Viking Therapeutics Inc (VKTX) 2025 Q1 法說會逐字稿

Welcome to the Viking Therapeutics' first-quarter 2025 financial results conference call. (Operator Instructions)

歡迎參加 Viking Therapeutics 2025 年第一季財務業績電話會議。（操作員指示）

As a reminder, this conference call is being recorded today, April 23, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

提醒一下，本次電話會議於今天（2025 年 4 月 23 日）錄製。現在，我想將會議交給 Viking 的投資者關係經理 Stephanie Diaz。請繼續，史蒂芬妮。

Hello, and thank you for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.

您好，感謝您參加今天的電話會議。今天與我一起出席的是 Viking 總裁兼執行長 Brian Lian；以及 Viking 的財務長 Greg Zante。

Before we begin, I'd like to caution that comments made during this conference call today, April 23, 2025, will contain forward-looking statements under the Safe Harbor provisions of the U.S. Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones.

在我們開始之前，我想提醒一下，今天（2025 年 4 月 23 日）的電話會議中所發表的評論將包含根據 1995 年美國證券訴訟改革法案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陳述。

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely 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 statements made today. I encourage you to review all the company's filings with the Securities and Exchange Commission concerning these and other matters.

前瞻性陳述受風險和不確定性的影響，可能導致實際結果有重大差異，且不利的報告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。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。

I'll now turn the call over to Brian Lian for his initial comments.

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 first quarter ended March 31, 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 3 月 31 日的第一季財務業績，並介紹我們開發計劃和營運的最新進展。

In the first quarter of 2025, Viking continued to build upon the strong momentum achieved in 2024. In the past year, we announced positive data from four separate clinical programs, including our VK2735 subcutaneous program for obesity, our VK2735 oral tablet program for obesity, our VK2809 program for the treatment of NASH and fibrosis, and our VK0214 program for X-linked adrenoleukodystrophy.

2025 年第一季度，維京繼續鞏固 2024 年的強勁發展勢頭。在過去的一年裡，我們公佈了四個獨立臨床計畫的積極數據，包括用於治療肥胖症的 VK2735 皮下注射計畫、用於治療肥胖症的 VK2735 口服片劑計畫、用於治療 NASH 和纖維化的 VK2809 計畫以及用於治療 X 連鎖腎臟病的 VK0214 計畫。

By any measure, 2024 was our most productive year to date, and this positive momentum has continued into 2025. During the first quarter, the company made great progress toward the initiation of Phase 3 trials for our subcutaneous VK2735 program, and we expect to commence these studies later this quarter. The company also announced the initiation of Phase 2 trial evaluating the tablet formulation of VK2735 in subjects with obesity.

無論以何種標準衡量，2024 年都是我們迄今為止最富有成效的一年，這種積極勢頭一直延續到 2025 年。在第一季度，該公司在啟動皮下 VK2735 項目 3 期試驗方面取得了重大進展，我們預計將於本季度晚些時候開始這些研究。該公司也宣布啟動第二階段試驗，評估 VK2735 片劑對肥胖患者的療效。

Later in the first quarter, we announced the completion of enrollment in this trial. We believe this study's rapid enrollment reflects continued enthusiasm for our obesity program, and we look forward to announcing the results of the study later this year.

在第一季後期，我們宣布了該試驗的招募完成。我們相信，這項研究的快速招募反映了人們對我們的肥胖症計劃的持續熱情，我們期待在今年稍後公佈研究結果。

Also during the first quarter, Viking entered into a long-term, large-scale manufacturing agreement to support the future commercialization of VK2735 in obesity. The agreement provides for both API and fill-and-finish activities, which we believe will be sufficient to support a potential multibillion-dollar annual-product opportunity.

此外，在第一季度，Viking 還簽署了一項長期、大規模製造協議，以支持 VK2735 在肥胖症領域的未來商業化。該協議規定了 API 和填充及完成活動，我們相信這足以支援潛在的數十億美元的年度產品機會。

During the quarter, the company also made progress with its newest program evaluating a series of internally developed agonist of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile in in vivo models.

本季度，該公司還在最新項目上取得了進展，該項目評估了一系列內部開發的胰淀素受體激動劑，這些激動劑在體內模型中顯示出改善體重和代謝狀況的效果。

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

在審查第一季財務業績後，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.

謝謝，布萊恩。

In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later this month.

結合我的評論，我想建議參與者參考維京向美國證券交易委員會提交的 10-Q 表格，我們預計將於本月稍後提交該表格。

I'll now go over our results for the first quarter.

我現在來回顧一下我們第一季的業績。

Research and development expenses were $41.4 million for the three months ended March 31, 2025, compared to $24.1 million for the same period in 2024. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock-based compensation, and salary and benefits, partially offset by decreased expenses related to preclinical studies.

截至 2025 年 3 月 31 日的三個月，研發費用為 4,140 萬美元，而 2024 年同期為 2,410 萬美元。成長的主要原因是與我們的候選藥物製造、臨床研究、股票薪酬以及工資和福利相關的費用增加，但部分被與臨床前研究相關的費用減少所抵消。

General and administrative expenses were $14.1 million for the three months ended March 31, 2025, compared to $10 million for the same period in 2024. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and insurance, partially offset by decreased expenses related to salaries and benefits.

截至 2025 年 3 月 31 日的三個月，一般及行政費用為 1,410 萬美元，而 2024 年同期為 1,000 萬美元。成長的主要原因是與法律和專利服務、股票薪酬和保險相關的費用增加，但部分被與工資和福利相關的費用減少所抵消。

For the three months ended March 31, 2025, Viking reported a net loss of $45.6 million or $0.41 per share compared to a net loss of $27.4 million or $0.26 per share in the corresponding period in 2024. The increase in net loss for the three months ended March 31, 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 3 月 31 日的三個月，維京報告淨虧損為 4,560 萬美元，即每股 0.41 美元，而 2024 年同期淨虧損為 2,740 萬美元，即每股 0.26 美元。截至 2025 年 3 月 31 日的三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 March 31, 2025, Viking held cash, cash equivalents and short-term investments of $852 million, compared to $903 million as of December 31, 2024.

回顧資產負債表，截至 2025 年 3 月 31 日，維京持有的現金、現金等價物和短期投資為 8.52 億美元，而截至 2024 年 12 月 31 日為 9.03 億美元。

This concludes my financial review, and I'll now turn the call back over to Brian.

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.

謝謝，格雷格。

I'll now provide an overview of our pipeline programs and outlined next steps for each 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.

我現在將概述我們的管道項目，並概述每個項目的後續步驟，從我們的主要肥胖項目 VK2735 開始。VK2735 是胰高血糖素樣勝肽 1（或稱 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。

The company's prior Phase 1 trial for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics and treated subjects demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.

該公司先前對 VK2735 皮下製劑進行的 1 期試驗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 28 天後體重較基線減輕了約 8%，且沒有出現平台期的跡象。

Following the successful completion of Phase 1 studies, we initiated a Phase 2a study called the VENTURE study. This study evaluated 13 weeks of dosing with VK2735 in subjects with obesity. As we reported last year, the VENTURE study successfully achieved its primary and secondary endpoints. Subjects receiving VK2735 achieved statistically significant reductions in main body weight from baseline ranging up to 14.7%.

在成功完成第 1 階段研究後，我們啟動了第 2a 階段研究，稱為 VENTURE 研究。這項研究評估了肥胖患者使用 VK2735 13 週的療效。正如我們去年報導的那樣，VENTURE 研究成功實現了其主要和次要終點。接受 VK2735 治療的受試者的體重較基線顯著降低，下降幅度高達 14.7%。

The study also showed VK2735 to be safe and well-tolerated 13 weeks of dosing with the majority of treatment emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI 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的，大多數治療出現的不良事件為輕度或中度。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 results from follow-up visits conducted at four and seven weeks after completion of dosing, were highlighted in a presentation at Obesity Week 2024, the annual meeting of the Obesity Society. The follow-up data showed that subjects receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up visit.

這些結果以及服藥完成後四週和七週進行的隨訪的其他結果在肥胖協會年會 2024 肥胖週的一次演講中進行了重點介紹。追蹤數據顯示，接受 VK2735 治療的受試者在七週的追蹤中維持了大部分減重效果。

This included the 2.5mg weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks after the last dose would it was administered. In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following completion of the 13-week dosing period was conducted. We believe the pharmacokinetic result support the potential for once-monthly dosing in the maintenance setting, and the company is planning to further evaluate a monthly dosing regimen later this year.

其中包括每週 2.5 毫克的劑量，這是評估的最低劑量，在最後一次服藥後七週內，超過 90% 的初始體重減輕得以維持。在一組參與者中，對完成 13 週給藥期後不同時間點的 VK2735 血漿水平進行了評估。我們相信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。

Following the successful conclusion of the Phase 2 VENTURE study and after receiving feedback from a Type C meeting with the FDA last summer, we made the decision to advance VK2735 into Phase 3 development for obesity. In this sense, we requested an end-of-Phase 2 meeting with the agency, which took place in the fourth quarter of last year.

在第 2 階段 VENTURE 研究成功結束後，並在去年夏天收到與 FDA 的 C 類會議的回饋後，我們決定將 VK2735 推進到針對肥胖症的 3 階段開發。為此，我們要求與該機構舉行第二階段結束會議，該會議於去年第四季舉行。

The feedback from this meeting was extremely helpful in informing our overall development plan and in particular, our Phase 3 plan for the program. Since the end of Phase 2 meeting, our team has been working diligently to prepare for the initiation of the Phase 3 trials, and we remain on track to initiate these studies later this quarter.

這次會議的回饋對於我們制定整體發展計劃，特別是該計劃的第三階段計劃非常有幫助。自第二階段會議結束以來，我們的團隊一直在努力為啟動第三階段試驗做準備，我們仍有望在本季稍後啟動這些研究。

In parallel with the advancement of the subcutaneous formulation of VK2735, Viking is also evaluating an oral tablet formulation. 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 have already achieved.

在推進 VK2735 皮下製劑研發的同時，Viking 也正在評估口服錠劑的製劑。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，或者對於那些尋求維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。

We believe the key differentiating advantage of our obesity program is that we have both a tablet formulation and a subcutaneous formulation that utilize the same molecule. These formulations create the potential to transition patients from one formulation to another, with the possibility of reducing the risk of unexposed active safety or tolerability challenges. We believe this represents a potentially valuable option for those with obesity and the clinicians.

我們相信，我們的肥胖症治療計畫的關鍵差異化優勢在於，我們既有利用相同分子的片劑配方，也有利用相同分子的皮下配方。這些配方使患者能夠從一種配方過渡到另一種配方，並有可能降低未暴露的活性安全性或耐受性挑戰的風險。我們相信這對肥胖患者和臨床醫生來說是一個潛在的有價值的選擇。

Viking Phase 1 study for the oral formulation was a randomized, double-blind placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter square. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days was secondary and exploratory objectives evaluating the pharmacokinetics of oral VK2735, as well as changes in body weight and other metrics.

Viking 口服製劑的 1 期研究是一項隨機、雙盲安慰劑對照研究，研究對象為體重指數至少為每平方公尺 30 公斤的健康成年人。研究的主要目的是評估連續 28 天每天服用一次 VK2735 片劑的安全性和耐受性，次要和探索性目標是評估口服 VK2735 的藥物動力學以及體重和其他指標的變化。

As with the VENTURE Phase 2 study, the oral Phase 1 trial successfully achieved its objectives. The data from this study showed that cohort receiving VK2735 demonstrated dose-dependent reductions in main body weight from baseline ranging up to 8.2% after 28 days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered.

與 VENTURE 第 2 階段研究一樣，口服第 1 階段試驗也成功實現了其目標。研究數據顯示，接受 VK2735 治療的患者族群在 28 天後體重從基線開始呈現劑量依賴性下降，降幅高達 8.2%。在服用最後一次劑量四周後的第 57 天的隨訪中觀察到持續的體重減輕效果，從基線開始體重減輕高達 8.3%。

Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once daily dosing at doses up to and including 100mg. The majority of observed treatment-emergent adverse events were mild or moderate with most reported as mild.

根據對減肥軌蹟的初步評估，該公司認為，持續治療超過 28 天可能會進一步減輕體重。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。觀察到的治療中出現的大多數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. The results from this study were presented at the 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。該研究結果於去年 11 月在肥胖週會議上發表。

Following the successful conclusion of the Phase 1 study, in January of this year, Viking announced the initiation of Phase 2 trial called the VENTURE-Oral dosing trial in subjects with obesity. The VENTURE-Oral trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate wait the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 doses, an oral tablet once daily for 13 weeks.

在第 1 階段研究成功結束後，今年 1 月，Viking 宣布啟動針對肥胖患者的第 2 階段試驗，即 VENTURE-Oral 給藥試驗。VENTURE-Oral 試驗是一項隨機、雙盲、安慰劑對照、多中心研究，旨在評估 VK2735 劑量（每日一次口服片劑，持續 13 週）的安全性、耐受性、藥物動力學和減肥效果。

In March, we announced completion of enrollment for this trial and that the trial had successfully met its enrollment objective, enrolling approximately 280 adults who are obese or adults who are overweight with at least one weight-related co-morbid condition.

今年 3 月，我們宣布該試驗的招募工作已完成，並且成功達到了招募目標，招募了約 280 名肥胖成年人或超重且至少患有一種體重相關合併症的成年人。

Enrolled subjects have been equally randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent 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. We believe the rapid enrollment of this trial speaks to the continued high level of interest and enthusiasm for new weight-loss options among both clinicians and their patients. We expect to report data from this study in the second half of 2025.

入選受試者被隨機分配到六個劑量組或安慰劑組之一。研究的主要終點是治療 13 週後體重相對於基線的百分比變化。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。我們相信，此次試驗的快速招募表明臨床醫生及其患者對新的減肥方法的興趣和熱情持續高漲。我們預計將在 2025 年下半年報告這項研究的數據。

Beyond our accretive program, last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonist of the amylin receptor. We believe activation of the amylin receptor represents an important additional mechanism related to appetite and weight management. Progress with our amylin program is continuing, and we expect to file an IND for the program later this year.

除了我們的增值計劃之外，去年在美國糖尿病協會的年會上，我們還宣布了一項新計劃，評估一系列新型胰淀素受體激動劑。我們相信胰淀素受體的活化代表了與食慾和體重管理相關的重要附加機制。我們的胰淀素計畫正在繼續進展，我們預計將於今年稍後為該計畫提交 IND。

Moving to additional corporate milestones, in the first quarter, we announced that we had entered into an important supply agreement related to the VK2735 program. This agreement provides for large scale API manufacturing as well as fill-and-finish capacity for both the injectable and oral formulations of VK2735.

在第一季度，我們宣布已達成其他公司里程碑，涉及 VK2735 計畫的重要供應協議。該協議為 VK2735 注射劑和口服劑型提供了大規模 API 製造以及填充能力。

With this important partnership in place, Viking believes it will have access to a commercial supply of API, auto-injectors, vial and syringe kits, and oral tablets sufficient to support a potential multibillion-dollar annual-product opportunity.

憑藉這一重要的合作夥伴關係，Viking 相信它將能夠獲得足夠的 API、自動注射器、小瓶和注射器套件以及口服片劑的商業供應，以支持潛在的數十億美元的年度產品機會。

With respect to the company's financial position, as Greg indicated in his comments, Viking continues to maintain a strong balance sheet with more than $850 million in cash as of the end of the first quarter. This provides us with the runway to complete our planned Phase 3 trials for VK2735 obesity program, as well as to aggressively pursue the clinical development of our additional programs.

關於公司的財務狀況，正如格雷格在評論中所指出的，維京繼續保持強勁的資產負債表，截至第一季末，現金超過 8.5 億美元。這為我們完成 VK2735 肥胖症計畫的 3 期試驗以及積極推進其他項目的臨床開發提供了平台。

In other corporate matters, like many others, we are awaiting clarity on how the potential introduction of tariffs might impact our current and future operations. At this point, we expect minimal near near-term impact across our development programs. As to the longer-term impact on potential commercial activities, it's too early for us to assess what the tariff environment maybe at some point in the future. We look forward to these important negotiations being completed as soon as practicable.

在其他公司事務中，與許多其他事務一樣，我們正在等待明確潛在的關稅徵收將如何影響我們當前和未來的營運。目前，我們預計短期內對我們的開發項目的影響將微乎其微。至於對潛在商業活動的長期影響，現在評估未來某個時候的關稅環境還為時過早。我們期待這些重要的談判能盡快完成。

In conclusion, we are excited to report that the tremendous progress Viking made in 2024 has carried over into the first quarter of 2025. Following the company's most productive year to date, Viking made great progress preparing for the initiation of Phase 3 trials for subcutaneous VK2735, which are on track to begin in the second quarter.

最後，我們很高興地報告，維京在 2024 年的巨大進步已經延續到了 2025 年第一季。繼公司迄今為止最富有成效的一年之後，Viking 在準備啟動皮下 VK2735 的 3 期試驗方面取得了巨大進展，該試驗預計將在第二季度開始。

In the first quarter, we also announced both the initiation and completion of enrollment in our Phase 2 VENTURE-Oral dosing trial. We believe that this study's rapid enrollment reflects the continued enthusiasm for our program, and we look forward to reporting data from this study in the second half of the year.

在第一季度，我們也宣布了第二階段 VENTURE-Oral 給藥試驗的啟動和完成。我們相信，這項研究的快速招募反映了人們對我們計畫的持續熱情，我們期待在今年下半年報告這項研究的數據。

With respect to our new amylin agonist program, we continue to make progress toward an IND filing, which we expect to submit later this year. Also during the first quarter, we are happy to sign a broad multiyear-manufacturing agreement to support the future commercialization of VK2735. This comprehensive agreement provides large-scale annual supply of API. as well as fill-and-finish capacities for both the injectable and oral product forms.

關於我們的新胰淀素激動劑項目，我們在 IND 申請方面繼續取得進展，預計將於今年稍後提交。此外，在第一季度，我們很高興簽署了一項廣泛的多年期製造協議，以支持 VK2735 未來的商業化。這項綜合協議提供了大規模的年度 API 供應。以及注射劑和口服產品的填充和完成能力。

And finally, our strong balance sheet allows us to continue to advance each of these programs effectively and aggressively, including through Phase 3 trials for the VK2735 obesity program and other key inflection points.

最後，我們強勁的資產負債表使我們能夠繼續有效、積極地推進每一個項目，包括透過 VK2735 肥胖症項目的 3 期試驗和其他關鍵轉折點。

This concludes our prepared comments for today. Thanks very much 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。非常感謝您的參與，我們現在開始提問。操作員。

(Operator Instructions)

（操作員指示）

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

Hi. Congrats on the quarter and thanks for taking the questions. This is [Otsum Ono] on for Joon. Just a couple from us.

你好。恭喜本季取得佳績，感謝您回答問題。這是 [Otsum Ono] 為 Joon 表演的。距離我們只有幾對。

Is the Phase 2 VENTURE-Oral read out going to include the four-week follow-up data or will the top line data only include data with 13 weeks of dosing? And then as a follow-up, when do you plan on introducing the auto-injector into the Phase 3 and what are the plans and timing for each study? Thank you.

階段 2 VENTURE-Oral 讀數是否會包括四週的追蹤數據，或者頂線數據是否僅包括 13 週的給藥數據？然後作為後續問題，您計劃何時將自動注射器引入第 3 階段，每項研究的計劃和時間安排是什麼？謝謝。

Yes, thanks for the questions. For the at the top line data from the Oral study, we historically reported the top line data when they're available. And so I would expect that's likely before the four-week follow-up data are available but keep in mind they'll be top line data.

是的，謝謝你的提問。對於 Oral 研究的頂線數據，我們歷來會在獲得頂線數據時進行報告。因此我預計這可能發生在四周追蹤數據公佈之前，但請記住它們將是頂線數據。

With the introduction of the auto-injector, that would be as soon as we can introduce it. I would say that's most likely early next year, and we will be doing a bridging study with the vial and syringe comparing to the auto-injector in the interim.

隨著自動注射器的推出，我們很快就會推出它。我想說這很可能是在明年年初，在此期間我們將對小瓶和注射器與自動注射器進行比較研究。

Thank you, Brian.

謝謝你，布萊恩。

Thanks.

謝謝。

Michael Ulz, Morgan Stanley.

摩根士丹利的邁克爾·烏爾茲。

Good afternoon and thanks for taking the question.

下午好，感謝您回答這個問題。

Maybe just one on the Phase 2 VENTURE-Oral data that you plan to share in the second half of this year. Just curious if there's a specific level of weight loss you're looking to achieve there? And how do you think about that level of weight loss at the lower doses versus the higher doses? Thanks.

也許只是您計劃在今年下半年分享的第 2 階段 VENTURE-Oral 數據中的一個。我只是好奇您是否希望達到特定的減重目標？您認為低劑量和高劑量的減肥效果如何？謝謝。

Yes. Thanks, Mike.

是的。謝謝，麥克。

Hard to project. It's a larger study than the Phase 1, but it's obviously dosing longer as well. So I think if we can show 8% or so, which is what we showed at the high dose last time from has shown that after 12 weeks, I think we'd have it competitive profile. That's a really hard to know prior to unblinding the data.

很難投射。這項研究比第一階段的規模更大，但顯然給藥時間也更長。所以我認為如果我們能夠顯示出 8% 左右的效果，也就是我們上次在高劑量下所顯示的效果，那麼 12 週後，我認為我們就會有競爭力。在揭開數據神秘面紗之前，這一點確實很難知道。

And with the lower doses, yes, just really hard to prognosticate on what the efficacy might be. Hopefully, over time, as you see continued accumulation, you'll see those lower doses performed well, but it's hard to tell.

而且，由於劑量較低，確實很難預測其療效。希望隨著時間的推移，隨著您看到持續積累，您會看到那些較低劑量的表現良好，但這很難說。

Great. Thank you.

偉大的。謝謝。

Thanks, Mike.

謝謝，麥克。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Hi, thanks for the question. I'm wondering how you're currently looking at the potential positioning of the doctor candidate if you were to evaluate its potential as a co-formulation with 2735 hourly in the clinical progression of this candidate. Would you do that? Thanks.

你好，謝謝你的提問。我想知道，如果您要評估其作為與 2735 小時聯合配方在該候選藥物的臨床進展中的潛力，您目前如何看待醫生候選藥物的潛在定位。你會這麼做嗎？謝謝。

Yes. Thanks, Ryan.

是的。謝謝，瑞安。

So the first study there would be the typical sad-mad study like we did with the 2735 program. We would like to evaluate the combination regimen as soon as we can, but that probably wouldn't happen until next year some time. We'd like to understand the single-agent profile first.

因此，第一個研究將是典型的悲傷-瘋狂研究，就像我們對 2735 計劃所做的那樣。我們希望盡快評估聯合治療方案，但可能要到明年某個時候才能實現。我們想先了解單一代理人的概況。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Hey, congrats on the progress and thanks for taking my questions.

嘿，恭喜你取得進展，謝謝你回答我的問題。

Are you planning to test oral VK2735 and other indications besides obesity like type 2 diabetes? And then I had a follow-up question, if I could.

您是否計劃測試口服 VK2735 以及其他除肥胖症之外的適應症，例如第 2 型糖尿病？如果可以的話，我還有一個後續問題。

Yes, thanks, Jay.

是的，謝謝，傑伊。

Well the Phase 3 program will consist of one study in obese subjects, and one study in obese diabetics. And so in that second study, those will be type 2 patients and we will be looking at that weight change and glycemic control. But that will give us a lot of really useful data, we think.

第三階段計畫將包括一項針對肥胖受試者的研究和一項針對肥胖糖尿病患者的研究。因此，在第二項研究中，我們將研究第 2 型糖尿病患者，並觀察他們的體重變化和血糖控制。但我們認為這將為我們提供大量真正有用的數據。

Okay, great. Thank you for that. And then you can share any comments on recent obesity deals, especially for novel targets and small molecules and assets coming out of China? And maybe comment on the overall level of strategic interest in the obesity space.

好的，太好了。謝謝你。然後，您能否分享一些關於最近的肥胖交易的評論，特別是針對來自中國的新目標、小分子和資產？並可能對肥胖領域的整體策略利益水準進行評論。

Yes. It's hard for us to comment on any VD-type discussions. But I'd say there continues to be high interest in the space, and I think we have a very attractive portfolio. But hard to give a lot of color on the discussions there.

是的。我們很難對任何 VD 類型的討論發表評論。但我想說的是，人們對這個領域的興趣仍然很高，而且我認為我們的投資組合非常有吸引力。但很難對那裡的討論給出太多的描述。

Okay. Fair enough. Thanks for taking the questions.

好的。很公平。感謝您回答這些問題。

Thanks, Jay.

謝謝，傑伊。

Hardik Parikh, JPMorgan.

摩根大通的 Hardik Parikh。

Hey, Brian, thanks for the update today.

嘿，布萊恩，謝謝你今天的更新。

I think in the past, you've mentioned that you were shorting through some logistics before kind of initiating that Phase 3 for 2735. I was wondering if you can kind of provide us an update there?

我想，您過去曾提到過，在啟動 2735 的第三階段之前，您正在做一些物流的準備。我想知道您是否可以為我們提供最新資訊？

And then are the remaining to-dos, are they more regulatory in nature like with FDA or are they more internal operational items? And then the second part is, is there any chance that the initiation of the Phase 3 bleeds into 3Q? Thank you.

那麼剩下的待辦事項是像 FDA 一樣更具監管性質，還是更具內部營運項目？第二部分是，第三階段的啟動是否有可能延續到第三季？謝謝。

Thanks, Hardik. Well right now we plan to initiate the study in the second quarter and there's no reason to think we can't do that. As far as what is happening in preparation for the study, primarily it's logistical, getting the supplies ready, getting the sites up and ready. And a lot of different doses, there will be a titration scheme in the study. So having the proper number of doses, label the manufactured and prepared for administration that just, it's a big lift. It's a lot of people, a lot larger overall program than the Phase 2a study.

謝謝，哈迪克。目前，我們計劃在第二季啟動這項研究，沒有理由認為我們做不到這一點。至於研究的準備工作，主要是後勤方面，準備物資，準備好場地。對於許多不同的劑量，研究中都會有一個滴定方案。因此，掌握適當的劑量、標記生產並準備給藥的劑量，這是一個很大的進步。與第 2a 階段研究相比，此計畫涉及的人員很多，整體規模也大得多。

Okay. Thank you.

好的。謝謝。

Thanks, Hardik.

謝謝，哈迪克。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Yes, good afternoon. Thanks for taking my questions. And congrats on the progress, Brian, on multiple fronts.

是的，下午好。感謝您回答我的問題。布萊恩，恭喜你在多個方面取得的進步。

So on the manufacturing side with CordenPharma, are you able to comment on what sort of COGS you're targeting in a steady state and maybe differences between the data and oral and any metrics. Should we be looking at API per year or something like that? And then I have a quick follow-up.

那麼，在 CordenPharma 的製造方面，您能否評論一下您在穩定狀態下所針對的 COGS 類型，以及數據和口服以及任何指標之間的差異。我們是否應該每年查看一次 API 或類似的東西？然後我有一個快速的跟進。

No, I think it's hard to talk about COGS. Those are pretty tightly held information, but I say we'll have margins that are consistent with other peptide products. Nothing unusual about what the margins might be. The scale of the manufacturing agreement is large and there are tiers to pricing as scale increases. So we think that's very favorable to us, but unable to give a lot of granularity on that specific price points.

不，我認為談論 COGS 很困難。這些都是嚴格保密的訊息，但我認為我們的利潤將與其他勝肽產品一致。利潤率沒有什麼不尋常的。製造協議的規模很大，隨著規模的擴大，定價有層次。因此我們認為這對我們非常有利，但無法提供關於具體價格點的詳細資訊。

Okay. And nothing between the peptide versus oral. And on the oral study quickly, Brian, remind us of the objective for this 30mgmaintenance that you have. And follow-up to the 90mg cohort you're doing.

好的。勝肽和口服之間沒有任何區別。關於口頭研究，Brian，請提醒我們您進行這項 30mgmaintenance 的目標。並跟進您正在進行的 90 毫克隊列。

And maybe just help us understand how to think about that data versus a regular 90mg that you're doing versus the higher dose 120mg. Was just trying to understand why you're doing the 30mg maintenance.

也許只是幫助我們理解如何看待這些數據，與您正在使用的常規 90 毫克和較高劑量 120 毫克進行比較。只是想了解你為什麼要進行 30 毫克的維護。

Thanks for the (technical difficulty) question. Yes, sure.

感謝您提出（技術難題）問題。是的，當然。

We'll see, that step down you titrate up to 90mg and then I think people stay there for four weeks or so and then you come down to 30mg for the five remaining weeks. That's really to understand if you can come down from a high dose to a lower dose and prevent weight gain.

我們會看到，逐漸將劑量滴定至 90 毫克，然後我認為人們會在那裡停留四周左右，然後在剩下的五週內將劑量降至 30 毫克。這實際上是為了了解您是否可以從高劑量降至較低劑量並防止體重增加。

I'm sorry, just a quick and dirty test on a low-dose maintenance. We think it should provide sufficient drug to prevent weight gain. And we've always thought the oral would be well-utilized in a low-dose maintenance setting once you've lost weight down to some target range, you can transition potentially to a monthly injection or to a daily low-dose oral.

抱歉，我只是對低劑量維護進行了快速而粗略的測試。我們認為應該提供足夠的藥物來防止體重增加。我們一直認為，口服藥物在低劑量維持治療中會得到很好的利用，一旦你的體重減到某個目標範圍，你就可以過渡到每月注射一次或每日低劑量口服。

So this is just one way to understand that possibility a little bit better. I mean, it would be even better weight loss continues, which is a possibility. But I think our goal here is to understand if at least we prevent weight regain.

這只是更好地理解這種可能性的一種方法。我的意思是，如果繼續減肥，效果會更好，這也是有可能的。但我認為我們的目標是了解我們是否至少可以防止體重反彈。

Got it. Thank you.

知道了。謝謝。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Hi, and thanks for taking my question. I appreciate it.

你好，謝謝你回答我的問題。我很感激。

Just as far as the Phase 3 for the injectable, do you have a better sense of how you might incorporate the question, durability? I think you mentioned you're going to look at monthly later on in the year, but is it possible it's going to be incorporated into the Phase 3 trials?

就注射劑的第三階段而言，您是否對如何解決耐久性問題有了更好的認識？我想您提到您將在今年稍後進行月度審查，但它是否有可能被納入第三階段試驗？

And then for the auto-injector, you also said you're going to be conducting a bridging study. Does auto-injector need to be incorporated into the Phase 3 study in any way?

對於自動注射器，您也說過您將進行一項橋接研究。自動注射器是否需要以任何方式納入第三階段研究？

Thanks, Annabel.

謝謝，安娜貝爾。

The auto-injector, we'll introduce the auto-injector into the Phase 3 and the which is why we're doing that comparative study from the vial and syringe to the auto-injector. So that's the reason for that comparison study.

自動注射器，我們將把自動注射器引入第三階段，這就是我們對從小瓶和注射器到自動注射器進行比較研究的原因。這就是進行比較研究的原因。

As far as the monthly regimen, first step there has to do the initial study, which will involve a titration upward using the weekly regimen to some high-dose level and then transition people on to the monthly regimen. Whether or not we would introduce that into the Phase 3 program is TBD. Right now, the Phase 3 protocols do not incorporate that. But if there were an extension study or something like that, maybe that's a possibility to incorporate the monthly.

就每月治療方案而言，第一步必須進行初步研究，包括使用每週治療方案向上滴定到某個高劑量水平，然後讓人們過渡到每月治療方案。我們是否會將其引入第三階段計劃還有待確定。目前，第三階段協議尚未納入這一點。但如果有擴展研究或類似的東西，也許有可能將其納入月度研究。

Got it. And as a follow-up, with dosing for the oral, if all of these doses are tolerable, will you likely keep the doses or start to pare them down as you move into Phase 3?

知道了。作為後續研究，對於口服劑量，如果所有這些劑量都是可以耐受的，您是否會保留這些劑量，或者在進入第 3 階段時開始減少劑量？

Yes, I think we'll have to see what the data look like. I think it's premature to pick doses now, and we haven't seen any of the Phase 2 data.

是的，我想我們必須看看數據是什麼樣的。我認為現在選擇劑量還為時過早，而且我們還沒有看到任何第二階段的數據。

Okay. Thank you.

好的。謝謝。

Thanks, Annabel.

謝謝，安娜貝爾。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. Thanks for taking our question and then for the update.

偉大的。感謝您回答我們的問題並提供最新消息。

So regarding the Phase 3, the subcu can comment on that potential design of the Phase 3. How different similar to other obesity trial have been conducted. And then regarding the amylin, what is the potential target profile you try to get before the IND, given we are in DC and preclinical data, how much better (technical difficulty) amylin? Thank you.

因此，關於第 3 階段，subcu 可以對第 3 階段的潛在設計發表評論。與其他已進行的肥胖症試驗有何不同？然後關於胰淀素，考慮到我們處於 DC 和臨床前數據，您在 IND 之前嘗試獲得的潛在目標概況是什麼，胰淀素有多好（技術難度）？謝謝。

Yes, thanks, Roger. Well will with the Phase 3 trials where those -- we'll announce all the details as we initiate the studies, but I would say they'll conform to guidance. So that is, you know, minimum of 4500 people total across the two studies, one in obese subjects, one obese diabetics and 52 weeks of post titration treatment.

是的，謝謝，羅傑。我們將在第三階段試驗中公佈所有細節，但我想說它們將符合指導。因此，您知道，這兩項研究總共至少有 4500 人參與，一項是肥胖受試者，一項是肥胖糖尿病患者，並進行了 52 週的滴定後治療。

As far as the doses and titration scheme of things like that, we'll wait to start the studies before we provide any further color on those. With the amylin program, we've done a lot of work with a lot of different compounds looking at various combinations and formulation work to understand the best amylin candidate to bring forward. And that took quite a while but I think we have a really interesting compound. So we'll bring that into the clinic bi-weekly, long-acting amylin, bring them into clinic, hopefully by the end of the year.

至於劑量和滴定方案之類的問題，我們將等待研究開始後再提供進一步的資訊。透過胰淀素計劃，我們對許多不同的化合物進行了大量的研究，研究了各種組合和配方工作，以了解最佳的胰淀素候選藥物。這花了很長時間，但我認為我們得到了一個非常有趣的化合物。因此，我們將每兩週將長效胰淀素帶到診所，希望能在今年底前帶到診所。

Thank you.

謝謝。

Thanks, Roger.

謝謝，羅傑。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Thanks. Thanks for taking our question and congratulations on the progress.

謝謝。感謝您回答我們的問題，並祝賀您的進展。

For the maintenance study that you're contemplating, I am curious about the design framework here considering. So looking across some of the obesity studies with the maintenance components, like [attain, maintain] with tirzepatide and [ofocripron], TRIUMPH-6 with [tirzepatide]. None of them actually used the same compound transitioning from subcu to oral.

對於您正在考慮的維護研究，我對這裡考慮的設計框架感到好奇。因此，回顧一些含有維持成分的肥胖研究，例如使用 tirzepatide 和 [ofocripron] 的 [達到、維持]、TRIUMPH-6 和[替澤帕肽]。實際上，他們都沒有使用相同的化合物從皮下過渡到口服。

So we're just curious what parameters would you like to explore such as longer interval, lower doses? And do you need to reconsider plateauing before the transition?

所以我們只是好奇您想探索哪些參數，例如更長的間隔、更低的劑量？您是否需要在過渡之前重新考慮停滯狀態？

Yes. Thanks, Andy. The plateau on exposures or body weight, you referring to?

是的。謝謝，安迪。您指的是曝光或體重的穩定期嗎？

Full body weight so basically (multiple speakers) Plateau in body weight and then transition to the maintenance phase of that part of the study?

所以基本上是全身重量（多位發言者）體重達到穩定期然後過渡到研究的那部分維持階段？

Yes, great question.

是的，很好的問題。

No, I don't think we'd want to wait for the plateau because I don't know when that might happen. It might happen quite a bit later. So we would like to be able to titrate up some elevated dose and then explore a less frequent regimen at a variety of doses. And then also look at the transition to an oral regimen as well. We get a lot of information on that success from that study.

不，我認為我們不想等待平台期，因為我不知道那什麼時候會發生。這可能要等到相當長一段時間後才會發生。因此，我們希望能夠逐漸增加一些劑量，然後探索各種劑量下較低頻率的治療方案。然後也要考慮轉變為口服療法的轉變。我們從這項研究中獲得了大量有關成功的資訊。

Cool, that's helpful. And maybe a commercial question. I know this is some maybe several years away, but with the success of Lilly Direct and also the complexity officially contracting for rebates and discounts. I'm curious if direct-to-consumer models for the obesity market is already substantial and sufficient for this kind of a standalone Viking to take a look at it without going through all the complexity of negotiations, price negotiations, that kind of stuff.

太棒了，這很有幫助。這或許是個商業問題。我知道這可能還需要幾年的時間，但隨著 Lilly Direct 的成功以及正式簽訂回扣和折扣合約的複雜性。我很好奇，針對肥胖市場的直接面向消費者的模式是否已經足夠強大，足以讓這種獨立的維京人去研究它，而不需要經歷複雜的談判、價格談判之類的事情。

Yes, it's a really great question. And I think in normal times, which probably would be a more challenging, but what we've seen with the introduction of these compound pharmacies and these and other direct-to-consumer models don't have any sales force that is a viable channel. So you're right. It's a little early for us to make a decision like that. But the viability of that sort of model is proven now. And so it gives us optionality and it just opens different avenues to market the product.

是的，這是一個非常好的問題。我認為在正常時期，這可能更具挑戰性，但隨著這些複合藥局和其他直接面向消費者的模式的推出，我們看到沒有任何可行的銷售管道。所以你是對的。我們現在做這樣的決定還為時過早。但這種模式的可行性現在已經得到證實。因此，它為我們提供了選擇權，並開闢了推銷產品的不同途徑。

Great. And one more, if I can squeeze in.

偉大的。如果我能擠進去的話，再來一個。

So basically the learnings that you've gained from advancing VK2375, including potentially longer half-life, [flow TMAX]. oral formulation, how much of that can be up apply to your amylin program?

因此，基本上您從推進 VK2375 中獲得的經驗包括可能更長的半衰期、[流量 TMAX]。口服製劑，其中有多少可以應用於您的胰淀素計劃？

Yes, that's a good question. And we do think the amylin's probably are amenable to oral formulation and so I think that's really interesting.

是的，這是個好問題。我們確實認為胰淀素可能適合口服製劑，所以我認為這真的很有趣。

The half-life semi, each compound is a little different. And as you know, the amylin's obviously different peptide than the dual agonist. So I don't know, you can translate a whole lot since the molecules are different. But we do think the PK profile is supportive of a weekly regimen. But other than that, since it's a different molecule, it's hard to translate a lot.

半衰期半，每個化合物都有點不同。如您所知，胰淀素的勝肽與雙重激動劑明顯不同。所以我不知道，由於分子不同，你可以翻譯很多東西。但我們確實認為 PK 概況支持每週進行一次的治療方案。但除此之外，由於它是一種不同的分子，所以很多內容很難翻譯。

Got it. That's super helpful. Thanks so much, Brian.

知道了。這非常有幫助。非常感謝，布萊恩。

Thanks, Andy.

謝謝，安迪。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

Yes. Thanks, guys, for taking my questions.

是的。謝謝大家回答我的問題。

For the oral 2735 program, is a formulation lockdown or are you doing anymore formulation optimization work?

對於口服 2735 項目，是配方鎖定還是正在進行配方優化工作？

Yes. Thanks, Biren.

是的。謝謝，Biren。

We're always doing additional experimentation with the formulations, but I think right now we're pretty set with this formulation. We may make a minor change to the formulation, but nothing that would be, I think, considered too significant.

我們一直在對配方進行額外的實驗，但我認為現在我們對這個配方已經相當滿意了。我們可能會對錶述方式做一些小的改變，但我認為，這些改變不會太重大。

Got it. And then for the monthly subcu regimen that you're hoping that that trial later this year, can you maybe disclose how many patients, what type of treatment duration of the three-month study can assume that you would need to run a separate Phase 3 with that regimen later on?

知道了。然後，對於您希望在今年稍後進行試驗的每月皮下注射療法，您能否透露有多少患者，三個月研究的治療持續時間是哪種類型，您可以假設您稍後需要使用該療法進行單獨的第 3 階段？

Yes, we don't know what the steps to the subsequent study would be. It would either be a dedicated longer Phase 2 or Phase 3, not clear yet. And as far as the number of doses, we haven't disclosed that. The first study would be more of a PK study to look at the exposures and what does the exposures look like when you transition someone from a weekly regimen to monthly regimen. So you think not, you know, 50 or 60 per arm, a lot lower than that, more like a PK study.

是的，我們不知道後續研究的步驟是什麼。這將是專用的更長的第 2 階段或第 3 階段，目前尚不清楚。至於劑量數量，我們尚未透露。第一項研究更像是一項 PK 研究，用於觀察暴露情況以及當某人從每周治療方案轉變為每月治療方案時暴露情況如何。所以你認為不是每隻手臂 50 或 60，而是比這低很多，更像是 PK 研究。

But as far as the overall number in this study, we'll disclose that once we start the study. And duration, it's going to take a little while to get up to the top doses. So there is a titration element there. You can't just stop our people at the at the monthly dosing load. So I would say probably a little longer than three months.

但就本研究中的總體數字而言，一旦我們開始研究，我們就會揭露。且持續時間較長，需要一段時間才能達到最高劑量。因此那裡有一個滴定元素。你不能僅僅因為每月的劑量負荷就阻止我們的人民。所以我認為可能要比三個月稍長一點。

Perfect. Thank you.

完美的。謝謝。

Thanks, Biren.

謝謝，Biren。

Thomas Smith, Leerink Partners.

Leerink Partners 的 Thomas Smith。

Hey, guys, good afternoon. Thanks for taking the questions.

嘿，大家下午好。感謝您回答這些問題。

Just with respect to the Phase 2 VENTURE-Oral study, congrats on the [map in a room]. And I was wondering if you could comment at all on the baseline characteristics. Are the patients who have enrolled there and how that compares to the Phase 2 study for injectable 2735?

就 VENTURE-Oral 第 2 階段研究而言，祝賀[房間裡的地圖]。我想知道您是否可以對基線特徵發表評論。那裡招募的患者有哪些？與注射劑 2735 的 2 期研究相比如何？

A great question, Tom and I have not looked at that, the data, demographic data there. What we've seen in the past is that the body weights are right around 100, the BMIs are in the mid-30s. I have no reason to believe this trial would be different, but I don't know. I just haven't looked at that information.

這個問題問得很好，湯姆和我還沒看過那裡的數據、人口統計。我們過去看到的情況是，體重在 100 左右，BMI 在 30 左右。我沒有理由相信這次審判會有所不同，但我不知道。我只是還沒看過那些資訊。

Understood. And then just a follow-up, if I could on the manufacturing and supply front. I appreciate the scaled CordenPharma deal. But could you comment on whether you think you need additional commercial capacity or redundancy and what the plan would be for that? Thanks.

明白了。然後，如果可以的話，我再跟進一下製造和供應方面的情況。我很欣賞 CordenPharma 的規模化交易。但是您能否評論一下您是否認為您需要額外的商業容量或冗餘，以及針對這些容量或冗餘的計劃是什麼？謝謝。

Yes, great question. We do plan to have redundancy across all elements of the supply chain, and that's partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something where to unexpected were to happen. So we do expect to put in place redundancies across the board.

是的，很好的問題。我們確實計劃在供應鏈的所有環節實現冗餘，這部分是為了預測需求，但也只是作為一種安全機制，以便在發生意外情況時有備份。因此，我們確實希望全面裁員。

Got it. That makes sense. Thanks for taking my questions.

知道了。這很有道理。感謝您回答我的問題。

Thanks, Tom.

謝謝，湯姆。

George Farmer, Scotiabank.

加拿大豐業銀行的喬治法默。

Hi, thanks for taking my questions.

你好，謝謝你回答我的問題。

Brian, can you comment on your level of comfort with the food effect or liquid effect on absorption of 2735 that you need to engage in any further exploration or that can be part of the second part of future studies?

Brian，您能否評論一下您對食物或液體對 2735 吸收的影響的滿意程度，您是否需要進行進一步的探索，或者可以將其作為未來研究的第二部分？

Thanks, George.

謝謝，喬治。

We have not done a food effect study. We will do a food effect study and it's a large molecule. So I would certainly expect there to be a food effect. But we haven't done the study at this point.

我們還沒有做過食物效應研究。我們將進行食物效應研究，這是一個大分子。所以我當然期望食物能產生效應。但我們目前還沒有進行這項研究。

Okay. So you're comfortable without understanding that right now before going into any additional studies, do you think? Where is that something that will be elucidated on the outcome of Phase 2?

好的。所以，您認為，在進行任何進一步研究之前，即使現在不了解這一點，您也能安心嗎？關於第二階段的結果，哪裡可以闡明這一點？

We'll see that after we're done with the Phase 2. We have to see what the profile looks like in the Phase 2 study first.

完成第二階段後我們就會看到這一點。我們必須先看看第二階段研究中的情況是什麼樣的。

Okay. And then do you expect any sort of compare competition for API starting materials with Lilly and Novo as certain as Lilly start scaling up manufacturing of tirzepatide for you guys have adequate supply of 2735 going forward?

好的。那麼，您是否預計禮來公司和諾和諾德公司在 API 起始材料方面會出現任何形式的競爭，因為禮來公司肯定會開始擴大 tirzepatide 的生產，因為您未來有足夠的 2735 供應？

Yes. So when we talk to suppliers about that, we have not had anyone raise any alarms on starting materials being in short supply. So I don't know, but no one has meant that to us. So it seems like the starting materials should be available as we scale up.

是的。因此，當我們與供應商談論此事時，並沒有人對原材料短缺發出警報。所以我不知道，但是沒有人對我們說過這個意思。因此，隨著我們擴大規模，起始材料似乎應該可用。

Okay. Thanks.

好的。謝謝。

Thanks, George.

謝謝，喬治。

Yale Jen, Laidlaw & Company.

耶魯仁萊德勞公司。

Good afternoon and thanks for taking the questions.

下午好，感謝您回答問題。

Just like to see what do you anticipate when you thought a Phase 3 study, how many current because you already prepared and what might be the optimum number of sites as the study progresses? And another follow-up question here. Is there any status report in terms of the partnering of either 0214 or 2809? Thanks.

就像看看當您考慮進行第 3 階段研究時您預期什麼，目前有多少個站點因為您已經準備好了，並且隨著研究的進展，最佳站點數量可能是多少？這裡還有另一個後續問題。有沒有關於 0214 或 2809 合作的現況報告？謝謝。

Yes. Thanks, Yale.

是的。謝謝，耶魯。

With the fibroid programs, both are available for licensing. And so we're always receptive to interests in those programs. And there is some interest in the programs, we just don't get a lot of detail on the ongoing and if anything, it's ongoing.

對於肌瘤項目，兩者都可以獲得許可。因此，我們始終樂於接受對這些項目的興趣。人們對這些項目有一些興趣，但我們沒有獲得有關其正在進行的許多細節，如果有的話，它正在進行中。

And with the Phase 3 footprint, hard to give a lot of details on the number of sites. Obviously, big studies. Both of the studies are large. They'll use a lot of the same sites. There is a fair amount of independent sites for each study as well. But we haven't disclosed the number of patients or the number of sites or anything like that at this point.

由於第三階段的足跡，很難提供有關網站數量的詳細資訊。顯然，這是一項大型研究。這兩項研究的規模都很大。他們會使用許多相同的網站。每項研究也都有相當數量的獨立站點。但目前我們還沒有透露患者人數、站點數量或諸如此類的資訊。

Okay, great. Thanks and congrats on the progression.

好的，太好了。感謝並祝賀你的進步。

Thanks, Yale.

謝謝，耶魯。

Jeet Mukherjee, BTIG.

Jeet Mukherjee，BTIG。

Great. Thanks for taking the questions. Two from me.

偉大的。感謝您回答這些問題。我有兩個。

Just given the good maintenance of weight loss you saw in Phase 1 oral study, are you meaningfully evaluating dosing regimen longer than once a day for that? And the second question was just around thoughts of pace of enrollment in your Phase 3 trials given the rapid enrollment you saw in the Phase 2 Oral study? Thank you.

鑑於您在第一階段口服研究中看到的減重效果良好，您是否正在有意義地評估每天一次以上的給藥方案？第二個問題是，鑑於您在第二階段口服研究中看到的快速招募，您對第三階段試驗的招募速度有何看法？謝謝。

Yes. Thanks, Jeet. With the pace of enrollment in Phase 3, much larger studies, but it is encouraging to see the speed of enrollment and the continued high level of interest among study participants and clinicians. So hopefully that continues in Phase 3, but we won't know until we really get it up and running.

是的。謝謝，Jeet。隨著第三階段的招募速度加快，研究規模也更大，但看到招募速度以及研究參與者和臨床醫生持續的高興趣，令人鼓舞。所以希望這種情況在第三階段能夠繼續下去，但我們只有在真正啟動並運行它時才會知道。

With the oral kind of persistence of effect in the Phase 1 study, it is something that we would like to explore in the upcoming maintenance study. So we will likely explore something less frequent than a daily dose in that study.

由於第一階段研究中口服藥物的療效具有持久性，因此我們希望在即將進行的維持研究中進行探索。因此，我們可能會在該研究中探索比每日劑量更低的劑量。

At this time, we must end the call. The company apologizes for those questions that we were unable to answer here. I would now like to turn the conference back over to Stephanie Diaz for any closing remarks.

這時候我們必須結束通話。公司對於我們無法在此回答的問題深表歉意。現在，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. Thank you.

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。謝謝。

The conference has 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。