Viking Therapeutics Inc (VKTX) 2024 Q2 法說會逐字稿

Welcome to the Viking Therapeutics second quarter 2024 financial results conference call.

歡迎參加 Viking Therapeutics 2024 年第二季財務業績電話會議。

(Operator instructions)

（操作員說明）

As a reminder, this conference call is being recorded today, July 24, 2024.

謹此提醒，本次電話會議於今天（2024 年 7 月 24 日）錄製。

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

我現在想將會議轉交給 Viking 投資者關係經理 Stephanie Diaz。

Please go ahead, Stephanie.

請繼續，史蒂芬妮。

Hello, and thank you all for participating in today's call.

大家好，感謝大家參加今天的電話會議。

Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.

今天加入我的是 Viking 總裁兼執行長 Brian Lian；格雷格·贊特 (Greg Zante)，Viking 的財務長。

Before we begin, I'd like to caution that comments made during this conference call today, July 24, 2024, will contain forward-looking statements under the safe harbor provision of the US Securities Litigation Reform Act of 1995 including statements about Viking's expectations regarding its development activities, time lines and milestones.

在我們開始之前，我想提醒大家，在今天（2024 年7 月24 日）的電話會議上發表的評論將包含1995 年美國證券訴訟改革法案安全港條款下的前瞻性陳述，包括有關Viking 對以下方面的預期的陳述：其開發活動、時間表和里程碑。

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.

前瞻性陳述存在風險和不確定性，可能導致實際結果出現重大不利差異，且報告的結果不應被視為未來績效的指標。

These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statements made today.

這些前瞻性陳述僅代表今天的情況，本公司不承擔修改或更新今天所做的任何陳述的義務。

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

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及其他事項的所有文件。

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

我現在將把電話轉給 Brian Lian，徵求他的初步意見。

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast.

謝謝斯蒂芬妮，祝所有透過電話或網路廣播收聽的人下午好。

Today, we'll review our financial results for the second quarter and six months ended June 30, 2024, and provide an update on recent progress with our clinical programs and operations.

今天，我們將回顧截至 2024 年 6 月 30 日的第二季和六個月的財務業績，並提供我們臨床專案和營運的最新進展。

The first half of 2024 has been an exciting time at Viking.

2024 年上半年對 Viking 來說是一段令人興奮的時光。

During the first quarter, we announced positive results from the Phase-II VENTURE trial evaluating VK2735 for the treatment of obesity.

第一季度，我們宣布了評估 VK2735 治療肥胖的 II 期 VENTURE 試驗的正面結果。

This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

該試驗表明，經過 13 週的治療後，體重明顯下降。

We also announced the initial results from a Phase I trial evaluating a novel oral formulation of VK2735 in healthy volunteers, which showed encouraging reductions in body weight and excellent tolerability after 28 days of dosing.

我們也發表了一項 I 期試驗的初步結果，該試驗在健康志願者中評估了 VK2735 的新型口服製劑，結果顯示給藥 28 天後體重明顯下降，且耐受性良好。

The positive momentum from these readouts continued into the second quarter with the announcement of the 52-week histology results from our Phase IIb VOYAGE trial, evaluating VK2809 for the treatment of NASH and fibrosis.

隨著我們 IIb 期 VOYAGE 試驗的 52 週組織學結果的公佈，這些讀數的積極勢頭持續到第二季​​度，該試驗評估了 VK2809 對 NASH 和纖維化的治療效果。

This study successfully achieved secondary and exploratory endpoints of improvement in NASH resolution rate, fibrosis, and the combination of both.

這項研究成功實現了 NASH 緩解率、纖維化以及兩者組合改善的次要和探索性終點。

I'll summarize the highlights from these studies later in the call.

我將在稍後的電話會議中總結這些研究的要點。

During the second quarter, Viking also announced early results from a series of internally developed dual agonist of the amylin and calcitonin receptors at the 84th scientific sessions of the American Diabetes Association.

第二季度，Viking 也在美國糖尿病協會第 84 屆科學會議上公佈了一系列內部開發的胰淀素和降鈣素受體雙重激動劑的早期結果。

These compounds demonstrated body weight reductions, decreased food intake, and improved metabolic profile in animal models.

這些化合物在動物模型中顯示出體重減輕、食物攝取量減少和代謝狀況改善。

Finally, we ended the second quarter with a strong balance sheet with over $900 million in cash providing the resources to aggressively advance each of our pipeline programs.

最後，我們在第二季結束時擁有強勁的資產負債表，擁有超過 9 億美元的現金，為積極推進我們的每個管道項目提供了資源。

I'll provide further details on our operations and development activities after we review our financial results for the second quarter and six months ending June 30.

在我們審查第二季和截至 6 月 30 日的六個月的財務表現後，我將提供有關我們營運和開發活動的更多詳細資訊。

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

接下來，我會將電話轉給 Viking 財務長 Greg Zante。

Thanks, Brian.

謝謝，布萊恩。

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

結合我的評論，我想建議參與者參考 Viking 向美國證券交易委員會提交的 10-Q 表格，我們預計將在今天晚些時候提交該文件。

I'll now go over our results for the second quarter and six months ended June 30, 2024, beginning with results for the quarter.

我現在將回顧第二季和截至 2024 年 6 月 30 日的六個月的業績，從本季的業績開始。

Research and development expenses were $23.8 million for the three months ended June 30, 2024, compared to $13.9 million for the same period in 2023.

截至2024年6月30日止三個月的研發費用為2,380萬美元，而2023年同期為1,390萬美元。

The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates, clinical studies, preclinical studies, salaries and benefits, and stock-based compensation.

這一增長主要是由於與公司候選藥物製造、臨床研究、臨床前研究、工資和福利以及股票薪酬相關的費用增加。

General and administrative expenses were $10.3 million for the three months ended June 30, 2024, compared to $9.8 million for the same period in 2023.

截至 2024 年 6 月 30 日止三個月的一般及行政費用為 1,030 萬美元，而 2023 年同期為 980 萬美元。

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

這一增長主要是由於與股票薪酬和第三方顧問提供的服務相關的費用增加，但部分被與法律和專利服務相關的費用減少所抵消。

For the three months ended June 30, 2024, Viking reported a net loss of $22.3 million or $0.20 per share compared to a net loss of $19.2 million or $0.19 per share in the corresponding period in 2023.

截至 2024 年 6 月 30 日的三個月，Viking 報告淨虧損 2,230 萬美元，即每股 0.20 美元，而 2023 年同期淨虧損為 1,920 萬美元，即每股 0.19 美元。

The increase in net loss for the three months ended June 30, 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6月30日止三個月的淨虧損增加，主要是由於前面提到的研發費用以及一般和管理費用的增加，部分被利息收入與2023年同期相比的增加所抵消。

I'll now go over the results for the six months ended June 30, 2024.

我現在將回顧截至 2024 年 6 月 30 日的六個月的結果。

Our research and development expenses for the six months ended June 30, 2024, were $47.9 million compared to $24.9 million for the same period in 2023.

截至 2024 年 6 月 30 日的六個月，我們的研發費用為 4,790 萬美元，而 2023 年同期為 2,490 萬美元。

The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, preclinical studies, stock-based compensation, salaries and benefits, services provided by third-party consultants, and regulatory services.

這一增長主要是由於與候選藥物製造、臨床研究、臨床前研究、股票薪酬、工資和福利、第三方顧問提供的服務以及監管服務相關的費用增加。

Our general and administrative expenses for the six months ended June 30, 2024, were $20.3 million compared to $19.4 million for the same period in 2023.

截至 2024 年 6 月 30 日的六個月，我們的一般及管理費用為 2,030 萬美元，而 2023 年同期為 1,940 萬美元。

The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, and services provided by third-party consultants, partially offset by a decrease in expenses related to legal and patent services.

這一增長主要是由於與股票薪酬、工資和福利以及第三方顧問提供的服務相關的費用增加，但部分被與法律和專利服務相關的費用減少所抵消。

For the six months ended June 30, 2024, Viking reported a net loss of $49.6 million or $0.46 per share, compared to a net loss of $38.8 million or $0.44 per share in the corresponding period in 2023.

截至 2024 年 6 月 30 日的六個月，Viking 報告淨虧損 4,960 萬美元，即每股 0.46 美元，而 2023 年同期淨虧損為 3,880 萬美元，即每股 0.44 美元。

The increase in net loss for the six months ended June 30, 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6月30日止六個月的淨虧損增加，主要是由於前面提到的研發費用以及一般和管理費用的增加，部分被利息收入與2023年同期相比的增加所抵銷。

Turning to the balance sheet at June 30, 2024, Viking held cash, cash equivalents, and short-term investments of $942 million, compared to $362 million as of December 31, 2023.

截至 2024 年 6 月 30 日的資產負債表，Viking 持有現金、現金等價物和短期投資為 9.42 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.

謝謝，格雷格。

As I mentioned in my opening remarks, the first half of 2024 has been an exciting period for the Viking team.

正如我在開場白中提到的，2024 年上半年對於 Viking 團隊來說是一個激動人心的時期。

In recent months, the company has announced positive results from three clinical programs with each readout demonstrating what we believe to be best-in-class results.

近幾個月來，該公司宣布了三個臨床項目的積極結果，每個讀數都證明了我們認為是同類最佳的結果。

Further, the company recently announced preclinical data from a new internal program that we expect to become an important addition to the company's pipeline.

此外，該公司最近公佈了一項新的內部計劃的臨床前數據，我們預計該計劃將成為該公司管道的重要補充。

I'll first review the status of our lead obesity program, VK2735.

我將首先回顧我們的主要肥胖計劃 VK2735 的狀態。

This compound is a dual agonist of the glucagon-like peptide 1 or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide or GIP receptor.

該化合物是胰高血糖素樣勝肽 1 或 GLP-1 受體以及葡萄糖依賴性促胰島素多肽或 GIP 受體的雙重激動劑。

A Phase I single and multiple ascending dose study of VK2735 demonstrated the promising safety, tolerability and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for up to four weeks.

VK2735 的 I 期單次和多次遞增劑量研究表明，當每週皮下注射給藥長達 4 週時，VK2735 具有良好的安全性、耐受性和藥物動力學。

In addition, subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.

此外，研究中的受試者在 28 天後體重較基線減輕了約 8%，且沒有出現平台期跡象。

Last fall, we initiated the Phase II study of VK2735, known as the VENTURE trial.

去年秋天，我們啟動了 VK2735 的 II 期研究，即 VENTURE 試驗。

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.

該試驗是一項隨機、雙盲、安慰劑對照、多中心研究，評估了每週一次皮下注射 VK2735 的安全性、耐受性、藥物動力學和減肥功效，持續 13 週。

In the first quarter, Viking announced positive top line results from the VENTURE study, which successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK2735 demonstrating reductions in body weight at all doses compared with placebo.

第一季度，Viking 宣布了 VENTURE 研究的積極頂線結果，該研究成功實現了其主要終點和所有次要終點，接受 VK2735 的患者與安慰劑相比，在所有劑量下體重均有所減輕。

On the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% as well as statistically significant reductions in body weight relative to placebo ranging up to 13.1%.

在主要終點方面，接受 VK2735 治療的患者的平均體重較基線下降了 14.7%，具有統計學意義，相對於安慰劑，體重下降了 13.1%。

Statistically significant differences compared to placebo were observed for all VK2735 doses, starting at week one and were maintained throughout the course of the study.

從第一週開始，所有 VK2735 劑量與安慰劑相比均觀察到統計學上的顯著差異，並在整個研究過程中保持這一差異。

Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing.

所有治療組的體重減輕在 13 週內都在進展，並且沒有表現出穩定的跡象。

We believe this suggests that further weight loss could be achieved through extended dosing beyond the 13-week treatment period of this study.

我們相信這表明在本研究的 13 週治療期之後延長給藥可以實現進一步的減重。

The VENTURE study also showed VK2735 treatment to be safe and well tolerated over the 13-week trial with the majority of treatment-emergent adverse events being characterized as mild or moderate and primarily related to expected GI effects resulting from activation of the GLP-1 axis.

VENTURE 研究還表明，在為期13 週的試驗中，VK2735 治療是安全的且耐受性良好，大多數治療中出現的不良事件被描述為輕度或中度，主要與GLP-1 軸激活引起的預期胃腸道影響有關。

Following completion of dosing in the VENTURE study, patients returned to their respective clinical sites at various time points for follow-up assessments, including pharmacokinetic measurements.

VENTURE 研究完成給藥後，患者在不同時間點返回各自的臨床中心進行後續評估，包括藥物動力學測量。

We believe the resulting PK data merit the development of less frequent dosing regimens.

我們相信由此產生的 PK 數據值得開發頻率較低的給藥方案。

To this end, we expect to explore monthly dosing of VK2735 in a future study.

為此，我們預計在未來的研究中探索 VK2735 的每月給藥劑量。

We believe the flexibility afforded by offering both a weekly and a monthly regimen should provide an attractive option for patients who wish to tailor-dosing to their individual lifestyle and preference.

我們相信，提供每周和每月一次的治療方案所提供的靈活性應該為那些希望根據個人生活方式和偏好調整劑量的患者提供一個有吸引力的選擇。

Details on trial design will be provided as we get closer to trial initiation.

當我們接近試驗啟動時，將提供有關試驗設計的詳細資訊。

In the second quarter, following completion of the VENTURE study, we requested and were granted a Type C meeting with the FDA to help us plan for next steps in the development of VK2735.

在第二季度，VENTURE 研究完成後，我們請求並獲得 FDA 批准舉行 C 型會議，以幫助我們規劃 VK2735 開發的後續步驟。

Based on written feedback from the agency, we intend to advance VK2735 into Phase III development for obesity.

根據該機構的書面回饋，我們打算將 VK2735 推進到肥胖症的 III 期開發。

As a next step, we plan to schedule an end of Phase II meeting with the agency to review development plans and we currently expect this meeting to take place in the fourth quarter of this year.

下一步，我們計劃安排與該機構舉行第二階段會議，以審查開發計劃，目前預計該會議將於今年第四季舉行。

In parallel with the development of a subcutaneous formulation of VK2735, we are also developing an oral tablet formulation of this compound.

在開發 VK2735 皮下製劑的同時，我們也正在開發該化合物的口服藥錠製劑。

We believe a tablet formulation could represent an attractive treatment option for patients who are hesitant to initiate injection-based therapy or for those seeking to maintain the weight loss they have already achieved.

我們相信，對於那些對開始注射治療猶豫不決的患者或那些尋求維持已經實現的體重減輕的患者來說，片劑配方可能是一種有吸引力的治療選擇。

A key advantage in this regard is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule.

在這方面的一個關鍵優勢是有可能將患者從皮下製劑轉變為使用相同分子的口服製劑。

We believe this may reduce the risk of unexpected safety or tolerability challenges, and could be an attractive option for both patients and clinicians.

我們相信這可能會降低意外安全性或耐受性挑戰的風險，並且對於患者和臨床醫生來說可能是一個有吸引力的選擇。

Last year, Viking initiated the Phase I study to evaluate the tablet formulation of VK2735.

去年，Viking啟動了I期研究來評估VK2735的片配方。

This study was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter square.

這項研究是一項隨機、雙盲、安慰劑對照研究，對像是體重指數最低為每平方公尺 30 公斤的健康成年人。

The primary objective was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days.

主要目的是評估 VK2735 片劑的安全性和耐受性，每天一次，持續 28 天。

Secondary and exploratory objectives included an evaluation of the pharmacokinetics of orally administered VK2735 and as well as various pharmacodynamic measures, including changes in body weight and other metrics.

次要和探索性目標包括評估口服 VK2735 的藥物動力學以及各種藥效學測量，包括體重和其他指標的變化。

In the first quarter of this year, we reported the initial data from this study.

今年第一季度，我們報告了這項研究的初步數據。

With respect to safety and tolerability, oral VK2735 was shown to be safe and well tolerated following once-daily dosing for up to 28 days at doses that were titrated up to 40 milligrams.

就安全性和耐受性而言，口服 VK2735 在每日一次、劑量滴定至 40 毫克、持續長達 28 天的情況下被證明是安全且耐受性良好的。

Among subjects receiving VK2735 all treatment-emergent adverse events were reported as mild or moderate in severity with the majority reported as mild.

在接受 VK2735 治療的受試者中，所有治療引起的不良事件的嚴重程度均報告為輕度或中度，其中大多數報告為輕度。

No clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with VK2735 compared with placebo.

與安慰劑相比，接受 VK2735 治療的受試者中胃腸道不良事件未報告有臨床意義的差異。

In addition to safety and tolerability, and exploratory assessment of change in body weight was conducted.

除了安全性和耐受性之外，還對體重變化進行了探索性評估。

Subjects receiving oral VK2735 demonstrated dose-dependent reductions in body weight, ranging up to 5.3% from baseline.

接受口服 VK2735 的受試者表現出劑量依賴性體重減輕，較基線降低高達 5.3%。

Placebo-adjusted reductions in body weight reached up to 3.3% from baseline.

安慰劑調整後體重較基線下降高達 3.3%。

Weight loss over the 28-day window of this study was progressive at the 20- and 40-milligram dose levels with no plateau observed.

在本研究的 28 天窗口內，20 毫克和 40 毫克劑量下的體重減輕是漸進的，沒有觀察到平台期。

Based on the promising weight loss signal observed in this study, along with the excellent tolerability profile at doses up to 40 milligrams per day, further dose escalation was pursued.

基於本研究中觀察到的有希望的減重訊號，以及每日劑量高達 40 毫克的優異耐受性，我們進一步增加了劑量。

In the second quarter, we filed an IND with the FDA to allow the addition of US-based enrollment in order to facilitate an improved rate of study progression.

第二季度，我們向 FDA 提交了 IND 申請，允許增加美國的註冊，以促進研究進展率的提高。

Following clearance of the IND, we continued dose escalation and have since completed dosing in cohorts of both 60-milligram daily and at 80 milligrams daily.

IND 批准後，我們繼續增加劑量，並已完成每日 60 毫克和每日 80 毫克的兩組給藥。

A 100-milligram daily dosing cohort is currently ongoing.

目前正在進行每日 100 毫克的劑量組治療。

We recently submitted an abstract describing this study for presentation this fall at Obesity Week.

我們最近提交了一份描述這項研究的摘要，以便在今年秋天的肥胖週上展示。

We believe the data generated from this study support evaluation of oral VK2735 in a larger, longer Phase II trial in patients with obesity.

我們相信，這項研究產生的數據支持在肥胖患者中進行更大規模、更長的 II 期試驗中對口服 VK2735 的評估。

To this end, we plan to initiate a 13-week study in the fourth quarter of this year.

為此，我們計劃在今年第四季啟動一項為期13週的研究。

Moving to our third clinical program, VK2809 for the treatment of MASH or NASH, in the second quarter, we announced positive histology results from the 52-week VOYAGE study of VK2809 in patients with NASH and fibrosis.

轉向我們的第三個臨床項目，即用於治療 MASH 或 NASH 的 VK2809，我們在第二季度宣布了 VK2809 在 NASH 和纖維化患者中進行的 52 週 VOYAGE 研究的陽性組織學結果。

As a reminder, 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.

提醒一下，VK2809 是一種口服的甲狀腺激素受體小分子激動劑，對肝組織以及受體的 β 亞型具有選擇性。

The Phase IIb VOYAGE study was a randomized, double-blind, placebo-controlled, multicenter international trial, designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis.

IIb 期 VOYAGE 研究是一項隨機、雙盲、安慰劑對照、多中心國際試驗，旨在評估 VK2809 對活檢確診的 NASH 和纖維化患者的療效、安全性和耐受性。

Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction as well as F2 and F3 fibrosis.

透過磁振造影質子密度脂肪分數以及 F2 和 F3 纖維化測量，納入的患者肝臟脂肪含量至少為 8%。

The initial data from the VOYAGE study reported last year demonstrated that the study had successfully achieved its primary endpoint with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo.

去年報告的 VOYAGE 研究的初步數據表明，該研究已成功實現其主要終點，接受 VK2809 治療的患者與安慰劑相比，從基線到第 12 週肝臟脂肪含量顯著降低。

The median relative change from baseline in liver fat among patients treated with VK2809 ranged from 38% to 55% after 12 weeks.

12 週後，接受 VK2809 治療的患者肝臟脂肪相對於基線的中位數相對變化範圍為 38% 至 55%。

In addition, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat.

此外，在接受 VK2809 治療的患者中，高達 85% 的患者肝臟脂肪相對減少了至少 30%。

Efficacy on liver fat was independent of either fibrosis status or the presence of type 2 diabetes.

對肝臟脂肪的功效與纖維化狀態或是否存在第 2 型糖尿病無關。

Reduction of liver fat is associated with the greater likelihood of histologic benefit in NASH, suggesting that VK2809 held the potential to provide benefits on histology endpoints assessing NASH resolution and fibrosis improvement.

肝臟脂肪的減少與 NASH 的組織學獲益的可能性更大相關，這表明​​ VK2809 有可能為評估 NASH 消退和纖維化改善的組織學終點提供益處。

Last month, Viking announced additional results from the VOYAGE study, demonstrating the successful achievement of the trial's secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment.

上個月，Viking 宣布了 VOYAGE 研究的更多結果，證明該試驗的次要終點已成功實現，該終點評估了治療 52 週後透過肝臟活檢評估的組織學變化。

The histology results showed that patients receiving VK2809 experienced clinically and statistically significant improvements in NASH resolution rate, fibrosis stage, and the combination endpoint of NASH resolution and fibrosis improvement.

組織學結果顯示，接受 VK2809 治療的患者在 NASH 消退率、纖維化階段以及 NASH 消退和纖維化改善的組合終點方面經歷了臨床和統計學上的顯著改善。

On the endpoint of NASH resolution without worsening fibrosis, VK2809-treated patients demonstrated resolution rates ranging from 63% to 75% compared with 29% for placebo.

在 NASH 消退且纖維化不惡化的終點上，接受 VK2809 治療的患者的消退率在 63% 至 75% 之間，而安慰劑組為 29%。

On the secondary endpoint evaluating the proportion of patients demonstrating at least a one-stage improvement in fibrosis with no worsening of NASH, the proportion of VK2809-treated patients demonstrating improvements in fibrosis range from 44% to 57%, compared with 34% for placebo.

在評估纖維化至少一階段改善且 NASH 未惡化的患者比例的次要終點中，VK2809 治療的患者纖維化改善的比例為 44% 至 57%，而安慰劑組為 34% 。

On the secondary endpoint evaluating the proportion of patients experiencing both the resolution of NASH and at least a one-stage improvement in fibrosis, the proportion of VK2809-treated patients achieving both measures ranged from 40% to 50%, compared with 20% for placebo.

在評估 NASH 消退和纖維化至少一階段改善的患者比例的次要終點上，VK2809 治療的患者實現這兩項指標的比例為 40% 至 50%，而安慰劑組為 20% 。

Turning to safety and tolerability, VK2809 demonstrated an encouraging profile through 52 weeks of treatment with minimal differences compared with the previously reported results from 12 weeks.

至於安全性和耐受性，VK2809 在 52 週的治療中表現出令人鼓舞的表現，與先前報告的 12 週結果相比差異很小。

The majority, 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate.

據報告，接受 VK2809 治療的患者中，大多數（94%）與治療相關的不良事件為輕度或中度。

Discontinuations due to adverse events were low and balanced among placebo and treatment arms.

因不良事件而停藥的比例較低，安慰劑組和治療組之間保持平衡。

VK2809 also demonstrated excellent gastrointestinal tolerability through 52 weeks of treatment with similar rates of nausea, diarrhea, stool frequency and vomiting among VK2809-treated patients as compared to placebo.

透過 52 週的治療，VK2809 也表現出優異的胃腸道耐受性，與安慰劑相比，VK2809 治療患者的噁心、腹瀉、大便頻率和嘔吐發生率相似。

We believe these data clearly demonstrate VK2809's best-in-class efficacy on both NASH resolution and fibrosis improvement, along with the potential for cardiovascular benefit through improvement in plasma lipids.

我們相信這些數據清楚地證明了 VK2809 在 NASH 消退和纖維化改善方面的一流功效，以及透過改善血脂對心血管有益的潛力。

We are currently preparing for an end of Phase II meeting with the FDA to discuss the registration path for VK2809 in NASH, and we expect this meeting to occur in the fourth quarter of this year.

我們目前正在準備與 FDA 舉行第二階段會議，討論 VK2809 在 NASH 中的註冊路徑，我們預計這次會議將於今年第四季舉行。

I'll now move to our fourth clinical program, VK0214, for the treatment of the rare neuromuscular disorder called X-linked adrenoleukodystrophy or X-ALD.

我現在將轉向我們的第四個臨床項目 VK0214，用於治療稱為 X 連鎖腎上腺腦白質營養不良或 X-ALD 的罕見神經肌肉疾病。

VK0214 is our second thyroid hormone receptor beta agonist in clinical development.

VK0214是我們臨床開發中的第二種甲狀腺激素受體β激動劑。

Like VK2809, VK0214 is also an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor.

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 異構體進行選擇。

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 acids.

X-ALD 是一種罕見且使人衰弱的代謝性疾病，是由基因突變導致超長鏈脂肪酸過氧化物酶體轉運蛋白功能喪失而引起的。

As a result, patients are unable to efficiently metabolize these assets and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.

因此，患者無法有效地代謝這些物質，而這些化合物的累積被認為有助於 X-ALD 的發生和進展。

VK0214 is being evaluated in a Phase Ib study enrolling patients with the adrenomyeloneuropathy or AMN form of X-ALD, which is the most common form of the disorder.

VK0214 正在一項 Ib 期研究中進行評估，該研究招募了患有腎上腺脊髓神經病變或 AMN 形式的 X-ALD 的患者，這是該疾病最常見的形式。

This trial is a randomized, double-blind, placebo-controlled, multicenter study in adult male patients with AMN.

該試驗為 AMN 成年男性患者的隨機、雙盲、安慰劑對照、多中心研究。

The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VK0214 and administered orally once daily for 28 days.

研究的主要目的是評估 VK0214 的安全性、耐受性和藥物動力學，每天口服一次，持續 28 天。

The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids.

該研究還包括對極長鏈脂肪酸血漿水平變化的探索性評估。

We recently completed enrollment in this study and expect to announce the top line results later this year.

我們最近完成了這項研究的招募，並預計在今年稍後公佈最終結果。

I will now briefly summarize our newest program, targeting the amylin receptor for the treatment of obesity.

現在我將簡要總結我們的最新計劃，以胰淀素受體為目標來治療肥胖。

During the second quarter, Viking presented preclinical data at the American Diabetes Association Scientific Sessions from an internally developed dual amylin and calcitonin receptor agonist program.

第二季度，Viking 在美國糖尿病協會科學會議上展示了內部開發的雙胰淀素和降鈣素受體激動劑計畫的臨床前數據。

As the amylin receptor plays an important role in food intake and metabolic control, we believe it may represent an important target for therapeutic intervention in obesity and an attractive opportunity to expand the company's pipeline in this area.

由於胰島澱粉樣多肽受體在食物攝取和代謝控制中發揮重要作用，我們相信它可能代表肥胖治療幹預的重要目標，也是擴大公司在該領域管道的有吸引力的機會。

The company's ADA presentation highlighted the effects of treatment on body weight, food intake and metabolic profile in healthy rats and in diet-induced obese mice.

該公司的 ADA 演示強調了治療對健康大鼠和飲食誘導的肥胖小鼠的體重、食物攝取和代謝特徵的影響。

The study results demonstrated that Viking series of dual amylin calcitonin receptor agonist reduced food intake in lean rats in the period from 0 to 72 hours following a single dose.

研究結果表明，Viking系列雙胰淀素降鈣素受體激動劑在單次給藥後0至72小時內減少了瘦大鼠的食物攝取。

At 72 hours post dose, Viking's compounds resulted in up to 8% body weight reductions compared to vehicle-treated animals.

給藥後 72 小時，與媒介物治療的動物相比，Viking 的化合物導致體重減輕高達 8%。

In a diet-induced obese mouse model, treatment with Viking's amylin agonist for 24 days resulted in up to 10% weight loss from baseline.

在飲食誘導的肥胖小鼠模型中，使用 Viking 的胰淀素激動劑治療 24 天，體重較基線減輕了 10%。

We believe this mechanism represents an interesting approach to using body weight, both as a single agent or in conjunction with other mechanisms.

我們相信這種機制代表了一種利用體重的有趣方法，無論是作為單一藥物還是與其他機制結合。

We plan to move our amylin program into clinical development in 2025.

我們計劃於 2025 年將胰淀素計畫轉入臨床開發。

In conclusion, the first half of 2024 was a period of intense activity at the company, highlighted by the announcement of successful results from three different clinical trials as well as the introduction of a new pipeline program targeting obesity.

總而言之，2024 年上半年是該公司活動頻繁的時期，其中三個不同臨床試驗的成功結果的公佈以及針對肥胖的新管道計劃的推出尤為突出。

The VENTURE Phase II study of VK2735 demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection as well as promising safety and tolerability.

VK2735 的 VENTURE II 期研究表明，每週皮下注射給藥 13 週後，體重較基線減少約 15%，並且具有良好的安全性和耐受性。

We're currently planning for an end of Phase II meeting with the FDA and plan to initiate Phase III development upon completion of that dialogue.

我們目前正在計劃結束與 FDA 的第二階段會議，並計劃在對話完成後啟動第三階段開發。

The Phase I study of the oral tablet formulation of VK2735 demonstrated excellent safety and tolerability and positive signs of clinical activity.

VK2735口服片劑的I期研究顯示出優異的安全性和耐受性以及臨床活性的正面跡象。

We expect to initiate a Phase II trial for this program later this year.

我們預計將在今年稍後啟動該計畫的二期試驗。

And the recent readout from our Phase IIb VOYAGE study of our thyroid hormone receptor beta agonist, VK2809, in NASH, demonstrated that up to 75% of VK2809-treated patients achieved NASH resolution with no worsening of fibrosis, up to 57% achieved at least a one-stage improvement in fibrosis with no worsening of NASH, and up to 50% achieved both the resolution of NASH and improvement in fibrosis.

我們的甲狀腺激素受體β激動劑VK2809 在NASH 中的IIb 期VOYAGE 研究的最新結果表明，接受VK2809 治療的患者中，高達75% 的NASH 得到緩解，並且纖維化沒有惡化，高達57% 的患者至少達到了緩解纖維化得到一階段改善，NASH 沒有惡化，高達 50% 的患者同時實現了 NASH 消退和纖維化改善。

We plan to schedule an end of Phase II meeting with the FDA later this year to discuss the development path for VK2809.

我們計劃在今年稍後與 FDA 召開第二階段會議，討論 VK2809 的開發路徑。

With respect to our orphan disease program, VK0214, we recently completed enrollment in a Phase Ib study in patients with the adrenomyeloneuropathy form of the disease and expect to announce data from this trial later this year.

關於我們的孤兒疾病計畫 VK0214，我們最近完成了一項針對患有該疾病的腎上腺脊髓神經病變患者的 Ib 期研究的入組，並預計在今年稍後公佈該試驗的數據。

Finally, during the second quarter, Viking presented promising preclinical data from a series of new internally developed dual agonist of the amylin and calcitonin receptors at the annual meeting of the American Diabetes Association.

最後，在第二季度，Viking 在美國糖尿病協會年會上展示了一系列新的內部開發的胰島澱粉樣蛋白和降鈣素受體雙重激動劑的有希望的臨床前數據。

We believe these compounds have the potential to add value to our pipeline, both as single agents and in combination with other mechanisms.

我們相信這些化合物有潛力為我們的產品線增加價值，無論是作為單一藥物還是與其他機制結合。

Finally, to support Viking's maturing pipeline, the company ended the quarter with a strong balance sheet of $942 million, providing the runway needed to execute key milestones for each program.

最後，為了支持 Viking 日趨成熟的產品線，該公司在本季結束時擁有 9.42 億美元的強勁資產負債表，為執行每個專案的關鍵里程碑提供了所需的跑道。

This concludes our prepared comments for today.

我們今天準備的評論到此結束。

Thanks very much for joining us, and we'll now open the call for questions.

非常感謝您加入我們，我們現在開始提問。

Operator?

操作員？

(Operator Instructions)

（操作員說明）

Joon Lee, Truist Securities.

李俊，Truist 證券公司。

This is [Asim] on for Joon.

這是 Joon 的 [Asim]。

Congrats on the quarter.

恭喜本季。

So further in response from the FDA, has the FDA made any commentary on Phase III design or what on the Phase II conversation will center around?

那麼，作為 FDA 的進一步回應，FDA 是否對 III 期設計做出了任何評論，或者 II 期對話將圍繞什麼進行？

And just to make sure I heard correctly, is monthly dosing under consideration for the Phase III?

為了確保我沒聽錯，第三階段是否正在考慮每月給藥？

And just one more.

還有一個。

Based on what you've seen so far in terms of tolerability for the oral, are you considering additional cohorts beyond 100 milligrams?

根據您迄今為止所觀察到的口服耐受性，您是否正在考慮增加超過 100 毫克的隊列？

Hi, Asim.

嗨，阿西姆。

Thanks for the questions.

感謝您的提問。

So the end of Phase II meeting that one of the primary goals of that dialogue was to understand if we were okay to go forward into Phase III.

因此，在第二階段會議結束時，對話的主要目標之一是了解我們是否可以進入第三階段。

And we feel based on the feedback that we are okay to go forward.

根據回饋，我們認為我們可以繼續前進。

As far as trial design and things like that, that would be discussed more in a subsequent meeting, in end of Phase II meeting.

至於試驗設計之類的事情，將在隨後的第二階段會議結束時的會議上進行更多討論。

And as far as the details on what doses and frequencies, we're just not in a position to outline trial design at this point.

至於劑量和頻率的細節，我們目前無法概述試驗設計。

With the oral dosing, we're at 100 milligrams right now.

口服劑量目前為 100 毫克。

The dose level review team generally meets upon completion of cohorts and makes a recommendation whether or not to proceed.

劑量水平審查小組通常在隊列完成後開會，並提出是否繼續進行的建議。

So hard to say if we would proceed, we haven't had completion of this cohort yet.

很難說我們是否會繼續，因為我們還沒有完成這個隊列。

Steve Seedhouse, Raymond James.

史蒂夫席德豪斯，雷蒙德詹姆斯。

Thank you for taking the questions.

感謝您提出問題。

Having completed the 60- and 80-milligram oral cohorts in the Phase I and moved to 100 milligrams, I guess the inference there is safety and tolerability were acceptable.

在完成第一階段的 60 毫克和 80 毫克口服組並轉移到 100 毫克後，我認為安全性和耐受性的推論是可以接受的。

But can you just elaborate on that inference what you've seen to 80 milligrams, and if you're also seeing a dose response on weight loss through 80 milligrams?

但您能否詳細說明您所看到的 80 毫克的推論，以及您是否也看到了 80 毫克減肥的劑量反應？

Steve, thanks.

史蒂夫，謝謝。

We're blinded to the data.

我們對數據視而不見。

So hard to comment on weight changes.

很難對體重變化發表評論。

Tolerability seems to be continuing to be very encouraging, I'll just say that.

我只想說，耐受性似乎繼續非常令人鼓舞。

On that trial, can you clarify just the titration schema of those 60-, 80-. and 100-milligram cohorts, what's the starting dose?

在那次試驗中，您能澄清一下 60-、80-的滴定方案嗎？和 100 毫克隊列，起始劑量是多少？

And what are the titration steps there?

滴定步驟是什麼？

Yes.

是的。

No, good question.

不，好問題。

We typically -- what we've done is we've started each cohort with the highest dose from the prior cohort.

我們通常所做的是，我們以前一隊列的最高劑量開始每個隊列。

So the 40-milligram started at 20 for a week and then went to 40, the 60 started at 40 and then went to 60. and then the 80 started at 60 and then went to 80.

所以40毫克從20毫克開始，持續一周，然後到40毫克，60毫克從40毫克開始，然後到60毫克。

That's the typical approach that we've used as we escalate in doses.

這是我們在增加劑量時所使用的典型方法。

Okay.

好的。

And just regarding Phase III since you're now able to move directly into that.

至於第三階段，因為你現在可以直接進入第三階段。

I wanted to clarify, do you have enough drug on hand and enough cash to complete the fully complete the Phase III program that you intend to propose to FDA for an obesity indication.

我想澄清一下，您手頭上是否有足夠的藥物和足夠的現金來完成您打算向 FDA 提議的肥胖適應症的 III 期項目。

Yes.

是的。

Another great question.

另一個很好的問題。

Yes.

是的。

We do have enough supply on hand to meet really all of our planned clinical trials with both the subQ and the orals.

我們手頭上確實有足夠的供應來滿足我們計劃的所有 subQ 和口服臨床試驗。

So we won't be needing further material.

所以我們不需要更多的材料。

We're always making material, but we won't be needing any further material to complete the planned studies.

我們一直在製作材料，但我們不需要任何進一步的材料來完成計劃的研究。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Hey, thanks for providing this update and taking the questions.

嘿，感謝您提供此更新並回答問題。

Can you please comment on how many Phase III studies you're thinking of running for subQ 2735?

您能否評論一下您正在考慮針對 subQ 2735 進行多少項 III 期研究？

And also how much each study might cost?

每項研究可能要花多少錢？

And I guess since you were considering Phase IIb versus Phase III, I guess what were some of the deciding factors in selecting to go ahead straight to Phase III?

我想既然您正在考慮 IIb 期與 III 期，我猜想選擇直接進入 III 期的一些決定因素是什麼？

Thanks, Jay.

謝謝，傑伊。

Yes, for the clinical path in Phase III, the guidance requires two studies and a minimum of 4,500 people in those studies with at least 3,000 exposed to the drug.

是的，對於 III 期臨床路徑，該指南要求兩項研究，並且這些研究中至少有 4,500 人參與，其中至少有 3,000 人接觸過該藥物。

As far as the specifics of the trials we plan to conduct, I think it's early to disclose those details.

至於我們計劃進行的試驗的具體細節，我認為現在披露這些細節還為時過早。

But we would be looking to the guidance for the overall design strategy there.

但我們會尋求整體設計策略的指導。

I may have forgot your -- the cost.

我可能忘了你的——費用。

Greg, do you want to talk about it?

格雷格，你想談談嗎？

Yes, Jay.

是的，傑伊。

I think with respect to the cost, the Phase III registration program for subQ would be around $300 million, conforming the guidance.

我認為就成本而言，subQ的III期註冊計劃將在3億美元左右，符合指導意見。

Okay.

好的。

Great.

偉大的。

And if I could please sneak in one more question on the oral Phase II study.

如果可以的話，請再問一個關於口頭二期研究的問題。

Since that's expected to be 13 weeks of treatment.

因為預計需要 13 週的治療。

Is it fair to assume that a pivotal study could be started following the completion of the oral Phase II study?

假設在完成口頭 II 期研究後可以開始一項關鍵研究是否公平？

Good question.

好問題。

It's early to say.

現在說還早。

We're kind of in the process of designing the Phase II.

我們正在設計第二階段。

But I think too early to call that.

但我認為現在這樣說還太早。

Annabel Samimy with Stifel.

安娜貝爾·薩米米和斯蒂菲爾。

Hi, thanks for taking my question.

您好，感謝您提出我的問題。

And the 60- to 80-milligram, you made clear that the safety and tolerability were holding up and then it allowed you to move into the 100-milligram.

對於 60 至 80 毫克，您明確表示安全性和耐受性保持不變，然後允許您進入 100 毫克。

What are the thresholds to stop dosing for the oral?

停止口服給藥的閾值是多少？

I guess that's my first question.

我想這是我的第一個問題。

And the second is related to the Phase III program.

第二個與第三階段計劃有關。

Can you talk about some of the exploration that you feel that you need to do versus want to do with the injectable I guess as it relates to titration, dose finding, and I guess, the administration profile you mentioned there's going to be potential for monthly?

您能談談您認為需要對注射劑進行的一些探索嗎？

So does this all need to be conducted within the Phase III?

那麼這一切都需要在第三階段進行嗎？

Or are you doing any side exploratory Phase IIs in conjunction with that?

或者您正在做任何與之相關的側面探索性第二階段？

So if you can just clarify that, that would be great.

因此，如果您能澄清這一點，那就太好了。

Yes.

是的。

Thanks, Annabel.

謝謝，安娜貝爾。

With the dose escalation studies with the oral formulation, normally the stopping in a Phase I study is driven by adverse events or a plateau on exposures or a plateau on some other metrics that you deem important.

對於口服製劑的劑量遞增研究，通常 I 期研究的停止是由不良事件或暴露水平或您認為重要的其他一些指標的平台引起的。

And so the decision to continue escalating is driven by the dose level review team, and they've not indicated any reason to stop escalation.

因此，繼續升級的決定是由劑量水平審查小組推動的，他們沒有表明任何停止升級的理由。

We do plan to start a Phase II study later this year.

我們確實計劃在今年稍後開始第二階段研究。

So at some point, there needs to be a decision to proceed on to the Phase II.

因此，在某個時候，需要做出繼續第二階段的決定。

We're not at that stage right now, and it's hard to say when we would get to that stage.

我們現在還沒有達到那個階段，也很難說我們什麼時候能達到那個階段。

But we do plan to start the Phase II later this year.

但我們確實計劃在今年稍後啟動第二階段。

With respect to the overall Phase III strategy and doses and titration schedules and the cadence of titration, also the cadence of overall dosing, it's just too early to discuss that right now.

關於總體 III 期策略、劑量和滴定時間表以及滴定節奏以及整體給藥節奏，現在討論還為時過早。

We're designing the Phase III program right now, but it's -- we have to have the end of Phase II meeting and then outline the path forward from there.

我們現在正在設計第三階段計劃，但我們必須讓第二階段會議結束，然後概述從那裡開始的前進道路。

Okay.

好的。

And then I guess if I can ask another question related to the other program that you have.

然後我想我是否可以問與您擁有的其他程式相關的另一個問題。

We hear or understand that a lot of potential partners are more interested in next-generation drugs.

我們聽說或了解到許多潛在合作夥伴對下一代藥物更感興趣。

So when we hear something like that, with the -- you have a dual agonist.

所以當我們聽到類似的事情時，你就有了雙重激動劑。

So where do you think that fits into the mix of next-generation drugs?

那麼您認為這適合下一代藥物的組合嗎？

And you have a DACRA, how important is it to move that forward as a potential next generation for -- and explore different combinations or explore exactly where it stands for some of the other novel mechanisms in development?

有了 DACRA，作為潛在的下一代技術，探索不同的組合或探索它代表其他正在開發的新穎機制有多重要？

So how are you thinking about your novelty versus potential future novelty that you have in your portfolio and where that -- where you stand in the mix?

那麼，您如何看待您的新穎性與您的投資組合中未來潛在的新穎性以及您在其中的立場？

Yes.

是的。

Thanks, Annabel.

謝謝，安娜貝爾。

And it's always hard to know what defines the next generation.

而且總是很難知道下一代的定義是什麼。

It seems like most of the oral agents today are based on older scaffolds.

看來現今大多數口服製劑都是基於較舊的支架。

So what defines next generation is a little murky to us.

所以下一代的定義對我們來說有點模糊。

The backbone here has been a GLP-1 agonist that additional activities added onto, whether it's GIP or glucagon or amylin.

這裡的主幹是 GLP-1 激動劑，添加了額外的活性，無論是 GIP、胰高血糖素或胰淀素。

I think having a GLP-1/GIP agonist with the potential to add amylin agonism on top of it could represent really best-in-industry efficacy profile.

我認為 GLP-1/GIP 激動劑具有在其基礎上添加胰淀素激動劑的潛力，可以真正代表業界最佳的功效。

So that would be an attractive area to explore.

因此，這將是一個有吸引力的探索領域。

But we've seen already earlier this year, really good data from the amylin mono-agonist mechanism.

但我們今年稍早已經看到了來自胰淀素單激動劑機制的非常好的數據。

So I think that program has a couple of different areas that can be explored as a single agent and in potential combination with other mechanisms.

因此，我認為該計劃有幾個不同的領域，可以作為單一代理進行探索，也可以與其他機制結合。

Roger Song with Jefferies.

羅傑宋與傑弗里斯。

Great.

偉大的。

Maybe just a follow-up on the partnership discussions, understanding you have open-door policy for the potential partner.

也許只是合作關係討論的後續行動，了解您對潛在合作夥伴有開放政策。

But given this new development FDA allowed you to proceed into Phase III directly versus you need to got into the Phase II, do you think that will change the conversation you have been having with the potential partners?

但鑑於 FDA 允許您直接進入第三階段而不是需要進入第二階段的這項新開發，您認為這會改變您與潛在合作夥伴之間的對話嗎？

Any comments will be helpful.

任何評論都會有幫助。

And I have a follow-up.

我有一個後續行動。

Yes, sure.

是的，當然。

Thanks, Roger.

謝謝，羅傑。

Yes, no real additional comment to add on partnering discussions.

是的，對於合作討論沒有任何真正的附加評論。

We've been consistent with our receptivity to interests and opportunities and we remain so.

我們一直堅持對興趣和機會的接受態度，而且仍然如此。

In the meantime, we're well capitalized and focused on execution of the development programs and I think, in our view, continued execution, we'll continue to add value to the pipeline.

同時，我們資本充足，專注於開發計畫的執行，我認為，在我們看來，繼續執行，我們將繼續為管道增加價值。

And I think that's all we can say at this point.

我想這就是我們現在能說的。

Yes.

是的。

Understood.

明白了。

And then another key topic is related to the scalability, particularly for your -- now you have two formulations subQ and oral, particularly with oral understanding you have been having discussion with various CDMO.

然後另一個關鍵主題與可擴展性相關，特別是對於您來說，現在您有兩種配方 subQ 和口頭，特別是在口頭理解方面，您一直在與各種 CDMO 進行討論。

Can you just remind us then what the scale of the investment in terms of the dollar and the time to be able to build the capacity to potentially need commercial demand as an oral peptide also considering this dosing is going even higher with the good tolerability?

您能否提醒我們，以美元計算的投資規模以及能夠建立作為口服勝肽潛在需要商業需求的能力的時間是多少，同時考慮到這種劑量會隨著良好的耐受性而變得更高？

Yes.

是的。

Good question, Roger.

好問題，羅傑。

I mean we -- in answer to Steve's question, we currently have enough API to get through all of our planned clinical studies with both the subQ and the oral.

我的意思是，在回答 Steve 的問題時，我們目前有足夠的 API 來完成所有計劃的 subQ 和口服臨床研究。

And we continue to engage with suppliers for both the raw materials and the finished product, and we certainly expect to be able to supply the initial commercial demand at the appropriate time.

我們將繼續與原料和成品供應商合作，我們當然希望能夠在適當的時間滿足最初的商業需求。

What the CapEx requirement is, it's probably a better question for the CDMOs or the companies that are building out their own facilities.

資本支出要求是什麼，對於 CDMO 或正在建立自己設施的公司來說，這可能是一個更好的問題。

At this point, our supply will be derived from CDMO sources though.

目前，我們的供應將來自 CDMO 來源。

So the CapEx from Viking is limited.

因此 Viking 的資本支出是有限的。

Andy Hsieh, William Blair.

安迪謝，威廉布萊爾。

Thanks for taking our questions.

感謝您回答我們的問題。

So Brian, I'm curious about your strategic positioning for the amylin program.

布萊恩，我很好奇你對胰島澱粉樣多勝肽計畫的戰略定位。

I'm just curious what areas you would like to potentially position this asset?

我只是好奇您希望將該資產定位在哪些領域？

Would it be kind of increasing the magnitude of weight loss in the type 2 diabetes or the preservation of lean body mass?

它是否會增加第 2 型糖尿病患者的體重減輕幅度或保持去脂體重？

So that's question number one.

這是第一個問題。

I also like to take your temperature on two topics, if you don't mind.

如果您不介意的話，我還想了解您對兩個主題的看法。

One is on the titration.

一是關於滴定。

If you look across the landscape, it seems like other companies are exploring more rapid titration with kind of a more aggressive step up?

如果你縱觀全局，似乎其他公司正在探索更快速的滴定，並採取更積極的措施？

Is that something that is worthwhile exploring for the 2735 program?

這對於2735計劃來說是值得探索的嗎？

And the other topic is really on the monthly dosing that you just mentioned.

另一個主題實際上是關於您剛才提到的每月劑量。

Obviously with the half-life at the end of the cycle, the drug level would be pretty low.

顯然，隨著週期結束時的半衰期，藥物水平會相當低。

Just curious if you can talk about that delta when you go from the end of the cycle to the next cycle, that increase and it's relevance to the AE profile?

只是好奇您是否可以談論從週期結束到下一個週期時的增量、增量以及它與 AE 曲線的相關性？

And I have two just really quick check-in questions.

我有兩個非常快速的登記問題。

Sure, Hsieh.

當然，謝。

I'll try to remember this, but you may have to repeat it one or more.

我會盡力記住這一點，但您可能需要重複一次或多次。

So with the amylin compound, really interesting mechanism that as a standalone I think has a lot of promise.

因此，胰島澱粉樣多肽類化合物是一種非常有趣的機制，作為一個獨立的機制，我認為它有很大的前景。

And in combination, I think, also has a lot of promise.

我認為，兩者結合起來也有很大的希望。

And we think both are worth exploring.

我們認為兩者都值得探索。

So where they would actually position in the overall landscape, it's early to say.

因此，現在說它們在整體格局中的實際位置還為時過早。

But to the extent maybe you could spare GLP-1 use or not and see even further improvements in efficacy, we just don't know yet what that profile will look like.

但在某種程度上，您是否可以不使用 GLP-1，並看到功效的進一步改進，我們只是還不知道該配置會是什麼樣子。

So we'll have to follow where the data lead us.

因此，我們必須遵循數據的指引。

As far as the question on the different titration approaches, I think our tolerability profile and the PK profile would lend themselves to alternative titration cadences, but we did the three-week in the VENTURE study, which looked really promising.

至於不同滴定方法的問題，我認為我們的耐受性概況和 PK 概況將有助於替代滴定節奏，但我們在 VENTURE 研究中進行了為期三週的研究，看起來非常有希望。

I think we could probably go to two weeks.

我想我們可能會持續兩週。

Certainly, we could use four weeks and maybe that would lead to an even further improvement in tolerability, so we're not yet at a position to say one way or another what's the preferred titration scheme, but I think we could probably go faster.

當然，我們可以用四個星期，也許這會導致耐受性進一步改善，所以我們還不能以某種方式說出首選滴定方案是什麼，但我認為我們可能會走得更快。

With respect to the monthly dosing, you're right.

關於每月劑量，你是對的。

As you dose monthly by the end of the month -- now keep in mind the half-life is 180 hours or so, so it's more than one week.

當您在月底之前每月服藥時，請記住，半衰期約為 180 小時左右，因此超過一周。

But by the end of the month, you are at a lower level than you were at the beginning of the month.

但到了月底，你的水平會比月初低。

And as long as you're in a therapeutic range, that next dose might not be expected to result in any tolerability challenges.

只要您處於治療範圍內，下一劑量可能不會導致任何耐受性挑戰。

We won't know until we get into a study using it.

在我們進行使用它的研究之前我們不會知道。

But it seems like generally, with these mechanisms, tolerability is observed early.

但通常情況下，透過這些機制，可以儘早觀察到耐受性。

And if you get through those first few weeks, tolerability tends to wane, at least with the injectables.

如果你撐過了最初幾週，耐受性往往會減弱，至少對於注射劑來說是如此。

And tolerability issues seem to wane.

而且耐受性問題似乎正在減弱。

So if you're within the therapeutic plasma levels for 28 days or 30 days, and you're just raising those levels a little bit.

因此，如果您在治療血漿水平內保持 28 天或 30 天，那麼您只需稍微提高這些水平即可。

It seems like you would reduce the risk of tolerability challenges.

看起來你會降低耐受性挑戰的風險。

But again, hard to say at this point.

但現在還很難說。

Yes, that's super helpful.

是的，這非常有幫助。

And then, Greg, maybe just one quick one.

然後，格雷格，也許只是一個快速的。

So for the $300 million cost that you mentioned, does that include the cardiovascular outcomes trial?

那麼，您提到的 3 億美元費用中，是否包括心血管結果試驗？

And then I guess, the monthly dosing that Brian, you're talking about, I'm assuming that you're talking about that in the context of the Phase II study and not a Phase III study.

然後我想，布萊恩，你所說的每月劑量，我假設你是在第二階段研究而不是第三階段研究的背景下談論的。

Andy, on the cost side, that's just -- the $300 million is the Phase III registration program, not any outcomes, additional studies for that.

安迪，在成本方面，這只是 - 3 億美元是 III 期註冊計劃，而不是任何結果，而是為此進行的額外研究。

Got it.

知道了。

And then with the monthly, yes we haven't decided what the next study will look like with the monthly at this point.

然後是月度研究，是的，我們目前還沒有決定下一次研究將是什麼樣的月度研究。

Mike Olson, Morgan Stanley.

麥克‧奧爾森，摩根士丹利。

Hi.

你好。

This is Rohit on for Mike.

這是羅希特替麥克發言。

Thanks for taking our questions.

感謝您回答我們的問題。

Just in terms of dose escalating for oral VK2735, is there a point where tablet size and available supply become an issue and how high you can dose the drug?

就口服 VK2735 的劑量遞增而言，片劑大小和可用供應量是否會成為一個問題，以及您可以服用多高的藥物劑量？

Yes.

是的。

No, it's a good question.

不，這是一個好問題。

Probably, we're not there just yet.

也許，我們還沒到那一步。

But yes, I think those are considerations that need to be taken into account when you dose up with oral.

但是，是的，我認為當您口服劑量時需要考慮這些因素。

I think moving forward, if the oral was used as a maintenance therapy after target weight was achieved.

我認為，如果在達到目標體重後將口服藥物用作維持治療，那麼向前邁進。

That likely reduces dramatically the actual requirements of API.

這可能會大大降低 API 的實際需求。

And if the dosing were able to be less frequent, that also would dramatically reduce the API demand.

如果能夠降低給藥頻率，那麼 API 需求也會大大減少。

So a lot of moving parts there and trying to project the API demands moving forward.

因此，那裡有很多移動部件，並試圖預測 API 需要向前推進。

Justin Zelin, BTIG.

賈斯汀·澤林，BTIG。

Hi, Brian.

嗨，布萊恩。

Thanks for taking my question, and congrats on the progress here.

感謝您提出我的問題，並祝賀這裡的進展。

Maybe just a decision to move to a monthly dosing regimen including that in the move forward program.

也許只是決定轉向每月給藥方案，包括前進計劃中的方案。

Was that based off of the PK/PD data that you've seen thus far?

這是基於您迄今為止看到的 PK/PD 數據嗎？

And do you think you'll be able to present that data perhaps at obesity week?

您認為您能夠在肥胖週上展示這些數據嗎？

Yes.

是的。

Thanks, Justin.

謝謝，賈斯汀。

Yes, it is based on the PK profile.

是的，它是基於PK設定檔的。

The PK profile does suggest that monthly is feasible.

PK 概況確實顯示每月一次是可行的。

We won't know until we actually do a study, but at least what it looks like today is it's feasible.

在我們真正進行研究之前我們不會知道，但至少今天看起來是可行的。

Thomas Smith, Leerink Partners.

托馬斯史密斯，Leerink 合夥人。

Good afternoon, thanks for taking the questions.

下午好，感謝您提出問題。

Congrats on the progress.

祝賀取得的進展。

So you're going to have multiple Phase III programs ready to start here in the -- pretty much in the near term.

因此，幾乎在短期內，您將準備好啟動多個第三階段專案。

I know you've previously talked about having a partner potentially for NASH.

我知道您之前曾談到尋找一個可能治療 NASH 的合作夥伴。

Can you just provide an update on how you're thinking about business development and partnerships across obesity and NASH?

您能否介紹一下您對肥胖和 NASH 領域的業務發展和合作夥伴關係的最新看法？

I guess, your appetite to execute across these programs on your own?

我想，您有興趣獨自執行這些程序嗎？

Yes.

是的。

Thanks, Tom.

謝謝，湯姆。

We're capitalized to proceed with all of these programs, fortunately.

幸運的是，我們有足夠的資金來開展所有這些計劃。

With the obesity program, we will be moving aggressively into a Phase III development program as soon as possible.

透過肥胖計劃，我們將盡快積極進入第三階段開發計劃。

With the NASH program, the plan there is to have an end of Phase II meeting and receive the feedback and understand what the current thinking is around registration paths.

對於 NASH 計劃，計劃召開第二階段會議並接收回饋並了解當前關於註冊路徑的想法。

And what we've been saying or what we've been preferring with that program really is to work with the larger party together on a registration path.

我們一直在說或我們一直更喜歡該計劃的實際上是與更大的團體在註冊路徑上合作。

So that remains the preference for the NASH program.

因此，這仍然是 NASH 計劃的首選。

Got it.

知道了。

That makes sense.

這就說得通了。

And then I just wanted to ask, one, just on sort of the earlier maybe preclinical work you have ongoing in obesity.

然後我只想問，第一，關於您在肥胖方面正在進行的早期臨床前工作。

I mean you're going to move the DACRA program into the clinic next year.

我的意思是，明年您將把 DACRA 計畫轉移到診所。

It seems like a pretty quick turnaround from preclinical and getting that into the clinic.

從臨床前到進入臨床，這似乎是相當快速的轉變。

Can you just talk about some of the other targets that you, I guess, may be interested in, but more about how much preclinical work you have ongoing with respect to some of these targets and how we can think about the potential cadence or the timing for advancing some of these earlier efforts into the clinic?

您能否談談您可能感興趣的其他一些目標，但更多地談談您在其中一些目標方面正在進行多少臨床前工作，以及我們如何考慮潛在的節奏或時間安排將這些早期的一些努力推進到臨床？

Yes.

是的。

No, thanks, Tom.

不，謝謝，湯姆。

We're pretty busy and everybody's stretched pretty thin.

我們很忙，每個人都捉襟見肘。

We do have other programs that we haven't disclosed that I think will, over time, add further value to the pipeline.

我們確實還有其他尚未披露的計劃，我認為隨著時間的推移，這些計劃將進一步增加管道的價值。

So it remains a pretty active -- preclinical development remains a pretty active component of the company's activities.

因此，它仍然相當活躍——臨床前開發仍然是公司活動的相當活躍的組成部分。

But we generally don't disclose targets in that work until we're a little bit closer to the decision to move into the clinic.

但我們通常不會透露這項工作的目標，直到我們更接近進入臨床的決定。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Good afternoon, thanks for taking the questions.

下午好，感謝您提出問題。

And congrats on all the progress.

並祝賀所有的進展。

I've got two questions here.

我這裡有兩個問題。

The first one is in terms of the orals 2735 for the obesity week readout, do we anticipate that will also include the 100 milligrams as well?

第一個是關於肥胖週讀數的口服 2735，我們是否預期也將包括 100 毫克？

And would that also be used that as a basis for your 13-week study?

這是否也可以作為您 13 週學習的基礎？

Then I have a follow-up.

然後我有一個後續行動。

Yes.

是的。

Thanks, Yale.

謝謝，耶魯。

We will present all of the data that we have at the time, and I would expect the 100-milligram cohort to be included.

我們將展示當時擁有的所有數據，我預計 100 毫克隊列也將包括在內。

And as far as the Phase II doses, we haven't decided yet, so we need to complete the ongoing cohorts and understand -- get unblinded on the data and understand what the profile looks like before we select those doses.

至於第二階段的劑量，我們還沒有決定，所以我們需要完成正在進行的隊列並了解——在我們選擇這些劑量之前，對數據進行非盲處理並了解概況。

Okay.

好的。

Great.

偉大的。

That's helpful.

這很有幫助。

And the next question here is basically for the end of Phase II meeting, what do you anticipate to bring on the table in terms of the sort of subjects you want to discuss at least at this point?

下一個問題基本上是第二階段會議結束時的問題，至少在這一點上，您預計將討論哪些主題？

Well, with the target population, normally that's pretty well defined by the guidance.

嗯，對於目標人群，通常指導方針已經很好地定義了。

It's a BMI of at least 30 or at least 27 with one -- with at least one weight-related comorbidity.

BMI 至少為 30 或至少 27，且至少有一種與體重相關的合併症。

And then in the second study, it's generally overweight people with type 2 diabetes.

然後在第二項研究中，通常是患有第 2 型糖尿病的超重人群。

So those would be the, broadly speaking, the target populations for the Phase III program.

因此，從廣義上講，這些人將是第三階段計畫的目標群體。

This concludes our question-and-answer session.

我們的問答環節到此結束。

I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

我想將會議轉交給斯蒂芬妮·迪亞茲（Stephanie Diaz）發表閉幕詞。

Thank you all for dialing in today and for your continued support of Viking Therapeutics.

感謝大家今天的撥通以及對 Viking Therapeutics 的持續支持。

We look forward to speaking again soon.

我們期待很快再次發言。

Thank you, and have a good afternoon.

謝謝您，祝您下午愉快。

The conference has now concluded.

會議現已結束。

Thank you for attending today's presentation.

感謝您參加今天的演講。

You may now disconnect.

您現在可以斷開連線。