Altimmune Inc (ALT) 2025 Q2 法說會逐字稿

Good morning ladies and gentlemen and welcome to the Altimmune second-quarter 2025 financial results conference call. (Operator Instructions)

女士們、先生們，大家早安！歡迎參加Altimmune 2025年第二季財務業績電話會議。 （操作員指示）

As a reminder, this call is being recorded. Let me introduce your host for today’s conference call, Lee Roth, President of Burns McClellan Investor Relations Advisor to Altimune. Lee, you may begin.

提醒一下，本次電話會議正在錄音。請容許我介紹一下今天電話會議的主持人，Burns McClellan 總裁、Altimune 投資人關係顧問 Lee Roth。 Lee，您可以開始發言了。

Thanks, Olivia. Good morning everyone. Once again, thank you for joining us for the Altimmune second 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. 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.

謝謝，奧莉維亞。大家早安。再次感謝您參加 Altimmune 2025 年第二季財務表現及業務更新電話會議。今天的電話會議將由我們的執行長 Vipin Garg 博士、首席醫療官 Scott Harris 博士、財務長 Greg Weaver、首席科學官 Scot Roberts 博士和首席商務官 Ray Jordt 主持，他們將參與問答環節。

Our second-quarter 2025 financial results and corporate update press release was issued earlier this morning and it 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.

我們於今天早上早些時候發布了2025年第二季度財務業績及公司更新新聞稿，可在Altimmune網站的「投資者關係」版塊查看。在開始之前，我想提醒大家，根據1995年《私人證券訴訟改革法》的安全港條款，關於未來預期、計劃和前景的言論構成前瞻性陳述。

Altimmune cautions that these forward looking statements are subject to risks and uncertainties and these could cause our actual results to differ materially from those indicated. 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 sec. I also direct you to read the forward looking statement disclaimer in our press release issued this morning which is available on our website.

Altimmune 提醒您，這些前瞻性陳述受風險和不確定性的影響，這些風險和不確定性可能導致我們的實際結果與預期結果有重大差異。如需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。此外，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，該新聞稿可在我們的網站上查閱。

Any statements made on this call speak only as of today’s date, August 12, 2025 and the company does not undertake any obligation to update any 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.

本次電話會議中的任何陳述僅代表截至今日（2025年8月12日）的觀點，本公司不承擔更新任何前瞻性陳述以反映今日或之後發生的事件或情況的義務。提醒您，本次電話會議將會被錄音，錄音回放可在 Altimmune 網站上取得。

With that, it’s my pleasure to turn the call over to Dr. Vipin Garg, President and Chief Executive Officer of Altimune.

我很高興將電話轉給 Altimune 總裁兼執行長 Vipin Garg 博士。

Thank you, Lee. Good morning everyone and thank you for joining us today for our second quarter financial results and corporate update. As many of you know, we presented the 24 week top line data from the impact trial at the end of June as we shared Pemvedutide achieved statistical significance in the primary endpoint of match resolution and across multiple objective measures of efficacy at 24 weeks of treatment. These included all noninvasive markers of inflammation and fibrosis, liver fat reduction and weight loss, along with best in class safety and tolerability without the need for dose titration.

謝謝，Lee。大家早安，感謝大家今天參加我們第二季的財務表現和公司更新。如大家所知，我們在6月底公佈了Impact試驗的24週頂線數據，並分享了Pemvedutide在24週治療期間，在主要終點匹配分辨率以及多項客觀療效指標方面均達到了統計學意義。這些指標包括所有發炎和纖維化的非侵入性指標、肝臟脂肪減少和體重減輕，以及同類最佳的安全性和耐受性，無需劑量調整。

These data will serve as the foundation of the package that we take to the FDA for our end of Phase 2 meeting in the fourth quarter and will inform the design of our Phase 3 program. In addition to the advancement of our NASH program, our Phase 2 trials in AUD and ALD, Reclaim and Restore are now underway. Alcohol use Disorder and alcohol-associated liver diseases are two indications with significant unmet needs and few to no treatment options for which we believe pemvidutide may be particularly well suited.

這些數據將作為我們提交給FDA的方案的基礎，該方案將於第四季度結束的II期臨床試驗會議上提交給我們，並將用於我們III期臨床試驗的設計。除了NASH計畫的推進之外，我們目前正在進行針對酒精性脂肪性肝炎（AUD）和酒精性肝病（ALD）的II期臨床試驗——「Reclaim」和「Restore」。酒精使用障礙和酒精相關肝病是兩個存在大量未滿足需求且治療方案很少甚至沒有的適應症，我們認為培維妥肽可能特別適合這兩個適應症。

As we announced yesterday, our Board has appointed Jerry Durso as Chairman of the Board, succeeding Dr. Mitch Sayer who has served in this role for the past seven years and will remain with us as a non Executive Director. This change reflects our planned advancement to Phase 3 development of pemvidutide in mash. Gerry has a wealth of commercial and corporate development experience including the building of a successful liver franchise as CEO of Intercept prior to its acquisition.

正如我們昨天宣布的，董事會已任命 Jerry Durso 博士為董事會主席，接替米奇·塞耶 (Mitch Sayer) 博士。塞耶博士已擔任該職位七年，並將繼續擔任公司非執行董事。此次人事變動反映了我們計劃推進培維妥肽 (pemvidutide) 在麥芽汁治療中的第三期開發。傑瑞擁有豐富的商業和企業發展經驗，包括在 Intercept 被收購之前擔任該公司首席執行官，成功打造了一個肝臟特許經營品牌。

We are excited to continue moving forward under Jerry’s leadership and look forward to Mitch’s ongoing contribution with $183.1 million in cash and cash equivalent. We have considerably strengthened our balance sheet as we work to continue to advance the development of pemvidutide and look forward to reaching additional milestones including the full 48 week impact data as the year progresses.

我們很高興能在傑瑞的領導下繼續前進，並期待米奇繼續貢獻1.831億美元現金及現金等價物。我們已大幅增強資產負債表，並將繼續推進培維妥肽的研發，並期待在未來取得更多里程碑，包括完整的48週影響數據。

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

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。

Thank you, Vipin. Those of you on the call with us are likely familiar with the impact top line data that we reported about six weeks ago. I’d like to expand upon a few of the key highlights of this positive and important data set.

謝謝Vipin。參加我們電話會議的各位可能都熟悉我們大約六週前報告的業績影響數據。我想進一步闡述這份積極且重要的數據中的幾個關鍵亮點。

First, we achieved match resolution up to 59.1% of subjects, a highly statistically significant result after 24 weeks of treatment. On the other measure of fibrosis improvement, we did not reach statistical significance but clear evidence of anti fibrotic activity was observed that was supported by additional objective measures of fibrosis improvement.

首先，我們實現了高達59.1%的受試者匹配分辨率，這在24週的治療後取得了高度統計顯著的結果。在纖維化改善的另一個指標上，我們並未達到統計學顯著性，但觀察到了明顯的抗纖維化活性證據，這得到了其他客觀的纖維化改善指標的支持。

As Vipin noted, multiple measures of efficacy that were assessed at the 24 week time point achieved statistical significance. We demonstrated impressive results in all of the non-invasive tests of liver fibrosis including enhanced liver fibrosis and vibration controlled transient elastography. In addition, the path URI based analysis of biopsies the showed a statistically significant improvement in liver fibrosis in a supplemental analysis.

如同Vipin所指出的，在24週時間點評估的多項療效指標均達到了統計意義。我們在所有非侵入性肝纖維化檢測中都取得了令人印象深刻的結果，包括增強型肝纖維化和振動控制瞬時彈性成像。此外，基於路徑URI的活檢分析在補充分析中顯示，肝纖維化得到了統計上顯著的改善。

We recently completed our analysis of another important non invasive test of fibro inflammation corrected T1 imaging or CT1 where a class leading effect for pemvidutide was observed at the 24 week time point. CT1 is a reproducible MRI based liver imaging method that has been correlated with changes in liver inflammation and fibrosis in clinical studies. Decreases in CT1 relaxation time of 80 milliseconds or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies.

我們最近完成了另一項重要的非侵入性纖維化發炎校正T1影像（CT1）檢查的分析，結果顯示培維妥肽在第24週時間點取得了同類領先的療效。 CT1是一種基於MRI的可重複肝臟影像方法，臨床研究顯示其與肝臟發炎和纖維化的變化有關。臨床研究表明，CT1弛豫時間縮短80毫秒或以上與肝臟發炎和纖維化的改善有關。

At 24 weeks, mean decreases from baseline and CT1 relaxation time were 145.0 and 147.9 milliseconds in the 1.2 and 1.8 milligram pemvidutide treatment arms respectively, compared with a decrease of 27.5 milliseconds in placebo representing a P value of less than 0.001 for both doses. These new data add additional depth to the data demonstrating that strong anti inflammatory and antifibrotic activity of pemvedutide treatment.

24週後，1.2毫克和1.8毫克培維妥肽治療組患者的CT1弛豫時間較基線平均分別縮短145.0毫秒和147.9毫秒，而安慰劑組患者則縮短了27.5毫秒，兩種劑量的P值均小於0.001。這些新數據進一步證明了培維妥肽治療具有強大的抗發炎和抗纖維化活性。

In addition to these impressive effects on the liver, pemvedutide was associated with a greater than 6% decrease in body weight at 24 weeks of treatment with a weight loss trajectory indicating that further weight loss was likely. Decreases in body weight are important in MASH patients as they succumb to the complications of obesity at greater rates than the complications of liver disease until cirrhosis actually develops. In the aggregate, the impact top line data compare very favorably to other NASH therapies including those that have read out at much later time points.

除了這些對肝臟的顯著影響外，培維妥肽在24週治療後還與體重下降超過6%相關，且體重下降軌跡顯示未來可能進一步下降。體重下降對MASH患者至關重要，因為在真正發展為肝硬化之前，他們死於肥胖併發症的幾率高於死於肝病併發症的幾率。總體而言，其療效頂線數據與其他NASH療法（包括那些在更晚時間點讀出的療法）相比非常有利。

Now moving to safety, pemvidutide demonstrated potentially class leading results in that important area. Through 24 weeks pemvidutide was remarkably well tolerated with only a single adverse event related discontinuation across the two pempidutide treatment arms versus two adverse event related discontinuations in the placebo group. It is worth noting that this excellent tolerability was achieved in the absence of dose titration which is unique for our GLP1.

現在談談安全性，培維妥肽在這一重要領域展現出潛在的領先水準。在24週的研究中，培維妥肽的耐受性非常好，兩個培維妥肽治療組僅有一例因不良事件而停藥，而安慰劑組則有兩例因不良事件而停藥。值得注意的是，這種優異的耐受性是在無需劑量滴定的情況下實現的，這對於我們的GLP1療法來說是獨一無二的。

For GLP1 based agents, the ability to start patients in a dose that is both effective and tolerable will be highly attractive to prescribers and will be another key differentiator for our therapy. We’re continuing to analyze the 24 week data and look forward to providing updates as the results become available. The team is preparing for our fourth quarter end to Phase 2 meeting with FDA that will further guide our Phase 3 plans. We will also be reporting the full 48 week data in the fourth quarter. This data will include the non invasive tests that were reported at the 24 week readout.

對於基於GLP1的藥物，能夠以有效且耐受的劑量開始治療對處方醫生極具吸引力，這也將成為我們療法的另一個關鍵差異化優勢。我們正在持續分析24週的數據，並期待在結果公佈後提供更新。團隊正在為第四季末與FDA舉行的2期臨床試驗會議做準備，這將進一步指導我們的3期臨床試驗計畫。我們也將在第四季報告完整的48週數據。這些數據將包括24週報告中報告的非侵入性檢測結果。

Weight Loss and Safety in addition to our NASH program, we’ve made progress in the development of pemvidutide in two additional indications, AUD and ALD, with the initiation of Phase 2 trials in these indications in May and July. AUD and ALD are serious and highly prevalent conditions. Recurrent treatment approaches are inadequate and innovation has been limited. We claim our AUD trial is a 24 week trial evaluating weekly 2.4 milligram pempedutide versus placebo.

減重與安全性 除了NASH計畫外，我們在培維妥肽治療AUD和ALD（酒精性肝病）的另外兩個適應症的開發方面也取得了進展，並於5月和7月啟動了這兩個適應症的2期臨床試驗。 AUD和ALD是嚴重且高發生率的疾病。復發性治療方法不足，創新也受到限制。我們聲明，我們的AUD試驗是一項為期24週的試驗，旨在評估每週2.4毫克培維妥肽與安慰劑的療效對比。

The primary endpoint is the change in the number of heavy drinking days with key secondary endpoints including other measures of alcohol intake and weight loss including the World Health Organization risk drinking level which has recently been accepted by FDA as an additional basis of approval in this indication. Restore the Phase 2 trial and ALDI started enrolling in July. It is a 48 week trial evaluating the 2.4 milligram weekly dose of pemfidutide versus placebo with a primary endpoint of change in liver stiffness measurement at 24 weeks.

主要終點是重度飲酒天數的變化，關鍵次要終點包括其他酒精攝取量和體重減輕指標，例如世界衛生組織風險飲酒水平，該水平最近已被FDA接受作為該適應症的額外批准依據。恢復二期臨床試驗，ALDI於7月開始招募病患。這是一項為期48週的試驗，評估每週2.4毫克劑量的pemfidutide與安慰劑的療效，主要終點是24週時肝臟硬度測量值的變化。

Liver stiffness is a non invasive measure of liver inflammation and fibrosis that characterizes the prognosis and severity of ALD. Key secondary endpoints include an assessment of liver stiffness at 48 weeks as well as changes in ELF score, alcohol consumption and body weight at both 24 and 48 weeks.

肝臟硬度是肝臟發炎和纖維化的非侵入性指標，可用於評估酒精性肝病 (ALD) 的預後和嚴重程度。關鍵次要終點包括48週時的肝臟硬度評估，以及24週和48週時的ELF評分、酒精攝取量和體重變化。

And with that, I’ll turn it now over to Greg Weaver who will review our second-quarter financial results.

現在，我將把時間交給 Greg Weaver，他將審查我們的第二季財務表現。

Greg thanks Scott. Beginning with the balance sheet, we finished the second quarter with total cash of $183.1 million. That’s an increase of approximately 40% over our cash position at the start of this year. We’ve raised $88 million in gross equity capital this year while adding the flexibility of $100 million (inaudible) debt facility, which we announced in the second quarter and drew down $15 million from that facility at signing. These strategic financial moves are part of our ongoing efforts to ensure that our balance sheet is able to support the continuing clinical development of pemvidutide.

格雷格感謝斯科特。從資產負債表來看，我們第二季末的總現金為1.831億美元。這比年初的現金狀況增加了約40%。今年，我們籌集了8,800萬美元的總股本，同時增加了1億美元（聽不清楚）債務融資的靈活性，這筆融資是我們在第二季宣布的，並在簽署協議時從該融資中提取了1,500萬美元。這些策略性財務舉措是我們持續努力的一部分，旨在確保我們的資產負債表能夠支持培維妥肽的持續臨床開發。

We are committed to staying focused on driving value as we work to position PEMVI to benefit NASH patients. Now to briefly comment on the Q2 financial results. First, R&D expenses which were $17.2 million for the three months ended June 30 as compared to $21 million in the same period of 2024 and this amount includes $11.2 million of direct costs related to pemvidutide development. Breaking that down further, including approximately $5.5 million for the impact Phase 2b trial, $2.6 million for AUD and ALD startup Phase 2 costs and $1 million for our pemvidutide oral formulation.

我們致力於專注於提升價值，致力於讓PEMVI造福NASH患者。現在簡要回顧一下第二季的財務表現。首先，截至6月30日的三個月，研發費用為1,720萬美元，而2024年同期為2,100萬美元，其中包括與培維妥肽開發相關的1,120萬美元直接成本。進一步細分，其中包括約550萬美元用於2b期臨床試驗，260萬美元用於AUD和ALD啟動2期成本，以及100萬美元用於培維妥肽口服製劑。

General and administrative expenses were consistent period over period at $5.7 million and $5.6 million for the quarters ended June 30, '25 and '24. Really nothing noteworthy to call out in our G&A net loss for the second quarter of 2025 was $22.1 million or $0.27 a share, compared to a net loss of $24.6 million or $0.35 a share in the second quarter of the prior year.

截至2025年6月30日及2024年6月30日的季度，一般及行政費用較去年同期持平，分別為570萬美元及560萬美元。 2025年第二季的一般及行政費用淨虧損為2,210萬美元，合每股0.27美元，而去年同期的淨虧損為2,460萬美元，合每股0.35美元，這實在沒什麼值得關注的。

With that, I’ll turn the call back to Vipin for closing remarks.

說完這些，我將把電話轉回給維平，請他做最後發言。

Thank you Greg. The second half of 2025 will be an exciting period for Altimmune as we report the 48 week impact data and prepare for our end of Phase 2 meeting while continuing to enroll the Phase 2 trials in AUD and ALD trials. This concludes our formal remarks and we would now like to open the line to take questions.

謝謝Greg。 2025年下半年對Altimmune來說將是令人興奮的一年，我們將報告48週的影響數據，並為II期會議的結束做準備，同時繼續招募AUD和ALD試驗的II期患者。我們的正式發言到此結束，現在我們想開始回答大家的提問。

(Operator Instructions) Annabel Samimy, Stifel.

（操作員指示）Annabel Samimy，Stifel。

Hi, this is Jayed on for Annabelle. Thanks for taking our question. I have two the first one related to the MASH development plan. You’ve had some time to digest the data and we did see fibrosis improvement not reach statistical significance, but to what extent could you still leverage the other improvements and a PathAI analysis at week 24? How does the FDA view these new measures and could you potentially get it into the label by including those endpoints in a Phase three?

大家好，我是 Jayed，為您解答 Annabelle 的問題。感謝您回答我們的問題。我有兩個問題，第一個與 MASH 發展計畫有關。您花了一些時間來消化數據，我們確實看到纖維化的改善沒有達到統計意義，但您還能在多大程度上利用其他方面的改善以及第 24 週的 PathAI 分析？ FDA 如何看待這些新指標？您是否有可能將這些終點納入藥品說明書中，以便在第三階段臨床試驗中應用？

Hi Jed, this is Scott and thank you for the question. There’s more and more emphasis being placed on noninvasive tests and the overall feeling among experts in the area is that we will be moving to a non invasive test or NIT based improvement at some point in the future. I think the FDA is warm to that. We actually haven’t seen that happen at this point. I want to remind you that we achieved highly statistically significant effects on ELF and VCTE sometimes called FibroScan, which are considered the best non invasive tests for assessing fibrosis.

你好，傑德，我是史考特，謝謝你的提問。現在人們越來越重視非侵入性檢測，該領域專家的總體看法是，未來某個時候我們會轉向非侵入性檢測或基於NIT的改進。我認為FDA對此很感興趣。實際上，我們目前還沒有看到這種情況發生。我想提醒你，我們在ELF和VCTE（有時稱為FibroScan）方面取得了高度統計顯著的效果，它們被認為是評估纖維化的最佳非侵入性檢測。

And Also the Path AI should remind you that PathAI analyses have been accepted in Europe as the basis of approval and that FDA is now reviewing that proposal and we should have some news in that in the near future.

此外，Path AI 應該提醒您，PathAI 分析已在歐洲被接受為批准的基礎，並且 FDA 目前正在審查該提案，我們應該在不久的將來得到一些消息。

So we think that based on these highly recognized and validated measures of fibrosis improvement, that we not only have excellent evidence that fibrosis improvement is occurring, we’re actually meeting what could be FDA and EMA expectations for approval in both of these areas. So as we’ve said before, there is a great deal of evidence that we have very potent anti fibrotic effects. We’re very confident about our ability to be able to hit these effects in Phase 3.

因此，我們認為，基於這些經過高度認可和驗證的纖維化改善指標，我們不僅擁有確鑿的證據表明纖維化正在改善，而且我們實際上已經達到了FDA和EMA在這兩個領域獲得批准的預期。正如我們之前所說，有大量證據顯示我們具有非常強效的抗纖維化作用。我們對在第三階段達到這些效果的能力充滿信心。

Yeah, I just want to add that just to remind everybody that this readout was at 24 week, at 48 week or beyond, which is where really the Phase 3 program will be designed for. We believe that we will hit the statistical significance in the fibrosis endpoint with longer trial and larger trial. That would reduce the placebo noise. That’s really the reason we didn’t hit the endpoint in this 24 week study.

是的，我只是想補充一下，提醒大家，這個讀數是在24週、48週或更長時間後得出的，而這正是3期臨床試驗設計的目標。我們相信，透過更長的試驗時間和更大規模的試驗，我們將在纖維化終點方面達到統計顯著性。這將減少安慰劑效應。這正是我們在這項24週研究中未能達到終點的真正原因。

So we feel very good about going into a Phase 3 program in spite whether the NITs are allowed or not. Even without that, we should hit the fibrosis endpoint in a longer Phase 3 trial.

所以，無論是否允許使用NIT療法，我們都對進入III期臨床試驗充滿信心。即使沒有NIT療法，我們也應該能夠在更長時間的III期臨床試驗中達到纖維化終點。

Thank you. I had one more question. It’s related to the AUD and ALD trial. I could be wrong about this, but I do recall you guys mentioning that you would test different doses, like 1.2, 1.8, 2.4 with titrations. But it looks like you’re only testing the 2.4 milligrams in these trials. Is there a particular reason for that?

謝謝。我還有一個問題。這與AUD和ALD試驗有關。我可能記錯了，但我記得你們有提到過，會用滴定法測試不同的劑量，例如1.2毫克、1.8毫克、2.4毫克。但看起來你們在這些試驗中只測試了2.4毫克。這有什麼特別的原因嗎？

Yeah, Jayad, I mean, we think that for a Phase 2 trial, it’s appropriate to only test one dose. We’re testing the most efficacious dose and then we’ll have that conversation with FDA and other regulatory agencies going forward. And there’s always the opportunity to expand that and to analyze different doses in a Phase 3 program. But we think that we’re going in with what will be our most efficacious dose and then we can reexamine other doses as the program unfolds.

是的，Jayad，我的意思是，我們認為對於二期試驗來說，只測試一種劑量是合適的。我們正在測試最有效的劑量，之後我們會與FDA和其他監管機構進行溝通。在三期計畫中，我們總是有機會擴大試驗範圍，分析不同的劑量。但我們認為，我們首先會採用最有效的劑量，然後隨著專案的進展，我們可以重新評估其他劑量。

Thank you. Now, next question coming from the lineup. Ellie Murr, would you be as your line is now open.

謝謝。現在，下一個問題來自陣容。 Ellie Murr，你的線路現在開放了，請問您願意嗎？

Hey, this is Jasmine on for Ellie. Thank you for taking our question. So on your end of Phase 2 meeting, can you talk about what you’re hoping to discuss with the FDA and align with them on are you planning to discuss the possibility of an NIT based Phase 3 design with them and will we get an update after this meeting? Thank you.

嗨，我是Jasmine，為Ellie做節目。感謝您回答我們的問題。那麼，在您結束第二階段會議後，您能否談談您希望與FDA討論哪些內容？您是否計劃與他們討論基於NIT的第三階段設計的可能性？會議結束後我們會收到最新消息嗎？謝謝。

Hey Jasmine, thanks for the question. I think that we really can’t provide a lot of details about the meeting and our proposals until we actually have the meeting. And there will be a lot of topics to discuss. And you know, the opinions of the FDA on this are shifting right now and we’re keeping our ears very close the ground on this. So we expect to be able to have a very rich conversation with the FDA along multiple lines of approaching this and have an update for you after the end of the Phase II meeting.

嘿，Jasmine，謝謝你的提問。我認為在會議正式召開之前，我們真的無法提供關於會議和我們提案的太多細節。而且會有很多話題需要討論。你知道，FDA 對此的意見正在發生變化，我們正在密切關注此事。因此，我們期待能夠與 FDA 就多方面處理此事進行非常深入的對話，並在 II 期會議結束後向你提供最新進展。

Okay, awesome. Thank you.

好的，太棒了。謝謝。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米、派珀·桑德勒。

Hi, this is Dominic on for Yasmin Rahimi. Congratulations on a great quarter and thank. You for taking our question. So we just had a few questions. The first one, was there any measures. On alcoholic consumption in the IMPACT Study that could de risk, reclaim and restore. And then kind of going with that. What is the timing for those readouts. And what do you need to see to advance in the Phase 3?

大家好，我是 Dominic，接替 Yasmin Rahimi 的節目。恭喜您本季取得了優異的成績，謝謝。感謝您回答我們的問題。我們有幾個問題。第一個問題，IMPACT 研究中，關於酒精消費，是否有任何措施可以降低風險、恢復健康並恢復活力？然後，接下來就是這些指標的發佈時間。您需要看到哪些數據才能推進第三階段的研究？

Right. So you know, we are continuing to analyze the data sets from the IMPACT trial and we’ll have an update on any alcohol measures as we continue to provide data. As you know, we’re continuing to analyze the results of the trial and we’ll provide on that information as we further analyze the data. We think we have a great deal of evidence for the effects of penvedutide on AUD and ALD. As you’re aware, we have a very impressive animal study showing about an 80% drop in alcohol consumption in animals who were given free choice.

對。你知道，我們正在繼續分析IMPACT試驗的數據集，並在持續提供數據的同時更新所有酒精指標。如你所知，我們正在繼續分析試驗結果，並在進一步分析數據後提供相關資訊。我們認為我們有大量證據證明噴維妥肽對酒精中毒（AUD）和酒精性肝病（ALD）的影響。如你所知，我們進行了一項非常令人印象深刻的動物研究，結果顯示，在自由選擇的動物中，酒精攝取量下降了約80%。

As well, there’s a huge literature on the effects of GLP1 agents in alcohol consumption, both observational trials and at least one randomized trial. And as you know, with ALD, the pathophysiologic basis of that is fat induced liver inflammation, very similar to mash.

此外，關於GLP1藥物對酒精攝取的影響，有大量文獻，包括觀察性試驗和至少一項隨機試驗。如你所知，酒精性肝病（ALD）的病理生理基礎是脂肪誘導的肝臟炎症，與酒精性肝病非常相似。

So we feel very confident of our ability to hit the endpoints in both the AUD and ALD trial and in terms of the Phase 3 development program in those indications. We’ll meet with the FDA after the Phase 2 results and get agreement on what that program looks like. Thank you.

因此，我們非常有信心在AUD和ALD試驗以及針對這些適應症的3期開發項目中達到終點。我們將在獲得2期結果後與FDA會面，就該項目的具體細節達成一致。謝謝。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. Congrats for the progress and thank you for taking our question. Maybe just also on the end of phase meeting, how much more work you need to do before you can request the meeting? My understanding you have not requested the meeting. How much data from the 48-week readout is needed to finalize the Phase 3 design proposal? And then I have a follow up question. Thank you.

太好了。恭喜您的進展，並感謝您回答我們的問題。關於階段結束會議，您還需要做多少工作才能申請會議？據我了解，您還沒有申請會議。需要多少48週的讀數資料才能最終確定第三階段的設計方案？然後我還有一個後續問題。謝謝。

Yeah, Roger, we feel very good about having that meeting by the end of the year and we’ll have the results of that meeting and share it with the Street. Other companies have met with 24 weeks of data and I want to remind you that we have a lot of information on 48 weeks of data and dosing from our obesity momentum study. So consequently we don’t really. We feel confident that we’ll have the data to go in and we’ll have that meeting. We should have it sometime in the fourth quarter and we’ll inform the street on what the results of that meeting were.

是的，羅傑，我們對年底前召開會議感到非常滿意，我們會把會議結果與華爾街分享。其他公司已經提供了24週的數據，我想提醒大家，我們掌握了大量48週的數據和劑量信息，這些信息來自我們的肥胖動量研究。因此，我們不會真的這麼做。我們有信心，我們會收集到足夠的數據，並召開會議。我們應該會在第四季的某個時候召開，屆時我們會將會議結果告知華爾街。

Got it. Thank you. And then my follow up question is with the new chairman appointment, so how will the corporate strategy evolve regarding the partnership for Phase 3 and commercialization? It seems you’re more focused on the commercialization now. Thank you.

明白了。謝謝。接下來我的問題是，隨著新董事長的任命，公司在第三期臨床試驗和商業化方面的合作策略將如何發展？看來您現在更專注於商業化。謝謝。

Yes, that’s as you can imagine, that’s part of the natural evolution. The board is continuously evaluating the skill set at the board level. Given that we are now moving into Phase 3, the board felt that addition of bringing Jerry as chairman would be an added advantage for the management team to move forward. So his experience in domain area, in building a liver disease company and ultimately being part of that M&A transaction would be important as we, as we move forward. Kada, thank you.

是的，正如您所想，這是自然發展的一部分。董事會正在持續評估董事會層面的技能組合。鑑於我們目前正進入第三階段，董事會認為聘請傑瑞擔任董事長將為管理團隊的未來發展帶來額外優勢。因此，他在這方面的經驗，包括創建肝病公司的經驗，以及最終參與併購交易的經驗，對於我們未來的發展至關重要。 Kada，謝謝。

Catherine Okoukoni, Citizens.

凱瑟琳·奧庫科尼，公民。

Hi, this is Katherine on for John. I have a quick question about the T1 responses and how the results from IMPACT compared to other programs. I know that you said kind of best-in-class, but if you could kind of give us some kind of ranges from the other competitor programs. Thanks.

大家好，我是凱瑟琳，接替約翰。我想問一個簡單的問題，關於T1的回饋，以及IMPACT的結果與其他專案相比如何。我知道您說IMPACT是同類最佳，但您能否給我們一些與其他競爭項目相比的水平？謝謝。

Yeah, Catherine. So as you’re aware, the results that we have were in the range of a reduction of about 145 to 140 milliseconds that was seen in this trial, but was also seen in a prior trial or Phase 1b trial in patients with fatty liver. And based on the public data, we’re seeing readouts of approximately 50 to 60 for rezmudirom and up to about 107 for tirzepatide.

是的，凱瑟琳。如您所知，我們得到的結果大約是減少了145到140毫秒，這在本次試驗中得到了證實，但在之前的一項試驗或針對脂肪肝患者的1b期試驗中也得到了證實。根據公開數據，我們發現瑞澤帕肽的讀數大約減少了50到60毫秒，而替澤帕肽的讀數則高達107毫秒。

So you can see that these results that we’re getting 147 versus a range of 50 to 107 are clearly superior to other compounds, at least those that are reported in the public domain. In that given the association of CT1 with reduction of both MASH activity and fibrosis, that this is one other measure among many measures showing the potent anti inflammatory and anti fibrotic activity of the compounds.

所以你可以看到，我們得到的結果是147，而範圍在50到107之間，這明顯優於其他化合物，至少是那些已公開報導的化合物。鑑於CT1與降低MASH活性和纖維化之間的關聯，這是眾多指標中的一項，顯示這些化合物具有強大的抗發炎和抗纖維化活性。

Patrick Trucchio, H.C. Wainwright.

派崔克‧特魯基奧、H.C. 溫賴特。

Hi, good morning and congrats on all the progress. I just have a couple of follow up questions on expectations around the Phase three program and and then as well just maybe looking further ahead to potential commercialization and the product profile that’s emerging. I guess the first part of the. Question is just around kind of updated thoughts on dosing strategy. 1.2 milligram, 1.8 milligram and then the higher dose and how you’re thinking about the dose selection for the Phase 3 and then as well for the primary endpoints.

大家好，早安，恭喜你們取得的所有進展。我有幾個後續問題，關於對第三階段專案的預期，以及對未來潛在的商業化和正在出現的產品概況的展望。我想第一部分是關於給藥策略的最新想法。 1.2毫克、1.8毫克，然後是更高的劑量，以及你們如何考慮第三階段的劑量選擇，以及主要終點的劑量選擇。

How are you thinking about primary endpoint? Co primary endpoint, you know, would NASH resolution as primary with fibrosis improvement or would there be a co primary design? And I guess how would you power for both? And then just as it relates to just the commercial potential, just based on, I mean there’s a lot of data and I think there’s a lot of. Points of differentiation here. So if the Phase 3 were to reproduce the impact efficacy and tolerability, I guess how do you see the positioning in MASH if there’s an eventual approval?

您如何看待主要終點？您知道，NASH 緩解和纖維化改善是共同的主要終點嗎？或會不會有共同的主要設計？您如何評估兩者的效力？至於商業潛力，我認為有很多數據，有很多差異。所以，如果 III 期臨床試驗能夠重現療效和耐受性方面的影響，如果最終獲得批准，您如何看待 MASH 的定位？

Patrick, I’ll take the first part of the question for the commercial potential. I’ll turn that over to Vippin. So as you were aware, we studied the 1.2 and the 1.8 milligram doses in impact and even at the 1.8 milligram dose, which is not our most potent dose for weight loss, we still achieve 6.2% weight loss at only 24 weeks. And the trajectory of the weight loss indicated there was a lot more weight loss to be had. So we think it’s going to be very attractive to put the 2.4 milligram dose into Phase 3 would not only give more weight loss to the extent that it could promise even more, provide even more efficacy, we find that very attractive.

派崔克，我先回答問題的第一部分，關於商業潛力。我會把這個問題交給Vippin。如你所知，我們研究了1.2毫克和1.8毫克劑量的效果，即使是1.8毫克的劑量，雖然這不是我們最有效的減肥劑量，但我們仍然在24週內實現了6.2%的減重。而且減重軌跡表明，減重效果還有很大的提升空間。因此，我們認為將2.4毫克劑量納入第三期臨床試驗將非常有吸引力，它不僅能帶來更多的減重效果，還能帶來更大的希望，提供更強的療效，我們認為這非常有吸引力。

Regarding the other two doses that’s currently being looked at very critically and we’ll discuss that with the agency and have an update for the street after we have our end of Phase 2 meeting. As you’re aware, there are two endpoints in MASH resolution and fibrosis improvement. In the IMPACT study we had a dual endpoint, meaning that we either had a hit MASH resolution or fibrosis improvement for the trial to be successful and consequently IMPACT was a successful trial.

關於目前正在嚴格審查的另外兩種劑量，我們將與監管機構討論，並在二期會議結束後向市場更新進展。如您所知，MASH 消退和纖維化改善有兩個終點。在 IMPACT 研究中，我們設定了雙重終點，這意味著要么 MASH 消退達到預期，要么纖維化改善達到預期，試驗才能成功，因此 IMPACT 試驗是一次成功的試驗。

We could go in to Phase 3 with a similar strategy of dual endpoints. There’s also the possibility of CO endpoints when you have to hit both, et cetera, and then in the background you have endpoints based on non invasive tests, which we feel are very exciting.

我們可以採取類似的雙終點策略進入第三階段。此外，還有可能採用CO終點，即需要同時達到兩個終點等等。此外，在後台，我們還擁有基於非侵入性測試的終點，我們覺得這些非常令人興奮。

And by the way, EMA has approved the use of a path AI methodology for actually reading out NASH resolution and fibrosis improvement using computerized algorithms assisted by the pathologist, but driven predominantly by the computer, which we think is going to reduce greatly the noise that we’re seeing in the trial and probably help us control the placebo response and really express the anti fibrotic potential of the compound.

順便說一句，EMA 已批准使用路徑 AI 方法，透過病理學家協助的電腦演算法實際讀出 NASH 分辨率和纖維化改善情況，但主要由電腦驅動，我們認為這將大大減少我們在試驗中看到的噪音，並可能幫助我們控制安慰劑反應並真正表達化合物的抗纖維化潛力。

So we think there’s a lot of things at play here in terms of the discussion with the FDA. It’s going to be a very exciting and important end of Phase 2 meeting. And as soon as we have further information, we’ll update the street. So with that I’m going to turn the commercial discussion over to Vipin.

所以我們認為，就與FDA的討論而言，有很多事情需要商榷。這將是第二階段會議非常令人興奮且重要的收尾階段。一旦我們獲得更多信息，我們將立即向市場通報。因此，我將把商業討論交給Vipin。

Yeah, I just want to emphasize one other thing with regards to the FDA discussions. You know, one thing I want to remind everybody is that we have a very large safety database that we have already accumulated on pemvidutide. It’s a part of our discussion with would be how do we leverage that? We think there is an opportunity to reduce the number of exposures in terms of the safety database.

是的，關於FDA的討論，我只想強調一點。我想提醒大家的是，我們已經累積了非常龐大的培維妥肽安全資料庫。我們討論的一部分是如何利用這個資料庫？我們認為，就安全資料庫而言，有機會減少暴露次數。

So we’ll certainly be having that dialogue with the FDA, as Scott said, among many other things that we’ll be discussing with the FDA. So looking forward to that. Patrick, in terms of commercial potential of pemvidutide, as we have said all along, and as you pointed out, the multiple potential points of differentiation, first and foremost, we are combining two mechanisms.

因此，正如斯科特所說，我們肯定會與FDA進行對話，此外還會討論許多其他事宜。我們對此充滿期待。派崔克，就培維妥肽的商業潛力而言，正如我們一直強調的，以及您所指出的，它有多個潛在的差異化優勢，首先，我們將兩種機制結合起來。

Direct action in the liver, a direct acting agent in the liver with a metabolic agent with weight loss. So really think of it. We’re treating NASH with obesity. And when you look at the MASH landscape, everybody’s talking about the benefit of adding weight loss on top of liver directed effect. We’re bringing that in single molecule. We’re combining these two mechanisms. So we’re treating MASH, but on top of that people are losing weight. 60% to 80% of patients with MASH are obese or overweight, so they would benefit from losing weight.

直接作用於肝臟，一種直接作用於肝臟的藥物與一種代謝藥物一起作用，從而減輕體重。所以，認真想想。我們正在治療伴隨肥胖症的NASH。而當你觀察MASH的現狀時，每個人都在談論在肝臟直接作用的基礎上增加減肥效果的好處。我們將這種效果融入單分子藥物中。我們將這兩種機制結合起來。因此，我們不僅治療MASH，患者還能減輕體重。 60%到80%的MASH患者是肥胖或超重，因此減重對他們有好處。

So that’s number one, which we believe is a very big advantage or differentiating factor for pemvidutide. You know, in our work, in our market research, it’s clear that physicians are looking for a drug where people will not only improve their liver health, but will also lose weight.

所以這是最重要的，我們認為這是培維妥肽的一個非常大的優勢或差異化因素。你知道，在我們的工作中，在我們的市場研究中，很明顯醫生們正在尋找一種不僅能改善肝臟健康，還能幫助人們減肥的藥物。

Secondly, safety and tolerability is going to be very, very important. And as you can see from our data, we are seeing class leading tolerability profile. We think that can be leveraged. Patients like that, doctors like that, lack of dose titration is going to be a major plus when we go, when we commercialize pemvidutide. So it’s really the benefit of combining the two mechanisms and on top of that having a very clean safety and tolerability profile that we think is going to speak well in terms of the commercial success of the product.

其次，安全性和耐受性將非常非常重要。正如您從我們的數據中看到的，我們看到了業內領先的耐受性特徵。我們認為這一點可以加以利用。患者和醫生都喜歡這種無需劑量調整的方案，而當我們將培維妥肽商業化時，這將是一個很大的優勢。因此，將兩種機制結合起來確實很有好處，而且最重要的是，它具有非常清晰的安全性和耐受性特徵，我們認為這將對產品的商業成功起到良好的作用。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Hi, thanks for taking our questions. This is William on for Myong today. Two from us. Maybe I’ll start with the first. So now that we know that Lily. Has gotten positive FDA buy in on pursuing high risk masld, a high risk MASLD trial for their Retta and Tirzepatide. They’re using NITS for patient screening and then foregoing biopsies completely for primary FSP endpoint and looks like even in the trial looking more of an outcomes type trial.

嗨，感謝您回答我們的問題。今天是 William 代替 Myong 提問。我們有兩個問題。我先從第一個開始。現在我們知道 Lily 已經獲得了 FDA 的積極支持，正在進行一項針對 Retta 和 Tirzepatide 的高風險 MASLD 試驗。他們正在使用 NITS 進行患者篩檢，然後完全放棄活檢作為主要 FSP 終點，而且看起來即使在試驗中也更像是一項結果型試驗。

How do you see this as an opportunity for PENVI to execute on a capital efficient Phase 3 trial? And is your understanding that this still only biopsies are a way to secure subpart H accelerated approval? And then I have a follow up.

您如何看待這對 PENVI 來說是一個進行高效資本運作的 3 期臨床試驗的機會？您是否認為，目前仍只有活檢才能獲得 H 類加速批准？然後我還有一個後續問題。

Well, thanks, William. Yeah, I mean I think it’s really exciting. I think it creates a real opportunity for us in non invasive tests. And you know, we’re taking a very careful look at that and we think that there’s real opportunity for us here and we’ll certainly have that discussion with the FDA.

嗯，謝謝，威廉。是的，我覺得這真的很令人興奮。我認為這為我們在非侵入性檢測領域創造了真正的機會。而且，我們正在非常仔細地研究這個問題，我們認為這對我們來說是一個真正的機會，我們肯定會與FDA進行討論。

Yeah, as we have said and then we will look at every potential opportunity to come up with an innovative trial design and incorporate all of these things that are now becoming clear that the FDA is. So we’ll certainly have all of those discussions. We can’t get into the specifics right now, but we’ll definitely talk about it once we’ve had the end of Phase 2 meeting.

是的，正如我們之前所說，我們會考慮每一個潛在的機會，提出一個創新的試驗設計，並將FDA現在越來越明確的所有因素納入其中。所以我們肯定會進行所有這些討論。我們現在無法透露具體細節，但第二階段會議結束後我們一定會討論。

Yeah. Let me add to that William, that you know, there are a lot of exciting things happening here. The development of nits, the movement toward AI based reading in Europe and we think there’s a good chance that FDA will pick that up.

是的。威廉，我補充一下，你知道，這裡有很多令人興奮的事情正在發生。蝨子的研究進展，歐洲基於人工智慧的閱讀趨勢，我們認為FDA很有可能會注意到這些。

And you saw that we had very positive results from the AI based analyses that really reduce the noise from the manual pathologist readout. So there are other developments here that are going to increase our probabilities of success in Phase 3. And you know, we’re very interested in those and share your excitement and plan to have that discussion with the FDA this fourth quarter.

您也看到了，我們從基於人工智慧的分析中獲得了非常積極的成果，這確實減少了病理學家手動讀數的噪音。所以，還有其他進展將提高我們在第三階段成功的機率。您知道，我們對此非常感興趣，與您一樣興奮，並計劃在第四季度與FDA進行討論。

Got it. And then also again, I was sort of thinking of Crosstown Pier. Merck has their efinopegdutide readout coming out shortly and they’re looking at biopsy results at 48 weeks. Slightly different glucagon ratio here. But what could their data mean in terms of your 48 week data potentially in Phase 3 or obviously just your NIT data coming up the end of the year? And what may you be specifically looking for to bring you additional confidence in Phase 3 sort of going forward? And what will guide you, help guide you in development of that Phase 3?

明白了。然後，我又想起了 Crosstown Pier 的情況。默克的 efinopegdutide 數據很快就要出來了，他們正在研究 48 週的活檢結果。胰高血糖素比率略有不同。但是，他們的數據對您可能在 3 期臨床試驗中的 48 週數據，或者顯然只是對您年底即將公佈的 NIT 數據意味著什麼？您具體希望尋找哪些指標來增強您對第 3 期臨床試驗的信心？什麼將指導、幫助您進行 3 期臨床試驗？

Right. Well, as you noted, William, the reading out at 48 weeks and another glucagon compound is read out at 48 weeks. And these have lesser ratios of glucagon. And as Vipin mentioned, we read out at only 24 weeks. So we think that our readouts at 48 weeks, had we done the biopsied week 48 weeks, would has been as good, if not better than the other compounds. And that’s certainly supported by the very potent noninvasive test results we’re seeing at week 24.

對。威廉，正如你所說，48週的讀數和另一種胰高血糖素化合物的讀數都是在48週時。這些化合物的升糖素比例較低。正如維平所提到的，我們只在24週時讀取。所以我們認為，如果我們在第48週進行活檢，那麼我們在48週時的讀數會和其他化合物一樣好，甚至更好。這一點也得到了我們在24週看到的非常有效的非侵入性檢測結果的支持。

I want to remind you that there hasn’t been an incretin, let alone a glucagon containing incretin that is read out at week 24. And at week 24 our match resolution was comparable to or superior to other compounds at week 24 and better than compounds reading out at later time points in 48 to 72 weeks. So we think that a efinopegdutide readout will be further confirmation of the efficacy of the compound.

我想提醒大家，目前還沒有一種腸促胰島素，更不用說一種含有腸促胰島素的升血糖素，能夠在24週時讀取結果。而在第24週，我們的匹配分辨率與其他化合物相當或優於其他化合物，並且優於在48至72週的後續時間點讀取結果的化合物。因此，我們認為，efinopegdutide的讀數將進一步證實該化合物的有效性。

Now, as you know, we don’t have a biopsy at week 48, but we have the noninvasive test and we expect to be able to use the non invasive test to model and to predict what we would have seen a week 48 had we done the 48 week biopsy. So, you know, we think that data will be very supportive of our mechanism and our efficacy.

現在，正如你所知，我們沒有在48週進行活檢，但我們有非侵入性測試，我們期望能夠利用非侵入性測試來建模並預測如果我們在48週進行活檢，48週後會出現什麼情況。所以，你知道，我們認為這些數據將非常支持我們的機制和療效。

Corinne Johnson, Goldman Sachs,

高盛的 Corinne Johnson

Good morning. Maybe just one from us. How should we think about the cadence of research and development spend from here as these AUD and ALD studies studies get up and further running and enrollment increases? Thanks. Thanks. Appreciate the call.

早安.我們可能只有一個問題。隨著這些AUD和ALD研究的開展和進一步開展，以及入組人數的增加，我們該如何考慮未來研發支出的節奏？謝謝。謝謝。感謝您的來電。

This is Greg. And in terms of the R and D spend investment in AUD and ALD, these are Phase 2 trials. They’re baked into our budget for this year, so they’re incorporated in our cash Runway. These are relatively modest in size and we’re on it. Don’t anticipate anything unusual in our burn rate going forward in the near term as related to AUD and ALD.

我是格雷格。關於AUD和ALD的研發支出，目前處於二期試驗階段。這些試驗已計入我們今年的預算，因此已納入我們的現金流跑道。這些試驗規模相對較小，我們正在推進中。短期內，我們與AUD和ALD相關的資金消耗率預計不會有任何異常。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Thanks for taking a question. Just a quick one. Very interested in the oral program that you are advancing. So I’m curious, maybe from a technological perspective, we think about it as a gastric absorption enhancer. And also just curious if you can. Tell us a little bit more about. How you would position this formulation in the grand scheme of things. Thank you.

感謝您回答問題。我只想問一個簡單的問題。我對您正在推進的口服藥物計畫非常感興趣。所以，我很好奇，也許從技術角度來看，我們認為它是一種胃吸收促進劑。如果您可以的話，請再多介紹一下。您如何從整體上定位這個配方？謝謝。

Thanks for the question. You know, we’ve been at this for a little while here and, you know, I’m excited to share that we’ve had a big breakthrough in the activity. You know, from the very beginning, we focused on two elements to really differentiate an oral formulation of the peptide from others that are out there. Robelsis, for example. The first is to get away from the food restriction. You mentioned gastric absorption. That’s exactly what we’re trying to get away from.

謝謝你的提問。你知道，我們研究這個已經有一段時間了，我很高興能和大家分享，我們在這個領域取得了重大突破。你知道，從一開始，我們就專注於兩個要素，以真正區分這種勝肽的口服製劑與市面上其他產品。例如，Robelsis。首先是擺脫食物限制。你提到了胃吸收。這正是我們想要擺脫的。

And we’ve done that from the beginning and focused on that because when it’s absorbed in the gut or in the stomach, then it’s really about, you know, very tight food restrictions that you’re aware of for the Rybelsis indication. So that’s one of the things we wanted to do. And the secondary feature was to make sure that it really made sense from a cost of goods standpoint.

我們從一開始就專注於此，因為當它在腸道或胃中被吸收時，Rybelsis 的適應症確實需要非常嚴格的食物限制。所以這是我們想要做的事情之一。其次，我們也要確保它從產品成本的角度來說確實合理。

As you know, oral absorption is always inefficient compared to subcutaneous injection. But to make it work, we had a fairly high threshold for what we would be interested in. And so I think that things are looking very, very good in that respect. I think this breakthrough that we had was mechanism based that it went just the way we expect and we looking forward to translating that into a preclinical development and nomination there. So as far as the impact to the commercial situation, I’ll let Vipin speak to that.

如您所知，口服吸收與皮下注射相比效率始終較低。但為了使其發揮作用，我們對感興趣的領域設定了相當高的門檻。因此，我認為在這方面的情況非常非常好。我認為我們取得的這一突破是基於機制的，其進展正如我們預期的那樣，我們期待將其轉化為臨床前開發並獲得提名。至於對商業情勢的影響，我請Vipin來談談。

Yeah, I mean, our strategy with the oral program is very similar to what you would expect with what’s being done with other programs. Really a life cycle management question. As this field grows, there would be attractiveness to the oral program.

是的，我的意思是，我們對口語項目的策略與其他項目的策略非常相似。這其實是一個生命週期管理的問題。隨著這個領域的發展，口語項目的吸引力也會越來越大。

As Scott mentioned, oral delivery is never going to be as efficient as subcutaneous injection. So we believe that both of these formulations would be important in terms of developing commercially the value proposition around pemvidutide.

正如斯科特所說，口服給藥永遠不會像皮下注射那麼有效。因此，我們認為這兩種劑型對於圍繞培維妥肽的商業價值主張發展都至關重要。

Thank you. And there are no further questions in the queue at this time. I will now turn the call back over to Dr. Vipin Garg for any closing remarks.

謝謝。目前沒有其他問題了。現在我將把電話轉回給Vipin Garg博士，請他做最後發言。

Thank you all 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 the day.

感謝大家今天參加我們的電話會議。一如既往，我們感謝您一直以來的支持，並期待在未來幾個月繼續為您提供最新資訊。祝大家今天過得愉快！

This concludes today’s conference call. Thank you for your participation. And you may now disconnect.

今天的電話會議到此結束。感謝您的參與。現在您可以掛斷電話了。