義的差異化，而 pemvi 的預期特徵正提供了這一點。接下來我把時間交給 Greg，請他回顧我們的財務結果。

Thank you very much, and good morning. I'll begin with a brief review of our fourth quarter 2025 P&L. R&D expense in the fourth quarter 2025, was $18.4 million compared to $19.8 million in the same period of 2024. Variance in R&D spend related to the end of the Phase 2b trial in late 2025.

非常感謝，各位早安。我先簡要回顧我們 2025 年第四季的損益表（P&L）。2025 年第四季研發費用為 1,840 萬美元，較 2024 年同期的 1,980 萬美元下降。研發支出差異主要與 2025 年底第二期 b 試驗結束有關。

Breaking that down further, the Q4 2025 R&D spending included $12.8 million of direct costs related to pemvidutide development, of which $3.1 million for the IMPACT Phase 2b trial, 7.4 million for the Phase 2 trials in AUD and ALD and $1.2 million in CMC-related expenses.

進一步拆解來看，2025 年第四季的研發（R&D）支出包含與 pemvidutide 開發相關的 1,280 萬美元直接成本，其中包括 IMPACT 第 2b 期試驗的 310 萬美元、AUD 與 ALD 第 2 期試驗的 740 萬美元，以及 120 萬美元的 CMC 相關費用。

Fourth quarter 2025, R&D also included $1.3 million in noncash stock-based comp, which is flat in comparison with the same quarter prior year.

2025 年第四季，研發費用亦包含 130 萬美元的非現金股票基礎薪酬，與前一年同期相比持平。

Moving to G&A. The G&A expenses were $10.5 million and $5.1 million for the quarter's end [1231] '25 and '24 respectively. The Q4 increase in G&A year-over-year was driven by a onetime noncash and cash stock compensation and payroll charge due to executive transition, which totaled $2.6 million along with increases in professional fees and other compensation-related expense.

接著談 G&A。截至 2025 年與 2024 年第四季末（[1231]）的 G&A 費用分別為 1,050 萬美元與 510 萬美元。第四季 G&A 年增主要由於因高階主管交接所產生的一次性非現金與現金股票薪酬及薪資費用，合計 260 萬美元，另加上專業服務費與其他薪酬相關費用的增加。

Fourth quarter 2025, G&A included total noncash stock-based comp of compared to $1.8 million in the prior year period. Net loss for the fourth quarter of 2025, was $27.4 million or $0.27 a share compared to a net loss of $23.2 million or $0.33 a share in the fourth quarter of 2024.

2025 年第四季，G&A 包含的非現金股票基礎薪酬總額，相較於前一年同期的 180 萬美元。2025 年第四季淨損為 2,740 萬美元（每股 0.27 美元），相較於 2024 年第四季淨損 2,320 萬美元（每股 0.33 美元）。

Total full year 2025, cash OpEx was approximately $67.5 million, excluding noncash comp of $16 million. We anticipate the use of cash will trend up this year as we approach the launch of the MASH Phase 3 trial.

2025 全年現金營運費用（cash OpEx）約為 6,750 萬美元，不含 1,600 萬美元的非現金薪酬。我們預期今年隨著接近啟動 MASH 第 3 期試驗，現金使用量將呈上升趨勢。

As Christophe mentioned earlier, we're actively finalizing the last details of the study plan and the other last important details for the Phase 3 when ready, we will update you and come back and provide more guidance on the timing of cash flows and related details.

如 Christophe 先前提到的，我們正積極敲定研究計畫的最後細節，以及第 3 期試驗的其他關鍵細節；待準備就緒後，我們將向各位更新，並就現金流時點及相關細節提供更多指引。

Now moving over to the balance sheet. We reported total cash of $274 million at year-end 2025. We've made a great deal of progress in building the financial position, having recorded net proceeds totaling approximately $208 million last year, in a combination of $174 million in net equity capital raised and $35 million in fund of the Hercules tranche loan facility.

接著看資產負債表。我們在 2025 年底的現金總額為 2.74 億美元。我們在強化財務狀況方面取得重大進展，去年合計錄得約 2.08 億美元的淨募資款項，其中包括 1.74 億美元的淨股權資金募集，以及來自 Hercules 分期貸款融資（tranche loan facility）基金的 3,500 萬美元。

And in addition, we raised $75 million in a registered direct offering announced in January with Alyeska Investment Group. The proceeds from this offering, along with $8 million raised off of our ATM facility in January, equates to a pro forma cash position today of approximately $340 million.

此外，我們在 1 月宣布與 Alyeska Investment Group 進行一項註冊直接發行（registered direct offering），募集 7,500 萬美元。本次發行的募集款項，加上 1 月透過我們的 ATM（at-the-market）機制募集的 800 萬美元，使得我們目前的備考（pro forma）現金部位約為 3.40 億美元。

We forecast that our current cash position would provide an operating cash runway into 2028 based on our current expectations for the scope and timing of the MASH Phase 3 plan along with the cost of both the AUD and ALD Phase 2 trials.

我們預估，依據目前對 MASH 第 3 期計畫的範圍與時程之預期，以及 AUD 與 ALD 兩項第 2 期試驗的成本，我們現有的現金部位可提供營運現金跑道延伸至 2028 年。

Our intent is on having the cash resources necessary to execute the MASH Phase 3 trial. We'll continue to be strategic and opportunistic in our approach to securing access to the forecasted capital needed to fund the Phase 3 and we'll keep you updated on our progress and with that, I'll turn the call back to Jerry.

我們的目標是具備執行 MASH 第 3 期試驗所需的現金資源。我們將持續以策略性且把握時機的方式，確保取得為第 3 期試驗提供資金所需的預估資本，並會向各位更新進展；接下來我把電話交回給 Jerry。

Thanks a lot, Greg. As we highlighted today, we've entered 2026, with a great deal of momentum. We've made significant progress as we evolve into a late clinical stage organization and we're committed to further advancing our promising differentiated liver therapy and creating long-term value for our shareholders. So this concludes our formal remarks, and we'd now like to take questions. Operator?

非常感謝，Greg。如同我們今天強調的，我們帶著強勁動能進入 2026 年。隨著我們發展為後期臨床階段的組織，我們已取得顯著進展，並致力於進一步推進我們具前景且具差異化的肝臟療法，為股東創造長期價值。以上為我們的正式說明，接下來我們願意回答問題。接線員？

(Operator Instructions)

(接線員指示)

Roger Song, Jefferies.

Jefferies 的 Roger Song。

Excellent. Congrats for the update and, thank you for, thank you for taking our questions. So first question related to the Phase 3. We all see the FDA have some new single pivotal framework. Just curious, have you talked with the FDA about that potential change? And then is that possible you can further save the cost from a Phase 3 if FDA allow you to do some amendment for the Phase 3?

很好。恭喜更新，也謝謝、謝謝你們回答我們的問題。第一個問題與第 3 期相關。我們都看到 FDA 有一些新的單一關鍵性試驗（single pivotal）框架。想請問你們是否已就這個潛在變動與 FDA 討論過？另外，如果 FDA 允許你們對第 3 期做一些修訂，是否有可能進一步節省第 3 期的成本？

Thanks for the question, Roger. Christophe, maybe you get on one?

謝謝你的問題，Roger。Christophe，也許你來回答這個？

So we discussed this -- we haven't discussed this at the end of Phase 2 meeting, the path for approval for the MASH programs is the one single trial for accelerated approval and then all the which final approval for clinical outcomes.

我們有討論過這個——我們在第 2 期結束會議（end of Phase 2 meeting）時沒有討論這點；MASH 計畫的核准路徑是以單一試驗取得加速核准（accelerated approval），之後再以臨床結局（clinical outcomes）取得最終核准。

So this doesn't really apply directly for us. That knew it doesn't change anything from how we're approaching our development program towards approval.

所以這對我們並不算直接適用。這個新內容不會改變我們目前朝向核准所採取的開發策略。

Got it. That makes sense. And then just knowing you're still finalizing the protocol, just any strategical plan you can share at this point in terms of the interim versus the final outcome of a split and then different two primary endpoints for the interim, if anything this year. Thank you.

了解。這很合理。另外，知道你們仍在敲定試驗方案（protocol），目前在策略上是否能分享一些內容，例如期中（interim）與最終結果的拆分，以及期中若有兩個主要終點（primary endpoints）的不同設定等，今年是否會有任何更新？謝謝。

Yeah. Thanks, Roger. A lot of progress there. Maybe Christophe can give the big picture on that.

好的。謝謝，Roger。這方面有很大進展。也許 Christophe 可以從大方向說明。

Yeah. So the first is that we are having a fairly standard design for the Phase 3, so we have our two primary point guidance, which is MASH resolution without worsening of fibrosis and fibrosis improvement without MASH worsening. And this is how we powered our study.

好的。首先，我們的第 3 期採用相當標準的設計，因此我們有兩個主要終點指引：在不惡化纖維化的情況下達成 MASH 緩解（MASH resolution without worsening of fibrosis），以及在不惡化 MASH 的情況下改善纖維化（fibrosis improvement without MASH worsening）。我們的研究即依此進行統計把握度（power）設計。

Our study is powered more than 90% on this endpoint. And that gives us a sample size that is around 990 patients, so 330 patients per arm.

本研究在該終點上的把握度超過 90%。這對應的樣本數約為 990 名受試者，也就是每個治療組 330 名。

As we highlighted, that power should give us the sufficient patients to reach the approval and the split of the alpha is, as you know, for the accelerated approval, the part one is 0.1 and then the other -- the rest of the alpha goes all the way to the clinical outcome.

如我們所強調的，這樣的把握度應能提供足夠的受試者數以達成核准；而 alpha 的拆分（split of the alpha）如你所知，針對加速核准的第一部分是 0.1，其餘的 alpha 則一路分配到臨床結局。

The live thanks is with powered based on our assumptions for the 1.8 milligram dose. So as mentioned, we're very well powered for this. In our trial, we have the option for an upside with the 2.4 milligram dose. And so we're really hoping that we'll see some added benefits there.

本研究的設計把握度是基於我們對 1.8 毫克劑量的假設。因此如前所述，我們在這方面的把握度非常充足。在試驗中，我們也保留 2.4 毫克劑量帶來上行空間（upside）的可能。因此我們非常希望能在那裡看到額外的效益。

Thank you so much.

非常感謝。

Thanks Roger.

謝謝 Roger。

Ellie Merle, Barclays.

Barclays 的 Ellie Merle。

Hi, this is Jasmine on for Eli. I have two. So first, from your conversations with the FDA, what does the agency stand now on flexibility to consider NITs as a potentially registrational endpoint is the thinking for including the NIT cohort that we could potentially need more flexibility on this in the future that you might be able to amend and use discount work for approval more quickly? And then secondly, can you talk about your plans in MASH F4 and potential time lines there? Thanks.

嗨，我是 Jasmine，代 Eli 提問。我有兩個問題。第一，根據你們與 FDA 的溝通，目前主管機關對於將 NITs 作為可能的註冊性（registrational）終點的彈性立場如何？納入 NIT 族群（cohort）的想法是否是因為我們未來可能需要在這方面有更大的彈性，並且你們或許能透過修訂（amend）並使用折扣工作（discount work）來更快取得核准？第二，能否談談你們在 MASH F4 的計畫以及可能的時間表？謝謝。

Thanks, Jasmine. Maybe I'll start and then turn it back to Christophe. On the first question, we did broach the point of end points on NITs in the end of Phase IIb process, the agency at that point said it was premature to consider that, which is why you see the biopsy driven end points.

謝謝你，Jasmine。也許我先回答，然後再交回給Christophe。關於第一個問題，我們在IIb期流程末段確實有提到NIT的終點；當時主管機關表示現在討論仍為時過早，這也是為什麼你會看到以活檢為驅動的終點。

Nonetheless, we'll capture all of that data. So that process at the agency will be ongoing. But again, the as we finalize the protocol, you'll see the biopsy-driven endpoint as part of that. Maybe you want to pick up the second?

不過，我們會收集所有這些資料。因此，與主管機關的這個流程會持續進行。但同樣地，隨著我們最終敲定試驗方案，你會看到以活檢為驅動的終點會納入其中。第二個問題也許你想接著回答？

Sure. No. I mean in the context of the a MASH assist approval, we see agency slowly moving towards that direction. So we've incorporated it in our trials, and we've put everything in case they change during the conduct of the study. So we are in a good shape here if they were to go there.

當然。不。我的意思是，在MASH加速核准的背景下，我們看到主管機關正逐步朝那個方向前進。所以我們已把它納入我們的試驗設計中，並且把所有內容都準備好，以防在研究進行期間他們改變要求。因此，如果他們真的往那邊走，我們這裡的準備狀況會很好。

The other questions on the F4. I mean, our current focus is clearly on the F2 and F3. We believe there is some potential here with the mechanism of actions and the direct effect on the lever to impact the F4.

至於F4的其他問題。我的意思是，我們目前的重點很明確是在F2與F3。我們相信，基於其作用機轉以及對肝臟的直接作用，這裡對於影響F4仍有一些潛力。

At this point in time, our teams and is really dedicated towards the execution of the Phase 3 and putting all the last pieces in place to start.

就目前而言，我們的團隊確實專注於第三期的執行，並把所有最後的拼圖就位，以便啟動。

Okay, thank you.

好的，謝謝。

Thanks, Jasmine.

謝謝你，Jasmine。

Yasmeen Rahimi, Piper Sandler.

Yasmeen Rahimi，Piper Sandler。

This is [Domic] on for Yas. So we just got a few here. The first one related to the Phase 3 for MASH. What are the great limiting steps to kick off that study? And how are you thinking about the time lines for and top line data?

我是代替Yas發言的[Domic]。我們這裡有幾個問題。第一個與MASH的第三期試驗相關。啟動該研究的主要限制步驟是什麼？以及你們如何看待時程與主要（top line）數據的公布時間？

Okay. Maybe I'll start on the first half and then Christophe can take the second. We're very focused on bringing pemvi to patients as soon as we can. I think we're approaching the preparation on both the financial and the operational fronts, as Christophe outlined, we like where things sit on the clinical side. Good clearance from the FDA, good insight on our proposal regarding Europe.

好的。也許我先回答前半段，然後Christophe再回答後半段。我們非常專注於盡快把pemvi帶給病患。我認為我們正同時在財務與營運兩個面向做準備；如Christophe所概述，我們對臨床端目前的狀態感到滿意。已獲得FDA良好的放行（clearance），也對我們在歐洲的提案有良好的洞見。

So all things are moving in parallel. We expect that all will be in line to start the trial as we progress through this year, and we'll narrow the guidance as things come to fruition. Again, the teams are moving quickly here and this parallel approach is going to lead us to initiation of the trial.

因此，各項工作都在並行推進。我們預期隨著今年的進展，所有事項都會到位以啟動試驗；而當事情逐步落實時，我們也會收斂並更新指引。同樣地，團隊在這裡推進很快，這種並行方式將帶領我們完成試驗啟動。

Yeah. I mean, I can just add to what Jerry says, we are in we're preparing everything on the regulatory side. We have alignment with the FDA. We have done our homework on what is expected from the European or we're in good shape here. We don't expect any major changes on our approach.

是的。我想我可以補充Jerry所說的：我們正在法規端把所有事情都準備好。我們已與FDA達成一致。我們也已就歐洲方面的預期完成功課，因此目前狀態良好。我們不預期我們的方法會有任何重大變更。

So it's about now execution, getting the team to finalize the last details. whether it's in our protocols, some of the key aspects of the protocol and then moving forward to be ready to start as soon as possible.

所以現在重點在於執行：讓團隊把最後細節定案，不論是試驗方案本身，或方案中的一些關鍵面向，然後往前推進，盡快準備好啟動。

Okay. Great. And then I just have one more question on reclaim. We decided for that trial. Your thoughts on what you hope to see and what would you consider clinically meaningful on alcohol usage for that.

好的。很好。我還有一個關於reclaim的問題。我們為那個試驗做了決定。你們希望看到什麼？以及你們會把酒精使用方面的哪些變化視為具有臨床意義？

Thank you so much.

非常感謝。

So this study of the AUD is analyzing the heavy drinking days over a period of seven days or a week. And we have powered the study to see a fairly conservative change.

因此，這項AUD研究是在分析七天（或一週）期間的重度飲酒日數。而且我們在試驗設計的統計檢定力（power）上，是以觀察相當保守的變化幅度為目標。

So hopefully, we'll see that. We are also capturing other endpoints like the zero drinking days, as well as some of those WH risk because this could be endpoints that will be discussed with the FDA if we move that program forward.

所以希望我們能看到那樣的結果。我們也會收集其他終點，例如零飲酒日數，以及一些WH風險相關指標，因為如果我們推進這個計畫，這些可能會成為與FDA討論的終點。

So we have -- we're going to look at all these aspects when we get the data and hopefully, we'll see some improvement. As a reminder, the mechanism of action is well suited for this, both on the reward system through the GLP-1 side of it, as well as the direct effect on the liver, which is quite unique compared to what other progress currently in development.

因此，等我們拿到數據後，會從所有這些面向來評估，並希望能看到一些改善。提醒一下，這個作用機轉非常適合此適應症：一方面透過GLP-1路徑作用於獎賞系統，另一方面也對肝臟有直接作用；相較於目前其他正在開發中的方案，這點相當獨特。

Great, thank you.

很好，謝謝。

Corinne Johnson, Goldman Sachs.

Corinne Johnson，Goldman Sachs。

Hi, this is Anupam on behalf of Corinne Johnson. Maybe can you just tell us about the additional financing through the year? And what you are anticipating needing to lift the completion of the Phase 3 in the MASH program? Any color on that?

嗨，我是代表Corinne Johnson的Anupam。你們能否談談今年內額外融資的情況？以及你們預期為了推動MASH計畫第三期完成，還需要哪些資金？能否提供一些說明？

Yeah. So maybe I'll start on that, and then Greg could pick it up. As I mentioned a couple of times already, including in the prepared remarks, we're preparing on both the financial and the operational side. On the financial side, as Greg outlined, we've improved our position.

好的。也許我先回答，然後Greg再補充。如我先前已提過幾次（也包含在事先準備的發言中），我們正同時在財務與營運兩端做準備。在財務面，如Greg所概述，我們已改善了我們的狀況。

He referenced roughly $340 million on the balance sheet at the end of February that gives us runway into 2028. We'd like to make further progress as we progress to initiate trial.

他提到截至2月底資產負債表上約有3.4億美元，這讓我們的資金跑道可延伸到2028年。隨著我們推進並準備啟動試驗，我們希望能再取得更多進展。

We believe we have good line of sight on some options on how we would approach that in parallel to all the good operational work that Christophe and his team is doing. And then we'll access the appropriate tools along the way. Greg, anything else you want to reiterate?

我們相信，對於如何推進這件事，我們對一些選項有相當清晰的掌握，並會與Christophe及其團隊所做的優秀營運工作並行推進。然後我們會在過程中採取合適的工具。Greg，你還有什麼想再強調的嗎？

I'll just pick up that. I think we have a sense of purpose here in making sure we've got the strength of our resources in hand as we begin the next necessary steps to launch this trial this year. Just basically just have a clear line of sight on what that looks like, how much that's going to take and confident that we'll get there.

我補充一下。我認為我們有明確的使命感，確保在今年開始啟動這項試驗所需的下一步時，我們手上具備足夠強健的資源。基本上，我們對那會是什麼樣子、需要多少資源有清楚的可視性（line of sight），也有信心能達成。

Annabelle Samimi, Stifel.

Annabelle Samimi，Stifel。

Hi, thank you for, taking my question.

嗨，謝謝你們讓我提問。

Thanks for all the color on the profile and the physician receptivity. So I just want us from a competitive landscape. We'll likely be seeing more data from Reta and servo in obesity this year with the full knowledge that this is in obesity. What are some of the key data points that you as a team are looking for that may translate into MASH and could potentially have implications for the competitive landscape on the glucagon agonist front. Maybe you can just give us an idea of how you're thinking about the entire competitive landscape for these specific dual agonists?

謝謝你們就產品特性與醫師接受度提供的所有說明。我想從競爭格局的角度問一下。我們今年可能會看到Reta與servo在肥胖症方面更多數據，當然我們也知道那是在肥胖症領域。你們團隊正在關注哪些關鍵數據點，可能可轉譯到MASH，並可能對胰高血糖素致效劑（glucagon agonist）這條線的競爭格局產生影響？也許你們可以談談你們如何看待這些特定雙重致效劑的整體競爭格局？

Sure. We're always paying attention to what's happening in the marketplace. And we look at ourselves and what we have in terms of great tolerability, quality weight loss that we haven't seen with these other agents. Our simplicity of our titration and tolerability, which we've emphasized is really seen as something quite important.

當然。我們一直密切關注市場上正在發生的事情。同時我們也檢視自身，以及我們在耐受性佳、減重品質優異方面所具備的優勢，而這些是我們在其他藥物上尚未看到的。我們在劑量滴定與耐受性上的簡單性——我們也一再強調——確實被視為相當重要的一點。

For very obese patients, I think that there is going to be a role for managing that. but that has to be balanced with tolerability and efficacy elsewhere and the direct acting effects that we have shown in the ratio that we're showing in the 1:1 ratio, we believe, are very important.

對於非常肥胖的患者，我認為在管理上將會有其角色；但這必須與其他方面的耐受性與療效，以及我們在所呈現的比例（我們相信 1:1 的比例）中所展現的直接作用效果取得平衡，而我們認為這些都非常重要。

If you're talking about the results of obesity, there may be some read over there, of course, but the trial that they're looking at shouldn't read out for quite some time on outcomes.

如果你談的是肥胖的結果，當然可能會有一些外溢解讀，但他們正在看的那項試驗在結局（outcomes）方面應該還要相當一段時間才會讀出結果。

Our trial will be very heavily focused on mash patients. So that's our focus F2, F3 and the size of the market is such that there are going to be enough patients who need help that there will be ultimately many roles, I think, for pemvidutide, particularly if we deliver on the differentiation and the profile that we just talked about.

我們的試驗將會非常聚焦於 MASH 患者。所以這是我們的重點：F2、F3；而市場規模之大，意味著會有足夠多需要協助的患者，因此最終我認為 pemvidutide 會有多種角色，特別是如果我們能兌現剛才談到的差異化與產品特徵（profile）。

I think just maybe one other -- just maybe one other point Linda touched on. The ratio matters. I think you think about the BI compound, for instance, I mean, obviously, we'll see some additional data from them.

我想再補充一點——也是 Linda 提到的另一個重點。比例很重要。例如你看看 BI 的化合物，當然，我們也會看到他們更多的數據。

But I think the work we've done with our own compound, we believe the balance ratio is part of what's driving some of the elements around the tolerability profile, which again -- we saw a good solid picture in our Phase 2 without a titration.

但就我們自己化合物所做的工作而言，我們相信平衡的比例是推動耐受性特徵中某些要素的原因之一；而且再次強調——我們在第二期試驗中、在沒有滴定的情況下，就看到了相當穩健一致的結果圖像。

Now we have the opportunity to put a simple titrate and then maybe move forward on that as well. So we're looking at all of the competitive entrants.

現在我們有機會採用一個簡單的滴定方式，然後也許在此基礎上繼續推進。因此我們正在觀察所有競爭者的進展。

It's why we focused on this call, frankly, a lot more detail on the differentiation story because it's how -- we view the work that we are doing currently in executing the Phase 3 and also really always understanding how we're going to position pemvi to bring the benefit to the patients that needed the most.

坦白說，這也是為什麼我們在這通電話會議上更著重於差異化故事的細節：因為這關係到——我們如何看待目前正在執行第三期試驗的工作，以及我們如何真正持續理解要如何定位 pemvi，將效益帶給最需要的患者。

Yeah. And let me -- I just want to correct myself right now. The pemvidutide study is with their 8:1 GLP glucagon. And that is in the mass population. I was looking at the 2 trial in my head.

是的。另外讓我——我想立刻更正一下我剛才的說法。pemvidutide 的研究是採用他們的 8:1 GLP：胰高血糖素（glucagon）比例。而那是在 MASH 人群中。我剛剛腦中想到的是另一個第二項試驗。

So I just want to make sure I correct that. Either way, I think the tolerability for server was going to be quite significant for them and when you look at the complicated titration schedule, that is going to be of concern as well.

所以我想確保把這點更正清楚。不管怎樣，我認為他們在耐受性方面的負擔會相當顯著；而且當你看到那個複雜的滴定時程，這也會是一個令人擔憂的點。

Okay, great.

好的，很棒。

Thank you very much.

非常感謝。

Patrick Trucchio, HC Wainright.

Patrick Trucchio，HC Wainright。

Good morning, Louis Santos here in for Patrick. Congratulations on all the progress. My question is regarding the match noninvasive tests that you are using.

早安，我是 Louis Santos，代替 Patrick 發言。恭喜各位取得所有進展。我的問題是關於你們正在使用的 MASH 非侵入性檢測（noninvasive tests）。

So now that you have alignment with the FDA, did they provide any clarity on using it as primary rather than just surrogate as well as the AI biopsy reads or pemvidutide accelerated approval?

既然你們現在已與 FDA 對齊，他們是否就將其作為主要終點而不僅是替代指標（surrogate），以及 AI 輔助的活檢判讀或 pemvidutide 的加速核准（accelerated approval）提供任何更明確的說明？

Great stuff, yes,So on the discussion with the FDA, so as mentioned, the needs are not -- are too premature now, and we just want to be really ready on this. However, I mean the opportunity with our two cohorts is actually several fold once it fulfills some of those -- the requirements for the safety as well as the long-term clinical outcome but also to enroll a little faster our Phase 3 trials because we know and we've done that we'll look into it.

很好的問題，是的。關於與 FDA 的討論，如同提到的，目前 NITs（非侵入性檢測）還——還太早，我們只是希望在這方面做好充分準備。不過，我們兩個隊列（cohorts）的機會其實是多重的：一旦滿足某些——安全性以及長期臨床結局的要求，同時也能讓我們第三期試驗收案更快一些，因為我們知道——而且我們也做過——我們會去評估這件事。

I will be happy to actually have the patient having different options, so to the biopsies and the knits. So that will give us some advantage there, and we're hoping this will be playing in our favor. With regard to the AIM MASH, this is still a consensus based on the pathology reading.

我也很樂見讓患者有不同選項，包括活檢以及 NITs。這會在那方面帶給我們一些優勢，我們也希望這能對我們有利。至於 AIM MASH，目前仍是基於病理判讀的共識（consensus）。

At the end of pathologist is responsible, where we believe this could help us is actually in reducing variability potentially if we do the right training, et cetera, having a lower placebo response and trying to play in our favor.

最終仍由病理醫師負責；而我們認為它可能幫得上忙的地方，是如果我們做對訓練等工作，或許能降低變異性，進而降低安慰劑反應，讓結果更有利於我們。

So we're putting those pieces into place right now. We're having a lot of discussions with key pathologists and with the AIM MASH assist company that's AI and we're putting all the pieces of that and getting very close to having a really a really strong path toward biopsies, but also, as mentioned before, having the flexibility around the needs in case FDA changes their mind.

所以我們現在正在把這些環節建置起來。我們正與關鍵病理醫師以及提供 AIM MASH Assist（AI）的公司進行大量討論，把所有拼圖都拼起來；我們也非常接近建立一條非常——非常扎實的活檢路徑，但同時，如先前所說，也保留 NITs 的彈性，以防 FDA 改變想法。

That sounds great. Very quickly, can you update us on your CMC manufacturing readiness. And do you plan to scale for global trial manufacturing supply for both obesity and MASH simultaneously? Or do you plan to partner on then?

聽起來很棒。很快問一下，你們能否更新 CMC 製造準備度？你們是否計畫同時為肥胖與 MASH 的全球試驗製造供應進行放大（scale-up）？還是你們計畫在那方面尋求合作夥伴？

So Scott Roberts can take the question. Just one point on the front is that we're focused on the mac trial, okay? We're focused on positioning pemvi as a liver compound.

Scott Roberts 可以回答這個問題。先補充一點：我們聚焦在 MASH 試驗，好嗎？我們聚焦把 pemvi 定位為一個肝臟用藥（liver compound）。

Yeah, that's exactly right. And as far as writing this for the Phase 3, we believe that we're there, we're ready to go on that. As far as MASH, a global trial, that's really not an issue before MASH. We were really developing the process for obesity. We can scale to that size as necessary, but the company is focused on MASH and for those indications in the US and the rest of the world where exactly where we need to be.

對，完全正確。就第三期而言，我們相信我們已經到位、準備就緒可以推進。至於 MASH 的全球試驗，在 MASH 這邊其實不是問題。我們原本是在為肥胖適應症開發製程。我們可以視需要放大到那樣的規模，但公司目前聚焦在 MASH，以及在美國與世界其他地區、我們需要推進的那些適應症上。

Michael DeFor, Evercore ISI.

Michael DeFor，Evercore ISI。

Hey guys, thanks so much for taking my questions. Two for me. I just want to -- the first one, I just want to drill down on a prior question that was asked. Now that you received the FDA minutes, were the key elements that are fully locked and what is the single biggest remaining variable that you're still optimizing?

各位好，謝謝你們回答我的問題。我有兩個問題。第一個我想——我想針對先前有人問過的問題再深入一點。既然你們已收到 FDA 會議紀要（minutes），哪些關鍵要素已完全定案？而目前你們仍在優化的、最大的單一變數是什麼？

And secondly, with the request for EU scientific advice now submitted, is there any early read on whether EU fee that could change anything meaningful versus the FDA aligned plan? Thank you.

第二，既然你們已提交 EU 科學諮詢（scientific advice）的申請，是否有任何初步跡象顯示 EU 的回饋可能會相較於與 FDA 對齊的計畫，帶來任何實質性的改變？謝謝。

Thanks for the questions, Michael Christoph. Yes.

謝謝你的問題，Michael。我是 Christoph。是的。

Yeah. So on the FDA unit, and the discussion with them, I mean, the we are really in the last phases of finalizing our protocol. We have all the elements, like I mentioned, the sample size. We talked to all of our biostatisticians. We have the primary endpoint aligned, the population, et cetera.

是的。關於 FDA 的會議紀要以及與他們的討論，我們目前確實正處於最終定稿試驗方案（protocol）的最後階段。我們已具備所有要素，如我提到的樣本數（sample size）。我們與所有生物統計師都討論過。主要終點（primary endpoint）、受試人群（population）等也都已對齊。

What we're looking at is finalizing some like, for example, the biopsy is a critical point, and we want to really take the time to do it in the most comprehensive manner and having our team of pathologists with us.

我們目前在做的是把一些事項定案；例如，活檢是一個關鍵節點，我們希望真正花時間以最全面的方式來完成，並讓我們的病理學家團隊全程參與。

So we're taking the time to do this, the most appropriate way and these are the kind of last details, some of QC, for example, things like this.

因此我們正在花時間以最恰當的方式來做，這些就是最後的一些細節，例如部分品管（QC）之類的事項。

So these are really the final stages of those aspects with regard to the EU, we've worked with regulatory consultants. We have a good understanding. We actually even have biostatisticians that are advising the EMA that worked with us. We've put together all the PCs.

所以就這些面向而言，確實已進入最後階段；就歐盟方面，我們已與法規顧問合作。我們有很好的理解。我們甚至也有為 EMA 提供建議、並曾與我們合作的生物統計學家。我們已把所有的 PC 都整理完成。

So we don't expect anything to hold us back and we -- our protocol and the design of the study shouldn't change based on the scientific advice.

因此我們不預期會有任何事情阻礙我們，而我們——我們的試驗方案與研究設計也不應該因科學諮詢而改變。

John Wallebin, Citizens.

John Wallebin，Citizens。

Mostly on the reclaim program. Firstly, how thinking about the mechanism of action? Like as far as having GLP and glucagon specifically maybe being beneficial over just GLP-1 agonism in the collated diseases? And also logistically, how do you guys plan on kind of moving forward on the Phase 3 program.

主要是關於 reclaim 計畫。第一個問題，你們如何看待作用機轉？例如在合併疾病中，相較於僅有 GLP-1 促效作用，GLP 加上胰高血糖素（glucagon）是否可能特別有利？另外在執行面上，你們打算如何推進第三期（Phase 3）計畫？

Are you guys going to kind of move forward with AUD and then wait for ALD data? Or do you want to kind of see both before moving forward? Thank you.

你們會先推進 AUD，然後等待 ALD 的數據嗎？還是想在推進前先同時看到兩者？謝謝。

Yeah. Maybe I'll start with the second question and then Christophe can take the mechanistic one. So we'll -- as we said, we're going to expect the readout on the AUD trial in quarter three. They'll assess the data and then plan next steps.

好的。我先回答第二個問題，然後 Christophe 再回答機轉的問題。如同我們所說，我們預期在第三季拿到 AUD 試驗的讀出結果。我們會評估數據，然後規劃下一步。

That would happen immediately upon receipt of the data no need to wait for ALD. We like the fact that we have a second Phase 2 going in ALD. But as the enrollment will finish this year, that will be a later readout.

一收到數據就會立刻進行，無需等待 ALD。我們也很高興同時在 ALD 有第二個第二期試驗在進行。但由於收案會在今年完成，讀出時間會比較晚。

Yeah. On the mechanism of action, so it's well recorded in the literature that GLP-1 have a central effect on the reward system and the type of alcohol use that those patients will have. The difference is the direct effect on the liver.

是的。就作用機轉而言，文獻中已有充分記載：GLP-1 對獎賞系統具有中樞作用，會影響這些患者的飲酒行為型態。差異在於對肝臟的直接作用。

They are now more and more -- and recently in January, at the MASH conference, it was clearly talking about the fat in liver of these patients, but also some elements of early fibrosis, so it would be very suited for these populations to not only treat the alcohol use and the cravings and that reward aspect but also to directly deliver because the liver is already substantially damaged.

現在越來越多——而且就在今年一月的 MASH 會議上，已明確談到這些患者的肝臟脂肪，但也包括一些早期纖維化的要素；因此這類族群非常適合，不僅治療酒精使用、渴求與獎賞面向，也能直接介入，因為肝臟其實已經受到相當程度的損傷。

And even with early fibrosis with clearly the dual mechanism of action and the tolerability I will add in that particular population is extremely suitable for a product like pemvidutide.

即便是早期纖維化，憑藉明確的雙重作用機轉以及耐受性——我補充一下——在這個特定族群中，對像 pemvidutide 這樣的產品而言是極其合適的。

This population feels good they are not having -- you don't want to add side effects or implications to dams, so they really want to get their lever treated as well as the cravings.

這個族群自覺狀況還不錯——你不希望再增加副作用或帶來其他影響，所以他們真的希望在控制渴求的同時，也把肝臟治療好。

Thank you so much.

非常感謝。

Andy Hsieh, William Blair.

Andy Hsieh，William Blair。

Thanks for taking our questions. We have two questions. One is related to the prepared remarks that you made, highlighting that Sema failures might be a potential segment to provide clinical differentiation.

謝謝讓我們提問。我們有兩個問題。第一個與你們事先準備的發言有關，你們提到 sema 治療失敗者可能是一個可提供臨床差異化的潛在族群。

So can you tell us a little bit about the exclusion, inclusion criteria regarding the length of the washout period in the upcoming Phase 3 trial. So that's question number one.

能否請你們多談一些即將進行的第三期試驗中，關於排除／納入標準，以及停藥清洗期（washout period）長度的規定？這是第一個問題。

Question number two has to do with kind of the pathologist panel that you decided. I'm curious if it's just like a two-person panel, a three-person panel. Can you talk about the education process, if you don't mind?

第二個問題是關於你們決定採用的病理學家小組。我想了解是兩人小組、三人小組，還是其他配置？也請談談培訓流程（education process），如果方便的話。

So I'll start with the first one. Clearly, what we hear and what's been presented in the past conferences is that sema is hard to tolerate that most patients do not reach the MASH effective dose that the titration is complex for them. and that there are a lot of dropouts of treatment after already 6 months to a year. So this is a challenge there.

我先回答第一個。很明顯，我們聽到的以及過去會議上呈現的是：sema 的耐受性不佳，多數患者無法達到對 MASH 有效的劑量，對他們而言滴定（titration）很複雜，而且在治療 6 個月到 1 年後就有很多人中途停藥。因此這是一個挑戰。

If that's the case for us, clearly, we will accept these patients in our Phase 3 trials and we want to be able -- if they have not tolerated sema to bring them on board because they will have an option which we decide again to have and I want to remind you to the extremely strong efficacy we've seen in our Phase 2 study, as well as the (inaudible).

如果我們也遇到這種情況，很明確地，我們會在第三期試驗中納入這些患者；我們希望能夠——如果他們無法耐受 sema——把他們納入，因為他們將有一個替代選項，而我們再次認為這個選項是可行的。我也想提醒各位，我們在第二期研究中看到極其強的療效，以及(聽不清楚)。

So both together is a perfect option for this population with a real chance now to address the liver and their metabolic causes for that match. With regard to the pathologist, we're still finalizing these details where towards the end of this, our thinking right now is to have it has to be a consensus.

因此兩者結合，對這個族群而言是非常理想的選項，現在也確實有機會同時處理肝臟問題以及造成 MASH 的代謝原因。至於病理學家方面，我們仍在敲定細節；目前的想法是必須採共識判讀。

So we're thinking to have a few pathologists, and the reading would be two plus one type of reading with the consensus, the plus one would be if there is no consensus between the two pathologists.

因此我們考慮配置幾位病理學家，採用「兩位加一位」的判讀方式並以共識為準；若兩位病理學家無法達成共識，則由「加一位」介入。

Clearly, the advantage here for us is the AIM MASH assist. If really that decreases the viability and help that consensus, it should also accelerate and streamline the process and so for us, these two aspects, decreasing variability and streamlining the process are good positive perspective to execute our study in the best possible way.

很明顯，對我們而言的優勢是 AIM MASH assist。如果它真的能降低變異性並促進共識，也應該能加速並精簡流程；因此對我們來說，降低變異性與精簡流程這兩點，都是以最佳方式執行研究的正向前景。

William Wood, B. Riley Securities.

William Wood，B. Riley Securities。

Thank you so much for taking our questions. Two from us, if we may. All your reclaim trial, it's focused on drinks per day in alcohol consumption but I was curious if there are any NITs looking at the liver or additional measurements that could read through to either your ALD or Phase 3 trials since you'll be evaluating the 2.4 mg dose in both the AUD ALD and then obviously, the Phase 3 as well as could you provide any color on how far along you are in your ALD trial enrollment? And then I have a second follow-up.

非常感謝讓我們提問。我們有兩個問題。你們的 reclaim 試驗聚焦在酒精攝取的每日飲酒量，但我想了解是否有任何非侵入性檢測（NITs）用來觀察肝臟，或其他額外量測，能夠延伸解讀到你們的 ALD 或第三期試驗；因為你們會在 AUD、ALD 以及第三期中都評估 2.4 mg 劑量。另外也能否提供一些資訊：你們的 ALD 試驗收案目前進度到哪裡？然後我還有第二個追問。

All right. On the AUD, so we don't have too many -- we have the typical liver enzyme, et cetera. We're looking at a heavy drinking days. We're looking at the zero day of drinking, we're looking at those the WHO risk classification, if you wish, and how these patients will change.

好的。關於 AUD，我們沒有太多——我們有典型的肝酵素等指標。我們會看重度飲酒日（heavy drinking days）。我們會看零飲酒日（zero day of drinking），也會看 WHO 風險分級（risk classification），如果你願意這麼說，以及這些患者會如何改變。

But also since it's a patient reported outcome, we also have blood tests such as the test, which is a little bit like you would see in the HBA1C, which reflects the alcohol impregnation.

但另外，由於這是一個患者回報結果（patient reported outcome），我們也有血液檢測，例如某項檢測，有點像你在 HbA1c 會看到的那種，用來反映酒精暴露程度。

So we believe that here, we have -- and we have all the other markers of the effectiveness of the drug such as weight loss, et cetera.

因此我們相信在這裡，我們已經——而且我們也有藥物有效性的所有其他指標，例如體重下降等等。

So we have in our a number of things that will be very helpful to be -- to prepare for discussions with the FDA granted the data come out positive on this on the we are enrolling as per plan. As you know, this is a more severe population. So it will be more difficult to enroll.

因此，我們手上有許多事情將非常有助於——在數據呈現正面結果、且我們依計畫持續招募的前提下——為與 FDA 的討論做好準備。如你所知，這是一個病情更嚴重的人群。因此招募會更困難。

I mean, we successfully enrolled very rapidly our AUD trial much faster than anticipated. But here on the ALD, we're on track for as per plan and moving forward smoothly as I can't give you any more forecast on that at this point.

我的意思是，我們在 AUD 試驗中的招募非常成功，速度比預期快得多。但在 ALD 這邊，我們正依計畫推進、進展順利；目前我無法就此提供更多預測。

Okay. And then in your Phase 3 trial, maybe I missed it, but will you be evaluating any cardiovascular benefits? Or maybe how do you plan to assess MACE since you're not conducting a separate CVOT trial.

好的。另外，在你們的第 3 期試驗中，也許我漏聽了，但你們會評估任何心血管方面的益處嗎？或者，既然你們不會進行單獨的 CVOT 試驗，你們打算如何評估 MACE？

No, this is a great question. First, I mean, we've already seen some great improvements on the lipids. On the inflammation, we clearly have a decrease in inflammation in with pemvidutide. We've seen improvement in lipids at week 24 in our latest data similarly at week 48.

不，這是個很好的問題。首先，我的意思是，我們已經在血脂方面看到一些很好的改善。在發炎方面，使用 pemvidutide 我們清楚看到發炎下降。我們在最新數據中看到第 24 週血脂改善，第 48 週也同樣如此。

So we believe there is a real potential here to see some cardiovascular benefits we will clearly look at the scenario of Phase 3 MASH trial. However, the FDA doesn't want us to include this as the clinical outcome for liver-related events, clearly, these are two separated aspects, but we'll have the data built in, in our Phase 3.

因此我們相信這裡確實有潛力看到一些心血管方面的益處，我們也會在第 3 期 MASH 試驗的情境中清楚地加以觀察。然而，FDA 不希望我們把這個納入作為肝臟相關事件的臨床結局；很明顯，這是兩個分開的面向，但我們會在第 3 期中內建相關數據。

Okay, thank you.

好的，謝謝。

Boris Peaker, Titan Partners.

Boris Peaker，Titan Partners。

Great, thanks for squeezing me in I guess I just want to focus on the muscle preservation and obviously, it's one of the key differenting elements of the drug. I'm just curious, the observed weight loss today, can you comment whether the muscle preservation was stronger at the lower or the higher end of the DMI scale? And what can you potentially do in the Phase 3 study in terms of enrollment to maximize the impact of this muscle preservation, particularly considering to the large and international study?

很好，謝謝讓我插個問題。我想我主要想聚焦在肌肉保留上；顯然，這是該藥物的關鍵差異化要素之一。我只是好奇，就目前觀察到的體重下降而言，你能否評論一下：在 DMI 量表較低端或較高端時，肌肉保留是否更強？另外，在第 3 期研究的招募方面，你們可能可以做些什麼來最大化這種肌肉保留的影響，特別是考量到這是一個大型且國際性的研究？

Yeah. So the muscle of preservation in the lean mass is critical, as you say, because this is something that in that population, that's aging. Our average patient is 55 and older, and that's -- they start losing their bone, their muscles. And so we don't want to add anything to this.

是的。如你所說，瘦體重的肌肉保留非常關鍵，因為在那個逐漸老化的人群中，這點很重要。我們的平均患者年齡是 55 歲以上，而他們——開始流失骨質與肌肉。因此我們不希望再加劇這種情況。

So we want to keep the muscles in this population we've demonstrated some very interesting data already in our VCT trial, and we would have to continue demonstrating this.

所以我們希望在這個人群中保留肌肉；我們已在 VCT 試驗中展示了一些非常有意思的數據，並且需要持續證明這一點。

How we are integrating this in the Phase 3, we are actually in some discussions right now, whether it's a full mechanistic study or if it's a substudy that is put into the trial is something that we're defining as we are speaking today.

至於我們如何在第 3 期中整合這點，我們目前正在進行一些討論：究竟是完整的機轉研究，或是把一個子研究納入試驗中，這些都是我們此刻正在釐清與定義的。

Regarding the BMI, I mean, there's no difference between the it works. It's all different type of BMI and it's consistent throughout. That's what we've seen in our VCT study.

關於 BMI，我的意思是，沒有差異——它都有效。在各種不同的 BMI 類型中效果一致。這就是我們在 VCT 研究中看到的。

Scott, I'm just curious what specific test to biomarkers are you monitoring to better understand this muscle preservation. So is it just a Dexa scan, hand strength, MRI, where are you specifically monitoring? And what do you think you'd need potentially get a claim in the label on some kind of muscle preservation.

Scott，我只是好奇，你們正在監測哪些特定檢測或生物標記，以更好地理解這種肌肉保留？所以只是做 Dexa 掃描、握力、MRI，還是你們具體在監測哪些？另外，你認為若要在標籤上取得某種肌肉保留的宣稱，可能需要什麼？

Yeah. That's I mean, that's a complicated question because you're getting a claim would require some clearly will have MRI. We'll have this kind of, like you mentioned, Dexa, we would like to better understand. We have some ideas how this is working as well. We believe that one-to-one ratio is one of the key aspects that could lead to this.

是的。我的意思是，這是個複雜的問題，因為要取得宣稱需要一些明確的——我們肯定會有 MRI。也會有你提到的這類 Dexa；我們希望能更好地理解。我們也有一些關於其作用機制的想法。我們相信一比一的比例是可能導致這點的關鍵因素之一。

So if we can make that link and during our Phase 3, clearly, that would be an important distinction and differentiator at launch. So we're putting all the pieces together as we're first -- first, we're finalizing that protocol for the MASH and putting the pieces on that lean MASH preservation as well in parallel.

因此，如果我們能建立那個連結，並且在第 3 期期間清楚證明，這在上市時將會是一個重要的區隔點與差異化優勢。所以我們正在把所有拼圖拼起來：首先——首先，我們正在定稿 MASH 的試驗方案，同時也並行把瘦體重／MASH 的保留相關要素納入其中。

Great, thank you very much for taking my questions.

很好，非常感謝回答我的問題。

I show no further questions at this time. I'd like to turn it over to Jerry Durso for closing remarks.

我目前沒有看到其他問題。我想把時間交給 Jerry Durso 做結語。

So thanks, everybody, for joining us today. A lot going on in the company, a lot of progress. We're moving forward towards the Phase 3 execution. We have work to do, but we're in a good position, and we definitely look forward to providing further updates as we progress. Thanks, everybody, and have a great day.

所以謝謝大家今天加入我們。公司有很多事情在進行，也有很多進展。我們正朝第 3 期的執行持續推進。我們還有工作要做，但我們處於良好位置，也非常期待在推進過程中提供更多更新。謝謝大家，祝各位有美好的一天。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating, and you may now disconnect.

感謝各位參與，現在可以掛線。