Altimmune Inc (ALT) 2025 Q3 法說會逐字稿

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

女士們、先生們，早安，歡迎參加 Altimmune 2025 年第三季財務業績電話會議。 （操作說明）提醒各位，本次電話會議正在錄音。

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

現在我來介紹今天電話會議的主持人，Lee Roth，他是Burns McClellan投資者關係公司的總裁，也是Altimmune公司的顧問。謝謝，接下來由您發言。

Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune’ s third-quarter 2025 Financial Results and Business Update Conference Call. On today's call, you'll hear from Dr. Vipin Garg, our Chief Executive Officer; Dr. Christophe Arbet-Engels, our Chief Medical Officer; Linda Richardson, our Chief Commercial Officer; and Greg Weaver, our Chief Financial Officer. Following management's prepared remarks, we'll open the line for the Q&A session.

謝謝接線員，大家早安。感謝各位參加 Altimmune™ 2025 年第三季財務業績及業務更新電話會議。在今天的電話會議上，您將聽到我們執行長 Vipin Garg 博士、首席醫療官 Christophe Arbet-Engels 博士、首席商務官 Linda Richardson 以及首席財務長 Greg Weaver 的演講。管理階層發言結束後，我們將進入問答環節。

Our third-quarter 2025 financial results and corporate update press release was issued this morning and can be found on the Investor Relations section of the Altimmune website.

我們於今天上午發布了 2025 年第三季財務業績和公司最新動態新聞稿，可在 Altimmune 網站的投資者關係部分找到。

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 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 the company's filings with the SEC.

在正式開始之前，我想提醒各位，所有關於未來預期、計劃和前景的言論均構成1995年《私人證券訴訟改革法案》安全港條款所界定的前瞻性陳述。 Altimmune公司特此提醒，這些前瞻性陳述受風險和不確定性因素的影響，可能導致實際結果與預期結果有重大差異。有關可能影響公司未來業績和營運的風險因素，請參閱本公司向美國證券交易委員會（SEC）提交的文件。

I 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, November 6, 2025, 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 the Altimmune website.

請同時閱讀我們今天早上發布的新聞稿中的前瞻性聲明免責聲明，該新聞稿現已發佈在我們的網站上。本次電話會議中的任何聲明僅代表截至2025年11月6日（即今日）的觀點，本公司不承擔任何義務更新任何前瞻性聲明以反映今日或之後發生的事件或情況。再次提醒，本次電話會議正在錄音，錄音回放可在Altimmune網站收聽。

With that, it's now my pleasure to turn the call over to Dr. Vipin Garg, President and Chief Executive Officer of Altimmune. Vipin?

接下來，我很高興將電話交給 Altimmune 的總裁兼執行長 Vipin Garg 博士。 Vipin？

Good morning, everyone, and thank you for joining us today for our third-quarter financial results and corporate update. This is a very exciting time for Altimmune. We are on the brink of a major inflection point with our clinical programs. Pemvidutide, the foundation of our pipeline is ripe with opportunity to redefine treatment for those with serious liver diseases like MASH, alcohol use disorder, or AUD, and alcohol-associated liver disease or ALD.

各位早安，感謝各位今天蒞臨參加我們第三季財務業績及公司最新進展發布會。對於Altimmune而言，這是一個令人興奮的時刻。我們的臨床計畫正處於一個重要的轉折點。作為我們產品線的基石，Pemvidutide蘊藏著巨大的潛力，可望重新定義MASH、酒精使用障礙（AUD）和酒精相關性肝病（ALD）等嚴重肝病患者的治療方案。

On today's call, we will emphasize a few key points. The upcoming Q4 milestone of the 48-week IMPACT data readout, the in-person end of Phase II meeting with the FDA in Q4 that was recently granted, the continued strengthening of company's balance sheet and the recent talent additions to the executive team.

在今天的電話會議上，我們將重點放在幾個關鍵點。即將於第四季度公佈的48週IMPACT數據里程碑事件、近期獲准在第四季度與FDA舉行的II期臨床試驗結束會議、公司資產負債表的持續改善以及近期高管團隊的人才補充。

The 24-week data from our IMPACT trial shared earlier this year established rapid efficacy of pemvidutide for those with MASH, providing potential best-in-class MASH resolution shortly after initiating treatment and compelling antifibrotic activity and weight loss. The convincing nature of these data has allowed us to move into preparations for Phase III and to receive confirmation of an in-person end of Phase II meeting scheduled with the FDA before year-end to gain agreement on the design for our Phase III program.

今年稍早公佈的IMPACT試驗24週數據顯示，pemvidutide對MASH患者俱有快速療效，預計在治療開始後不久即可達到同類最佳的MASH緩解效果，並展現出顯著的抗纖維化活性和減重效果。這些數據令人信服，使我們能夠著手準備III期臨床試驗，並已確認將於年底前與FDA舉行II期臨床試驗結束會議，以就III期臨床試驗方案達成一致。

We also look forward to the 48-week data from the IMPACT trial, which we expect to share before the end of the year. Beyond MASH, we announced that we have successfully completed enrollment in the RECLAIM Phase II trial of pemvidutide in AUD. The rapid enrollment of RECLAIM which was completed ahead of schedule, is a testament to our team's continued ability to execute and the significant interest from patients and physicians in pemvidutide as a potential new therapy.

我們也期待IMPACT試驗的48週數據，預計在年底前公佈。除了MASH試驗之外，我們還宣布已成功完成pemvidutide治療酒精使用障礙（AUD）的RECLAIM II期試驗的患者招募。 RECLAIM試驗的快速招募提前完成，證明了我們團隊持續高效的執行能力，以及患者和醫生對pemvidutide作為潛在新療法的濃厚興趣。

In addition, we began enrolling the ALD Phase II trial in the third-quarter. As our clinical programs progress, we are ensuring we have the necessary financial resources and executive talent in place to support the next phase of our growth. This includes the recent expansion of our leadership team with the appointment of Dr. Christophe Arbet-Engels, as Chief Medical Officer; Linda Richardson as Chief Commercial Officer; and Robin Abrahams as Chief Legal Officer.

此外，我們於第三季啟動了ALD II期臨床試驗的受試者招募工作。隨著臨床計畫的推進，我們正在確保擁有必要的財務資源和高階主管人才，以支持下一階段的成長。這包括近期我們擴充了領導團隊，任命Christophe Arbet-Engels博士為首席醫療官；Linda Richardson為首席商務官；以及Robin Abrahams為首席法務官。

With that, I'll turn the call over to Christophe to speak further to our promising pemvidutide programs. Christophe?

那麼，我將把電話交給克里斯托夫，讓他進一步談談我們前景可觀的安眠藥項目。克里斯托夫？

Thank you, Vipin. I am very pleased to be here today and to be joining the Altimmune team at such an exciting juncture. From my perspective, I recognize the significant potential of pemvidutide for the treatment of patients with MASH, AUD, and ALD. Given its 1:1 glucagon GLP-1 ratio, pemvidutide is uniquely designed to maximize the contribution of each mechanism. In effect, pemvidutide is a combination therapy in a single molecule.

謝謝Vipin。我非常高興今天能來到這裡，在這個令人興奮的時刻加入Altimmune團隊。在我看來，pemvidutide在治療MASH、AUD和ALD患者方面具有巨大的潛力。 pemvidutide的胰高血糖素和GLP-1比例為1:1，其獨特的設計能夠最大限度地發揮每種機制的作用。實際上，pemvidutide是一種單分子聯合療法。

Early data from the IMPACT trial demonstrated the potential of this dual mechanism of action with rapid and robust MASH resolution achieving statistical significance at just 24 weeks. I want to reinforce how meaningful the observed efficacy is at this early time point as most other MASH program achieved this level of response only after treating for 48 weeks or more.

IMPACT試驗的早期數據顯示，這種雙重作用機制具有顯著潛力，能夠快速有效地緩解MASH症狀，且在短短24週內即達到統計意義。我想強調的是，在如此早期階段觀察到的療效意義重大，因為大多數其他MASH治療方案需要48週或更長時間才能達到類似的療效水準。

The 24-week results demonstrated significant and very encouraging anti-inflammatory activity based on biopsies and a range of noninvasive tests, which are becoming increasingly important in clinical practice and in the ongoing regulatory conversation. The statistical significance achieved across a panel of NIT we are assessing in the IMPACT trial provides strong support for pemvidutide antifibrotic effects, which we will look to continue to assess in the upcoming 48-week readout.

為期 24 週的結果顯示，基於活檢和一系列非侵入性檢測，該藥物具有顯著且令人鼓舞的抗炎活性，這些檢測在臨床實踐和持續的監管討論中正變得越來越重要。在 IMPACT 試驗中，我們正在評估一系列非侵入性檢測指標，這些指標均獲得了統計意義上的顯著性，這為 pemvidutide 的抗纖維化作用提供了強有力的支持，我們將在即將進行的 48 週結果解讀中繼續評估這些作用。

Speaking of the 48-week readout, we look forward to assessing the data and the potential of a longer treatment duration on NIT measurement, as well as further weight loss. Recall, we had early and significant MASH resolution in our 24-week biopsy data and strong evidence of antifibrotic activity supported by the NIT analysis, along with the continuing weight loss and excellent tolerability.

談到48週的療效評估，我們期待評估相關數據，以及延長治療時間對NIT測量結果和體重進一步減輕的影響。回顧一下，我們在24週的活檢數據中觀察到MASH早期且顯著的消退，NIT分析也提供了強有力的抗纖維化活性證據，同時體重持續下降，且耐受性良好。

The emerging recognition that improvements in certain NITs are likely to translate to clinical improvement has led regulatory agencies to consider allowing the use of NIT data as a measure of efficacy in MASH clinical trial. In clinical practice, MASH patients are often diagnosed and courses of treatment determined based on these noninvasive tests and the possibility of the regulatory agencies more closely aligning with clinical practice bodes particularly well for pemvidutide given the strength of our NIT data.

人們逐漸認識到，某些非侵入性檢測（NIT）的改進很可能轉化為臨床療效的提升，這促使監管機構考慮允許將NIT數據作為MASH臨床試驗中療效的衡量指標。在臨床實踐中，MASH患者的診斷和治療方案的發展通常是基於這些非侵入性檢測。鑑於我們NIT數據的可靠性，監管機構與臨床實踐更加緊密合作的可能性對pemvidutide而言尤其有利。

Dr. Mazen Noureddin, lead investigator on the IMPACT trial will deliver a late-breaking oral presentation on the 24-week IMPACT results at the upcoming annual AASLD Liver Meeting. The acceptance of this abstract reinforces the significance of the data from the IMPACT trial and pemvidutide's opportunity in the broader MASH landscape.

IMPACT試驗的主要研究者馬贊·努雷丁博士將在即將召開的AASLD肝病年會上就IMPACT試驗24週的最新結果發表口頭報告。此摘要的接收進一步凸顯了IMPACT試驗數據的重要性，以及培維妥肽在更廣泛的MASH治療領域中的應用前景。

Our confidence in pemvidutide is underscored by the collective data surrounding the molecule from the seven trials completed to date. We are now preparing for a scheduled face-to-face end of Phase II meeting with the FDA before year-end to review our proposed Phase III MASH program. The Phase III trial will include the flexibility of using NITs and AI reads as an approvable endpoint in our registrational program if regulatory process moves in that direction.

我們對pemvidutide的信心源自於迄今為止完成的七項試驗所收集的分子相關數據。我們目前正準備在年底前與FDA舉行面對面的II期臨床試驗結束會議，以審查我們擬定的III期MASH試驗方案。如果監管流程朝著這個方向發展，III期試驗將允許我們靈活地將NITs和AI讀數作為註冊申請中的可批准終點。

Beyond MASH, we believe that the balanced glucagon and GLP-1 agonism that is the hallmark of pemvidutide makes it a promising therapeutic candidate in both alcohol use disorder and alcohol-associated liver disease. In AUD, we have completed recruitment and randomization in the RECLAIM trial that we were able to fully enroll this trial ahead of schedule is a strong indicator of the significant interest and major unmet need in this indication. We look forward to reporting results next year.

除了MASH之外，我們相信，pemvidutide的標誌性特徵——平衡的胰高血糖素和GLP-1受體激動作用——使其成為治療酒精使用障礙和酒精相關性肝病的一種極具前景的候選藥物。在酒精使用障礙方面，我們已完成RECLAIM試驗的招募和隨機分組，並且能夠提前完成全部受試者的入組，這有力地表明了該適應症領域存在著巨大的未滿足需求和濃厚的市場關注度。我們期待明年公佈試驗結果。

Our ALD trial, RESTORE, was initiated in the third-quarter and enrollment is ongoing. Importantly, patients with ALD currently lack any approved therapies, and we believe pemvidutide's dual mechanism of action may make a difference for these patients. We look forward to these results of these trials and further understanding the potential of pemvidutide in the additional large patient population of unmet need.

我們的ALD臨床試驗RESTORE已於第三季啟動，目前正在進行病患招募。值得注意的是，目前ALD患者尚無任何核准療法，我們相信pemvidutide的雙重作用機制可能對這些患者產生正面影響。我們期待這些試驗的結果，並進一步了解pemvidutide在更多未被滿足醫療需求的患者群體中的應用潛力。

I am excited to be at Altimmune and to lead these programs forward. And with that, I will turn the call to our Chief Commercial Officer, Linda Richardson, to discuss how we are preparing for Phase III success in MASH. Linda?

我很高興加入 Altimmune，並領導這些項目向前發展。接下來，我將把電話交給我們的首席商務官琳達·理查森，請她談談我們如何為 MASH 的 III 期臨床試驗做好準備。琳達？

Thanks, Christophe, and good morning, everyone. It's great to be here at Altimmune at this exciting time, and I echo Christophe's enthusiasm for joining this team and helping to shape the future of this significant therapeutic candidate. A quick background on me. I've been involved in all facets of commercialization for over 30 years at organizations of all sizes. I have experience in MASH, rare hepatic diseases, cardiometabolic diseases, including diabetes and dyslipidemia and addiction medicine.

謝謝 Christophe，大家早安。在這個激動人心的時刻來到 Altimmune，我感到非常榮幸。我和 Christophe 一樣，對加入這個團隊並參與塑造這款重要候選療法的未來充滿熱情。簡單介紹一下我自己。我在商業化的各個方面都擁有超過 30 年的經驗，曾在各種規模的公司工作。我的經驗涵蓋 MASH（多發性動脈粥狀硬化性肝炎）、罕見肝病、心血管代謝疾病（包括糖尿病和血脂異常）以及成癮醫學。

We have a great opportunity in front of us with pemvidutide in MASH as well as AUD and ALD, and I look forward to helping prepare for potential commercialization in each of these areas of high unmet need. My decision to join Altimmune was driven by the opportunity to bring real therapeutic advances to patients and the providers that care for them.

我們面前有一個絕佳的機會，那就是在 MASH、AUD 和 ALD 領域，pemvidutide 的應用前景廣闊。我期待著為這些亟需治療的領域未來的商業化做好準備。我加入 Altimmune 的初衷，是希望能為患者及其醫護人員帶來真正的治療突破。

Pemvidutide has this potential. Why do I believe this? With pemvidutide, we have one therapy that provides two important mechanisms of action, delivering improvements on three critical elements of MASH management. The single therapy is clear. The two mechanisms of action, glucagon and GLP-1 agonism in a balanced 1:1 ratio provide both direct liver effects and metabolic improvements, resulting in three important benefits for patients.

培維肽具有這種潛力。我為什麼這麼認為？培維肽是一種能夠提供兩種重要作用機制的單一療法，可改善MASH治療的三個關鍵要素。這種單一療法的優勢顯而易見。其兩種作用機轉－升血糖素和GLP-1受體激動劑－以1:1的平衡比例發揮作用，既能直接作用於肝臟，又能改善代謝，進而為患者帶來三項重要益處。

One, rapid MASH resolution in as soon as 24 weeks; two, anti-inflammatory and antifibrotic effects in the liver as demonstrated in multiple NIT assessments; and three, quality weight loss, including lean muscle sparing effects.

第一，MASH 最快可在 24 週內快速消退；第二，多項 NIT 評估表明，MASH 具有抗發炎和抗纖維化作用；第三，體重減輕品質高，包括保留瘦肌肉的作用。

Additionally, pemvidutide has demonstrated a potential best-in-class tolerability profile with low discontinuation rates in the IMPACT trial. This could be another differentiating feature compared with other MASH therapies. My enthusiasm aside, I would like to highlight some feedback from recent market research we did in Europe. Health care professionals in a small group of payers were provided with a projected blinded product profile of pemvi along with other blinded profiles of current and future potential MASH therapies.

此外，在IMPACT試驗中，pemvidutide展現出潛在的同類最佳耐受性，停藥率低。這可能是其與其他MASH療法相比的另一項差異化優勢。除了我個人的熱情之外，我還想重點介紹我們近期在歐洲進行的市場調查的一些回饋。我們向一小部分支付方的醫療保健專業人員提供了pemvidutide的預期盲法產品概況，以及其他現有和未來潛在MASH療法的盲法概況。

First, 70% to 80% of the physicians surveyed indicated a high or very high likelihood to prescribe pemvidutide based on the blinded product profile in both F2 and F3 patients. Here are some representative qualitative comments from hepatologists on pemvi's differentiating features. It's quite impressive, the fibrosis and the weight loss seems to be a class leader and the side effect profile is good.

首先，在接受調查的醫生中，70%至80%的人表示，根據盲法產品特性，他們有很高或非常高的可能性為F2期和F3期患者開具pemvidutide處方。以下是一些肝病專家對pemvidutide差異化特徵的代表性定性評估。它的效果令人印象深刻，在改善纖維化和減輕體重方面似乎處於領先地位，而且副作用也較少。

And another quote, for overweight and obese patients, it would be my go-to substance, my first-line approach, more powerful than other dual agonists with strong fibrosis data. Lean mass preservation would be a meaningful differentiator, very important in MASH and chronic liver disease. This is very encouraging early feedback. In particular, the significance of demonstrating lean muscle mass preservation is potentially very differentiating.

還有一位患者表示，對於超重和肥胖患者，這將是我的首選藥物，我的首選治療方案，它比其他具有強效抗纖維化數據的雙重激動劑更有效。維持瘦體重將是重要的差異化因素，這在MASH和慢性肝病中尤其重要。這些早期回饋令人鼓舞。特別是，能夠證明其能夠保持瘦肌肉量，這可能具有非常顯著的差異化意義。

There is growing interest in the prevalence and effects of sarcopenia in patients with MASLD. A 2024 meta-analysis found that sarcopenia was associated not only with progression, but also correlated with MASLD-associated mortality.

人們對MASLD患者中肌肉減少症的盛行率和影響越來越感興趣。 2024年的一項統合分析發現，肌肉減少症不僅與疾病進展有關，而且與MASLD相關死亡率也相關。

Other publications project that the prevalence of sarcopenia may be as high as one in four patients. Initial payer feedback was also encouraging. Payers provided us with a positive reimbursement outlook across the EU with broad coverage expected given payers' positive perception of the pemvi value proposition. We will continue to identify aspects of pemvidutide therapy that may be important to payers, particularly as more therapies enter the MASH field.

其他文獻預測，肌肉減少症的盛行率可能高達四分之一。初步的支付方回饋也令人鼓舞。鑑於支付方對pemvi價值主張的正面看法，歐盟範圍內的支付方對報銷前景持樂觀態度，預計報銷範圍將十分廣泛。我們將繼續探索pemvidutide療法中可能對支付方重要的方面，尤其是在更多療法進入MASH領域之後。

Patients and prescriber receptivity is critical, but reimbursement and access are equally important elements of a successful product launch. I've had the opportunity to work closely with our clinical team to incorporate specific endpoints that we believe will be important drivers of market uptake and support a successful launch following potential regulatory approval. It's an optimal time to ensure that commercial considerations are designed into the Phase III MASH program to accentuate the differentiators of pemvidutide from current approved therapies and those to come.

病患和處方醫師的接受度至關重要，但醫保報銷和藥物可近性對於產品成功上市同樣重要。我有幸與臨床團隊緊密合作，將我們認為能夠顯著推動市場接受度並支持潛在監管批准後成功上市的特定終點納入考量。現在正是將商業考量融入III期MASH項目，以凸顯pemvidutide與現有已核准療法以及未來療法差異化優勢的最佳時機。

Alongside MASH, the AUD and ALD programs are very exciting and could expand substantially the addressable market for pemvidutide. The rapid recruitment of our AUD trial that we discussed earlier is evidence of interest in this space and the patient need for new therapeutic options as well.

除了MASH專案之外，AUD和ALD專案也令人振奮，預計將大幅拓展pemvidutide的潛在市場。我們先前提到的AUD試驗的快速招募，也證明了市場對該領域的濃厚興趣以及患者對新療法的需求。

In closing, I'm very excited to be here at Altimmune at such a crucial time. I look forward to continuing to update all of you on our commercial vision, plans, and expectations for pemvidutide. I'll now turn it over to Greg to review our financial results for the third-quarter.

最後，我非常高興能在這樣一個關鍵時刻來到 Altimmune。我期待繼續向大家報告我們對 pemvidutide 的商業願景、計劃和預期。現在，我將把時間交給 Greg，讓他來回顧我們第三季的財務表現。

Thank you, Linda, and hello. Beginning with our balance sheet at September 30, total cash was $211 million, representing an increase of 60% over our cash position at the start of the year. We've made measurable strides as we source capital through a combination of available options, having raised $127 million through the first nine months of the year, building the cash position required to support our key development milestones.

謝謝琳達，您好。截至9月30日，我們的資產負債表顯示，現金總額為2.11億美元，較年初成長了60%。我們透過多種融資管道籌集資金，取得了顯著進展。今年前九個月，我們已籌集到1.27億美元，為實現關鍵發展目標提供了所需的現金儲備。

Another step we've taken to add to our financial flexibility was to amend our Hercules debt agreement, where we increased the overall facility size to $125 million and funded $20 million on executing that amendment today. The amendment improved several of the key terms extending the interest-only period, for example. You'll see that we're filing a $400 million shelf registration today, along with a new $200 million ATM facility. Consider these filings as part of our ongoing effort to assure the financial tools are in place to meet our needs going forward.

為了進一步增強財務靈活性，我們採取的另一項措施是修訂了 Hercules 債務協議，將整體融資規模增加至 1.25 億美元，並在今天執行該修訂時支付了 2,000 萬美元。此次修訂改善了多項關鍵條款，例如延長了僅付息期。您今天還會看到我們提交了一份 4 億美元的暫擱註冊申請，以及一份新的 2 億美元的 ATM 融資申請。請將這些申請視為我們持續努力的一部分，以確保我們擁有足夠的金融工具來滿足未來的需求。

Our cash position continued to strengthen through Q3 and into Q4. I'm happy with the trajectory and confident in the ability to build the balance sheet required to meet our development needs and position pemvi for success.

我們的現金狀況在第三季和第四季持續增強。我對這一發展趨勢感到滿意，並有信心建立必要的資產負債表，以滿足我們的發展需求，並使pemvi走向成功。

Now to comment on the Q3 and year-to-date financial results. R&D expenses were $15 million for the three months ended September 30, '25, compared to $19.8 million in the same period of 2024. The three-month variance in R&D spend was related to the timing of CRO development cost year-over-year. The Q3 2025 spend included $9.2 million of direct costs related to pemvidutide development, including roughly $3.7 million for the IMPACT Phase IIb trial, $3.4 million for AUD and ALD start-up costs and $1.3 million for CMC.

現在來談談第三季和年初至今的財務表現。截至2025年9月30日的三個月，研發費用為1,500萬美元，而2024年同期為1,980萬美元。研發支出三個月的差異與CRO（合約研究組織）開發成本的年度結算時間有關。 2025年第三季的支出包括與pemvidutide開發相關的920萬美元直接成本，其中包括約370萬美元的IMPACT IIb期試驗費用、340萬美元的AUD和ALD啟動成本以及130萬美元的CMC（化學、製造和控制）費用。

G&A expenses were $5.9 million and $5 million for the quarter ended September 30, 2025, and 2024, respectively. This increase was driven by professional fees and noncash stock-based compensation. To note, the total noncash stock-based comp was $3.6 million in Q3 and $11.1 million year-to-date. No surprises there.

截至2025年9月30日及2024年9月30日止季度，一般及行政費用分別為590萬美元及500萬美元。這一成長主要由專業服務費和非現金股權激勵支出推動。值得注意的是，第三季非現金股權激勵支出總額為360萬美元，年初至今累計達1,110萬美元。這並不令人意外。

Net loss for the third-quarter of 2025 was $19 million or $0.21 of share compared to $22.8 million or $0.32 per share in the third-quarter of last year. So, in summary, we are well positioned in terms of our financial footing. And with that, I'll turn the call back to Vipin for some closing remarks.

2025年第三季淨虧損為1,900萬美元，即每股虧損0.21美元，去年同期淨虧損為2,280萬美元，即每股虧損0.32美元。總而言之，我們的財務狀況良好。接下來，我將把電話轉回給Vipin，請他做總結發言。

Thank you, Greg. As highlighted today, we look forward to sharing the 48-week IMPACT data in Q4 and to discussing our progression into Phase III clinical development at our end of Phase II meeting with the FDA. As always, we thank you for your continued support and look forward to sharing further details of our progress.

謝謝格雷格。正如今天所強調的，我們期待在第四季度分享為期48週的IMPACT數據，並在與FDA舉行的II期臨床試驗結束會議上討論我們進入III期臨床開發階段的進展。一如既往，感謝您的持續支持，我們期待與您分享更多進展細節。

This concludes our formal remarks, and we would now like to take questions. Operator?

我們的正式發言到此結束，現在我們來回答問題。接線生？

(Operator Instructions)

（操作說明）

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Congrats for all the progress. Maybe a couple of question. First is on the upcoming 48-week data from the Phase II IMPACT MASH. So how much of the data will inform your conversation with the FDA and then also the Phase III design? And then what's the current thinking about the Phase III in terms of the 24 versus the 48-week time point and then the NIT and AI biopsy-driven AI-based biopsy endpoints?

恭喜你們取得的所有進展。我有幾個問題。首先是即將公佈的II期IMPACT MASH試驗的48週數據。這些數據中有多少將用於你們與FDA的溝通，以及III期試驗的設計？其次，目前對於III期試驗中24週和48週時間點的選擇，以及基於非免疫檢測（NIT）和人工智慧（AI）驅動的活檢終點，你們有什麼想法？

Yes. Roger, thank you for the question. So as far as the end of Phase II meeting with the FDA is concerned, as you know, the end of Phase II meeting was requested on the basis of the 24-week data. So really, there would not be any 48-week data that would be part of that discussion at this point. Obviously, we will submit 48-week data when that's available.

是的，羅傑，謝謝你的提問。關於與FDA召開的二期臨床試驗結束會議，如你所知，這次會議是基於24週的數據提出的。所以，目前來說，48週的數據不會納入討論範圍。當然，一旦有48週的數據，我們就會提交。

But we believe and apparently, the FDA agrees with us that we have sufficient data at 24-week to request and now FDA has granted a meeting to us on the basis of that data. So, I think we're in a good shape. Christophe, did you want to add anything to that?

但我們相信，而且顯然FDA也同意我們的觀點，我們有足夠的24週數據來提出申請，現在FDA已經基於這些數據同意與我們會面。所以，我認為我們情況不錯。克里斯托夫，你還有什麼要補充的嗎？

No, I think that's correct. The 24-week data were strong enough to grant the submissions and grant the meeting, and we are in good shape with those discussions by the end of the year.

不，我認為沒錯。 24週的數據足以支持提交申請和召開會議，我們有信心在年底前順利完成這些討論。

And about the 48-week data, I think, Roger, did you want to repeat your question, please?

關於 48 週的數據，羅傑，你想再問一次嗎？

Yes, sure. So just the 48-week data, how -- what's the current thinking about the Phase III design based on the 48-week data?

當然可以。那麼，僅憑這48週的數據，目前對這48週數據的III期臨床試驗設計有何看法？

So the 48-week data, we expect to continue confirming what we've seen in the 24-week data and the strength of this with the added weight loss and hopefully as well on the needs. We are in discussions. We will be discussing with the FDA this current regulatory environment with the potential change from those biopsy readings to the needs, and we will have more clarity when we meet at the end of Phase II meeting.

因此，我們預期48週的數據將持續證實我們在24週數據中觀察到的結果，並增強其在減重方面的療效，希望也能滿足患者的需求。我們正在與FDA進行討論。我們將與FDA探討當前的監管環境，以及從活檢結果到患者需求評估的潛在變化，我們將在二期臨床試驗結束時與他們會面，屆時情況會更加明朗。

Yes. And our goal, Roger, is to design a very flexible trial, Phase III program, so we can take advantage of any of the changes that take place whenever they take place. So, we'll go in with a very comprehensive, flexible design in terms of the Phase III program and should changes take place over the course of next months and year, we can certainly incorporate them and pivot to those and appropriately change our endpoints when that happens.

是的。羅傑，我們的目標是設計一個非常靈活的III期臨床試驗方案，以便我們隨時可以應對任何變化。因此，我們將採用非常全面、靈活的III期臨床試驗方案設計，如果在未來幾個月或一年內發生任何變化，我們當然可以將其納入方案，並根據變化調整試驗終點。

Yasmeen Rahimi, Piper Sandler.

亞斯敏·拉希米，派珀·桑德勒。

And congrats on the RECLAIM enrollment completion. I guess the first question is based on sort of discussion with the key opinion leaders in the space, do you have any idea in like, I guess, the probability of the different scenarios of potentially using NITs or AI-based histological reading. If you could just maybe help us understand based on the three scenarios, which one they think has a high probability of being able to get a sign-off. That's question one.

恭喜您完成RECLAIM註冊。我想問的第一個問題是基於與該領域關鍵意見領袖的討論，您是否了解在不同情況下使用NIT或基於AI的組織學判讀的可能性？能否請您根據這三種情況，幫我們分析一下他們認為哪一種最有可能獲得批准？這是第一個問題。

And then question two is, help us understand, I guess, the advantages of using AI-based biopsy reading versus traditional histology reading and especially when it comes to Phase III studies and if any other sponsors have implemented that?

第二個問題是，請幫助我們理解，與傳統的組織學讀片相比，使用基於人工智慧的活檢讀片有哪些優勢，尤其是在 III 期研究中，以及其他贊助商是否已經實施了這種讀片方式？

And then the third question is on RECLAIM, maybe help us conceptualize what would be considered a clinically meaningful endpoint in the primary endpoint there. And I'll jump back in the queue.

第三個問題是關於RECLAIM研究的，能否請您幫我們理解一下，在主要終點中，什麼才算是具有臨床意義的終點？我稍後會重新排隊。

All right. So, I will start with the NITs. The NITs, there are a lot of different discussions ongoing at this point in time. We're going to -- we are aware that some of these discussions will occur with the AASLD meeting coming up at the end of this week, and we will learn more around that. We know the FDA is looking through the -- at this very closely.

好的。那麼，我先從非侵入性治療（NIT）說起。目前關於非侵入性治療有很多不同的討論正在進行中。我們知道，其中一些討論將在本週末即將舉行的美國肝病研究協會（AASLD）會議上進行，屆時我們將了解更多相關資訊。我們也知道，美國食品藥物管理局（FDA）正在密切關注此事。

And there is -- from our understanding, there is an increasing interest to look at those NITs. So as Vipin shared, we are designing our Phase III in order to really have the flexibility to adapt to any changes on the regulatory landscape.

據我們了解，目前各界對新型資訊科技（NITs）的興趣日益濃厚。正如Vipin所說，我們正在設計三期臨床試驗，以便能夠靈活應對監管環境的任何變化。

On the AI, there are differences. The histopathologist in general, look at a narrow part of the slides and estimate the level of fibrosis based on a number of criteria, but that introduces quite a large amount of variability and the AI on the other aspect look at the total area of fibrosis and doesn't quantify the stages only, but allows just a gradual and more comprehensive evaluations of the slides.

在人工智慧方面，兩者存在差異。組織病理學家通常只觀察切片的一小部分，並根據一系列標準來評估纖維化程度，但這會引入相當大的變異性；而人工智慧則會觀察纖維化的總面積，不僅量化纖維化的分期，還能對切片進行更全面、更漸進的評估。

So, this is something that allows for rapid evaluations with less variability. And we know that this has been already approved by the EMA as an approach to look at the biopsies. And the last -- the third point was, I'm not sure I fully heard the questions on the primary endpoint if you, that was.

所以，這種方法可以實現快速評估，且變異性更小。我們知道，EMA已經批准這種方法用於活檢分析。最後一點——第三點是，我不確定我是否完全聽清了關於主要終點的問題。

The RECLAIM trial.

RECLAIM 試驗。

That's right.

這是正確的。

Yes. The RECLAIM trial. So, the primary endpoint of the RECLAIM trial is the number of heavy drinking days that we are going to be looking at and those change from baseline.

是的，是RECLAIM試驗。 RECLAIM試驗的主要終點是重度飲酒天數，我們將觀察這些天數與基線相比的變化。

Yes. It's the number of heavy drinking days per week that's.

是的，指的是每週大量飲酒的天數。

Per week, correct

每週，正確

That's the endpoint that we'll be looking at. And Yasmeen, we're really excited about the fact that this trial enrolled almost five months earlier than we were expecting. So, it really shows the critical unmet need out there and the fact that physicians and patients really like the drug. And so, we're really excited about that.

這就是我們將要關注的終點。亞斯敏，我們非常高興這項試驗的入組時間比預期提早了近五個月。這充分顯示了目前亟待滿足的重大醫療需求，也證明了醫生和病人都非常喜歡這種藥物。所以，我們對此感到非常興奮。

Do you have any follow-up questions?

您還有其他問題嗎？

Thank you. I'm good.

謝謝。我沒事。

Patrick Trucchio, H.C. Wainwright & Company.

Patrick Trucchio，H.C. Wainwright & Company。

At 24 weeks, you reported statistically significant antifibrotic activity across multiple NITs. And I'm wondering what magnitude of change of 48 weeks would reinforce this confidence in fibrosis improvement as a key Phase III endpoint. And then separately, I think you've referenced expectation of continued weight loss through 48 weeks. What level of incremental loss or lean mass preservation would confirm pemvidutide's quality weight loss advantage and support differentiation?

在第24週，您報告了在多個非侵入性試驗（NIT）中均觀察到具有統計意義的抗纖維化活性。我想知道，到第48週時，纖維化改善這項關鍵III期終點指標的變化幅度需要達到什麼程度才能增強我們對此指標的信心？另外，您似乎也提到了預期體重會在48週內持續下降。那麼，體重減輕或瘦體重維持達到什麼程度才能證實培維妥肽在高品質減重方面的優勢，並支持其差異化應用？

So at -- yes, at 24 weeks, we saw very strong data on our fibrosis and we continued to see the weight loss that was not plateauing. As you know, some of the NITs can evolve at different time of the improvement for each of those patient. So, we continue to believe based on this, that we will see added improvements at the patients on the study at 48 weeks after our 24 weeks. And we will see which one.

是的，在第24週時，我們看到了關於纖維化的非常強勁的數據，而且體重持續下降，沒有出現平台期。如您所知，一些非免疫性發炎指標（NITs）的改善時間可能因人而異。因此，基於這些結果，我們仍然相信，在24週後的第48週，研究中的患者將會出現進一步的改善。至於具體是哪些改善，我們將拭​​目以待。

We expect, for example, maybe lever stiffness to be something that should be improved, and we will have those data very soon. So, we're really excited about this. And again, with what we've seen on the 24-week, that bodes well for what hopefully we should see on the 48-week.

例如，我們預期槓桿剛度可能需要改進，而且我們很快就能獲得相關數據。所以，我們對此感到非常興奮。此外，根據我們在第24週觀察到的情況，這預示著我們預計在第48週看到更好的結果。

Yes. And the weight loss, we -- as you said, Patrick, we expect to continue to have additional weight loss, just like we saw with our MOMENTUM trial. And just to remind everybody, this wasn't even our best dose in terms of weight loss. It was 1.2 and 1.8. So, the 2.4 milligram, we get even higher weight loss.

是的。至於體重減輕，正如你所說，帕特里克，我們預計體重還會繼續下降，就像我們在 MOMENTUM 試驗中看到的那樣。而且需要提醒大家的是，這甚至還不是我們目前為止減重效果最好的劑量。最佳劑量是 1.2 毫克和 1.8 毫克。所以，2.4 毫克的劑量能帶來更顯著的減重效果。

So clearly, there's plenty of runway there in terms of achieving additional weight loss as well. And just to clarify, as far as the NITs are concerned, they don't all move in tandem. Some of them move early, some move later. So, what we need to show at 48 week is continued maintenance of many of these NITs because we've already achieved such high levels and then additional improvement in some of them.

顯然，在進一步減重方面還有很大的提升空間。需要澄清的是，就神經內分泌指標（NITs）而言，它們並非同步變化。有些指標變化較早，有些則變化較晚。因此，我們需要在第48週證明，許多神經內分泌指標能夠繼續保持較高水平，因為我們已經達到了很高的水平，並且其中一些指標還能進一步提升。

Just to bring the weight -- this is Scott Roberts. Just to bring the weight loss back home, recall that of the direct-acting MASH agents that work directly in the liver, for example, the FGF21s, the thyroid beta agonist, there is no weight loss associated with that. So, we're already ahead of the game with respect to direct-acting agents. And so any additional weight loss and the shape of the curve with a not plateauing certainly bodes well for realizing more weight loss is really just icing on the cake.

簡單來說——我是史考特羅伯茲。簡單來說，就是體重減輕，回想一下，那些直接作用於肝臟的MASH藥物，例如FGF21s和甲狀腺β受體激動劑，並不會導致體重減輕。所以，就直接作用藥物而言，我們已經領先一步了。因此，任何額外的體重減輕，以及曲線形狀沒有出現平台期，都預示著未來能夠實現更大的體重減輕，這簡直是錦上添花。

Yes, I think I'll touch on -- this is Linda. Thanks for the question. I touched on a little bit this concept of lean muscle mass sparing. When you look at various agents and you look at the studies, most of this has been seen in weight loss studies. So, we look at pemvidutide and the MOMENTUM trial, and we had the -- really a study duration of 48 weeks where our lean loss ratio was about 22% compared to other agents that were in the 39%, 26%, 37% range across the board.

是的，我想我會稍微談到這一點——我是琳達。謝謝你的提問。我剛才稍微提到了保留瘦肌肉量這個概念。當你研究各種藥物和相關研究時，你會發現大部分研究都集中在減重方面。例如，我們研究了培維妥肽和MOMENTUM試驗，這項研究持續了48週，結果顯示我們的瘦肌肉量減少率約為22%，而其他藥物的瘦肌肉量減少率則普遍在39%、26%和37%之間。

This matches more closely what natural weight loss would look like if you were doing traditional diet and exercise. You're always going to see some impact on lean muscle, but this matches what you would see kind of in the routine weight loss field.

這更接近透過傳統飲食和運動實現的自然減肥效果。雖然瘦肌肉肯定會受到影響，但這與常規減肥方法的效果基本一致。

When we look at that and we see our weight loss, building this promise into studying in Phase III further, what happens in a longer trial when we have our 52-week study data from a Phase III, if we see continuing loss of weight but muscle mass preservation, this would be extremely interesting to the field. And when we're looking at a forward testing product profile, this is one of the advantages that we very well may have.

當我們審視這些數據，看到體重減輕的效果，並基於此在三期臨床試驗中進一步研究時，如果在更長的試驗期內，我們獲得了52週的三期臨床試驗數據，並且觀察到體重持續減輕但肌肉量得以保持，這將對該領域極具吸引力。當我們展望產品的未來發展前景時，這正是我們可能擁有的優勢之一。

So, when I talked about working closely with the team, putting in these markers and preparing to evaluate them fully in a Phase III trial is exactly the kind of thing that I need to have that can resonate with payers and physicians and patients down the line. So that's kind of bringing all of what we know about our product together and ensuring we have the best shot on goal in Phase III.

所以，當我談到與團隊緊密合作，引入這些指標並準備在三期臨床試驗中對其進行全面評估時，這正是我需要的，它能夠引起支付方、醫生和患者未來的共鳴。這實際上是將我們對產品的所有了解整合起來，確保我們在三期臨床試驗中取得最佳效果。

Jon Wallabin, Citizens.

Jon Wallabin，市民。

I was hoping you could talk a little bit about alcoholic use disorder and alcoholic liver disease as distinct opportunities. It just seems like there's going to be significant overlap in the advantages or disadvantages of running one program versus both.

我希望您能談談酒精使用障礙和酒精性肝病這兩種不同的治療機會。感覺同時進行這兩個項目和只進行其中一個項目，在優缺點方面可能會有很多重疊之處。

Yes, that's a great question, Jonathan. So, I mean, that's the reason we decided to expand the program into AUD and ALD because we believe there is significant opportunity in both of those, and we could be sort of the frontrunner in terms of driving value proposition, additional value proposition for pemvidutide.

是的，喬納森，這是一個很好的問題。我的意思是，這就是我們決定將該項目擴展到酒精使用障礙（AUD）和酒精性肝病（ALD）的原因，因為我們相信這兩個領域都存在巨大的機會，而且我們有可能在推動pemvidutide的價值主張和附加價值主張方面成為領跑者。

So, it's not just MASH, AUD, and ALD. These are very similar product profile that we are looking for in terms of having this dual mechanism of action working directly in the liver, as well as in case of AUD having reduction of cravings. So, bringing these multiple features together is really important.

所以，我們尋找的不僅僅是MASH、AUD和ALD。這些產品的特性非常相似，都希望擁有雙重作用機制，既能直接作用於肝臟，又能像AUD一樣減少對酒精的渴望。因此，將這些多重特性結合起來至關重要。

AUD typically leads to ALD. So, AUD and ALD go hand-in-hand. So, the idea here is that if we can get -- if we can show success in AUD chances that will also be successful in ALD. We've actually already shown the endpoint that we used in MASH one of the NITs is what would be the endpoint for ALD. So, we already have some idea that the drug is working on these endpoints. So, we're very excited about these additional that can be developed independent of MASH beyond MASH.

酒精使用障礙（AUD）通常會導致酒精性肝病（ALD）。因此，AUD 和 ALD 密切相關。我們的想法是，如果我們能在治療 AUD 方面取得成功，那麼治療 ALD 也很有可能成功。事實上，我們已經證明，在 MASH 研究中，我們使用的終點指標（MASH 是 NIT 之一）可以作為 ALD 的終點指標。因此，我們已經初步了解該藥物對這些終點指標有效。所以，我們對這些可以獨立於 MASH 研究之外開發的額外終點指標感到非常興奮。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Just going back to the product profile and pricing and payer discussions, maybe for Linda. I mean, how -- I understand the potential differentiation, how exciting that could be for MASH. I guess the landscape is shifting a little bit now with obviously, with semaglutide possibly having MASH some combinations that are in development or seeking development with FGF21.

回到產品概況、定價和付款方討論，也許對琳達來說是這樣。我的意思是，我理解潛在的差異化優勢，這對MASH來說是多麼令人興奮。我想現在的情況正在發生一些變化，顯然，隨著司美格魯肽可能與MASH聯合使用，一些正在開發或尋求開發的聯合療法也與FGF21聯合使用。

So, I guess maybe you can talk about how you think about MASH pricing when we have some of these other alternatives that could potentially help on the liver side, but indirectly and longer term. I just want to think about that because some physicians are really starting to think about payer pushback and cost. So how should we think about that?

所以，我想您或許可以談談您對MASH定價的看法，尤其是在我們有一些其他替代方案可能對肝臟方面有所幫助的情況下，儘管這些方案是間接的、長期的。我之所以想探討這個問題，是因為有些醫生確實開始考慮支付方的阻力以及成本問題。那我們該如何看待這些問題呢？

Absolutely. Perfect question related to the payer landscape. Reimbursement is largely -- you're looking at what is the value proposition of the drug for, I would say, physicians, patients, and the payers. You want to have something that's actually doing what it says it's going to do. And the value proposition is based on the data.

沒錯。這個問題問得好，跟支付方的情況很相關。報銷很大程度上取決於藥物的價值主張，我認為，這關係到醫生、病人和支付者的利益。你肯定希望藥物能真正發揮其宣稱的療效。而價值主張則取決於數據。

So, when you test a product that has the activity that we do, we have in one drug, two mechanisms of action that provide a host of benefits and excellent tolerability to date. Then you look at some of the carving off, what kind of quality weight loss, what are the lipid impacts? What are other things downstream that you're seeing? The total package of the value proposition leads into assessing what it's worth. Instead of someone having to take two drugs, and have two sets of side effects, two co-pays or wait for a development program to bring that together or face tolerability issues that don't allow them to stay on. We see that with some of the GLP-1s currently.

所以，當你測試像我們這樣具有活性成分的產品時，你會發現，我們的一種藥物就包含兩種作用機制，能夠帶來許多益處，而且迄今為止耐受性極佳。接下來，我們會檢視一些副作用，例如減重效果如何，對血脂的影響如何，以及其他一些後續效應。所有這些價值主張最終都會影響我們對產品價值的評估。這樣一來，患者就無需服用兩種藥物，承受兩套副作用，支付兩份自付費用，也無需等待研發項目將兩種藥物整合，或者面臨耐受性問題而無法堅持服用。我們目前在一些GLP-1受體激動劑中就看到了這種情況。

We see other products downstream coming together with their combinations, but let's see what their tolerability profiles look like. Let's see not having this 1:1 ratio, what they look like. So, the package of what you can get in a product and the early onset of action, I believe as this is going to become a very crowded marketplace, payers are not going to want to necessarily pay for something that takes 72 weeks to see if it's working, how long do they have to be on this? Is the tolerability there?

我們看到下游產品也開始推出組合產品，但讓我們看看它們的耐受性如何。讓我們看看在非1:1比例的情況下，它們的耐受性會如何。因此，產品組合及其早期起效性至關重要。我認為，隨著市場競爭日益激烈，支付方未必願意為需要72週才能看出療效的產品買單。患者需要服用多久？耐受性如何？

When you show the MASH resolution that we saw at 24 weeks, which was outstanding. And then you look at the evidence that we provided in antifibrotic activity with via NITs at 24 weeks, we are pretty much pushing up on what everyone else can do in one molecule with all these benefits. So, my plan will be to focus on what we bring to the table, communicating the value of early activity that you can monitor. You don't have to wait 72 weeks to see some sort of improvement.

當我們展示我們在24週時觀察到的MASH消退情況時，這非常出色。再看看我們在24週時透過NITs提供的抗纖維化活性證據，我們幾乎已經超越了其他所有同類藥物，在所有這些優勢上都取得了顯著進展。因此，我的計劃是重點宣傳我們的優勢，強調早期活性監測的價值。您無需等待72週才能看到任何改善。

Look at that, look at the total benefits and then see where you fit in the spectrum of what the pricing brackets will be. You're bringing more than a generic, even paying for a generic and another product that you might want to use together is still a different activity than having it all in one.

仔細看看，看看所有好處，然後再看看你的預算在哪個價位區間。你買的不僅僅是普通藥品，即使你同時購買普通藥品和另一種你可能想一起使用的產品，也和一次性購買所有產品是完全不同的。

And that's where the value proposition will come as we build additional data as we have other data coming out in the Phase III program that we currently don't even have access to in our 24-week data. So, my plan is to be positioned for the future and drive the very best deliverable assets that we can from this molecule.

隨著我們累積更多數據，價值主張也將隨之顯現。目前，我們在24週數據中還無法取得III期臨床試驗的其他數據。因此，我的計劃是為未來做好準備，並盡可能從該分子中開發出最優質的可交付資產。

Great. That's great context. Just a couple more for me. Just going into AASLD, I know that raising awareness of pemvi is very important. So, can you just give us some color around how you're going to be doing that at the upcoming meeting and how you're going to raise awareness among KOLs? And just on one other quick question, RECLAIM, obviously, enrolled very quickly. How is the ALD enrollment going?

太好了。這些資訊很有幫助。我還有幾個問題。我即將參加AASLD年會，我知道提高人們對PEMVI的認識非常重要。您能否簡要介紹一下您將在即將召開的會議上如何進行這項工作，以及如何提高KOL（關鍵意見領袖）的認識？還有一個小問題，RECLAIM專案的註冊速度非常快。 ALD計畫的註冊情況如何？

All right. So, on the -- on our presence at AASLD, we have a number of activities that we have planned, a lot of engagements with KOL, one-on-one discussions with all of them, with patients advocacy group as well, and we're going to be continuing. I want to remind you that we have also two presentations, one oral and one posters that were accepted as late breaker and that will be there at this time.

好的。關於我們在AASLD的行程，我們計劃開展一系列活動，包括與關鍵意見領袖（KOL）的多次交流，與他們進行一對一的討論，也會與患者權益倡導組織進行溝通，這些活動我們將繼續進行。我想提醒大家，我們還有兩篇報告，一篇是口頭報告，一篇是海報展示，已被AASLD接收為最新研究成果，屆時也會在會上進行展示。

And we also have a receptions where we have a lot of our clinical investigators, principal investigators from our studies and a lot of interest there where we're going to meet as well. So, we're going to have a large presence at AASLD with some very exciting data that will be presented through those late-breaking presentation.

我們也會舉辦招待會，屆時我們的許多臨床研究人員、研究的主要研究者以及其他有興趣的人士都會到場與我們見面。因此，我們將在AASLD大會上佔據重要位置，並透過最新研究成果展示一些非常令人振奮的數據。

And I would just add that having been in the MASH space previously, I do know a lot of the folks who are working with us at Intercept and in hepatology and gastroenterology. And I look forward to rekindling through some of the meetings that we've had set up, relationships with them as well as seeing old friends in the patient advocacy group.

我還要補充一點，由於我之前也參與過MASH項目，所以我認識很多在Intercept和肝病學、胃腸病學領域與我們共事的人。我期待透過我們安排的一些會議與他們重續舊誼，也期待見到患者權益倡導組織的老朋友們。

So, we are well -- there's -- the company may not have had as many contacts before and Christophe and I being new to the organization, but we will leverage the one from the investigators that we've been working with. And I think really having the podium presentation close at late-breaker is a great way to end that meeting for us.

所以，我們目前的情況是——公司之前可能人脈不多，我和克里斯托夫也是新加入公司的，但我們會充分利用我們一直合作的研究人員提供的人脈。我認為在最新研究成果發布會上演講，對我們來說是結束會議的絕佳方式。

Yes, we'll have a very large presence. So, we are really looking forward to it. It will be very exciting to bring pemvi out in the open.

是的，我們會投入大量資源。所以，我們非常期待。把pemvi帶到公眾視野中，想想就令人興奮。

And regarding the ALD enrollment, we are moving forward as planned. We're happy where we are right now with this enrollment. Obviously, the AUD was even more exciting by getting this study enrolled much earlier, which doesn't happen too often, but it's a testament to what the team can do and the interest in this area from patients and physicians. So, we're excited, and we continue to move forward as we anticipated.

關於酒精性肝病（ALD）的入組，我們正按計畫推進。我們對目前的入組情況感到滿意。顯然，酒精使用障礙（AUD）研究的入組工作進展更快，更令人振奮。這種情況並不常見，但這充分證明了團隊的能力以及患者和醫生對該領域的濃厚興趣。因此，我們感到非常興奮，並將繼續按照預期推進研究。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

This is William on for Mayank. Congratulations on a very nice quarter. Looking forward to seeing the upcoming AASLD presentation. Two for us. In terms of your Phase II 24-week biopsy results, I was curious if you could talk to any new or incremental analysis that you may have performed that we may get.

我是William，代表Mayank。恭喜你們本季表現出色。期待你們即將在AASLD會議上的報告。我們有兩個問題。關於你們的II期24週切片結果，我想請教你們是否進行了任何新的或增量分析，以便我們了解。

And specifically, do you know if there's, by any chance, any F2 or F3 analysis that you did on the study? And in regards to F4 patients, by chance upon sort of reevaluation of the biopsies were any included in the study and how the data from your F3 patients might inform how pemvi may perform in the F4 population? And then I have a follow-up.

具體來說，您是否知道這項研究中是否進行過任何F2或F3期的分析？關於F4期患者，在對活檢樣本進行重新評估時，是否有任何F4期患者被納入研究？您F3期患者的數據能否為pemvi在F4期族群的療效提供參考？我還有一個後續問題。

Yes. No, we continue to analyze our data. We're -- there's a large amount of information’s we can gather that will help us drive some of the Phase III. With regard to those different stages, I want to remind you the design included only Phase II and -- sorry, only F2 and F3 patients. There was no F4 patients.

是的。不，我們仍在繼續分析數據。我們可以收集大量信息，這些信息將有助於我們推進部分三期臨床試驗。關於這些不同的階段，我想提醒各位，設計僅包含二期臨床試驗，而且——抱歉，僅包含F2和F3期患者。沒有F4期患者。

We did some post-hoc exploratory analysis. The sample size are small because the study was designed with a small number of patients. So I'm cautious there. But we are very encouraged by what we're seeing. So, in particular, with these Phase II -- F2, F3 patients.

我們進行了一些事後探索性分析。由於這項研究的設計初衷就是針對少量患者，所以樣本數較少。因此，我對此持謹慎態度。但我們對目前觀察到的結果感到非常鼓舞，尤其是在這些二期臨床試驗（F2、F3期）的患者身上。

So, we continue to have supportive data to move into the Phase III in this population and look forward to the design of this and discussing this with the FDA.

因此，我們繼續獲得支持數據，可以進入該族群的 III 期臨床試驗，並期待該試驗的設計以及與 FDA 的討論。

Got it. And then in terms of RECLAIM, as it's been said, it's obviously enrolled pretty far ahead of plan. I was curious if there's been any type of baseline analysis that's been compiled. And if so, could you touch on how those baseline characteristics may compare to the original plan? And then also how that informs to your interest in your RESTORE ALD trial, where you're also looking at these liver-specific endpoints such as VCT and ELF?

明白了。關於RECLAIM試驗，正如之前所說，它的入組進度顯然遠遠超前於計劃。我想知道是否有任何基線分析數據。如果有，您能否談談這些基線特徵與原計劃相比有何不同？此外，這些數據與您在RESTORE ALD試驗中關注的肝臟特異性終點（例如VCT和ELF）有何關聯？

And maybe what's the broader data package that you're looking for to collect that would help qualify as Phase III enabling?

或許您希望收集的更廣泛的資料包是什麼，才能有助於滿足 III 期臨床試驗的要求？

So with regard to the RECLAIM data, we haven't -- we just finished the enrollment. We haven't done a baseline analysis at this point in time of all this information. Obviously, AUD and ALD are kind of a continuum with the patients in AVD being less severe than the patients in ALD. But there's a clear unmet need in this population, and we are looking at the evolution in those both the most severe and the more -- the less severe populations. This is -- we're going to be looking at different parameters.

關於RECLAIM數據，我們剛完成招募，目前還沒有對所有資訊進行基線分析。顯然，酒精使用障礙（AUD）和酒精性肝病（ALD）在某種程度上是一個連續光譜，酒精使用障礙患者的病情通常比酒精性肝病患者輕。但這人群顯然存在著未被滿足的需求，我們正在研究病情最嚴重和較輕人群的演變。我們將考察不同的參數。

Clearly, we just mentioned the days of heavy drinking, but as well liver parameters. We know that those population have fatty livers and increase liver stiffness, and we're going to be looking at this as our primary endpoint for ALD. And that's where we are at this point in time. But again, there's -- we hear a lot of enthusiasm around this area.

顯然，我們剛才提到了酗酒時期的情況，以及肝臟指標。我們知道，這些族群有脂肪肝和肝臟硬度增加的問題，我們將把這些當作酒精性肝病的主要終點指標。這就是我們目前的研究方向。但話說回來，我們聽到了很多關於這個領域的熱情。

Well, and I think the timing of this, just with the interest in no alcohol drinks, mocktails, dry January. Every week, there's something coming out on alcohol use. And here, again, we have a product that is designed to help on two fronts. You can look at the glucagon direct-acting liver effects. I'm thinking if somebody is drinking that much that they want to cut back, they've probably have done a little damage, just may not know it, but they're thinking about their drinking.

嗯，我覺得這個產品的推出時機恰到好處，正值人們對無酒精飲料、無酒精雞尾酒以及「一月戒酒」活動的興趣高漲之際。幾乎每週都有關於飲酒方面的新消息。而這款產品，正是從兩個面向著手設計的。首先，它能直接作用於肝臟，抑制升糖素的分泌。我想，如果有人飲酒過量，想要減少飲酒，那麼他們可能已經對肝臟造成了一些損害，只是他們自己可能沒有意識到，但他們確實在反思自己的飲酒問題。

And then you look at what you would get with the GLP-1 side, which may be helping with cravings. And again, it is one product bringing together two activities that do more benefit for patients with a tolerability profile.

然後，你再看看GLP-1的作用，它可能有助於緩解食慾。再次強調，這是一款結合了兩種活性成分的產品，對耐受性良好的患者來說益處更大。

So, this is really the way we're looking at how can this drug best infiltrate indications that make the most sense, whether it's MASH, whether it's AUD, ALD, you look for where are your strengths and play to your strengths.

所以，我們實際上是在思考如何讓這種藥物最好地滲透到最合適的適應症中，無論是 MASH、AUD、ALD，都要找到自己的優勢並發揮優勢。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

I have three. The first one, since you said that Europe has approved AI biopsy reads and that you intend to propose the PathAI platform to the FDA later this quarter, what are the practical steps -- next steps once the clearance comes? Like for example, are your imaging and workflow systems already validated for PathAI? Or would there be a ramp-up period before you could implement the AI read in Phase III? And then I have two follow-ups.

我有三個問題。第一個問題，既然您提到歐洲已經批准了人工智慧活檢判讀，並且您計劃在本季度晚些時候向FDA提交PathAI平台，那麼一旦獲得批准，接下來的實際步驟是什麼？例如，您的成像和工作流程系統是否已經針對PathAI進行了驗證？或者在將人工智慧判讀應用於III期臨床試驗之前，是否需要一個過渡期？另外，我還有兩個後續問題。

Yes. The way that the AI works is they digitize the slides. And so as long as they have good slides, and we've learned how to do that, that was part of our Phase IIb study. We have excellent specimens and how to handle those. As long as they have good specimens to work with, they have their own proprietary digitalization technique. So, it will be a seamless introduction of that technology into the readout.

是的。人工智慧的工作原理是將切片數位化。只要切片品質好（我們已經掌握瞭如何處理切片，這是我們二期b研究的一部分），我們就能順利地將這項技術無縫整合到讀片流程中。

Okay. And relatedly, how will NIT tracking actually be implemented operationally in Phase III in terms of frequency, imaging cadence, data interpretation? Any color you could offer on that?

好的。另外，在第三階段，NIT追蹤在頻率、成像節奏和資料解讀等方面將如何實際操作？您能否就此提供一些資訊？

So we're going to -- I mean, there's different visits over the 52 weeks with clearly imaging happening at on quarters and 6 months, week 24 and week 48, and then they will be continuing examinations towards clinical outcome for this -- for the patients. And the NITs, we can -- it's much more -- it's much easier to do this more frequently.

所以，我們將——我的意思是，在52週內會有多次隨訪，影像檢查會在每季度、6個月、第24周和第48週進行，然後他們會繼續進行檢查，以評估患者的臨床療效。而且，對於非侵入性檢查（NIT），我們可以——更頻繁地進行這些檢查要容易得多。

So, we have different visit schedule that can be even on a monthly basis, especially early on, where we can look at some of the blood-based need and get this information very early. So, we'll get some very nice reads on how those NITs are moving rapidly in the treatment algorithm here.

因此，我們有不同的追蹤安排，甚至可以每月一次，尤其是在早期階段，這樣我們就可以了解一些血液檢測方面的需求，並儘早獲取相關資訊。這樣，我們就能很好地了解這些非免疫檢測指標在治療流程中的進展。

Got it. And my final question is regards to Lilly's Retatrutide. I know it's very early and a lot needs to happen between now and then. But any thoughts on pemvi's competitive positioning? Should pemvi and Retatrutide compete against each other in the MASH space?

明白了。我的最後一個問題是關於禮來公司的瑞達瑞肽（Retatrutide）。我知道現在下結論還為時過早，未來還有很多事情要處理。但您對pemvi的市場定位有什麼看法？ pemvi和瑞達瑞肽應該在MASH領域競爭嗎？

Yes. So as you know, Mike, Retatrutide is a triple agonist. And it's really the benefit here is the same as with dual agonist, we believe the 1:1 ratio is more important here because we are balancing both GLP-1 and glucagon activity in the same molecule. So, we are getting full benefit. Glucagon is working directly in the liver, whereas GLP-1 is working indirectly through metabolic effects through weight loss.

是的。如你所知，麥克，瑞他曲肽是一種三重激動劑。它的優點與雙重激動劑相同，我們認為1:1的比例在這裡更為重要，因為我們在同一個分子中平衡了GLP-1和胰高血糖素的活性。因此，我們能夠獲得全部益處。升糖素直接作用於肝臟，而GLP-1則透過代謝效應間接發揮作用，進而減輕體重。

So really adding GIP on top of that is not relevant for the MASH space. It may be more relevant for the obesity field. So, we think we are very well positioned versus the Retatrutide in the MASH as well as AUD and ALD space.

因此，在現有基礎上添加 GIP 對 MASH 領域來說意義不大。它可能對肥胖症領域更有意義。所以，我們認為在 MASH 以及 AUD 和 ALD 領域，我們相對於 Retatrutide 有著非常大的優勢。

We know and we'll have some new data at AASLD around the anti-inflammatory aspects on the liver level, which is also really important, and we're excited to have really that 1:1 ratio is really important for the direct activity on the liver.

我們知道，而且我們將在 AASLD 上獲得一些關於肝臟層面抗發炎作用的新數據，這也非常重要，我們很高興能夠真正實現 1:1 的比例，這對於直接作用於肝臟至關重要。

Andy Hsieh, William Blair.

謝家華，威廉布萊爾。

This is [Kelsey Lucerne] on for Andy. We had a question around the preclinical development program for the oral formulation of pemvidutide. Just curious if you could share next steps and time lines for advancing this candidate and any sort of thoughts around positioning relative to the injectable? Will it also be progressing in MASH as an alternative to the injectable form and who you might see as your competitors for this program?

這裡是 Kelsey Lucerne，她代表 Andy 提問。我們有一個關於 pemvidutide 口服製劑臨床前開發專案的問題。請問您能否分享一下該候選藥物的下一步研發計畫和時間表，以及它相對於注射的市場定位？它是否會作為注射劑的替代方案參與 MASH 研究？您認為該專案有哪些競爭對手？

Sure. Happy to take that question. So, recall that our last earnings call, I expressed a lot of excitement and enthusiasm for what was characterized as appropriately as a breakthrough in our oral formulation program. So, we're continuing to push that forward. Obviously, next steps have to do with an IND in the clinical trial, the timing of that will be more clear on as time progresses here.

當然。我很樂意回答這個問題。回想一下，在上次財報電話會議上，我曾對我們口服製劑計畫的突破性進展表達了極大的興奮和熱情。目前，我們正在繼續推進該項目。顯然，下一步需要提交臨床試驗的IND申請，具體時間安排會隨著時間的推移而更加明朗。

But as far as how does it fit into the landscape, I think there's two important features here that should be appreciated. The first is unlike an oral pill, a small molecule, this is still pemvidutide. It's unaltered. Once it enters the bloodstream following the oral administration, it acts just like pemvi. So we get the long half-life. We get the excellent tolerability profile that we've seen so far.

但就它如何融入現有藥物體係而言，我認為有兩個重要特點值得關注。首先，與口服藥片不同，它是一種小分子藥物，本質上仍然是培維妥肽，未發生任何變化。口服後，一旦進入血液循環，它的作用就與培維妥肽完全相同。因此，它具有較長的半衰期，目前為止也展現了良好的耐受性。

So, we have the best of both worlds, will. We have the specificity and potency of the peptide that is pemvidutide as opposed to a small molecule. And yet, we have the oral formulation. So we're really excited about that potential. And we think that as it stacks up against the others, which the vast majority, as you know, are small molecules, we have a real advantage there.

所以，我們兼具兩者的優勢。我們擁有勝肽類藥物pemvidutide的特異性和效力，而非小分子藥物。同時，我們還有口服製劑。因此，我們對它的潛力感到非常興奮。而且我們認為，與其他藥物相比——如您所知，絕大多數藥物都是小分子藥物——我們擁有真正的優勢。

So we're excited about the program. We've made, as I mentioned last time, real headway. We're continuing to progress that, and we'll share more data as appropriate.

所以我們對這個項目感到非常興奮。正如我上次提到的，我們已經取得了實質進展。我們將繼續推進這個項目，並將在適當的時候分享更多數據。

Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I will now hand over the conference to Dr. Garg for closing comments.

謝謝大家。女士們、先生們，問答環節到此結束。現在我將把會議交給加格博士，請他作閉幕致詞。

Well, thank you, everyone, again for joining us. The coming weeks will be incredibly exciting. We look forward to sharing updates on the 48-week data and the end of Phase II meeting with the FDA and hope to see some of you at AASLD. Thank you.

再次感謝各位的參與。接下來的幾週將會非常令人興奮。我們期待與大家分享48週數據的最新進展以及與FDA舉行的II期臨床試驗結束會議，也希望能在AASLD會議上見到各位。謝謝。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議到此結束。感謝您參加今天的報告會。您可以斷開連線了。