Viking Therapeutics Inc (VKTX) 2025 Q4 法說會逐字稿

Welcome to the Viking Therapeutics fourth quarter and full year 2025 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, February 11, 2026.

歡迎參加 Viking Therapeutics 2025 年第四季及全年財務業績電話會議。（操作員說明）提醒各位，本次電話會議將於2026年2月11日進行錄音。

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

現在我將把電話交給維京遊輪的投資者關係經理史蒂芬妮·迪亞茲女士。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.

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。

Before we begin, I'd like to caution that comments made during this conference call today, February 11, 2026, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones. 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. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

在開始之前，我想提醒大家，今天（2026 年 2 月 11 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。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。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 fourth quarter and full year ended December 31, 2025, and review recent progress with our development programs and operations. 2025 was another strong year for Viking, with the company achieving multiple important milestones with our expanding obesity pipeline. With the subcutaneous formulation of our lead molecule, VK2735, following the positive efficacy, safety and tolerability data generated from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program in obesity. The Phase III VANQUISH program includes two studies.

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12月31日的第四季和全年財務業績，並回顧我們研發專案和營運的最新進展。 2025年對Viking而言又是強勁的一年，公司在不斷擴大的肥胖症產品線中取得了多項重要里程碑式的成就。憑藉我們主要分子 VK2735 的皮下製劑，以及從 II 期 VENTURE 研究中獲得的積極療效、安全性和耐受性數據，Viking 啟動了其 III 期 VANQUISH 肥胖症臨床計畫。VANQUISH III 期計畫包括兩項研究。

VANQUISH-1 is evaluating the treatment of adults with obesity, and VANQUISH-2 is evaluating the treatment of adults with obesity and type two diabetes.

VANQUISH-1 正在評估肥胖成人的治療效果，VANQUISH-2 正在評估肥胖和第 2 型糖尿病成人的治療效果。

In the fourth quarter, we announced completion of enrollment ahead of schedule in VANQUISH-1. Enrollment in VANQUISH-2 is nearing completion. With respect to our oral VK2735 program, in the third quarter of last year, the company announced positive top line results from the Phase II VENTURE oral dosing study in patients with obesity. This trial successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. We recently completed an end of Phase II meeting with the FDA regarding next steps with the oral formulation and are excited to advance this program further into development.

第四季度，我們宣布 VANQUISH-1 的招生工作提前完成。VANQUISH-2 的招生工作即將完成。關於我們的口服 VK2735 項目，去年第三季度，該公司宣布了針對肥胖患者的 II 期 VENTURE 口服給藥研究的積極頂線結果。該試驗成功達到了主要和次要終點，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。我們最近與 FDA 完成了關於口服製劑後續步驟的 II 期結束會議，並很高興能進一步推進該專案的開發。

Other important milestones achieved during 2025 include the initiation of a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly subcutaneous dosing, daily oral dosing or weekly oral dosing. Earlier in the year, Viking also signed a comprehensive manufacturing and supply agreement with Corden Pharma to support the potential commercialization of VK2735. Under the terms of the agreement, Corden Pharma will provide large-scale supply of active pharmaceutical ingredients, as well as fill and finish capacities for both our subcutaneous and oral formulations. We believe this agreement provides supply potentially sufficient to support a multibillion-dollar revenue opportunity.

2025 年取得的其他重要里程碑包括啟動 VK2735 的維持劑量研究，以評估各種維持方案的效果，包括每月皮下注射、每日口服或每週口服。今年早些時候，Viking 還與 Corden Pharma 簽署了一項全面的生產和供應協議，以支持 VK2735 的潛在商業化。根據協議條款，Corden Pharma 將為我們的皮下注射和口服製劑提供大規模的活性藥物成分供應，以及填充和包裝能力。我們相信，這項協議提供的供應量可能足以支持數十億美元的收入機會。

Also during the year, the company continued to add key staff in clinical, supply chain and manufacturing roles, and we recently announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. In this role, Neil will oversee the development and execution of our commercial strategy.

今年，該公司繼續在臨床、供應鏈和製造職位上增加關鍵人員，我們最近宣布任命 Neil Aubuchon 為公司首席商務官。尼爾將負責監督我們商業策略的製定和執行。

I will have additional comments on our operations and development activities following a review of our financial results for the fourth quarter and year ended December 31. With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

在審查截至 12 月 31 日的第四季和年度財務業績後，我將對我們的營運和發展活動發表更多評論。接下來，我將把電話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-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31, 2025, beginning with the quarter. Research and development expenses were $153.5 million for the three months ended December 31, 2025, compared to $31 million for the same period in 2024. The increase was primarily due to expenses related to running two Phase III clinical trials, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies.

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-K 表格文件，我們預計該文件很快就會提交。接下來，我將介紹截至 2025 年 12 月 31 日的第四季和全年業績，首先從第四季開始。截至 2025 年 12 月 31 日止的三個月，研發費用為 1.535 億美元，而 2024 年同期為 3,100 萬美元。成長的主要原因是與進行兩項 III 期臨床試驗、股票選擇權補償以及薪資和福利相關的支出，部分被藥物候選產品生產和臨床前研究相關支出的減少所抵消。

General and administrative expenses were $11.3 million for the three months ended December 31, 2025, compared to $15.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation.

截至 2025 年 12 月 31 日止三個月的管理費用為 1,130 萬美元，而 2024 年同期為 1,530 萬美元。下降的主要原因是法律和專利服務相關費用減少，但部分被股票選擇權激勵相關費用增加所抵銷。

For the three months ended December 31, 2025, Viking reported a net loss of $157.7 million or $1.38 per share compared to a net loss of $35.4 million or $0.32 per share in the corresponding period in 2024. The increase in net loss for the three months ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the same period in 2024.

截至 2025 年 12 月 31 日的三個月，Viking 公司報告淨虧損 1.577 億美元，即每股虧損 1.38 美元，而 2024 年同期淨虧損為 3,540 萬美元，即每股虧損 0.32 美元。截至 2025 年 12 月 31 日止三個月的淨虧損增加，主要是由於研發費用增加，部分被一般及行政費用減少和利息收入增加所抵消，與 2024 年同期相比。

I'll now go over the results for the full year ended December 31, 2025. Research and development expenses were $345 million for the year ended December 31, 2025, compared to $101.6 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, regulatory services and consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $48.4 million for the year ended December 31, 2025, compared to $49.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance and salaries and benefits.

接下來我將介紹截至 2025 年 12 月 31 日的全年業績。截至 2025 年 12 月 31 日止年度，研發費用為 3.45 億美元，而 2024 年同期為 1.016 億美元。成長的主要原因是與臨床研究、候選藥物生產、股票選擇權、薪資和福利、監管服務和諮詢相關的支出增加，部分被與臨床前研究相關的支出減少所抵消。截至 2025 年 12 月 31 日止年度，一般及行政費用為 4,840 萬美元，而 2024 年同期為 4,930 萬美元。下降的主要原因是法律和專利服務相關費用減少，但部分被股票選擇權激勵、保險、工資和福利相關費用增加所抵消。

For the year ended December 31, 2025, Viking reported a net loss of $358.5 million or $3.19 per share compared to a net loss of $110 million or $1.01 per share in the corresponding period in 2024. The increase in net loss for the year ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the year ended December 31, 2024.

截至 2025 年 12 月 31 日止年度，Viking 公司報告淨虧損 3.585 億美元，即每股虧損 3.19 美元，而 2024 年同期淨虧損為 1.1 億美元，即每股虧損 1.01 美元。截至 2025 年 12 月 31 日止年度淨虧損增加，主要是由於研發費用增加，部分被一般及行政費用減少和利息收入增加所抵消，與截至 2024 年 12 月 31 日止年度相比。

Turning to the balance sheet. At December 31, 2025, Viking held cash, cash equivalents and short-term investments of $706 million compared to $903 million as of December 31, 2024.

接下來看一下資產負債表。截至 2025 年 12 月 31 日，Viking 持有現金、現金等價物和短期投資 7.06 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. In 2025, Viking made significant progress 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 that has demonstrated promising efficacy, safety and tolerability across multiple clinical trials. Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity. During 2025, we continued to advance both of these formulations further into development.

謝謝你，格雷格。2025 年，Viking 在其領先的肥胖症計畫 VK2735 中取得了重大進展。VK2735 是一種胰高血糖素樣勝肽 1 (GLP-1) 受體和葡萄糖依賴性胰島素萎縮多肽 (GIP) 受體的雙重激動劑，在多項臨床試驗中均表現出良好的療效、安全性和耐受性。Viking公司正在開發VK2735的注射和口服劑型，用於治療肥胖症。2025年，我們繼續推動這兩種配方的進一步研發。

We also initiated a novel study designed to explore maintenance dosing with this compound. With respect to the subcutaneous VK2735 program, the company's prior Phase I and Phase II studies both demonstrated impressive weight loss and encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after four weekly doses with no signs of plateau.

我們還啟動了一項新的研究，旨在探索該化合物的維持劑量。關於皮下注射 VK2735 項目，該公司先前的 I 期和 II 期研究均表明，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均令人鼓舞。在 I 期研究中，接受 VK2735 治療的參與者在接受四周每週一次的治療後，體重較基線下降了約 8%，且沒有出現平台期跡象。

The company's subsequent Phase II VENTURE study demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses with no signs of plateau. The VENTURE 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. Adverse events generally occurred early in the course of treatment, resolved quickly and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor.

該公司隨後進行的 II 期 VENTURE 研究表明，經過 13 週的每週給藥後，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%，且沒有出現平台期跡象。VENTURE 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。不良事件通常發生在治療早期，很快就消退，主要與活化 GLP-1 受體引起的預期胃腸道反應有關。

These results were highlighted in a presentation at the 2025 ObesityWeek Conference in November. The final results were also published last month in Obesity, the peer-reviewed Journal of the Obesity Society.

這些結果在 2025 年 11 月舉行的肥胖週會議上進行了重點介紹。最終結果也於上個月發表在《肥胖症》（Obesity）雜誌上，該雜誌是肥胖症學會的同行評審期刊。

Following the VENTURE study, the company completed a Type C meeting with the FDA as well as an end of Phase II meeting to discuss next steps with the subcutaneous formulation. Based on feedback from the agency, in June of 2025, the company initiated the VANQUISH Phase III registration program. The VANQUISH program consists of two clinical trials evaluating VK2735, one e in adults with obesity a one 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.

在 VENTURE 研究之後，該公司與 FDA 舉行了 C 類會議以及 II 期結束會議，討論了皮下製劑的下一步措施。根據該機構的回饋，該公司於 2025 年 6 月啟動了 VANQUISH 第三階段註冊計畫。VANQUISH 計劃包括兩項臨床試驗，分別評估 VK2735 的療效，一項針對肥胖成人，另一項針對肥胖和 2 型糖尿病成人。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 was designed to target enrollment of approximately 4,500 patients, and the VANQUISH-2 study is targeting enrollment of approximately 1,100 patients. Participants in each trial will be randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15% and 20% weight loss. Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period.

VANQUISH-1 研究的目標是招募約 4,500 名患者，而 VANQUISH-2 研究的目標是招募約 1,100 名患者。每項試驗的參與者將被隨機分配到每週服用 7.5 毫克、12.5 毫克、17.5 毫克或安慰劑的組別。VANQUISH 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，在治療 78 週後體重較基線的百分比變化。次要和探索性終點將評估一系列額外的安全性和有效性指標，包括達到至少 5%、10%、15% 和 20% 體重減輕的患者百分比。每項研究都將包含一個擴展部分，讓參與者有機會在完成主要給藥期後繼續接受治療，包括在最初 78 週治療期內隨機分配到安慰劑的患者。

In November 2025, five months after initiation, we announced that the VANQUISH-1 study was fully enrolled and that enrollment had exceeded the planned 4,500 patient enrollment target. Enrollment in the VANQUISH-2 study is ongoing, and we expect to complete enrollment later this quarter. Both the VANQUISH-1 and VANQUISH-2 studies were initiated using a vial and syringe for administration of VK2735.

2025 年 11 月，在啟動五個月後，我們宣布 VANQUISH-1 研究已完成全部入組，入組人數超過了計劃的 4,500 名患者入組目標。VANQUISH-2 研究的入組工作正在進行中，我們預計將在本季稍後完成入組。VANQUISH-1 和 VANQUISH-2 研究均採用小瓶和注射器給藥 VK2735。

In the fourth quarter of 2025, we initiated a bioequivalent study to allow for the introduction of an auto-injector device, which may represent a more convenient method of administration for some people. We are happy to report that this study was successfully completed, enabling the introduction of the auto-injector for all participants in the VANQUISH program. We expect this transition to occur later this quarter.

2025 年第四季度，我們啟動了一項生物等效性研究，以便引入自動注射器裝置，這對某些人來說可能是一種更方便的給藥方法。我們很高興地報告，這項研究已成功完成，使得VANQUISH計劃的所有參與者都能使用自動注射器。我們預計這一轉變將在本季晚些時候發生。

I will now provide an update on Viking's oral tablet formulation of VK2735. We believe an oral tablet formulation may 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 have already achieved. Preliminary data tracking the recent launch of another oral peptide for obesity has demonstrated promising initial uptake. We believe this indicates continued interest in new weight-loss therapies among both patients and clinicians and represents an expansion of the overall market opportunity.

接下來我將介紹 Viking 公司生產的 VK2735 口服藥錠的最新情況。我們認為，對於那些可能更喜歡以口服療法開始治療的人，或者對於那些希望保持已經取得的減肥成果的人來說，口服片劑製劑可能是一個有吸引力的選擇。近期推出的另一種用於治療肥胖症的口服勝肽的初步數據顯示，其初期市場反應良好。我們認為這顯示患者和臨床醫生對新的減重療法持續保持著濃厚的興趣，也代表著整體市場機會的擴大。

As with our subcutaneous program, prior Phase I and Phase II studies evaluating the oral formulation of VK2735 successfully achieved their objectives. In the Phase I study, cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 daily doses. The Phase I study also demonstrated encouraging safety and tolerability, with the majority of observed treatment-emergent adverse events reported as mild or moderate, with most reported as mild.

與我們的皮下注射方案一樣，先前對 VK2735 口服製劑進行的 I 期和 II 期研究均成功達到了預期目標。在 I 期研究中，接受 VK2735 治療的患者群體表現出劑量依賴性的平均體重下降，在 28 天給藥後，平均體重較基線下降幅度高達 8.2%。I 期研究也顯示出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，其中大多數為輕度。

Following the Phase I study, we completed the Phase II study of VK2735 called the VENTURE-Oral dosing study. In the third quarter of 2025, the company announced positive top line results from this study, with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses greater than 15 milligrams starting at week one e and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks compared with only 5% of placebo-treated subjects.

在第一階段研究之後，我們完成了 VK2735 的第二階段研究，即 VENTURE-口服給藥研究。2025 年第三季度，該公司宣布了這項研究的積極初步結果，接受每日一次片劑治療的參與者在 13 週後平均體重出現了統計學上的顯著下降，與基線相比下降幅度高達 12.2%。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觀察到統計學上的顯著差異，且這種差異一直持續到 13 週的治療期結束。在接受 VK2735 治療的受試者中，高達 80% 的人在 13 週後體重減輕了至少 10%，而接受安慰劑治療的受試者中只有 5% 的人達到了這一目標。

The VENTURE-Oral dosing study also included an exploratory cohort designed to assess weight loss maintenance. In this cohort, participants were rapidly up titrated to a 90-milligram daily dose. 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 at six weeks. Following down titration to 30-milligram daily doses for the remaining seven weeks of the study, mean weight loss was further improved to 9.2% from baseline.

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。經過四周每天服用 90 毫克後，參與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 毫克治療期間體重減輕迅速且持續，六週後體重較基線平均減少了 8.1%。在研究的剩餘七週內，劑量逐漸減少至每日 30 毫克，平均體重減輕幅度較基線進一步改善至 9.2%。

These results support our belief that effective weight maintenance may be achieved with a low-dose oral treatment strategy following down titration from either higher oral doses or potentially from a subcutaneous dosing regimen. The progressive weight loss observed following transition to lower doses also suggests that effective weight maintenance might be achieved with doses lower than the 30-milligram level evaluated in this study. Importantly, the oral tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. Among VK2735 recipients, 98% of drug-related treatment emergent adverse events were characterized as mild or moderate in severity.

這些結果支持了我們的觀點，即透過從較高口服劑量或皮下給藥方案逐漸減少劑量，然後採用低劑量口服治療策略，可以有效地維持體重。過渡到較低劑量後觀察到的體重逐漸減輕也表明，低於本研究中評估的 30 毫克劑量水平的劑量可能也能有效維持體重。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 VK2735 接受治療的患者中，98% 的藥物相關治療中出現的不良事件被描述為輕度或中度。

In the dose range we plan to explore in future studies, we believe the data show no meaningful difference between GI-related adverse events in subjects treated with VK2735 compared with placebo. The tolerability data from the VENTURE-Oral dosing study also suggests that future titration regimens starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile.

在我們計劃在未來研究中探索的劑量範圍內，我們認為數據顯示，接受 VK2735 治療的受試者與接受安慰劑治療的受試者相比，胃腸道相關不良事件沒有顯著差異。VENTURE-口服給藥研究的耐受性數據也表明，未來從較低劑量開始並採用較長滴定間隔的滴定方案可能會進一步改善口服 VK2735 的耐受性。

Following completion of the VENTURE-Oral dosing study, we held an end of Phase II meeting with the FDA to discuss potential next steps in the oral clinical development program. Based on feedback from the agency, the company plans to advance oral VK2735 into Phase III development for obesity. We currently expect to initiate this program in the third quarter of this year, and we'll provide more details on study design in the coming months.

在完成 VENTURE-口服給藥研究後，我們與 FDA 舉行了 II 期結束會議，討論口服臨床開發計劃的潛在下一步措施。根據監管機構的回饋，該公司計劃將口服 VK2735 推進至治療肥胖症的 III 期臨床試驗階段。我們目前預計將於今年第三季啟動該計劃，並將在未來幾個月提供有關研究設計的更多細節。

A unique and differentiating characteristic of VK2735 is its extended half-life and PK profile relative to other agents. We believe this provides an opportunity to introduce dosing regimens that potentially improve convenience and flexibility for some patients. An important factor in this differentiation is the ability to use the same dual-acting GLP-1 and GIP co-agonist molecule in both subcutaneous and oral formulations. This affords patients the ability to remain on the same active compound during their treatment with either the tablet or injection formulations and may lead to reduced side effects compared with options that require switching between different therapeutic agents. We believe this could improve adherence to treatment, which is a key element in realizing the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function and increased quality of life.

VK2735 的一個獨特且區別於其他藥物的特徵是其半衰期和藥物動力學特徵較其他藥物更長。我們認為這為引入可能提高部分患者用藥便利性和靈活性的給藥方案提供了機會。這種差異的一個重要因素是能夠在皮下和口服製劑中使用相同的雙效 GLP-1 和 GIP 共激動劑分子。這樣一來，患者在接受片劑或註射劑治療期間，就可以繼續使用同一種活性成分，與需要在不同治療藥物之間切換的治療方案相比，副作用可能會減少。我們相信這可以提高治療依從性，這是實現減重長期益處（如改善心血管健康、增強身體機能和提高生活品質）的關鍵因素。

To further explore VK2735's potential for novel dosing, in the fourth quarter of 2025, we initiated the Phase I study to evaluate a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735 for 19 weeks. Subjects will subsequently transition to a range of maintenance regimens, including monthly, weekly and every other week subcutaneous doses, as well as 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. 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.

為了進一步探索 VK2735 的新型給藥方案的潛力，我們在 2025 年第四季啟動了 I 期研究，以評估一系列維持給藥方案。在本研究中，所有受試者將接受為期 19 週的每週一次的 VK2735 初始劑量。受試者隨後將過渡到一系列維持治療方案，包括每月、每週和每隔一週的皮下注射，以及每週口服、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。探索性終點將評估體重從基線到第 19 週的變化，以及從第 19 週到研究結束（第 31 週）的體重變化。

In January, we announced that enrollment in the maintenance study was complete, and we currently expect to report the results in the third quarter of this year. Beyond our VK2735 program, in 2025, we made significant progress advancing a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor represents an important potential mechanism for the regulation of appetite and body weight. We have continued to make progress with our lead amylin agonist, and we expect to file an IND for this program later this quarter.

今年一月，我們宣布維持治療研究的招募工作已經完成，目前預計今年第三季公佈研究結果。除了我們的 VK2735 計畫之外，在 2025 年，我們在推進一系列新型胰淀素受體激動劑方面取得了重大進展。早期數據表明，胰淀素受體的活化是調節食慾和體重的重要潛在機制。我們在主要胰淀素激動劑方面持續取得進展，預計將於本季稍後提交該計畫的IND申請。

As Viking's pipeline expands and matures, we continue to carefully manage other key corporate matters to support and optimize our programs. As part of this process, we have increased staffing across a range of scientific and operational roles, including supply chain management, manufacturing and quality. In addition, in January of this year, the company announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. Neil brings more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions within the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735, and we are excited to have him on board at this important time in the company's evolution.

隨著 Viking 的管道不斷擴大和成熟，我們將繼續謹慎管理其他關鍵的公司事務，以支援和優化我們的專案。作為這個過程的一部分，我們增加了各個科學和營運職位的員工人數，包括供應鏈管理、製造和品質等。此外，今年1月，該公司宣布任命尼爾‧奧布雄為公司商務長。Neil擁有超過20年的行業經驗，其中包括在禮來公司近17年的工作經驗。他曾在心血管代謝領域的全球商業和行銷職能部門擔任領導職務，這使他具備獨特的資格來領導我們 VK2735 的商業策略，我們很高興在這個公司發展的重要時刻有他加入。

With respect to further commercial preparation, in 2025, Viking also signed a broad manufacturing agreement with CordenPharma, a global leader in peptide manufacturing, to supply large-scale active pharmaceutical ingredient as well as fill and finish capabilities for both our subcutaneous and oral formulations. This comprehensive and fully transferable agreement allows us to hit the ground running at the appropriate time and is a sufficient scale to enable meaningful revenue generation.

關於進一步的商業準備，Viking 還於 2025 年與勝肽類藥物製造領域的全球領導者 CordenPharma 簽署了一項廣泛的生產協議，由 CordenPharma 為我們的皮下和口服製劑提供大規模的活性藥物成分以及填充和包裝能力。這項全面且完全可轉讓的協議使我們能夠在適當的時候迅速開展工作，並且規模足以產生可觀的收入。

Finally, we continue to carefully manage our balance sheet to ensure that we are financially positioned for success. As Greg reported a few minutes ago, the company held over $700 million in cash at the end of 2025, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials for VK2735 as well as pursuing development of our additional programs.

最後，我們將繼續謹慎管理資產負債表，以確保我們在財務上處於有利地位，從而取得成功。正如 Greg 幾分鐘前報導的那樣，到 2025 年底，公司將擁有超過 7 億美元的現金，這使我們能夠實現重要的公司里程碑，包括完成我們正在進行的 VK2735 III 期肥胖症試驗，以及推進我們其他項目的開發。

In conclusion, 2025 was a year of important clinical achievements which position us to execute and increase the opportunities for our pipeline in the years ahead. We expect both our subcutaneous and oral VK2735 programs to be in Phase III trials this year, setting the stage to potentially introduce the industry's first oral and subcutaneous therapeutic options, utilizing the same dual GLP-1 and GIP coagonist molecule. In addition, our maintenance study results are expected later this year, providing an opportunity to further differentiate our programs with novel dosing regimens.

總之，2025 年是我們在臨床方面取得重要成就的一年，這為我們在未來幾年執行和增加研發管線的機會奠定了基礎。我們預計今年皮下注射和口服 VK2735 計畫都將進入 III 期試驗，這將為推出業內首個口服和皮下治療方案奠定基礎，該方案採用相同的雙重 GLP-1 和 GIP 共激動劑分子。此外，我們的維持治療研究結果預計將於今年稍後公佈，這將為我們透過新的給藥方案進一步區分我們的計畫提供機會。

Our amylin program is expected to advance into clinical development shortly, adding further depth to our weight loss portfolio. We have also established a foundation for commercial activities by entering into a comprehensive manufacturing agreement, appointing commercial leadership and maintaining a strong balance sheet to support us through key upcoming milestones. We look forward to providing further updates in the coming quarters.

我們的胰淀素計畫預計很快就會進入臨床開發階段，進一步豐富我們的減重產品組合。我們還透過簽訂全面的生產協議、任命商業領導層和保持強勁的資產負債表，為商業活動奠定了基礎，以支持我們度過即將到來的關鍵里程碑。我們期待在接下來的幾季提供更多最新消息。

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

我們今天的演講到此結束。感謝各位的參與，現在我們開始接受提問。操作員？

(Operator Instructions) Steve Seedhouse, Cantor Fitzgerald.

（操作說明）史蒂夫·西德豪斯，坎托·菲茨杰拉德。

Hi, thank you. This is [Timur Vanica] on for Steve. Congratulations on the oral program advancement to Phase III. So first, could you talk about whether you will also need to run a Phase III study in patients with diabetes? And then, did you receive any feedback from the FDA on improving nausea rates even in the placebo arm, perhaps to lower the nausea rates with extended titration regimen? Thank you.

您好，謝謝。我是蒂穆爾·瓦尼卡，替史蒂夫上場。恭喜您透過口試計畫進入第三階段。首先，您能否談談是否還需要對糖尿病患者進行 III 期研究？那麼，您是否收到 FDA 關於改善安慰劑組噁心發生率的任何回饋，例如透過延長滴定方案來降低噁心發生率？謝謝。

Hi Timur, thanks for the questions. We're probably not going to get into too many details with respect to the specifics of the communication from the FDA, but I think we feel pretty comfortable with the transition into Phase III. What was the first part of that question again?

蒂穆爾，你好，謝謝你的提問。我們可能不會過多談及 FDA 溝通的具體細節，但我認為我們對進入 III 期臨床試驗感到相當有信心。那題的第一部分是什麼來著？

Phase III.

第三階段。

Oh, yes, yes. So we'll talk about all the design elements as we get closer to launch. But you might imagine that it would parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm.

哦，是的，是的。所以，隨著發布日期的臨近，我們會討論所有的設計元素。但你可以想像，它的整體設計典範與 VANQUISH-1 和 VANQUISH-2 相似。

Thank you very much.

非常感謝。

Thanks, Tim.

謝謝你，提姆。

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

Hey guys, congrats on the progress and thanks for taking our questions. A lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of [row and HIS]. Does this change your go-to-market strategy? And would you consider partnering with either [Row or HIMS] or someone like them to help sell 2735?

各位，恭喜你們取得的進展，感謝你們回答我們的問題。自從你開始第三階段計畫以來，肥胖領域發生了許多變化，包括日益增長的影響力…[行和 HIS]。這會改變你的市場推廣策略嗎？您是否考慮與 Row 或 HIMS 或類似公司合作，以協助銷售 2735？

And also, we appreciate that you don't need an outcomes trial in obesity, but since the competition has, they have outcomes data, would you need to generate outcomes data to be reimbursed by payers? Or would your focus be more on the cash paying patients? And by the way, does the $700 million in cash cover the expense for developing oral 2735? Thank you.

另外，我們理解您不需要進行肥胖症的結果試驗，但既然競爭對手有結果試驗，他們就有結果數據，您是否需要產生結果數據才能獲得支付方的報銷？還是您會更關注自費患者？順便問一下，這 7 億美元現金是否足以支付口服 2735 的研發費用？謝謝。

Thanks, Joon. A lot to unpack there. I'll go through the first part and then let Neil comment on the commercial strategy. What was the -- yes. Yes.

謝謝你，Joon。這裡面有很多資訊需要分析。我先講解第一部分，然後讓尼爾對商業策略發表評論。是什麼——是的。是的。

As far as partnering, there are a lot of different options available to us. And I think those companies are -- they provide a pretty good avenue to access the market, but probably not something that we're going to disclose at this point. But a lot of different options available to us. Neil, do you want to add to that? Our new Chief Commercial Officer is here.

在合作方面，我們有許多不同的選擇。我認為這些公司——它們提供了一條很好的進入市場的途徑，但目前我們可能不會透露這些資訊。但我們有很多不同的選擇。尼爾，你還有什麼要補充的嗎？我們的新任首席商務官到崗了。

Yes. Thanks, Joon. Look, I think there's -- what I always say on this is that there are some disadvantages with being a small company, but there's also some advantages. And as you point out, things are changing very, very rapidly. And we're starting here really from a blank slate.

是的。謝謝你，Joon。你看，我認為——我一直都說——小公司有一些劣勢，但也有一些優勢。正如你所指出的，情況變化非常非常快。我們現在真的是從一張白紙開始。

And so that we can take a look at the market with a blank slate mentality and think about where it's heading not just today, but where it's going to be a couple of years from now and optimize our commercial strategy accordingly.

這樣我們就可以以全新的視角看待市場，思考它不僅在今天會走向何方，而且在未來幾年內會走向何方，並據此優化我們的商業戰略。

So as Brian said, we wouldn't disclose what that strategy is at this moment. But suffice to say that we're looking at all options and all channel possibilities and deciding what's going to be the right approach for us. But the fact that we have flexibility is something that is an advantage for us for sure.

正如布萊恩所說，我們目前不會透露該策略是什麼。但總而言之，我們正在考慮所有選項和所有管道的可能性，並決定哪種方法對我們來說是正確的。但我們擁有靈活性這一點，對我們來說無疑是一大優勢。

And you're right to say, Joon, that the space is really evolving on a weekly basis. And so what might look attractive today might be different when we're getting set to launch. I mean I think two years ago, people probably wouldn't have given a lot of credence to the compounding avenue or some of these other partnering opportunities, where now, they're very important players in the space. So rapid evolution here, and we'll be able to, I think, adapt quickly to whatever the market dictates at that time.

你說得對，Joon，這個領域確實每週都在改變。因此，今天看起來很有吸引力的東西，到了我們準備發布的時候，可能就不一樣了。我的意思是，我認為兩年前，人們可能不會太重視複利投資或其他一些合作機會，而現在，它們已成為該領域非常重要的參與者。所以這裡發展迅速，我認為我們能夠迅速適應屆時市場的任何變化。

And Joon, on the cash front, yes, the short answer is we do have sufficient cash to get through three major catalysts, including the upcoming maintenance trial, data from our Phase III subcu trials. And also, yes, the oral Phase III trials get into top line data, we are sufficiently funded to get there.

Joon，關於現金方面，是的，簡而言之，我們確實有足夠的現金來應對三個主要催化劑，包括即將進行的維持試驗和我們 III 期皮下試驗的數據。是的，口服 III 期試驗一旦獲得初步數據，我們就有足夠的資金來實現這一目標。

Great. Thank you so much.

偉大的。太感謝了。

Hardik Parikh, JPMorgan.

Hardik Parikh，摩根大通。

Hey, thank you very much for the time and Congratulations on the update so far. I was just wondering on the Phase III, I understand you can't give much detail there. I was just wondering on the design of actual tablet itself. I remember in the Phase IIa program, you guys used tablets that were in 30-milligram increments. Would you consider anything different here for the design of the tablet itself for Phase III?

嘿，非常感謝您抽出時間，也祝賀您目前的更新進展順利。我只是想了解第三階段的情況，我知道你不能透露太多細節。我只是對平板電腦本身的設計感到好奇。我記得在 IIa 期試驗中，你們使用的是 30 毫克劑量的藥片。對於第三階段的平板電腦設計，您是否考慮過做出一些不同的改變？

Yes. That's a good question, Hardik. Yes, and again, like you mentioned, we'll give all details at the appropriate time. But the tablet size and tablet count were a little high in that Phase II study. We learned a lot from that.

是的。問得好，哈迪克。是的，正如您所說，我們會在適當的時候提供所有細節。但在該 II 期研究中，藥片的尺寸和數量都略高。我們從中學到了很多。

So we'll be reducing both of those in the upcoming Phase III program, both the size and the count.

因此，在即將開始的第三階段計劃中，我們將減少這兩個方面，即規模和數量。

Andy Hsieh, William Blair.

謝家華，威廉布萊爾。

Oh, great, thanks for taking our questions. So maybe two parter, if you don't mind. For the maintenance study, I'm curious about your view on successes. I mean, there's a lot of different scientific questions you're asking. But just in light of ortho with the [attainment can] actually gaining 5 pounds, I'm just curious about your view on what success looks like?

哦，太好了，謝謝你們回答我們的問題。如果可以的話，或許可以分成兩個部分。關於維護研究，我很想聽聽您對成功的看法。我的意思是，你提出的問題有很多不同的科學問題。但考慮到骨科手術後體重實際上增加了 5 磅，我很好奇您認為成功是什麼樣的？

Second part, it has to do with the Phase III trial. I know you kind of frame it as an oral Phase III trial, but is it possible to include, let's say, like a subcu arm that basically titrate patients until the maximum weight loss is obtained and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy? Thank you.

第二部分與 III 期試驗有關。我知道你們將其定位為口服 III 期試驗，但是否有可能加入，比如說，一個皮下注射組，基本上是逐步調整患者劑量，直到達到最大減重效果，然後過渡到口服，從而探索更長期的維持劑量策略？謝謝。

Yes. Thanks, Andy. Really good questions. What does success look like? Well, we look at 3, I guess, major buckets there.

是的。謝謝你，安迪。問得真好。成功是什麼樣的？嗯，我想，我們主要關注以下三個面向。

Everybody titrates up to this high weekly level. And then you have some people transitioning to monthly injections, some transitioning to every other week injections, some transitioning to oral daily and some transitioning to oral weekly.

每個人的用量都會逐漸增加到這個較高的每週用量水準。然後，有些人過渡到每月注射一次，有些人過渡到每兩週注射一次，有些人過渡到每天口服一次，有些人過渡到每週口服一次。

So after that transition to the maintenance period, I think the best case scenario would be you see a continued progression of weight loss. That would indicate that you could continue on after the initial weekly dose and continue to lose weight with a less frequent dosing regimen. I think the base case is that you would stay flat and prevent weight regain once you've into the maintenance portion of the study. And then obviously, the least desirable -- although it will depend on the data -- the least desirable would be a rebound following the transition.

所以，在過渡到維持期之後，我認為最好的情況就是體重持續下降。這表明，在最初的每週劑量之後，您可以繼續服用，並以較低的給藥頻率繼續減肥。我認為基本情況是，一旦進入研究的維持階段，你的體重就會保持平穩，防止反彈。顯然，最不希望看到的——儘管這取決於數據——是轉型後的反彈。

I think we're favorably positioned there because of the extended half-life. So I think we should have good coverage at the doses we're exploring to activate the receptors through the course of the month, but we won't know. I think an important question also is when you reduce the frequency and you are still at that elevated dose, do you reintroduce any sort of GI signal. And what we've seen from other agents being dosed less frequently is that seems to be less of a risk than maybe we thought earlier on.

我認為我們在這方面處於有利地位，因為其半衰期較長。所以我認為，在我們正在探索的劑量下，我們應該能在一個月內很好地激活受體，但我們無法確定。我認為一個重要的問題是，當你降低給藥頻率但劑量仍然很高時，是否會重新引入任何胃腸道訊號。我們從其他藥物減少給藥頻率的情況中看到，這似乎比我們之前認為的風險要小。

As far as the -- sorry, the transition for what the maintenance or the extension window might look like in the VANQUISH studies, yes, we're not sure. We'd like to see these data and then let that drive what the extension window might look like. I mean right now, the extension in the VANQUISH studies allows people who are on placebo to continue on and be guaranteed access to therapy. But if we see something really intriguing in the maintenance study, we may have some options to introduce a less frequent dosing regimen or other regimen into that maintenance window for the VANQUISH study. So I think you were asking more about the oral Phase IIIs, but we may have an opportunity to do something creative in the extension for the VANQUISH studies.

至於——抱歉，VANQUISH 研究中維護或擴展視窗的過渡情況，是的，我們不確定。我們希望看到這些數據，然後根據這些數據來決定擴展視窗的外觀。我的意思是，目前 VANQUISH 研究的延期允許服用安慰劑的人繼續接受治療，並保證他們能夠獲得治療。但是，如果我們在維持治療研究中發現一些真正有趣的東西，我們可能會有一些選擇，在 VANQUISH 研究的維持治療窗口期內引入較少頻率的給藥方案或其他方案。所以我覺得你問的更多是關於口服 III 期試驗，但我們或許有機會在 VANQUISH 研究的擴展階段做一些創新性的事情。

Thank you so much for answering the questions.

非常感謝您回答這些問題。

William Wood, B. Riley Securities.

威廉·伍德，B. Riley 證券公司。

Hi, yes, and thank you for taking our questions and congratulations on a very nice quarter and year for that matter. Just curious in terms of your Phase I maintenance, it looks like you've split your 15 mg once every month into a once every two weeks dosing. And so I'm just kind of curious on what the decision was behind that in terms of PK modeling and then also potentially just sort of GI, how that may actually lead to further insight on what you can do with maintenance?

您好，是的，感謝您回答我們的問題，並祝賀您度過了一個非常成功的季度，也祝賀您今年取得了非常出色的成績。我只是好奇你的第一階段維持治療方案，看起來你把每個月一次的 15 毫克劑量分成了每兩週一次的劑量。所以我很好奇，從 PK 模型和 GI 的角度來看，這個決定背後的考量是什麼，以及這可能如何能讓我們更深入地了解維持治療方面可以做些什麼？

Yes. Thanks, William. Yes, we originally planned to do the 15 mgs once monthly. Once we got the trial underway, we started receiving more and more of these comments from investigators and just from our own market research that people were going to less frequent regimens every two weeks, every three weeks. And we thought, well, since we've got the study up and running, we could split that 15 into [27.5] and get an answer at a lower every other week maintenance dose.

是的。謝謝你，威廉。是的，我們最初計劃每月服用一次 15 毫克。一旦試驗開始，我們就從研究人員和我們自己的市場調查中收到了越來越多的此類評論，即人們正在轉向每兩週、每三週進行一次的治療方案。我們當時想，既然我們已經開始進行這項研究，我們可以把 15 分成 [27.5]，然後以較低的每隔一周的維持劑量來獲得答案。

And we didn't have an every other week regimen in there. So it seemed like an opportune time to make a slight adjustment there while retaining those higher dose -- higher strength of monthly doses.

而且我們當時也沒有每隔一週進行一次的治療方案。所以，這似乎是一個合適的時機，在保持較高劑量（每月較高劑量強度）的同時，對那裡進行一些調整。

Thank you. And then also just maybe thinking about the end of Phase II outcome and sort of the Phase III trials coming up. When we say trials, should we expect 1? Or do you think we can probably get -- or do you think it will be more 2? And then in terms of size, do you think we can get a reduced size sort of based on what we are -- since it is the same molecule based on what we've seen in the VANQUISH trials?

謝謝。然後，或許還會想到 II 期臨床試驗的最終結果，以及即將到來的 III 期臨床試驗。當我們說試驗時，我們應該預期會有 1 次嗎？還是你認為我們大概能得到──或者你認為會是2？那麼就尺寸而言，您認為我們能否根據我們所看到的——因為根據我們在 VANQUISH 試驗中看到的，它是相同的分子——來獲得更小的尺寸呢？

Yes, great question. As I said earlier, probably it's going to look like the VANQUISH program. So I think you could do a single study and have diabetes patients in there as well, but it's likely cleaner to keep them separate and do two studies. And your point about same molecule, that's a really important point. And you might imagine that, yes, we would be able to leverage some of the data generated in the subcu program to reduce the overall size of the oral Phase III program, and that's very important to leverage some of those data.

是的，問得好。正如我之前所說，它可能會看起來像 VANQUISH 程式。所以我認為你可以做一項研究，把糖尿病患者也納入其中，但最好還是將他們分開，做兩項研究，這樣可能更清晰明了。你提到的同一種分子這一點，非常重要。你可能會認為，是的，我們可以利用皮下注射計畫產生的一些數據來減少口服 III 期計畫的整體規模，而利用這些數據非常重要。

Got it. Very helpful. I'll hop back in the queue. Thank you again for taking our questions and very nice quarter. Thank you.

知道了。很有幫助。我重新排隊。再次感謝您解答我們的問題，這個季度過得非常愉快。謝謝。

Thanks, William.

謝謝你，威廉。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Great. Congrats for the update. I understand that you will give us more detail around the Phase III oral design. Just curious about the thinking around the duration. Given you -- this is oral [map], do you think about -- can test this a little bit shorter than the VANQUISH right now, maybe making this [order] and the subcu can get to the Phase III result relatively close and get those two into the label and approval in the relatively similar time fashion? And another question is anything you need to finish or generate before you start the Phase III oral in 3Q?Thank you.

偉大的。恭喜您更新成功。我知道您將向我們提供有關 III 期口服設計的更多細節。只是好奇關於時長安排的想法。鑑於這是口服[地圖]，您是否考慮過——能否比現在的 VANQUISH 測試時間更短一些，或許可以使這種[訂單]和皮下注射能夠相對接近地獲得 III 期結果，並在相對相似的時間內將這兩種藥物納入標籤並獲得批准？還有一個問題，在第三季開始三期口服試驗之前，您還需要完成或準備哪些工作？謝謝。你。

Yes. Thanks, Roger. Really good questions. I think good point. The trial duration we expect in the oral program will likely be not as long as the VANQUISH study.

是的。謝謝，羅傑。問得真好。我覺得你說得對。我們預期口服試驗計畫的試驗持續時間可能不會像 VANQUISH 研究那麼長。

So you could see a reduction in the length, possibly. You could see a reduction in the size, and you might see a reduction in the intensity of clinic visits. And all of those might speak to a cheaper and more efficient execution on the Phase III program orally -- oral Phase III program. And that might compress that window from the availability of all of the subcu Phase III data and the oral Phase III data. Likely still be separate filings, but I wouldn't anticipate that as being a dramatic delay between the two, given the efficiencies of the oral program.

所以長度可能會縮短。你可能會看到就診次數減少，也可能會看到門診就診頻率降低。所有這些都可能表明，第三階段試驗項目可以透過口頭方式以更便宜、更有效率的方式進行——第三階段試驗項目。這可能會縮短獲得所有皮下注射 III 期數據和口服 III 期數據的窗口期。雖然可能仍會分別提交申請，但考慮到口頭程序的效率，我預計兩者之間不會出現明顯的延遲。

Got it. Thank you. Anything -- any data you need to generate before you start the Phase III oral in 3Q?

知道了。謝謝。有什麼需要收集的數據嗎？例如在第三季開始 III 期口服試驗之前需要產生哪些數據？

No, nothing that's really gating there. No.

不，那裡沒有什麼真正的限制。不。

Got it thank you.

明白了，謝謝。

Thanks Roger.

謝謝羅傑。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Hi, thanks for taking my question. Just a question on the maintenance studies, I want to drill down a little bit more. Do you expect that we can get a good sense of oral tolerability from the maintenance study? Anything with the injectable to the oral arm that could give us an idea of GI effects? Or do you expect that given that these patients were already on the injectable GLP, GIP, they wouldn't really have those tolerability effects? So I guess, what are your expectations with the tolerability there?

您好，感謝您回答我的問題。關於維護研究，我有個問題想問得更深入一些。您認為我們能夠從維持治療研究中獲得良好的口服耐受性資訊嗎？注射劑和口服劑之間有什麼聯繫，可以讓我們了解其胃腸道影響嗎？或者您認為，鑑於這些患者已經在使用注射用GLP、GIP，他們就不會出現這些耐受性問題？所以我想問，您對那裡的容忍度有何預期？

Yes. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subcu doses which give really high exposures to an oral dose that is a fairly low oral dose than the exposures are lower with the tablet anyway. So I would expect to see minimal GI side effects. But it's possible, but I guess it would be a surprise to see something significant there.

是的。謝謝你，安娜貝爾。我預計它的耐受性會相當不錯。你之前一直服用較高劑量的皮下注射藥物，這種藥物會使你接觸到非常高的劑量，而現在你服用的口服劑量卻相當低，因為口服劑量本身就比片劑的劑量要低。因此，我預計只會觀察到極少的胃腸道副作用。但這並非不可能，不過我想如果在那裡看到什麼重要的東西，應該會讓人感到驚訝。

Okay, that's great. Thank you.

好的，太好了。謝謝。

Thanks, Annabel.

謝謝你，安娜貝爾。

Biren Amin, Piper Sandler.

比倫·阿明，派珀·桑德勒。

Yeah, hi, guys. Thanks for taking my questions. Maybe just to start on the oral Phase III program. Have you gained agreement with the FDA on patient numbers and duration for the oral Phase III trial? So maybe that's the first question. And second question, on the supply of oral 2735 for the Phase III, is that readily available? Or are you going to need to make supply? Is that the gating item for starting the trial in Q3? Thanks.

嗨，大家好。謝謝您回答我的問題。或許可以先啟動口服三期臨床試驗計畫。您是否已與 FDA 就口服 III 期試驗的患者人數和持續時間達成一致？所以，這或許是第一個問題。第二個問題，關於 III 期臨床試驗中口服 2735 的供應，是否容易取得？還是你需要自己生產？這是第三季啟動試驗的門檻項目嗎？謝謝。

Yes. Thanks, Biren. We have a constant chain of supply moving through at different stages. So we wouldn't anticipate there to be a real challenge on the supply side. I mean, obviously, all these things are difficult, but we don't think supply is really going to be an issue there.

是的。謝謝你，比倫。我們的供應鏈始終處於運作狀態，各個環節正在進行中。因此，我們預計供應方面不會出現真正的挑戰。我的意思是，很顯然，所有這些事情都很困難，但我們認為供應方面不會真的有問題。

It takes a little while to make it, but it's -- we shouldn't have any shortages or anything like that.

製作需要一些時間，但是——我們應該不會出現任何短缺之類的情況。

As far as the sizes of the studies, I mean, we, of course, outlined our anticipated clinical development plan to the FDA, and we feel comfortable with the responses that we're okay to proceed at the design level that we presented.

至於研究規模，我的意思是，我們當然已經向 FDA 概述了我們預期的臨床開發計劃，我們對 FDA 的回應感到滿意，認為我們可以按照我們提出的設計水平繼續進行。

Perfect. And then maybe if I could just have a couple of follow-ups. Can you talk about the status of the auto-injector and when you plan to introduce that into the VANQUISH studies? So that's first. And then on the amylin, when can we expect the Phase I to start given IND filing later this quarter?

完美的。然後，或許我可以再進行幾次後續跟進。您能否談談自動注射器的現狀，以及您計劃何時將其引入 VANQUISH 研究？這是第一點。那麼關於胰淀素，考慮到IND申請將於本季稍後提交，我們預計I期臨床試驗何時開始？

And could we expect Phase I data later this year? And what does that look like?

我們能否在今年稍後看到第一階段試驗數據？那會是什麼樣子呢？

Yes. Thanks. The auto-injector, we did complete the bioequivalent study since our last quarterly update. It was a great study, turned out very positive for us, and we anticipate introducing the auto-injector this quarter. So that went according to schedule.

是的。謝謝。自上次季度更新以來，我們已經完成了自動注射器的生物等效性研究。這是一項很棒的研究，結果對我們來說非常積極，我們預計將在本季推出自動注射器。事情按計劃進行。

As far as the amylin agonist, later in the quarter, we'll file the IND. And if we're able to proceed, and I would expect that we should be able to -- probably, the first dosing would occur in the second quarter. A little early to say just yet, but that's probably the likely timing. And it would parallel the VK2735 clinical program where we start with the SAD study, a single ascending dose study and then proceed to a multiple ascending dose study. So I would say if any data are available, likely be later in '26 for the stat portion.

至於胰淀素激動劑，我們將在本季稍後提交IND申請。如果我們能夠繼續推進，而且我預計我們應該能夠推進——大概，第一次給藥將在第二季度進行。現在下結論還為時過早，但這很可能就是最終時間。這將與 VK2735 臨床項目類似，我們將從 SAD 研究（單次遞​​增劑量研究）開始，然後進行多次遞增劑量研究。所以我認為，如果能獲得任何數據的話，統計部分可能要到 2026 年晚些時候才能公佈。

Great. Thank you.

偉大的。謝謝。

Thanks.

謝謝。

Mike Ulz, Morgan Stanley.

麥克烏爾茲，摩根士丹利。

Hi. This is Rohit on for Mike. Can you just talk about any read-throughs to oral VK2735 from the strong early uptake of Novo's oral Wegovy? And then secondly, in regards to R&D spend, should we consider the quarterly spend the new norm moving forward? Thank you.

你好。這是羅希特替補麥克上場。能否談談諾和諾德的口服藥物 Wegovy 早期取得的強勁療效是否能對口服藥物 VK2735 產生影響？其次，關於研發支出，我們是否應該將季度支出視為未來的新常態？謝謝。

Yes. Thanks, Rohit. Good question. I think we've seen now with the oral peptide uptake, it's the fastest drug launch in history. So I think that bodes well for anybody developing an oral peptide.

是的。謝謝你，羅希特。問得好。我認為我們現在已經看到，口服勝肽的吸收速度是歷史上最快的藥物上市速度。所以我認為這對任何開發口服勝肽的人來說都是個好兆頭。

And for that compound, in particular, it sort of puts to bed -- we hope puts to bed this nonsense around how bad 30 minutes is to consume anything. And it's just kind of a joke that that's a big deal.

特別是對於這種化合物而言，它在某種程度上已經終結了——我們希望終結這種關於30分鐘內攝取任何東西有多糟糕的無稽之談。這簡直是個笑話，居然有人會把這當成一件大事。

And on the quarterly cash usage, I think -- you can think about it will range a bit as we move forward here between likely $60 million and $90 million per quarter. So that's about all I could say about that. So a range in that window there.

至於季度現金使用情況，我認為——你可以想像，隨著我們不斷推進，它可能會在每個季度 6000 萬美元到 9000 萬美元之間波動。關於這件事，我只能說這麼多了。所以，這個視窗的範圍就是如此。

Thank you.

謝謝。

Thomas Smith, Leerink Partners.

Thomas Smith，Leerink Partners。

Hey guys, good afternoon. Congrats on the progress. Now that you have the maintenance study fully enrolled, are there any notable differences you'd highlight here specifically on the baseline characteristics relative to the VENTURE subcu or the oral studies? And then maybe a follow-up on the amylin program. Is this going to be a similar design and execution out of Australia as what you did with the 2735 Phase I experience? And could you help frame expectations for what you'd be looking for out of the MAD portion of that study with respect to weight loss? Thanks so much.

各位，下午好。恭喜你取得進展。既然維持治療研究已經全部招募完畢，您能否特別強調一下與 VENTURE 皮下或口服研究相比，基線特徵方面有哪些顯著差異？然後或許可以對胰淀素計畫進行後續研究。這次的設計和執行是否會與你們在澳洲進行的 2735 Phase I 專案類似？您能否幫助我們明確一下，您希望從該研究的 MAD 部分中獲得哪些關於減肥方面的預期結果？非常感謝。

Yes. Thanks, Tom. No, I think we'd be targeting a U.S.-based for the amylin study, U.S.-based clinical sites. And hard to say it's SAD. The first part will be a SAD study.

是的。謝謝你，湯姆。不，我認為我們會選擇美國本土的臨床試驗中心來進行胰淀素研究。很難說這是件令人悲傷的事。第一部分將是一項季節性情感性疾患（SAD）研究。

So always difficult to really interpret any efficacy data from a single dose. But in primates, it looks pretty potent, more potent than the VK2735 compounded under both single and multiple dose scenarios. So it looks pretty good, but haven't been in humans yet. On the demographics for the maintenance study, the main baseline is people had to be -- BMI greater than 30. They're pretty small cohorts.

因此，要真正解讀單次給藥的療效數據總是很困難的。但在靈長類動物身上，它看起來效力很強，在單次和多次給藥的情況下，其效力都比 VK2735 複方製劑更強。所以看起來相當不錯，但還沒有在人體上進行過試驗。在維護研究的人口統計方面，主要基線是人們必須—BMI 大於 30。這些都是規模很小的群體。

So I don't know -- I would anticipate -- and I don't have access to that, I don't know the answer right now, but I expect there to be more women than men. I expect it to be mostly white. And they're all normal glycemic, so no diabetics. But I wouldn't expect it to be dramatically different than the VENTURE Phase II demographics, but I don't have the demographics in front of me.

所以我不知道——我預計——而且我也沒有這方面的資訊，我現在不知道答案，但我預計女性人數會比男性多。我預計它大部分會是白色的。而且它們的血糖值都正常，所以不會影響糖尿病患者。但我認為它不會與 VENTURE 第二階段的人口統計數據有太大不同，但我手頭上沒有人口統計數據。

Got it. That's helpful. Thanks, Brian.

知道了。那很有幫助。謝謝你，布萊恩。

Thanks.

謝謝。

Yale Jen, Laidlaw & Company.

耶魯‧詹，萊德勞公司。

Thanks for taking the questions and congrats on the quarters and the year. Two questions here. First one is that in terms of the maintenance study, although we are still seeking for -- looking for the data, do you -- depends on that, do you anticipate you will have -- you still need a larger scale so the maintenance study to be sort of finalized the alternate path forward as well as when you -- at the same time, you're conducting the Phase II study -- Phase III study for the oral?

感謝您回答問題，並祝賀您取得季度和年度佳績。這裡有兩個問題。首先，就維持治療研究而言，雖然我們仍在尋找數據，但您是否——取決於此，您是否預計會——您仍然需要更大規模的數據，以便最終確定維持治療研究的替代方案，以及——同時，您是否正在進行口服的 II 期研究——III 期研究？

Yes. Thanks, Yale. Unknown yet. As I mentioned earlier, it might be possible to introduce some maintenance arms into the extension in the VANQUISH studies, but we don't know yet. I would anticipate, though, a larger subsequent study, whether that's part of an extension or a stand-alone, that would likely be required to really understand longer-term maintenance and what the ideal dose is.

是的。謝謝耶魯。尚不清楚。正如我之前提到的，VANQUISH 研究的擴展部分或許可以引入一些維護機制，但我們目前還不知道。不過，我預計後續還需要進行更大規模的研究，無論是作為一項擴展研究還是一項獨立研究，才能真正了解長期維持治療的效果以及理想的劑量是多少。

Okay. And maybe just a quick one on the auto injectors. I don't know whether that will be [a year pain] in terms of supply issue. And how do you see that going forward that -- once you transition everything into the -- all the subcu to the auto injectors?

好的。或許還可以簡單談談自動噴油嘴。我不知道這是否會造成長達一年的供應困難。那麼，您如何看待未來的發展——一旦您將所有部件都過渡到自動噴油器——所有子系統都過渡到自動噴油器？

Yes. We don't anticipate any supply issues there with the auto-injectors. The supplier is capable of producing a very high capacity. So no anticipated issues at this point with auto-injector supply.

是的。我們預計自動注射器的供應不會有任何問題。該供應商具備極高的產能。因此，目前預計自動注射器的供應不會有問題。

Okay, great. Thanks a lot and congrats.

好的，太好了。非常感謝，也恭喜你。

Thanks a lot.

多謝。

Ryan Deschner, Raymond James.

Ryan Deschner，Raymond James。

Thanks for the question. Was there any notable differences in the end of Phase II meeting minutes for oral VK2735 versus the meeting you had for the injectable version? And would any patients in the maintenance study be transitioned to auto-injector?

謝謝你的提問。口服 VK2735 的 II 期臨床試驗結束會議紀錄與注射劑型的會議紀要有何顯著差異？維持治療研究中是否會有病人過渡到使用自動注射器？

On the second part, no, it's a good question, but no, these are going to be a vial and syringe, and the study is well underway now. So no, we're not going to introduce the auto-injector in the maintenance study.

關於第二部分，不，這是一個很好的問題，但是不，這些將是小瓶和注射器，而且這項研究現在已經順利進行中。所以，我們不會在維護研究中引入自動噴射器。

As far as the oral end of Phase II and the subcu into Phase II, we're not getting into the details of the discussions. But I'd say the feedback was consistent with what we heard from the end of Phase II for the subcu formulation. Different INDs, but many of the same people participated. So I think that we're comfortable going forward and pretty consistent feedback between the two meetings.

至於第二階段的口服給藥和第二階段的皮下給藥，我們不打算深入討論細節。但我認為，這些回饋與我們從第二階段皮下製劑結束時聽到的回饋是一致的。雖然各獨立研究組（IND）不同，但許多參與者是相同的。所以我認為我們接下來的工作進展順利，兩次會議的回饋也相當一致。

Okay, thanks Brian.

好的，謝謝你，布萊恩。

Thanks, Ryan.

謝謝你，瑞恩。

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

我們的問答環節到此結束。我謹將會議交還給史蒂芬妮·迪亞茲女士，請她作總結發言。請繼續。

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

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。再見。

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。