Altimmune Inc (ALT) 2025 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Altimmune First Quarter 2025 Financial Results Conference Call. After the speakers' presentation, there will be a question-and-answer session. (Operator Instructions) As a reminder, this call is being recorded.

女士們、先生們，大家好，歡迎參加 Altimmune 2025 年第一季財務業績電話會議。演講者演講結束後，將有問答環節。（操作員指示）提醒一下，此通話正在被錄音。

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

現在我將介紹今天電話會議的主持人 Lee Roth，他是 Burns McClellan 總裁，同時也是 Altimmune 的投資人關係顧問。李，你可以開始了。

Thanks Gigi. Good morning everyone. Once again thank you all for joining us for Altimmune’s first quarter 2025 financial results and business update conference call.

謝謝 Gigi。大家早安。再次感謝大家參加 Altimmune 2025 年第一季財務表現及業務更新電話會議。

On today’s call you will hear from Dr. Vipin Garg, our Chief Executive Officer; Dr. Scott Harris, our Chief Medical Officer; and Greg Weaver, our Chief Financial Officer. Dr. Scot Roberts, our Chief Scientific Officer and Ray Jordt, our Chief Business Officer will join us for the Q&A session.

在今天的電話會議上，您將聽到我們的執行長 Vipin Garg 博士、我們的首席醫療官 Scott Harris 博士和我們的財務長 Greg Weaver 的演講。我們的首席科學官 Scot Roberts 博士和首席商務官 Ray Jordt 將參加我們的問答環節。

Our first quarter 2025 results and corporate update press release was issued earlier this morning and can be found on the Investor Relations section of the Altimmune website. Before we begin, I’d like to remind everyone that remarks made about future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

我們的 2025 年第一季業績和公司更新新聞稿已於今天早上發布，可在 Altimmune 網站的投資者關係部分找到。在我們開始之前，我想提醒大家，關於未來預期、計劃和前景的言論構成了 1995 年《私人證券訴訟改革法案》安全港條款所指的前瞻性陳述。Altimmune 警告稱，這些前瞻性陳述受風險和不確定性的影響，可能導致實際結果與預期結果有重大差異。

For a full 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 Securities and Exchange Commission. I’d also direct you to read the forward-looking statement disclaimer in our press release issued this morning, which is now available on the website.

為了全面了解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提交的文件。我還建議您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，該免責聲明現已在網站上發布。

Any statements made on this conference call speak only as of today’s date, May 13, 2025, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that may occur on or after today. As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website.

本次電話會議所作的任何陳述僅代表截至今天（2025 年 5 月 13 日）的觀點，本公司不承擔更新任何前瞻性陳述以反映今天或之後可能發生的事件或情況的義務。提醒一下，本次通話正在錄音，並將在 Altimmune 網站上提供音訊重播。

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

話雖如此，現在我很高興將電話轉給 Altimmune 總裁兼執行長 Vipin Garg 博士。維平？

Thank you, Lee. Good morning, everyone and thank you for joining us today for our first quarter financial results and corporate update.

謝謝你，李。大家早安，感謝大家今天參加我們的第一季財務表現和公司更新活動。

As you can imagine, we are very excited about the upcoming readout of our IMPACT Phase 2b NASH trial, which we expect to announce this quarter. Based on the class leading liver fat reduction of pemvidutide and the use of biopsy rereads to minimize placebo response, we are confident of achieving the trial’s key efficacy and safety objectives. If successful, pemvidutide would become the only incretin to achieve statistical significance on NASH endpoints at only 24 weeks of treatment.

正如您所想像的，我們對即將公佈的 IMPACT 第 2b 階段 NASH 試驗結果感到非常興奮，我們預計將於本季度公佈。基於培維妥肽領先的肝臟脂肪減少效果以及使用活檢重讀來最大限度地減少安慰劑反應，我們有信心實現該試驗的關鍵功效和安全性目標。如果成功的話，培維妥肽將成為唯一一種在僅 24 週的治療中就對 NASH 終點達到統計意義的腸促胰島素。

Furthermore, it will be the first therapy of any kind to combine these effects with clinically meaningful weight loss at this early time point. If approved, we believe that pemvidutide could provide a complete solution for the treatment of NASH.

此外，這將是第一個將這些效果與早期具有臨床意義的減肥方法結合的治療方法。如果獲得批准，我們相信 pemvidutide 可以為 NASH 的治療提供完整的解決方案。

We announced today that we have entered into a credit facility with Hercules Capital for up to $100 million. This is strategically important as we build upon our balance sheet strength and provide flexibility to support our continued development of pemvidutide.

我們今天宣布，我們已與 Hercules Capital 達成高達 1 億美元的信貸協議。這具有重要的戰略意義，因為我們可以增強資產負債表實力並提供靈活性來支持我們繼續開發 pemvidutide。

Greg will speak further on our financing later on the call. Our recent R&D day event marked an important milestone in pursuing our vision of pemvidutide becoming the treatment of choice in liver and cardiometabolic diseases. We unveiled our plans for Phase 2 trials in alcohol use disorder, or AUD, and alcohol liver disease, or ALD. Both AUD and ALD are areas of significant unmet medical need with limited treatment options.

格雷格稍後將在電話會議上進一步討論我們的融資問題。我們最近舉辦的研發日活動標誌著我們追求讓培維妥肽成為治療肝臟和心臟代謝疾病的首選藥物願景的一個重要里程碑。我們發表了針對酒精使用障礙（AUD）和酒精性肝病（ALD）的 2 期試驗計畫。AUD 和 ALD 都是醫療需求嚴重未被滿足且治療選擇有限的領域。

Pemvidutide has the potential to disrupt the treatment paradigm in both these conditions if we are able to demonstrate a reduction in alcohol consumption in combination with an amelioration of fat reduced induced liver inflammation and fibrosis. This profile of clinical benefits was enthusiastically received by various physician groups and patients, which adds to our conviction for developing pemvidutide in these indications. The expansion into these indications demonstrates our commitment to establish pemvidutide as a potential foundational treatment across multiple fibrotic liver diseases and their primary causes.

如果我們能夠證明酒精攝取量減少，同時脂肪減少引起的肝臟發炎和纖維化得到改善，那麼培維妥肽有可能顛覆這兩種疾病的治療模式。這項臨床益處受到了各種醫生團體和患者的熱烈歡迎，這增強了我們在這些適應症中開發 pemvidutide 的信心。這些適應症的擴展表明我們致力於將培維妥肽確立為多種纖維化肝病及其主要病因的潛在基礎治療方法。

With that, I will now turn the call over to Dr. Scott Harris, our Chief Medical Officer, to provide a clinical development update. Scott?

現在，我將把電話轉給我們的首席醫療官斯科特哈里斯博士，以提供臨床開發更新資訊。史考特？

Thank you, Vipin. We are approaching an important milestone in our MASH program. The top line data from the IMPACT Phase 2b trial, which are expected in the second quarter. We are pleased to report that the trial enrolled a total of 212 participants with biopsy confirmed F2/F3 MASH, which increased the study power over the original target.

謝謝你，Vipin。我們的 MASH 計劃即將迎來一個重要的里程碑。IMPACT 第 2b 階段試驗的頂線資料預計將於第二季公佈。我們很高興地報告，該試驗共招募了 212 名經活檢確診為 F2/F3 MASH 的參與者，這提高了研究能力，超過了最初的目標。

As a reminder, the dual primary endpoints are MASH resolution or fibrosis improvement at 24 weeks. We also plan to provide data on key secondary endpoints, including weight loss, non-invasive tests of fibrosis, such as FibroScan and ELF, liver fat reduction, and serum lipids.

提醒一下，雙重主要終點是 24 週時的 MASH 消退或纖維化改善。我們還計劃提供關鍵次要終點的數據，包括減重、纖維化的非侵入性測試（如 FibroScan 和 ELF）、肝臟脂肪減少和血清脂質。

We also look forward to reporting an adverse event profile that confirms the safety and tolerability of pemvidutide. As Vipin mentioned, if successful, pemvidutide would become the only incretin to achieve statistical significance on MASH endpoints at only 24 weeks of treatment. Further, it will be the first therapy of any kind to combine these effects with clinically meaningful weight loss at this early time point. While the top line efficacy data readout will be at 24 weeks of treatment, we are continuing to treat patients for a total of 48 weeks. This will allow us to estimate the effect of pemvidutide or MASH biopsy endpoints using non-invasive tests and determine the additional weight loss achieved by these patients at this time point.

我們也期待報告不良事件概況，以確認 pemvidutide 的安全性和耐受性。正如 Vipin 所提到的，如果成功，培維妥肽將成為唯一一種在僅 24 週的治療中就對 MASH 終點達到統計學意義的腸促胰島素。此外，這將是第一個將這些效果與早期具有臨床意義的減肥相結合的治療方法。雖然頂線療效數據讀數將在治療 24 週時顯示，但我們將繼續對患者進行總共 48 週的治療。這將使我們能夠使用非侵入性測試評估 pemvidutide 或 MASH 活檢終點的效果，並確定這些患者此時實現的額外體重減輕。

We are now on the final stages of rereading the biopsies. The baseline patient demographics and characteristics, including age, sex, body weight, BMI, diabetes status, ratio of F2 to F3, liver fat content, non-invasive measures of fibrosis, and liver function are consistent with our expectations and closely approximate other studies in MASH.

我們現在正處於重讀活檢結果的最後階段。基線患者的人口統計和特徵，包括年齡、性別、體重、BMI、糖尿病狀況、F2 與 F3 的比例、肝臟脂肪含量、纖維化的非侵入性測量和肝功能與我們的預期一致，並且與 MASH 中的其他研究非常接近。

To maximize the integrity and robustness of our histology readout, both baseline and end of treatment biopsies for all subjects are being reread in a blinded fashion using independent reads from three pathologists and a modal approach to scoring, similar to recent successful studies in this indication.

為了最大程度地提高組織學讀數的完整性和穩健性，所有受試者的基線和治療結束時的活檢都以盲法重新讀取，使用三位病理學家的獨立讀數和模態評分方法，類似於最近在該適應症中的成功研究。

Precedent has shown that re-reading both the baseline and end of treatment biopsies significantly reduces the placebo response rate in MASH trials and implementing this procedure will add to the likelihood of trial success.

先例表明，重新閱讀基線和治療結束時的活檢結果可顯著降低 MASH 試驗中的安慰劑反應率，而實施此程序將增加試驗成功的可能性。

Finally, the most compelling reason we are confident heading into the IMPACT readout is that our Phase 1b MASLD study demonstrated a dose dependent liver fat reduction of up to 76.4%, which is greater than that associated with other successful trials and is class leading for MASH therapeutics.

最後，我們對 IMPACT 讀數充滿信心的最令人信服的原因是，我們的 1b 期 MASLD 研究表明劑量依賴性肝臟脂肪減少高達 76.4%，這比其他成功試驗的減少幅度更大，並且在 MASH 療法中處於領先地位。

Recall that liver fat reduction has been shown to be the principal driver of MASH resolution and fibrosis improvement in MASH clinical trials. Given our confidence in the upcoming data, we are preparing for the initiation of a Phase 3 trial in NASH and intend to hold the end of Phase 2 meeting with the FDA in the fourth quarter of this year for this indication. This timeline would allow us to initiate a registrational program in early 2026.

回想一下，在 MASH 臨床試驗中，肝臟脂肪減少已被證明是 MASH 消退和纖維化改善的主要動力。鑑於我們對即將公佈的數據充滿信心，我們正在準備啟動 NASH 的 3 期試驗，並打算在今年第四季與 FDA 就該適應症舉行 2 期結束會議。這個時間表將使我們能夠在 2026 年初啟動註冊計劃。

Turning now to two additional indications that we unveiled at our March R&D day event, Alcohol Use Disorder, or AUD, and Alcohol Liver Disease, or ALD, we are progressing towards Phase 2 trial initiations in these indications in Q2 and Q3, respectively. The Phase 2 trial in AUD will evaluate pemvidutide versus placebo in approximately one hundred patients over a 24-week period.

現在談談我們在 3 月研發日活動中公佈的另外兩個適應症，即酒精使用障礙 (AUD) 和酒精性肝病 (ALD)，我們分別在第二季度和第三季度朝著這兩個適應症的 2 期試驗啟動邁進。澳洲的 2 期試驗將在 24 週內對大約一百名患者進行 pemvidutide 與安慰劑的比較評估。

Patients in the pemvidutide arm will receive the 2.4 milligram dose titrated over eight weeks to maximize tolerability in this patient population. The primary efficacy endpoint is the patient reported change in heavy drinking days with the timeline follow back method as established by FDA guidance, with key secondary endpoints of changes in alcohol consumption by PEF and weight loss.

培維妥肽組患者將接受 2.4 毫克劑量，並在八週內進行滴定，以最大限度地提高該患者群體的耐受性。主要療效終點是患者報告的重度飲酒天數的變化，採用 FDA 指南建立的時間線回溯法，關鍵次要終點是 PEF 和體重減輕導致的酒精消耗量變化。

Similar to our AUD trial, the Phase 2 ALD trial will evaluate pemvidutide versus placebo in approximately 100 patients, but over a 48-week treatment period. We will employ a 2.4 milligram dose of pemvidutide with the same dose titration method as in AUD. The key endpoint, change in liver stiffness measurement by FibroScan, will be assessed at 24 week and 48 weeks, along with key secondary endpoints of change in alcohol consumption and weight loss.

與我們的 AUD 試驗類似，第 2 階段 ALD 試驗將在約 100 名患者中評估 pemvidutide 與安慰劑的療效，但治療期為 48 週。我們將以 2.4 毫克劑量的培維妥肽，劑量滴定方法與 AUD 相同。將在第 24 週和第 48 週評估關鍵終點，即透過 FibroScan 測量的肝臟硬度變化，以及酒精消耗量和體重減輕變化的關鍵次要終點。

Both AUD and ALD are large patient populations with treatment options that either have proven ineffective in clinical practice in the case of AUD or don’t exist in the case of ALD. Our market research suggests the drug with the target profile of pemvidutide, one that reduces alcohol consumption, liver inflammation, and body weight would be well received by patients and physicians.

AUD 和 ALD 都是龐大的患者群體，但對於 AUD 而言，臨床實踐證明其治療無效，而對於 ALD 而言，則不存在任何治療選擇。我們的市場調查顯示，以培維妥肽為目標藥物，能夠減少酒精攝取、肝臟發炎和體重，將受到患者和醫生的歡迎。

Furthermore, obesity is recognized to be a key risk factor for poor outcomes in both AUD and ALD, and not unexpectedly patients with these conditions have a high incidence of metabolic abnormalities, including hypertension and hyperlipidemia. If these efficacy trials are successful in AUD and ALD, we believe that pemvidutide has the potential to redefine the approach to the treatment of these serious conditions.

此外，肥胖被認為是導致 AUD 和 ALD 預後不良的關鍵風險因素，且患有這些疾病的患者發生代謝異常（包括高血壓和高血脂）的發生率很高，這並不令人意外。如果這些療效試驗在 AUD 和 ALD 中取得成功，我們相信 pemvidutide 有可能重新定義治療這些嚴重疾病的方法。

MASH and ALD are the two most frequent conditions leading to liver transplantation in the United States. So the long term potential benefits of pemvidutide, if positive, are significant. We are excited to initiate the trials and look forward to sharing our progress along the way.

MASH 和 ALD 是美國最常見的兩種需要肝臟移植的疾病。因此，如果是積極的，那麼培維妥肽的長期潛在益處是巨大的。我們很高興啟動試驗並期待分享我們的進展。

With that, I’ll now turn it over to Greg Weaver, our Chief Financial Officer, to review our financial results for the first quarter. Greg?

現在，我將把時間交給我們的財務長 Greg Weaver，來審查我們第一季的財務表現。格雷格？

Thank you, Scott, and good morning, everyone. Let me begin with adding some color around our cash position, our recent use of the ATM and today’s announcement of the credit facility with Hercules Capital. I am quite happy with the progress we have made over the recent months in building the cash runway required to support the pemvidutide clinical development program in MASH, ALD, and AUD. I am confident that the cash position we construct will support the needs of the pemvidutide program over time.

謝謝你，斯科特，大家早安。首先，我想介紹一下我們的現金狀況、我們最近對 ATM 的使用情況以及今天宣布的與 Hercules Capital 的信貸安排。我對近幾個月來我們在建立支持 MASH、ALD 和 AUD 的 pemvidutide 臨床開發計劃所需的現金跑道方面取得的進展感到非常高興。我相信，我們建立的現金狀況將能夠長期滿足 pemvidutide 計劃的需求。

Briefly about the ATM facility. This is one of several financing tools available to us. We have raised $35 million net off the facility in the first quarter of 2025, an additional $16 million since April 1.

簡單介紹一下 ATM 設施。這是我們可用的幾種融資工具之一。我們在 2025 年第一季透過該設施淨籌集了 3,500 萬美元，自 4 月 1 日以來又籌集了 1,600 萬美元。

The $100 million credit facility announced this morning is another important piece of the financing strategy and Hercules is a high quality partner. The facility provides tranche funding that is optional, flexible and significantly extends our cash runway. There's a $15 million funding at closing up front and an additional $25 million available in 2025 subject to milestones that align with our business plans. The remaining $60 million on the facility is available beginning in 2026 and subject to milestones and conditions.

今天早上宣布的 1 億美元信貸額度是融資策略的另一個重要組成部分，而 Hercules 是一位優質的合作夥伴。該工具提供可選的、靈活的分期融資，並大大延長了我們的現金流。交易結束時將預先獲得 1500 萬美元的資金，並且根據與我們的業務計劃相符的里程碑，將在 2025 年額外提供 2500 萬美元的資金。該設施剩餘的 6000 萬美元將於 2026 年開始提供，但需遵守里程碑和條件。

Terms of the facility include interest only for 24 months, which can be extended up to 42 months. The duration of the facility is 48 months. Terms are at market rates and no warrants are included in the facility. We view Hercules as a long-term partner with the ability to grow alongside us as we continue to advance pemvidutide.

該貸款條款包括 24 個月的僅利息，可延長至 42 個月。該設施的期限為48個月。條款以市場價格計算，且該設施不包含任何認股權證。我們將 Hercules 視為長期合作夥伴，在我們繼續推動 pemvidutide 的過程中，它有能力與我們共同成長。

Now to briefly comment on the Q1 financial results, we ended the first quarter of 2025 with $150 million in cash, cash equivalents and short-term investments as compared to $132 million at year-end 2024. The increase in our cash balance is related to equity sales off the ATM facility totaling the $35 million during the first quarter.

現在簡要評論第一季的財務業績，截至 2025 年第一季度，我們的現金、現金等價物和短期投資為 1.5 億美元，而 2024 年底為 1.32 億美元。我們的現金餘額增加與第一季 ATM 設施的股權銷售總額 3,500 萬美元有關。

R&D expenses were $15.8 million for the three months ended March 31, 2025 compared to $21.5 million same period of 2024. R&D expenses in the first quarter included $9.2 million of direct costs related to the development of pemvidutide specifically to upfront CRO costs for the IMPACT trial.

截至 2025 年 3 月 31 日的三個月，研發費用為 1,580 萬美元，而 2024 年同期為 2,150 萬美元。第一季的研發費用包括與 pemvidutide 開發相關的 920 萬美元直接成本，特別是 IMPACT 試驗的前期 CRO 成本。

G&A expenses were $6 million for the quarter ended March 31, 2025 compared to $5.3 million in the same period of 2024. The increase was primarily related to a $500,000 increase in non-cash.com and other labor related expense.

截至 2025 年 3 月 31 日的季度，一般及行政費用為 600 萬美元，而 2024 年同期為 530 萬美元。這一增長主要與非現金及其他勞動力相關費用增加 50 萬美元有關。

Net loss for the first quarter of 2025 was $19.6 million, $0.26 a share compared to a net loss of $24.4 million or $0.34 a share for the first quarter of the prior year 2024.

2025 年第一季淨虧損為 1,960 萬美元，每股虧損 0.26 美元，去年同期 2024 年第一季淨虧損為 2,440 萬美元，每股虧損 0.34 美元。

With that, I'll now turn the call back to Vipin for closing remarks. Vipin?

現在，我將把電話轉回給維平，請他做最後發言。維平？

Thank you, Greg. We are entering a truly exciting time for Altimmune with the upcoming MASH data and the initiation of our AUD and ALD phase 2 trials. We expect 2025 to be a transformative year for the company. This concludes our formal remarks, and we would now like to open the line to take questions. Operator?

謝謝你，格雷格。隨著即將發布的 MASH 數據以及 AUD 和 ALD 第 2 階段試驗的啟動，我們正進入 Altimmune 真正令人興奮的時刻。我們預計 2025 年將成為公司的轉型之年。我們的正式發言到此結束，現在我們想開始回答問題。操作員？

(Operator Instructions) Our first question comes from the line of Yasmeen Rahimi from Piper Sandler.

（操作員指示）我們的第一個問題來自 Piper Sandler 的 Yasmeen Rahimi。

Good morning team. Thank you so much for all the great updates and very much looking forward to the IMPACT study reading out here in 2Q. Two questions.

大家早安。非常感謝您提供的所有精彩更新，並非常期待第二季發布的 IMPACT 研究報告。兩個問題。

The first one is Scott, you mentioned that you guys are analyzing the baseline biopsies again. Have you had a chance to maybe provide some commentary around what the distribution F2 and F3 are and sort of how representative this Phase 2b population baseline characteristics are versus maybe some of the other Phase 2b successful Phase 2bs that we have seen? That's question one.

第一個是史考特，你提到你們正在再次分析基線活檢。您是否有機會對 F2 和 F3 的分佈情況以及該 2b 階段人群基線特徵與我們所見過的其他一些 2b 階段成功案例相比的代表性提供一些評論？這是第一個問題。

Question two is directed to Vipin. I think speaking with investors we always find that they are excited about pemvidutide but may need help to think about post impact. What is the ideal population within MASH obese that would be ideal for pemvee? If you could provide color there that would be really helpful.

第二個問題是針對維平的。我認為，與投資者交談時我們總是發現他們對培維妥肽感到興奮，但可能需要幫助來考慮後續影響。MASH 肥胖中最適合 pemvee 的人是哪些？如果您能提供顏色，那將會非常有幫助。

And then the third one is obviously upon positive data from the IMPACT study you do have the opportunity to think about partnering this asset if you could provide also Vipin and team some commentary around how you're thinking about partnership opportunities. So appreciate if you could tackle these three part questions and I'll jump back in the queue.

然後第三個顯然是根據 IMPACT 研究的積極數據，您確實有機會考慮與該資產合作，如果您可以為 Vipin 和團隊提供一些關於您如何看待合作機會的評論。如果您能解答這三個部分的問題，我將不勝感激，我將重新回到隊列中。

Absolutely. Thanks for your questions. Yes Scott, you want to take the first question?

絕對地。感謝您的提問。是的，史考特，你想回答第一個問題嗎？

Yes, well, yes, we're in the absolute final stages of rereading the biopsies and what we're going to present are the demographics of that final qualifying population. So based on that we can't give you precise numbers. We would say in confidence. If you look at the other studies in terms of the age of the patients, the average proportion of women, the F2, F3 distribution, the distribution of diabetics, the fibrous skin scores, the Elf, the liver fat at baseline, the ALT levels, if you look at what we're seeing in the population that will be evaluated as that data comes to us, it looks very, very similar to other studies. So I think that investors can look at this and say that this will be very meaningful in terms of its comparability to other studies.

是的，嗯，是的，我們正處於重新閱讀活檢結果的最後階段，我們將要呈現的是最終合格人群的人口統計。因此，我們無法基於此給出精確的數字。我們可以自信地說。如果您從患者年齡、女性平均比例、F2、F3 分佈、糖尿病患者分佈、纖維皮膚評分、Elf、基線肝臟脂肪、ALT 水平等方面來觀察其他研究，如果您觀察我們在獲得這些數據後將要評估的人群中看到的情況，就會發現它們與其他研究非常非常相似。因此我認為投資者可以看到這一點，並認為這與其他研究的可比性非常有意義。

In terms of your question about the patient population? Yes. What we are doing is we're really leveraging the unique features of pemvidutide, which really combines, which combines direct effect in the liver with weight loss. So really the way we look at MASH is, it's MASH with obesity. As you know, 80% of the patients, 80% to 90% of patients with the MASH have obesity. So we're treating both the root cause of MASH, which is obesity, as well as the serious condition that results from obesity, which is liver fibrosis.

關於患者族群的問題？是的。我們所做的是真正利用培維妥肽的獨特功能，它真正結合了對肝臟的直接作用和減肥作用。所以我們真正看待 MASH 的方式是，它是患有肥胖症的 MASH。眾所周知，80% 的患者，80% 到 90% 的 MASH 患者都有肥胖症。因此，我們既要治療 MASH 的根本原因，即肥胖，也要治療由肥胖引起的嚴重疾病，即肝纖維化。

So by combining these two effects, we're really bringing these two features to the table and really we believe that's added value proposition for MASH and even the other indication that we are pursuing. So everything we are doing has a common element here where we are looking at obesity as this important secondary endpoint. So we think that really gives us an advantage in terms of identify the patient population that would be most benefited from pemvidutide.

因此，透過結合這兩種效果，我們真正將這兩種特性帶到了桌面上，我們真的相信這是 MASH 的附加價值主張，甚至是我們正在追求的其他適應症的附加價值主張。因此，我們所做的一切都有一個共同點，就是我們將肥胖視為重要的次要終點。因此，我們認為這確實為我們提供了優勢，讓我們能夠確定最能從培維妥肽中受益的患者群體。

With regards to your second question, as far as partnering is concerned, as we have stated, our goal is to move forward into phase 3 development of pemvidutide as quickly as possible. We are putting all of the pieces in place to make that happen. Along the way we are open to discussions and if a compelling partnership comes together, we'll certainly look at it. But that's not going to be the gating factor in terms of our ability to move forward with Phase 3 in MASH as well as in AUD and ALD.

關於您的第二個問題，就合作而言，正如我們所說，我們的目標是盡快推進 pemvidutide 的 3 期開發。我們正在採取一切必要措施來實現這一目標。在這個過程中，我們願意進行討論，如果建立了引人注目的合作夥伴關係，我們一定會考慮。但這並不是我們推動 MASH 以及 AUD 和 ALD 第三階段工作的限制因素。

Thank you so much.

太感謝了。

Thank you. One moment for our next question. Our next question comes from the line of Liisa Bayko from Evercore.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 Evercore 的 Liisa Bayko。

Hi there. Thanks for taking the questions and congratulations on the progress. Can you talk a little bit about, what you're seeing in the study in terms of discontinuations, how you're handling the discontinuations in terms of the data, and how should we think about any loss from the re-reads and things like that? Curious. Thanks.

你好呀。感謝您回答問題，並祝賀您取得進展。您能否稍微談談，您在研究中看到了哪些停藥情況，您如何處理資料停藥，以及我們應該如何看待重新閱讀等造成的損失？好奇的。謝謝。

Yes. Liisa, let me answer that question. I can't give you absolute numbers and study discontinuations, but what I can say is looking across the trial, the discontinuations that we're seeing and also those due to adverse events, we're very, very happy with the data that we're seeing so far. The trial has been going very well, especially with regards to discontinuations. Obviously we'll have that data at the time of the readout. The discontinuations are handled in different ways in trials.

是的。Liisa，讓我來回答這個問題。我無法給出絕對數字和研究中止的情況，但我可以說的是，縱觀整個試驗，我們看到的中止情況以及由於不良事件導致的中止情況，我們對迄今為止看到的數據非常非常滿意。試驗進展非常順利，特別是在停藥方面。顯然，我們會在讀數時獲得該數據。在試驗中，對中止的處理方式有所不同。

As you know, some compounds have looked at completer analyses, others have done what's called the full intention to treat, where all discontinuations are treating as non-responders. And then there's the midway, which is an imputation method which has been used in other trials as well. Our goal is to have all that information available at the time of the readout. I can't give you finite information on the rereads at this point, but it's what we're seeing is in line with what we had projected for patients who qualify.

如您所知，一些化合物已經進行了更完整的分析，其他化合物已經進行了所謂的完全意向治療，其中所有停藥均視為無反應者。然後還有中間方法，這是一種在其他試驗中也使用過的歸因方法。我們的目標是在讀數時提供所有資訊。我目前無法向您提供有關重讀的有限信息，但我們所看到的結果與我們對符合條件的患者的預測一致。

Okay, great. And then just one more question. I've been getting some questions on the importance of weight loss in this study because it really is obviously a MASH first study and weight loss is sort of secondary. So I guess how do you see the importance and how do we think about benchmarking weight loss in this study? I know you said to expect something like semaglutide, but what does that actually really mean? And I know this study will have a combination of patients with MASH diabetics. They won't be encouraged necessarily on lifestyle and other factors. So taking that all together, how should we think about how much weight loss to expect in a study like this? Thank you.

好的，太好了。還有一個問題。我一直在思考這項研究中減肥的重要性，因為這顯然是一項 MASH 首要研究，而減肥只是次要的。那麼我想您如何看待這一重要性以及我們如何看待在這項研究中對減肥進行基準測試？我知道您說過要期待像司美格魯肽這樣的東西，但這實際上意味著什麼？我知道這項研究將會結合患有 MASH 糖尿病的患者。他們不一定會因為生活方式和其他因素而受到鼓勵。那麼綜合考慮這些因素，我們該如何預測在這樣的研究中體重會減輕多少呢？謝謝。

Yes, great question, Liisa. Weight loss is extremely important. If you look at the patient population up through F3, they ate predominantly of the comorbidities of obesity and the cardiovascular risk. And if you don't achieve meaningful weight loss in the treatment of mashed patients, you're really [pitching holing] the product into a late F3, F4 type population to treat fibrosis. And the goal is to be holistic and treat all the patients from the least severe to the most severe and we think we have that in our product.

是的，很好的問題，Liisa。減肥極為重要。如果您觀察 F3 以上的患者群體，您會發現他們主要患有肥胖症和心血管風險的合併症。如果在治療肥胖症患者時沒有達到明顯的減重效果，那麼你實際上就是將產品投放到晚期 F3、F4 型人群中來治療纖維化。我們的目標是全面治療所有患者，從病情最輕到病情最重，我們認為我們的產品已經實現了這一目標。

As Vipin mentioned before in his comments, and I repeated that, first of all, we'll be the only incretin reading out of 24 weeks. And that will differentiate us from the other compound because speed is effectiveness and when you're treating people with F3, they may not have a lot of time before they get into F4 once again into F3 they start progressing very quickly, as little as two years. You really wonder if you want to have a slow acting drug, one that works indirectly by weight loss as being your factor. You need to have direct action within the liver and our ability to read out at 24 weeks is really going to differentiate us from the incretins because we'll have both the weight loss and the direct acting effects, and compared to the other compounds reading out at 24 weeks, particularly the FGF 21s will have meaningful weight loss.

正如維平之前在評論中提到的那樣，我也重複了一遍，首先，我們將是 24 週內唯一的腸促胰島素讀數。這將使我們與其他化合物區分開來，因為速度就是有效性，當你用 F3 治療患者時，他們可能沒有太多時間進入 F4，再次進入 F3 時，他們會開始迅速進展，只需兩年。您真的想知道是否想要一種緩慢起效的藥物，一種透過減肥間接起作用的藥物。您需要在肝臟內進行直接作用，我們在 24 週時讀取的能力確實會將我們與腸促胰島素區分開來，因為我們既有減肥效果，又有直接作用效果，並且與在 24 週時讀取的其他化合物相比，特別是 FGF 21s 將具有顯著的減肥效果。

So we will be a complete solution for MASH. We think that with successful readout both in the MASH endpoints in the weight loss, we will be highly differentiated not only against the incretins, but all compounds. Now, regarding your question about the weight loss that we expect, as you know, in the semaglutide trial they had a weight loss of about 10% at 72 weeks. That has to be scaled back to what you would expect at 24 weeks, going one third of the amount of time.

因此我們將為 MASH 提供完整的解決方案。我們認為，透過成功讀取減重中的 MASH 終點，我們不僅可以針對腸促胰島素進行高度區分，而且可以針對所有化合物進行高度區分。現在，關於您所問的我們預期的體重減輕情況，如您所知，在司美格魯肽試驗中，他們在 72 週時體重減輕了約 10%。這必須縮減到 24 週的預期時間，即三分之一的時間。

So our position is that any clinically significant, clinically meaningful weight loss that we see will be highly differentiating, but I think that we can roughly project that it would be very similar to semaglutide. As you mentioned, lifestyle interventions like diet and exercise are not used in MASH trials. That compares against weight loss trials where it is, so you tend to have lower placebo response rates. So all in all, I think that comparing this to the semaglutide trial at 24 weeks, something that's meaningful and clinically significant, will be very similar to semaglutide in its weight loss, but then clearly differentiate from the FGF21s by providing significant weight loss, which these compounds don't have.

因此，我們的立場是，我們看到的任何具有臨床意義的、有臨床意義的體重減輕都會有很大的不同，但我認為我們可以粗略地預測它與司美格魯肽非常相似。正如您所提到的，MASH 試驗中並不採用飲食和運動等生活方式介入。與減肥試驗相比，安慰劑反應率往往較低。總而言之，我認為將其與 24 週的 semaglutide 試驗進行比較是有意義的，具有臨床意義，其減肥效果與 semaglutide 非常相似，但與 FGF21s 有明顯區別，因為它可以顯著減輕體重，而這些化合物沒有。

Now, one other point is, as I mentioned in my comments, although we are reading out now this quarter at 24 weeks, we are also reading out by the end of the year at 48 weeks so that we will have a lot of information. Another catalyst in the second half of the year, we are going to have 48-week weight loss. We are also going to have non-invasive testing that will allow us to predict what the biopsy results would have been at week 48 had we done a biopsy at that point.

現在，另一點是，正如我在評論中提到的那樣，雖然我們現在以 24 週的時間讀出本季度的數據，但我們也會以 48 週的時間讀出年底的數據，這樣我們就會獲得大量資訊。下半年的另一個催化劑是，我們將進行48週的減肥。我們還將進行非侵入性測試，以便我們預測如果在第 48 週進行活檢，活檢結果會是什麼。

As you know from other studies, the biopsy response grows with time. So anything we see at 24 weeks will be magnified and even greater in the 48-week readout.

正如您從其他研究中了解到的那樣，活檢反應會隨著時間的推移而增強。因此，我們在 24 週看到的任何情況在 48 週的讀數中都會放大甚至更大。

Very helpful, thank you. And then just final question from me. As you think about phase 3 and I know you'll be pending, all this data meeting with FDA towards the end of the year is taking the higher dose into phase 3 consideration. And also I know you're really focused on kind of like how rapid the response is and how are you thinking about a potentially earlier six month endpoint? Thank you.

非常有幫助，謝謝。然後我還有最後一個問題。當您考慮第 3 階段時，我知道您將會等待，今年年底與 FDA 舉行的所有這些數據會議都會將更高劑量納入第 3 階段的考慮。而且我也知道您真正關注的是響應速度有多快，以及您如何考慮可能提前六個月完成的終點？謝謝。

Well, those are great questions, Lisa. So we're strongly considering taking the 2.4 milligram dose into Phase 3. And it's not because we expect better MASH effects, it's that we expect to get better weight loss, reminding you that the 1.8 milligram dose that we have in this trial is not the optimal dose for achieving weight loss. Pertinent to your prior question, that has to be understood in looking at the data that we will get higher weight loss if we employ the 2.4 milligram dose in Phase 3 as we intend.

嗯，這些都是很好的問題，麗莎。因此，我們強烈考慮將 2.4 毫克劑量帶入第 3 階段。這並不是因為我們期望獲得更好的 MASH 效果，而是我們期望獲得更好的減肥效果，提醒您，我們在本次試驗中使用的 1.8 毫克劑量並不是實現減肥的最佳劑量。與您先前的問題相關，從數據上看，我們必須明白，如果我們按照計劃在第 3 階段採用 2.4 毫克劑量，我們將獲得更高的減肥效果。

Now, regarding the more rapid response, the FDA and their guidance does not provide a time course for these trials. One possibility here, as you mentioned, would be to do readouts at not only the end of a year, 48 weeks or 52 weeks, but also at six months. That's something we're strongly considering for two reasons. The first is that it would then also make put a stake in the ground for earlier, more rapid mash effects. But second, it would also allow us to read out the trial results six months earlier. So both of those elements, adding the 2.4 milligram dose and doing an earlier readout are something that's strongly being considered. We are writing that program as we speak. We are well ahead of our timeline for having an end of Phase 2 meeting with the FDA in the fourth quarter, and these are things that we will discuss with them and I think they'll be very open to that discussion.

現在，關於更快的反應，FDA 及其指南並未提供這些試驗的時間表。正如您所提到的，一種可能性是不僅在一年、48 週或 52 週結束時進行讀數，而且在六個月結束時也進行讀數。我們正在認真考慮這一點，原因有二。首先，它也將為更早、更快速的混合效果奠定基礎。其次，它還能讓我們提前六個月讀出試驗結果。因此，這兩個因素，即增加 2.4 毫克劑量和進行早期讀數，都是認真考慮的事情。我們一邊說話，一邊編寫該程式。我們遠遠提前於第四季度與 FDA 舉行第二階段會議的時間表，這些都是我們將與他們討論的事情，我認為他們會非常樂意進行討論。

Thank you so much for answering all my questions.

非常感謝您回答我的所有問題。

Thank you. One moment for our next question. Our next question comes from the line of Roger Song from Jefferies.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 Jefferies 的 Roger Song。

Excellent. Thanks, team, for the update. And then taking our question, I have a couple questions related to the IMPACTS study as well. The first one is understanding the trial is well overpowered for both endpoints, but just curious how you think about which endpoints are a bit harder to hit based on all the historical data. And then that's number one.

出色的。感謝團隊的更新。然後回答我們的問題，我也有幾個與 IMPACTS 研究相關的問題。第一個是了解試驗對於兩個端點而言都具有極強的效力，但只是好奇您如何根據所有歷史數據來考慮哪些端點更難達到。這是第一點。

Number two is your recent ESO data regarding this MASH resolution index, the translation to the MASH biopsy. So how you think about that index will correlate with the fibrosis improvement as well. Thank you.

第二個是您最近關於此 MASH 分辨率指數的 ESO 數據，即 MASH 活檢的翻譯。因此，您對該指數的看法也將與纖維化的改善有關。謝謝。

Yes, Roger. Well, as you mentioned, the trial is extremely well powered and by enrolling additional patients, we've even added to the likelihood of trial success. Historically, the fibrosis improvement endpoint has been harder to hit than the MASH resolution endpoint. I think that's a well established effect.

是的，羅傑。嗯，正如您所說，這項試驗的效果非常好，透過招募更多患者，我們甚至增加了試驗成功的可能性。從歷史上看，纖維化改善終點比 MASH 解決終點更難實現。我認為這是一個已證實的效果。

In our trial, we have dual endpoints, which mean that we can hit either MASH resolution or fibrosis improvement to be successful. But that being the case, we believe that we'll be successful in hitting both endpoints based on all the factors that were mentioned. In terms of what was presented at EASL that was a new index developed by Rohit Loomba at UCSD, who also developed the concept of a 30% decrease. Liver fat content was also associated with, with MASH resolution, and he's continued to evolve this to getting an index that's even more sensitive and specific than that. And this mash resolution index combines liver fat reduction, the change in ALT level and baseline AST level, and it has an area under the curve in an ROC analysis approaching 0.9, which is very, very predictive with high sensitivity and specificity.

在我們的試驗中，我們有雙重終點，這意味著我們可以達到 MASH 解析度或纖維化改善即可獲得成功。但既然如此，我們相信，基於上述所有因素，我們將成功達到這兩個終點。就 EASL 上展示的內容而言，這是加州大學聖地牙哥分校的 Rohit Loomba 開發的新指數，他也提出了 30% 下降的概念。肝臟脂肪含量也與 MASH 解析度有關，他不斷改進這種方法，以獲得比這更敏感、更具體的指數。此脂肪分解指數結合了肝臟脂肪減少、ALT 水平和基線 AST 水平的變化，其 ROC 分析曲線下面積接近 0.9，具有極強的預測性，具有很高的敏感性和特異性。

Based on that index, applying it to our original data, in the 1.8 milligram dose group, our highest dose group, over 90% of patients will be hitting MASH resolution. That's extremely important. What it comes down to, Roger, is basically this liver fat reduction continues to be the greatest driver of MASH resolution of fibrosis improvement, shown consistently in all trials and pretty much accepted by experts as being the primary driving force for hitting MASH resolution and also fibrosis improvement. And we also have the highest liver fat content, the highest liver fat content reduction of any compound that's right now in active development for MASH.

根據該指數，將其應用於我們的原始數據，在 1.8 毫克劑量組（我們的最高劑量組）中，超過 90% 的患者將達到 MASH 消退。這極為重要。羅傑，歸根結底，肝臟脂肪的減少基本上仍然是 MASH 解決纖維化改善的最大驅動力，這在所有試驗中都得到了一致證明，並且幾乎被專家接受為實現 MASH 解決和纖維化改善的主要驅動力。而我們的產品還具有最高的肝臟脂肪含量，在目前為 MASH 積極開發的所有化合物中，我們的產品具有最高的肝臟脂肪含量降低率。

So based on all those factors, the power of the study, the readouts that we keep having by applying indices like the MASH Resolution Index or liver fat reduction, what we know about the science, we are very, very confident about the trial's success. I would also add to that, as I did before in my comments, that controlling the placebo response is key to obtaining statistical significance. And the best way to do that is to use a method of taking all the biopsies at the end of the trial, scrambling them so the pathologist is blind as to when the biopsy actually was done and then rereading them on a blinded basis.

因此，基於所有這些因素、研究的力量、我們透過應用 MASH 分辨率指數或肝臟脂肪減少等指數不斷獲得的讀數以及我們對科學的了解，我們對試驗的成功非常有信心。我還要補充一點，正如我之前在評論中所說的那樣，控制安慰劑反應是獲得統計意義的關鍵。而最好的方法是在試驗結束時提取所有活檢樣本，將它們打亂，這樣病理學家就不知道活檢的實際完成時間，然後在盲法基礎上重新閱讀它們。

We know that biopsy results are upgraded in severity early in the trial and downgraded later in the trial for a variety of reasons. It's been shown consistently based on that a placebo patient who biologically has no change will have a response simply based on the sequence of the biopsy reads. So scrambling all the biopsies so the pathologist is unaware of the timing and sequence has been shown in clinical trials to reduce the placebo response rate. So we think that three important factors. First, are magnitude of liver fat reduction, second, the sample size that we're using going into the readout, and third, the rereading of the biopsies all move us towards trial success.

我們知道，由於各種原因，活檢結果的嚴重程度在試驗早期會升級，而在試驗後期會降低。事實已一再證明，服用安慰劑但生物學上沒有發生任何變化的患者將僅根據活檢讀數的順序做出反應。因此，臨床試驗表明，將所有活檢樣本打亂，使病理學家不知道時間和順序，可以降低安慰劑反應率。所以我們認為有三個重要因素。首先，肝臟脂肪減少的幅度，其次，我們用於讀數的樣本量，第三，對活檢的重新讀取，所有這些都使我們走向試驗的成功。

Excellent. Thank you. Thank you, Scott.

出色的。謝謝。謝謝你，斯科特。

Thank you. One moment for our next question. Our next question comes from the line of Annabel Samimy from Stifel.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 Stifel 的 Annabel Samimy。

Hi, thanks for taking my questions. I just want to follow on. The comments about the Phase 3 program. We all know that one of the issues that plagues mass development is the long development pathway. So if you're successful here in achieving the fibrosis response in six months and realize that you're going to design the phase 3 program with a 6-month program.

你好，謝謝你回答我的問題。我只是想繼續跟進。關於第三階段計劃的評論。我們都知道，困擾大眾發展的一個問題是發展路徑太長。因此，如果您成功地在六個月內實現了纖維化反應，並意識到您將採用 6 個月的計劃來設計第 3 階段計劃。

But do you see any avenue to tighten the development timelines or will FDA be still sticking with its typical years long pathway? And how do you see this evolving over time, especially as we see additional movement on these biomarkers at the recent conferences? Do you see greater acceptance from the FDA from that? And I guess I have to ask a follow up question to that. Just generally speaking, how have your interactions with FDA changed with all the movement there? Anything to the positive or negative that you are seeing? Thanks.

但是，您是否看到任何可以縮短開發時間表的方法，或者 FDA 是否仍將堅持其典型的長達數年的路徑？您認為這種情況會如何發展，特別是我們在最近的會議上看到這些生物標記有了更多的進展？您是否認為 FDA 會對此有更高的接受度？我想我必須就此提出一個後續問題。總體來說，隨著 FDA 的各項舉措的推進，您與 FDA 的互動發生了哪些變化？您看到了什麼正面或負面的事情嗎？謝謝。

Hey, thanks Annabel. Let me handle those questions. We believe we have the opportunity here to shorten that development path. For one, we could have a readout at six months. We may combine that, by the way, with having two readouts, one at six months and one at 12 months, in different patient populations so that patients only have to go through two biopsies, one at baseline and one at either six months or a separate group cohort in 12 months.

嘿，謝謝安娜貝爾。讓我來處理這些問題。我們相信我們有機會縮短這一發展道路。首先，我們可以在六個月後得到一個讀數。順便說一下，我們可以結合不同的患者群體進行兩次讀數，一次在六個月時，一次在 12 個月時，這樣患者就只需要進行兩次活檢，一次在基線時，一次在六個月時或 12 個月內的單獨組群中。

Again, we have not made final decisions about that. I think Liisa in her prior comments was absolutely correct. There's an opportunity that has to be looked at, but again, we have to look at it with the FDA. So we can't make any firm announcements about that, only the fact that we're looking at that. We are very encouraged by the enrollment rate that we had in the IMPACT trial. We have been told it's the fastest enrolling trial today date. It shows that patients like the drug and that investigators enjoyed putting their patients in the trial. And one of the big motivating factors was the fact that people could lose weight, but they also liked the tolerability of the drug. We think that will play out in the final results of the trial, the tolerability and adverse events.

再次強調，我們尚未就此做出最終決定。我認為 Liisa 之前的評論是完全正確的。這是一個值得考慮的機會，但我們必須與 FDA 一起研究。因此，我們無法對此做出任何明確的聲明，只能說我們正在關注此事。IMPACT 試驗的入學率令我們非常鼓舞。我們被告知今天是最快的招生試驗日期。這顯示患者喜歡這種藥物，研究人員也樂於讓他們的患者參與試驗。其中一個很大的激勵因素是人們可以減肥，而且他們也喜歡這種藥物的耐受性。我們認為這將在試驗的最終結果、耐受性和不良事件中反映出來。

So we think that combining a faster enrollment ramp, we could also accelerate the timeline. You are absolutely correct that there's a great deal of interest in biomarkers. I think that there's greater and greater acceptance over the course of time. It has to meet the FDA's legal standards. Ultimately FDA is a body governed by laws and regulations in terms of what they consider to be proof. There's every evidence that they want to move away from the biopsy endpoints, but whether they've met that standard is yet to be seen. We think that going into our program that we are probably going to need biopsy endpoints for efficacy. But those noninvasive tests are very important because holistically, showing the entire response, both the biopsy response and the non-invasive test is shown to be important.

因此，我們認為，結合更快的入學速度，我們也可以加快時間表。您說得完全正確，人們對生物標誌物非常感興趣。我認為隨著時間的推移，人們的接受度會越來越高。它必須符合 FDA 的法律標準。從根本上來說，FDA 是一個受法律法規管轄的機構，其認定的證據是合法的。有充分的證據表明他們想要擺脫活檢終點，但他們是否達到了該標準還有待觀察。我們認為，在我們的計畫中，我們可能需要活檢終點來檢驗療效。但是這些非侵入性測試非常重要，因為從整體上看，顯示整個反應，活檢反應和非侵入性測試都很重要。

Now, going back to our IMPACT program, as you are aware, we have a biopsy readout at 24 weeks. We don't have it at week 48 weeks. We didn't want to subject the patients to another biopsy. We didn't think that they would accept that going into a trial. But nonetheless, in getting to your point here, we have the biomarkers both at week 24 and week 48. We could use that to model the response. We saw that in the recent data with Resmitteram where they were able to give a forecast of their response in cirrhotics with their FibroScan results in their open label study at one and two years. We believe that using that biomarker data for four weeks creates a very important catalyst for us also at the end of the year.

現在，回到我們的 IMPACT 計劃，正如您所知，我們在 24 週時進行活檢讀數。在第 48 週時我們沒有它。我們不想讓患者再接受一次切片檢查。我們不認為他們會接受這審判。但儘管如此，說到你的觀點，我們在第 24 週和第 48 週都有生物標記。我們可以用它來模擬響應。我們在 Resmitteram 的最新數據中看到，他們能夠透過一年和兩年的開放標籤研究中的 FibroScan 結果預測肝硬化的反應。我們相信，使用四周的生物標記數據也會在年底為我們創造一個非常重要的催化劑。

Regarding your last question about FDA interactions, we haven't noticed any difference. We are not aware that there's been any meaningful changes in any of the FDA divisions with which we interact with MASH, that would be liver and nutrition. We've not seen any changes. We've not had any formal interactions with the agency since our last meeting with them but we will be meeting with them in the fourth quarter of this year and we don't anticipate there will be any difference from our interactions with in the past.

關於您最後一個關於 FDA 相互作用的問題，我們沒有註意到任何差異。我們不知道與我們合作的 MASH 的 FDA 部門（即肝臟和營養部門）是否發生了任何重大變化。我們沒有看到任何變化。自從上次與該機構會面以來，我們還沒有與該機構進行任何正式互動，但我們將在今年第四季度與他們會面，我們預計與過去的互動不會有任何不同。

Hey Annabel. I just wanted to add one more point to the trial size and the efficiency of trial. One thing to keep in mind that we have a very large safety database on pemvidutide, unlike other MASH programs because of our database in obesity, as well as a very successful end of Phase 2 meeting we've already had with the FDA from a safety perspective, safety and tolerability perspective. So that should give us additional reason in terms of designing the trial for Phase 3 for MASH where we might be able to get more efficiency. In other words, we may not need as many patients exposed to drug because we already have a very sizable safety database.

嘿，安娜貝爾。我只是想就試驗規模和試驗效率再補充一點。需要記住的一點是，我們擁有一個非常大的關於 pemvidutide 的安全資料庫，這與其他 MASH 計劃不同，因為我們擁有肥胖症方面的資料庫，而且從安全性、安全性和耐受性的角度來看，我們已經與 FDA 進行了非常成功的第 2 階段會議。因此，這應該為我們設計 MASH 第 3 階段試驗提供額外的理由，以便我們能夠獲得更高的效率。換句話說，我們可能不需要那麼多病患接觸藥物，因為我們已經擁有非常龐大的安全資料庫。

Fantastic. Thank you.

極好的。謝謝。

Thank you. One moment for our next question. Our next question comes from the line of Eliana Merle from UBS.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自瑞銀的 Eliana Merle。

Hey this is Jasmine on for Eliana. Thanks so much for taking our question. So when you meet with the FDA for your end of Phase 2 after IMPACT, do you expect to discuss MASH F4 Cirrhosis with them at that time? And just what can you say about your latest plans and timelines there?

嘿，我是 Jasmine，為 Eliana 表演。非常感謝您回答我們的問題。那麼，當您在 IMPACT 之後與 FDA 會面討論第 2 階段結束時，您是否希望與他們討論 MASH F4 肝硬化？您能透露一下您最近的計劃和時間表嗎？

And then second question. Can you just confirm for us your cash running Runway at the Hercules facility? And are there any specifics that you can share on what that Runway includes? Thanks.

然後是第二個問題。您能否向我們確認一下 Hercules 工廠的現金運作？能分享一下 Runway 的具體內容嗎？謝謝。

Scott, do you want to take the first question?

史考特，你想回答第一個問題嗎？

Yes, Jasmine, I'll take the first question, then I'll hand it over to Greg for the second. So we are extremely interested in F4. We believe that we will be successful in F4. If you look at the populations of F4 that have enrolled in trials to date, it's been an early F4. Patients who are considered child A child by the child’s puturcot classification. These are people who have good liver synthetic function, so haven't developed the complications of cirrhosis and they also have high liver fat.

是的，Jasmine，我先回答第一個問題，然後交給 Greg 回答第二個問題。所以我們對F4非常感興趣。我們相信F4一定會成功。如果你看一下迄今為止參加試驗的 F4 族群，你會發現這是一個早期的 F4。根據兒童 Puturcot 分類，被認定為 A 類兒童的患者。這些人的肝臟合成功能良好，所以還沒有出現肝硬化的併發症，而且他們的肝臟脂肪含量也很高。

So consequently, although they are technically F4, they're, they're behaving like they're F3. And we think we're going to be extremely successful in F3. And I think that forecast we're going to be extremely successful in F4. So yes, we have drawn out an F4 trial. Now, we can't give you details on that until we get confirmation with the agency, but to your question, we intend to discuss F4 with the FDA. I would imagine that we would have a fibrosis improvement improvement trial that we would use for accelerated approval in F4 as well as follow these people to outcome to full approval. So you're absolutely right. We're very interested. This is going to be a big part of our meeting and I think we are going to have a high probability of success in F4.

因此，儘管從技術上講它們是 F4，但它們的行為卻像 F3。我們認為我們將在 F3 中取得巨大的成功。我認為這個預測我們將在 F4 中取得極大的成功。是的，我們已經制定了 F4 試驗。現在，在我們得到該機構的確認之前，我們無法向您提供詳細信息，但對於您的問題，我們打算與 FDA 討論 F4。我認為我們將進行一項纖維化改善改進試驗，我們將用它來加速 F4 的批准，並追蹤這些人的結果直到完全批准。所以你完全正確。我們非常感興趣。這將是我們會議的重要部分，我認為我們在 F4 中取得成功的可能性很高。

I want to also remind everyone that our drug has both metabolic and direct effects on MASH. Right. So back to my original point and Liisa's point about the importance of weight loss. We will clearly be able to treat the metabolic abnormalities of F0, F1, F2 and even F3. But we have the direct effects that are going to be potent for F3 and F4. So unlike some other drugs that might be restricted to certain points in MASH development, say the FGF21s to F3, F4, the other incretins, F0, F1 and F2, we have the opportunity to treat all of MASH. In other words, we can be a complete solution for the disease, both F0. Well, from F0 to F4. Greg.

我還想提醒大家，我們的藥物對 MASH 既有代謝作用，也有直接作用。正確的。所以回到我最初的觀點和 Liisa 關於減肥重要性的觀點。我們將能夠明確治療F0、F1、F2甚至F3的代謝異常。但我們的直接影響對於 F3 和 F4 來說將是巨大的。因此，與其他一些可能僅限於 MASH 發展某些階段的藥物不同，例如 FGF21 到 F3、F4、其他腸促胰島素、F0、F1 和 F2，我們有機會治療所有 MASH。換句話說，我們可以針對F0這兩種疾病進行徹底的解決方案。嗯，從 F0 到 F4。格雷格。

Thanks, Scott. And Jasmine, Good question. Let me add a little color around our Hercules facility that we announced this morning. And the effect on the Runway? Positive effect on our Runway. The facility is broken into four tranches. The first will be funded this week. Upon closing, we disclosed that as $15 million. The second tranche available later this year and then the balance across 2026. I'll break down the Runway answer in two steps.

謝謝，斯科特。茉莉，這個問題問得好。讓我稍微介紹一下我們今天早上宣布的 Hercules 工廠。對跑道有什麼影響？對我們的跑道產生正面影響。該設施分為四個部分。第一個項目將於本週獲得資助。交易結束時，我們披露該金額為 1500 萬美元。第二批款項將於今年稍後到位，其餘款項將於 2026 年到位。我將分兩步驟來解釋 Runway 的答案。

First on today's cash position gives us Runway in Q3 of 2026. And if you layer on top the optional draws, if we were to draw all of them, it could extend the Runway for as much as another year. Now that's more details to be disclosed in the 10-Q to file later today.

首先，今天的現金狀況為我們提供了 2026 年第三季的運作。如果你將可選的抽籤疊加起來，如果我們將它們全部抽籤，那麼 Runway 的時間可能會再延長一年。更多細節將在今天稍後提交的 10-Q 文件中披露。

Okay, Super helpful. Thanks so much.

好的，非常有幫助。非常感謝。

Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani from B Riley.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 B Riley 的 Mayank Mamtani。

Good morning, team. Thanks for taking your questions and congrats on the recent progress. Scott, I don't know if I heard from you. Could you comment on the range of placebo responses you are expecting on fibrosis and MASH resolution endpoints? As you mentioned, we've seen a relatively broad range in prior trials and if you're able to comment at all, sorry to push you here on the female to male ratio and what baseline weight is relative to your prior Phase 1b MASLD study, if you could maybe comment on that and then I have a follow up.

早安，各位團隊。感謝您的提問，並祝賀您最近的進展。史考特，我不知道我是否收到你的來信。您能否評論一下您預期的纖維化和 MASH 消退終點的安慰劑反應範圍？正如您所提到的，我們在先前的試驗中看到了相對較廣的範圍，如果您能夠發表評論，很抱歉在這裡向您詢問女性與男性的比例以及相對於您之前的 1b 期 MASLD 研究的基線體重，如果您可以對此發表評論，然後我會跟進。

Mayank. I'm sorry, I didn't hear the second part of the question. I heard the first part about the range of placebo response. Could you repeat the second and then I'll...

瑪雅克。抱歉，我沒有聽清楚問題的第二部分。我聽到了有關安慰劑反應範圍的第一部分。你能重複第二遍嗎，然後我會…

Yes. Sorry, yes. The female to male ratio and then the baseline weight relative to your priority Phase 1b MASLD study. So both baseline demographics questions.

是的。抱歉，是的。相對於您的優先 1b 期 MASLD 研究，女性與男性的比例以及基線體重。所以這兩個都是基線人口統計問題。

Yes, the first question is the range of placebo response has been wide in these trials. In the semaglutide Phase 2 trial it was 32%. And we've seen other readouts in 20%. We've even seen readouts in single digits. We think that the unifying factor here is how you handle the placebo response and in the trials that have re-read their biopsies by scrambling them, we're seeing placebo responses for fibrosis improvement between about 7% and 13%. So we can't be absolute about what our placebo response is. We think that our trial is very well powered because we have a better treatment effect and a larger sample size than those trials that read out successfully. But we would hope that we would drive down the placebo response to those ranges.

是的，第一個問題是這些試驗中安慰劑反應的範圍很廣。在司美格魯肽第 2 期試驗中，這一比例為 32%。我們還看到了 20% 的其他讀數。我們甚至看過個位數的讀數。我們認為，這裡的統一因素是如何處理安慰劑反應，在透過打亂活檢結果重新讀取的試驗中，我們看到安慰劑反應對纖維化改善的程度在 7% 到 13% 之間。所以我們無法絕對知道我們的安慰劑反應是什麼。我們認為我們的試驗非常有力，因為與那些成功讀出的試驗相比，我們有更好的治療效果和更大的樣本量。但我們希望能夠將安慰劑反應降到這些範圍內。

Regarding the baseline characteristics as I mentioned before, we are in the final stages of rereading the biopsies so the exact numbers are not available to us. But we think we're very close and rather than getting into numbers that we're just going to have to reannounce, which could be confusing to people, we think it's better to say that the range of females to males, things like the baseline weight, will be very similar not only to other trials in the space if you line them up and we've done that, but also as what our targets were.

關於我之前提到的基線特徵，我們正處於重讀活檢結果的最後階段，因此我們無法獲得確切的數字。但我們認為我們已經非常接近了，而不是討論我們必須重新宣布的數字，這可能會讓人們感到困惑，我們認為最好地說，女性和男性的範圍，比如基線體重，不僅會非常相似，如果你把它們排成一行，就像我們已經這樣做了一樣，而且也與我們的目標非常相似。

So I think you're going to be very happy when you see that. But until we have the final numbers, we're a little reluctant to put them out there because it could create confusion.

所以我想當你看到它時你會非常高興。但在我們得到最終數字之前，我們不太願意公佈它們，因為這可能會造成混亂。

Understood, thank you. And with secondary endpoints you may include as part of your top line release next month and obviously want to understand which NIT should be focused on at this 24 week time point versus maybe the 48 week because the 48 week could be important as you also think about powering the long term outcomes trial as part of your end of Phase 2 FDA discussion. So if you could maybe segment that, that would be helpful.

明白了，謝謝。您可能會將次要終點作為下個月發布的重要內容之一，並且顯然想要了解在這個 24 週時間點應該關注哪個 NIT，或者可能是 48 週，因為 48 周可能很重要，因為您還考慮在第 2 階段 FDA 討論結束時推動長期結果試驗。因此，如果您可以對其進行細分，那將會很有幫助。

Right, I want to first start by saying that we don't believe that we need the 48-week data to meet with the FDA, their sponsors that met with 24-week data. It will be helpful in the discussions, and we can certainly add it in. But you're correct, those non-invasive tests are going to be extremely helpful for us to predict and model the changes in the liver biopsy results that would have occurred had we done the biopsy at week 48.

好的，首先我想說的是，我們認為我們不需要 48 週的數據來與 FDA 會面，他們的贊助商只需要 24 週的數據。這將有助於討論，我們當然可以將其添加進去。但您說得對，這些非侵入性測試將非常有助於我們預測和模擬如果我們在第 48 週進行活檢的話肝活檢結果會發生的變化。

So the primary. Endpoints that we'll read out will be mashed resolution of fibrosis improvement by the FDA guideline definitions. The key secondary endpoints will be things such as weight loss, liver fat reduction, changes and non-invasive tests such as fiber scan, and EF will also have liver fat reduction by MRI, PDFF. And we'll have adverse events, discontinuations and study demographics. I believe that would be a comprehensive view of what we'll have and probably what we'll also have at week 48 as well.

所以是主要的。我們將讀出的終點將根據 FDA 指南定義混合纖維化改善的分辨率。關鍵的次要終點將是體重減輕、肝臟脂肪減少、變化和纖維掃描等非侵入性測試，EF 還將透過 MRI、PDFF 進行肝臟脂肪減少。我們也會遇到不良事件、停藥和人口統計研究。我相信這將是對我們將要擁有的一切以及我們在第 48 週可能也會擁有的一切的全面了解。

Understood. And lastly, could you touch on the impact you believe based on pemvi's mechanism would be on bone and muscle health and or muscle health. Thanks for taking a question.

明白了。最後，您能否談談您認為基於 pemvi 的機制會對骨骼和肌肉健康或肌肉健康的影響。感謝您提出問題。

Well, bone health is extremely important. You are seeing accelerated bone loss with other compounds. There was a recent readout at ASLD and was also published of a 5% bone mineral density loss versus placebo in cirrhotic patients. You have to also recognize that in a cirrhotic population placebos are losing bone density and it could be as much as 5% over the trial duration of 96 weeks based on what we know from other databases.

嗯，骨骼健康極為重要。您會看到其他化合物加速了骨質流失。ASLD 最近發布了一份報告，報告也指出肝硬化患者與安慰劑組相比，骨礦物質密度損失了 5%。您還必須認識到，在肝硬化族群中，安慰劑會導致骨密度降低，根據我們從其他資料庫了解到的情況，在 96 週的試驗期間，骨密度降低幅度可能高達 5%。

So adding in the natural 5% with the 5% that you lose with FGF21s, that's significant, that's 10% and that has to be looked at very carefully. That's not something that we're seeing with pemvedutide. We're not seeing it with the FGF20 with the GLP1s. As you are aware, lean mass preservation is extremely important in this population. We know that in the semaglutide data where in two trials they lost approximately 40% of their body weight as lean mass. They had a four to seven fold higher rate of pelvic and hip fractures and this was seen as susceptible populations. That's the key that you see it in the elderly and you see it in postmenopausal women, which is not an insignificant number or proportion of the patients that are being treated with these drugs.

因此，將自然的 5% 與使用 FGF21s 而損失的 5% 相加，這是相當可觀的，即 10%，必須非常仔細地看待。這不是我們在培維妥肽中看到的情況。我們沒有看到 FGF20 與 GLP1 有關聯。如您所知，對於這一人群來說，保持瘦體重極為重要。我們知道，在兩次試驗中，索馬魯肽的數據表明，他們的體重減少了約 40%（瘦體重）。他們的骨盆和髖部骨折發生率高出四到七倍，因此被視為易感人群。關鍵在於，你在老年人和停經後婦女身上也看到了這種情況，而這些患者在接受這些藥物治療的患者中佔比並不小。

So consequently these are extremely important features of drugs as you're saying here. Mayank, it's important not just to look at the MASH effects in the weight loss, but holistically at the whole patient. And we believe the fact that we have class leading effects in lean mass preservation, we lose only 21.9% of our body weight loss as lean mass over 48 weeks. Glucagon appears to preserve muscle and lean mass and that's going to be extremely important in all populations that are obese and overweight. Not just an obesity population but a MASH population with obesity as well.

因此，正如您所說的，這些是藥物極其重要的特徵。Mayank，重要的不僅是看減肥中的 MASH 效果，還要從整體上看整個患者。我們相信，我們在瘦體重保存方面具有一流的效果，在 48 週內，我們僅損失了體重減輕的 21.9% 的瘦體重。胰高血糖素似乎可以維持肌肉和瘦體重，這對於所有肥胖和超重人群來說都極為重要。不僅有肥胖族群，還有患有肥胖症的 MASH 族群。

Thank you. Look forward to the data update.

謝謝。期待數據更新。

Thank you. One moment for our next question. Our next question comes from the line of Jon Woolaben from Citizens.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 Citizens 的 Jon Woolaben。

Hi, this is Kathryn on for Jon. I have kind of a quick question about the speed that you expect liver fat as well as histologic change with the GLP glucagon agonist? Whether you expect any differentiation from some of the others that we've seen, I guess mainly cervidutide. Is there any reason to believe that pemvidutide should be faster? And also in terms of biomarkers, are there any that you expect to change from the 24-week readout to the 48-week readout in particular or is it more of you're expecting to see sustained improvements both at the later time point. Thank you.

大家好，我是凱瑟琳，為喬恩解答。我有一個簡單的問題，關於您預期使用 GLP 升血糖素激動劑後肝臟脂肪和組織學變化的速度？無論您是否期望它與我們見過的其他一些產品有任何區別，我猜主要是頸椎肽。有什麼理由相信 pemvidutide 應該更快嗎？另外，就生物標記而言，您是否預計從 24 週讀數到 48 週讀數會發生改變，或者您是否更期望在稍後的時間點看到持續的改善。謝謝。

Yes, great question, Kathryn. So speed is important. Speed first of all implies efficacy. The faster you work, the more efficacious you are, and speed is important. F3 patients, comparison to cirrhosis and complications within two years. We know that from the data. And the change in liver fat content predicts the histological change at 24-weeks. So, speed of liver fat content reduction, speed of histologic changes. Now the 76.4% is at 24 weeks. We also have very similar effects at 12 weeks. That data has been published in J Hepatology and in fact, in our own internal data, we're even seeing these effects as early as six weeks. So we believe that we not only have the most potent drug, but also the fastest acting drug.

是的，凱瑟琳，問得好。所以速度很重要。速度首先意味著功效。工作越快，效率越高，速度很重要。F3患者，與兩年內出現肝硬化及併發症的比較。我們從數據中知道這一點。肝臟脂肪含量的變化可以預測24週時的組織學變化。因此，肝臟脂肪含量減少的速度，組織學變化的速度。現在 76.4% 是 24 週。12 週時我們也觀察到了非常相似的效果。這些數據已發表在《J Hepatology》雜誌上，事實上，在我們自己的內部數據中，我們甚至早在六週內就看到了這些影響。因此我們相信我們不但擁有最有效的藥物，而且擁有起效最快的藥物。

Now, regarding cervedutide, that molecule has a ratio of GLP-1 to glucagon of 8:1. We are 1:1. We have a much greater amount of glucagon in our molecule. And it's the glucagon that's driving the change in liver fat reduction. That's what it is. So we believe that what we're seeing at 24 weeks would not be achievable by a compound with lower glucagon content.

現在，關於西維妥肽，該分子中的 GLP-1 與胰高血糖素的比例為 8:1。我們是1：1。我們的分子中含有大量的升血糖素。正是升糖素推動了肝臟脂肪的減少。就是這樣。因此，我們相信，24 週時觀察到的效果是胰高血糖素含量較低的化合物無法實現的。

We believe that it's contributing some to cervidutide, but if you look at their liver fat reduction, it's lower. It's in the range of 58% to 62%. So we believe that we have a molecule, more glucagon, more liver fat reduction, faster liver fat reduction, faster histological change, and that we are an agent that can read out at 24 weeks. In contrast to cervidutide, we don't think that they could do it. So we believe that we'll be differentiated against all of the prior incretins that have read out not only through tirzepatide and semaglutide, but also cerberdutide as well.

我們相信它對頸椎肽有一定貢獻，但如果你觀察它們的肝臟脂肪減少情況，你會發現它的作用較低。其範圍在 58% 至 62% 之間。因此我們相信，我們有一種分子，升糖素更多，肝臟脂肪減少更多，肝臟脂肪減少更快，組織學變化更快，而且我們是一種可以在 24 週時讀出的藥劑。與子宮頸肽相比，我們認為他們做不到這一點。因此，我們相信，我們將與之前所有已讀出的腸促胰島素有所區別，不僅透過 tirzepatide 和 semaglutide，而且還透過 cerberdutide。

So regarding your second question, we believe the biomarker response will grow between 24 week and 48 weeks. There's been a lot of talk in this conference call regarding nits and the fact they're becoming more and more reliable and predictive of what's going on. We saw a lot of attention being placed on the change in the FibroScan data and the cirrhotic cohorts and the Resmiteron trials.

關於您的第二個問題，我們認為生物標記反應將在 24 週到 48 週之間增長。這次電話會議中有很多關於蝨子的討論，事實上蝨子變得越來越可靠，並且能夠預測正在發生的事情。我們看到 FibroScan 數據、肝硬化患者群體和 Resmiteron 試驗的變化引起了廣泛關注。

So biomarkers are getting there. They are there, in fact. And we think that what we see at 24 weeks and we'll report out on that will grow over 48 weeks. We think they will be all of them. They all move in tandem. ELF and FibroScan are felt to be at this point the best non-invasive tests. And in fact, there's even talk now of combining the two for prognosis, a combined score of ELF and FibroScan.

生物標誌物正在發揮作用。事實上，它們就在那裡。我們認為，我們在 24 週時觀察到的情況以及我們將報告的情況將在 48 週內增長。我們認為他們都是這樣的。它們齊頭並進。目前，ELF 和 FibroScan 被認為是最好的非侵入性測試。事實上，現在甚至有人討論將兩者結合起來進行預後，即 ELF 和 FibroScan 的綜合評分。

We think we're going to have meaningful results in both and we think those results at 24 weeks will be even better at 48 weeks and will be an indicator of how we would have done at 48 weeks with a biopsy at that time point. And that will be in the fourth quarter of this year.

我們認為我們將在這兩方面獲得有意義的結果，我們認為 24 週的結果在 48 週時會更好，並且將成為我們在 48 週時進行活檢的結果的一個指標。那將是在今年第四季。

Thank you so much.

太感謝了。

Thank you. One moment for our next question. Our next question comes from the line of Andy Hsieh from William Blair.

謝謝。請稍等片刻，回答我們的下一個問題。我們的下一個問題來自 William Blair 的 Andy Hsieh。

Great. Thanks for taking our question. Just one quick one for us. We are just wondering about the overlap between clinical sites that you use for obesity and MASH compared to potential sites for AUD and ALD that you look to activate in the coming quarters. Thank you.

偉大的。感謝您回答我們的問題。對我們來說只有一個快速答案。我們只是想知道，您用於治療肥胖症和 MASH 的臨床站點與您希望在未來幾季內啟用的治療 AUD 和 ALD 的潛在站點之間的重疊情況。謝謝。

Hi Andy. Thanks for the question. There is some overlap. I don't have the data in front of me right now. I can't give you percentages. But the underlying unifying feature of all these patients is obesity and many sites specialize in this area as well as they would. Obesity and liver disease are MASH. So there's obviously going to be some overlap. But offhand I don't have those numbers in front of me right now.

你好，安迪。謝謝你的提問。存在一些重疊。我現在面前沒有數據。我無法給你百分比。但所有這些患者的根本共同特徵是肥胖，並且許多中心都專門研究這一領域。肥胖和肝病是 MASH。因此顯然會存在一些重疊。但目前我面前還沒有這些數字。

Yes. So the sites that we picked for AUD and ALD will also have some overlap with the MASH and obesity populations as well. But again, I don't have that number in front of me to provide for you on this call.

是的。因此，我們為 AUD 和 ALD 選擇的站點也會與 MASH 和肥胖族群有一些重疊。但同樣，我面前沒有這個號碼，無法在這次通話中為您提供。

Thank you. At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.

謝謝。現在，我想將會議交還給 Vipin Garg 作結束語。

Thank you everybody for joining our call today. As always, we appreciate your continued support and look forward to keeping you updated in the months ahead. Have a wonderful rest of your day.

感謝大家今天參加我們的電話會議。像往常一樣，我們感謝您的持續支持，並期待在未來幾個月內為您提供最新資訊。祝您今天剩餘的時間過得愉快。

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。感謝您的參與。您現在可以斷開連線。