Fractyl Health Inc (GUTS) 2025 Q2 法說會逐字稿

Good afternoon. Welcome to Fractyl Health second quarter 2025 financial results and business updates call. As a reminder, (Operator Instructions) I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl. Brian, you may now begin.

午安.歡迎參加 Fractyl Health 2025 年第二季財務業績和業務更新電話會議。提醒一下，（操作員指示）我現在將電話轉給 Fractyl 投資者關係和企業發展主管 Brian Luque。布萊恩，你現在可以開始了。

Thank you. This afternoon we issued a press release that outlines the topics we plan to discuss today. This release is available at www.rackle.com under the investors tab. Joining us on the call today are Doctor Harith Rajagopalan, Chief Executive Officer, and Lisa Davidson, Chief Financial Officer.

謝謝。今天下午我們發布了一份新聞稿，概述了我們今天計劃討論的話題。此新聞稿可在 www.rackle.com 的「投資者」標籤下找到。今天參加電話會議的有執行長 Harith Rajagopalan 博士和財務長 Lisa Davidson。

During this call, we make forward-looking statements which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filing, including the quarterly report on Form 10-Q filed today, which I encourage you to review.

在本次電話會議中，我們做出了前瞻性陳述，其中涉及風險和不確定性，可能導致實際結果與我們的前瞻性陳述有重大差異。我們在提交給美國證券交易委員會的文件中提供了一份全面的風險因素清單，包括今天提交的 10-Q 表季度報告，我鼓勵您查看一下。

Any forward-looking statements on the call are subject to substantial risks and uncertainties. Speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements, even if subsequent events caused the company's views to change. It is now my pleasure to pass the call over to Harry.

電話會議中的任何前瞻性陳述都存在重大風險和不確定性。僅代表通話原始日期的觀點，我們不承擔更新或修改任何聲明的義務，即使後續事件導致公司的觀點改變。現在我很高興將電話轉給哈利。

Fractyl Thank you, Brian. Good afternoon, everyone. Fractyl is tackling the next major crisis in metabolic care, weight regain after GLP-1 discontinuation. Tens of millions of people are struggling with their weight and will start a GLP-1 with the hope of achieving lasting weight loss, but most will stop the drug within a year. Nearly all will regain weight.

Fractyl 謝謝你，布萊恩。大家下午好。Fractyl 正在應對代謝護理的下一個重大危機，即停用 GLP-1 後的體重反彈。數千萬人正在與體重作鬥爭，他們開始服用 GLP-1，希望實現持久的減肥效果，但大多數人會在一年內停藥。幾乎所有人的體重都會反彈。

This rebound problem is a massive unmet need because most patients cannot stay on drug therapy for weight loss for the rest of their lives. And when they stop drug therapy, not only does their weight come back, but so too does their profound hunger and all of the metabolic complications associated with obesity, including type two diabetes.

反彈問題是一個巨大的未滿足的需求，因為大多數患者無法終生堅持藥物治療減肥。而當他們停止藥物治療時，不僅體重會反彈，而且飢餓感也會增強，並且會出現與肥胖相關的所有代謝併發症，包括二型糖尿病。

Fractyl Health may be the first company with a scalable solution to this problem because our therapies target the root cause of disease for the very first time. Since our last earnings call, we have strengthened our balance sheet, further sharpened our strategic focus, and delivered on critical milestones. This focused execution sets us up for a transformational second half of the year. Last week, we strengthened our financial position through a $23 million underwritten public offering of common stock with accompanying warrants that could provide up to a total of $69 million in proceeds.

Fractyl Health 可能是第一家針對該問題提供可擴展解決方案的公司，因為我們的療法首次針對疾病的根本原因。自上次財報電話會議以來，我們加強了資產負債表，進一步強化了策略重點，並實現了關鍵里程碑。這種專注的執行為我們下半年的轉型做好了準備。上週，我們透過承銷 2,300 萬美元的普通股公開發行以及附帶的認股權證增強了我們的財務狀況，這些認股權證可提供總計高達 6,900 萬美元的收益。

This financing was led by leading healthcare investors, including Nantahala Capital, Aar1 Capital Management, Second Line Capital, 683, and Silver Ark. Investors who understand the significance of our upcoming catalysts and chose to scale their investments alongside them. With this capital structure in place, we've positioned ourselves to fully capture the value of our clinical and strategic progress in the months ahead.

此次融資由領先的醫療保健投資者領投，包括 Nantahala Capital、Aar1 Capital Management、Second Line Capital、683 和 Silver Ark。投資者了解我們即將推出的催化劑的重要性，並選擇隨之擴大投資。有了這個資本結構，我們就能在未來幾個月充分掌握臨床和策略進展的價值。

With the proceeds from this primary capital raise, we expect to extend our cash runway through important REMAIN-1 Midpoint Cohort milestones with next month's three month randomized data readout, as well as the six month randomized data from this cohort in the first quarter of 2026. We sharpened our strategic focus by reducing our burn rate from $25.4 million in quarter one to $19.8 million in quarter two as we wound down our spend on non-critical programs following the strategic reprioritization earlier in the year.

利用此次主要融資所得，我們預計透過下個月的三個月隨機數據讀數以及 2026 年第一季該群體的六個月隨機數據，延長我們的現金流，實現 REMAIN-1 中點群體的重要里程碑。我們在今年稍早進行策略重新調整後，減少了對非關鍵項目的支出，將資金消耗率從第一季的 2,540 萬美元降低到第二季的 1,980 萬美元，從而加強了我們的策略重點。

Going forward, we will continue to see reduced cash burn be a key area of focus with disciplined cash management through the Remain one pivotal study milestones ahead. We have also delivered on key milestones across our Revita and Rejuva programs during this time.

展望未來，我們將繼續把減少現金消耗作為重點關注領域，並透過未來的重要研究里程碑進行嚴格的現金管理。在此期間，我們還在 Revita 和 Rejuva 計劃中實現了關鍵里程碑。

Revita is emerging as a foundational therapy to reset the body's metabolic set point in obesity and type two diabetes. Last week, we reported new data from our German real world registry study that reinforced Revita's durability, showing up to two years of benefit in weight maintenance and blood sugar control following a single treatment.

Revita 正成為一種重置肥胖症和第二型糖尿病患者代謝設定點的基礎療法。上週，我們報告了來自德國真實世界註冊研究的新數據，該研究強化了 Revita 的持久性，表明一次治療後即可在維持體重和控制血糖方面獲得長達兩年的益處。

What is impressive about the new data from Germany is not only the duration of the effect of up to 2 years, but also the potency of the therapy over that period of time, with even greater improvements in body weight at two years than at one year. What this implies is that Revita can deliver real-world results that could get even better over time as the body accommodates to a more physiologic and healthy relationship with food.

來自德國的新數據令人印象深刻的不僅是長達 2 年的效果持續時間，而且是治療在這段時間內的效力，兩年內體重的改善甚至比一年內更大。這意味著 Revita 可以帶來現實世界的效果，隨著身體逐漸適應與食物更生理、更健康的關係，效果可能會隨著時間的推移而變得更好。

These long-term outcomes are consistent with prior Revita clinical studies and solidify its potential as a real-world non-pharmacologic solution for sustained metabolic results with a broad set of potential indications in obesity and metabolic disease. Our near-term focus is solving weight regain after GLP-1 discontinuation, a challenge that is now recognized by patients, physicians, and payers alike.

這些長期結果與 Revita 先前的臨床研究一致，並鞏固了其作為現實世界非藥物解決方案的潛力，以實現持續的代謝結果，並在肥胖和代謝疾病方面具有廣泛的潛在適應症。我們的近期重點是解決 GLP-1 停藥後體重反彈的問題，這項挑戰目前已得到患者、醫生和付款人的一致認可。

In June, we shared three-months month open label data from the REVEAL-1 cohort. Patients who stopped Tirzepatide and received a single Revita procedure demonstrated weight stability at three months, with nearly half losing even more weight after stopping the drug. This is the first human clinical evidence that Revita may stabilize weight after stopping GLP-1s.

6 月份，我們分享了 REVEAL-1 隊列的三個月開放標籤資料。停止使用 Tirzepatide 並接受一次 Revita 手術的患者在三個月內體重保持穩定，近一半的患者在停藥後體重減輕更多。這是第一個人體臨床證據，證明 Revita 可能在停止使用 GLP-1 後穩定體重。

Enrolment of our Remain one pivotal complete, complete and randomizations are on track. We continue to see a favourable safety profile and strong procedural consistency across sites, important indicators for study success and potential commercial scale. Next month, we expect to report three-month randomized data from the REMAIN-1 Midpoint Cohort.

我們剩下的一個關鍵的完整、完整和隨機化的招生工作正在按計劃進行。我們繼續看到良好的安全性和跨站點的強大程序一致性，這是研究成功和潛在商業規模的重要指標。下個月，我們預計將報告 REMAIN-1 中點隊列的三個月隨機數據。

These are people with obesity but without type two diabetes, who have lost 15% of their total body weight with Tirzepatide before randomization to Revita or sham. This will be the first blinded, controlled data set assessing whether Revita can preserve GLP-1 induced weight loss and metabolic benefit. The goal of the REMAIN-1 Midpoint Cohort will be to establish an early efficacy signal for Revita in a rigorous sham-controlled study ahead of our pivotal cohort, for which top line data are expected in the second half of next year.

這些人患有肥胖症，但沒有第二型糖尿病，在隨機接受 Revita 或假手術治療之前，他們已經透過 Tirzepatide 減掉了 15% 的體重。這將是第一個盲法、受控資料集，評估 Revita 是否可以保留 GLP-1 誘導的減肥和代謝益處。REMAIN-1 中點隊列的目標是透過一項嚴格的假對照研究，為 Revita 建立早期療效訊號，以領先我們的關鍵隊列，預計該隊列的頂線數據將於明年下半年公佈。

We believe this randomized midpoint data in September will be a key proof point for the therapy, and we are optimistic for a positive outcome. For the REMAIN-1 Midpoint Cohorteadout, including the 3-month readout next month, success means showing clear separation between Revita and Shaam on weight regain over time. More specifically, we are aiming to show that Revita performs at least 50% better than what one would expect from tirzepatide withdrawal alone.

我們相信，9 月的隨機中點數據將成為該療法的關鍵證明點，我們對積極結果持樂觀態度。對於 REMAIN-1 中點隊列研究（包括下個月的 3 個月讀數），成功意味著隨著時間的推移，Revita 和 Shaam 在體重恢復方面顯示出明顯的差異。更具體地說，我們的目標是證明 Revita 的效果比單獨戒斷 tirzepatide 所預期的效果至少好 50%。

Based on surmount four data from Eli Lilly, patients who discontinue tirzepatide typically regain 5% to 6% of their body weight by three months. If Revita treated patients show only 3% weight regain or less at the same time point, that would not only be statistically significant, it would also be a highly meaningful result for patients, for physicians, and for payers.

根據禮來公司的四項數據，停用替澤帕肽的患者通常會在三個月內恢復體重的 5% 至 6%。如果接受 Revita 治療的患者在同一時間點體重僅反彈 3% 或更少，這不僅具有統計意義，而且對患者、醫生和付款人來說也是一個非常有意義的結果。

To put Revita his in context, we shared three month data from our open label revealed one study in June, where the median weight regain was less than 0.5% point or just one of weight change compared to the 5% to 6% body weight or GBP10 to GBP15 of weight regain typically seen by this time point when patients stop tirzepatide. That early signal of weight loss maintenance was incredibly encouraging, and we believe it bodes very well and sets a strong precedent heading into the next month of randomized readout from Remain one.

為了將 Revita 放在背景中，我們在 6 月分享了一項開放標籤研究的三個月數據，其中體重恢復的中位數不到 0.5% 或僅為體重變化的 1%，而當患者停止使用 tirzepatide 時，通常體重恢復的幅度為 5% 至 6% 或 10 至 15 英鎊。早期減肥維持的訊號令人難以置信地鼓舞人心，我們相信這是一個好兆頭，並為下個月留歐派的隨機讀數樹立了強有力的先例。

GLP-1 Success with Remain one could position Revita as the LASIK for obesity, a straightforward one-time intervention that targets a root cause of disease and offers a potential for a lasting alternative to chronic disease management. This is not just theoretical. Our recent field visits to clinical trial sites and multiple advisory boards have confirmed three key themes. First, GI physicians are incredibly excited about Revita and believe it can be a valuable tool in their armamentarium as they increasingly move into treating obesity and metabolic disease.

GLP-1 與 Remain 的成功結合可以將 Revita 定位為肥胖症的 LASIK，這是一種針對疾病根本原因的直接一次性幹預措施，並為慢性病管理提供持久的替代方案。這不僅僅是理論上的。我們最近對臨床試驗地點和多個諮詢委員會的實地考察確認了三個關鍵主題。首先，胃腸病醫生對 Revita 感到非常興奮，並相信隨著他們越來越多地轉向治療肥胖症和代謝疾病，它可以成為他們醫療設備中的寶貴工具。

Second, based on the rapidity of enrolment in Remain one and the enthusiasm they see from patients, GI physicians anticipate significant procedure volumes upon potential FDA approval. And third, GLP-1 prescribers know that most of their patients do not want to be on these drugs for the rest of their lives, either because of side effects, costs, or concerns about long-term drug therapy.

其次，根據「留守計畫」的登記速度以及患者表現出的熱情，胃腸病醫生預計，一旦獲得 FDA 批准，手術量將會大幅增加。第三，GLP-1 處方者知道，大多數患者並不想終生服用這些藥物，要么是因為副作用，要么是因為費用，要么是因為對長期藥物治療的擔憂。

And with these insights in mind, we are building the foundation for commercial scale. In June, we announced a non-binding letter of intent with Bariendo, a nationwide endoscopic obesity care platform to prepare for potential adoption of Revita pending FDA approval. This collaboration could help create a ready-made distribution channel across high volume, ambulatory and hospital endoscopy centers. The collaboration will focus on pre-commercial preparation, including workflow design, provider education, health economic analysis, and the development of referral pathways.

基於這些見解，我們正在建立商業規模的基礎。6 月份，我們宣布與全國性內視鏡肥胖護理平台 Bariendo 簽署一份不具約束力的意向書，為等待 FDA 批准 Revita 的潛在採用做準備。此次合作有助於在高容量、門診和醫院內視鏡中心建立現成的分銷管道。此次合作將著重於商業化前的準備工作，包括工作流程設計、提供者教育、健康經濟分析和轉診途徑的發展。

As we pioneer new therapeutic areas in metabolic medicine, we are also establishing a leadership position that is built to last. In June, we were granted two new US patents reinforcing our foundational innovations in duodenal mucosal resurfacing. Today, our portfolio includes over one hundred granted patents throughout the world, including thirty-two granted US patents and nearly forty pending applications, making rattle the clear innovation leader in gut-targeted metabolic therapy.

當我們開拓代謝醫學新治療領域時，我們也正在建立持久的領導地位。六月，我們獲得了兩項新的美國專利，鞏固了我們在十二指腸黏膜重鋪領域的基礎創新。如今，我們的產品組合涵蓋了全球一百多項已授權專利，其中包括三十二項已授權的美國專利和近四十項正在申請的專利，這使得 Rattle 成為腸道靶向代謝治療領域當之無愧的創新領導者。

Let me now turn to Rejuva. With Rejuva, we believe we have created a truly breakthrough therapy. The first potentially one and done smart GLP-1 platform designed to program pancreatic beta cells to secrete GLP-1 in response to nutrients, potentially delivering durable, physiologic, metabolic control at far lower circulating GLP-1 levels than required by injectable therapies.

現在讓我來談談 Rejuva。我們相信，透過 Rejuva，我們已經創造了一種真正突破性的療法。第一個潛在的一次性智慧 GLP-1 平台，旨在編程胰臟 β 細胞響應營養物質而分泌 GLP-1，從而可能在遠低於注射療法所需的循環 GLP-1 水平下提供持久的生理代謝控制。

RejuvaRJVA-001 has completed pre-clinical efficacy, toxicity, and biodistribution studies. CMC manufacturing is progressing well and nearly complete. We reached agreement with regulators on the design of the RJVA-001 phase 1/2 clinical study. It will be an open label multicentre study that will evaluate the safety, tolerability, and preliminary efficacy of RJVA-001 in adults with inadequately controlled type two diabetes, despite multiple glucose lowering agents.

RejuvaRJVA-001 已完成臨床前效能、毒性和生物分佈研究。CMC製造進展順利，已接近完成。我們就 RJVA-001 1/2 期臨床研究的設計與監管機構達成協議。這將是一項開放標籤多中心研究，旨在評估 RJVA-001 對使用多種降血糖藥物但仍控制不佳的二型糖尿病成年人的安全性、耐受性和初步療效。

In May, we submitted the first module of our clinical trial application. Pending regulatory clearance, we expected those first patients and report preliminary data in 2026. RJVA-001 could redefine the risk-benefit profile of long-term GLP-1 therapy, and open the door to a durable, potentially curative solution for chronic metabolic disease.

五月份，我們提交了臨床試驗申請的第一個模組。在獲得監管部門批准後，我們預計將於 2026 年迎來首批患者並報告初步數據。RJVA-001 可以重新定義長期 GLP-1 治療的風險效益狀況，並為慢性代謝疾病的持久、潛在治癒解決方案打開大門。

We believe that the future of metabolic care lies in durability, in physiologic design, and in root cause solutions that work in the real world. With Revita, we aim to be the LASIK for obesity. With Rejuva, we are reprogramming the pancreas itself for life. Our execution is tight, our focus is clear, and our opportunity is substantial. Lisa will not walk through the financials.

我們相信，代謝護理的未來在於耐用性、生理設計以及在現實世界中有效的根本原因解決方案。透過 Revita，我們的目標是成為肥胖症的 LASIK。利用 Rejuva，我們可以對胰臟本身進行重新編程，使其能夠存活下去。我們的執行很嚴密，我們的重點很明確，我們的機會很大。麗莎不會詳細介紹財務狀況。

Thank you, Hari. In the second quarter of 2025, we continue to invest in the execution of our clinical strategy across both the Revita and Rejuva programs. R&D expense for the quarter was $21.2 million compared to $16.8 million in the second quarter of 2024, reflecting the continued advancement of the Remain one clinical study in the Rejuva program.

謝謝你，哈里。2025 年第二季度，我們將繼續投資於 Revita 和 Rejuva 計畫的臨床策略執行。本季研發費用為 2,120 萬美元，而 2024 年第二季為 1,680 萬美元，這反映了 Rejuva 計畫中剩餘一項臨床研究的持續推進。

Including personal related costs. SG&A expense was $4.9 million compared to $6.2 million in the same quarter last year. The reduction is primarily due to the lower stock-based compensation. Net loss for the quarter was $27.9 million compared to $17.2 million in quarter two 2024, largely due to changes in non-cash fair value of notes and warrants and increased operating expenses.

包括個人相關費用。銷售、一般及行政費用為 490 萬美元，去年同期為 620 萬美元。減少的主要原因是股票薪酬減少。本季淨虧損為 2,790 萬美元，而 2024 年第二季為 1,720 萬美元，這主要是由於票據和認股權證的非現金公允價值變動以及營運費用增加所致。

As of June '30, we had $22.3 million in cash in cash equivalent. Based on our current operating plans and after considering the net proceeds from the underwritten public offering, we expect our current cash position to fund operations into 2026 through key upcoming data readouts from the REMAIN-1 Midpoint Cohort. With that I will turn the call back over to her.

截至 6 月 30 日，我們擁有現金等價物 2,230 萬美元。根據我們目前的營運計劃，並考慮承銷公開發行的淨收益後，我們預計目前的現金狀況將透過 REMAIN-1 中點隊列即將發布的關鍵數據讀數為 2026 年的營運提供資金。說完我就把電話轉回給她。

Thank you, Lisa. To wrap up, we believe Fractyl is building what comes next in metabolic care. This is an exciting period of focus and execution for the business. We are entering our data rich catalyst heavy stretch with momentum, focus, and capital in place. As a reminder, we have a rich set of clinical milestones ahead. Next month, we expect randomized three-month data, post-tirzepatide discontinuation in forty-five patients randomized two to one to Revita versus Sham in the REMAIN-1 Midpoint Cohort. In the fourth quarter, we expect incremental 6 month open label data from the REVEAL-1 Cohort.

謝謝你，麗莎。總而言之，我們相信 Fractyl 正在建立代謝護理領域的新紀元。對於企業來說，這是一個令人興奮的專注和執行時期。我們正以強勁的勢頭、集中的精力和充足的資本進入數據豐富的催化劑階段。提醒一下，我們面前還有一系列豐富的臨床里程碑。下個月，我們預計在 REMAIN-1 中點隊列中對 45 名患者進行隨機三個月的數據，這些患者停用 tirzepatide 後，以二比一的比例隨機接受 Revita 治療和 Sham 治療。在第四季度，我們預計 REVEAL-1 Cohort 將獲得增量的 6 個月開放標籤資料。

In the first quarter of 2026, we expect six month randomized data from the REMAIN-1 Midpoint Cohort, and the six month time point is significant because it aligns with the time point for the registrational main one pivotal study. In the second quarter of 2026, we expect to see the first one-year open label data from the REVEAL-1 Cohort.

2026 年第一季度，我們預計將從 REMAIN-1 中點隊列中獲得六個月的隨機數據，六個月的時間點很重要，因為它與註冊主要關鍵研究的時間點一致。2026 年第二季度，我們預計將看到 REVEAL-1 Cohort 的第一個為期一年的開放標籤資料。

One year after stopping a GLP-1, undergoing a single treatment, and then following patients to see weight maintenance over time. And in the second half of 2026, we expect the six-month top line primary endpoint data from the Remain one pivotal cohort. Also, in the second half of 2026, we anticipate submitting a pre-market approval application or PMA with the FDA for Revita in weight maintenance.

停止服用 GLP-1 一年後，接受單一治療，然後追蹤患者以觀察體重隨時間的變化。到 2026 年下半年，我們預計將獲得來自「留歐派」關鍵隊列的六個月主要終點頂線數據。此外，我們預計將在 2026 年下半年向 FDA 提交 Revita 用於維持體重的上市前批准申請或 PMA。

With a stronger balance sheet to execute against these exciting milestones, sharper strategic focus, and these exciting upcoming catalysts, the near-term future is bright for guts. With that, I would like to thank the people who make this work possible. To our employees, thank you for your relentless drive and belief in our mission.

憑藉更強大的資產負債表來實現這些令人興奮的里程碑、更清晰的戰略重點以及這些令人興奮的即將到來的催化劑，短期內，Guts 的前景一片光明。在此，我要感謝那些讓這項工作成為可能的人。對於我們的員工，感謝你們對我們使命的不懈努力和信念。

To the physicians and investigators advancing our clinical programs with care and commitment, we are proud to partner with you. To the patients participating in our trials, thank you for your courage and your trust, and to our investors, thank you for your continued support and conviction. Operator, we are now ready to take questions.

對於那些以關懷和承諾推進我們臨床計畫的醫生和研究人員來說，我們很榮幸能與你們合作。對於參與我們試驗的患者，感謝你們的勇氣和信任；對於我們的投資者，感謝你們的持續支持和信念。接線員，我們現在可以回答問題了。

Thank you. At this time, we will collect the question answer session. (Operator Instructions). In our first question comes from a line of Jason Gerberry of Bank of America Securities, the line is now open.

謝謝。此時，我們將收集問答環節。（操作員指令）。我們的第一個問題來自美國銀行證券公司的 Jason Gerberry，該線路現已開通。

Hey guys, thanks for taking my questions. I guess just first on, the midpoint, update in September, beyond, I guess maintenance of preservation of the weight.

嘿夥計們，謝謝你們回答我的問題。我想先是中點，9 月的更新，之後我想維持體重。

Any other, data points that you guys plan to share that you just kind of flag in terms of what you think will be important in the update just beyond sort of the main efficacy measure, and we plan to speak to any outliers in the data set and then you know on Rejuva IND clearance any status update in terms of what are the gating items there would be helpful thanks.

你們計劃分享的任何其他數據點，只是根據您認為在更新中除了主要功效測量之外還重要的內容進行標記，我們計劃討論數據集中的任何異常值，然後您知道，在 Rejuva IND 審批方面，任何狀態更新，就其中的門控項目而言，都會很有幫助，謝謝。

Thanks, Jason. I appreciate the question. So, on the midpoint update, there is a reminder forty-five patients, randomized two to one to Revita versus Sham, three months post tirzepatide discontinuation. We expect that patients who stopped tirzepatide at three months should regain 5% to 6% of their body weight. If we can cut that in half, we think we have got a blockbuster of therapy on our hands. It is important for us in the midpoint data update to be able to provide.

謝謝，傑森。我很感謝你提出這個問題。因此，在中點更新中，有一條提醒，四十五名患者在停用 tirzepatide 三個月後，以二比一的比例隨機接受 Revita 治療和 Sham 治療。我們預計，停用 tirzepatide 三個月後患者的體重將恢復 5% 至 6%。如果我們能夠將這一數字減半，我們認為我們將獲得一項轟動性的治療方法。對我們來說，能夠提供中點資料更新非常重要。

People visibility into the things that will really matter for the pivotal studies read out in H2 2026 and in particular safety, tolerability, and the effectiveness of weight loss maintenance. I expect that we'll continue to see the excellent safety and tolerability signals that we've already been sharing in our REVEAL study and all of our prior clinical work and enough information on the dispersion of the weight.

人們可以了解 2026 年下半年關鍵研究中真正重要的事情，特別是安全性、耐受性和減肥維持的有效性。我希望我們將繼續看到我們在 REVEAL 研究和所有先前臨床工作中已經分享的出色的安全性和耐受性信號以及有關體重分散的足夠資訊。

Maintenance effect in order for people to be able to get a critical appraisal of how things are shaping up for the pivotal study of 315 randomized patients, which is also already underway, and I think that should answer your question on outliers. It is going to be important for us to understand what we need to understand, to believe that the pivotal will be successful.

維持效應是為了讓人們能夠對 315 名隨機患者的關鍵研究的進展情況進行批判性評價，這項研究也已經在進行中，我認為這應該可以回答你關於異常值的問題。對我們來說，理解我們需要理解的內容並相信關鍵問題將會成功是很重要的。

There are additional things that we are looking at in this REMAIN-1 midpoint cohort. Many of them do not occur at three months but actually occur at six months. And so, as an example, there are DEXA scans that are built into the study, but they occur at baseline six months and Twelve months, but not at three months. There's additional laboratory measures that we are also going to be. Looking at as well, but you can expect to see more information on those in the months ahead, may not, but the most important thing for right now, safety, tolerability and effectiveness with enough visibility to understand how the overall population is behaving in a manner to look ahead to the pivotal.

我們也正在關注 REMAIN-1 中點佇列中的其他事項。其中許多情況並非在三個月時發生，而是在六個月時發生。舉個例子，研究中內建了 DEXA 掃描，但它們在基線六個月和十二個月時進行，但不在三個月時進行。我們還將採取額外的實驗室措施。看看也是一樣，但你可以期望在未來幾個月看到更多有關這些信息，也許不會，但現在最重要的是安全性、耐受性和有效性，並具有足夠的可見性來了解整體人群的行為方式，以展望關鍵時刻。

With respect to Rejuva IND, there's been tremendous progress behind the scenes. I know we just talked about like how we filed our CTA module. The bottom line is that we are weeks away from seeing the. Lot release of our GMP product. All of the assays look like they have gone well, and all of our other testing has gone well as well. We're wrapping up our reports and we will update you in due course, but we remain committed to the timelines that we pre we publicly shared, which is, first prelim preliminary data in 2026.

就 Rejuva IND 而言，幕後已經取得了巨大的進展。我知道我們剛才討論瞭如何歸檔我們的 CTA 模組。底線是，我們還需要幾週的時間才能看到結果。我們的 GMP 產品批號放行。所有的檢測看起來都進展順利，我們所有的其他測試也都進展順利。我們正在完成報告，並將在適當的時候向您更新，但我們仍然致力於我們先前公開分享的時間表，即 2026 年的第一批初步數據。

Thank you, Jason.

謝謝你，傑森。

Thanks.

謝謝。

Thank you one moment for our next question.

感謝您的提問。

In our next question comes from a line of Michael Ulz of Morgan Stanley, your line is now open.

我們的下一個問題來自摩根士丹利的 Michael Ulz，您的線路現已開放。

Yeah. Hi, this is Rohit on for Mike. Thanks for taking our questions. As the GLP-1 market evolves, can you share any new learnings or trends that you are seeing, that stand out for the outlook of Revita and Rejuva? Thanks.

是的。大家好，我是 Rohit，為 Mike 服務。感謝您回答我們的問題。隨著 GLP-1 市場的發展，您能否分享您所看到的任何新經驗或趨勢，這些經驗或趨勢對於 Revita 和 Rejuva 的前景有何影響？謝謝。

Yeah, certainly. Thank you for the question. It is a broad question, and one could take that in a lot of different ways. Let me just talk about my personal experience and conversation with key stakeholders and how they feel about it. Two years ago, the question that patients were asking their doctors is how do I get access to these medicines?

是的，當然。謝謝你的提問。這是一個很廣泛的問題，人們可以用很多不同的方式來看待它。我只想談談我的個人經驗以及與主要利害關係人的對話以及他們對此的感受。兩年前，患者向醫師詢問的問題是如何取得這些藥物？

And today, when I go and talk to prescribers, the single biggest question that they are telling me that they're hearing is when can I stop taking this medicine? It is amazing to me is how rapidly people have completely routinized the assumption that they can lose weight on the GLP-1 and are now asking what is next.

今天，當我去和開藥醫生交談時，他們告訴我，他們聽到的最大問題是，我什麼時候可以停止服用這種藥？令我驚訝的是，人們如此迅速地完全接受了可以透過 GLP-1 減肥的假設，並且正在詢問下一步該怎麼做。

And what I'm equally surprised about is how willingly the prescribers recognize that patients do not want to be on GLP-1 drugs for the rest of their lives. I think that bodes incredibly well for both Revita and Rejuva, but for different reasons. When I then the other thing that I'm noticing is that the general perception of the GLP-1 category is that they are excellent drugs, but the weaknesses are becoming more clearly apparent in the real world in a manner that would not be visible from phase three studies.

同樣令我感到驚訝的是，開處方者多麼願意承認患者並不想終生服用 GLP-1 藥物。我認為這對 Revita 和 Rejuva 來說都是一個好兆頭，但原因不同。然後我注意到的另一件事是，人們普遍認為 GLP-1 類藥物是優秀的藥物，但其弱點在現實世界中變得越來越明顯，而這種弱點在第三階段的研究中是看不到的。

You may know that in our talk about Cleveland Clinic showing that the real world effectiveness of semaglutide and tirzepatide in Cleveland Clinic. Patients is substantially worse than how they looked in clinical trials. I will tell you that I've now visited other clinical trial sites who read that paper, have done their own analysis, and are confirming exactly that same finding.

您可能知道，在我們關於克利夫蘭診所的討論中，展示了克利夫蘭診所的司美格魯肽和替澤帕肽的實際有效性。患者的狀況比臨床試驗中的情況要糟糕得多。我會告訴你，我現在已經訪問了其他臨床試驗站點，他們閱讀了該論文，進行了自己的分析，並證實了完全相同的發現。

And all of these, I think, speak to the value that we can bring because that, because the limitations that the drugs have on real world effectiveness do not affect our disease modifying approach. So, I will stop there, otherwise I could keep going, but I think the two key messages are the desire for patients to stop and a need for better real-world outcomes. Thanks.

我認為，所有這些都說明了我們可以帶來的價值，因為藥物在現實世界中有效性的限制不會影響我們的疾病改良方法。所以，我就到此為止，否則我可以繼續說下去，但我認為兩個關鍵訊息是希望患者停止治療以及需要更好的現實世界結果。謝謝。

Thank you.

謝謝。

Thank you one moment for our next question. Our next question comes from line of Michael DeFiore of Evercore ISI. Your line is now open. Hello.

感謝您的提問。我們的下一個問題來自 Evercore ISI 的 Michael DeFiore。您的線路現已開通。你好。

Hello guys. This is JP in view of Michael. Congrats on the quarter and thanks for taking our questions. The first one on the nine patients in the two year follow up in Germany, three remain in the GLP-1 therapy throughout. Could you please help us understand the relative contribution of GLP-1 to the observed outcomes? And are there any notable differences in weight loss or glycaemic control between the ones who stay in GLP-1 or not?

大家好。這是麥可眼中的 JP。恭喜本季取得佳績，感謝您回答我們的問題。第一項對德國9名患者在兩年的追蹤中，有3名患者全程堅持接受GLP-1治療。您能幫助我們了解 GLP-1 對觀察結果的相對貢獻嗎？繼續使用 GLP-1 和不繼續使用 GLP-1 的患者在體重減輕或血糖控制方面是否有顯著差異？

And the second question also regarding the process, given the natural weight variability, can you construe your weight measurement protocols like timing, repeatability, escape calibration, and how you account for day to day fluctuations? I mean, it is well known that weight can vary a lot during the day, so that is what we want to understand a little bit more about the protocol. Thank you.

第二個問題也與該過程有關，考慮到自然的重量變化，您能否解釋您的重量測量協議，例如時間、重複性、逃脫校準，以及如何解釋日常波動？我的意思是，眾所周知，體重在一天中可能會有很大變化，所以我們想更多地了解該協議。謝謝。

Sure, absolutely. So, nine patients in Germany, three of them were on a GLP-1. They were on a GLP-1 when they entered the study. They have been on a GLP-1 for two years. We do not believe that there is a contribution from the GLP-1 to the weight loss seen in the patients in Germany because when you exclude those patients, you look at the others, there's also a consistent signal of weight loss and the profile.

當然，絕對是如此。德國的 9 名患者中，有 3 名服用 GLP-1。他們在參與研究時正在服用 GLP-1。他們服用 GLP-1 已經兩年了。我們不認為 GLP-1 對德國患者的體重減輕有任何貢獻，因為當你排除這些患者時，再看看其他患者，也會發現體重減輕的訊號和特徵一致。

Await a single treatment, early effects, and sustained results has been true across our clinical work for patients who are on any other background medical therapy. And so therefore we believe that this is sort of an important point to make because of the evolving GLP-1 landscape and its utilization, but we do not think it affects our interpretation.

對於正在接受任何其他背景醫學治療的患者，我們在整個臨床工作中都觀察到單次治療就能獲得早期效果和持續效果。因此，我們認為，鑑於 GLP-1 格局及其應用的不斷發展，這是一個重要的觀點，但我們認為這不會影響我們的解釋。

With respect to weight variability, I'm going to assume that the conversation we're talking about here is around the remain pivotal study. And we have been very focused on all of the potential sources of variability in the trial. Measuring weight is one of them. And they, we have explicit quality control protocols like other companies do that are running obesity studies where the scale that the sites are using must.

關於體重變化，我假設我們在這裡討論的話題是圍繞著關鍵研究展開的。我們一直非常關注試驗中所有潛在的變異來源。測量體重就是其中之一。我們有明確的品質控制協議，就像其他進行肥胖研究的公司一樣，研究地點使用的規模必須符合要求。

Be appropriately calibre calibrated on a regular basis, that this is accounted for, and that the manner in which the weight is being measured in patients is also consistent. Nonetheless, we all know that there is some weight variability from people from time to time. I know it when I step on the scale every morning myself. And so therefore, I think that we can do what we can to control it, but human beings are what they are.

定期對口徑進行適當的校準，確保這一點得到說明，並且測量患者體重的方式也是一致的。儘管如此，我們都知道，人們的體重有時會有所不同。當我每天早上站在體重計上時，我就知道這一點。因此，我認為我們可以盡力控制它，但人類就是人類。

Thank you very much.

非常感謝。

Thanks.

謝謝。

Thank you one moment for our next question. Our next question comes on line of Whitney Ijem of Canaccord Genuity, your line is now open.

感謝您的提問。我們的下一個問題來自 Canaccord Genuity 的 Whitney Ijem，您的線路現已開放。

Hey guys, just a quick follow up thinking about durability, for the REMAIN-1 Midpoint Cohort, will you continue to track those patients and then present updates at like nine months, Twelve months? Beyond that, how should we be thinking about that as like an early signal for durability ahead of the larger cohort follow up?

嘿，夥計們，關於耐久性，我只想快速跟進一下，對於 REMAIN-1 中點隊列，您會繼續跟踪這些患者，然後在九個月或十二個月時提供更新嗎？除此之外，我們應該如何將其視為更大規模群體追蹤之前耐久性的早期訊號？

So thanks Whitney. If you go to our corporate deck on page four, you will see our upcoming catalyst, and I'll be happy to say that on the REVEAL-1 Cohort, this is the open label court where we've already shared three month data back in June. We will share six-month data in Quarter four and then one-year open label data in Quarter two. 2026 for the remain midpoint cohort, we are currently projecting three month data in September, which is next month, and then randomized six month data early in Quarter one.

所以謝謝惠特尼。如果您查看第四頁的公司演示文稿，您將看到我們即將推出的催化劑，我很高興地說，在 REVEAL-1 Cohort 上，這是開放標籤法庭，我們在 6 月份已經分享了三個月的數據。我們將在第四季度分享六個月的數據，然後在第二季分享一年的開放標籤數據。對於剩下的中點隊列，2026 年我們目前預計在 9 月（即下個月）發布三個月的數據，然後在第一季初發布隨機的六個月數據。

We have not gone out into additional data points, but all of these patients will be followed for a year. You can reasonably expect that you will get incremental data updates over time. And all of that now helps by the time we see our six month primary endpoint data from the pivotal cohort, there will be an ample body of six months and Twelve month data to look at from REVEAL-1 and the midpoint cohort in order to help inform the regulatory but also the commercial value proposition of Revita and weight maintenance.

我們還沒有獲取額外的數據點，但所有這些患者都將被追蹤一年。您可以合理地預期，隨著時間的推移，您將獲得增量資料更新。所有這些都有助於我們在看到關鍵隊列的六個月主要終點數據時，從 REVEAL-1 和中點隊列中可以查看大量的六個月和十二個月數據，以幫助告知監管機構以及 Revita 和體重維持的商業價值主張。

Got it. Okay. And then I guess just I was curious about longer term then like or will the mid either the midpoint or the pivotal cohort be tracked longer than that such that over time, post approval, let's say, or whatever you could present updates on eighteen months and twenty-four months durability or is that not something we should expect from these studies?

知道了。好的。然後我想我只是對長期情況感到好奇，或者中間點或關鍵隊列是否會被跟踪更長時間，以便隨著時間的推移，比如說批准後，或者無論你能否提供有關十八個月和二十四個月耐久性的更新，或者這不是我們應該從這些研究中期待的嗎？

Well, we're excited about the two-year durability we're seeing in Germany and the two-year durability we've seen from our prior Revita-1 study and the durability we've seen in our pooled analysis and all of our types of diabetes studies. We think it is a major advantage of the therapy, and our intention will be to follow these patients longer and report those data as they emerge.

嗯，我們對在德國看到的兩年耐久性、從先前的 Revita-1 研究中看到的兩年耐久性以及我們在匯總分析和所有類型的糖尿病研究中看到的耐久性感到非常興奮。我們認為這是該療法的一大優勢，我們的目的是更長時間地追蹤這些患者並在出現數據時報告這些數據。

Okay, perfect. That, that is helpful. And then, on the point of the DEXA scans that you mentioned, that will be coming at the six month time point, can you talk about any expectations there either pre-clinically or just mechanistically, like how should we be thinking about the potential of Revita to sort of differentiate, in that regard?

好的，完美。那，那很有幫助。然後，關於您提到的 DEXA 將在六個月後進行的掃描，您能否談談對此的任何預期，無論是臨床前還是機械方面的，例如我們應該如何看待 Revita 在這方面的差異化潛力？

There is a pre-clinical study that I just reviewed that showed that the muscle, that the weight loss in duodenal bypass has is principally a fat mass loss rather than a muscle mass loss. That is the only preclinical work that I have seen. It is not ours. So I think that one way to think about this is, what is the weight regained phenotype looking like in those who are stopping tirzepatide.

我剛剛審查了一項臨床前研究表明，十二指腸旁路手術導致的肌肉重量損失主要是脂肪質量損失而不是肌肉質量損失。這是我見過的唯一的臨床前工作。這不是我們的。所以我認為思考這個問題的一種方式是，那些停止服用 tirzepatide 的人體重恢復的表型是什麼樣的。

And what will the weight, what will the body composition difference be in individuals with Revita assuming that they're able to maintain that body weight loss? I have been unable to find, maybe you can tell me differently, any evidence of what happens in tirzepatide withdrawal or semaglutide withdrawal in the DEXA scans of those patients who have stopped taking those medicines.

那麼，假設使用 Revita 的患者能夠維持減輕的體重，那麼他們的體重和身體組成會有什麼不同呢？我無法找到，也許您可以告訴我不同的說法，在那些已停止服用這些藥物的患者的 DEXA 掃描中，沒有發現任何關於 tirzepatide 停藥或 semaglutide 停藥後發生的情況的證據。

We know that those trials had DEXA scans, but I don't know what they showed after the drug was stopped. Now we will get an answer and I am excited to see what it has to show.

我們知道這些試驗進行了 DEXA 掃描，但我不知道停藥後結果如何。現在我們將得到答案，我很高興看到它所展示的內容。

Got it. Likewise, yeah. Okay, perfect, super helpful thanks very much.

知道了。同樣，是的。好的，非常好，非常有幫助，非常感謝。

Thank you one moment for the next question. And our next question comes online of Jeffrey Cohen of Latinberg Airlines now open.

謝謝您的提問。我們的下一個問題來自拉丁堡航空公司的傑弗裡·科恩 (Jeffrey Cohen)。

Hey, good afternoon. Thanks for taking our questions. I wanted to expand upon the last question. Could you hypothesize a bit, how the last discussion reflects upon BMI’s as far as, treatment groups, BMIs prior to tirzepatide, or BMIs after treatment of tirzepatide.

嘿，下午好。感謝您回答我們的問題。我想進一步闡述最後一個問題。您能否稍微假設一下，最後的討論如何反映治療組的 BMI、使用 tirzepatide 之前的 BMI 或使用 tirzepatide 治療後的 BMI。

Sure. I mean, I think we, there is a study called SURMOUNT-4 from Eli Lilly that I think may speak to this best. These are individuals who had obesity but not type two diabetes. They were given tirzepatide for a period of 36 weeks and then they were randomized to either discontinuation of the tirzepatide or ongoing treatment with tirzepatide for an additional year. Individuals who had lost body weight on tirzepatide during the open label run-in phase over the first thirty six week period of time lost a little bit over 20% of their body weight.

當然。我的意思是，我認為我們有一項來自禮來公司的名為 SURMOUNT-4 的研究，我認為它最能說明這一點。這些人患有肥胖症，但沒有第二型糖尿病。他們接受了為期 36 週的 tirzepatide 治療，然後隨機分配到停止 tirzepatide 治療或繼續接受 tirzepatide 治療一年。在開放標籤導入期的前 36 週內，使用 tirzepatide 減輕體重的個體體重減輕了 20% 多一點。

But by one month, and this is true for total body weight, it's also true for BMI. By one month, they had regained about 3% of their body weight, by 3 months, they had regained 5% to 6% of their body weight, by six months they had regained 9% to 10% of their body weight, and by one year, they had regained, I want to say about 12% of their body weight, 11% to 12% of their body weight. And so, what is true for total body weight is also true for BMI. And so, what you can see is that these patients are losing.

但到了一個月後，這對總體重來說是正確的，對 BMI 來說也是如此。到一個月時，他們的體重恢復了大約 3%；到三個月時，他們的體重恢復了 5% 到 6%；到六個月時，他們的體重恢復了 9% 到 10%；到一年時，我想說，他們的體重恢復了大約 12%、11% 到 12%。因此，整體重適用的情況也適用於 BMI。所以，你可以看到這些病人的病情正在惡化。

Really significant amounts of body weight. And what, when you tie that back to the DEXA scan, the general perception in the field is that these people are regaining mostly fat mass and not muscle mass. So that the BMI regain or the weight regain may be actually underestimating the metabolic problem caused by the weight loss and then the regain. And that is what we are hoping to be able to show, we can do something about with Revita and weight maintenance.

體重確實很大。而且，當你將其與 DEXA 掃描聯繫起來時，該領域的普遍看法是，這些人主要恢復的是脂肪質量而不是肌肉質量。因此，BMI 恢復或體重反彈實際上可能低估了體重減輕和反彈所引起的代謝問題。這就是我們希望能夠展示的，我們可以利用 Revita 和體重維持來做一些事情。

Got it. And then, one more if I could, as far as treatment goes, what have you found to be duration time and any information you can provide on. Patients and their preferences and also any variations within the energy delivered and the duration of energy delivered as well as the length of the duodenum.

知道了。然後，如果可以的話，我會再問一個問題，就治療而言，您發現治療持續時間是多長，您可以提供任何相關資訊嗎？患者及其偏好以及輸送能量和輸送能量持續時間以及十二指腸長度的任何變化。

Sure, okay, so, well, there's like four questions in there, Jeff, so number one is. I will start with the end. Okay. Length of ablations. In the remain one study, we are ablating an average of sixteen centimetre’s length of the duodenum, or eight ablations of two centimetres each. That is slightly better than the average that we were seeing in REVEAL-1, which was an average of 7.5 or ablations per patient or fifteen.

當然，好的，那麼，嗯，這裡面有四個問題，傑夫，第一個是。我先從結尾說起。好的。消融的長度。在剩下的一項研究中，我們消融了平均十六公分長的十二指腸，或者說消融了八次，每次兩公分。這比我們在 REVEAL-1 中看到的平均值略好一些，即平均每位患者進行 7.5 次消融或 15 次消融。

And definitely much better than what we had done in prior studies. This is important and relevant for two reasons. First, it is relevant because we are not seeing any signal of safety or tolerability with higher lengths of ablation. And yet we have also seen dose dependent effects in our earlier clinical work and so we will be analysing the, in a post hoc way, the length of ablation versus the magnitude of effect in order to further substantiate the efficacy that we've already feel like we've established with the dose.

並且絕對比我們之前的研究成果好得多。這很重要且相關，原因有二。首先，它是相關的，因為我們沒有看到任何關於更長消融時間的安全性或耐受性的信號。然而，我們在早期的臨床工作中也看到了劑量依賴性效應，因此我們將事後分析消融時間與效應大小，以進一步證實我們已經感覺到的透過劑量確定的療效。

In our earlier work. And the absence of any safety intolerability suggests that we are continuing to optimize the clinical profile here without causing any harm to patients, which is highly encouraging for us with respect to the magnitude and durability of the efficacy that can be achieved. Average procedure time as people are blading a longer length of the duodenum is still about an hour or less, and we have.

在我們早期的工作中。並且沒有任何安全不耐受現象表明我們正在繼續優化臨床概況，而不會對患者造成任何傷害，這對於我們能夠達到的療效的大小和持久性來說是非常令人鼓舞的。由於人們切除的十二指腸較長，因此平均手術時間仍約為一小時或更短，我們已經做到了。

We're very pleased by the observation that as we go through the various clinical trial sites and the new physicians who are performing the procedure, we are seeing excellent clinical results and excellent quality and length of duodenal ablation, even with new users, as they are getting up to speed on the technology, which strengthens our sense for the ease of the learning curve.

我們非常高興地觀察到，當我們走過不同的臨床試驗地點並接觸到進行該手術的新醫生時，我們看到了出色的臨床結果以及十二指腸消融的出色質量和持續時間，即使是新用戶，他們也能快速掌握該技術，這增強了我們對學習曲線簡易性的感覺。

Now, the last point that I would make. Is that we are not changing the actual ablation energy delivered or the time of the energy that that ablation is delivered. So, the only thing that we are making is to the length of the duo that has ablated. And with respect to patient preference.

現在，我要講最後一點。我們不會改變實際傳遞的消融能量或輸送消融能量的時間。因此，我們唯一要做的就是對已經消融的二重奏的長度進行調整。並尊重患者的偏好。

A lot of people asked us whether they were, whether the rapid enrolment that we saw in Romain was simply because people were getting free tirzepatide in order to be able to enter the study. And what I, there is two things that argue that patients are really excited about Revita. The first one is That patients were choosing the Revita weight maintenance trial over other weight loss drug therapy trials being run concurrently at clinical trial sites that had both.

很多人問我們，我們在羅曼看到的快速入學是否僅僅是因為人們獲得了免費的 tirzepatide 才能參加研究。我認為，有兩件事表明患者對 Revita 確實很感興趣。第一個是，患者選擇 Revita 體重維持試驗，而不是在同時進行這兩種試驗的臨床試驗地點進行的其他減重藥物治療試驗。

Second one is we have lost very few patients. tirzepatide prior to endoscopic randomization to either Revita or sham. The vast majority of the patients in this trial have continued all the way through, and both of those are very encouraging empirical evidence for patient preference. Hope I got all those questions answered.

第二點是我們失去的病人很少。在內鏡隨機分配到 Revita 或假手術組之前使用 tirzepatide。本次試驗中的絕大多數患者都堅持完成了整個治療過程，這兩項都是患者偏好方面非常令人鼓舞的經驗證據。希望我已得到所有這些問題的答案。

Super, yeah, thanks for taking them, all. I appreciate it.

太棒了，是的，謝謝大家接受它們。我很感激。

Thank you one moment for the next question. And our next question comes from line of William Wood of Balley Securities, your line is now open.

謝謝您的回答，請回答下一個問題。我們的下一個問題來自 Balley Securities 的 William Wood，您的線路現已開通。

Thanks for taking our questions and congrats on a very nice quarter. Just to clarify a couple sort of building on what a couple other people asked, specifically for the REVEAL-1, I know you sort of touched on this with in regard to Remain. It looks like you have now treated twenty-two patients on REVEAL-1. When you report the 6 month data, should we expect that all patients to have completed the 6 months, or is this going to be more of a subpopulation, say the 13 patients that priorly treated the three month cut and.

感謝您回答我們的問題，並祝賀本季度取得了非常好的業績。只是為了澄清幾個其他人提出的問題，特別是針對 REVEAL-1，我知道您在談到留歐問題時提到了這一點。看起來您現在已經使用 REVEAL-1 治療了 22 位患者。當您報告 6 個月的數據時，我們是否應該預期所有患者都已完成 6 個月的治療，或者這是否會是一個亞群，比如說之前接受過 3 個月治療的 13 名患者。

And with that six month, you mentioned that we should get more data, specifically DEXA, and this is where you were referencing Remain, but I was curious if we'll be also getting DEXA, in the REVEAL trial, which could sort of tease out if there is a weight regain demonstrated what that gain is composed of. So just sort of understanding that and then I have a quick, very quick follow up.

並且您提到，在這六個月內，我們應該獲得更多數據，特別是 DEXA，這就是您提到 Remain 的地方，但我很好奇我們是否也會在 REVEAL 試驗中獲得 DEXA，這可以弄清楚體重是否會反彈，以及反彈的成分是什麼。所以只是稍微理解一下，然後我就可以快速地跟進。

Yeah, the majority of the patients in the 22 that we're mentioning were treated early enough to be able to be followed and report six month data in quarter four, and I think it's in the generally in the. Better interest to be able to provide more data on more patients if possible so you can expect that in the fourth quarter data. We do not have DEXA scans in the open label cohort.

是的，我們提到的 22 名患者中的大多數都得到了早期治療，因此能夠在第四季度進行追蹤並報告六個月的數據，我認為總體而言是這樣。如果可能的話，最好能夠提供更多患者的更多數據，這樣您就可以期待第四季度的數據。我們在開放標籤佇列中沒有 DEXA 掃描。

We do not have anything to compare it to and while we. Also REVEAL one is an open label study, and we are tracking weight. We at least have the historical comparator of weight regained from tirzepatide withdrawal.

我們沒有任何東西可以與之比較，而我們。此外，REVEAL 一項是開放標籤研究，我們正在追蹤體重。我們至少有一個從停用替澤帕肽後體重恢復的歷史比較器。

From SURMOUNT-4. But as I alluded to earlier, we do not have similar data on what happens to body composition upon tirzepatide discontinuation. So, I do not have any historical comparator there. So, you are going to have to wait for the randomized data for us to be able to understand what the DEXA show and how to interpret them.

來自 SURMOUNT-4。但正如我之前提到的，我們並沒有關於停用 tirzepatide 後身體組成會發生什麼變化的類似數據。所以，我沒有任何歷史比較器。因此，您必須等待隨機數據，我們才能了解 DEXA 顯示的內容以及如何解釋它們。

Got it. And then just to quickly verify, on you noted at least in the PR that you expect to do the first patients, for REJUVA-1 and then report, preliminary data, in 2026. Is that, we should expect first dose and data in 2026 as in both occurring in 2026, or is it the first dose could actually occur in third quarter, fourth quarter this year, and then data in 2026?

知道了。然後只是為了快速驗證，您至少在 PR 中提到，您預計將在 2026 年為 REJUVA-1 進行首批患者試驗，然後報告初步數據。也就是說，我們應該預期第一劑疫苗和數據會在 2026 年出現，還是第一劑疫苗實際上可能在今年第三、第四季出現，然後在 2026 年出現數據？

Yeah, as stated, expecting first doses and preliminary data, both in 2026.

是的，正如所說，預計第一批劑量和初步數據將在 2026 年獲得。

Got it appreciate that and thanks for the call. I will hop back in you.

明白了，非常感謝，也感謝您的來電。我會跳回你身邊。

Thank you.

謝謝。

Thank you. I will return the call back to Doctor Raja Gopalan for closer remarks.

謝謝。我會回電給 Raja Gopalan 博士，以便進一步了解情況。

Well, thank you all for joining the call today. It's, as I said, an exciting period with a data rich catalyst heavy set of quarters ahead, and our team is incredibly excited by the therapies that we're developing and the prospects for the patients in front of us, and we look forward to continuing to share our updates on our progress with all of you and thanks very much.

好吧，感謝大家今天參加電話會議。正如我所說，這是一個令人興奮的時期，未來幾季將充滿數據豐富的催化劑，我們的團隊對我們正在開發的療法以及我們面前的患者的前景感到非常興奮，我們期待著繼續與大家分享我們的進展更新，非常感謝。

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。