Viking Therapeutics Inc (VKTX) 2024 Q4 法說會逐字稿

Welcome to the Viking Therapeutics' fourth-quarter and full-year 2024 financial results conference call. (Operator Instructions)

歡迎參加 Viking Therapeutics 2024 年第四季和全年財務業績電話會議。（操作員指令）

As a reminder, this conference call is being recorded today, February 5, 2025.

提醒一下，本次電話會議於今天（2025 年 2 月 5 日）錄製。

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

現在，我想將會議交給 Viking 的投資者關係經理 Stephanie Diaz。請繼續，史蒂芬妮。

Hello and thank you 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, February 5, 2025, will contain forward-looking statements under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995 including statements about Viking's expectations regarding its development activities, timelines, and milestones.

大家好，感謝大家參加今天的電話會議。今天與我一起參加的是 Viking 總裁兼執行長 Brian Lian；以及 Viking 的財務長 Greg Zante。在我們開始之前，我想提醒一下，今天（2025 年 2 月 5 日）在電話會議上發表的評論將包含根據美國 1995 年私人證券訴訟改革法安全港條款的前瞻性陳述，包括有關 Viking 對其開發活動、時間表和里程碑的期望的陳述。

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

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

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

我鼓勵您查看該公司向美國證券交易委員會提交的有關這些事項和其他事項的所有文件。

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

現在我將把電話轉給布萊恩，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 three months and full year ended December 31, 2024, and provide an update on recent progress with our development programs and operations.

謝謝斯蒂芬妮，祝透過電話或網路廣播收聽的各位聽眾下午好。今天，我們將回顧截至 2024 年 12 月 31 日的三個月和全年的財務業績，並介紹我們開發計劃和營運的最新進展。

2024 was an exceptionally busy year for Viking. During the year, the company reported successful results from four different studies across our pipeline. These include: the announcement of positive data from our VK2735 subcutaneous program for obesity; the results of our VK2735 oral tablet program for obesity; the histology results from our VK2809 program for the treatment of MASH and fibrosis; and the initial proof of concept data from our VK0214 program for X-ALD.

2024 年對維京來說是異常忙碌的一年。今年，該公司報告了其整個研發過程中四項不同研究的成功結果。其中包括：公佈我們針對肥胖症的VK2735皮下注射計畫的正面數據；我們的 VK2735 口服片劑治療肥胖症的計劃的結果；我們的 VK2809 計畫治療 MASH 和纖維化的組織學結果；以及我們針對 X-ALD 的 VK0214 程序的初步概念驗證資料。

With respect to VK2735, our lead program for obesity, in the first quarter of 2024, we announced positive results from the Phase 2 VENTURE trial, evaluating subcutaneous administration in obese subjects. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

關於我們針對肥胖症的主要項目 VK2735，我們在 2024 年第一季度宣布了第二階段 VENTURE 試驗的積極結果，該試驗評估了肥胖受試者的皮下給藥。這項試驗表明，經過13週的治療後體重顯著減輕。

Later in the first quarter, we announced the initial results from a 28-day Phase 1 trial evaluating an oral tablet formulation of VK2735 which demonstrated excellent tolerability and encouraging reductions in body weight. In the second quarter of 2024, we announced histology results from the Phase 2b VOYAGE trial, evaluating our novel thyroid hormone receptor beta agonist VK2809 for the treatment of MASH and fibrosis. This study successfully achieved its primary, secondary, and exploratory endpoints, showing reductions in liver fat 12 weeks and improvements in MASH resolution rate and fibrosis after 52 weeks.

在第一季末，我們公佈了為期 28 天的第 1 階段試驗的初步結果，該試驗評估了 VK2735 口服片劑的配方，結果顯示其具有出色的耐受性並能令人鼓舞地減輕體重。2024 年第二季度，我們公佈了第 2b 期 VOYAGE 試驗的組織學結果，評估了我們的新型甲狀腺激素受體 β 激動劑 VK2809 治療 MASH 和纖維化的效果。研究成功實現了其主要、次要和探索性終點，顯示 12 週後肝臟脂肪減少，52 週後 MASH 消退率和纖維化有所改善。

And finally, in the fourth quarter of 2024, the company announced positive results from a 28-day Phase 1b clinical trial of our second novel thyroid hormone receptor beta agonist, VK0214, in patients with X-linked adrenoleukodystrophy or X-ALD. Results from this study showed VK0214 to be safe and well tolerated and treated patients demonstrated significant reductions in plasma levels of very long chain fatty acids compared with placebo.

最後，在 2024 年第四季度，該公司宣布了我們的第二種新型甲狀腺激素受體β激動劑 VK0214 對 X 連鎖腎上腺腦白質營養不良或 X-ALD 患者進行的 28 天 1b 期臨床試驗的積極結果。研究的結果表明，VK0214 安全且耐受性良好，與安慰劑相比，接受治療的患者血漿中極長鏈脂肪酸水平顯著降低。

During the year, the company also announced the addition of a new program to its pipeline focused on a series of internally developed agonist of the amylin receptor. In animal models, these compounds demonstrated improvements in body weight and metabolic profile.

年內，該公司還宣佈在其產品線中增加一個新項目，重點放在一系列內部開發的胰島澱粉樣勝肽受體激動劑。在動物模型中，這些化合物表現出體重和代謝狀況的改善。

On the corporate side, during the first quarter of 2024, Viking closed a successful public offering of common stock, raising more than $630 million in gross proceeds, providing the resources to aggressively move forward with our pipeline programs. I'll have additional comments on our operations and development activities after we review our financial results for the fourth quarter and year ending December 31.

在公司方面，2024 年第一季度，維京成功完成普通股公開發行，籌集了超過 6.3 億美元的總收益，為積極推進我們的管道計劃提供了資源。在我們審查第四季度和截至 12 月 31 日的年度財務業績後，我將對我們的營運和發展活動提出更多評論。

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

為此，我將把電話轉給 Viking 的財務長 Greg Zante。

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, 2024, beginning with the quarter.

謝謝，布萊恩。結合我的評論，我想建議參與者參考維京向美國證券交易委員會提交的 10-K 表格，我們預計很快就會提交該表格。我現在將從本季開始，回顧截至 2024 年 12 月 31 日的第四季和全年業績。

Research and development expenses were $31 million for the three months ended December 31, 2024, compared to $20.5 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, salaries and benefits, and stock-based compensation, partially offset by decreased expenses related to clinical and preclinical studies.

截至 2024 年 12 月 31 日的三個月，研發費用為 3,100 萬美元，而 2023 年同期為 2,050 萬美元。成長的主要原因是與我們的候選藥物製造、工資和福利以及股票薪酬相關的費用增加，但部分被與臨床和臨床前研究相關的費用減少所抵消。

General and administrative expenses were $15.3 million for the three months ended December 31, 2024, compared to $8.8 million for the same period in 2023. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, insurance and professional fees.

截至 2024 年 12 月 31 日的三個月的一般及行政費用為 1530 萬美元，而 2023 年同期為 880 萬美元。成長的主要原因是法律和專利服務、股票薪酬、工資和福利、保險和專業費用相關費用的增加。

For the three months ended December 31, 2024, Viking reported a net loss of $35.4 million or $0.32 per share compared to a net loss of $24.6 million or $0.25 per share in the corresponding period of 2023. The increase in net loss for the three months ended December 31, 2024, and was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023.

截至 2024 年 12 月 31 日的三個月，維京報告淨虧損為 3,540 萬美元或每股 0.32 美元，而 2023 年同期淨虧損為 2,460 萬美元或每股 0.25 美元。截至 2024 年 12 月 31 日的三個月的淨虧損增加，主要是由於先前提到的研發費用以及一般及行政費用的增加，但與 2023 年同期相比，利息收入的增加部分抵消了這一增加。

I'll now go over our results for the full year ended December 31, 2024. Our research and development expenses for the year ended December 31, 2024, were $101.6 million compared to $63.8 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation and salaries and benefits, partially offset by a decrease in expenses related to clinical and preclinical studies.

我現在將介紹截至 2024 年 12 月 31 日的全年業績。截至 2024 年 12 月 31 日止年度，我們的研發費用為 1.016 億美元，而 2023 年同期為 6,380 萬美元。成長的主要原因是與我們的候選藥物製造、股票薪酬以及工資和福利相關的費用增加，但部分被與臨床和臨床前研究相關的費用的減少所抵消。

Our general and administrative expenses for the year ended December 31, 2024 were $49.3 million compared to $37 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional fees, insurance and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services.

截至 2024 年 12 月 31 日止年度，我們的一般及行政費用為 4,930 萬美元，而 2023 年同期為 3,700 萬美元。成長的主要原因是股票薪資、薪資和福利、專業費用、保險和第三方顧問提供的服務相關費用的增加，但部分被法律和專利服務相關費用的減少所抵消。

For the year ended December 31, 2024, Viking reported a net loss of $110 million or $1.01 per share compared to a net loss of $85.9 million or $0.91 per share in the corresponding period in 2023. The increase in net loss for the year ended December 31, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023.

截至 2024 年 12 月 31 日的年度，維京報告淨虧損為 1.1 億美元或每股 1.01 美元，而 2023 年同期淨虧損為 8,590 萬美元或每股 0.91 美元。截至 2024 年 12 月 31 日止年度的淨虧損增加，主要是由於先前指出的研發費用以及一般及行政費用的增加，但與 2023 年同期相比，利息收入的增加部分抵消了這一增加。

Turning to the balance sheet. At December 31, 2024, Viking cash, cash equivalents and short-term investments of $903 million compared to $362 million as of December 31, 2023.

轉向資產負債表。截至 2024 年 12 月 31 日，維京現金、現金等價物及短期投資為 9.03 億美元，而截至 2023 年 12 月 31 日為 3.62 億美元。

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

我的財務審查到此結束，現在我將把電話轉回給布萊恩。

Thanks, Greg. I'll now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs starting with our lead obesity program, VK2735.

謝謝，格雷格。我現在將總結 2024 年的臨床亮點，並概述我們的後續計劃，從領先的肥胖症計劃 VK2735 開始。

VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. The company's initial Phase 1 single and multiple ascending dose trial for VK2735, demonstrating the promising safety, tolerability and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection to four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.

VK2735 是胰高血糖素樣勝肽 1（GLP-1 受體）和葡萄糖依賴性胰島素促泌多肽（GIP 受體）的雙重激動劑。該公司對 VK2735 進行的初步 I 期單劑量和多劑量遞增試驗證明了 VK2735 在每週皮下注射至四周時具有良好的安全性、耐受性和藥物動力學。研究中的對像在 28 天後體重較基線下降了約 8%，且沒有出現平台期的跡象。

Following these results, the company initiated a Phase 2 study called the VENTURE study to evaluate longer-term dosing with VK2735 in subjects with obesity. This trial was a randomized, double-blind, placebo-controlled multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 administered subcutaneously once weekly for 13 weeks.

根據這些結果，該公司啟動了一項名為 VENTURE 的 2 期研究，以評估肥胖患者長期使用 VK2735 的效果。該試驗是一項隨機、雙盲、安慰劑對照的多中心研究，評估了每週一次皮下注射 VK2735 持續 13 週的安全性、耐受性、藥物動力學和減肥效果。

In the first quarter of 2024, the company announced positive results from the VENTURE trial, which successfully achieved its primary and secondary endpoints. The study demonstrated that patients receiving VK2735 achieved statistically significant reductions in mean body weight from baseline ranging up to 14.7%. 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.

2024年第一季度，該公司宣布了VENTURE試驗的積極成果，該試驗成功實現了其主要和次要終點。研究表明，接受 VK2735 治療的患者平均體重較基線顯著降低，下降幅度高達 14.7%。VENTURE 研究還表明，VK2735 在 13 週的給藥過程中是安全且耐受性良好的，大多數治療中出現的不良事件為輕度或中度。

Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI effects resulting from activation of the GLP-1 receptor. These data were presented last November at ObesityWeek, the Annual Meeting of the Obesity Society.

不良事件通常發生在治療過程的早期，主要與 GLP-1 受體活化引起的預期胃腸道影響有關。這些數據於去年 11 月在肥胖協會年會「肥胖週」上發表。

This presentation also provided updated results from follow-up visits that occurred four and seven weeks after the last dose of VK2735 was administered. These results showed that cohorts receiving VK2735 maintain the majority of their weight loss through the seven-week follow-up visit after administration of the final dose of VK2735. 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 the last dose was administered.

本次報告也提供了最後一次服用 VK2735 後四週和七週的追蹤最新結果。這些結果表明，接受 VK2735 治療的患者在註射最後一劑 VK2735 後的七週隨訪中保持了大部分減肥效果。其中包括每週 2.5 毫克的劑量，這是評估的最低劑量，在最後一次服藥後七週內，初始體重減輕的 90% 以上得以維持。

In a subset of participants, and evaluation of plasma levels of VK2735 at various time points following the 13-week dosing period was also conducted. We believe these pharmacokinetic results provide support for the feasibility of once-monthly dosing in the maintenance setting, and we plan to further evaluate monthly dosing later this year.

在一組參與者中，也對 13 週給藥期後各個時間點的 VK2735 血漿濃度進行了評估。我們相信這些藥物動力學結果為維持治療中每月一次給藥的可行性提供了支持，我們計劃在今年稍後進一步評估每月一次給藥。

Following completion of the VENTURE study, Viking requested and was granted a Type C meeting with the FDA to discuss next steps for the program. Based on written feedback from this meeting, we advanced VK2735 into Phase 3 development for obesity. To this end, in the fourth quarter of 2024, we completed the successful end of Phase 2 meeting with the agency which was extremely helpful in informing our next steps and the Phase 3 plan for the program.

VENTURE 研究完成後，Viking 請求並獲準與 FDA 舉行 C 類會議，討論該計劃的下一步行動。根據這次會議的書面回饋，我們將 VK2735 推進到針對肥胖症的 3 期開發。為此，我們在 2024 年第四季度與該機構成功完成了第二階段會議，這對我們了解下一步和第三階段計劃非常有幫助。

We currently expect to initiate Phase 3 trials evaluating subcutaneous VK2735 for the treatment of obesity in the second quarter of 2025. Also in 2024, we completed a Phase 1 study to evaluate an oral tablet formulation of VK2735. The company believes that tablet formulation could represent an attractive treatment option for those who may be hesitant to initiate injection-based therapy or for those seeking to maintain the weight loss they've already achieved. An important differentiating advantage of a tablet formulation of VK2735 is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule.

我們目前預計將於 2025 年第二季啟動評估皮下 VK2735 治療肥胖症的 3 期試驗。此外，在 2024 年，我們完成了第 1 階段研究，以評估 VK2735 的口服藥錠配方。該公司認為，對於那些不願意開始注射療法或尋求維持已達到的減肥效果的人來說，片劑劑型可能是一種有吸引力的治療選擇。VK2735 片劑製劑的一個重要的區別優勢是能夠讓患者從皮下製劑過渡到使用相同分子的口服製劑。

Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be a valued option for both patients and clinicians. Our Phase 1 study was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days.

Viking 認為這可能會降低意外安全性或耐受性挑戰的風險，並且對患者和臨床醫生來說都是一個有價值的選擇。我們的第一階段研究是一項隨機、雙盲、安慰劑對照研究，研究對象為體重指數至少為每平方公尺 30 公斤的健康成年人。研究的主要目的是評估 VK2735 片劑每日服用一次，連續服用 28 天的安全性和耐受性。

Secondary and exploratory objectives included an evaluation of the pharmacokinetics of oral VK2735 as well as changes in body weight and other metrics. The results of this study were presented at the ObesityWeek Conference last November. This presentation highlighted data showing that cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 days.

次要和探索性目標包括評估口服 VK2735 的藥物動力學以及體重和其他指標的變化。這項研究的結果於去年 11 月在肥胖週會議上發表。本次報告重點展示的數據顯示，接受 VK2735 治療的患者群在 28 天後表現出劑量依賴性平均體重從基線下降，降幅高達 8.2%。

Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight.

在追蹤中觀察到體重持續減輕，最高達 8.3% ，直至第 57 天，即服用最後一次劑量後的四週。根據對減肥軌蹟的初步評估，該公司認為，持續治療超過 28 天可能會進一步減輕體重。

Oral VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 milligrams. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild. Similarly, all gastrointestinal adverse events were reported as mild or moderate with the majority reported as mild. Based on these results, Viking designed and recently initiated a Phase 2 trial called the VENTURE-Oral Dosing trial to evaluate longer-term dosing with the tablet formulation in subjects with obesity.

口服 VK2735 經過 28 天的每日一次給藥（劑量高達 100 毫克）也表現出令人鼓舞的安全性和耐受性。觀察到的大多數治療中出現的不良事件都是輕度或中度的，其中大多數報告為輕度。同樣，所有胃腸道不良事件均被報告為輕度或中度，其中大多數被報告為輕度。根據這些結果，Viking 設計並最近啟動了一項名為 VENTURE-Oral Dosing 試驗的 2 期試驗，以評估肥胖患者長期服用片劑的情況。

The VENTURE-Oral Dosing trial is 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. The trial will enroll approximately 280 adults who are obese, or adults who are overweight with at least one weight-related comorbid condition.

VENTURE-Oral Dosing 試驗是一項隨機、雙盲、安慰劑對照的多中心研究，旨在評估 VK2735 以口服片劑形式每日一次服用 13 週的安全性、耐受性、藥物動力學和減肥效果。該試驗將招募約 280 名肥胖成年人或超重且患有至少一種體重相關合併症的成年人。

Patients will be evenly randomized to 1 of 6 dosing arms or placebo. The primary endpoint of the study will assess the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We are pleased to have the VENTURE-Oral Dosing trial underway and we expect to report data from this study in the second half of 2025.

患者將被隨機分配到6個劑量組之一或安慰劑組。研究的主要終點將評估治療 13 週後體重相對於基線的百分比變化。次要和探索性終點將評估一系列額外的安全性和有效性措施。我們很高興 VENTURE-Oral Dosing 試驗正在進行中，我們預計將在 2025 年下半年報告這項研究的數據。

Turning to our other metabolic programs. I'll provide a brief update on our NASH and rare disease programs, starting with our VK2809 program. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta isoform of the receptor. In 2024, we announced final data from a 52-week study of VK2809 in patients with biopsy-confirmed MASH and fibrosis.

轉向我們的其他代謝計劃。我將簡要介紹我們的 NASH 和罕見疾病項目，從 VK2809 計畫開始。VK2809 是一種口服的甲狀腺激素受體小分子激動劑，對肝臟組織以及受體的β同工型具有選擇性。2024 年，我們公佈了對經活檢確診的 MASH 和纖維化患者進行的 VK2809 52 週研究的最終數據。

This study called VOYAGE evaluated as a primary endpoint, the change in liver fat following 12 weeks of once daily treatment with VK2809. Secondary endpoints include assessments of histologic changes following 52 weeks of treatment.

這項名為 VOYAGE 的研究以 VK2809 每日一次治療 12 週後肝臟脂肪的變化作為主要終點進行評估。次要終點包括 52 週治療後的組織學變化評估。

In 2023, we reported that VOYAGE had successfully achieved its primary endpoint with patients who received VK2809 demonstrating statistically significant mean reductions in liver fat from baseline to week 12 as compared with placebo.

2023 年，我們報告 VOYAGE 已成功實現其主要終點，與接受安慰劑治療的患者相比，接受 VK2809 治療的患者從基線到第 12 週的肝臟脂肪平均減少具有統計學意義。

In June of 2024, Viking announced the successful achievement of the trial's secondary endpoints, with VK2809-treated patients demonstrated statistically significant and best-in-class improvements in NASH resolution rate, fibrosis stage and the combination endpoint of NASH resolution and fibrosis improvement compared with placebo. The final results from the VOYAGE study were presented last November in an oral late-breaker presentation at the Annual Meeting of the American Association for the Study of Liver Disease.

2024 年 6 月，Viking 宣布成功實現試驗的次要終點，與安慰劑相比，接受 VK2809 治療的患者在 NASH 緩解率、纖維化分期以及 NASH 緩解與纖維化改善的綜合終點方面均表現出統計學上顯著且最佳的改善。VOYAGE 研究的最終結果於去年 11 月在美國肝病研究協會年會的口頭最新報告中公佈。

In the fourth quarter of 2024, we completed an end-of-Phase 2 meeting with the FDA to get the next steps for VK2809 in NASH. Feedback from this meeting was helpful in outlining the future clinical path for this program. And we remain interested in exploring partnering opportunities for further development. Turning to our fourth clinical program.

2024 年第四季度，我們與 FDA 完成了第 2 階段結束會議，以了解 VK2809 在 NASH 中的下一步。這次會議的回饋有助於概述該計劃的未來臨床路徑。我們仍然有興趣探索進一步發展的合作機會。談談我們的第四個臨床項目。

In October 2024, we reported positive results from a 28-day Phase 1b study of our small molecule drug candidate VK0214 in patients with the rare neuromuscular disorder called X-linked adrenoleukodystrophy, X-ALD. Like VK2809, VK0214 is also an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor.

2024 年 10 月，我們報告了小分子候選藥物 VK0214 對患有罕見神經肌肉疾病 X 連鎖腎上腺腦白質營養不良 (X-ALD) 的患者進行的 28 天 1b 期研究的積極結果。與 VK2809 一樣，VK0214 也是一種口服小分子，針對甲狀腺激素受體的 β 同工型進行選擇。

X-ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a peroxisomal transporter of very long chain fatty assets. As a result, patients are unable to efficiently metabolize these assets and their accumulation is believed to contribute to the onset and progression of X-ALD.

X-ALD 是一種罕見且使人衰弱的代謝紊亂，是由基因突變引起的，導致過氧化物酶體轉運蛋白的極長鏈脂肪酸功能喪失。因此，患者無法有效代謝這些物質，而這些物質的累積被認為導致了 X-ALD 的發生和發展。

Activation of the thyroid receptor beta has been shown to increase the expression of an important compensatory transporter of very long-chain fatty acids, leading to improved metabolism and clearance of these compounds. Our Phase 1b trial was a multicenter, randomized, double-blind, placebo-controlled international study in men with the adrenomyeloneuropathy or AMN form of X-ALD. The study enrolled patients across three cohorts, placebo and VK0214 doses of 20 milligrams and 40 milligrams daily.

研究表明，甲狀腺受體β的活化可以增加一種重要的極長鏈脂肪酸補償轉運蛋白的表達，從而改善這些化合物的代謝和清除。我們的 1b 期試驗是一項針對患有腎上腺脊髓神經病變或 AMN 形式的 X-ALD 的男性的多中心、隨機、雙盲、安慰劑對照的國際研究。研究招募了三組患者，分別服用安慰劑和 VK0214 劑量，每日分別為 20 毫克和 40 毫克。

The primary objectives were to evaluate the safety and tolerability of VK0214 in subjects with AMN. An exploratory objective was to evaluate the effects of VK0214 on plasma levels of very long chain fatty acids. The data from this study showed that treatment with VK0214 resulted statistically significant reductions in mean plasma levels of very long chain fatty acids at both the 20-milligram and 40-milligram doses compared to placebo. Plasma levels of the important 26 carbon very long chain fatty acid reduced by approximately 38% relative to placebo after four weeks of once daily dosing.

主要目標是評估 VK0214 對 AMN 患者的安全性和耐受性。探索性目標是評估 VK0214 對血漿極長鏈脂肪酸水平的影響。研究數據顯示，與安慰劑相比，VK0214 治療在 20 毫克和 40 毫克劑量下均導致血漿中極長鏈脂肪酸平均水平顯著降低。經過四周每日一次的給藥後，重要的 26 碳極長鏈脂肪酸的血漿濃度與安慰劑相比降低了約 38%。

In addition, subject to receive VK0214 experienced reductions in other important plasma lipids. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B, and lipoprotein a.

此外，接受 VK0214 治療的受試者的其他重要血漿脂質也經歷了降低。與基線和安慰劑相比，LDL 膽固醇、載脂蛋白 B 和脂蛋白 a 的平均減少量。

Importantly, VK0214 also demonstrated encouraging safety and tolerability with treatment and merchant adverse events generally reported as mild to moderate. As there is currently no pharmacologic treatment available for X-ALD. We are very pleased to achieve these first-in-class results, and we'll look to partner this important program with an organization that has the appropriate expertise in rare disorders.

重要的是，VK0214 也表現出令人鼓舞的安全性和耐受性，治療和商家不良事件通常報告為輕度至中度。因為目前尚無針對 X-ALD 的藥物治療。我們非常高興能取得這些一流的成果，我們將尋求與在罕見疾病方面擁有適當專業知識的組織合作開展這項重要計畫。

Finally, in June of 2024 at the end meeting of the American Diabetes Association, we announced data from a new program targeting novel agonists of the amylin receptor for the potential treatment of obesity. We are pleased with the progress made to date with this program, and we expect to file an IND and initiate a Phase 1 clinical trial later this year.

最後，在 2024 年 6 月美國糖尿病協會的最後一次會議上，我們公佈了一項新計劃的數據，該計劃針對的是胰島澱粉樣多肽受體的新型激動劑，可用於治療肥胖症。我們對該計畫迄今為止的進展感到滿意，我們預計將在今年稍後提交 IND 並啟動第一階段臨床試驗。

Moving to corporate and financial matters. As Greg discussed in his comments, we completed 2024 with a strong balance sheet and over $900 million in cash. This provides us with the runway to complete Phase 3 trials for the VK2735-obesity program as well as aggressively pursue clinical development with our other programs.

轉向公司和財務事務。正如格雷格在評論中所討論的那樣，我們在 2024 年擁有強勁的資產負債表和超過 9 億美元的現金。這為我們完成VK2735肥胖計畫的第三階段試驗以及積極推進其他計畫的臨床開發提供了平台。

In conclusion, 2024 was a year of exciting clinical successes at Viking. We began 2025 in a strong position with more valuable clinical assets than at any time in Viking's history, and we are confident in our position for future success. Going forward, the company will prioritize our VK2735 program, and we are happy to be advancing both the subcutaneous and oral formulations of this compound in the clinic.

總而言之，2024 年是維京令人興奮的臨床成功的一年。2025年伊始，我們處於強勢地位，擁有比維京歷史上任何時候都多的寶貴臨床資產，我們對未來的成功充滿信心。展望未來，公司將優先考慮我們的 VK2735 項目，我們很高興能夠在臨床上推進該化合物的皮下和口服製劑。

We plan to initiate Phase 3 trials with the subcutaneous formulation in the second quarter, and we expect to report data from the ongoing Phase 2 VENTURE-Oral Dosing trial in the second half of the year. In addition, we plan to file an IND for our novel amylin agonist program later this year and look forward to moving this program into clinical development. Based on our strong financial position, we plan to continue an aggressive development pace with each of these programs.

我們計劃在第二季度啟動皮下製劑的第三階段試驗，並預計在今年下半年報告正在進行的第二階段 VENTURE 口服給藥試驗的數據。此外，我們計劃在今年稍後為我們的新型胰島澱粉樣勝肽激動劑計畫提交 IND，並期待將該專案推向臨床開發階段。基於我們強大的財務狀況，我們計劃繼續積極推動每個專案的發展。

We look forward to providing further updates in the months ahead. This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions. Operator?

我們期待在未來幾個月提供進一步的更新。今天的準備評論到此結束。非常感謝您加入我們，現在我們開始提問。操作員？

We will now begin the question-and-answer session. (Operator Instructions)

我們現在開始問答環節。（操作員指令）

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Thank you very much for the question. I wanted to see if I could give some more detail from the discussion on the feedback at the end of Phase 2 meeting, particularly details on the potential number of size or maybe even potential comparator arms for the Phase 3 studies that you plan to initiate next quarter.

非常感謝您的提問。我想看看我是否可以從第二階段會議結束時的反饋討論中提供更多細節，特別是有關您計劃下個季度啟動的第三階段研究的潛在規模數量或什至潛在比較組的細節。

Yes. Thanks, Ryan. We'll provide more detail on the study design when we announced the initiation. But the size would certainly conform to guidance, which requires at least 4,500 people in the Phase 3 program.

是的。謝謝，瑞安。當我們宣布啟動時，我們將提供有關研究設計的更多細節。但規模肯定會符合指導，即第三階段計劃至少需要 4,500 人。

For these two studies, there will be one in obese subjects and one in -- obese subjects with type 2 diabetes. We would plan to use multiple doses and conform and that we would target a 52-week treatment window as well. But we'll provide further details on the doses and other items when the trials initiate.

在這兩項研究中，一項針對肥胖受試者，另一項針對患有第 2 型糖尿病的肥胖受試者。我們計劃使用多劑量並進行符合性測試，我們也將目標設定為 52 週的治療窗口。但我們將在試驗開始時提供有關劑量和其他項目的更多詳細資訊。

Got it. Thank you very much, Brian.

知道了。非常感謝，布萊恩。

Thanks Ryan.

謝謝瑞安。

Mike Ulz, Morgan Stanley.

摩根士丹利的 Mike Ulz。

Good afternoon and thanks for taking the question. Maybe just on the Phase 3 obesity study. It looks like you narrowed the timing for the start there to 2Q versus first half '25 previously. Just curious what the rationale for that and kind of the remaining steps to getting that study going?

下午好，感謝您回答這個問題。也許只是針對第三階段肥胖症研究。看起來你將開始的時間從之前的 25 年上半年縮小到了第二季。只是好奇這樣做的理由是什麼以及進行這項研究的剩餘步驟是什麼？

Yes. Thanks, Mike. We're just -- it's primarily logistical making the formulation, making the drug product to enter into the study. So having better visibility on the time lines for production of the clinical material allows us to focus the time -- the window a little bit better. But everything is going according to plan. So nothing -- no issues, just big complicated exercise, and we're well into it, though.

是的。謝謝，麥克。我們只是 — — 主要負責後勤配製、生產用於研究的藥品。因此，更好地了解臨床材料生產的時間表使我們能夠更好地集中時間 - 窗口。但一切正按計劃進行。所以沒什麼——沒有問題，只是一項大型複雜的演習，而且我們已經投入其中。

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

This is Asim Rana on for Joon Lee. Are these studies going to be standard weight loss studies? Or are you looking to include anything differentiating? And then how long do you think it will take to recruit patients? And then I have a follow-up.

我是 Asim Rana，為 Joon Lee 主持。這些研究會成為標準的減肥研究嗎？或者您想添加任何有區別的內容？那麼您認為招募患者需要多長時間？然後我有一個後續問題。

Yes, sure. Well, the primary endpoint would be a change in body weight. Diabetes study will also include glycemic endpoints as you typically would in type 2 diabetes study. But primary endpoint would be a change in body weight. I forgot the second question.

是的，當然。嗯，主要終點是體重的變化。糖尿病研究還將包括血糖終點，就像在第 2 型糖尿病研究中通常會做的那樣。但主要終點是體重的變化。我忘了第二個問題。

Just how long it will take to recruit patients?

招募患者到底要多久？

Yes. Yes, we can't give guidance on that just yet. We need to start the study and understand timelines to site initiation as well as what the enrollment queue looks like. So we'll be able to provide that later, but can't be right now.

是的。是的，我們現在還不能就此提供指導。我們需要開始研究並了解網站啟動的時間表以及註冊隊列的情況。因此我們稍後可以提供該服務，但現在還不能。

Okay. Just one more. Are these studies starting concurrently? And have you secured API for both Phase 3 studies? Thank you.

好的。還剩一個。這些研究是同時開始的嗎？您是否已獲得用於這兩項第 3 階段研究的 API？謝謝。

Yes, we do have the API for both studies, not the API to get through the Phase 3 program. And we do hope to start them as close as possible to concurrent as we can.

是的，我們確實有這兩項研究的 API，但沒有通過第 3 階段計劃的 API。我們確實希望讓它們盡可能接近並發。

Thank you.

謝謝。

Jay Olson, Oppenheimer.

傑伊奧爾森、奧本海默。

Oh, hey, congrats on all the progress and thanks so much for taking the question. I think, Brian, you had mentioned that you were planning to test monthly for the subcu formulation later this year. Can you just talk about your thoughts on the study design and whether or not that can be implemented into Phase 3 and eventually get into the label? And then I have one follow-up, if I could.

哦，嘿，祝賀您取得的所有進展，非常感謝您回答這個問題。布萊恩，我想你曾經提到過你計劃在今年晚些時候每月對 subcu 配方進行測試。您能否談談您對研究設計的想法，以及它是否可以實施到第 3 階段並最終進入標籤？如果可以的話，我還有一個後續問題。

Yes. The long-term goal would be to have something in the label. Whether or not it would be in the initial NDA, too early to tell right now. The study that we'd like to initiate will be a study where we rapidly titrate people to a high dose of VK2735 and then transition them from the weekly to the monthly cadence and really look for weight regain, how does -- we're not anticipating further weight loss, but how does maintenance work at this less frequent dosing interval.

是的。長期目標是在標籤中包含一些內容。目前還無法確定這是否會出現在最初的保密協議中。我們想要啟動的研究將是一項快速滴定受試者至高劑量 VK2735 的研究，然後將他們的用藥頻率從每週一次轉變為每月一次，並真正觀察體重恢復的情況，我們並不期望進一步減輕體重，而是希望在這種較低頻率的給藥間隔下，維持效果如何。

Okay, great. And then further along the lines of maintenance dosing, I think you mentioned there was an option to transition from subcu to the oral formulation. Is that something that you were planning to do in a separate study?

好的，太好了。然後進一步沿著維持劑量的思路，我想您提到有一個從皮下注射過渡到口服製劑的選項。這是您在單獨的研究中計劃要做的事情嗎？

Yes. So ideally, this would be in the same study. So we would transition some to a low-dose oral. But we're working through the protocol currently. And the plan would be we do the first study as sort of a PK exploratory study and then followed up with a little bit longer-term study to look at longer-term maintenance effects.

是的。因此理想情況下，這應該在同一項研究中。因此我們會將一些藥物轉為低劑量口服。但我們目前正在執行該協議。我們的計劃是，首先進行一項 PK 探索性研究，然後再進行一些長期研究，以觀察長期維持效果。

Okay, great. Thanks. That's super helpful. Appreciate taking the questions.

好的，太好了。謝謝。這非常有幫助。感謝您回答這些問題。

Thanks a lot, Jay.

非常感謝，傑伊。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Hi, thanks for taking my question. Just a couple for me. For the Phase 2 oral VENTURE trial, it looks like it's a pretty broad dose range still. And any reason why it's not more narrow? And at the highest dose, is that something that you'll realistically be pursuing? Or are you still just testing the maximum tolerability again?

你好，謝謝你回答我的問題。對我來說只有一對。對於第 2 階段口服 VENTURE 試驗，看起來劑量範圍仍然相當廣泛。為什麼它沒有變得更窄呢？在最高劑量下，這是你實際追求的結果嗎？或者你仍然只是再次測試最大耐受力？

Yes. Thanks, Annabel. TBD on what the dose range would be in a subsequent study. We're just giving this one underway. But we really want to know when you treat for a longer period of time, do these lower doses continue to mature on body weight reduction?

是的。謝謝，安娜貝爾。劑量範圍具體是多少還有待後續研究確定。我們剛開始這個工作。但我們確實想知道，當您進行較長時間的治療時，這些較低的劑量是否會繼續對體重減輕產生效果？

It looked like the lower doses did have that in the Phase 1 study. But it was so short and so small that it's really hard to tell. It does seem like as we get further accumulation with longer-term dosing, you should see this sort of maturing efficacy signal. But we haven't done the study yet, so we'll see how it out.

在第一階段的研究中，較低劑量似乎確實有這樣的效果。但它太短太小，所以很難看清楚。看起來，隨著​​我們透過長期給藥進一步積累，你應該會看到這種成熟的功效訊號。但我們還沒有進行這項研究，所以我們將觀察結果如何。

And at the highest dose, are you comfortable that you've tested maximum tolerability? Or are you just trying to push as broad a dose range as you can?

在最高劑量下，您是否認為已經測試了最大耐受性？或者您只是想盡可能擴大劑量範圍？

Yes. The Phase 1 study was very well tolerated at 100. We pushed a little bit higher here and we were okay to do that. So could we go even higher? I don't know.

是的。階段 1 研究在 100 時耐受性非常好。我們在這裡稍微推高了一點，我們可以做到這一點。那我們還能走得更高嗎？我不知道。

We only proposed 120. I think we could probably defend higher doses. But we balance that against the -- what we know about the accumulation rate as being slow. And almost certainly, we're not at steady state at 28 days. So it's a balance where you pick that top dose. But 120 seems to be -- it will be an interesting dose to look at.

我們只提議120。我認為我們或許可以主張更高的劑量。但我們將其與我們所知道的積累速度緩慢的情況進行權衡。幾乎可以肯定的是，我們在 28 天後還沒有達到穩定狀態。因此，選擇最佳劑量需要保持平衡。但 120 似乎——這將是一個值得關注的劑量。

Okay. And then just as a follow-up, any updates on the manufacturing agreement and why it might be taking so long to finalize?

好的。然後作為後續問題，有關製造協議有任何更新嗎？

Yes, spending a lot of time on manufacturing. We continue to work toward a comprehensive agreement or set of agreements. And the goal is really to enable the launch of a substantial commercial product and complicated discussions but making a lot of good progress, and we'll have more to say at the appropriate time.

是的，在製造上花了很多時間。我們將繼續努力達成一項或一系列全面協議。我們的真正目標是為了推出一款實質性的商業產品，雖然討論很複雜，但已經取得了很多良好的進展，我們會在適當的時候透露更多消息。

Thank you.

謝謝。

Thanks, Annabel.

謝謝，安娜貝爾。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B.Riley Securities。

Yes, good afternoon. Thanks for taking our questions and congrats on the operational progress. Just on the VENTURE oral Phase 2 study, I appreciate the rationale for choice of top dose selection there. Are you able to comment, Brian, on the 13-week weight loss expectation? And if you could also help us think about the cost of goods sold based on the manufacturing contracts you're working on to secure the API would be helpful. And then I have a follow-up.

是的，下午好。感謝您回答我們的問題，並對營運進度表示祝賀。僅就 VENTURE 口服第 2 階段研究而言，我很欣賞其中選擇最佳劑量的理論基礎。布萊恩，您能對 13 週的減肥預期做出評論嗎？如果您還能幫助我們根據您正在執行的製造合約來考慮銷售商品的成本，那麼保護 API 將會很有幫助。然後我有一個後續問題。

Yes. I'd say on both of those, a little too early to tell. We can't really predict where the weight loss might land after 13 weeks. When we look at the four-week graphs, you can see the trends continuing downward. But where do those go from here, it's really hard to predict. With COGS, it's -- I think it's premature to start discussing COGS as we're in a Phase 2 trial with the program. We certainly wouldn't want to target a product that isn't profitable though.

是的。我想說，對於這兩點，現在說還太早。我們確實無法預測 13 週後體重會減輕多少。當我們查看四周圖表時，您會發現趨勢持續下降。但接下來這些會去往何方，真的很難預測。對於 COGS，我認為現在開始討論 COGS 還為時過早，因為該計劃尚處於第二階段試驗。我們當然不想瞄準一款不賺錢的產品。

Okay. Got it. And then the concepts like weight regain or lean muscle mass preservation, any plans to study that as part of these Phase 2 studies, the oral and the once-monthly subcu? Or is that more TBD as those studies progress?

好的。知道了。然後是體重恢復或肌肉質量保存等概念，有任何計劃將這些作為第 2 階段研究的一部分進行研究嗎，口服和每月一次的皮下注射？或者隨著研究的進展，這個問題還有待解決？

Well, the maintenance study that I think Jay asked about would be really to target weight regain. So that's where we dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low-dose daily oral. And the primary objective is to understand how we regain manifests after you make that transition to either the monthly or the low-dose oral.

嗯，我認為傑伊詢問的維持研究實際上是為了防止體重恢復。因此，我們先讓患者每週注射一次，直到劑量增加到高劑量，然後再過渡到每月注射一次或每日口服一次低劑量。主要目標是了解在轉變為每月一次或低劑量口服藥物後，我們的恢復情況如何。

The muscle mass preservation, is that more amylin focused?

肌肉質量的保存是否更重視胰淀素？

No. We will do DEXAs Phase 3 program, but no intention at this point to evaluate like our 5211 molecule for muscle presentation. But we will be doing DEXA -- I think everybody's DEXA in their Phase 3 programs on a subset of patients.

不。我們將進行 DEXA 第 3 階段計劃，但目前無意評估我們的 5211 分子是否適用於肌肉呈現。但我們將進行 DEXA — — 我認為每個人的 DEXA 都會在他們的第 3 階段計劃中針對一部分患者進行研究。

Got it. Got it. And lastly, on 2809 for MASH, obviously, you've been working through the post end of Phase 2 feedback and obviously, having strategic discussions. Is there any update to how maybe the counterparty feedback might be coming as obviously, there have been a slew of positive commercial and clinical updates in that space that could warrant a very positive return on investment? And maybe the complexity is not as bad as maybe it was thought a few years ago.

知道了。知道了。最後，關於 MASH 的 2809，顯然，您一直在努力完成第 2 階段結束後的回饋，並且顯然進行了策略討論。是否有任何最新消息表明交易對手的反饋可能會如何，因為顯然該領域已經出現了一系列積極的商業和臨床更新，可以保證非常積極的投資回報？也許複雜性並不像幾年前想像的那麼糟。

Yes, sure. Well, hard to comment on discussions around partnering for really either of the assets. We had a very busy schedule at JPMorgan. And we're in the follow-up period now, but nothing further to say at this time on partnering. I think the overhang with the MASH program is the requirement for biopsies and that does complicate Phase 3 trials. But we'll see where some of the conversations lead.

是的，當然。嗯，很難評論雙方資產合作的討論。我們在摩根大通的日程安排非常繁忙。目前我們正處於後續階段，但目前關於合作還沒有進一步的消息可說。我認為 MASH 計劃的難題在於需要進行活檢，而這確實使第 3 階段試驗變得複雜。但我們會看看一些對話會有什麼結果。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

Yeah, hi guys. Thanks for taking my questions. Maybe let me just start with the monthly subcu dose study. Is the plan to evaluate the 10 and 15 milligram doses? And how are you thinking about timing of the start of the monthly subcu relative to the Phase 3 weekly subcu study?

是的，大家好。感謝您回答我的問題。也許讓我先從每月皮下劑量研究開始。計劃是否對 10 毫克和 15 毫克劑量進行評估？您如何考慮相對於第 3 階段每週皮下注射研究開始每月皮下注射的時間？

Yes, thanks. We're not going to disclose the doses until we get the study initiation. But we would intend to keep people on the weekly for probably four weeks before we transition them to the monthly. But all those details, we would disclose when we start the study.

是的，謝謝。在研究開始之前，我們不會透露劑量。但我們打算先讓人們使用周報大概四周，然後再過渡到月報。但我們會在開始研究時披露所有這些細節。

Got it. And then maybe a follow-up question on the amylin program, what needs to be completed for IND submission this year?

知道了。然後也許是關於胰島澱粉樣勝肽計畫的後續問題，今年 IND 提交需要完成什麼？

Well, all of the IND-enabling work, particularly the tox work, but we hope to have that done to enable an IND filing this year.

嗯，所有 IND 支援工作，特別是毒性工作，但我們希望完成這些工作以便於今年提交 IND 申請。

Great, thanks.

太好了，謝謝。

Thanks, Biren.

謝謝，Biren。

Hardik Parikh, JP Morgan.

Hardik Parikh，摩根大通。

Hey, Brian, thanks for all the updates today. A couple of questions. First is on the subcu program. So I believe it was at our conference in January, where you announced that the first time that you would also be studying it in the type 2 diabetes plus obesity population. Was that originally part of your plan? Or was that more of a result of the FDA meetings you've had?

嘿，布萊恩，謝謝你今天的所有更新。幾個問題。首先是關於 subcu 程式。所以我相信這是在我們一月份的會議上，您首次宣布您將在 2 型糖尿病和肥胖症人群中對其進行研究。這原本是你計畫的一部分嗎？或者這更多是您參加過的 FDA 會議的結果？

And then the second one is on the oral program. You said data in the second half of the year. Is there any kind of thought process on whether that data would be headline data? Or could we see a full readout in the second half?

第二個是關於口語節目。你說的是下半年的數據。是否有過這樣的思考：這些數據是否會成為頭條數據？或者我們能在下半場看到完整的結果嗎？

Yes. Thanks, Hardik. The data of timing, generally, we report top-line data when it's available. And then the final data are generally reported later. So when we have the key elements of the top-line data set, which will probably be body weight change and safety profile, we would intend to release it.

是的。謝謝，哈迪克。時間數據，一般來說，我們會在數據可用時報告頂線數據。最終的數據一般會在稍後報告。因此，當我們掌握了頂線資料集的關鍵元素（可能是體重變化和安全性概況）時，我們打算發布它。

With the Phase 3 trial choices, the playbook there is -- it's not unique to us, it's generally a Phase 3 study in obese subjects. And then a separate Phase 3 study will be subjects with type 2 diabetes and the obesity studies, the larger of the two diabetes would be the smaller of the two. But that enables some discussion of glycemic control in the label.

對於第 3 階段試驗的選擇，我們的策略並不是獨一無二的，它通常是針對肥胖受試者的第 3 階段研究。然後，單獨的第 3 階段研究將針對患有 2 型糖尿病和肥胖症的受試者進行研究，兩種糖尿病中較大的一種將是兩種糖尿病中較小的一種。但這使得標籤中一些關於血糖控制的討論成為可能。

Okay. And then just 1 more just follow-up on the amylin program. You're still deciding to which candidate you're going to kind of take forward. Is it possible that it could be one of those assets that you disclosed, I believe, back in ADA last year?

好的。然後再進行 1 次有關胰淀素計畫的後續跟進。您仍在決定選擇哪位候選人。我相信，這有可能就是您去年在 ADA 中披露的那些資產之一嗎？

Yes, it's possible. We have a number that looks really interesting, but that's possible, yes.

是的，有可能。我們有一個看起來很有趣的數字，但這是可能的，是的。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Thanks for taking our questions. Just curious about your view on PK as data were presented at the ObesityWeek. So first, looking at the accumulation, I'm curious if there is like a multiple that you're looking for in the initial phase that would lend evidence to potentially longer dosing interval like you mentioned, the monthly dosing interval.

感謝您回答我們的問題。我只是好奇您對 PK 的看法，因為數據是在 ObesityWeek 上呈現的。因此，首先，看看積累，我很好奇在初始階段是否存在您所尋找的倍數，這可以為可能更長的給藥間隔提供證據，就像您提到的那樣，即每月的給藥間隔。

And then also in terms of the plasma level, is there like a minimum that you're looking at the end of week four to give you confidence that the weight regain would be minimized?

那麼就血漿水平而言，在第四週結束時是否存在一個最低值，以讓您確信體重反彈會降到最低？

Yes. Good questions. The way we looked at -- starting with the second question, it seems as though when we look at that 2.5 mg dose over 13 weeks, that leads to 9% weight loss, which is pretty good. So it feels like if you can maintain plasma levels in the neighborhood of that 2.5 mg dose after four weeks, four weeks from the prior dose, you're probably in a range that will prevent any significant weight gain.

是的。好問題。從第二個問題開始，我們研究的方式是，似乎當我們觀察 13 週內 2.5 毫克的劑量時，體重減輕了 9%，這相當不錯。因此感覺如果您可以在四周後，也就是服用前一周的劑量後將血漿水平維持在 2.5 毫克劑量附近，那麼您的體重可能就處於可以防止體重明顯增加的範圍內。

And so that's just kind of a high level the way we're looking at. And yes, there's more numbers behind that, but that's kind of the way we consider it.

這只是我們所觀察到的一種高層次的東西。是的，這背後有更多的數字，但這就是我們考慮它的方式。

With the accumulation, interesting when you look at the accumulation graphs, even the 5-milligram cohort after 13 weeks is still accumulating. And I think that speaks to the highly differentiated half-life we have that allows the accumulation to happen even though you've been fixed that 5-milligram dose for 10 weeks in that study, they're still an accumulation ongoing. So where does it go at higher doses, we're not quite sure, but I think it suggests that the 13-week data probably understate the long-term efficacy of what's possible.

隨著積累，有趣的是，當你查看積累圖時，即使是 13 週後的 5 毫克組仍在積累。我認為這說明了我們具有高度差異化的半衰期，這使得積累得以發生，即使在該研究中你已經將 5 毫克的劑量固定了 10 週，它們仍然在持續積累。那麼，我們不太確定在更高的劑量下會發生什麼，但我認為這表明 13 週的數據可能低估了可能的長期療效。

And just a quick follow-up, Brian. I'm curious with the accumulation graph that you showed, would you be able to provide the follow-up period? So for example, like a 16-week follow-up with the accumulation PK? Or is that simply not measured in the VENTURE study?

還有一個簡短的後續問題，布萊恩。我對您展示的累積圖很感興趣，您能提供後續時期嗎？那麼，例如進行 16 週的追蹤和累積 PK？或者這在 VENTURE 研究中根本沒有測量過？

Yes. Well, that is actually the graph below it in the poster. When you look at the plasma level decay, that's over the following 7 weeks. So that would be 19 weeks total in that -- I mean, the final time point in that second graph would represent 19 weeks from day one of the study, if that makes sense.

是的。嗯，這其實就是海報下方的圖表。當您觀察血漿水平衰減時，那是在接下來的 7 週內。所以總共是 19 週——我的意思是，第二張圖表中的最後一個時間點代表從研究第一天開始的 19 週，如果這說得通的話。

Right. Right. That's right. That makes sense. Okay, great. Thanks so much, Brian.

正確的。正確的。這是正確的。這很有道理。好的，太好了。非常感謝，布萊恩。

Yeah. Thanks, Andy.

是的。謝謝，安迪。

Yale Jen, Laidlaw & Company.

耶魯仁萊德勞公司。

Great. Thanks for taking the questions and congrats on the progress. Just a few quick ones. The first is that for the Phase 3 study in terms of type 2 diabetes patients. Would you also potentially seek a label on the diabetes alone or simply just a part of the obesity? Then I have a follow-up.

偉大的。感謝您回答問題，並祝賀您的進展。僅舉幾個例子。第一個是針對第2型糖尿病患者的3期研究。您是否也可能尋求單獨針對糖尿病的標籤或僅僅是針對肥胖的一部分的標籤？然後我有一個後續問題。

Yes. Thanks, Yale. It's a great question. Really, we wouldn't be submitting a type 2 diabetes package for approval for treatment of type 2 diabetes. It's for inclusion in an obesity label in people with obesity and type 2 diabetes.

是的。謝謝，耶魯。這是一個很好的問題。實際上，我們不會提交 2 型糖尿病套餐以供批准治療第 2 型糖尿病。它適用於肥胖和 2 型糖尿病患者的肥胖標籤。

And a follow-up question here is that in terms of material preparing, is auto injector part of that? And if so, what's the situation there?

這裡的後續問題是，就材料準備而言，自動注射器是其中的一部分嗎？如果有，那裡的情況怎麼樣？

Yes. We do plan to introduce an auto-injector in the Phase 3 program. So we would anticipate the product to launch as an auto-injector.

是的。我們確實計劃在第 3 階段計劃中引入自動注射器。因此我們預計該產品將以自動注射器的形式推出。

And do you need to do a bridging study on that? Or that's not necessary if you don't start with auto injector for the Phase 3?

您需要對此做一個鋪墊研究嗎？或者如果您在第 3 階段沒有啟動自動注射器，那就沒有必要了？

Yes, we probably would do a bridging study just to make sure that we have bioequivalence with the auto-injector. So I think that would be the intention there.

是的，我們可能會做一項橋接研究，以確保我們與自動注射器具有生物等效性。所以我認為這就是他們的意圖。

Okay, great. Thanks a lot. And again, congrats on all the progress.

好的，太好了。多謝。再次恭喜您所取得的所有進步。

Thanks a lot, Yale.

非常感謝，耶魯。

(Operator Instructions)

（操作員指令）

Justin Zelin, BTIG.

BTIG 的賈斯汀·澤林 (Justin Zelin)。

Thanks for taking the questions and congrats on the updates here. Brian, I wanted to ask about the upcoming late stage oral, small molecule obesity readout in the field. And just your latest thoughts on the benefits associated with and the scalability of peptide API as compared to small molecules.

感謝您回答問題，並祝賀這裡的更新。布萊恩，我想詢問有關該領域即將進行的後期口服小分子肥胖症讀數的問題。您最近對勝肽 API 與小分子相比的益處和可擴展性有何看法？

Yes. So hard to predict the data upcoming. It's always -- I always do a bad job at that. But we'll wait for it just like everybody else.

是的。很難預測即將出現的數據。我總是——我總是做得不好。但我們會像其他人一樣等待它。

As far as scalability of peptides versus small molecules, I think there is some misperception out there that the small molecules are universally easier to make than peptides.

就勝肽與小分子的可擴展性而言，我認為存在一些誤解，認為小分子普遍比肽更容易製造。

That's -- I mean, I'm a small molecule chemists totally false, but I know that's the perception. Peptide chemistry is pretty simple. It's pretty low tech. It's scalability that is the challenge. The chemistry is not. And we're, I think, comfortable that we'll be able to produce scale that supports a multibillion-dollar franchise.

那是——我的意思是，我是一名小分子化學家，這完全是錯誤的，但我知道這是人們的看法。肽化學非常簡單。這技術含量很低。可擴展性才是挑戰。但化學卻不是這樣。我認為，我們有信心形成支撐價值數十億美元的特許經營權的規模。

Thanks again, Brian. Congrats again.

再次感謝你，布萊恩。再次恭喜。

Thanks, Justin.

謝謝，賈斯汀。

[Fiona Gia], Jeffries.

[菲奧娜·吉亞]，傑弗里斯。

Hi James. Thanks for taking the question and congrats on the quarter. So my question is on the amylin program. Can you just comment on the characterization of the compound that you selected? Because I seem to remember from ADA, most of the compound seem to follow a balanced profile.

嗨，詹姆斯。感謝您回答這個問題並祝賀本季取得佳績。我的問題是關於胰淀素計劃的。您能否評論一下您所選擇的化合物的特性？因為我似乎記得 ADA，大多數化合物似乎都遵循平衡的曲線。

But I think there are like one or two that are more amylin biased. Can you comment on the like any characterization of the DC that you might select?

但我認為有一兩種比較偏向胰淀素。您能否對您可能選擇的 DC 的任何特徵進行評論？

Yes. All of them are -- well, we do have a range, but the ones that are of greatest interest are much more balanced more toward that 1:1 when you look at the -- I think we look at calcitonin to amylin 3, pretty much 1:1 maybe up to 3 or 5 to 1, but as close as possible to 1:1. I'm not sure that answers the question, but --.

是的。所有這些都是 — — 好吧，我們確實有一個範圍，但當你看的時候，最令人感興趣的那些更加平衡，更接近 1:1 — — 我認為我們看降鈣素與胰島澱粉樣多肽 3，幾乎是 1:1，可能高達 3 或 5 比 1，但盡可能接近 1:1。我不確定這能回答這個問題，但是--.

It's very helpful. Thank you.

這非常有幫助。謝謝。

Thanks, Jonas.

謝謝，喬納斯。

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

我們的問答環節到此結束。我想將會議交還給史蒂芬妮·迪亞茲，請她作最後發言。

Thank you very much for joining us today. We look forward to updating you again the coming months. Have a good afternoon.

非常感謝您今天加入我們。我們期待在接下來的幾個月中再次為您更新。祝下午愉快。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。