Viking Therapeutics Inc (VKTX) 2025 Q3 法說會逐字稿

Welcome to the Viking Therapeutics third quarter 2025 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, October 22, 2025.

歡迎參加 Viking Therapeutics 2025 年第三季財務業績電話會議。（操作員說明）提醒各位，本次電話會議將於2025年10月22日進行錄音。

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

現在我將把會議交給維京遊輪的投資者關係經理史蒂芬妮·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 Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, October 22, 2025, and 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, time lines and milestones.

大家好，感謝各位參加今天的電話會議。今天和我一起接受訪問的是維京遊輪總裁兼執行長布萊恩·連，以及維京遊輪首席財務長格雷格·贊特。在開始之前，我想提醒大家，今天（2025 年 10 月 22 日）的電話會議上發表的評論將包含 1995 年美國私人證券訴訟改革法案安全港條款下的前瞻性聲明，包括有關 Viking 對其開發活動、時間表和里程碑的預期聲明。

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.

前瞻性陳述存在風險和不確定性，可能導致實際結果與預期結果有重大不利差異，因此，已公佈的結果不應被視為未來績效的指標。這些前瞻性聲明僅代表截至今日的觀點，本公司不承擔任何義務對今日所作的任何聲明進行修訂或更新。

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

我建議您查閱該公司就這些事項及其他事項向美國證券交易委員會提交的所有文件。

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

現在我將把電話交給布萊恩連，請他發表初步評論。

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the third quarter and nine-months ended September 30, 2025, and review recent progress with our development programs and operations. The third quarter was a busy and productive time for Viking.

謝謝斯蒂芬妮，也祝所有透過電話或網路直播收聽的朋友們下午好。今天，我們將回顧截至 2025 年 9 月 30 日的第三季和前九個月的財務業績，並回顧我們近期在發展計畫和營運方面的進展。第三季度對維京隊來說是忙碌而富有成效的時期。

The early part of the quarter was focused on ramping up our Phase III VANQUISH Obesity program evaluating VK2735, our dual agonist of the glucagon-like peptide on and glucose-dependent insulin entropic polypeptide receptors. Later in the quarter, we were excited to announce positive top line results from a Phase II clinical trial of the oral tablet formulation of VK2735 in patients with obesity.

本季度初，我們重點介紹了 III 期 VANQUISH 肥胖症項目，該項目評估 VK2735，這是一種胰高血糖素樣肽和葡萄糖依賴性胰島素熵多肽受體的雙重激動劑。本季度晚些時候，我們很高興地宣布，VK2735 口服片劑製劑在肥胖患者中的 II 期臨床試驗取得了積極的初步結果。

This trial, called the VENTURE Oral dosing trial successfully achieved its primary and secondary end points with patients receiving VK2735 demonstrating statistically significant reductions in bodyweight compared with placebo. The study also showed VK2735 treatment to be safe and well tolerated through 13-weeks of daily dosing with the majority of treatment-emergent adverse events categorized as mild or moderate.

這項名為 VENTURE 口服給藥試驗的試驗成功達到了其主要和次要終點，接受 VK2735 治療的患者與接受安慰劑治療的患者相比，體重出現了統計學意義上的顯著下降。該研究還表明，在為期 13 週的每日給藥期間，VK2735 治療安全且耐受性良好，大多數治療期間出現的不良事件被歸類為輕度或中度。

In addition to the third quarter clinical activities, we recently announced the initiation of a clinical study to evaluate maintenance dosing with VK2735. This novel study will assess weight loss maintenance using monthly subcutaneous dosing daily oral dosing or weekly oral dosing. I'll have additional comments on our operations and development activities following a review of our third quarter and nine-month financial results.

除了第三季的臨床活動外，我們最近還宣布啟動一項臨床研究，以評估 VK2735 的維持劑量。這項新穎的研究將評估每月皮下注射、每日口服或每週口服的減肥效果。在審查第三季和前九個月的財務表現後，我將對我們的營運和發展活動發表更多評論。

For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

為此，我將把電話轉交給維京遊輪的財務長格雷格·贊特。

Thanks, Brian. 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 shortly. I'll now go over our results for the third quarter and first nine-months of 2025, beginning with the quarter. Research and development expenses were $90 million for the three months ended September 30, 2025, compared to $22.8 million for the same period in 2024.

謝謝你，布萊恩。結合我的發言，我建議各位參閱 Viking 向美國證券交易委員會提交的 10-Q 表格文件，我們預計該文件很快就會提交。接下來，我將介紹我們 2025 年第三季和前九個月的業績，首先從第三季開始。截至 2025 年 9 月 30 日止的三個月，研發費用為 9,000 萬美元，而 2024 年同期為 2,280 萬美元。

The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits and regulatory services, partially offset by a decrease in stock-based compensation. General and administrative expenses were $8.6 million for the three-months ended September 30, 2025, compared to $13.8 million for the same period in 2024.

成長的主要原因是臨床研究、公司候選藥物生產、薪資福利和監管服務等相關支出增加，部分被股票選擇權激勵的減少所抵消。截至 2025 年 9 月 30 日止三個月，一般及行政費用為 860 萬美元，而 2024 年同期為 1,380 萬美元。

The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation. partially offset by increased expenses related to salaries and benefits. For the three-months ended September 30, 2025, Viking reported a net loss of $90.8 million or $0.81 per share compared to a net loss of $24.9 million or $0.22 per share in the corresponding period in 2024.

下降的主要原因是法律和專利服務以及股權激勵相關支出減少，但部分被工資和福利相關支出增加所抵消。截至 2025 年 9 月 30 日的三個月，Viking 公司報告淨虧損 9,080 萬美元，即每股虧損 0.81 美元，而 2024 年同期淨虧損為 2,490 萬美元，即每股虧損 0.22 美元。

The increase in net loss for the three months ended September 30, 2025, and was primarily due to the increase in research and development expenses noted previously compared to the same period in 2024. I'll now go over the results for the first nine-months of 2025. Research and development expenses were $191.5 million for the nine-months ended September 30, 2025, compared to $70.7 million for the same period in 2024.

截至 2025 年 9 月 30 日止三個月的淨虧損增加，主要是由於先前提及的研發費用較 2024 年同期增加。接下來我將介紹2025年前九個月的業績。截至 2025 年 9 月 30 日的九個月，研發費用為 1.915 億美元，而 2024 年同期為 7,070 萬美元。

The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits, stock-based compensation and regulatory services partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $37.1 million for the nine-months ended September 30, 2025, compared to $34 million for the same period in 2024.

成長的主要原因是臨床研究、公司候選藥物生產、工資和福利、股票選擇權激勵以及監管服務等相關支出增加，部分被臨床前研究相關支出減少所抵銷。截至 2025 年 9 月 30 日的九個月期間，一般及行政費用為 3,710 萬美元，而 2024 年同期為 3,400 萬美元。

The increase was primarily due to increased expenses related to stock-based compensation and insurance, partially offset by decreased expenses related to legal and patent services. For the nine months ended September 30, 2025, Viking reported a net loss of $202 million or $1.80 per share compared to a net loss of $74.5 million or $0.69 per share in the corresponding period in 2024.

成長的主要原因是股票選擇權激勵和保險相關費用增加，部分被法律和專利服務相關費用減少所抵銷。截至 2025 年 9 月 30 日的九個月，Viking 公司報告淨虧損 2.02 億美元，即每股虧損 1.80 美元，而 2024 年同期淨虧損為 7,450 萬美元，即每股虧損 0.69 美元。

The increase in net loss for the nine months ended September 30, 2025, was partly 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. Turning to the balance sheet. At September 30, 2025, Viking held cash, cash equivalents and short-term investments of $715 million compared to $903 million as of December 31, 2024.

截至 2025 年 9 月 30 日的九個月淨虧損增加，部分原因是先前提及的研發費用和一般及行政費用增加，部分原因是與 2024 年同期相比利息收入增加。接下來看一下資產負債表。截至 2025 年 9 月 30 日，維京持有現金、現金等價物和短期投資 7.15 億美元，而截至 2024 年 12 月 31 日，這一數字為 9.03 億美元。

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

我的財務回顧到此結束，現在我將把電話交還給布萊恩。

Thanks, Greg. I'll now provide an update on Viking's clinical advancements and other progress from the third quarter, beginning 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 insulin atrophic polypeptide, or GIP receptor. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity.

謝謝你，格雷格。接下來，我將介紹 Viking 在第三季的臨床進展和其他進展，首先介紹我們的主導肥胖症計畫 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萎縮多肽或 GIP 受體的雙重激動劑。Viking公司正在推動VK2735的皮下和口服製劑的研發，用於治療肥胖症。

With respect to the subcutaneous formulation, prior Phase I and Phase II study results demonstrated impressive weight loss as well as encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the multiple dose Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 28-days of once weekly dosing with no signs of plateau.

關於皮下製劑，先前的 I 期和 II 期研究結果表明，每週給肥胖受試者給藥後，體重減輕效果顯著，且安全性、耐受性和藥物動力學也令人鼓舞。在多劑量 I 期研究中，接受 VK2735 治療的受試者在每週一次給藥 28 天后，體重較基線下降了約 8%，且沒有出現平台期跡象。

Following completion of the Phase I studies, the company conducted a Phase II study called the VENTURE study. The results from this study demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13-weekly doses. The study also showed VK2735 to be safe and well tolerated through 13-weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate.

完成第一階段研究後，該公司進行了第二階段研究，稱為 VENTURE 研究。該研究結果表明，經過 13 週的給藥後，平均體重較基線有統計學意義上的顯著下降，降幅高達 14.7%。該研究還表明，VK2735 在 13 週的給藥期間安全且耐受性良好，大多數治療期間出現的不良事件被描述為輕度或中度。

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. These Phase II data were highlighted in a presentation at the 2024 Obesity Week Conference. A manuscript describing the results of the VENTURE study has been accepted for publication in a leading medical journal, which we expect to publish in early 2026.

不良事件通常發生在治療早期，主要與活化 GLP-1 受體引起的預期胃腸道反應有關。這些第二階段的數據在 2024 年肥胖週會議上進行了重點介紹。描述 VENTURE 研究結果的手稿已被頂尖醫學期刊接受發表，我們預計將於 2026 年初發表。

Following completion of the VENTURE study, we scheduled a Type C meeting with the FDA and the subsequent end of Phase II meeting with the agency to review our development plans. Based on feedback from these meetings, the company advanced VK2735 into Phase III development for obesity. In June of this year, the company announced the initiation of the VANQUISH Phase III registration program.

VENTURE 研究完成後，我們安排了與 FDA 的 C 類會議，隨後又安排了與該機構的 II 期結束會議，以審查我們的開發計劃。根據這些會議的回饋，該公司將 VK2735 推進到治療肥胖症的 III 期臨床試驗階段。今年6月，該公司宣布啟動VANQUISH III期註冊計畫。

The VANQUISH program consists of two trials evaluating VK2735, one in adults with obesity and one in adults with obesity and type two diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78-weeks.

VANQUISH 計劃包括兩項評估 VK2735 的試驗，一項針對肥胖成年人，另一項針對肥胖和 2 型糖尿病成年人。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 patients. The VANQUISH-2 study will target enrollment of approximately 1,100 patients. Participants in each of these trials will be randomized to weekly treatment arms of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams 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.

VANQUISH-1 研究的目標是招募約 4,500 名患者。VANQUISH-2 研究計畫招募約 1100 名患者。每項試驗的參與者將被隨機分配到每週接受 7.5 毫克、12.5 毫克、17.5 毫克或安慰劑治療的治療組。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相比，在 78 週治療後體重較基線的百分比變化。

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieved greater than 5%, 10%, 15% and 20% body weight reduction. Each study will include an open-label extension, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

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，包括體重減輕超過 5%、10%、15% 和 20% 的患者百分比。每項研究都將包括一個開放標籤擴展期，讓參與者有機會在主要給藥期結束後繼續接受治療。

Enrollment in the VANQUISH studies has been proceeding well. We currently expect the VANQUISH-1 study to complete enrollment by the end of this year, and we expect the VANQUISH-1 study to complete enrollment in the first quarter of 2026. Along with the development of a subcutaneous formulation, Viking is also advancing an oral tablet formulation of VK2735.

VANQUISH 研究的招募工作進展順利。我們目前預計 VANQUISH-1 研究將於今年底完成入組，並預計 VANQUISH-1 研究將於 2026 年第一季完成入組。除了開發皮下製劑外，Viking 也正在推動 VK2735 的口服藥錠製劑的研發。

The company believes a tablet formulation could represent an attractive option for those who might prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they've already achieved. An important differentiating feature of our obesity program is that both the tablet formulation and the subcutaneous formulation utilizes the same molecule.

該公司認為，片劑配方對於那些可能更喜歡口服療法開始治療的人，或者那些希望保持已經取得的減肥成果的人來說，可能是一個有吸引力的選擇。我們肥胖症治療方案的一個重要差異在於，片劑和皮下注射劑型都使用了相同的分子。

We believe this may reduce the risk of unexpected safety or tolerability challenges that might occur when transitioning patients from one therapeutic to another. A prior Phase I study of 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.

我們認為這可以降低患者從一種療法過渡到另一種療法時可能出現的意外安全性或耐受性問題的風險。先前的 I 期口服製劑研究成功實現了其目標，接受 VK2735 治療的受試者在每日給藥 28 天后，平均體重較基線呈劑量依賴性下降，降幅高達 8.2%。

The Phase I study also demonstrated encouraging safety and tolerability through 28-days at doses up to and including 100 milligrams per day. The majority of observed treatment-emergent adverse events were mild or moderate with most reported as mild. These results were presented at the 2024 ObesityWeek Conference last November.

I 期研究還表明，在 28 天內，每日劑量高達 100 毫克時，藥物具有令人鼓舞的安全性和耐受性。觀察到的治療期間出現的不良事件大多為輕度或中度，其中大多數被報告為輕度。這些結果已於去年 11 月在 2024 年肥胖週會議上發表。

Following these positive Phase I results, in January of this year, we announced the initiation of a Phase II study called the VENTURE-Oral dosing study to evaluate the tablet formation of VK2735 in subjects with obesity. This study was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13-weeks.

繼這些積極的 I 期研究結果之後，今年 1 月，我們宣布啟動一項名為 VENTURE-口服給藥研究的 II 期研究，以評估 VK2735 在肥胖受試者中的片劑形成。本研究是一項隨機、雙盲、安慰劑對照的多中心研究，旨在評估每日一次口服 VK2735 片劑 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 was the percent change in body weight from baseline after 13-weeks of treatment. In the third quarter, the company announced positive top line results from the VENTURE-Oral dosing study. The study successfully achieved its primary and secondary endpoints with impressive reductions in body weight observed as well as an encouraging safety and tolerability profile.

研究的主要終點是治療 13 週後體重較基線的百分比變化。第三季度，該公司公佈了 VENTURE-口服給藥研究的正面初步結果。該研究成功達到了其主要和次要終點，觀察到體重顯著減輕，並且安全性和耐受性良好。

Participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Reductions in body weight were progressive at all doses through the course of the study. Statistically significant differences compared to both baseline and placebo were observed for all doses greater than 15 milligrams starting at week one and continuing throughout the 13-week treatment period.

每天服用一次 VK2735 口服片劑的參與者，在 13 週後平均體重出現統計學意義上的顯著下降，與基線相比下降幅度高達 12.2%。在整個研究過程中，所有劑量組的體重均呈現逐漸下降趨勢。從第一週開始，所有劑量大於 15 毫克的劑量與基線和安慰劑相比均觀察到統計學上的顯著差異，且這種差異持續到整個 13 週的治療期結束。

Up to 97% of subjects in the VK2735 treatment groups achieved at least 5% weight loss compared with 10% of placebo-treated subjects and up to 80% of subjects in VK2735 treatment groups achieved at least a 10% weight loss compared with only 5% of placebo-treated subjects. The VENTURE-Oral dosing study also included an exploratory cohort designed to assess the weight loss maintenance. In this cohort, participants were rapidly up titrated to a 90-milligram daily dose.

VK2735 治療組中高達 97% 的受試者體重減輕了至少 5%，而安慰劑組只有 10% 的受試者體重減輕了至少 10%；VK2735 治療組中高達 80% 的受試者體重減輕了至少 10%，而安慰劑組只有 5% 的受試者體重減輕了至少 10%。VENTURE-口服給藥研究還包括一個探索性隊列，旨在評估體重減輕的維持。在本組受試者中，劑量迅速增加至每日 90 毫克。

After four weeks of daily dosing at 90 milligrams, participants were down-titrated to 30-milligram daily doses and maintained at 30 milligrams daily for seven weeks. Weight loss in this cohort was shown to be rapid and progressive through the 90-milligram treatment period, reaching a mean reduction of 8.1% from baseline. Following down titration to 30-milligram daily doses for seven weeks, mean weight loss was further improved to 9.2% from baseline.

在連續四周每天服用 90 毫克後，受試者逐漸減少劑量至每天 30 毫克，並維持每天 30 毫克的劑量七週。該組受試者在 90 毫克治療期間體重迅速減輕，並持續下降，平均比基線水平減少了 8.1%。在將劑量逐漸降低至每日 30 毫克，持續七週後，平均體重減輕幅度比基線進一步提高至 9.2%。

These results support our belief that an effective weight maintenance may be achieved with a low-dose oral treatment strategy following down titration from either high oral doses or potentially from a sub-cutaneous dosing regimen. The data also suggests that effective weight maintenance might be achieved with doses lower than the 30-milligram strength evaluated in this study.

這些結果支持了我們的觀點，即透過從高口服劑量或皮下給藥方案逐漸減少劑量，採用低劑量口服治療策略，可以有效地維持體重。數據還表明，使用低於本研究中評估的 30 毫克劑量，可能也能有效維持體重。

Importantly, the oral tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13-weeks of once-daily dosing. Among subjects receiving VK2735, 98% of reported drug-related treatment emergent adverse events were characterized as mild or moderate in severity. In addition, 99% of treatment-emergent adverse events that were GI in nature were also reported as mild or moderate.

重要的是，VK2735 的口服藥片配方在 13 週的每日一次給藥中也表現出令人鼓舞的安全性和耐受性。在接受 VK2735 治療的受試者中，98% 報告的與藥物相關的治療中出現的不良事件被描述為輕度或中度嚴重程度。此外，99% 的治療期間出現的胃腸道不良事件也被報告為輕度或中度。

When assessing these results, particularly in the dosing range expected in future studies, we believe the data suggests no meaningful difference overall between GI adverse events among subjects treated with VK2735 compared with placebo. Importantly, GI-related adverse events were generally observed early in treatment with decreasing frequencies reported upon repeat dosing.

在評估這些結果時，尤其是在未來研究預期的劑量範圍內，我們認為數據表明，接受 VK2735 治療的受試者與接受安慰劑治療的受試者之間，胃腸道不良事件總體上沒有顯著差異。值得注意的是，胃腸道相關不良事件通常在治療早期出現，隨著重複給藥，報告的發生頻率逐漸降低。

Across the combined study arms, the weekly rates of nausea or vomiting did not exceed 5% at any point after the third week of the study. The overall tolerability data suggests that future titration regimens, starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile.

在所有研究組中，從研究的第三週開始，每週噁心或嘔吐的發生率均未超過 5%。整體耐受性數據表明，未來的滴定方案，從較低劑量開始，並採用較長的滴定間隔，可能會進一步改善口服 VK2735 的耐受性。

In the coming days, we plan to submit to the FDA and end of Phase II meeting request to discuss potential next steps for oral VK2735. Under normal circumstances, we would expect to hold this meeting later in the fourth quarter of this year. As I mentioned a moment ago, the subcutaneous Phase II VENTURE results were highlighted in the presentation at the 2024 ObesityWeek Conference.

在接下來的幾天裡，我們計劃向 F​​DA 提交 II 期臨床試驗結束會議請求，討論口服 VK2735 的潛在後續步驟。正常情況下，我們預計今年第四季稍後會召開這次會議。正如我剛才提到的，皮下注射 II 期 VENTURE 研究結果在 2024 年肥胖週會議上進行了重點介紹。

This presentation also showed that subjects receiving VK2735 maintain the majority of their weight loss through follow-up visits occurring up to seven weeks after administration of the last dose. This included the 2.5 milligram weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven-weeks after administration of the last dose.

該演示還表明，接受 VK2735 治療的受試者在最後一次給藥後長達七週的追蹤中，大部分體重減輕情況得以維持。這其中包括每週 2.5 毫克的劑量，這是評估的最低劑量，在最後一次給藥後 7 週，超過 90% 的初始體重減輕得以維持。

In a subset of participants, an evaluation of VK2735 plasma levels was conducted at various time points following completion of the 13-week dosing period. We believe the combined PK and durability results from this study support the potential for once-monthly dosing in the maintenance setting. To this end, yesterday, we announced the initiation of a Phase I study designed to evaluate maintenance dosing regimens following initial weight loss achieved with weekly subcutaneous injections.

在部分參與者中，在完成 13 週給藥期後的不同時間點對 VK2735 血漿濃度進行了評估。我們認為，本研究的藥物動力學和耐久性結果綜合表明，在維持治療中，每月一次給藥是可行的。為此，昨天我們宣布啟動一項 I 期研究，旨在評估透過每週皮下注射來實現初步減肥後的維持劑量方案。

In this study, all subjects will receive initial weekly doses of VK2735 for a period of up to 19-weeks. Subjects will subsequently transition to a range of VK2735 maintenance doses, including monthly subcutaneous doses, weekly oral doses, daily oral doses or placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various dosing regimens.

在本研究中，所有受試者將接受初始每週劑量的 VK2735，療程最長可達 19 週。隨後，受試者將過渡到一系列 VK2735 維持劑量，包括每月皮下注射、每週口服、每日口服或安慰劑。本研究的目標是評估 VK2735 在這些不同給藥方案下的安全性、耐受性和藥物動力學特性。

Exploratory endpoints will assess change in body weight from baseline as well as change in body weight from week 19 to the end of the study at week 31. We expect to report the results from this study in the mid 2026-time frame. In addition to the progress we've made this year with our VK2735 program, the company has continued to advance a series of novel agonist targeting the amylin receptor.

探索性終點將評估體重從基線到第 19 週以及從第 19 週到研究結束（第 31 週）期間的體重變化。我們預計將於 2026 年中期公佈這項研究的結果。除了今年我們在 VK2735 專案上的進展外，該公司還繼續推進一系列針對胰淀素受體的新型激動劑的研發。

Early data support our belief that activation of the amylin receptor represents an important additional mechanism for the regulation of appetite and body weight. During the third quarter, we continued to make progress toward an IND, which we expect to file in the first quarter of 2026. The planned Phase I studies will consist of an initial single ascending dose study followed by a multiple ascending dose study.

早期數據支持我們的觀點，即胰淀素受體的活化是調節食慾和體重的重要附加機制。第三季度，我們繼續朝著IND申請取得進展，預計將於2026年第一季提交IND申請。計劃中的 I 期研究將包括一項初始的單次遞增劑量研究，隨後進行一項多次遞增劑量研究。

Finally, as our pipeline progresses, Viking continues to carefully manage its balance sheet to ensure that we are financially positioned to achieve multiple value inflection points. As Greg reported a few minutes ago, the company had $715 million in cash as of the end of the third quarter, which allows us to complete our planned Phase III obesity trials for VK2735, as well as to pursue development of our additional programs.

最後，隨著我們管道的推進，維京繼續謹慎管理其資產負債表，以確保我們在財務上處於有利地位，從而實現多個價值轉折點。正如 Greg 幾分鐘前報導的那樣，截至第三季末，該公司擁有 7.15 億美元的現金，這使我們能夠完成計劃中的 VK2735 III 期肥胖症試驗，並繼續開發我們的其他項目。

In conclusion, during the first three quarters of 2025, the company continued to make strong and steady progress with each of our programs. In June of this year, Viking initiated the Phase III VANQUISH registration program, including trials in patients with obesity and patients with obesity and type two diabetes. Enrollment for these trials is proceeding well, and we look forward to completing enrollment in both studies in the relatively near term.

總之，在 2025 年前三個季度，公司各項計畫均取得了強勁且穩定的進展。今年 6 月，Viking 啟動了 III 期 VANQUISH 註冊計劃，其中包括對肥胖患者和肥胖合併 2 型糖尿病患者的試驗。這些試驗的招募工作進展順利，我們期待在不久的將來完成這兩項研究的招募工作。

In the third quarter, we announced positive top line results from the Phase II VENTURE-Oral dosing study which successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared to placebo. The study also showed VK2735 to be safe and well tolerated through 13-weeks of daily dosing.

第三季度，我們公佈了 II 期 VENTURE-口服給藥研究的積極頂線結果，該研究成功達到了其主要和次要終點，接受 VK2735 治療的患者與接受安慰劑治療的患者相比，體重出現了統計學意義上的顯著下降。該研究還表明，VK2735 在 13 週的每日給藥期間是安全且耐受性良好的。

The study achieved an important development goal, which was to identify a suitable dosing range moving forward. In the near term, we plan to submit an end of Phase II meeting request to the FDA in order to discuss potential next steps with the oral formulation. We also recently initiated a Phase I study of VK2735 designed to evaluate a range of novel maintenance dosing strategies. And we expect to report the results of this study in 2026. This concludes our prepared comments for today. Thanks for joining us.

該研究實現了重要的發展目標，即確定了未來合適的劑量範圍。近期，我們計劃向 F​​DA 提交 II 期臨床試驗結束會議請求，以便討論口服製劑的後續步驟。我們最近也啟動了 VK2735 的 I 期研究，旨在評估一系列新的維持劑量策略。我們預計將於 2026 年公佈這項研究的結果。我們今天的演講到此結束。謝謝您的參與。

And we'll now open the call for questions. Operator?

現在開始接受提問。操作員？

(Operator Instructions) Steve Seedhouse, Cantor.

（操作說明）史蒂夫·西德豪斯，坎托爾。

Thanks for the broad update. Just obviously, enrollment is going very well in Phase III. I wanted to ask if you had any sense of early signs of patient persistence, discontinuation rate? And if you're happy with what you see there on trial execution side. And then on the maintenance study, hoping you could expand on just the 19-week induction versus 12-week maintenance.

感謝您提供如此全面的資訊。很明顯，第三階段的招募工作進展非常順利。我想問一下，您是否對患者的堅持率和停藥率的早期跡像有任何了解？如果你對試驗執行方面所看到的情況感到滿意的話。然後是關於維持治療的研究，希望您能詳細介紹 19 週的導入期與 12 週的維持期之間的差異。

What are you doing during that induction phase? How fast are you titrating patients up what dose is being contemplated there? I would appreciate any details there.

在入職訓練階段，你在做什麼？你們給患者增加劑量的速度有多快？目前考慮的劑量是多少？如果您能提供更多細節，我將不勝感激。

Yes. Thanks, Steve. Yes, the VANQUISH studies have enrolled maybe a little ahead of schedule. I think that reflects a fair amount of enthusiasm for the program. And we're happy to see that nothing notable at this point. We're still pretty early in the treatment windows. There's nothing that's suggestive of any persistence issues or anything like that. It's so far going very well according to plan.

是的。謝謝你，史蒂夫。是的，VANQUISH 研究的受試者招募工作可能比原計劃提前了一些。我認為這反映了大家對這個專案相當高的熱情。我們很高興看到到目前為止沒有什麼特別值得注意的事情發生。目前我們還處於治療窗口期的早期階段。沒有任何跡象表明存在任何持久性問題或其他類似問題。目前一切進展順利，完全符合計畫。

With the maintenance study, we're titrating people up. We can't start the maintenance portion on that -- the level of dose that we're targeting. So you got to titrate up to that dose before transitioning to the monthly cadence. And so we'll titrate people up to 17.5 mg. Some will go up to 22.5%, some to 20, and then we'll have another cohort go up to 15 milligrams.

透過維護研究，我們正在逐步增加人員數量。我們不能以這個劑量水平開始維持治療。所以你需要在過渡到每月一次的用藥頻率之前，先逐步增加劑量。因此，我們將逐步增加劑量，直至達到 17.5 毫克。部分受試者的劑量將達到 22.5%，部分受試者的劑量將達到 20%，然後我們也會安排另一組受試者的劑量達到 15 毫克。

So those titration windows are what takes us to get up to 19 weeks. And it's a little bit of an acceleration in the titration window versus the four-week blocks in the Phase III study. And then I don't know, was there another question on that?

所以，這些滴定視窗需要我們花費長達 19 週的時間。與 III 期研究中的四周週期相比，滴定視窗的調整速度略有加快。然後，我不知道，關於這個問題還有其他問題嗎？

No, that was it. Just can I follow up on the maintenance study? Are you making any changes to just the tablets like the size or dose in the tablets for the maintenance phase? Or like is the auto-injector for the subcutaneous formulation available for this study?

不，就是這樣。我可以跟進一下維護性研究嗎？您是否對維持治療階段的藥片進行任何更改，例如藥片的大小或劑量？或者，這項研究是否可以使用皮下注射劑的自動注射器？

Yes. Good questions. No, there's no auto-injector here. This will be the vial and the syringe form and the tablets are smaller. There's a 17.5% and 27.5% for the dailies and then 110 mg dose for the weekly.

是的。問得好。不，這裡沒有自動噴油嘴。這將以小瓶和注射器的形式出現，而片劑則較小。每日劑量有 17.5% 和 27.5% 兩種規格，每週劑量為 110 毫克。

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

Just following up on the prior question on the maintenance study, are you able to share what the month -- the doses for the monthly subcu daily oral and the weekly oral that are being tested? And I have a quick follow-up after that.

關於維持治療研究，我再補充一下先前的問題，您能否分享一下目前正在測試的每月皮下注射、每日口服和每週口服的劑量？之後我還有一個簡短的後續問題。

Yes. The monthly doses will continue from their last weekly dose. So that's -- the range would be 15, 17.5, 20 and 22.5 on the monthly cadence. And the dailies then will be 17.5 and a second one at 27.5, and then the weekly is 110 mg for the oral --

是的。每月劑量將從上次每週劑量開始繼續。所以，以月節奏計算，範圍將是 15、17.5、20 和 22.5。那麼每日兩次的劑量分別是 17.5 毫克和 27.5 毫克，每週一次的口服劑量為 110 毫克。--

Got it. Is there any reason why the 19 weeks doses are entered it up to 17, 22 and 20. They seem to be a little bit higher than what you're testing in Phase II.

知道了。19 週的劑量為何要輸入到 17、22 和 20 呢？它們似乎比你們在二期臨床試驗中測試的數值略高一些。

Yes. Well, it's right. The reason is we don't know -- we want to explore what is the right monthly dose. And we don't know what that is right now. So it's a little bit of a range finder on what's the right monthly dose level.

是的。沒錯。原因是我們不知道——我們想探索一下合適的每月劑量是多少。我們現在還不知道那是什麼。所以它有點像量程探測器，可以幫助確定合適的每月劑量水平。

Got it. And last question for the (technical difficulty), what are some of the key considerations as you're screening for multiple compounds? Is it just a efficacy and tox profile or potential compatibility with 2735? And will it be a small molecule, peptide, would it be subcu or orally dose?

知道了。最後一個問題（技術難題），在篩選多種化合物時，有哪些關鍵考量？只是功效和毒性特徵，還是與 2735 的潛在相容性？它會是小分子藥物還是勝肽類藥物？給藥途徑是皮下注射還是口服？

Yes. Thanks, Joon. I'd say all of the above are important for us. I think historically, the -- and ours is a peptide. And historically, the amylin peptides formulation has been challenging there. So we look at all of those fairly early in the development program. And I think we have a very good lead here that is the one we're going to bring into the clinic.

是的。謝謝你，Joon。我認為以上所有因素對我們都很重要。我認為從歷史上看，——而我們的是一種勝肽。從歷史上看，胰淀素勝肽的配方一直是那裡的挑戰。因此，我們在開發計劃的早期階段就會考慮所有這些因素。我認為我們目前有一個非常好的領先優勢，我們將把這個優勢帶到診所。

Ryan Deschner, Raymond James.

Ryan Deschner，Raymond James。

My question is, if the maintenance study shows compelling evidence supporting one or more regimen. What's the next clinical step for validating a maintenance regimen and potentially getting it on a future label? And is it a realistic option at all to add an expansion arm to the banker study?

我的問題是，如果維持治療研究顯示出令人信服的證據支持一種或多種治療方案。驗證維持治療方案並有可能將其納入未來藥品標籤的下一步臨床步驟是什麼？在銀行家研究中加入擴展部門是否是現實可行的選擇？

I think that latter question is probably a little more challenging. Those studies are well on their way and adding a monthly regimen to the extension, probably -- it just probably complicates things. I think the next step there would be depending on what the data show a longer study, whether that's a Phase IIb or a Phase III to go right to label language. We don't know yet. We'll have to see what these data show us.

我認為後一個問題可能更具挑戰性。這些研究進展順利，在延期方案中加入每月一次的治療方案，可能只會讓事情變得更複雜。我認為下一步將取決於數據所顯示的結果，進行更長的研究，無論是 IIb 期還是 III 期，以便直接確定標籤語言。我們目前還不知道。我們得看看這些數據會告訴我們什麼。

And then maybe really quick. Can you notice any impact from the government shutdown on either the enrollment for the VANQUISH studies? Or has it had any impact on the timing of the amylin program?

然後可能很快就結束了。政府停擺是否對 VANQUISH 研究的參與人數產生了任何影響？或者說，這是否對胰淀素計畫的進度安排產生了任何影響？

No. We've actually -- I've been surprised that the line of communication with the FDA has been relatively unchanged a little bit of a surprise to us in a good way. So there hasn't been any impact just yet. Where we think it has a possibility of impacting is in the timing of an end of Phase II meeting. I mean we would hope based on when we plan to submit that packet that we would have that meeting by the end of the year.

不。實際上，我感到有些意外的是，與 FDA 的溝通管道基本上保持不變，這讓我們感到有些驚喜，也算是個好消息。所以目前還沒有產生任何影響。我們認為它可能產生影響的地方在於第二階段結束會議的時間表。我的意思是，根據我們計劃提交資料包的時間，我們希望能在年底前召開那次會議。

But I know there's a lot of people involved in those meetings. So we're not sure what, if any, impact of the timing would -- or the shutdown would have on that timing.

但我知道有很多人參與了這些會議。因此，我們不確定時間安排（或說停工）會對時間安排產生什麼影響（如果有的話）。

Thomas Smith, Leerink.

Thomas Smith，Leerink。

This is [William Patel] on for Thomas Smith. Congratulations on issuing the maintenance trial, really excited for those results. I just wanted to clarify what I think I may have heard earlier. So for the daily maintenance regimen, it will be 2 doses, it's going to be 17.5 milligrams and 27.5 milligrams, whereas the monthly or sorry, the weekly oral maintenance will be 100 milligrams.

這位是威廉·帕特爾，他正在替托馬斯·史密斯解說。恭喜發布維護試驗，非常期待試驗結果。我只是想澄清一下我之前可能聽到的一些事情。因此，日常維持治療方案將服用 2 次，劑量分別為 17.5 毫克和 27.5 毫克，而每月或抱歉，每週口服維持治療的劑量為 100 毫克。

Are those the only dose you'll be testing? And then for the 27.5 milligram, Will there be any up titration from the 17.5 to the 27.5? Or will it be directly to the 27.5?

你們只測試這些劑量嗎？那麼對於 27.5 毫克，從 17.5 毫克到 27.5 毫克之間會有遞增滴定嗎？還是直接到27.5？

Yes. On the first part of the question, the oral dose is 17.5 mg a day, 27.5 mg a day, and the weekly is 110 milligrams per week. There won't be a titration to the oral from the subcu, because the subcu exposures are just so much higher than the oral that we wouldn't anticipate any reason to titrate when you transition to the oral.

是的。問題的第一部分，口服劑量為每天 17.5 毫克、每天 27.5 毫克，每週劑量為每週 110 毫克。從皮下注射到口服不會進行劑量滴定，因為皮下注射的暴露量比口服高得多，所以我們預期在過渡到口服時沒有任何理由進行劑量滴定。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Just following on that question. When you move from the weekly injectable to the weekly oral, then at 110 milligrams. You don't believe there needs to be any titration. And there shouldn't be any tolerability issue jumping from the weekly injection to the weekly oral?

我接著剛才的問題問一下。當你從每週注射一次改為每週口服一次時，劑量為 110 毫克。你認為不需要進行滴定。從每週注射改為每週口服，應該不會有任何耐受性問題吧？

I wouldn't think so. I mean maybe that's one of the reasons we're doing the study, but we wouldn't anticipate there to be a significant tolerability challenge there, no.

我不這麼認為。我的意思是，這或許是我們進行這項研究的原因之一，但我們預計不會有嚴重的耐受性問題，不會。

And in any of those cohorts, are you having any kind of down titration for maintenance like you had in the Phase II VENTURE where you had 90 and then you went down to 30?

在這些隊列中，你們是否像在第二期 VENTURE 研究中那樣，對維持治療進行劑量遞減，從 90 人減少到 30 人？

No. I think that's what's happening generally when you're going like from 17.5 mg subcu to 17.5 mg oral, that is the down titration once you're on the oral, a further down titration, we -- that's not contemplated nor is it expected to be required.

不。我認為通常情況下，當你從皮下注射 17.5 毫克減量到口服 17.5 毫克時，就會發生這種情況。一旦開始口服，就需要進一步減量，而我們──既沒有考慮過，也不認為需要這樣做。

Okay. And then I guess, maybe just bigger picture. Can you tell us how you can best leverage the maintenance data, given that there's no real regulatory path to get that maintenance on the label. So is this something that you plan to leverage payers perhaps, given how important persistence is to get ultimate clinical benefit and then further justification to reimburse.

好的。然後我想，或許應該從更宏觀的角度來看問題。鑑於目前沒有真正的監管途徑將維護資訊標註在標籤上，您能否告訴我們如何才能最好地利用維護數據？鑑於堅持治療對於獲得最終的臨床效益以及進一步獲得報銷的合理性至關重要，您是否計劃利用這一點來爭取支付方的支持？

Have you talked to payers about how a maintenance regimen might potentially bring preferential adoption? Just any color around that would be great.

您是否與支付者討論過維持治療方案如何可能帶來優先採用？任何類似的顏色都可以。

Yes. Thanks, Annabel. It's a really important point, and you're exactly right. It's really a big deal to payers, and we've had a lot of discussions with payers, even though it's somewhat early in the commercial planning phase. We think these data could be quite powerful in providing evidence for how to keep people on therapy.

是的。謝謝你，安娜貝爾。這是一個非常重要的觀點，你說得完全正確。對於支付方來說，這確實是一件大事，儘管目前還處於商業規劃階段的早期，但我們已經與支付方進行了許多討論。我們認為這些數據對於如何讓人們堅持接受治療可能具有很強的說服力。

That's the best way to realize the long-term benefits, and that's the way payers will ultimately save money is keeping people on and increasing persistence rates. And that's exactly why we're exploring these different maintenance options.

實現長期效益的最佳途徑，也是支付方最終省錢的方式，就是讓人們繼續接受治療並提高治療持續率。正因如此，我們正在探索這些不同的維護方案。

Hardik Parikh, JPMorgan.

Hardik Parikh，摩根大通。

Congratulations on the progress thus far. I just wanted to ask you, with the recent Pfizer Mattera deal, I was just wondering, could you give your high-level thoughts on just what aspects of the deal you found favorable/unfavorable for Mattera?

祝賀你們迄今為止的進展。我只是想問一下，關於最近輝瑞收購Mattera的交易，您能否就這筆交易中您認為對Mattera有利/不利的方面談談您的看法？

Oh gosh. We typically don't comment on other people's deals. I think it's a much better question for Pfizer or Mattera management team. I don't really have any additional color than what's out there in the public domain.

我的天哪。我們通常不會對他人的交易發表評論。我認為這個問題比較適合問輝瑞或Mattera的管理團隊。除了公共領域已有的顏色之外，我並沒有其他額外的顏色。

Right. And just you talked about the next steps for the oral 275, you talked -- you don't have the FDA meeting later this quarter. Do you think you could have a green light on whether it's proceeding to a Phase IIb or Phase III by end of the year?

正確的。剛才您談到了口服 275 的下一步計劃，您談到了——本季度晚些時候沒有 FDA 會議。您認為今年底能否確定該專案是進入 IIb 期還是 III 期？

We hope to get information that will help us make that decision, whether we receive the final minutes by the end of the year, I don't know if not, it would probably be in the January time frame. But hopefully, we would have some understanding of any potential concerns at the agency with the potential to transition directly to Phase III. But yes, hard to know what the exact timing is right now.

我們希望獲得一些信息，以幫助我們做出決定。至於能否在年底前收到最終的會議記錄，我不知道；如果收不到，可能要等到一月了。但希望我們能夠了解該機構可能存在的任何潛在問題，從而有可能直接過渡到第三階段。但是，目前很難確定確切的時間。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Brian, congrats on all the progress across so many different fronts, including your Pioneering Maintenance Study. Maybe just to shift gears for a moment to bigger picture question. what sort of lessons learned or read across have you gotten from recent dynamics in the oral GLP-1 space? It seems like yesterday's update on Turn 601 kind of shows the high rate of attrition there and especially potential for safety.

Brian，恭喜你在眾多不同領域的進展，包括你的開創性維護研究。或許我們可以暫時轉換話題，探討一個更宏觀的問題。從近期口服GLP-1領域的動態發展中，您有哪些經驗教訓或借鏡之處？昨天關於 Turn 601 的更新似乎顯示了那裡的高損耗率，尤其是安全性方面的潛在風險。

And tolerability concerns with small molecule oral GLP-1s, what do you think is the read across or learnings that are important for your program? And then I had a follow-up, if I could.

對於小分子口服 GLP-1 類藥物的耐受性問題，您認為對您的專案而言，有哪些重要的借鏡或經驗教訓？然後，如果可以的話，我還有一個後續問題。

Yes. Well, I think one thing that we think stands apart with our program is that -- the safety profile looks very strong. The tolerability profile looks very strong as well. We learned a lot from our own the Phase II VENTURE-Oral dosing study about probably best to start at a lower dose than we started there and extend the titration windows.

是的。我認為我們專案的一大亮點是—安全性非常高。耐受性方面也表現非常出色。我們從自己的 II 期 VENTURE-口服給藥研究中學到了很多，例如最好從比我們當時開始的劑量更低的劑量開始，並延長滴定視窗。

But what we saw from that study based on the trajectories was really, really encouraging as we look at a longer-term dosing window. I think what you see in the oral studies generally is -- I mean, it's really difficult small molecule peptide or anything. It's really, really difficult to develop these therapeutics. So the attrition is, I guess, just a reflection of those challenges. But I think we feel really good about where we are in the competitive landscape with the oral peptide.

但從這項研究中，根據軌跡來看，我們在長期給藥窗口期內所看到的景象確實非常令人鼓舞。我認為在口服研究中通常看到的是——我的意思是，小分子勝肽或其他任何東西都非常困難。開發這些療法真的非常非常困難。所以，人員流失我想，正是這些挑戰的體現。但我認為我們對口服勝肽在競爭格局中的地位感到非常滿意。

Okay. And if I could please just ask a quick one on your DACRA IND filing. Can you just talk about what are some of the limiting steps and what sort of work you're doing there?

好的。請問我可以問一下關於您向 DACRA 提交 IND 申請的一個小問題嗎？您能談談有哪些限制性步驟以及您正在採取哪些措施嗎？

Yes. Thanks, Jay. One of the things that we are thinking about with that program just based on the potency looking a little bit better than the dual agonist 2735. One of the things we're trying to understand is a better candidate for oral therapy, since the potency would suggest that if it were to be replicated in oral, you might be able to dose at a fairly reasonably low level.

是的。謝謝你，傑伊。我們正在考慮的其中一點是，該方案的效力似乎比雙重激動劑 2735 略好一些。我們正在努力了解的是，哪種藥物更適合口服治療，因為它的效力表明，如果能以口服的方式複製其療效，或許就可以以相當合理的低劑量服用。

So we're working hard to understand that and would be, I think, a truly differentiated, really exciting compound. I think it's exciting anyway, it's a subcu formulation. But if the oral looks like we think it might, that might be something that's particularly exciting to pursue.

所以我們正在努力了解這一點，我認為這將是一種真正與眾不同、令人興奮的化合物。我覺得這很令人興奮，它是一種亞濃縮配方。但如果口試結果像我們預想的那樣，那可能是一件特別令人興奮的事情。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Yes. B. Riley Securities. Appreciate the detailed updates, Brian. Could you touch on what topics of interest are for this end of Phase II meeting regarding the oral? And how much of the subcu packages relevant here? And if you're looking for anything from the oral semi and the also FDA review also ongoing? And I don't believe I heard from you what dose levels you're contemplating for the next study, whether it be Phase III or Phase IIb for the oral? And then I have a follow-up.

是的。B. Riley 證券。感謝你提供的詳細更新信息，布萊恩。關於口試，您能否談談本次第二階段會議結束前的會議有哪些值得關注的主題？這裡涉及的子套餐有多少？如果您想了解口服半成品以及 FDA 正在進行的審查方面的任何資訊？而且，我好像還沒聽到您提到您正在考慮的下一項研究（無論是口服的 III 期研究還是 IIb 期研究）的劑量水平？然後我還有一個後續問題。

Yes. Thanks, Mayank. No, we haven't disclosed the doses that we would contemplate. We'd like to talk to the FDA about what the overall study design might look like, what the duration might look like, how are safety package looks. One thing we think we are able to leverage is the subcu safety package in the oral when it comes to long-term talks for the oral.

是的。謝謝，Mayank。不，我們還沒有透露我們考慮的劑量。我們想和 FDA 討論整體研究設計方案、研究持續時間以及安全方案的具體內容。我們認為，在進行長期口腔手術時，我們可以利用口腔手術中的皮下安全包。

So that's helpful. But understanding how the existing data would support transitioning to Phase III or for Phase IIb would be better. That's kind of what the goal of the, and the Phase II meeting is.

那很有幫助。但了解現有數據如何支持過渡到 III 期或 IIb 期會更好。這正是第二階段會議的目標。

Okay. And just maybe high level, as you also think about the broader financial structure of the company. Is the CV outcome trial still part of the consideration? And what else commercially you think you need beyond the studies you've talked about like the maintenance study, but are there other studies, any head-to-head studies versus current GLP-1s that are being thought about that we should think as we think about the spend in the next two-years?

好的。而且，或許還需要從更高的層次來考慮，例如從公司的整體財務結構角度來看問題。心血管結局試驗是否仍在考慮範圍？除了您提到的維持治療研究之外，您認為在商業上還需要哪些研究？是否有其他研究，例如與現有 GLP-1 藥物的直接比較研究，我們在考慮未來兩年的支出時應該考慮這些研究？

Yes. I think important studies that would support an NDA filing are kind of blocking and tackling type studies, renal impairment study, a hepatic impairment study, drug-drug interaction studies. These are sort of expected studies to conduct prior to filing. As far as an additional Phase III study or anything like that, nothing contemplated just yet. So we wouldn't anticipate any major expense on that side.

是的。我認為支持新藥申請的重要研究是一些基礎性研究，例如腎功能損害研究、肝功能損害研究、藥物交互作用研究。這些都是提交申請前需要進行的常規研究。至於是否會進行額外的 III 期研究或其他類似研究，目前還沒有任何計畫。因此，我們預計這方面不會有任何重大支出。

Rohit Bhasin, Morgan Stanley.

羅希特‧巴辛，摩根士丹利。

This is Rohit on for Mike. Can you just talk about your expectations for OpEx spend moving forward? Should we continue -- should we expect R&D to continue going up further? And then secondly, given the recent interest and activity in the MASH space, are there still plans to partner VK2809?

這是羅希特替補麥克上場。您能否談談您對未來營運支出的預期？我們是否應該繼續下去－是否應該預期研發投入會持續成長？其次，鑑於最近在 MASH 領域的關注和活動，是否仍有計劃與 VK2809 合作？

I think you -- our OpEx is up from prior quarter, obviously due to the progress on the Phase III activities. And we would expect that pace to continue approximately going forward. It could move around a little bit by quarter, but we would expect these higher levels as we get through the trial.

我認為——我們的營運支出比上一季增加，這顯然是由於第三階段活動的進展所致。我們預計這一速度將在未來繼續保持。每季可能會略有波動，但我們預計隨著試驗的進行，這些水平會越來越高。

And when we consider the MASH space, yes, you're right, Rohit. There is -- obviously, the space has come back a little bit into focus for investors and partners. And yes, I think we have seen a little bit of that uptick in interest. And what you've seen in the in the space generally is this recognition of value, whether it's the M&A we've seen in the obesity space or the M&A we've seen in the mass space we have two fantastically valuable assets in the same company. So I think we're in a really, really good position, and we have seen a little bit of interest in that -- in the MASH asset.

當我們考慮 MASH 領域時，是的，你說得對，Rohit。顯然，投資人和合作夥伴對這個領域的關注度又上升了一些。是的，我認為我們已經看到了這種興趣的輕微增長。而你在這個領域普遍看到的是這種價值的認可，無論是肥胖症領域的併購，還是大眾市場的併購，我們都看到同一家公司擁有兩項極具價值的資產。所以我認為我們處於非常非常有利的地位，而且我們已經看到有人對 MASH 資產表現出了一些興趣。

Yale Jen, Laidlaw & Company.

耶魯‧詹，萊德勞公司。

Congrats on all the progress. I just have two here. The first question is that the if the next step for the oral will be a Phase III eventually, would you consider basically just oral to oral in other words, high dose to low dose or subcu to our transition a little bit like the maintenance study. Then I have a follow-up.

祝賀你們取得的所有進展。我這裡只有兩個。第一個問題是，如果口服藥物的下一步最終是 III 期臨床試驗，您是否會考慮基本上只是口服到口服的過渡，換句話說，從高劑量到低劑量，或者從皮下注射到我們的過渡，有點像維持治療研究。然後我還有一個後續問題。

No, I think the oral study would be more of a traditional, you titrate up to a level and then stay there for 52-weeks, just to stay vanilla and stay within the confines of the guidance.

不，我認為口服研究會更傳統一些，你會逐漸增加劑量，然後保持這個劑量 52 週，這樣才能保持平穩，並符合指導原則。

Okay. Great. And also in terms of both the VANQUISH 1 and 2 study, there's a little bit time gap I guess in terms of completing the enrollment. So although this is a little bit early, it would you anticipate to report both data at the same time or report them sequentially when they are available?

好的。偉大的。另外，就 VANQUISH 1 和 2 研究而言，完成招募方面似乎存在一些時間差。雖然現在問這個問題還為時過早，但您預計會同時公佈這兩組數據，還是會在數據可用時按順序公佈？

Thanks, Yale. Good question. I can't answer that yet because I don't know the actual time difference in when the data would be available. I think historically, what we've seen as far as the reports has been companies report the data when they're available. And so if there's a few months' difference, you'd probably want to report them separately. And it's also important, I think, to give the study its own breathing room, so to speak, and have a single press release on each study.

謝謝耶魯。問得好。我現在還無法回答這個問題，因為我不知道數據實際可用時間會有多大差異。我認為從歷史數據來看，我們看到的都是公司在數據可用時才會公佈數據。因此，如果相隔幾個月，您可能需要分別申報。我認為，同樣重要的是，要給每項研究留出一些時間，讓它們各自有喘息的空間，每項研究只發布一份新聞稿。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Great. Maybe a quick one from us. One is, Brian, I believe you said before in the Phase IIa or Phase I or studies you plan to give us some update on the week of treatment, follow-up and then maybe some PK data. So just curious when -- and yes, the data is still coming in the coming months. And then the other thing is related to the dosing for the oral potential pilot Phase II understanding you haven't disclosed the full detail, but how likely a weekly given you are testing that in the maintenance study?

偉大的。或許我們可以快速地分享一下。布萊恩，我記得你之前說過，在 IIa 期或 I 期研究中，你計劃給我們一些關於治療週、隨訪以及藥物動力學數據的最新信息。所以只是好奇什麼時候公佈——是的，數據仍將在未來幾個月內公佈。還有一點與口服潛在 II 期試驗的劑量有關，雖然您尚未透露全部細節，但考慮到您正在維持研究中測試每週一次的劑量，這種可能性有多大？

And then how should we think about the now starting growth getting towards like 17.5 and 27.5 versus the higher dose as you get for the Phase II.

那麼，我們應該如何看待現在開始增長到 17.5 和 27.5 這樣的水平，以及 II 期試驗中獲得的更高劑量呢？

Yes. Thanks, Roger. Yes, I think we'll have to see what these data show and then go forward with what the that transition from subcu to oral would show for maintenance and make a decision on what the right maintenance dose would be following completion of this study. I think if we plan the phase -- supposing we could go into Phase III for the oral, we would.

是的。謝謝，羅傑。是的，我認為我們必須看看這些數據顯示了什麼，然後再根據從皮下注射過渡到口服的維持治療效果，在完成這項研究後決定合適的維持劑量。我認為如果我們計劃好階段——假設我們可以進入口服的 III 期臨床試驗，我們會這麼做。

If we were to add an extension to the Phase III studies that's the point at which we would think about adding a low-dose maintenance in those studies. So early to make that call right now, but I think we have some time, and we can add doses and make modifications to the extension period if we were to add an extension to the oral studies, again, assuming we can go into Phase III.

如果我們要延長 III 期研究，那時我們會考慮在這些研究中加入低劑量維持治療。現在下結論還為時過早，但我認為我們還有一些時間，如果我們要延長口服研究，我們可以增加劑量並對延長期進行修改，前提是我們能夠進入 III 期。

With respect to the additional data, we've not received the final PK report from the oral dosing study, the ventral oral dosing study. We expect to within the next couple of weeks, but just haven't received that yet.

關於補充數據，我們尚未收到口服給藥研究和腹側口服給藥研究的最終 PK 報告。我們預計在接下來的幾週內收到，但目前還沒有收到。

Andy Hsieh, William Blair.

謝家華，威廉布萊爾。

Congratulations on the likely enrollment phase for the VANQUISH program. So I'm very interesting by the maintenance study as probably everybody else does. So curious about your thoughts on the dose required for maintaining the weight loss during the active weight loss period, versus once patients reach maximum weight loss. So I guess at 19 weeks, it's likely that they're still very much in the active weight loss period.

恭喜VANQUISH計畫即將進入招生階段。所以，我對維護研究非常感興趣，可能其他人也是。我很想知道您對在積極減重期間維持減重效果所需的劑量，以及患者達到最大減重效果後所需的劑量有何看法。所以我覺得到了 19 週，他們可能還處於快速減肥期。

So how are you thinking about extrapolating that data into locations where most of them have reached maximum weight loss and transitioning into the maintenance loss?

那麼，您打算如何將這些數據推廣到大多數人已經達到最大減重目標並過渡到維持減重階段的地區？

Yes. Thanks, Andy. It's a good question. I think the point here is that you're right. Probably most of these people will not have reached the full depth of their weight loss. But our goal really is to understand what is the dose that can prevent weight regain. And I think then it's probably less important, we think that they've reached the nadir versus 40% of the nadir or something like that.

是的。謝謝你，安迪。這是個好問題。我認為關鍵在於你是對的。這些人中可能大多數人還沒有達到減肥的最終目標。但我們的真正目標是了解能夠防止體重反彈的劑量是多少。而且我認為，在這種情況下，我們認為他們已經達到最低點，而不是達到最低點的 40% 之類的，可能就沒那麼重要了。

The goal really is to understand what prevents that regain. It's possible that drive to rebound is greater once you experience a larger amount of weight loss. But I think we'll have a signal anyway here from a pretty substantial weight loss, what can keep them at that body weight. So I don't know that it would be significantly different if you actually hit somebody at the absolute bottom of their weight loss.

真正的目標是了解是什麼阻礙了這種恢復。體重減輕越多，反彈的慾望可能就越強。但我認為，無論如何，我們都能從相當大的體重減輕中得到一些訊號，說明是什麼因素能讓他們維持這樣的體重。所以，我不知道如果你真的在某人減肥的最低谷期進行打擊，結果會不會有很大的不同。

I see. That's fair. Maybe another one. I'm curious about your thinking in terms of Eli Lilly's cardiovascular outcomes in type two diabetes. It seems like additional A1C and weight loss didn't translate into additional cardiovascular protection. So obviously, you have a dual agonist, the same mechanism. So I'm curious about maybe your interpretation of that.

我懂了。這很合理。或許還有另一個。我對禮來公司在第二型糖尿病心血管治療方面所取得的成果很感興趣，想聽聽您的看法。似乎降低糖化血紅蛋白A1C水平和減輕體重並沒有轉化為額外的心血管保護作用。顯然，這是一個雙重激動劑，作用機制相同。所以我很想知道你對此有何解讀。

Yes. I don't think we've seen the full results from that study, so it's hard to know all of the details. I would expect a larger weight loss and accompanying A1C reductions to translate, but I don't think we have all of the details from that particular study.

是的。我認為我們還沒有看到那項研究的全部結果，所以很難了解所有細節。我預計更大的體重減輕和相應的 A1C 降低會有所轉化，但我認為我們還沒有掌握那項研究的所有細節。

Justin Zelin, BTIG.

Justin Zelin，BTIG。

Brian, we talked about the trends and increasing strategic interest in the metabolic disease and OBC space. Can you talk about your latest thinking on how you're thinking about either partnership or let's say, going alone towards commercialization in the obesity fields?

Brian，我們討論了代謝疾病和 OBC 領域的發展趨勢和日益增長的策略關注。您能否談談您最近對肥胖領域商業化的看法，無論是透過合作還是單幹？

Yes. Justin, yes, nothing has changed as far as our position. We're certainly receptive to outside interest and nothing's changed with respect to our thoughts that having a larger party involved would be very helpful in driving the program through commercialization. That said, I don't think it's mandatory. I think it's probably a preference, but it's not mandatory.

是的。賈斯汀，是的，我們的立場沒有任何改變。我們當然歡迎外界的興趣，而且我們仍然認為，有更大的參與者加入將非常有助於推動該計畫的商業化，而這一想法沒有任何改變。也就是說，我認為這並非強制性的。我認為這可能是一種個人偏好，但並非強制性的。

So I think we're prepared to go alone, but we're also prepared to engage with anybody who is interested. And in the meantime, I think it's just execute the Phase III trials and continue the commercial preparation that we've already embarked on.

所以我覺得我們已經做好獨自行動的準備，但我們也準備好與任何有興趣的人合作。同時，我認為我們應該繼續進行三期臨床試驗，並繼續我們已經開始的商業準備。

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。我謹將會議交還給史蒂芬妮·迪亞茲，請她作總結發言。

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

再次感謝您參與並對 Viking Therapeutics 的持續支持。我們期待在接下來的幾個月再次向您報告最新情況。祝你有美好的一天。

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

會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。