Altimmune Inc (ALT) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Altimmune first quarter 2026 financial results conference call. (Operator Instructions) As a reminder, this call is being recorded. I'll now introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.

各位女士、先生，早安，歡迎參加 Altimmune 2026 年第一季財務業績電話會議。(接線員指示) 提醒各位，本次電話會議將被錄音。現在我將介紹今天電話會議的主持人：投資人關係副總裁 Luis Sanay。Luis，請開始。

Thank you, operator. Good morning, everyone. Thank you for joining us for Altimmune's first quarter 2026 financial results and business update call. On today's call, you will hear from Jerry Durso, our President and Chief Executive Officer; Dr. Christophe Arbet-Engels, Chief Medical Officer; Linda Richardson, Chief Commercial Officer; and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we'll open the line for the Q&A session. Our first quarter 2026 earnings release was issued this morning and can be found on the Investor Relations section of our website.

謝謝，接線員。各位早安。感謝各位參加 Altimmune 2026 年第一季財務業績與業務更新電話會議。今天的電話會議中，您將聽到我們的總裁兼執行長 Jerry Durso、首席醫療長 Christophe Arbet-Engels 醫師、首席商務長 Linda Richardson，以及財務長 Greg Weaver 的發言。在管理團隊的準備發言之後，我們將開放 Q&A 問答時段。我們 2026 年第一季的財報新聞稿已於今早發布，可於我們網站的投資人關係專區查閱。

Before we begin, I would like to remind everyone that remarks made about future expectations, plans and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause 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 SEC filings.

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 提醒，這些前瞻性陳述存在風險與不確定性，可能導致實際結果與所示內容有重大差異。關於可能影響公司未來業績與營運之風險因素的說明，請參閱我們向 SEC 提交的文件。

I also direct you to read the forward-looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date, May 13, 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. As a reminder, this call is being recorded and will be available for audio replay on our website.

我也請各位閱讀我們今早發布新聞稿中的前瞻性陳述免責聲明。本次電話會議中的任何陳述僅截至今日（2026 年 5 月 13 日）有效，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。提醒各位，本次電話會議將被錄音，並可於我們網站收聽音訊重播。

With that, I'll now turn the call over to Jerry Durso.

接下來，我把電話交給 Jerry Durso。

Good morning, everyone, and thank you for joining us today for our first quarter 2026 financial results and business update call. During our last earnings call, I discussed that one of my first priorities as CEO was to strengthen Altimmune's foundation to equip us for the continued successful advancement of pemvidutide and support our evolution into a late-stage development company. Since the start of the year, we've made significant progress across multiple fronts and are excited about the opportunities ahead of us.

各位早安，感謝各位今天參加我們 2026 年第一季財務業績與業務更新電話會議。在上次財報電話會議中，我提到我擔任執行長後的首要任務之一，是強化 Altimmune 的基礎，以使我們能持續成功推進 pemvidutide，並支持我們演進成為一家後期開發公司。自今年年初以來，我們在多個面向取得顯著進展，並對未來的機會感到振奮。

Let me take a moment to highlight our recent progress. First, we have continued to enhance and build our team strategically to ensure we are best positioned to deliver on our vision as we enter a new phase for Altimmune. We've also remained focused on strengthening our financial foundation.

我先花一點時間重點說明我們近期的進展。首先，隨著 Altimmune 進入新階段，我們持續以策略性方式強化並擴建團隊，確保我們能以最佳狀態實現願景。我們也持續專注於強化財務基礎。

Importantly, in April, we completed an oversubscribed public offering resulting in USD225 million in gross proceeds. The proceeds from the April offering, along with our existing funds, results in a cash balance of approximately USD535 million as of April 13. We now have the financial resources to fully fund the company through our Phase III MASH 52-week data readout, which is expected in 2029. This financing highlights the confidence and the conviction of participating top-tier biotech investors in the potential of pemvidutide and represents another key step towards bringing pemvi to patients.

重要的是，我們在 4 月完成一項超額認購的公開發行，總募集金額為 2.25 億美元。4 月發行所得款項加上我們既有資金，使我們截至 4 月 13 日的現金餘額約為 5.35 億美元。我們現在具備充足的財務資源，可完全支應公司運作直至第三期 MASH 試驗 52 週數據讀出，預計於 2029 年公布。本次融資凸顯參與的頂尖生技投資人對 pemvidutide 潛力的信心與堅定看法，也代表我們將 pemvi 帶給病患的另一個關鍵里程碑。

We're entering a new phase for the company with the right team in place and a very strong balance sheet. We're now focused on execution and believe we're well-positioned to successfully execute our strategy. We believe that pemvidutide has the potential to bring meaningful benefit to people affected by a variety of hepatic diseases. The balanced one-to-one agonism of glucagon and GLP-1 in a single molecule achieved with pemvi makes it potentially well-suited for the liver conditions we're targeting.

公司正進入新階段，我們已具備合適的團隊與非常強健的資產負債表。我們目前專注於執行，並相信我們已處於有利位置，能成功落實策略。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肝臟適應症。

Additionally, pemvi incorporates our proprietary EuPort structure, which slows absorption and is believed to drive improved tolerability, potentially reducing GI and other side effects. This can lead to greater treatment adherence. Importantly, keeping patients on therapy at the right dose is crucial to the management of chronic diseases such as MASH. Recent market research we've conducted points to attributes that would drive prescribing in MASH, including a highly favorable tolerability profile that does not sacrifice efficacy and quality weight loss. These are two of the potentially differentiating characteristics of pemvidutide based on our clinical trials to date.

此外，pemvi 採用我們專有的 EuPort 結構，可減緩吸收，並被認為能提升耐受性，可能降低腸胃道（GI）及其他副作用。這可帶來更高的治療依從性。重要的是，讓病患以適當劑量持續接受治療，對於如 MASH 等慢性疾病的管理至關重要。我們近期進行的市場調查指出，能驅動 MASH 處方的特性包括：在不犧牲療效的前提下具高度良好的耐受性，以及高品質的體重下降。根據我們迄今的臨床試驗結果，這兩點是 pemvidutide 可能具差異化的特徵。

As the MASH market continues to evolve, there remains a significant unmet need. We believe pemvi has the potential to offer a differentiated profile for patients. Furthermore, the potential of pemvi has been recognized with breakthrough therapy designation in MASH by the FDA.

隨著 MASH 市場持續演進，仍存在顯著未被滿足的醫療需求。我們相信 pemvi 有潛力為病患提供具差異化的產品特性。此外，pemvi 的潛力已獲 FDA 在 MASH 領域授予突破性療法認定。

We're continuing to advance our efforts and expect to initiate our global Phase III study in MASH in the second half of this year. The MASH Phase III trial will be called the PERFORMA trial. We've now finalized the study protocol and submitted that to the FDA as part of the standard process. We've also completed the scientific advice process in Europe.

我們持續推進相關工作，並預期在今年下半年啟動全球第三期 MASH 研究。這項 MASH 第三期試驗將命名為 PERFORMA 試驗。我們已完成最終研究方案並依標準流程提交 FDA。我們也已完成在歐洲的科學諮詢程序。

The final study protocol is aligned with the feedback we've received from EMA. Altimmune is fully focused on the startup phase for a large global Phase III trial. We're moving quickly, partnering with a CRO who brings deep know-how in the MASH Phase III space. The Altimmune team is working closely with them, and we're progressing to activate the most experienced trial sites and then we'll look forward to initiating patient screening.

最終研究方案已與我們自 EMA 收到的回饋一致。Altimmune 全力聚焦於大型全球第三期試驗的啟動階段。我們正快速推進，並與一家在 MASH 第三期領域具深厚專業的 CRO 合作。Altimmune 團隊正與其密切合作，推進啟用最具經驗的試驗中心，接著我們將期待開始病患篩選。

While we have significant focus on our lead MASH program in initiating the PERFORMA study, we're also progressing on two additional indications. First, in AUD, an area of high unmet need, we remain on track to report top-line data from our Phase II trial next quarter. We remain encouraged by the strong scientific interest in this indication and look forward to the data readout. In ALD, we now expect to complete enrollment of the RESTORE trial in the third quarter of this year.

在我們高度聚焦於主要的 MASH 計畫並啟動 PERFORMA 研究的同時，我們也在推進另外兩項適應症。首先，在 AUD（酒精使用疾患）這個高度未被滿足的領域，我們仍按計畫於下季公布第二期試驗的主要（top-line）數據。我們對此適應症所獲得的強烈科學界關注仍感到鼓舞，並期待數據讀出。在 ALD（酒精性肝病）方面，我們目前預期將於今年第三季完成 RESTORE 試驗的受試者收案。

Pemvidutide represents a unique and compelling opportunity to improve the lives of people with MASH and other liver conditions. It has the potential to become an important tool for physicians as they look to improve upon the current treatment paradigm and meet the needs of their patients.

Pemvidutide 代表一項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。當醫師希望改善現有治療模式並滿足病患需求時，它有潛力成為重要工具。

With a stronger team in place and cash runway through the top-line readout of our PERFORMA Phase III MASH trial, we're now laser-focused on execution. We're moving with urgency on bringing pemvi to patients who may benefit from its promising therapeutic profile and creating long-term value for our shareholders.

在更強的團隊到位，且現金跑道可支應至 PERFORMA 第三期 MASH 試驗主要結果讀出之後，我們現在高度聚焦於執行。我們正以緊迫感推進，將 pemvi 帶給可能受益於其具前景治療特性的病患，並為股東創造長期價值。

With that, I'll turn the call over to Christophe for our clinical update.

接下來，我把電話交給 Christophe，請他提供臨床進度更新。

Thank you, Jerry. The startup activities for the PERFORMA Phase III MASH trial continue to progress as planned, and we are well on our way towards initiating the study in the second half of the year. In the last few weeks, we have finalized and submitted the study protocol to the FDA, and the Altimmune team is working closely with our CRO partner. We are ensuring the global infrastructure, vendors, labs, and clinical supply chains are in place to support a successful trial. These activities will allow us to initiate screening and start enrolling patients in the second half of the year.

謝謝你，Jerry。PERFORMA 第三期 MASH 試驗的啟動作業持續按計畫推進，我們正穩步邁向在今年下半年啟動研究。在過去幾週內，我們已完成並向 FDA 提交研究方案，Altimmune 團隊也正與我們的 CRO 合作夥伴密切協作。我們正確保全球基礎設施、供應商、實驗室與臨床供應鏈到位，以支持試驗成功。這些作業將使我們能在今年下半年啟動篩選並開始收納受試者。

We are also pleased to report alignment on the Phase III trial design with both FDA and now EMA. As we expected, feedback received from EMA validated our planned trial design and represented the final regulatory step in our Phase III preparation. This is an important milestone in our global development strategy as the data from the PERFORMA Phase III trial will form the basis for regulatory submission in multiple regions.

我們也很高興回報，我們已就第三期試驗設計與 FDA 以及目前的 EMA 達成一致。如我們所預期，EMA 所提供的回饋驗證了我們規劃的試驗設計，並代表我們第三期準備工作的最後一個監管步驟。這是我們全球開發策略中的重要里程碑，因為 PERFORMA 第三期試驗的數據將構成我們在多個地區進行監管申請的基礎。

Importantly, we achieved strong efficacy results at both 24 and 48 weeks in the Phase II IMPACT trial, particularly at 1.8 mg. We will introduce the 2.4 mg pemvidutide dose in Phase III, which has achieved additional weight loss in a previous obesity study and could potentially show increased liver efficacy beyond what was observed at the 1.8 mg dose in Phase II.

重要的是，我們在第二期 IMPACT 試驗中於第 24 週與第 48 週均取得強勁的療效結果，尤其是在 1.8 mg 劑量下。我們將在第三期導入 2.4 mg 的 pemvidutide 劑量；該劑量在先前的肥胖症研究中達成了額外的體重下降，且有可能在肝臟療效方面展現出較第二期 1.8 mg 劑量所觀察到更高的效果。

We also observed improved adherence to treatment and low discontinuation rate, lower than placebo, which is critical to addressing a serious chronic liver disease, such as MASH.Based on the strong Phase II data and based on the design and the powering of the pivotal Phase III study, we are looking forward for pemvi to continue showing benefits for MASH patients.

我們也觀察到治療依從性提升且停藥率偏低，甚至低於安慰劑組；這對於因應 MASH 等嚴重慢性肝病至關重要。基於強勁的第二期數據，以及關鍵性第三期研究的設計與統計效力（powering），我們期待 pemvi 能持續為 MASH 患者展現效益。

We have announced this morning the 48-week results from the Phase II IMPACT trial will be the subject of an oral presentation by Dr. Mazen Noureddin at the EASL conference later this month in Barcelona. This abstract for the oral presentation has been selected as a best of EASL abstract, which highlight the most noteworthy contribution to the scientific program at EASL.

我們今早宣布，第二期 IMPACT 試驗的 48 週結果將於本月稍晚在巴塞隆納舉行的 EASL 會議上，由 Mazen Noureddin 醫師進行口頭報告。該口頭報告摘要已獲選為 EASL 最佳摘要（best of EASL abstract），用以凸顯對 EASL 科學議程最具重要性的貢獻。

In addition, our presence at EASL conference will increase this year with another three posters about cardiovascular risk factors, including weight loss, NIT, and qFibrosis. We believe that the oral presentation and the interest from the scientific community through these activities speaks to the excitement around pemvidutide. We will also have a medical affair booth and participate in many interactions with KOLs and potential investigators for the PERFORMA Phase III trial. We look forward to engaging with the liver community and supporting their excitement on pemvidutide.

此外，我們今年在 EASL 會議的參與度將提高，另有三份海報聚焦於心血管風險因子，包括體重下降、NIT 與 qFibrosis。我們相信，口頭報告以及透過這些活動所獲得的科學界關注，反映出外界對 pemvidutide 的高度期待。我們也將設置醫學事務攤位，並與 KOL 及 PERFORMA 第三期試驗的潛在研究者進行多方交流。我們期待與肝病領域社群互動，並支持他們對 pemvidutide 的熱情。

While our near-term focus is now the execution of the PERFORMA Phase III MASH pivotal trial, we have another milestone approaching this year with the top-line data from the Phase II RECLAIM trial of pemvidutide in alcohol use disorder expected in the third quarter. We believe the AUD population, who has a high unmet need, is particularly suited for pemvidutide therapy because of the expected GLP-1 action on alcohol cravings, the direct glucagon activity on the early liver disease, including steatosis, inflammation, and early fibrosis, and the excellent tolerability which we have observed to date and is critical in this population.

雖然我們近期的重點已轉向執行 PERFORMA 第三期 MASH 關鍵性試驗，但今年我們也將迎來另一個里程碑：預計第三季公布 pemvidutide 用於酒精使用疾患（AUD）的第二期 RECLAIM 試驗主要（top-line）數據。我們認為 AUD 人群存在高度未被滿足的醫療需求，且特別適合 pemvidutide 治療，原因包括：預期 GLP-1 對酒精渴求的作用、胰高血糖素（glucagon）對早期肝病（包括脂肪變性、發炎與早期纖維化）的直接活性，以及我們迄今觀察到的優異耐受性，而這在該人群中至關重要。

As a reminder, the RECLAIM trial is evaluating the 2.4 mg dose of pemvidutide with a simple 2-step monthly titration scheme versus placebo in 100 subject with moderate to severe AUD. Subjects are dosed once weekly for 24 weeks, and the primary efficacy endpoint is the change from baseline in heavy drinking days, which are defined as five or more drinks for men and four or more drinks for women in a 24-hour period.

提醒一下，RECLAIM 試驗正在評估 2.4 mg 劑量的 pemvidutide，採用簡單的每月兩步驟劑量遞增方案，並與安慰劑在 100 名中度至重度 AUD 受試者中進行比較。受試者每週給藥一次，為期 24 週；主要療效終點為重度飲酒日（heavy drinking days）相較基線的變化，其中重度飲酒日定義為 24 小時內男性飲酒 5 杯或以上、女性飲酒 4 杯或以上。

Key secondary endpoints include zero heavy drinking days, a two-level reduction in the WHO risk drinking level, change in measures of alcohol consumption, and change in body weight and BMI. An important exploratory endpoint is the change in phosphatidylethanol, or PEth, which is a more objective blood-based biomarker of alcohol consumption that represents alcohol intake over the most recent four to eight weeks. We look forward to sharing the top-line data next quarter. In addition, the RESTORE trial in ALD evaluating pemvidutide's effect on liver-related NAS, markers of alcohol consumption, and body weight is continuing to enroll and we now expect to complete enrollment in the third quarter of this year.

關鍵次要終點包括：重度飲酒日為零、WHO 風險飲酒等級降低兩級、酒精攝取量相關指標的變化，以及體重與 BMI 的變化。一項重要的探索性終點為磷脂乙醇（phosphatidylethanol，PEth）的變化；PEth 是較客觀的血液型酒精攝取生物標記，可反映最近四到八週的酒精攝取量。我們期待在下一季分享主要數據。此外，評估 pemvidutide 對酒精性肝病（ALD）之肝臟相關 NAS、酒精攝取標記與體重影響的 RESTORE 試驗仍在持續收案，我們目前預期將於今年第三季完成收案。

In summary, with a heavy focus on the execution of the PERFORMA Phase III trial, we continue advancing our clinical development program for pemvi with important milestones expected throughout the rest of this year. These efforts are integral to our long-term value creation strategy, which centers on optimizing the therapeutic potential of our balanced 1-to-1 glucagon GLP-1 dual agonist, pemvidutide, in serious liver diseases.

總結而言，在高度聚焦於 PERFORMA 第三期試驗執行的同時，我們持續推進 pemvi 的臨床開發計畫，並預期今年剩餘期間將陸續達成重要里程碑。這些努力是我們長期價值創造策略不可或缺的一環；該策略核心在於，於嚴重肝病領域中最大化我們 1 比 1 平衡型胰高血糖素/GLP-1 雙重致效劑 pemvidutide 的治療潛力。

And with that, I will turn the call to Linda.

接下來，我把電話交給 Linda。

Thanks, Christophe, and good morning, everyone. The MASH market is evolving as approved drugs and a number of others in late-stage development represent a range of modalities that aim to address various segments of the broader MASH patient population. This reinforces our belief that as the market continues to evolve, distinct patient segments with unique needs will begin to emerge. Satisfying those needs will be a key driver of success. As Christophe mentioned, our IMPACT Phase III trial design has factored in key learnings from our Phase II data sets, and we believe this positions pemvi well for future competitiveness in the market.

謝謝你，Christophe，各位早安。隨著已核准藥物以及多項處於後期開發階段的候選藥物陸續出現，MASH 市場正在演變；這些療法涵蓋多種作用機制（modalities），旨在滿足更廣泛 MASH 患者族群中的不同分群需求。這也強化了我們的看法：隨著市場持續演進，具有獨特需求的不同患者分群將逐步浮現。滿足這些需求將是成功的關鍵驅動因素。如 Christophe 所提，我們的 IMPACT 第三期試驗設計已納入第二期數據集的關鍵學習，我們相信這使 pemvi 在未來市場競爭中具備良好定位。

The potential target product profile for pemvidutide in MASH includes strong early metabolic benefits, significant improvements in inflammation and fibrosis, and quality weight loss that also helps preserve lean muscle mass, combined with a patient-friendly, simple titration that leads to a low rate of discontinuation due to GI side effects. This combination of features and resulting potential benefits resonates with HCPs and leads us to believe pemvi may provide real advantages to patients facing serious liver diseases.

pemvidutide 在 MASH 的潛在目標產品特性（target product profile）包括：強勁的早期代謝效益、發炎與纖維化的顯著改善，以及高品質的體重下降（同時有助於保留瘦體重/肌肉量），並結合對患者友善、簡單的劑量遞增方式，以降低因腸胃道（GI）副作用而停藥的比例。這些特性組合及其潛在效益與醫療照護專業人員（HCPs）的需求相契合，也使我們相信 pemvi 可能為面臨嚴重肝病的患者帶來實質優勢。

During our last two earnings calls, I shared key data points from market research studies we commissioned engaging healthcare professionals in both the US and Europe. The feedback collected from these exercises highlighted the importance of potential key differentiating attributes for pemvi that would influence future prescribing decisions in MASH, a highly favorable tolerability profile that does not sacrifice efficacy and quality weight loss.

在過去兩次財報電話會議中，我分享了我們委託進行的市場研究之關鍵數據點；該研究邀請了美國與歐洲的醫療照護專業人員參與。這些研究所蒐集的回饋凸顯了 pemvi 可能具備的關鍵差異化屬性，將影響未來在 MASH 的處方決策，包括：高度良好的耐受性（不以犧牲療效為代價）以及高品質的體重下降。

First, let's discuss the highly favorable tolerability profile we've seen to date in our IMPACT trial, which did not include any dose titration. Results showed that both the 1.2 and 1.8 mg doses of pemvi were efficacious, showing early evidence of MASH resolution and NIT-based anti-fibrotic effects while being well-tolerated. In fact, there were fewer AE-related discontinuations in the two pemvi arms than in the placebo group.

首先，我們來討論迄今在 IMPACT 試驗中所見到的高度良好耐受性；該試驗並未包含任何劑量遞增。結果顯示，pemvi 的 1.2 mg 與 1.8 mg 劑量皆具療效，展現 MASH 緩解（resolution）的早期證據，以及以 NIT 為基礎的抗纖維化效果，同時耐受性良好。事實上，兩個 pemvi 組因不良事件（AE）而停藥的比例低於安慰劑組。

To potentially further enhance efficacy and optimize tolerability, our IMPACT trial design includes a simple titration schedule that begins with an active starting dose of 1.2 mgs and escalates to either a 1.8 or 2.4 mg dose after only one or two titration steps of four weeks. In a real-world setting, this patient-friendly, simple, and quick titration could readily translate to patients remaining on treatment longer, allowing for a greater likelihood of achieving therapeutic benefit, especially in a chronic condition like MASH.

為了可能進一步提升療效並最佳化耐受性，我們的 IMPACT 試驗設計納入一個簡單的劑量遞增時程：以 1.2 mg 的有效起始劑量開始，並在僅一到兩個、每次四週的遞增步驟後，提升至 1.8 或 2.4 mg 劑量。在真實世界情境中，這種對患者友善、簡單且快速的遞增方式，可能更容易轉化為患者更長時間維持治療，從而提高達成治療效益的機率，尤其是在像 MASH 這樣的慢性疾病中。

Let's compare this combination of simple titration and favorable tolerability to other therapies on the market or being evaluated for use in MASH. GLP-1 based therapies, in particular, have been associated with GI side effects that lead to discontinuations in both clinical trial and real-world settings. One competitor's Phase II trial included a titration schedule that used 12 different strengths over 20 weeks to get to the maximum dose and at least seven steps to get to the lowest effective dose, all in a proactive attempt to manage GI-related side effects. Still, approximately one in four patients discontinued therapy due to GI side effects.

接著，我們將這種「簡單遞增 + 良好耐受性」的組合，與市面上或正在評估用於 MASH 的其他療法進行比較。尤其是以 GLP-1 為基礎的療法，已被認為與腸胃道（GI）副作用相關，並在臨床試驗與真實世界情境中導致停藥。某競品的第二期試驗包含一個劑量遞增時程：在 20 週內使用 12 種不同劑量強度以達到最大劑量，且至少需要七個步驟才能達到最低有效劑量，皆是為了主動管理 GI 相關副作用。即便如此，約每四位患者就有一位因 GI 副作用而停止治療。

In clinical practice, dropout rates are typically even higher than those in clinical trials, where patients are actively managed and encouraged to stay on treatment. From our own market research, we know that physicians are now indicating that there is an emerging unmet need for new options for patients who could not tolerate semaglutide. How can patients get the efficacy they need when tolerability is a real barrier?

在臨床實務中，退組率通常甚至高於臨床試驗，因為在臨床試驗中，病患會被積極管理並被鼓勵持續接受治療。根據我們自身的市場調查，我們知道醫師目前指出，對於無法耐受司美格魯肽（semaglutide）的病患，正出現一項新選擇的未被滿足需求。當耐受性確實是一項重大障礙時，病患要如何獲得所需的療效？

Shifting the discussion now to the quality of weight loss as an additional potential differentiator for pemvi, we saw steady weight loss with our 1.8 mg dose in our Phase II MASH trial, with no evidence of plateauing over 48 weeks. This pattern also occurred in our obesity trial, where pemvi demonstrated less of an impact on lean muscle mass than has been reported in other GLP-1 trials. Rapid drops in weight loss have been associated with a greater negative impact on lean muscle mass.

現在把討論轉向減重品質，作為 pemvi 另一項潛在差異化因素；我們在第二期 MASH 試驗中以 1.8 mg 劑量觀察到穩定的體重下降，且在 48 週內沒有出現平台期的證據。這種模式也出現在我們的肥胖試驗中，pemvi 對瘦體重（lean muscle mass）的影響較其他 GLP-1 試驗報告的更小。體重快速下降與對瘦體重更大的負面影響有關。

Current projected average age at diagnosis for MASH patients in the US is between 55 and 60. This represents a high degree of overlap with the ages where preservation of lean muscle mass becomes a concern. Patients diagnosed with MASH and sarcopenia are at a significantly higher risk for adverse outcomes. Therefore, the importance of preserving lean muscle mass in the MASH population should not be underestimated.

目前預估美國 MASH 病患的平均診斷年齡介於 55 至 60 歲。這與需要關注瘦體重保存的年齡區間高度重疊。同時被診斷為 MASH 與肌少症（sarcopenia）的病患，其不良結局風險顯著更高。因此，對於 MASH 人群而言，保存瘦體重的重要性不容低估。

We naturally begin to lose lean muscle mass as we age, with an acceleration of loss around age 60. By age 70, many people have lost 25% to 30% of the muscle mass they possessed in their prime. Over time, loss of lean muscle mass and muscle weakness can lead to metabolic dysfunction, reduced mobility, difficulty performing activities of daily living, and falls and fractures.

隨著年齡增長，我們會自然開始流失瘦體重，且約在 60 歲左右流失速度加快。到 70 歲時，許多人已失去其壯年時肌肉量的 25% 至 30%。隨著時間推移，瘦體重流失與肌力下降可能導致代謝功能失調、行動力降低、日常生活活動執行困難，以及跌倒與骨折。

Clearly, therapies that help reduce the impact of lean muscle loss in patients with MASH are needed for this at-risk population, and we will be evaluating this in our Phase III MASH program. We continue to believe very strongly in the potential of pemvidutide to offer meaningful benefits to patients with MASH, and that its potential unique attributes position it well to stand out in a commercial setting. We look forward to generating additional clinical data to support these benefits in our Phase III MASH program and to sharing additional insights from our pre-commercial work along the way.

顯然，對於這個高風險族群，需要能協助降低 MASH 病患瘦體重流失影響的治療方式；我們將在第三期 MASH 計畫中評估此點。我們仍然非常堅信 pemvidutide 有潛力為 MASH 病患帶來具意義的效益，且其可能具備的獨特屬性，使其在商業化環境中具備突出的定位。我們期待在第三期 MASH 計畫中產出更多臨床數據以支持這些效益，並在過程中分享更多來自我們商業化前工作的洞見。

With that, I'll turn it over to Greg for the financial review.

接下來，我把時間交給 Greg 進行財務回顧。

Thanks, Linda. Good morning. Starting with the balance sheet here. A key strategic focus for the company was securing access to the capital required to successfully drive our clinical programs. To that end, in April, we're pleased to complete an oversubscribed public offering with gross proceeds of USD225 million, with participation from top-tier biotech investors.

謝謝，Linda。各位早安。先從資產負債表開始。公司的一項關鍵策略重點，是確保取得成功推進臨床計畫所需的資本。為此，我們很高興在 4 月完成一項超額認購的公開發行，募集總額為 2.25 億美元，並獲得頂級生技投資人參與。

As of March 31, we reported total cash of USD332 million, and on a pro forma basis, our cash position as of April 30 is USD535 million. This very strong cash position now provides us with the operating cash runway through the pro forma Phase III MASH 52-week data readout expected in 2029. Moving to our financial results for the quarter.

截至 3 月 31 日，我們報告的現金總額為 3.32 億美元；以備考（pro forma）基礎計算，截至 4 月 30 日的現金部位為 5.35 億美元。這個非常強勁的現金部位，現在可提供我們營運現金跑道，支撐至預計於 2029 年公布的第三期 MASH 52 週數據（備考基礎）。接著看本季的財務結果。

R&D expense in Q1 2026 was USD16.2 million, as compared to USD15.8 million for the same period prior year. The increase in R&D spend was driven primarily by the ongoing AUD and ALD trials, as well as the start-up cost for the PERFORMA Phase III trial in MASH, partially offset by a decrease in expenses related to the completion of the IMPACT Phase II trial in MASH, which was ongoing in 2025. The Q1 2026 spend includes USD9.5 million in direct costs related to pemvidutide development, of which USD3.7 million was for MASH and USD4.2 million for the Phase IIs in AUD and ALD, and USD1.6 million in CMC related expenses. Q1 2026 also included USD1.2 million in total non-cash stock comp.

2026 年第一季研發費用為 1,620 萬美元，較前一年度同期的 1,580 萬美元增加。研發支出增加主要由持續進行的 AUD 與 ALD 試驗，以及 MASH 的 PERFORMA 第三期試驗啟動成本所帶動；部分被與 2025 年仍在進行、現已完成的 MASH IMPACT 第二期試驗相關費用下降所抵銷。2026 年第一季支出包含與 pemvidutide 開發相關的 950 萬美元直接成本，其中 370 萬美元用於 MASH、420 萬美元用於 AUD 與 ALD 的第二期試驗，另有 160 萬美元為 CMC 相關費用。2026 年第一季亦包含合計 120 萬美元的非現金股票酬勞費用。

G&A expense in Q1 2026 totaled USD8.1 million, as compared to USD6 million for the same period in 2025. The increase in G&A primarily driven by an increase in severance costs and professional fees. The first quarter 2026 G&A included USD2.1 million in total non-cash stock comp. The net loss for the first quarter 2026 is USD22.6 million or USD0.18 a share, compared to a net loss of USD19.6 million or USD0.26 per share in the first quarter of 2025.

2026 年第一季一般及行政（G&A）費用合計 810 萬美元，較 2025 年同期的 600 萬美元增加。G&A 增加主要由資遣成本與專業服務費用上升所致。2026 年第一季 G&A 包含合計 210 萬美元的非現金股票酬勞費用。2026 年第一季淨損為 2,260 萬美元或每股 0.18 美元，相較之下，2025 年第一季淨損為 1,960 萬美元或每股 0.26 美元。

Looking ahead, we're looking forward to initiating the PERFORMA Phase III MASH trial in the second half of the year and top-line data readout from the Phase II AUD trial next quarter. With the stronger balance sheet providing us with the cash runway through Phase III data, we're now really focused on execution and looking forward to continuing to advance pemvidutide. This concludes our prepared remarks, and I'll now turn the call back to the operator for the Q&A session.

展望未來，我們期待在今年下半年啟動 PERFORMA 第三期 MASH 試驗，並於下季取得 AUD 第二期試驗的主要（top-line）數據讀出。在更強健的資產負債表提供我們可支撐至第三期數據的現金跑道之下，我們現在真正聚焦於執行，並期待持續推進 pemvidutide。以上為我們的準備發言，接下來我把電話交回給主持人進行問答環節。

Operator.

主持人。

(Operator Instructions) Ellie Merle, Barclays.

（主持人指示）Barclays 的 Ellie Merle。

Congrats on all the progress, and thanks for taking the question. You announced this morning some presentations at EASL. Can you go into some more details on what new information we'll learn from these? Thanks.

恭喜你們取得所有進展，也謝謝讓我提問。你們今天早上宣布在 EASL 有一些發表。你們能否更詳細說明一下，我們將從這些發表中得知哪些新資訊？謝謝。

Ellie, hi. Thanks for the question. Christophe, can you take that one?

Ellie，你好。謝謝你的問題。Christophe，你可以回答這題嗎？

Sure. The different presentations we're going to bring at EASL are regarding our qFibrosis, so additional evidence of early fibrosis, antifibrotic effects that we had at 24 weeks on our biopsy. It's a different type of reading from AI-generated read. We're going to have as well some look at our weight loss and potential lipid data, cardiovascular risk in this population.

當然。我們將在 EASL 帶來的不同發表，主要與我們的 qFibrosis 有關，也就是在切片檢體上於 24 週所觀察到的早期纖維化與抗纖維化效果的更多證據。這是一種不同類型的解讀方式，來自 AI 生成的判讀。我們也會呈現一些關於減重以及潛在血脂數據的分析，並探討此族群的心血管風險。

Obviously, very importantly, we'll have our 48-week data that we'll be sharing in this oral presentation that's been where the abstract was selected as best of EASL. We're really happy with this. It's an important contribution to the scientific program based on their selection, and we believe it is the case as well. Excited about it.

當然，非常重要的是，我們將分享 48 週數據，並在這場口頭報告中呈現；該摘要已被選為 EASL 的最佳摘要。我們對此非常高興。基於他們的遴選，這是對科學議程的重要貢獻，而我們也相信確實如此。我們很期待。

Great. Thanks.

很好。謝謝。

Roger Song, Jefferies.

Jefferies 的 Roger Song。

Congrats for the quarter and all the progress, and thank you for taking the question. Since you're finalizing the Phase III MASH trial starting second half, I'm just curious, interim analysis has been updated to the design, potential for futility or the sample size adjustment. That's a question for MASH. Then for AUD, you know, can you just elaborate on what will be the go/no-go decision criteria before you can commit more investment into the pivotal stage? Thank you.

恭喜本季表現與所有進展，也謝謝讓我提問。既然你們正在敲定下半年啟動的第三期 MASH 試驗，我想請教一下：設計中是否更新了期中分析，例如無效（futility）評估或樣本數調整的可能性？這是關於 MASH 的問題。另外就 AUD 而言，你們能否進一步說明，在承諾投入更多資金進入關鍵性（pivotal）階段之前，你們的 go/no-go 決策標準是什麼？謝謝。

Okay, maybe you start on the MASH. I'll take the AUD.

好，那也許你先從 MASH 開始。我來談 AUD。

Sure. On the MASH, the study is designed as an event-driven study to reach the final clinical outcome for final registration. The interim analysis is the 52 weeks, based on biopsy that will support the accelerated approval and for which we're going to have those finish that trial having to read out in 2029. There is no other interim analysis that is planned than these two, and we are again very well powered in order to reach these outcome. I'll let Jerry answer the AUD.

當然。關於 MASH，該研究設計為事件驅動型研究，以達成最終臨床結局，用於最終註冊核准。期中分析是在第 52 週，基於活檢結果，將支持加速核准；而我們預期該試驗完成並讀出結果要到 2029 年。除這兩次之外，沒有規劃其他期中分析；而且我們的統計把握度非常充足，以達成這些結局。AUD 的部分我讓 Jerry 來回答。

Yes. Thanks, Roger. You know, we're definitely encouraged by all the interest emerging in the AUD indication overall and definitely look forward to the readout and good to say that we can say the readout will happen next quarter at this point. Obviously, we'll assess the data fully once we get it and we'll look to disclose that to the market. We'll also then undertake the right conversation with the regulators. All of that will factor into what we think about is the potential value.

是的。謝謝你，Roger。你知道，我們確實受到整體 AUD 適應症日益升溫的關注所鼓舞，也非常期待讀出；而且很高興目前我們可以說，讀出將在下個季度發生。當然，一旦拿到資料，我們會完整評估，並尋求向市場揭露。之後我們也會與監管機構展開適當的對話。這些都會納入我們對潛在價值的判斷。

If we get to a situation where we believe there's value to move ahead with that indication, then we would definitely have a preference in that scenario to really explore non-dilutive options in terms of thinking about funding moving that program ahead. Again, next important step for us is to get the Phase II data readout, and that'll give us some additional insight on, again, an indication where we think pemvi can play a unique role, potentially not only the impact on drinking, but also on the direct liver benefit, which is such an important part of that disease as it progresses.

如果我們判斷該適應症值得推進，那麼在那種情況下，我們會明確偏好去深入探索非稀釋性的選項，來思考推進該計畫的資金來源。再次強調，對我們而言下一個重要步驟是取得第二期數據讀出；這將為我們提供更多洞見——同樣是在一個我們認為 pemvi 能扮演獨特角色的適應症上，可能不僅影響飲酒行為，也能帶來直接的肝臟獲益，而這在疾病進展過程中是非常重要的一環。

Got it. Thank you.

了解。謝謝。

Thanks.

謝謝。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Thanks for taking my question. Just to follow on the AUD questions. Thank you for laying out the differentiation that you see versus semaglutide. What I'm wondering here is, given that they have recently shown some pretty meaningful data in AUD with the addition of glucagon, are there any measurements that you're looking at for AUD that could show the benefit of the direct liver targeting that you'll have with pemvidutide over Wegovy? Any other things that you think that you should be incorporating into the trial or looking at the trial to further differentiate pemvi from Wegovy, given that Wegovy might be generic by the time you come to market?

謝謝讓我提問。我想延續 AUD 的問題。謝謝你們說明相較於 semaglutide 你們看到的差異化。我想問的是，鑑於他們最近在 AUD 上加入胰高血糖素後展示了一些相當有意義的數據，你們在 AUD 方面是否有任何量測指標，能顯示 pemvidutide 相較於 Wegovy 具有直接肝臟靶向的優勢？另外，考量到你們上市時 Wegovy 可能已成為學名藥，你們認為還有哪些應該納入試驗或在試驗中觀察的事項，以進一步凸顯 pemvi 與 Wegovy 的差異？

Then I guess another question on AUD. In terms of the clinically meaningful endpoints, you have heavy drinking days, clearly, and you also have some abstinence. Is it clear what the final endpoint should be for Phase III from a regulatory perspective? I'm just curious on that. Thank you.

那我想再問一個關於 AUD 的問題。就臨床上有意義的終點而言，你們有重度飲酒天數，當然也有一些戒酒（禁酒）。從監管角度來看，第三期的最終終點應該是什麼，是否已經明確？我只是好奇這點。謝謝。

Okay. Maybe Christophe will take that in order. First, the question on the differentiation and how do we see that evolving, and then second on the appropriate endpoints from a regulatory context.

好的。也許請 Christophe 依序回答。先談差異化以及我們如何看待其演進，接著再談從監管脈絡來看合適的終點。

Right. No, thank you. First, we're really excited to see those semaglutide data because this is clearly validating the hypothesis that pemvidutide has a real potential to show benefits in this population. In addition to this, as you mentioned, the glucagon part is really important. We believe that, and we know this has been demonstrated, there has been presentation in the past conferences, scientific conferences, that these patients have early markers of liver disease, including steatosis, inflammation, and even early fibrosis. Targeting the liver is really a critical aspect for us. That is something that the GLP-1 alone will not be able to achieve since there is no GLP-1 receptor in the liver.

好的。不，謝謝。首先，我們很興奮看到那些 semaglutide 的數據，因為這清楚驗證了這個假設：pemvidutide 在這個族群中確實有潛力展現效益。此外，如你所提到的，胰高血糖素的部分非常重要。我們相信，而且也知道已有證據顯示——過去在一些會議、科學研討會上已有報告——這些患者具有肝病的早期指標，包括脂肪變性、發炎，甚至早期纖維化。因此，鎖定肝臟對我們而言是非常關鍵的一環。而這是單靠 GLP-1 無法達成的，因為肝臟中沒有 GLP-1 受體。

In our study, we have markers of liver healthiness that we're going to be looking at. To your last point, we will obviously look at all the data that we will have and see how we can incorporate those differentiation factors into our Phase III, into the registration program, how to do this best, because we believe here that we have, again, a product that is really well suited for this population.

在我們的研究中，我們會觀察肝臟健康狀態的相關指標。至於你最後提到的點，我們當然會檢視我們將取得的所有數據，並思考如何把這些差異化因素納入我們的第三期、納入註冊計畫中，如何做到最好；因為我們相信，在這裡我們再次擁有一個非常適合這個族群的產品。

The last piece that I would remind you about is the adherence to treatment, to the tolerability in the population that is fairly healthy otherwise, and for which pemvidutide, if we continue to show what we've seen in our IMPACT Phase II MASH data, should be again having a clear advantage with that population. That's important.

最後我想提醒的一點是治療依從性與耐受性——在這個除此之外相對健康的族群中——而如果 pemvidutide 能持續展現我們在 IMPACT 第二期 MASH 數據中所看到的表現，那麼它在這個族群中應該會再次具有明顯優勢。這很重要。

Regarding the endpoints, for Phase III, right now, the FDA has proposed two endpoints, the zero drinking days, heavy drinking days, or a change in two steps, two levels in the WHO drinking ranking between those. We'll explore these two. We'll see where our data will lead us, and we'll have those discussions with the FDA when we reach the end of Phase II meeting.

關於終點，針對第三期，目前 FDA 提出了兩個終點：零飲酒天數、重度飲酒天數，或是在 WHO 飲酒分級中達到兩步、兩個等級的變化。我們會探索這兩者。我們會看數據將引導我們走向何處，並在第二期結束會議時與 FDA 進行討論。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Thanks so much for taking my question, congrats on the progress. Two questions from me. At your December IMPACT call, you said that there was no obvious path to reevaluate the 24-week biopsy data in an AIM-MASH-like way because Liver Explore is a different quantitative tool. That said, the EASL poster now says quantitative digital pathology showed fibrosis regression at 24 weeks. Can you clarify what exactly is new in that analysis? The second question is just given Roche's proposed acquisition of PathAI, does that change anything in how you plan to incorporate AIM-MASH AI Assist into the Phase III biopsy read process? Thank you.

非常感謝讓我提問，也恭喜進展。我有兩個問題。在你們 12 月的 IMPACT 電話會議上，你們提到沒有明顯途徑能以類似 AIM-MASH 的方式重新評估 24 週的活檢數據，因為 Liver Explore 是不同的量化工具。不過，EASL 的海報現在寫到，量化數位病理在 24 週顯示纖維化回退。你們能否釐清這項分析到底新增了什麼？第二個問題是，鑑於 Roche 擬收購 PathAI，這是否會改變你們在第三期活檢判讀流程中納入 AIM-MASH AI Assist 的計畫？謝謝。

Maybe I'll start with the second question first, and then Christophe can clarify. There are a lot of different AI tools, so it is a little important to track exactly which one is being used where. First, I think on the question of the acquisition by Roche Diagnostics of PathAI. As you would imagine, the teams are working extremely closely between Altimmune and Path on the Phase III incorporation of the AIM-MASH AI Assist.

也許我先回答第二個問題，然後再請 Christophe 釐清。AI 工具有很多種，因此追蹤到底哪一個用在何處會比較重要。首先，關於 Roche Diagnostics 收購 PathAI 的問題。如你所想像，Altimmune 與 Path 的團隊正就第三期納入 AIM-MASH AI Assist 進行非常緊密的合作。

You know, that conversation has continued fully since the announcement, and we don't anticipate any change to the process that's already been mapped and all the planning around how execution is going to work on being the first program that will be able to incorporate the AIM-MASH AI Assist tool to the pathologists in the Phase III.

你知道，自公告以來，這些對話一直持續進行，我們不預期已經規劃好的流程會有任何改變；也不預期圍繞執行方式的所有規劃會有變動——我們將成為第一個能在第三期中把 AIM-MASH AI Assist 工具提供給病理醫師使用的計畫。

Maybe just some clarity then, Christophe, on the qFibrosis data versus the AIM-MASH AI Assist?

那麼也許請你再釐清一下，Christophe，關於 qFibrosis 數據與 AIM-MASH AI Assist 之間的差異？

Again, I mean, sharing my enthusiasm, we are going to be the first registration study using that AIM-MASH AI Assist. We're looking and working with the PathAI team really closely. No change there. We're just moving forward directly. With the qFibrosis, it's a little different approach that is assessing. The AIM-MASH cannot because you need to do that in the, in prompting the pathologist to the reading, et cetera. Going back, we'd have some created, some internal, I mean, clearly some biases, et cetera. We cannot go back to the AIM-MASH AI Assist as you mentioned. The qFibrosis, it's different. It's an approach that subtract basically the steatosis around to allow to read in a more accurate manner through the AI process, just the fibrosis itself.

再次強調，我是分享我的熱忱，我們將會是第一個使用 AIM-MASH AI Assist 的註冊性研究。我們正與 PathAI 團隊非常密切地合作與推進。這部分沒有改變。我們只是直接往前推進。至於 qFibrosis，評估方式則有些不同。AIM-MASH 無法做到，因為你需要在提示病理學家進行判讀等流程中完成那些步驟。回頭看，我們會有一些建立出來的內部因素，顯然也會有一些偏差等等。如你所提到的，我們無法回到 AIM-MASH AI Assist。qFibrosis 則不同。它基本上是一種把周邊脂肪變性（steatosis）扣除掉的方法，讓 AI 流程能更精準地判讀、只聚焦在纖維化本身。

Those data are important. We believe that our drug, pemvidutide, is decreasing MASH or leading to MASH resolution very rapidly, very early, and that could be one of the factor that makes it harder for the pathologist to identify the changes in the fibrosis or some of the features. It's an interesting poster that we're going to be presenting, and we're really excited about showing this data and showing again that what we believe is that we see some very clear anti-fibrotic effects early, even at 24 weeks. Putting those together, it's very exciting to see what we're going to get at EASL.

這些數據很重要。我們相信我們的藥物 pemvidutide 正在非常快速、非常早期地降低 MASH 或促使 MASH 緩解，而這可能是使病理學家更難辨識纖維化變化或某些特徵的因素之一。這是一張我們將要發表的有趣海報，我們非常期待展示這些數據，並再次呈現我們所相信的：我們在早期就看到非常明顯的抗纖維化效果，甚至在 24 週時就已出現。把這些放在一起看，我們很興奮能在 EASL 看到最終會得到什麼結果。

Great. Thank you.

很好。謝謝。

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist Securities。

Thank you so much for taking my questions and congrats on getting accepted to EASL. A couple of questions on the Phase III trial design. Beyond the 52-week biopsy endpoint, I was wondering if you can provide a few more details. You know, you're moving from the no titration Phase II to starting with 1.2 mg and titrating. Can you just remind us for the rationale for the strategy? Then with the inclusion of You have both the 1.8 mg and the 2.4 mg arms for the primary endpoint. Can you talk a little bit about the statistical design there? Does it need to hit on both or how does that work? Thank you.

非常感謝回答我的問題，也恭喜你們獲 EASL 接受。我有幾個關於第三期試驗設計的問題。除了 52 週的活檢終點之外，我想知道你們是否能提供更多細節。你們從第二期的無滴定（no titration）改為以 1.2 mg 起始並進行滴定。能否請你們再提醒一下這個策略的理由？另外，在主要終點上你們同時納入 1.8 mg 與 2.4 mg 兩個組別。能否談談統計設計？是否需要兩個組別都達標，或是運作方式如何？謝謝。

Thank you for the questions. The first thing is I want to remind you about the 48 week data that shows that basically our 1.2 mg and 1.8 mg dose were efficient dose. Our 1.2 mg dose had a tolerability similar to placebo, and the 1.8 had a little more GI effect, but there was no titration. We believe we have an upside that we can propose to the patient with a very single step titration that will help them just improve in tolerability. We've seen our GI AEs occurring within the first four weeks max in general. We believe that that first step will really help because of that placebo-like tolerability. That's, that's why we designed it that way.

謝謝你的提問。第一點，我想提醒你 48 週的數據顯示，我們的 1.2 mg 與 1.8 mg 劑量基本上都是有效劑量。1.2 mg 的耐受性與安慰劑相近，而 1.8 mg 的腸胃道（GI）影響稍多一些，但當時並沒有滴定。我們相信，透過非常單一步驟的滴定，我們可以為病人帶來上行空間，幫助提升耐受性。一般而言，我們觀察到 GI 不良事件多在前四週內發生（最多）。我們相信第一個滴定步驟會非常有幫助，因為 1.2 mg 具有類似安慰劑的耐受性。這就是我們如此設計的原因。

With regard to the other part of the questions. What we have done is we've established those two arm. Our first key dose based on our Phase II data is the 1.8 mg dose. We believe it's a very efficacious dose. Our data support this, and on top of this, the tolerability and what we've seen at 48 weeks confirm this. That's our anchor dose, if you wish. We've seen added weight loss in the obesity program with the 2.4, based on this, we believe that there's a potential for added efficacy. That's why we included it.

至於問題的另一部分。我們設立了這兩個治療組。根據第二期數據，我們的第一個關鍵劑量是 1.8 mg。我們相信這是一個非常有效的劑量。我們的數據支持這點，而且 48 週所看到的耐受性也再次確認。如果你願意，可以把它視為我們的錨定劑量（anchor dose）。在肥胖症計畫中，我們看到 2.4 mg 帶來額外的體重下降；基於此，我們認為可能有額外療效的潛力。因此我們把它納入。

However, on the powering and the statistical approach, we've taken a more conservative approach to powering the study, and we've powered on the effect size of the 1.8 mg dose, both the 1.8 and the 2.4 mg. Because clearly this is more of an exploratory approach, if you wish, where we expect added benefits for these patients. That's how we've, we believe it's an upside on the efficacy part that we could see. And we're going to be looking at these at these endpoints at the end of the 52-week.

不過在樣本數估算（powering）與統計方法上，我們採取較保守的作法，並以 1.8 mg 劑量的效果量來進行研究的樣本數設計，同時涵蓋 1.8 與 2.4 mg。因為很明顯地，這更像是一種探索性作法，我們預期這些病人可能會有額外受益。我們認為在療效面向上可能會看到上行空間。我們會在 52 週結束時檢視這些終點。

Okay, great. Thank you so much.

好的，很好。非常感謝。

William Wood, B. Riley Securities.

William Wood，B. Riley Securities。

Thanks for taking our questions. Sort of a two from us. Just curious how you're seeing the long-term treatment of patients with MASH on pemvidutide. Has there been any sort of evaluation of dose reductions or what happens when patients dose reduce or even taking less frequent dose or is that expected to be looked at in some of your upcoming trials, maybe possibly even after your Phase III reads out?

謝謝回答我們的問題。我們有兩個問題。我想了解你們如何看待以 pemvidutide 對 MASH 病人的長期治療。是否有評估過減量，或病人減量後會發生什麼事，甚至改為較低頻率給藥？或者這是否預期會在你們接下來的一些試驗中評估，可能甚至在第三期讀出之後？

Then also just a quick add-on or follow-up to your EASL data that you're expecting. It looks like in the abstract of your CV presentation that we'll be getting some visceral adipose tissue data or just that? Could you just sort of confirm that we'll be getting that data in that poster, just given with what we've seen on the importance on sort of the CV benefits? Thanks.

另外，針對你們預期在 EASL 發表的數據再追問一下。看起來在你們心血管（CV）報告的摘要中，我們會拿到一些內臟脂肪組織（visceral adipose tissue）的數據，對嗎？鑑於我們看到其對 CV 益處的重要性，你能否確認在那張海報中會呈現這些數據？謝謝。

Right. On the dose reduction first, I mean, this is something that we've explored in our Phase II. We've seen very few patients reducing the dose, no discontinuation, and obviously we'll be looking at this and in our Phase III. We have put in place even for all the way to the 2.4, where these patients can reduce the dose. However, we are incentivizing that the patients in order to stay at the most efficacious dose, which is 1.8 mg dose or even all the way to 2.4. There's a whole system that is put in place to really have those efficacious dose tested, and allowing if there were any GI tolerability.

好的。先談減量：這是我們在第二期中已經探索過的事情。我們看到只有極少數病人減量，沒有停藥；當然我們也會在第三期中持續觀察。我們也建立了機制，即使是到 2.4 mg，病人也可以減量。不過，我們也透過一些安排來鼓勵病人維持在最有效的劑量，也就是 1.8 mg，甚至到 2.4 mg。我們設計了一整套系統，目的是確保能測試這些有效劑量，同時在出現任何 GI 耐受性問題時允許調整。

We believe even with the current titration scheme that we propose, that we're going to be even able to eliminate most of dose and limit really to just a few patient dose aspects. That's the upside. On the lipid and the cardiovascular risk, we'll be looking at lipid profile. To your questions, we have shown some lipid benefits through our previous studies and patient look at this, but we don't have like fat assessments in the poster itself.

我們相信，即使採用目前提出的滴定方案，我們也能進一步消除大多數需要減量的情況，並把它真正限制在少數病人的劑量調整上。這就是上行空間。至於血脂與心血管風險，我們會觀察血脂譜。回到你的問題，我們在先前研究中已顯示一些血脂方面的益處，也在病人層面持續關注，但在那張海報本身並沒有脂肪評估（fat assessments）的內容。

Thank you.

謝謝。

Thanks, William.

謝謝，William。

Arabella Ng, H.C. Wainwright.

Arabella Ng，H.C. Wainwright。

Thank you so much for taking the question. I was just wondering, will PERFORMA use a pre-filled syringe or auto-injector? If it is going to use an auto-injector, have you secured a partner for that? Just generally, are there any gating items you need to complete before you initiate the trial? Thank you so much.

非常感謝讓我提問。我想請教一下，PERFORMA 會使用預充式注射器還是自動注射器？如果會使用自動注射器，你們是否已經確定相關合作夥伴？更一般地說，在啟動試驗之前，是否有任何需要先完成的關鍵門檻事項？非常感謝。

Maybe I start on the last part first, and then we flip it to Christophe. As we said in the prepared remarks, and we'll stress, we're in the full startup phase on the trial. It's about really establishing the global infrastructure, ensuring the vendors are online and ready, initiation of the trial sites, ensuring that the clinical supply chain is ready to support the initiation. All of that activity is ongoing and the start of the trial with initiation in the second half is what we're moving towards. Christophe, maybe you take the other part.

也許我先從最後一部分開始回答，然後再交給 Christophe。正如我們在事先準備的發言中所說、也會再次強調，我們目前正處於該試驗的全面啟動階段。重點在於真正建立全球基礎設施，確保供應商上線並準備就緒，啟動各試驗中心，並確保臨床供應鏈已準備好支援啟動。所有這些工作都在進行中，而我們正朝著下半年啟動試驗（含中心啟動）這個目標推進。Christophe，也許你來回答另一部分。

For the PERFORMA Phase III study, we're not using the auto-injectors. We're going to do separately a comparability type study to use the auto-injectors at launch. That's how we've approached that aspect. We've got some good adherence with our approach right now from the Phase II. We're going to continue using that approach and have the auto-injector ready for launch.

在 PERFORMA 第三期研究中，我們不會使用自動注射器。我們會另外做一項可比性類型的研究，以便在上市時使用自動注射器。這就是我們在這一面向上的做法。依照我們目前從第二期延續下來的做法，病人依從性表現不錯。我們會持續沿用這個做法，並在上市時把自動注射器準備好。

Our next question comes from Corinne Johnson with Goldman Sachs.

下一個問題來自高盛（Goldman Sachs）的 Corinne Johnson。

Hi. This is [Anupam] on behalf of Corinne. Maybe, can you just tell about in terms of digital pathology fibrosis, how should we think about translating the outcomes based on these measures to the fibrosis improvement as it will be evaluated in the Phase III trial?

您好。我是代表 Corinne 的 [Anupam]。想請問在數位病理的纖維化評估方面，我們應該如何看待這些量測指標的結果，並將其轉譯為第三期試驗中將被評估的纖維化改善？

I mean, obviously, there's the two regulatory path that requires the biopsy, and that's the way regulatory agencies are looking at this. The digital pathology, you have different aspects. You have like the AIM-MASH AI Assist, which is a tool that assists the pathologists in reading and prompt the pathologists to the features on the biopsy slides, which is in itself should be able to decrease the variability, increase consensus between pathologists as they're all prompted to the same features, that's one approach. The other approach is some of the things we've done in our Phase II study that we'll be continuing to look into this Liver Explore that was highly significant at 24 week, demonstrates the impact on fibrosis directly in a continuous manner.

我的意思是，很明顯地，監管上有兩條路徑都需要做切片（biopsy），而監管機構也是以這種方式來看待這件事。至於數位病理，則有不同面向。例如 AIM-MASH AI Assist，這是一個協助病理醫師判讀、並提示病理醫師在切片玻片上關注特徵的工具；它本身應該能降低變異性、提高病理醫師之間的一致性，因為大家都被提示去看相同的特徵，這是一種做法。另一種做法是我們在第二期研究中做的一些事情，我們會持續深入研究；例如 Liver Explore，在第 24 週達到高度顯著，並以連續型的方式直接呈現對纖維化的影響。

The other one approach, which is this qFibrosis that we're presenting at EASL that is very interesting. I think here we have a little bit of a story when you decrease the fat in the liver very rapidly as we've seen at week 24, it becomes a little more challenging for the pathologist to read the fibrosis changes. Being able to subtract it in a way that's consistent with staging of those fibrosis is very valuable. These will be added assessments and confirming the biopsy read from the pathology through the AIM-MASH AI Assist. Clearly in our Phase III, the primary endpoint will be done on the biopsy using this AIM-MASH AI Assist tool for the reading. We'll have a whole bunch of evidence that we'll cross-reference at the end of the study at week 52 for the accelerated approval.

另外一種做法是我們將在 EASL 發表的 qFibrosis，這非常有意思。我認為在這裡有一個小故事：當你像我們在第 24 週看到的那樣，肝臟脂肪非常快速下降時，病理醫師要判讀纖維化變化會變得更具挑戰。若能以與纖維化分期一致的方式把這個因素「扣除/校正」掉，價值就非常高。這些都會作為額外的評估，並透過 AIM-MASH AI Assist 來確認病理端對切片的判讀。很明確地，在我們的第三期中，主要終點將以切片為基礎，並使用 AIM-MASH AI Assist 工具來進行判讀。在研究結束、第 52 週時，我們會有大量證據可相互交叉比對，以支援加速核准。

Okay, thank you.

好的，謝謝。

Jon Wolleben, Citizens

Jon Wolleben，Citizens。

Thanks for taking the question and the updates today. Two for me. You know, MASH trials are large and take a long time to run, but incretin trials go pretty fast. I'm wondering if you think about the pace of enrollment potentially being faster than we expect in a MASH trial because of the potential obesity benefit. Then big picture-wise, you guys talk a little bit about differentiation. We're seeing more and more triple agonists get announced. You have more data now, but do you think, down the road, dual agonists get leapfrogged by the triples that are all, you know, becoming more popular and crowded as well? Thanks.

謝謝讓我提問，也謝謝今天的更新。我有兩個問題。你知道，MASH 試驗規模很大、執行時間也很長，但腸泌素（incretin）試驗通常進展很快。我想請問，你們是否認為因為可能帶來肥胖方面的效益，MASH 試驗的入組速度可能會比我們預期更快？再從更宏觀的角度，你們談到一些差異化。我們看到越來越多三重促效劑（triple agonists）被宣布。你們現在有更多數據了，但你們是否認為，長期來看，雙重促效劑（dual agonists）會被三重促效劑超越，因為三重促效劑也越來越受歡迎、競爭也更擁擠？謝謝。

On the first question, look, we are expecting that the weight loss benefit to your first question and the overall profile of PEMB will help. We've seen in the other trials and as you referenced clearly, Jon, the other the speed of incretin trials that typically go quickly. We're understanding, we're building a robust study here but we're targeting for good, efficient, effective enrollment. The profile and the weight loss is one of the components that we think will help with that.

關於第一個問題，我們確實預期減重效益，以及 PEMB 的整體特性，會有所幫助。我們也在其他試驗中看到、正如你提到的很清楚，Jon，腸泌素試驗的速度通常都很快。我們理解這點，也正在建立一個很扎實的研究，但我們的目標是達到良好、有效率且有效的入組。我們認為其特性與減重效果是能幫助入組的因素之一。

Nothing else to add. I mean, maybe the design of the study is also attractive 'cause we have a couple of cohorts, so more chances for our patients and the PIs to include their patients. All in all, you're absolutely correct. I mean, the rate of enrollment is much higher for obesity when there is the weight loss. In addition, we have these features in the design of the study that will help

沒有其他要補充的。我的意思是，或許研究設計本身也很有吸引力，因為我們有幾個隊列（cohorts），因此對病人與主要研究者（PIs）而言，有更多機會把病人納入。總的來說，你說得完全正確。我的意思是，若有減重效果，肥胖領域的入組速度會高得多。此外，我們在研究設計中也有這些特點能提供幫助。

Jon, on your second question, we are developing and then when we talk about differentiation, we always have in mind the other combinations, including the triple G. Maybe Linda, you touch on how we see the ability of pemvidutide to be differentiated, not just kind of in with the products available today, but also with the coming therapies that might be available in the future.

Jon，關於你的第二個問題，我們在開發時、以及談到差異化時，始終會把其他組合療法放在心上，包括三重 G。也許 Linda 你來談談，我們如何看待 pemvidutide 的差異化能力——不僅是相對於目前已有的產品，也包括未來可能上市的療法。

Certainly, I think that we have an opportunity with PEMB to focus on our attributes of being both direct acting on the liver with the glucagon and with our ratio of 1-to-1 GLP-1 to that. The package of benefits that we're seeing delivered there are very competitive, even vis-a-vis the very metabolic forward as we've seen at this point, metabolic forward triple G. We the direct acting components haven't been as defined as ours in the 1-to-1 ratio. I think looking at a tolerability profile and efficacy on multiple points, our ability with our safety profile, frankly, to be used in combination with other agents if they need to, we're delivering the full package and our titration, unlike some of these others as we've talked to, is very simple and not complex.

當然。我認為我們有機會透過 PEMB 聚焦於我們的特點：同時具備以胰高血糖素（glucagon）對肝臟的直接作用，以及 GLP-1 與其 1 比 1 的比例。我們看到這套帶來的效益組合非常有競爭力，即使相較於目前所見、在代謝面向非常強調的三重 G 也是如此。相較之下，直接作用的組成在其他產品中並沒有像我們這種 1 比 1 比例那樣被清楚界定。我認為從耐受性與多個面向的療效來看，加上我們的安全性概況，坦白說，即使需要也能與其他藥物合併使用；我們提供的是完整的套件，而且我們的劑量滴定（titration）不像我們談到的某些其他產品那樣複雜，而是非常簡單。

You see, you know, we have that tolerability, and we have that effect on metabolic and even the opportunity to have additional weight loss. We're seeing ourselves as a pretty fulsome, well-rounded package that can hold our own and that we see, you know, early effects, sustained effects with weight loss, maybe some more efficacy with the 2.4 even on anti-fibrotic and weight measures. Right now, until we're really seeing things that aren't based on weight loss studies, really want to, you know, we'll keep an eye on the market, of course, but I think looking at even our quality of weight loss could be a differentiator. You're not dumping a ton of weight loss right away and leading to more muscle mass being lost.

你看，我們有那樣的耐受性，也有對代謝的效果，甚至還有進一步減重的機會。我們認為自己是一個相當完整、均衡的方案，能夠站穩腳步；而且我們看到早期效果、持續效果的減重，或許在 2.4 劑量下，無論在抗纖維化與體重指標上都能有更高的療效。目前在我們真正看到一些不是建立在減重研究基礎上的結果之前，我們當然會持續關注市場，但我認為即便是我們「減重的品質」也可能成為差異化因素。你不會一下子掉太多體重，進而導致更多肌肉量流失。

Obviously, always keeping an eye forward, but confident in our ability to continue to display the differentiating benefits in our Phase III trial and associated trials to, you know, make sure we have a very solid place in the MASH landscape in the future.

顯然，我們始終著眼未來，同時也對我們能夠在第三期試驗及相關試驗中持續展現差異化優勢充滿信心；也就是說，確保我們未來在 MASH 領域中擁有非常穩固的定位。

Andy Shea, William Blair.

Andy Shea，William Blair。

Thanks for taking our question. Just a question on ADA data presentation. The other GLP-1 glucagon assets, those guys will have both in the BC dataset and also the MASLD dataset. I'm curious about how you would interpret that data when the full results come out. Secondarily, I think you emphasized a lot during the call about the tolerability profile...

感謝讓我們提問。我有一個關於 ADA 數據呈現的問題。其他 GLP-1/胰高血糖素（glucagon）資產，那些公司會同時在 BC 數據集以及 MASLD 數據集中呈現。我很好奇，當完整結果出來時，你們會如何解讀那些數據。其次，我覺得你們在電話會議中非常強調耐受性概況……

Andy, you're cutting up. Can you repeat your initial question?

Andy，你的聲音斷斷續續。可以重複一下你一開始的問題嗎？

Sorry about that. It has to do with the GLP-1 glucagon competitive assets or survodutide that's going to be presented at ADA. I'm curious about how you would, you know, interpret their both the obesity data set and also the MASLD data set without biopsy. That's first question number one. Question number two, you mentioned about the tolerability a lot during the call. Looking back in the Phase II trials that you've conducted, MOMENTUM and IMPACT, I'm curious if you have any, you know, persistence or adherence data. You know, for example, percentage of patients, you know, persisted throughout the trial or towards the end. That could really paint a picture of, you know, patients staying on therapy for pemvi. Thanks.

抱歉。這與將在 ADA 發表的 GLP-1/胰高血糖素競品資產或 survodutide 有關。我想了解的是，在沒有活檢的情況下，你們會如何解讀他們的肥胖數據集以及 MASLD 數據集。這是第一個問題。第二個問題，你們在本次電話會議中多次提到耐受性。回顧你們已完成的第二期試驗 MOMENTUM 與 IMPACT，我想知道你們是否有任何持續用藥（persistence）或依從性（adherence）數據。例如，有多少比例的患者在整個試驗期間持續用藥，或至少持續到試驗末期。這可能有助於描繪患者在 pemvi 治療上持續用藥的情況。謝謝。

Maybe we'll start with that one because I think it's an important one which we've talked about a bunch. We do see in the 48 week data, when we talk about the strong tolerability profile, that this adherence and the fact that such a large percent of the patients on pemvi at both doses, frankly, stayed on therapy even more than placebo. When we talk about tolerability, we're not just talking it as a avoidance of some side effects, but it's also being able to get to the effective dose and stay on therapy, which we know are such a large part of the important real world treatment concerns for physicians. That kind of leads right to your other question, which was around survodutide and what we're seeing there.

也許我們先從這個問題開始，因為我認為這很重要，而且我們也談過很多次。在 48 週數據中，當我們談到強勁的耐受性概況時，我們確實看到依從性；而且在兩個劑量下使用 pemvi 的患者中，有很大比例實際上持續用藥，甚至高於安慰劑組。當我們談耐受性時，不只是指避免某些副作用，也包括能夠達到有效劑量並持續用藥；我們知道，這些都是醫師在真實世界治療中非常重要的考量。這也正好引出你的另一個問題，也就是關於 survodutide 以及我們在那裡看到的情況。

Maybe, Christophe, you want to pick that up?

Christophe，也許你來接著回答？

Again, first, I mean, in the IMPACT, MOMENTUM, et cetera, we see a clear dose response in favor of the higher doses of pemvidutide where patients stay on treatment. This is very encouraging for us, especially, I mean, on my, on my end as a physician, I mean, in a chronic therapy setting, keeping the patients on an efficacious dose on the long term is a key aspect of what we're trying to achieve here. Really encouraging data that we've seen here. Also, we have anecdotal evidence from some of our PIs telling us that are running different studies, also other GLP-1 or even those triple agonists, et cetera.

再說一次，首先，在 IMPACT、MOMENTUM 等試驗中，我們看到明確的劑量反應關係：較高劑量的 pemvidutide 更有利，患者能夠持續接受治療。這對我們非常鼓舞；尤其以我作為醫師的角度，在慢性治療情境下，讓患者長期維持在有效劑量上，是我們想要達成的關鍵面向。我們在這裡看到的數據非常令人振奮。此外，我們也從一些主要研究者（PI）那裡得到一些軼事性證據，他們正在執行不同研究，也包括其他 GLP-1，甚至那些三重致效劑等。

They are telling us that pemvidutide is a very different kind of approach for the patients, and the treatment satisfaction is much, it's much different. We feel that we have some advantage here, and that's really important in that chronic setting in MASH, in AUD, in ALD, et cetera. These are the kind of things. On the survodutide aspect, we've seen weight loss. They've seen weight loss similar to ours. It's been comparable. The big challenge in my mind is back to that tolerability. I mean, first, they needed a very long titration to get up to their efficacious dose. They even have set up some aspects where if they down titrate, you need a whole kind of new scheme to restart the patients, which is absolutely not our case.

他們告訴我們，pemvidutide 對患者而言是一種非常不同的治療方式，而治療滿意度也明顯不同。我們覺得在這方面有一些優勢，而這在 MASH、AUD、ALD 等慢性情境中非常重要。大概就是這些面向。至於 survodutide 方面，我們看到他們有減重效果。他們看到的減重與我們相近。是可比的。我認為最大的挑戰又回到耐受性。首先，他們需要非常長的滴定期才能達到有效劑量。他們甚至設計了一些機制：如果需要降滴定，就必須用一整套新的方案來重新啟動患者治療，而我們完全不是這種情況。

You've seen in the Phase II, you can jump the patients straight into their 1.8 mg dose without any titration. We are in two very different scenarios here. The discontinuation rate is almost one in four patients that is not staying on the drug. I do believe there's a couple of aspects that we have here. Survodutide look more like GLP-1 with a little bit of glucagon. That's the eight to one ratio. We've heard people saying just a little splash of glucagon on top of GLP-1. We believe that this ratio one to one is really important.

你們在第二期試驗中已看到，患者可以不需任何滴定就直接進入 1.8 mg 劑量。我們處於兩種非常不同的情境。停藥率接近每四位患者就有一位無法持續用藥。我確實認為我們在這裡有幾個面向的優勢。Survodutide 看起來更像是以 GLP-1 為主、加上一點胰高血糖素。也就是 8 比 1 的比例。我們聽過有人說，這就像在 GLP-1 上面只加了一點點胰高血糖素。我們相信 1 比 1 的比例非常重要。

Again, I cannot reemphasize in a chronic setting the importance of having adherence to treatment into an efficacious dose. I mean, this is a key aspect. Patients will stay. I'm sure that payers will be very happy with this. That we've seen it already in our study. We'll continue to look into it in the Phase III PERFORMA trial.

再次強調，在慢性治療情境下，能夠依從治療並維持在有效劑量上的重要性，我怎麼強調都不為過。這是關鍵面向。患者會持續用藥。我相信支付方也會對此非常滿意。我們已在研究中看到這一點。我們也會在第三期 PERFORMA 試驗中持續深入觀察。

That concludes today's question-and-answer session. I'd like to turn the call back to Jerry Durso for closing remarks.

今天的問答環節到此結束。我想把電話會議交回給 Jerry Durso 作結語。

Thanks, operator. We've made significant progress as we evolve into a late-stage company. Altimmune's focused on execution, and we're committed to further advancing our promising meaningfully differentiated liver therapy and creating long-term value for our shareholders. It's really an exciting time here, and I definitely look forward to updating you on our progress as we progress. Thanks a lot for joining today, and everybody have a great day. Take care.

謝謝，接線員。隨著我們發展成為一家後期階段公司，我們已取得顯著進展。Altimmune 專注於執行力，我們致力於進一步推進我們前景可期、且具實質差異化的肝臟療法，並為股東創造長期價值。現在確實是令人振奮的時刻，我也非常期待在我們持續推進的同時，向各位更新進展。非常感謝今天的參與，祝大家今天愉快。保重。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝各位參與。您現在可以掛線。