Viking Therapeutics Inc (VKTX) 2025 Q2 法說會逐字稿

Welcome to the Viking Therapeutics second quarter 2025 financial results conference management's prepared remarks. We will hold a Q&A session to ask the question at that time, (Operator Instructions) I would now like to turn the conference over to Vikings manager of investor relations, Stephanie Diaz. Please go ahead, Stephanie.

歡迎參加 Viking Therapeutics 2025 年第二季財務業績會議管理層的準備發言。屆時我們將舉行問答環節來提出問題，（操作員指示）現在我想將會議交給維京人投資者關係經理斯蒂芬妮·迪亞茲。請繼續，史蒂芬妮。

Hello and thank you all for participating in today's call. Joining me today is Brian Lan, Vikings President and CEO, and Greg Zante, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call today, July 23, 2025, will contain forward-looking statements under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Including statements about Viking's expectations regarding its development activities, timelines, and milestones.

大家好，感謝大家參加今天的電話會議。今天與我一起出席的是維京人總裁兼執行長 Brian Lan 和維京人財務長 Greg Zante。在我們開始之前，我想提醒一下，今天（2025 年 7 月 23 日）的電話會議中發表的評論將包含根據 1995 年美國私人證券訴訟改革法案的安全港條款的前瞻性陳述。包括有關 Viking 對其開發活動、時間表和里程碑的期望的聲明。

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today.

前瞻性陳述受風險和不確定性的影響，可能導致實際結果產生重大不利差異，且報告的結果不應被視為未來績效的指標。這些前瞻性陳述僅代表截至今日的觀點，本公司不承擔修改或更新今日所作任何陳述的義務。

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

我鼓勵您查看公司向美國證券交易委員會提交的有關這些事項和其他事項的所有文件。現在我將把電話轉給 Brian Lian 來聽取他的初步評論。

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the second quarter and six months ended June 30, 2025 and provide an update on recent progress with our development programs and operations.

謝謝，史蒂芬妮，各位透過電話或網路廣播收聽的聽眾下午好。今天，我們將回顧截至 2025 年 6 月 30 日的第二季和六個月的財務業績，並介紹我們開發計劃和營運的最新進展。

In the second quarter, the Viking team continued to focus on execution of our core clinical strategy. During the first six months of 2025, the company advanced both its VK2735 oral and subcutaneous programs further in clinical development.

第二季度，維京團隊繼續專注於執行我們的核心臨床策略。2025 年上半年，該公司在臨床開發方面進一步推進了 VK2735 口服和皮下注射計畫。

With respect to the subcutaneous formulation, in the second quarter, we have the initiation of the VANQUISH Phase 3 registration program evaluating VK2735 in patients with obesity. We are excited to have these important studies underway.

關於皮下製劑，我們在第二季度啟動了 VANQUISH 第 3 階段註冊計劃，評估 VK2735 對肥胖患者的作用。我們很高興這些重要的研究正在進行中。

Earlier in the year, we also announced both the initiation and the completion of enrollment in a Phase 2 trial, evaluating the oral tablet formulation of VK2735 in subjects with obesity. We're encouraged by the study's rapid enrollment, and we expect to announce the results of this trial later in the year.

今年早些時候，我們也宣布啟動並完成了第二階段試驗的招募，評估 VK2735 口服片劑對肥胖患者的療效。我們對這項研究的快速招募感到鼓舞，我們預計將在今年稍後公佈這次試驗的結果。

Also during the first six months of the year, Viking made progress with its newest program evaluating novel Agonist of the Amylin receptor. These compounds have demonstrated promising benefits on body weight and metabolic profile in [vivo] models. We look forward to filing an ID for this program in the fourth quarter of this year.

此外，在今年上半年，Viking 公司在評估新型胰淀素受體激動劑的最新專案上取得了進展。這些化合物已證明在體內模型中對體重和代謝狀況有顯著的益處。我們期待在今年第四季度為該計劃提交 ID。

Finally, an important milestone that was achieved during the first six months of 2025 was the announcement of a comprehensive manufacturing agreement to provide VK2735 API as well as fill and finish capacity to support the potential future commercialization of this compound.

最後，2025 年上半年實現的一個重要里程碑是宣布達成一項全面製造協議，提供 VK2735 API 以及填充和完成能力，以支援該化合物未來的潛在商業化。

I'll have additional comments on our operations and development activities following a review of our second quarter and six months financial results. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

在審查我們的第二季和六個月的財務表現後，我將對我們的營運和發展活動發表更多評論。為此，我將把電話轉給 Viking 的財務長 Greg Zante。

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Vikings Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the second quarter and first six months of 2025, beginning with the quarter.

謝謝，布萊恩。結合我的評論，我想建議參與者參考維京人向美國證券交易委員會提交的 10-K 表格，我們預計很快就會提交該表格。我現在將從本季開始，回顧 2025 年第二季和前六個月的業績。

Research and development expenses were $60.2 million for the three months ended June 30, 2025 compared to $23.8 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, pre-clinical studies, stock-based compensation, and salaries and benefits.

截至 2025 年 6 月 30 日的三個月，研發費用為 6,020 萬美元，而 2024 年同期為 2,380 萬美元。成長的主要原因是與臨床研究、候選藥物製造、臨床前研究、股票薪酬以及工資和福利相關的費用增加。

General and administrative expenses were $14.4 million for the three months ended June 30, 2025, compared to $10.3 million for the same period in 2024. The increase was primarily due to increased expenses related to stock-based compensation and salaries and benefits, partially upset by decreased expenses related to legal and patent services.

截至 2025 年 6 月 30 日的三個月，一般及行政費用為 1,440 萬美元，而 2024 年同期為 1,030 萬美元。成長的主要原因是與股票薪酬和工資及福利相關的費用增加，部分原因是與法律和專利服務相關的費用減少。

For the three months ended June 30, 2025, Viking reported a net loss of $65.6 million or $0.58 per share, compared to a net loss of $22.3 million or $0.20 per share in the corresponding period in 2024. The increase in net loss for the three months ended June 30, 2025 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period in 2024.

截至 2025 年 6 月 30 日的三個月，維京報告淨虧損為 6,560 萬美元，即每股 0.58 美元，而 2024 年同期淨虧損為 2,230 萬美元，即每股 0.20 美元。截至 2025 年 6 月 30 日的三個月淨虧損增加主要是由於與 2024 年同期相比，先前提到的研發費用以及一般及行政費用增加。

I'll now go over our results for the first six months of 2025. Research and development expenses were $101.5 million for the six months ended June 30, 2025, compared to $47.9 million for the same period in 2024.

現在我將回顧 2025 年前六個月的表現。截至 2025 年 6 月 30 日的六個月，研發費用為 1.015 億美元，而 2024 年同期為 4,790 萬美元。

The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, and salaries and benefits, partially offset by decreased expenses related to pre-clinical studies.

成長的主要原因是與臨床研究、候選藥物製造、股票薪酬以及工資和福利相關的費用增加，但與臨床前研究相關的費用減少部分抵消了這一增長。

General and administrative expenses were $28.5 million for the six months ended June 30, 2025, compared to $20.3 million for the same period in 2024.

截至 2025 年 6 月 30 日的六個月，一般及行政費用為 2,850 萬美元，而 2024 年同期為 2,030 萬美元。

The increase was primarily due to increased expenses related to stock-based compensation, legal and patent services, and insurance, partially offset by decreased expenses related to third party consultants.

成長的主要原因是與股票薪酬、法律和專利服務以及保險相關的費用增加，但部分被與第三方顧問相關的費用減少所抵消。

For the six months ended June 30, 2025, Viking reported a net loss of $111.2 million or $0.99 per share compared to a net loss of $49.6 million or $0.46 per share in the corresponding period in 2024. The increase in net loss for the six months ended June 30, 2025, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2024.

截至 2025 年 6 月 30 日的六個月，維京報告淨虧損為 1.112 億美元，即每股 0.99 美元，而 2024 年同期淨虧損為 4,960 萬美元，即每股 0.46 美元。截至 2025 年 6 月 30 日的六個月淨虧損增加主要是由於先前提到的研發費用以及一般及行政費用的增加，但與 2024 年同期相比，利息收入的增加部分抵消了這一增加。

Turning to the balance sheet at June 30, 2025, Viking out cash equivalents, and short-term investments of $808 million compared to $903 million as of December 31, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.

回顧 2025 年 6 月 30 日的資產負債表，維京的現金等價物和短期投資為 8.08 億美元，而截至 2024 年 12 月 31 日為 9.03 億美元。我的財務審查到此結束，現在我將把電話轉回給布萊恩。

Thanks, Greg. I'll now provide an update on our clinical pipeline and development programs, starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1 or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide or GIP receptor.

謝謝，格雷格。我現在將提供有關我們的臨床管道和開發計劃的最新信息，首先介紹我們的領先肥胖症計劃 VK2735。VK2735 是胰高血糖素樣勝肽 1 或 GLP-1 受體和葡萄糖依賴性胰島素促泌多肽或 GIP 受體的雙重激動劑。

Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity. Prior Phase 1 results of cutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics, with treated subjects demonstrating up to approximately 8% weight loss from baseline after 28 days of once weekly dosing with no signs of plateau.

Viking 正在推進 VK2735 的皮下和口服製劑，用於治療肥胖症。先前的 VK2735 皮膚製劑第 1 階段結果證明了其良好的安全性、耐受性和藥物動力學，接受治療的受試者在每週一次給藥 28 天后體重從基線減輕了約 8%，且沒有出現平台期的跡象。

Based on these results, Viking initiated a thirteen-week Phase 2 study called VENTURE, designed to evaluate the safety and weight loss effects of VK2735 in subjects with obesity. The study successfully achieved both its primary and secondary endpoints with subjects receiving VK2735 demonstrating statistically significant reductions in mean body weight from baseline, ranging up to 14.7%.

基於這些結果，Viking 啟動了一項為期十三週的 2 期研究，稱為 VENTURE，旨在評估 VK2735 對肥胖患者的安全性和減肥效果。研究成功實現了其主要和次要終點，接受 VK2735 治療的受試者的平均體重與基線相比有統計學上顯著的降低，降低幅度高達 14.7%。

The study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing, with the majority of treatment emerging adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor.

研究還表明，VK2735 在 13 週的給藥過程中是安全且耐受性良好，大多數治療的不良事件為輕度或中度的治療。不良事件通常發生在治療過程的早期，主要與 GLP-1 受體活化引起的預期胃腸道影響有關。

These results, as well as additional data from the study's follow-up visits, were highlighted in a presentation at the 2024 Obesity Week conference. This presentation showed that subjects receiving VK2735 maintained the majority of their weight loss through follow-up visits occurring up to seven weeks after the last dose of VK2735 was administered.

這些結果以及研究後續訪問的其他數據在 2024 年肥胖週會議的一次演講中進行了重點介紹。報告顯示，接受 VK2735 治療的受試者在服用最後一劑 VK2735 後長達七週的追蹤中保持了大部分減肥效果。

This included the 2.5 mg weekly dose, which was the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks after the last dose was given. In a subset of participants, an evaluation of plasma levels of VK2735 was conducted at various time points following completion of the 13 week dosing period.

其中包括每週 2.5 毫克的劑量，這是評估的最低劑量，在最後一次服藥七週後，超過 90% 的初始體重減輕得以維持。在一組參與者中，在完成 13 週給藥期後的不同時間點對 VK2735 的血漿濃度進行了評估。

We believe the pharmacokinetics results from this study support the potential for once monthly dosing in the maintenance setting, and the company plans to further evaluate a monthly dosing regimen later this year.

我們相信，這項研究的藥物動力學結果支持在維持治療中每月一次給藥的可能性，該公司計劃在今年稍後進一步評估每月一次的給藥方案。

Based on the VENTURE Phase 2 study results and following receipt of feedback from a Type C meeting with the FDA and the subsequent end of Phase 2 meeting with the agency, the company advanced VK2735 into Phase 3 development for obesity.

根據 VENTURE 第 2 階段研究的結果以及收到與 FDA 的 C 類會議的反饋以及隨後與該機構的第 2 階段會議結束後，該公司將 VK2735 推進到針對肥胖症的第 3 階段開發。

To this end, last month we announced the initiation of the VANQUISH Phase 3 registration program. The VANQUISH studies consist of two trials evaluating VK2735. 1 in adults with obesity and one in obese or overweight adults with type 2 diabetes.

為此，我們上個月宣布啟動 VANQUISH 第三階段註冊計畫。VANQUISH 研究包括兩項評估 VK2735.1 對肥胖成年人的試驗，以及一項針對患有第 2 型糖尿病的肥胖或超重成年人的試驗。

Each study is a randomized double blind, placebo-controlled multi-center trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.

每項研究都是一項隨機雙盲、安慰劑對照的多中心試驗，旨在評估每週一次皮下注射 VK2735 持續 78 週的療效和安全性。

The VANQUISH 1 study is targeting enrollment of approximately 4,500 adults with obesity, or adults who are overweight with at least one weight-related comorbid condition.

VANQUISH 1 研究的目標是招募約 4,500 名肥胖成年人，或至少有一種體重相關合併症的超重成年人。

The VANQUISH 2 study will target enrollment of approximately 1,100 adults with type 2 diabetes who are obese or overweight.

VANQUISH 2 研究的目標是招募約 1,100 名患有第 2 型糖尿病且肥胖或超重的成年人。

Participants in both trials will be randomized to one of four weekly treatment arms of 7.5 mg, 12.5 mg, 17.5 mg, or placebo. The primary endpoint of these trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment.

兩項試驗的參與者將被隨機分配到四個每週治療組之一，分別為 7.5 毫克、12.5 毫克、17.5 毫克或安慰劑。這些試驗的主要終點是接受 VK2735 治療的參與者與接受安慰劑治療的參與者在治療 78 週後體重相對於基線的百分比變化。

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% body weight reduction.

次要和探索性終點將評估一系列額外的安全性和有效性指標，包括體重減輕至少 5%、10%、15% 和 20% 的患者百分比。

Each study will include an open label extension, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period. We're excited to have these important studies underway, and we will provide further updates on their progress as warranted.

每項研究都將包括一個開放標籤擴展，讓參與者有機會在完成主要給藥期後繼續接受治療。我們很高興這些重要的研究正在進行中，我們將根據需要提供有關其進展的進一步更新。

During the second quarter, Viking also continued to advance its oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy, or for those seeking to maintain the weight loss they've already achieved.

第二季度，Viking 也繼續推進其 VK2735 口服片配方。該公司認為，對於那些可能更喜歡透過口服療法開始治療的人，或者對於那些尋求保持已經實現的減肥效果的人來說，片劑製劑可能是一種有吸引力的治療選擇。

An important differentiator for our obesity program is that it includes both a tablet formulation and a subcutaneous formulation that utilize the same molecule. We believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from one treatment to another.

我們的肥胖症治療計劃的一個重要區別是，它包括使用相同分子的片劑配方和皮下配方。我們相信這可能會減輕患者從一種治療方法轉換到另一種治療方法時可能出現的潛在安全性或耐受性挑戰。

In a prior Phase 1 study, the oral formulation successfully achieved its objectives, with cohorts receiving VK2735 demonstrating dose dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days of daily dosing.

在先前的 1 期研究中，口服製劑成功實現了其目標，接受 VK2735 治療的患者群表現出平均體重從基線開始的劑量依賴性降低，在 28 天的每日服藥後降低幅度高達 8.2%。

As with the subcutaneous formulation, the initial weight loss observed in the Phase 1 oral study showed encouraging durability with up to 8.3% reductions in body weight from baseline observed at follow-up visits through day 57, four weeks after the last dose was administered.

與皮下製劑一樣，第 1 階段口服研究中觀察到的初始體重減輕顯示出令人鼓舞的持久性，在隨訪中觀察到體重從基線下降了 8.3%，即最後一次給藥後四周。

The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once daily dosing at doses up to and including 100 mg. The majority of observed treatment emergent adverse events were mild or moderate, with most reported as mild.

VK2735 口服製劑在 28 天內每天服用一次（劑量高達 100 毫克）也表現出令人鼓舞的安全性和耐受性。觀察到的大多數治療出現的不良事件都是輕度或中度的，其中大多數報告為輕度。

Similarly, all observed gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild. These results were presented at the 2024 Obesity Week conference last November.

同樣，所有觀察到的胃腸道不良事件均報告為輕度或中度，其中大多數報告為輕度。這些結果於去年 11 月在 2024 年肥胖週會議上發表。

Based on the Phase 1 results, earlier this year, the company announced the initiation of a Phase 2 study of oral VK2735 in subjects with obesity. This study called the VENTURE oral dosing study is a randomized double blind placebo-controlled multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks.

根據第 1 階段的結果，該公司今年稍早宣布啟動針對肥胖患者口服 VK2735 的第 2 階段研究。這項名為 VENTURE 口服給藥研究的研究是一項隨機雙盲安慰劑對照多中心研究，旨在評估 VK2735 以口服片劑形式每日一次服用 13 週的安全性、耐受性、藥物動力學和減肥效果。

The primary endpoint of the study is to present change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. In March, the company announced that enrollment in the VENTURE oral dosing study had been completed.

研究的主要終點是顯示治療 13 週後體重相對於基線的變化。次要和探索性終點將評估一系列額外的安全性和有效性措施。今年三月，該公司宣布 VENTURE 口服給藥研究的招募工作已經完成。

The trial enrolled approximately 280 adults who are obese or who are overweight with at least one weight-related comorbid condition. Participants were evenly randomized to one of six dosing arms or placebo. We look forward to reporting the results from this study in the second half of the year.

該試驗招募了大約 280 名肥胖或超重且患有至少一種體重相關合併症的成年人。參與者被隨機分配到六個劑量組或安慰劑組。我們期待在今年下半年報告這項研究的結果。

In addition to our programs focused on in Cretan analogs, Viking continues to advance a series of novel agonists targeting the Amylin receptor. Early data for this program has supported the thesis that activation of the Amylin receptor represents an important additional mechanism, regulation of appetite and body weight.

除了我們專注於克里特島類似物的計畫外，Viking 也繼續推進一系列針對胰淀素受體的新型激動劑。該計劃的早期數據支持了以下論點：激活胰淀素受體代表著一種重要的附加機制，即調節食慾和體重。

During the second quarter, we continue to make progress with this program, and we expect to file an IND with the FDA in the fourth quarter of the year. To support our pipeline, Viking continues to maintain fiscal discipline and a strong balance sheet. As Greg reported, the company had more than $800 million in cash as of the end of the second quarter.

在第二季度，我們繼續推進該計劃，並預計將在今年第四季向 FDA 提交 IND。為了支持我們的管道，維京繼續保持財政紀律和強勁的資產負債表。根據格雷格報道，截至第二季末，該公司擁有超過 8 億美元的現金。

Provides us with the runway to complete our plan Phase 3 trials for VK2735 and obesity, as well as to aggressively pursue development of our additional programs.

為我們完成 VK2735 和肥胖症計劃的 3 期試驗提供了平台，並積極推進其他項目的開發。

In conclusion, the first half of 2025 was an exciting period for the Viking team. With respect to our VK2735 obesity program, we announced the initiation of the VANQUISH Phase 3 registration program, including trials in patients with obesity and obesity with type 2 diabetes.

總而言之，2025 年上半年對維京團隊來說是個令人興奮的時期。關於我們的VK2735肥胖症計劃，我們宣布啟動VANQUISH 3期註冊計劃，包括針對肥胖症患者和患有2型糖尿病的肥胖症患者的試驗。

Also during the first half of the year, we announced the initiation and completion of enrollment in our Phase 2 VENTURE oral dosing study. We believe the rapid enrollment we've observed in our VK2735 trials speaks to a continued strong demand for new and differentiated weight loss therapeutics. We remain on track to announce the topline data from the VENTURE oral study in the second half of the year.

此外，在今年上半年，我們宣布啟動並完成第二階段 VENTURE 口服給藥研究的招募。我們相信，我們在 VK2735 試驗中觀察到的快速招募表明對新型差異化減肥療法的持續強勁需求。我們將繼續按計劃在今年下半年公佈 VENTURE 口服研究的頂線數據。

With respect to our Amal and Agonist program, we continue to make progress toward an IND filing, and we expect to submit to the to the FDA later this year. Finally, our balance sheet remains strong, providing the runway to support the advancement of VK2735 through Phase 3 clinical trials, as well as to make progress with other key programs.

關於我們的 Amal 和 Agonist 項目，我們在 IND 申請方面繼續取得進展，我們預計將於今年稍後向 FDA 提交。最後，我們的資產負債表依然強勁，為支持 VK2735 通過 3 期臨床試驗的進展以及其他關鍵項目的進展提供了基礎。

This concludes our prepared comments for today. Thanks for joining us and we'll now open the call for questions, operator.

我們今天的準備評論到此結束。感謝您加入我們，我們現在開始問答環節，接線員。

We will now begin the question and answer session. (Operator Instructions) Please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. Thank you. At this time we'll pause momentarily to assemble our roster.

我們現在開始問答環節。（操作員指示）請注意，隊列中有大量參與者。公司將盡力解答盡可能多的問題。謝謝。此時我們將暫時暫停以整理我們的名冊。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Thank you. In the Phase 1 oral study, you reported fairly strong dose dependence regarding satiety and decreased appetite. Wondering if you would expect additional increase in patient satiety or decreased appetite at durations longer than 28 days in the Phase 2 oral study, particularly for the lower doses, and then have a quick follow up.

謝謝。在第 1 階段口服研究中，您報告了飽足感和食慾下降方面相當強烈的劑量依賴性。想知道在第 2 階段口服研究中，如果持續時間超過 28 天，您是否會預期患者的飽腹感會進一步增加或食慾會下降，特別是對於較低劑量，然後進行快速跟進。

Ryan, yeah, thanks. It would expect there to be some evidence of satiety as weight loss progresses, but we really don't know. What we've seen in other studies is that, it's a somewhat inconsistent signal. It doesn't always track dose or weight loss, but it did, as you point out in the Phase 1 study. So, we'll see what it does in the Phase 2, but it is a little inconsistent across other studies.

瑞安，是的，謝謝。隨著減肥的進展，預計會出現一些飽足感的跡象，但我們真的不知道。我們在其他研究中看到，這是一個有點不一致的訊號。它並不總是追蹤劑量或體重減輕，但正如您在第一階段研究中指出的那樣，它確實追蹤了劑量或體重減輕。因此，我們將觀察它在第二階段的表現，但它與其他研究有些不一致。

Got it. Thanks, Brian. And then in the Phase 2A readout, will this necessarily include data from all cohorts, specifically the maintenance dosing arm at topline. Thank you.

知道了。謝謝，布萊恩。然後在第 2A 階段的讀數中，這是否必然包括來自所有群組的數據，特別是頂線的維持劑量組的數據。謝謝。

Oh yeah, thanks.It will include all of the cohorts. It's a parallel cohort study, so they'll all be available at the same time. And that's going to be a really interesting cohort, the cohort that doses. Up to 90 and then comes back to 30 for the remaining. Four weeks, yeah, that, that's going to be really interesting cohort.

哦，是的，謝謝。它將包括所有的同伴。這是一項平行隊列研究，因此所有研究結果將同時提供。這將是一個非常有趣的群體，即服藥的群體。最多 90 個，然後剩餘部分回到 30 個。四周，是的，那將會是一群非常有趣的人。

Got it. Thank you very much, Brian.

知道了。非常感謝，布萊恩。

Thanks, Ryan.

謝謝，瑞安。

Joon Lee with Truist Securities.

Truist Securities 的 Joon Lee。

Thanks for the updates and for taking our questions. Seamless seamlessly transitioning from sub two to oral VK2735 for maintenance is really attractive. Do you have an oral dose in mind for the monthly dosing study due to start in 3Q? And will you have Phase 2 oral VENTURE data out before you start the monthly dosing study? Thank you.

感謝您提供最新消息並回答我們的問題。從 sub two 到口服 VK2735 的無縫無縫過渡進行維護確實很有吸引力。對於將於第三季開始的每月劑量研究，您是否考慮過口服劑量？在開始每月劑量研究之前，您是否會獲得第 2 階段口服 VENTURE 數據？謝謝。

Yeah, thanks. Joon. We don't have a dose yet because we don't have the Phase 2 oral data yet, so, I think those will be important data to evaluate when we select those maintenance doses. It doesn't need to be. We don't need to have those data prior to initiating the maintenance study, ideally we would, but we don't have to since the transition to oral happens after quite some time. There's a titration up to a high weekly dose. So not mandatory would be nice, but not mandatory.

是的，謝謝。俊。我們還沒有劑量，因為我們還沒有第二階段的口服數據，所以，我認為這些數據將是我們在選擇維持劑量時需要評估的重要數據。沒必要這樣。在開始維持研究之前我們不需要在獲得這些數據，理想情況下我們會這樣做，但我們不必這樣做，因為向口服的轉變需要相當長一段時間。每週劑量可逐漸增加至較高水準。因此，不強制會很好，但不是強制性的。

Thank you.

謝謝。

Thanks, Joon.

謝謝，Joon。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Yes, good morning. I should say good afternoon. Thanks for taking your questions, and congrats on the progress. So in your, Phase 3 VANQUISH trial, you have a top dose of 17.5 mg, and you look to go a slower titration schema. Could you maybe talk a little bit about your rationale for, going up from 15 mg there and, maybe just the schema titration schema relative to your prior pre trial.

是的，早安。我應該說下午好。感謝您的提問，並祝賀您的進展。因此，在您的第 3 階段 VANQUISH 試驗中，您的最高劑量為 17.5 毫克，並且您希望採用較慢的滴定方案。您能否稍微談談從 15 毫克增加劑量的理由，也許只是相對於您先前的試驗前的模式滴定方案。

Yeah, thanks. Mayank, yeah, in the thirteen-week study, we saw. Really excellent tolerability and I think, really encouraging efficacy at 15 mg. Well, in all the doses really, but at 15 mg. So we thought that there was a little bit of room to maybe go higher without representing any meaningful difference in safety or tolerability. So that's what we proposed and that was okay to.

是的，謝謝。Mayank，是的，在為期十三週的研究中，我們看到了。耐受性確實非常好，而且我認為 15 毫克的療效確實令人鼓舞。嗯，所有劑量都是這樣的，但劑量是 15 毫克。因此，我們認為，在不體現安全性或耐受性方面有任何顯著差異的情況下，可能還有進一步提高的空間。這就是我們提出的建議，而且沒問題。

Proceed at that dose. So and with the titration scheme. It looked good with the three cadence in the first study. Different people have different sensitivities and it just seemed like if we slowed it down. To four weeks between steps.

依該劑量繼續。因此，還有滴定方案。在第一項研究中，三種節奏看起來不錯。不同的人有不同的敏感度，就好像我們把它放慢了一樣。步驟之間間隔四周。

Maybe if someone had some challenge with tolerability another dose at the same level, certainly wouldn't hurt, so we just thought that, extending it to a four week block would be okay and.

也許如果有人在耐受性方面遇到困難，那麼以相同的水平服用另一劑量肯定不會有害，所以我們只是認為，將其延長至四周是可以的。

And that's kind of the standard presentation right now with the commercial products as well. So, both of those kind of fed into the decision.

這也是目前商業產品的標準展示。所以，這兩個因素都對決策產生了影響。

Thank you. And is there a scenario in VENTURE oral that may compel you to study oral formulation as a frontline therapy and also like a late stage development which could look as expansive as orfo and thanks for taking a Follow-up.

謝謝。VENTURE oral 中是否存在一種情況，可能會迫使您研究口服製劑作為一線療法，同時也像後期開發一樣，其範圍可能與 orfo 一樣廣泛，感謝您的後續跟進。

Oh yeah thanks. Hard to say. I mean we really need to see the data before we map out the next steps. I mean. Yeah. There is a scenario that it could be a frontline therapy but, It's premature without really having a good. Look at the data yet.

噢，是的，謝謝。很難說。我的意思是，在規劃下一步之前，我們確實需要查看數據。我是說。是的。有一種情況是，它可能是一種一線療法，但如果沒有真正的好處，現在下結論還為時過早。看看數據吧。

Jay Olsson with Oppenheimer.

傑伊·奧爾森 (Jay Olsson) 與奧本海默 (Oppenheimer) 合作。

Oh hey, congrats on the progress and thanks for taking the questions. For the Phase 3 VANQUISH programs, have you started patient dosing and can you share any rough predictions on how long you expect enrollment to complete?

哦，嘿，祝賀你取得進展，感謝你回答問題。對於第 3 階段 VANQUISH 項目，您是否已經開始對患者進行給藥？您能否分享預計完成招募需要多長時間的粗略預測？

Yeah, yes, we are dosing, and, I think it's just premature to make those timing projections, the studies. A month or so old, so it's difficult to know, what the real ramp is going to look like, but so far a lot of interest, a lot of enthusiasm, and, we're happy with the way it's, with the way it's looking right now.

是的，我們正在進行劑量控制，我認為現在進行這些時間預測和研究還為時過早。大約一個月前，所以很難知道真正的坡道會是什麼樣子，但到目前為止，人們很感興趣，很熱情，我們對它現在的樣子感到滿意。

Okay great thank you and if I could squeeze in one follow up for the sub 2 monthly maintenance study, are you planning a randomized withdrawal design?

好的，非常感謝，如果我可以擠出時間進行一次 2 個月以下的維持研究的跟進，您是否計劃採用隨機撤藥設計？

No, people will be titrated up to a high dose and then just transition to, a range of monthly doses, or, a selection of daily oral doses. That, that's kind of the general scheme.

不，人們會逐漸增加劑量到高劑量，然後過渡到一系列月劑量，或選擇每日口服劑量。這就是總體方案。

Okay, got it, thank you.

好的，知道了，謝謝。

Thanks, Jay.

謝謝，傑伊。

Hardik Parik, JP Morgan.

摩根大通的 Hardik Parik。

Hey, thank you very much for the updates today. There's a two part question on the oral program. So on the study that's underway, I saw that the arms with target doses of 60 mg or higher have essentially 6 weeks of titration and then seven weeks on the target dose. Just wondering if you could provide any details on the specific titration doses that you plan to use.

嘿，非常感謝您今天的更新。口語節目的問題分為兩部分。因此，在正在進行的研究中，我發現目標劑量為 60 毫克或更高的組別基本上需要 6 週的滴定時間，然後需要 7 週的目標劑量。只是想知道您是否可以提供有關您計劃使用的具體滴定劑量的任何詳細資訊。

And then the second part is just want to get your updated thoughts on the possibility that the oral program can advance straight to Phase 3, similar to the Phase 2.

第二部分只是想了解您對口服項目是否可以直接進入第三階段（類似於第二階段）的可能性的最新看法。

Thank you. Yeah, thanks Harrdik. The steps with the Phase 2. Yeah, if you're at, 60, and above you titrate in two week blocks.

謝謝。是的，謝謝 Harrdik。與第二階段的步驟相同。是的，如果您達到 60 歲或以上，您可以以兩週為一個週期進行滴定。

So like the 90, goes, I think it was 30, 60, 90 at two week blocks, so 120 is 32 weeks, 60, 90 to 120, so. The two week blocks there. And, whether or not we could go to Phase 3, unclear, let's, have a look at the data first, but I mean ideally, but not sure just yet. We have two data. Thank you.

所以就像 90 一樣，我認為它是 30、60、90，以兩週為一個時間段，所以 120 是 32 週，60、90 到 120，等等。那裡有兩個星期的時間段。而且，我們是否可以進入第三階段，還不清楚，讓我們先看一下數據，但我的意思是理想情況下，但現在還不確定。我們有兩個數據。謝謝。

Yeah, thanks. Mike Ulz, Morgan Stanley.

是的，謝謝。摩根士丹利的麥克烏爾茲。

Good afternoon, thanks for taking my question. Maybe just to follow up on the maintenance study and, I don't know if you can give us a sense of how many cohorts you're considering at this point and then also maybe how you're thinking about duration of treatment here. Thanks.

下午好，感謝您回答我的問題。也許只是為了跟進維持研究，我不知道您是否可以告訴我們您目前正在考慮多少個隊列，以及您可能如何考慮這裡的治療持續時間。謝謝。

Yeah, thanks, Mike. We haven't given a lot of detail there. It's a complex and sizable study, and so probably bigger than the VENTURE oral study as far as the number of arms because you're going to transition some people to a monthly injection and then others to a daily oral, and we'll have a weekly oral in there as well. So.

是的，謝謝，麥克。我們還沒有提供太多細節。這是一項複雜且規模龐大的研究，就試驗組數量而言，可能比 VENTURE 口服研究更大，因為有些人需要轉為每月注射一次，而另一些人則需要轉為每天口服一次，而且我們還會進行每週口服一次的研究。所以。

It's a sizable study, reasonably complex the post, transition, so when you transition the monthly or the daily oral, that's going to be a few months, around the three month window there. So, you get some feel for what the VK and what the body weight, curve looks like, but, we'll have more detail when we initiate the study.

這是一項相當大的研究，過渡期相當複雜，因此，當您過渡到每月或每日口服時，這將需要幾個月的時間，大約三個月的時間。因此，您會對 VK 以及體重曲線有一些了解，但是，當我們開始研究時，我們會提供更多詳細資訊。

Helpful thank you.

有幫助謝謝。

Thanks Mike.

謝謝邁克。

Steve Seedhouse, Cantor.

史蒂夫‧西德豪斯 (Steve Seedhouse)，領唱。

Hey, thanks so much. Just want to follow up on the decision, for the oral to move into Phase 3. Couple of questions about that. One is, do you need to meet with the [FDA] again or did you sort of satisfy, any questions or anything that needed addressing in your last meeting prior to starting the subcutaneous Phase 3 study? And then also more generally just how are you thinking about sort of the efficacy and tolerability, hurdle that you'd want to see ultimately to decide on pursuing that through a Phase 3 study.

嘿，非常感謝。只是想跟進該決定，讓口服藥物進入第三階段。關於這個有幾個問題。一個問題是，您是否需要再次與 [FDA] 會面，或者您是否已經解決了在開始皮下 3 期研究之前的上次會面中需要解決的任何問題或任何問題？然後更一般地說，您如何考慮療效和耐受性，以及您最終希望看到的障礙，以決定透過第三階段研究來追求這一目標。

Yeah thanks Steve. It's a different IND with the oral so if we were to, want to go into Phase 3 we'd likely try to schedule an end of Phase 2 meeting, so that that would. If we were to decide that we would want to have that meeting the sub 2 doesn't help us really or too much for us.

是的，謝謝史蒂夫。這是與口服不同的 IND，所以如果我們想要進入第 3 階段，我們可能會嘗試安排第 2 階段結束會議，這樣就可以了。如果我們決定要舉行那次會議，那麼 2 歲以下的孩子其實並沒有帶給我們太大的幫助。

As far as the advocacy and tolerability, yeah, really it's a hard one to handicap. The Phase 1 looked really encouraging on both, this is a longer dosing window, but it's larger as well, so with this, with a little bit of a different titration scheme, so really hard to know from these data what the next step is going to be until we see the data. I mean.

就倡導和容忍度而言，是的，這確實是一個很難阻礙的問題。第一階段對兩者都非常令人鼓舞，這是一個更長的給藥窗口，但也更大，因此有了這個，採用了稍微不同的滴定方案，因此在我們看到數據之前，很難從這些數據中知道下一步將是什麼。我是說。

Okay, can I just ask also, it looks like the street's not exactly modeling the R&D expense line, accurately. Can you just maybe provide some guidance on how you expect, separately, the clinical trial expense, the manufacturing expense, which is a component now, and just overall R&D line to evolve for the rest of the year.

好的，我還可以問一下，看起來華爾街並沒有準確地模擬研發費用線。您能否分別提供一些指導，說明您對臨床試驗費用、製造費用（現在是其中的一部分）以及今年剩餘時間內整體研發線將如何發展的預期。

Hey Steve. I think our R&D expenses will be going up a bit here in the third and fourth quarter, compared to 2nd quarter maybe by, 25% to third up basically from here forward, but, that's the guidance I provide there and it's a mix like you said of, clinical trial, manufacturing and other topics.

嘿，史蒂夫。我認為我們的研發費用在第三季和第四季會比第二季略有增加，從現在開始可能會增加 25% 到第三季度，但這是我提供的指導，就像你說的，它是臨床試驗、製造和其他主題的混合。

Great, thank you.

太好了，謝謝。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Thanks for that and take your questions. Two questions. So relates to the oral Phase 2 upcoming data. So, do you have some expectation, just give us some expectation around the high dose versus the maintenance dose given, both of them will be informative to the next step for oral either. Stand-alone or the maintenance. And then the, for the maintenance study, would you be considering the weekly dose for oral, given the long half-life, and then maybe thinking about low dose for [subcu] as a weekly dose.

謝謝您，並回答您的問題。兩個問題。因此與即將公佈的第二階段口服數據有關。那麼，您是否有一些期望，請給我們一些關於高劑量與維持劑量的期望，它們都將對口服的下一步提供資訊。獨立或維護。然後，對於維持研究，考慮到較長的半衰期，您是否會考慮每週口服劑量，然後也許考慮將低劑量 [subcu] 作為每週劑量。

Thank you.

謝謝。

Yeah, thanks Roger. So we are looking at a weekly, with the oral in that upcoming study, and we're not going to get too far in the details. But that will be one cohort, with the high dose in the oral relative to a maintenance dose, I'm not sure you're referring to a maintenance dose with the injectable versus the high dose oral or maintenance dose would be oral versus the high dose.

是的，謝謝羅傑。因此，我們正在研究每週一次的口頭研究，但我們不會深入探討細節。但那將是一個群體，口服高劑量相對於維持劑量，我不確定您指的是注射維持劑量與高劑量口服維持劑量，還是口服維持劑量與高劑量維持劑量。

Oh, just the oral Phase 2, the maintenance cohort. You have a one cohort, have the, from high to the low, cohort.

哦，只是口服第二階段，維持組。你有一個群體，有一個從高到低的群體。

Oh, yeah, that one, so that, the highest dose in the Phase 2 is 120 milligrams. You titrate up to 120 milligrams. And then that, the maintenance cohort goes up to 90 for, I believe, four weeks and then it comes back down to 30 for the remaining five weeks. And so the maintenance is quite a bit lower than that, the maintenance dose quite a bit lower than the highest dose.

哦，是的，那個，那麼，第二階段的最高劑量是 120 毫克。您滴定至 120 毫克。然後，我相信，維持隊列會在四周內增加到 90 人，然後在剩下的五週內又會降至 30 人。因此維持劑量比最高劑量低很多，維持劑量比最高劑量低很多。

Yes, just, in terms of expectation for the weight loss and then tolerability and what you want to see, as you move forward with those regimen?

是的，只是就減肥的期望和耐受性而言，以及在執行這些養生法時您希望看到什麼？

Yeah. We've said in the past, I mean, it's a tough one to handicap. And we saw 8% in the, at 100 mg in the four week study. I think if we were to see 8% here I think it would be about the best oral data reported so at that time point so that's kind of the maybe the hurdle we're looking at is, that's mid to high single digits some somewhere in there that 8% range and with tolerability, I think that's a, it's a very nuanced question.

是的。我們過去曾說過，我的意思是，這是一個很難預測的現象。在為期四週的研究中，我們發現 100 毫克的劑量增加了 8%。我認為，如果我們在這裡看到 8%，我認為這將是報告的最好的口服數據，所以在那個時間點，這可能是我們正在考慮的障礙，這是中等到高個位數，在 8% 的範圍內，並且具有耐受性，我認為這是一個非常微妙的問題。

We clearly saw outstanding tolerability in the Phase 1 study, but in Phase 2. What we saw in the injectable was some early, nausea and GI. Tolerability. Signals which you'd expect from the mechanism. But, those waned almost instantaneously, so second dose.

我們在第一階段的研究中清楚地看到了出色的耐受性，但在第二階段。我們在註射劑中看到的是一些早期的噁心和胃腸道症狀。耐受性。您期望從機制中得到的訊號。但是，這些症狀幾乎立即消失了，所以需要服用第二劑。

And later, really dropped off a cliff as far as tolerability. So you need to, I think, consider the pattern of any GI adverse events in the upcoming data set and so it's hard to say, well, if we see X percentage. That's going to be good or bad. It's just what is the overall treatment window look like as far as the [AEs]. And so that's what we'll need to look at.

後來，就容忍度而言，真的跌到了谷底。因此，我認為，你需要考慮即將到來的資料集中任何胃腸道不良事件的模式，所以很難說，如果我們看到 X 百分比。這有好有壞。這只是就整體治療窗口而言[不良事件]。這就是我們需要研究的。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

Yeah, hi guys, thanks for taking my questions. I want to understand the 78 week duration for the Phase 3 trials. Given you need 52 weeks for maintenance, those for FDA draft guidance. Should we assume the titration period in the Phase 3 is 26 weeks? And then the second question is, it's I think been close to a month since the Phase 3 started. When can we expect to see the trials posted on clin trials?

是的，大家好，感謝你們回答我的問題。我想了解第三階段試驗的 78 週持續時間。鑑於您需要 52 週的維護時間，這些是 FDA 的指導草案。我們是否應該假設第 3 階段的滴定期為 26 週？第二個問題是，我認為第三階段開始已經快一個月了。我們什麼時候可以看到臨床試驗結果？

Oh, with the second question, I would say shortly, very soon. And with the first question, yeah, the it's 52 weeks plus the titration window. That's what that, that's how you get the 78.

哦，對於第二個問題，我想說很快，很快。對於第一個問題，是的，是 52 週加上滴定視窗。就是這樣，這就是你得到 78 的方法。

Got it. And then maybe if I could have a follow-up, Brian, you talked about the oral data if it potentially, reads out, really favorably that there's a potential to go to Phase 3. How long would it take to manufacture the whole clinical supply if you make that decision?

知道了。然後，如果我可以進行後續跟進，布萊恩，您談到了口服數據，如果它有可能讀出來，真的很有利，有可能進入第三階段。如果您做出該決定，生產整個臨床供應需要多長時間？

Oh, I don't think that would be a gating factor. We have multiple batches sort of in progress at any given time, so, Phase 3 supply would not be, gating for initiation of a Phase 3 study there.

哦，我不認為這會是一個限制因素。我們在任何時候都有多個批次正在進行中，因此，第 3 階段的供應不會成為啟動第 3 階段研究的門檻。

Perfect thank you.

非常感謝。

How much we'd have on day one, I don't know, but we that wouldn't be a gating factor.

我不知道第一天我們能賺多少錢，但這不會成為限制因素。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Well thanks for taking our questions. Just a follow up on Byron's question earlier. The 78 weeks, I guess you know quick math if you subtract 52 weeks, that's 26. So, and then you kind of mentioned about the four week block at the earlier part of this, call.

好的，感謝您回答我們的問題。這只是對拜倫之前問題的後續回答。78 週，我想你知道，如果減 52 週，那就是 26 週。那麼，然後您在之前的部分提到了關於四周的時間區塊，打電話。

So I'm curious about what's in there that, caused it not divisible by four and then the second part has to do with the VANQUISH, dosing scheme. So, it seems like it's a little staggered, relative to the that bound. Obviously, your push goes a little higher. Hopefully there's some differentiation there from the magnitude weight loss perspective, but I'm just curious if there's also a reimbursement, motivation there to make it a staggered scheme. Thank you.

所以我很好奇這裡面是什麼，導致它不能被四整除，然後第二部分與 VANQUISH 劑量方案有關。因此，相對於那個界限，它似乎有點交錯。顯然，你的推力要高一些。希望從減肥幅度的角度來看會有一些區別，但我只是好奇是否也有報銷，動機來使其成為一個交錯的計劃。謝謝。

I don't, I'm not sure I understand the second part of the question. We would expect if it were, safe and effective that, the reimbursement picture would be similar to other approved agents, so it wasn't any real, I don't know, consideration there, as far as when we came to the trial design.

我不知道，我不確定我是否理解問題的第二部分。我們期望，如果它是安全有效的，那麼報銷情況將與其他核准的藥物相似，因此就我們進行試驗設計而言，這並沒有任何實際的考慮。

And with the titration window, yeah, I mean, it's, 26 weeks on the early doses and then 52 on the final doses. On the final at post titration doses.

是的，對於滴定窗口，我的意思是，早期劑量為 26 週，最終劑量為 52 週。在最終滴定劑量後。

Okay, so maybe let me clarify about the reimbursement. So anecdotally we're hearing from physicians that, if patients are not at one of these maintenance doses for 5, 10, 15, or is that bound, some might get, their, coverage was withdraw. So I'm just curious that that would motivate for the (inaudible)

好的，那麼讓我澄清一下有關報銷的事情。因此，我們從醫生那裡聽說，如果患者沒有按照這些維持劑量持續 5、10、15 或一定時間，那麼有些人的保險可能會被取消。所以我很好奇這會激勵（聽不清楚）

Yeah, yeah, no, I hear you. Yeah, we, we've heard that as well but, I think that in that case, the 7.5 would be a really attractive option for maintenance, if that's the dose they would, choose to pursue long term, but I would expect all of them to be reimbursed and intermediate doses, that's one of the reasons we did choose three is just to have you, multiple options of approved levels, so in that sense, it did feed into the design, but, the levels I thought were chosen really based on, the potential for good safety, tolerability and efficacy.

是的，是的，不，我聽到了。是的，我們也聽說過這個，但我認為在這種情況下，7.5 將是一個非常有吸引力的維持劑量選擇，如果這是他們選擇長期服用的劑量，但我希望所有這些劑量都能得到報銷，中間劑量，這是我們選擇三種劑量的原因之一，只是為了讓您有多個批准劑量的選擇，所以從這個意義上說，它確實融入了設計有效性的有效性。

Okay, great.

好的，太好了。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Thanks for taking the question. So just going back to the maintenance study for a moment, you had mentioned that you're probably looking to transition patients from the titration to maintenance at the three month time point. Just curious about how you selected that three month time point versus say six given that patients are probably They're losing weight beyond that point and they won't see maximal weight loss. So just some of the rationale behind that, please. Thanks.

感謝您回答這個問題。因此，讓我們暫時回到維持研究，您曾提到，您可能希望在三個月的時間點讓患者從滴定過渡到維持。我只是好奇您是如何選擇三個月的時間點而不是六個月的，因為患者的體重可能會在那個時間點之後下降，並且不會看到最大程度的減肥。請您解釋一下這背後的一些理由。謝謝。

Oh yeah, thanks. The sorry if I wasn't clear. The, when you transition to the monthly that's three months. The time to get to that transition point is longer than three months. And, really I think the goal here is to look at first what doses are sort of tolerated on a monthly cadence and then also, do you prevent weight gain? Any sort of a regain, and in that sense, you don't have to have people at their, lowest potential dose. You just want to have them at a, some level of weight loss that when they transition you can measure is the monthly going to prevent regain or assist further weight loss and just, see how that, how that works out.

噢，是的，謝謝。如果我沒有說清楚，很抱歉。然後，當你過渡到每個月時，那就是三個月。到達那個轉捩點的時間超過三個月。而且，我真的認為這裡的目標是首先查看每月可以耐受的劑量，然後查看是否可以防止體重增加？任何形式的恢復，從這個意義上來說，你不必讓人們處於最低的潛在劑量。你只是希望他們的體重減輕達到一定水平，這樣當他們轉變時，你可以測量每月的減肥效果，看看是否可以防止反彈或幫助進一步減肥，然後看看效果如何。

Okay, great. And if I could just ask a quick follow up when you're, I know that in the days you try looking at a number of doses going all the way up to 120 mg and clearly the goal is to push the dose to see what the, maximum tolerability could be, I guess, and maximum weight loss.

好的，太好了。如果我可以快速跟進一下，我知道在這些日子裡，您會嘗試觀察劑量，一直到 120 毫克，顯然目標是增加劑量，看看最大耐受性是多少，我想，以及最大減肥效果。

But what do you see as the likely viable commercial doses for the oral, given that they will be maintenance and is that really how you are looking at it, that there's a middle dose that was probably the most, the viable commercial dose.

但是，考慮到口服藥物將用於維持治療，您認為可行的商業劑量是多少？您真的是這樣看待這個問題的嗎？有一個中等劑量可能是最可行的商業劑量。

Yeah, it's a good question and, I think that, lower doses are, I think, more attractive in the maintenance setting, for all the reasons everybody knows, I mean COGS and production and all that stuff. But the really important attribute in this study is that arm that goes from 90 to 30, because if that's interesting, then it would suggest that people don't need to be on a high dose, for an indeterminate number of months, they could start and get some momentum with a high dose and then transition to a lower dose.

是的，這是個好問題，我認為，在維持治療中，較低的劑量更有吸引力，原因大家都知道，我的意思是成本、生產等等。但這項研究中真正重要的屬性是從 90 到 30 的那一組，因為如果這很有趣，那麼它就表明人們不需要服用高劑量，在不確定的幾個月內，他們可以開始服用高劑量並獲得一些動力，然後過渡到較低的劑量。

So It's an interesting sort of exploratory arm there. As far as feasibility, higher doses are, like I said, the margins are worse there, but what we have seen. In the past, I don't know, 9 to 12 months is some. Regression I think, in, price points in peptide production.

所以這是一個有趣的探索性機構。就可行性而言，正如我所說，更高的劑量會導致結果更差，但我們已經看到了。以前我不知道，9到12個月是一些。我認為，在勝肽生產的價格點上存在回歸。

So, where that, finally plateaus, we don't know, but, there has been some improvement on pricing, at least from what we've seen from some of the parties we speak with. So, that might change what's really feasible for oral dosing.

因此，我們不知道最終價格會在哪裡達到穩定水平，但價格確實有所改善，至少從我們交談過的一些相關方的情況來看是如此。因此，這可能會改變口服給藥的真正可行性。

Got it. Great. Thank you.

知道了。偉大的。謝謝。

Thanks, Annabel.

謝謝，安娜貝爾。

George Farmer, Scotiabank.

加拿大豐業銀行的喬治法默。

Hi, thanks for taking my questions. Brian, can you, comment a little bit on how you're thinking about the placebo patients in the VANQUISH study and how you can continue motivating them to remain on study? Imagine after a while if they're not losing weight, they'll rationalize that they're probably getting the placebo and may hop off. And then, second, can you talk a little bit more about your Amylin program and how you think it's differentiated from the others that are out there. Thanks.

你好，謝謝你回答我的問題。布萊恩，您能否稍微評論一下您對 VANQUISH 研究中安慰劑患者的看法，以及您如何繼續激勵他們繼續接受研究？想像一下，如果過了一段時間他們的體重沒有減輕，他們就會認為自己可能服用了安慰劑，並可能放棄。其次，您能否再多談談您的 Amylin 計劃以及您認為它與其他計劃有何不同。謝謝。

Yeah, thanks, George. The placebo question is always a really tough one, especially in these longer studies. We are, encouraging and counseling for diet and exercise, calorie restricted diet, and that will probably work.

是的，謝謝，喬治。安慰劑問題始終是一個非常棘手的問題，特別是在這些長期研究中。我們鼓勵並輔導人們控制飲食、運動、限制熱量飲食，這些可能會有效。

For some people to some degree, the regular visits with their clinician and the investigators, I think that some people that resonates with them. They like to come in and see the clinics.

對於某些人來說，在某種程度上，定期拜訪他們的臨床醫生和研究人員，我認為這會引起一些人的共鳴。他們喜歡來參觀診所。

I think a big attribute for us that will help maintain the placebo cohort is the eligibility to go into the open label extension after the trial is done. Every placebo recipient will be eligible to an active arm. And we think that will be a positive motivator to maintain participation but it's definitely a challenge for any long obesity study.

我認為，對我們來說，有助於維持安慰劑組的一個重要特徵是試驗結束後有資格進入開放標籤擴展期。每位安慰劑接受者都有資格加入活性組。我們認為這將成為維持參與的積極動力，但對於任何長期肥胖研究來說無疑是一個挑戰。

Yeah, from what the internal standards we use are some known amylin and agonists. I think, we're competitive on, appetite, reduction, food intake reduction, body weight. A reduction, so we don't have any, human, tolerability data yet, but from the efficacy side.

是的，我們使用的內部標準是一些已知的胰淀素和激動劑。我認為，我們在食慾、減少食物攝取、體重等方面具有競爭力。減少，因此我們還沒有任何人類耐受性數據，但從功效來看。

I think it looks very competitive thus far in the animal models that we've looked at. So a little pressure to make further predictions there, but it looks interesting.

我認為到目前為止，在我們觀察的動物模型中它看起來非常有競爭力。因此，做出進一步的預測會有點壓力，但看起來很有趣。

Okay, thanks.

好的，謝謝。

Thanks George.

謝謝喬治。

Justin Zelin, BTIG.

BTIG 的 Justin Zelin。

Thanks for taking the question and congrats on the progress. Brian, for the basically for vanquish, programs, can you talk about how you would use autoinjectors and study and if you would need like a bridging study, for the auto injectors.

感謝您提出這個問題，並祝賀您的進展。布萊恩，對於基本上是 Vanquish 計劃的項目，您能否談談如何使用自動注射器和進行研究，以及是否需要對自動注射器進行橋接研究。

Yeah, thanks, Justin. Good question. We will be transitioning people to the Auto injectors next year, early next year. So that's the plan. We will be doing a bioequivalent study in the interim that assesses the Auto-injector relative to the violent syringe. So, that's the current plan.

是的，謝謝，賈斯汀。好問題。明年，也就是明年初，我們將開始讓人們使用自動注射器。這就是計劃。在此期間，我們將進行生物等效性研究，評估自動注射器與暴力注射器的比較。這就是目前的計劃。

Got it. Okay. Great. Thanks for taking the questions.

知道了。好的。偉大的。感謝您回答這些問題。

Thanks Justin.

謝謝賈斯汀。

Yale Jen, Laidlaw

耶魯詹，萊德勞

Good afternoon and thanks for taking the questions. This is about, this is a little bit about the competitive side on the orals that the [Lili] will report the offer good from Phase 3 data in this, I think in this quarter. So how do you see any impact from that, your oral presentation pro oral product presentation also in this quarter?

下午好，感謝您回答問題。這是關於口服藥物競爭方面的一點信息，我認為 [Lili] 將在本季度報告第三階段的數據，該報價很好。那麼，您如何看待本季您的口頭演示和口頭產品演示會產生什麼影響？

I don't know, yeah, we'll see what those data showed. I think, the Phase 2 data looked interesting for [Gliron], we'll see what this longer study shows. I don't know, hard to say. I think it's safe to say though that the sector, the indication can accommodate multiple agents given the market opportunities so you know we don't think a single oral agent will really be the, I mean there's going to be multiple agents in in the space. So we're not too worried about another one.

我不知道，是的，我們會看看這些數據顯示了什麼。我認為，第 2 階段的數據對於 [Gliron] 來說很有趣，我們將看看這項更長期的研究會顯示什麼。我不知道，很難說。我認為可以肯定地說，考慮到市場機會，該領域、該適應症可以容納多個代理商，所以你知道我們不認為單一的口服代理商會真正成為，我的意思是該領域將會有多個代理商。所以我們並不太擔心另一個。

Okay, great. And maybe just one more. In terms of the calcitonin receptor, it seems not talking about that today too much. Was there any change in the status and.

好的，太好了。也許還剩一個。關於降鈣素受體，今天似乎沒有談太多這件事。狀態是否有任何變化？

Thanks.

謝謝。

No, we're pretty balanced on, on.

不，我們目前相當平衡。

Calcitonin and amylin in our hands, the more balanced, the better the weight loss when you skewed one way or another, it seemed to, I don't know, it didn't really impact food consumption as well as the more balanced. And does have to be 1 to 1, I don't know, pro pro probably not, but, the closer we got to 1 to 1. The better the overall body weight and food consumption profile. So ours is, it is.

我們手中的降鈣素和胰淀素越平衡，減肥效果就越好，當你以某種方式傾斜時，它似乎，我不知道，它並沒有真正影響食物消耗，以及更平衡。而且一定是 1 比 1，我不知道，專業人士可能不知道，但是，我們越接近 1 比 1。整體體重和食物消耗狀況越好。所以我們的就是這樣。

Okay, great. Thanks and congrats.

好的，太好了。謝謝並祝賀。

Thanks Yale.

謝謝耶魯。

As we are nearing the conclusion of today's call, our final question will come from Thomas Smith, Leerink.

今天的電話會議即將結束，我們的最後一個問題來自 Leerink 的 Thomas Smith。

Hi, this is Natron on for Thomas Smith. So for the amylin agonist program, what does it have to show in a face on trial, especially related to the VK2735 data to run continued development in obesity?

大家好，我是 Natron，為 Thomas Smith 服務。那麼對於胰淀素激動劑計劃，它在試驗中需要顯示什麼，特別是與 VK2735 數據相關的數據，以便在肥胖症方面繼續發展？

I missed the first part. Can you repeat the first part?

我錯過了第一部分。你能重複一下第一部分嗎？

Yeah, so what that has to show in the first one trial, especially compared to VK2735 data to warrant continued development in obesity.

是的，那麼第一次試驗必須顯示什麼，特別是與 VK2735 數據相比，才能確保肥胖症的持續發展。

Yeah, well, I think we would like to see some impact on body weight and be really good to. To learn the tolerability. Profile looks like as well. I think, thankfully we've moved past the everybody racing to the, four week goalpost and then claiming victory and you've got the best compound in the class. So we, the space has matured beyond that sort of silly attitude toward four week data. But we will see what the trajectory looks like what the safety and tolerability look like and then make a decision from there.

是的，我想我們希望看到對體重的一些影響，並且真的做得很好。學習耐受力。個人資料看起來也是一樣。我認為，值得慶幸的是，我們已經超越了每個人都在四周內爭奪目標然後宣稱勝利的階段，並且你已經擁有了同類中最好的化合物。因此，我們這個領域已經成熟，不再對四周資料抱持那種愚蠢的態度。但我們會觀察其發展軌跡、安全性和耐受性，然後據此做出決定。

Got it, thank you.

知道了，謝謝。

Thanks a lot.

多謝。

This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

我們的問答環節到此結束。我想將會議交還給史蒂芬妮·迪亞茲，請她做最後發言。

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months.

再次感謝您的參與和對 Viking Therapeutics 的持續支持。我們期待在未來幾個月內再次向您提供最新資訊。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。