Viking Therapeutics Inc (VKTX) 2023 Q2 法說會逐字稿

Welcome to the Viking Therapeutics Second Quarter 2023 Financial Results Conference Call. (Operator Instructions)

歡迎參加 Viking Therapeutics 2023 年第二季度財務業績電話會議。 （操作員說明）

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

我現在想將會議轉交給 Viking 投資者關係經理 Stephanie Diaz。請繼續，斯蒂芬妮。

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

大家好，感謝大家參加今天的電話會議。今天加入我的是 Viking 總裁兼首席執行官 Brian Lian；格雷格·贊特 (Greg Zante)，Viking 的首席財務官。

Before we begin, I'd like to caution that comments made during this conference call today, July 26, 2023, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

在我們開始之前，我想提醒大家，在今天（2023 年7 月26 日）的電話會議上發表的評論將包含1995 年美國私人證券訴訟改革法案安全港條款下的前瞻性聲明，包括有關Viking 的聲明關於其開發活動、時間表和里程碑的期望。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，報告的結果不應被視為未來業績的指標。這些前瞻性陳述僅代表今天的情況，公司不承擔修改或更新今天所做的任何陳述的義務。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 dialed in by phone or listening on the webcast. Today, we'll review our financial results for the second quarter and first 6 months of 2023 and provide an update on recent progress with our clinical programs and operations.

謝謝斯蒂芬妮，祝所有通過電話撥入或收聽網絡廣播的人下午好。今天，我們將回顧 2023 年第二季度和前 6 個月的財務業績，並提供臨床項目和運營的最新進展。

The first half of 2023 has been exceptional for Viking, with the company announcing positive clinical data from 2 programs and completing a successful financing to support the continued development of our pipeline. During the second quarter, we announced positive results from the Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis or NASH. The study successfully achieved its primary endpoint, confirming VK2809's best-in-class therapeutic profile for the treatment of NASH.

2023 年上半年對於 Viking 來說是不尋常的，該公司宣布了 2 個項目的積極臨床數據，並成功完成融資以支持我們管道的持續開發。在第二季度，我們宣布了 VK2809 在活檢確診的非酒精性脂肪性肝炎或 NASH 患者中進行的 2b 期 VOYAGE 研究的積極結果。該研究成功實現了其主要終點，證實了 VK2809 治療 NASH 的一流治療效果。

In the first half of the year, we also announced data from our first clinical study of VK2735, a dual GLP-1 and GIP receptor agonist for the potential treatment of obesity. This Phase 1 single ascending dose and multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity following 28 days of treatment. I will review these clinical results later in today's call. Along with the Phase 1 results for VK2735, we also announced the initiation of a new clinical study to evaluate a novel oral formulation of this compound.

今年上半年，我們還公佈了 VK2735 的首次臨床研究數據，VK2735 是一種 GLP-1 和 GIP 受體雙重激動劑，用於潛在治療肥胖症。這項 1 期單次劑量遞增和多次劑量遞增研究顯示出令人鼓舞的安全性和耐受性，以及治療 28 天后臨床活性的積極跡象。我將在今天的電話會議稍後回顧這些臨床結果。除了 VK2735 的 1 期結果外，我們還宣布啟動一項新的臨床研究，以評估該化合物的新型口服製劑。

Finally, during the second quarter of the year, we announced the closing of a successful public offering of common stock, raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of each of our programs through key clinical milestones. I'll provide further details on our operations and development activities after we review our financial results for the second quarter and first 6 months of 2023.

最後，在今年第二季度，我們宣布成功完成普通股公開發行，籌集了約 2.88 億美元的總收益，我們計劃將其用於通過關鍵的臨床里程碑持續推進我們的每個項目。在我們審查 2023 年第二季度和前 6 個月的財務業績後，我將提供有關我們運營和開發活動的更多詳細信息。

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 首席財務官 Greg Zante。

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

謝謝，布萊恩。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，我們預計今天將提交該表格。

I'll now go over our results for the second quarter and 6 months ended June 30, 2023, beginning with results for the quarter. Our research and development expenses for the 3 months ended June 30, 2023, were $13.9 million compared to $13.5 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits and third-party consultants, partially offset by decreased expenses related to clinical studies.

我現在將回顧第二季度和截至 2023 年 6 月 30 日的 6 個月的業績，從本季度的業績開始。截至2023 年6 月30 日的三個月，我們的研發費用為1,390 萬美元，而2022 年同期為1,350 萬美元。這一增長主要是由於與臨床前研究、候選藥物生產、庫存相關的費用增加。基於薪酬、工資和福利以及第三方顧問的費用，部分被臨床研究相關費用的減少所抵消。

Our general and administrative expenses for the 3 months ended June 30, 2023, were $9.8 million compared to $4.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation and salaries and benefits.

截至2023 年6 月30 日的三個月，我們的一般和管理費用為980 萬美元，而2022 年同期為410 萬美元。這一增長主要是由於與法律和專利服務、股票薪酬和工資相關的費用增加和好處。

For the 3 months ended June 30, 2023, Viking reported a net loss of $19.2 million, or $0.19 per share compared to a net loss of $17.4 million, or $0.23 per share in the corresponding period in 2022. The increase in net loss for the 3 months ended June 30, 2023, was primarily due to the increase in general and administrative expenses, noted previously, partially offset by increased interest income compared to the same period in 2022.

截至 2023 年 6 月 30 日的三個月，Viking 報告淨虧損 1,920 萬美元，即每股 0.19 美元，而 2022 年同期淨虧損為 1,740 萬美元，即每股 0.23 美元。截至2023 年6 月30 日的3 個月，主要是由於之前提到的一般和管理費用的增加，部分被與2022 年同期相比增加的利息收入所抵消。

I'll now go over the results for the 6 months ended June 30, 2023. Our research and development expenses for the 6 months ended June 30, 2023, were $24.9 million compared to $26.1 million for the same period in 2022. The decrease was primarily due to decreased expenses related to clinical studies, partially offset by increased expenses related to manufacturing for our drug candidates, stock-based compensation, salaries and benefits and regulatory services.

我現在回顧一下截至2023 年6 月30 日的6 個月的業績。截至2023 年6 月30 日的6 個月，我們的研發費用為2,490 萬美元，而2022 年同期為2,610 萬美元。減少額為主要是由於與臨床研究相關的費用減少，部分被與候選藥物生產、股票薪酬、工資和福利以及監管服務相關的費用增加所抵消。

Our general and administrative expenses for the 6 months ended June 30, 2023, were $19.4 million compared to $7.8 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation and salaries and benefits.

截至2023 年6 月30 日的6 個月，我們的一般和管理費用為1,940 萬美元，而2022 年同期為780 萬美元。這一增長主要是由於與法律和專利服務、股票薪酬和工資相關的費用增加和好處。

For the 6 months ended June 30, 2023, Viking reported a net loss of $38.8 million, or $0.44 per share, compared to a net loss of $33.5 million, or $0.43 per share in the corresponding period in 2022. The increase in net loss for the 6 months ended June 30, 2023, was primarily due to the increase in general and administrative expenses, noted previously, partially offset by increased interest income compared to the same period in 2022.

截至 2023 年 6 月 30 日的 6 個月，維京報告淨虧損 3880 萬美元，即每股 0.44 美元，而 2022 年同期淨虧損為 3350 萬美元，即每股 0.43 美元。截至2023 年6 月30日的6 個月，主要是由於之前提到的一般和管理費用的增加，但與2022 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 June 30, 2023, Viking held cash, cash equivalents and short-term investments of $392.9 million, compared to $155.5 million as of December 31, 2022.

轉向資產負債表。截至2023年6月30日，Viking持有現金、現金等價物和短期投資3.929億美元，而截至2022年12月31日為1.555億美元。

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 begin my comments with an update on our lead program, VK2809. VK2809 is an orally available, small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. During the second quarter, the company announced positive top-line results from the Phase 2b VOYAGE study evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis. We were very pleased to report that this study achieved its primary endpoint with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo.

謝謝，格雷格。我將首先介紹我們的主導項目 VK2809 的最新情況。 VK2809 是一種口服的甲狀腺激素受體小分子激動劑，選擇用於肝組織以及受體的 β 亞型。第二季度，該公司宣布了 2b 期 VOYAGE 研究的積極頂線結果，該研究評估了 VK2809 在活檢確診的 NASH 和纖維化患者中的作用。我們非常高興地報告，這項研究達到了主要終點，與安慰劑相比，接受 VK2809 治療的患者的肝臟脂肪含量從基線到第 12 週出現了統計上顯著的降低。

The median relative change from baseline in liver fat as assessed by magnetic resonance imaging, proton density fat fraction, ranged from 38% to 55% among patients receiving VK2809. Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content. This level of efficacy is associated with the greater likelihood of histologic benefit in NASH.

通過磁共振成像、質子密度脂肪分數評估，接受 VK2809 治療的患者肝臟脂肪相對於基線的中位相對變化範圍為 38% 至 55%。重要的是，接受 VK2809 治療的患者中，高達 85% 的患者肝臟脂肪含量相對減少了至少 30%。這種療效水平與 NASH 的組織學獲益的可能性更大有關。

Additionally, VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins, all of which have been correlated with cardiovascular risk. It is important to highlight that a number of studies evaluating other NASH development programs have demonstrated elevations in these lipids following treatment. In contrast, the Phase 2b VOYAGE data indicates that VK2809 may be unique in its potential to offer a cardioprotective benefit.

此外，接受 VK2809 治療的患者的低密度脂蛋白膽固醇、甘油三酯和致動脈粥樣硬化脂蛋白在統計上顯著降低，所有這些都與心血管風險相關。需要強調的是，許多評估其他 NASH 發展計劃的研究表明，治療後這些脂質會升高。相比之下，2b 期 VOYAGE 數據表明，VK2809 在提供心臟保護益處方面可能是獨一無二的。

Also important, VK2809 demonstrated encouraging safety and tolerability in this study. 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms. As in prior studies, VK2809 demonstrated excellent gastrointestinal tolerability in this study. Rates of nausea, diarrhea, stool frequency and vomiting were similar among VK2809-treated patients compared to placebo. These findings are consistent with a prior 12-week Phase 2a trial evaluating VK2809 in patients with hypercholesterolemia and nonalcoholic fatty liver disease.

同樣重要的是，VK2809 在這項研究中表現出令人鼓舞的安全性和耐受性。據報導，接受 VK2809 治療的患者中 94% 的治療相關不良事件為輕度或中度。因不良事件而停藥的比例較低，並且安慰劑組和治療組之間保持平衡。與之前的研究一樣，VK2809 在本研究中表現出優異的胃腸道耐受性。與安慰劑組相比，接受 VK2809 治療的患者的噁心、腹瀉、大便頻率和嘔吐發生率相似。這些發現與之前一項為期 12 週的 2a 期試驗一致，該試驗評估了 VK2809 在高膽固醇血症和非酒精性脂肪肝患者中的作用。

The Phase 2a study also successfully achieved both its primary and secondary endpoints, demonstrating significant reductions in liver fat and plasma lipids. Importantly, the reductions in liver fat were durable with the majority of patients remaining responders, 4 weeks after completion of dosing. The 12-week study also demonstrated the promising safety and tolerability of VK2809 with no serious adverse events reported. In our view, the top-line results of the VOYAGE trial, combined with the 8 previously completed studies of this compound, support our belief that VK2809's broad lipid-lowering properties along with its safety, excellent tolerability, significant liver fat reduction and oral route of administration, establish it as a best-in-class therapeutic for the treatment of NASH. We look forward to reporting data from the secondary and exploratory objectives from the VOYAGE study, including the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of 2024.

2a 期研究還成功實現了主要和次要終點，證明肝臟脂肪和血漿脂質顯著降低。重要的是，肝臟脂肪的減少是持久的，大多數患者在給藥完成 4 週後仍然有反應。為期 12 週的研究還證明了 VK2809 的安全性和耐受性，且未報告嚴重不良事件。我們認為，VOYAGE 試驗的主要結果，結合之前完成的8 項該化合物的研究，支持了我們的信念，即VK2809 具有廣泛的降脂特性及其安全性、優異的耐受性、顯著的肝臟脂肪減少和口服途徑管理，將其確立為治療 NASH 的最佳療法。我們期待報告 VOYAGE 研究的次要和探索性目標的數據，包括 2024 年上半年治療 52 週後通過肝活檢評估的組織學變化的評估。

Transitioning to our newest program, I'll now highlight recent progress with our lead obesity candidate, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor that is being evaluated for the treatment of obesity. Initial in vivo data from this program demonstrated improvements in weight loss, glucose control and insulin sensitivity among diet-induced obese mice following treatment as compared to a GLP-1 mono-agonist when administered at the same dose for the same period of time.

過渡到我們的最新計劃，我現在將重點介紹我們的主要肥胖候選藥物 VK2735 的最新進展。 VK2735 是胰高血糖素樣肽 1（或 GLP1 受體）和葡萄糖依賴性促胰島素多肽（或 GIP 受體）的雙重激動劑，正在評估其治療肥胖的效果。該計劃的初步體內數據表明，與在相同時間段內以相同劑量施用 GLP-1 單激動劑相比，飲食誘導的肥胖小鼠在治療後體重減輕、血糖控制和胰島素敏感性有所改善。

In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to those observed among animals treated with the GLP-1 mono-agonist. Based on these and other preclinical findings, Viking conducted a Phase 1 single ascending dose and multiple ascending dose study of VK2735 to evaluate its preliminary safety, tolerability and pharmacokinetic profile as well as its potential impact on exploratory measures. Earlier this year, we announced positive results from this trial with VK2735 demonstrated promising safety and tolerability, a predictable PK profile and encouraging signs of clinical benefit.

此外，相對於用GLP-1單激動劑治療的動物中觀察到的那些，用我們的化合物治療的動物中觀察到的肝臟脂肪含量的降低通常更大。基於這些和其他臨床前研究結果，Viking 對VK2735 進行了1 期單次遞增劑量和多次遞增劑量研究，以評估其初步安全性、耐受性和藥代動力學特徵以及對探索性措施的潛在影響。今年早些時候，我們宣布了 VK2735 試驗的積極結果，證明了良好的安全性和耐受性、可預測的 PK 曲線以及令人鼓舞的臨床獲益跡象。

The single ascending dose portion of this study enrolled healthy men and women and evaluated escalating doses of VK2735. The results of this portion of the study demonstrated that single doses of VK2735 were safe and well tolerated and that the compounds PK profile demonstrated favorable characteristics in humans. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170 to 250 hours, a Tmax ranging from approximately 75 to 90 hours, and excellent therapeutic exposures.

本研究的單次劑量遞增部分招募了健康男性和女性，並評估了 VK2735 的遞增劑量。這部分研究的結果表明，單劑量的 VK2735 是安全的且耐受性良好，並且化合物 PK 曲線在人類中表現出良好的特性。單次皮下給藥後，VK2735 的半衰期約為 170 至 250 小時，Tmax 約為 75 至 90 小時，並且具有出色的治療暴露。

The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter square. These subjects received VK2735 once weekly for 28 days. In this portion of the study, VK2735 demonstrated encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6%. Statistically significant differences in body weight compared to placebo were also maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered.

本研究的多劑量遞增部分招募了體重指數最低為每平方米 30 公斤的健康男性和女性。這些受試者每週接受一次 VK2735，持續 28 天。在這部分研究中，VK2735 表現出令人鼓舞的安全性和耐受性以及臨床活性的積極跡象。所有接受 VK2735 治療的隊列均表現出平均體重較基線下降，幅度高達 7.8%。與安慰劑相比，接受 VK2735 治療的隊列的平均體重也降低了 6%。與安慰劑相比，在第 43 天的隨訪時間點（最後一次服用 VK2735 後 21 天），體重的統計學顯著差異也得到維持或改善。

In addition, all cohorts treated with VK2735 demonstrated improvements in plasma glucose levels relative to placebo, though not all cohorts achieved statistical significance. VK2735 also demonstrated encouraging safety and tolerability following single and repeat dosing. The vast majority, 98% of observed adverse events were reported as mild or moderate and 99% of gastrointestinal-related adverse events were also reported as mild or moderate.

此外，與安慰劑相比，所有接受 VK2735 治療的隊列均顯示出血漿葡萄糖水平有所改善，但並非所有隊列均達到統計學顯著性。 VK2735 在單次和重複給藥後也表現出令人鼓舞的安全性和耐受性。絕大多數（98%）觀察到的不良事件報告為輕度或中度，99% 的胃腸道相關不良事件也報告為輕度或中度。

Given VK2735's promising tolerability, we believe that higher doses may be achieved with longer titration windows, and we plan to evaluate further dose escalation in future studies. Based on these Phase 1 results, the company plans to initiate a Phase 2 trial of VK-2735 in patients with obesity later this quarter. In addition to the formulation of VK2735 that is administered subcutaneously, we are also pursuing an oral formulation of this compound. Earlier this year, we announced the initiation of a Phase 1 clinical study to evaluate a novel tablet formulation of VK2735. This study is an extension of the Phase 1 single ascending dose and multiple ascending dose study concluded earlier in the year.

鑑於 VK2735 有希望的耐受性，我們相信通過更長的滴定窗口可以實現更高的劑量，並且我們計劃在未來的研究中評估進一步的劑量遞增。根據這些 1 期結果，該公司計劃在本季度晚些時候針對肥胖患者啟動 VK-2735 的 2 期試驗。除了皮下注射的 VK2735 製劑外，我們還在研究該化合物的口服製劑。今年早些時候，我們宣布啟動一項 1 期臨床研究，以評估 VK2735 的新型片劑配方。這項研究是今年早些時候結束的一期單次劑量遞增和多次劑量遞增研究的延伸。

The oral portion of the study is a randomized, double-blind, placebo-controlled study in healthy volunteers who have a minimum body mass index of 30 kilograms per meter squared. Subjects will receive daily oral doses for 28 days. The primary objective of the study is to evaluate the safety, tolerability and pharmacokinetics of VK2735 following 28 days of oral dosing. Exploratory endpoints include changes in body weight and plasma glucose. We believe the potential availability of both subcutaneous and oral formulations of VK2735 could provide patients with flexible dosing options and expand the compound's potential market opportunity. We expect to report the initial results from this study in the fourth quarter of this year.

該研究的口服部分是一項隨機、雙盲、安慰劑對照研究，受試者為健康志願者，這些志願者的最低體重指數為每平方米 30 公斤。受試者將每天口服劑量，持續 28 天。該研究的主要目的是評估 VK2735 口服給藥 28 天后的安全性、耐受性和藥代動力學。探索性終點包括體重和血糖的變化。我們相信，VK2735 皮下注射和口服製劑的潛在可用性可以為患者提供靈活的劑量選擇，並擴大該化合物的潛在市場機會。我們預計將在今年第四季度報告這項研究的初步結果。

I'll now provide an update on our third clinical candidate, VK0214. Like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor beta agonist. VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with X-linked adrenoleukodystrophy, or X-ALD. X-ALD is a rare and debilitating metabolic disorder. Patients with X-ALD have genetic mutations that disable the function of a peroxisomal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize very long chain fatty acids, and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.

我現在將提供我們的第三個臨床候選藥物 VK0214 的最新信息。與 VK2809 一樣，VK0214 是一種口服小分子甲狀腺激素受體 β 激動劑。 VK0214 目前正在 X 連鎖腎上腺腦白質營養不良 (X-ALD) 患者的 1b 期臨床試驗中進行評估。 X-ALD 是一種罕見且使人衰弱的代謝性疾病。 X-ALD 患者存在基因突變，導致超長鏈脂肪酸過氧化物酶體轉運蛋白的功能喪失。因此，患者無法有效代謝極長鏈脂肪酸，並且這些化合物的積累被認為有助於 X-ALD 的發生和進展。

Viking is currently enrolling a Phase 1b study evaluating VK0214 in patients with the adrenomyeloneuropathy or AMN form of X-ALD. AMN is the most common form of X-ALD affecting approximately 50% of patients. The decision to advance this program is based on positive results from a prior Phase 1 study in more than 100 healthy volunteers. In that study, VK0214 demonstrated dose-dependent exposures, no evidence of accumulation and the half-life consistent with anticipated once daily dosing.

Viking 目前正在開展一項 1b 期研究，評估 VK0214 對腎上腺脊髓神經病或 AMN 型 X-ALD 患者的療效。 AMN 是最常見的 X-ALD 形式，影響約 50% 的患者。推進該計劃的決定是基於之前對 100 多名健康志願者進行的第一階段研究的積極結果。在那項研究中，VK0214 表現出劑量依賴性暴露，沒有蓄積證據，且半衰期與預期每日一次給藥一致。

Subject to receive VK0214 experienced reductions in LDL-cholesterol, triglycerides, apolipoprotein B and lipoprotein (a). VK0214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures.

接受 VK0214 治療的受試者的 LDL 膽固醇、甘油三酯、載脂蛋白 B 和脂蛋白 (a) 均有所降低。 VK0214還表現出令人鼓舞的安全性和耐受性，沒有報告嚴重不良事件，也沒有觀察到胃腸道副作用、生命體徵或心血管指標的治療或劑量相關信號。

The ongoing Phase 1 trial is randomized, double-blind, placebo-controlled, multicenter study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VK0214 administered once daily for 28 days. But it also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids. This study continues to enroll and we expect to complete enrollment later this year.

正在進行的 1 期試驗是針對患有 AMN 的成年男性患者進行的隨機、雙盲、安慰劑對照、多中心研究。該研究的主要目的是評估 VK0214 每天一次、連續 28 天給藥的安全性、耐受性和藥代動力學。但它還包括對極長鏈脂肪酸血漿水平變化的探索性評估。這項研究仍在繼續招募，我們預計將在今年晚些時候完成招募。

Beyond the clinical achievements announced in the first half of the year, Viking also completed a successful public offering of common stock, raising gross proceeds of approximately $288 million. These funds position us well as we continue to invest in both the expansion and advancement of our pipeline.

除了上半年宣布的臨床成果外，Viking 還成功完成了普通股公開發行，籌集了約 2.88 億美元的總收益。這些資金使我們處於有利地位，因為我們繼續投資於管道的擴張和進步。

In conclusion, the first half of 2023 has been an exciting period for Viking. With respect to our lead program, VK2809, top-line data from our Phase 2b VOYAGE study affirmed our belief that VK2809 is a safe and effective therapeutic with best-in-class features, demonstrating significant reductions in liver fat, while providing cardioprotective benefits through robust lipid reductions. To date, VK2809 continues to deliver the largest reductions in liver fat reported for any oral agent at this stage of development.

總之，2023 年上半年對於 Viking 來說是一個激動人心的時期。關於我們的主導項目VK2809，我們2b 期VOYAGE 研究的主要數據證實了我們的信念，即VK2809 是一種安全有效的治療藥物，具有一流的功能，顯示出顯著減少肝臟脂肪，同時通過以下方式提供心臟保護益處：強勁的降脂作用。迄今為止，VK2809 繼續在這一開發階段的任何口服藥物中實現最大程度的肝臟脂肪減少。

With respect to VK2735, our dual GLP-1 GIP receptor agonist, the company's recently completed Phase 1 study demonstrated promising safety and tolerability and significant reductions in body weight following 28 days of dosing. Given these positive results, we plan to initiate a Phase 2 study of VK2735 in obesity later this quarter. In addition, we are pursuing a novel tablet formulation of this molecule that we believe will offer patients important dosing options and significantly expand the compound's potential market opportunity.

至於VK2735，我們的雙重GLP-1 GIP受體激動劑，該公司最近完成的1期研究證明了其良好的安全性和耐受性，並且在給藥28天后體重顯著降低。鑑於這些積極的結果，我們計劃在本季度晚些時候啟動 VK2735 治療肥胖症的 2 期研究。此外，我們正在開發這種分子的新型片劑配方，我們相信它將為患者提供重要的劑量選擇，並顯著擴大該化合物的潛在市場機會。

Finally, the Phase 1b study evaluating VK0214 in patients with adrenomyeloneuropathy continues to enroll, and we anticipate completing enrollment later this year. As we look ahead to each of our currently anticipated clinical milestones as well as others in the future, we are well positioned with a strong balance sheet with approximately $400 million in cash to support the aggressive development of our pipeline.

最後，評估 VK0214 對腎上腺脊髓神經病患者的 1b 期研究繼續入組，我們預計今年晚些時候完成入組。當我們展望當前預期的每一個臨床里程碑以及未來的其他里程碑時，我們擁有強大的資產負債表和約 4 億美元的現金來支持我們產品線的積極發展。

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

我們今天準備的評論到此結束。再次感謝您加入我們，我們現在將開始提問。操作員？

(Operator Instructions) And our first question here will come from Steve Seedhouse with Raymond James.

（操作員說明）我們的第一個問題將來自 Steve Seedhouse 和 Raymond James。

I wanted to ask first about the oral GLP, GIP tablet formulation. So you're going to have the Phase 2 study -- obesity study underway in the third quarter and you'll get the oral data later this year. I'm just curious what then becomes sort of the next step strategically for that molecule, if you can add it to that Phase 2 -- parallel Phase 2? And also specifically, are there any preclinical data necessary for the tablet formulation that you need to clear like with FDA for a separate IND for instance?

我想先問一下口服GLP、GIP片劑的配方。因此，您將在第三季度進行第二階段研究——肥胖研究，今年晚些時候您將獲得口頭數據。我只是好奇，如果你可以將它添加到第二階段——平行的第二階段，那麼該分子的下一步戰略是什麼？另外，具體來說，片劑配方是否需要任何臨床前數據，您需要像 FDA 申請單獨的 IND 那樣需要清除這些數據？

So the path forward would parallel the plan for the subcu formulation. So if the oral formulation looks promising, then we would seek to move that into a Phase 2 study that would likely be similar in design to the subcu Phase 2 study.

因此，前進的道路將與 subcu 制定計劃並行。因此，如果口服製劑看起來很有希望，那麼我們將尋求將其轉移到 2 期研究中，該研究的設計可能與 subcu 2 期研究類似。

With respect to the FDA requirements, it will likely be under a separate IND and probably have some more CMC-related information included in it. But we don't think anything will be, I think, gating to moving forward.

關於 FDA 的要求，它可能會在單獨的 IND 下，並且可能包含更多與 CMC 相關的信息。但我認為，我們不認為任何事情都會阻礙前進。

Okay. And also, there was a lot of data, of course, at ADA and emerging now for the oral formulations of some of the GLP-1 mono-agonists. And you guys have presented animal data comparing the subcutaneous version of this to semaglutide or tirzepatide preclinically. Is it possible or easy to do those comparisons with sort of oral control molecules preclinically as well? Do you have a sense of how your tablet formulation stacks up preclinically against what's out there and through Phase 2 now?

好的。當然，ADA 中也有很多關於某些 GLP-1 單激動劑口服製劑的數據。你們已經提供了動物數據，將其皮下注射版本與臨床前的索馬魯肽或替澤帕肽進行了比較。在臨床前是否也可能或容易與某種口服對照分子進行這些比較？您是否了解您的片劑配方在臨床前和第二階段中與現有藥物相比如何？

Yes. It's a good question. So we don't expect the oral efficacy to be on the same level as the subcu efficacy. And that's just -- we just don't know that we'll be able to achieve the same level of exposure as the subcu it's -- I doubted. But that doesn't mean there's not a terrific opportunity for it. When we looked at the oral formulation in some of the earlier animal models, it was effective at weight loss and it does show efficacy, probably, I don't know, 50%, 60% as good as the subcu.

是的。這是一個好問題。因此，我們預計口服功效不會與 subcu 功效處於同一水平。那隻是 - 我們只是不知道我們是否能夠達到與 subcu 相同的曝光水平 - 我對此表示懷疑。但這並不意味著沒有絕佳的機會。當我們在一些早期的動物模型中觀察口服製劑時，它對減肥有效，而且確實顯示出功效，我不知道，可能比 subcu 好 50%、60%。

We didn't pursue any specific dose-ranging comparisons. But in the 14- and 21-day models, they were -- it was very effective, but probably about 60%. I'm not remembering that percentage perfectly, so don't quote me on that, but it's probably [60-or-so-percent] as effective as the subcu.

我們沒有進行任何具體的劑量範圍比較。但在 14 天和 21 天的模型中，它們非常有效，但可能只有 60% 左右。我不太清楚這個百分比，所以不要引用我的話，但它可能 [60-or-so-percent] 與 subcu 一樣有效。

And I mean, are you able to get your hands on or synthesize the control molecules for some of these other clinical-stage emerging oral GLP-1 candidates? Do you have a sense of how it's backed up laterally as opposed to just versus your own subcutaneous formulation? Preclinically, of course.

我的意思是，您是否能夠獲得或合成其他一些臨床階段新興口服 GLP-1 候選藥物的控制分子？您是否了解它是如何橫向支持的，而不是僅僅與您自己的皮下製劑相比？當然是臨床前。

We've done a little bit of that. I don't want to get into the compounds we have tested against, but we have done a little bit of that. And I think from what we've seen, it looks very encouraging, but these are animal models with a lot of pretty large air bars. But I think we're comfortable with what we've seen in animals as far as exposures and weight loss thus far.

我們已經做了一點點。我不想討論我們測試過的化合物，但我們已經做了一些。我認為從我們所看到的來看，它看起來非常令人鼓舞，但這些動物模型有很多相當大的空氣酒吧。但我認為我們對迄今為止在動物身上看到的暴露和體重減輕感到滿意。

Our next question will come from Jay Olson with Oppenheimer.

我們的下一個問題將由傑·奧爾森和奧本海默提出。

For the oral 2735 data expected later this year, can you just talk about what kind of data we should be looking for and how you plan to disclose that?

對於今年晚些時候預計會出現的2735個口頭數據，您能否談談我們應該尋找什麼樣的數據以及您打算如何披露這些數據？

Did you say the clinical data or preclinical data, sorry?

抱歉，你說的是臨床數據還是臨床前數據？

Clinical.

臨床。

Oh, clinical. It would probably be roughly similar to what we announced with the subcu. So we'd look at PK and safety and tolerability and preliminary effects on body weight changes. We aren't doing the MRI-PDFF with the oral, but everything else, I think, is very parallel to the subcu.

哦，臨床。它可能與我們宣布的 subcu 大致相似。因此，我們會研究 PK、安全性、耐受性以及對體重變化的初步影響。我們沒有用口腔進行 MRI-PDFF，但我認為其他一切都與 subcu 非常相似。

Okay. And is that going to be QD dosing and are there any dietary restrictions around dosing?

好的。這是否是 QD 給藥？給藥方面是否有任何飲食限制？

It is QD dosing. We haven't disclosed dosing details on whether or not there are restrictions, but we don't think anything would be particularly problematic.

這是 QD 給藥。我們還沒有透露是否有限制的劑量細節，但我們認為不會有什麼特別的問題。

And then given the ongoing supply shortages for some of the competing weight loss compounds, can you just talk about the cadence of enrollment for your 2735 studies?

然後考慮到一些競爭性減肥化合物的供應持續短缺，您能談談 2735 研究的招募節奏嗎？

Yes. It's a little lumpy with 2735. This is a single site in Australia, and it comes in fits and starts, but we think we can have data from the study by the end of the year. But you have a little burst of enrollment than a little dry spell and then a burst of enrollment. So it's similar to the subcu enrollment pattern.

是的。 2735 個有點不穩定。這是澳大利亞的一個站點，而且時斷時續，但我們認為我們可以在今年年底之前獲得該研究的數據。但是，你會經歷一段短暫的入學高峰，而不是經歷一段短暫的干旱期，然後又迎來一陣入學高峰。所以它類似於 subcu 註冊模式。

And maybe one last question. Beyond GLP-1 and GIP, are there any other mechanisms for obesity that you're interested in?

也許還有最後一個問題。除了 GLP-1 和 GIP 之外，您還對其他肥胖機制感興趣嗎？

Yes. We have, I'd say, a fairly robust effort in the metabolic disorders and obesity in particular. I think not everything is ready for prime time right now, but we hope to talk more about those in the coming quarters. But I think we've got some exciting projects in-house here.

是的。我想說，我們在代謝紊亂和肥胖方面做出了相當大的努力。我認為現在還沒有一切準備好迎接黃金時段，但我們希望在未來幾個季度更多地討論這些問題。但我認為我們內部有一些令人興奮的項目。

Our next question will come from Joon Lee with Truist.

我們的下一個問題將由 Joon Lee 和 Truist 提出。

Just a follow-up on -- from Steve's prior question. Did you say you saw around 50% to 60% of the weight loss effect for your oral formulation versus the key formulation? And so in other words, 3% weight loss placebo-adjusted in the Phase 1 MAD study. Is that the bar or are there other considerations like different dosing regimen that makes that extrapolation difficult? And I have a follow-up.

只是史蒂夫之前問題的後續。您是否說過您的口服製劑與關鍵製劑相比，看到了約 50% 至 60% 的減肥效果？換句話說，在 MAD 第一階段研究中，經過安慰劑調整後，體重減輕了 3%。這是一個標準還是有其他考慮因素（例如不同的給藥方案）使得推斷變得困難？我有一個後續行動。

Yes, I think that extrapolation is very difficult because the animal studies are sort of sledgehammer studies, you're dosing at levels that aren't really relevant to people just to understand whether or not an effect exists. So I wouldn't use that as a benchmark for expectations in people. We just don't know yet what the effect in people would be.

是的，我認為外推是非常困難的，因為動物研究是一種大錘研究，你的劑量水平與人們並不真正相關，只是為了了解是否存在效果。所以我不會用它作為人們期望的基準。我們只是還不知道這會對人們產生什麼影響。

And can you just remind us how many arms you're testing in the oral formulation?

您能提醒我們您在口服製劑中測試了多少隻手臂嗎？

Yes, the ore formulation would be 5 arms. It will be placebo and then for escalating dose arms. We do have flexibility to add arms in that study if we like -- just like in the subcu study at cohorts, I mean.

是的，礦石配方是 5 個臂。它將是安慰劑，然後用於逐步增加劑量組。如果我們願意的話，我們確實可以靈活地在該研究中添加手臂——我的意思是，就像隊列中的 subcu 研究一樣。

Looking forward to data. And in terms of VK2809 for NASH, assuming good biopsy results in the first half of next year, what are you looking for in a potential partner who can take it forward? And how quickly do you think you can find such a partner?

期待數據。就 NASH 的 VK2809 而言，假設明年上半年活檢結果良好，您在尋找能夠推動該項目向前發展的潛在合作夥伴嗎？您認為多久能找到這樣的合作夥伴？

Yes. Well, I think great question. I think it depends on the -- on what the data look like. We're excited to see how the biopsies turn out and that I think will drive the interest. And the speed in which we would move forward, we would hope to upon completion of the study schedule and in a Phase 2 meeting with the FDA as soon as possible to discuss the design and outline of the Phase 3 program.

是的。嗯，我認為這是一個很好的問題。我認為這取決於數據的樣子。我們很高興看到活檢結果如何，我認為這會引起人們的興趣。至於我們前進的速度，我們希望在完成研究計劃後，盡快與 FDA 舉行第二階段會議，討論第三階段計劃的設計和大綱。

Our next question will come from Annabel Samimy with Stifel.

我們的下一個問題將來自安娜貝爾·薩米米和斯蒂菲爾。

Hi, this is [Stacy] calling in for Annabel. I guess 2 on our end. How are you thinking about the landscape following ADA and the strength of some of the new programs in the orals emerging? Do you feel that in your clinical trials, you might find populations that might be more suited to have dual agonist than single or triple? And how do you start identifying those patients? And I guess you're seeing potential encroachment from triple G for NASH or at least that's -- how it's been interpreted. Can you talk about the feedback from your side on how [tirzepatide] might affect your opportunity?

嗨，我是[史黛西]給安娜貝爾打電話。我猜我們這邊有 2 個。您如何看待 ADA 的前景以及口頭會議中出現的一些新項目的優勢？您是否認為在您的臨床試驗中，您可能會發現比單一或三重激動劑更適合雙重激動劑的人群？您如何開始識別這些患者？我猜你會看到三重 G 對 NASH 的潛在侵蝕，或者至少是這樣的——它是如何被解釋的。您能談談您方面對[替西帕肽]可能如何影響您的機會的反饋嗎？

Yes, a lot of talk about some of the data from ADA and how obesity uptake, the uptake of new obesity drugs is projected and how it looks right now, it looks very exciting. And I just -- as a reminder, we have an obesity drug. So to the extent those drugs are used widely, that's great, because we think we've got a phenomenal molecule in the VK2735. At this point, we haven't really seen from the obesity drugs compelling antifibrotic signal. So I think in that sense, some of the liver targeting agents and different mechanisms may have an edge on just an obesity type drug.

是的，很多人都在談論 ADA 的一些數據，以及肥胖的吸收情況、新的肥胖藥物的吸收情況的預測以及目前的情況，看起來非常令人興奮。我只是提醒一下，我們有一種減肥藥。因此，就這些藥物的廣泛使用而言，這很好，因為我們認為 VK2735 是一種非凡的分子。目前，我們還沒有真正從肥胖藥物中看到令人信服的抗纖維化信號。所以我認為從這個意義上說，一些肝臟靶向藥物和不同的機制可能比肥胖型藥物更有優勢。

I think when you look at the ADA updated guidelines that were announced at the conference, the ADA conference, the suggestion to screen earlier for NAFLD and NASH, we think that's a great update to the guidance. We think that, that will raise awareness. And I think really serve to funnel more patients into the GI specialist setting where they're probably more likely to receive a targeted agent versus just an obesity agent. And so we think that increase in awareness is, I think, favorable to the -- more of the pure NASH drugs.

我認為，當您查看會議上宣布的 ADA 更新指南、ADA 會議、及早篩查 NAFLD 和 NASH 的建議時，我們認為這是對指南的重大更新。我們認為，這將提高人們的認識。我認為這確實有助於將更多患者納入胃腸道專家環境，在那裡他們可能更有可能接受靶向藥物而不是肥胖藥物。因此，我認為，意識的提高有利於更多的純 NASH 藥物。

But at the end of the day, these are large markets. NASH is a pretty substantial market. There will be room for multiple modalities to coexist. If someone has morbid obesity and NASH, maybe something like retatrutide would be suitable for some period of time. But there are plenty of people who don't fit that description and very large populations that people aren't necessarily obese and they have NASH. If you look at Asians, they typically get a skinny NASH. So we don't necessarily see obesity drugs just taking over the NASH world. I think that's an overstatement.

但歸根結底，這些都是巨大的市場。 NASH 是一個相當大的市場。多種模式將有共存的空間。如果某人患有病態肥胖和 NASH，也許瑞他魯肽之類的藥物適合一段時間。但有很多人不符合這種描述，而且有很大一部分人不一定肥胖，但他們患有 NASH。如果你觀察一下亞洲人，你會發現他們的 NASH 症狀通常都很瘦。因此，我們不一定會看到肥胖藥物佔領 NASH 世界。我認為這有點言過其實了。

And our next question will come from Andy Hsieh with William Blair.

我們的下一個問題將由謝家華和威廉·布萊爾提出。

So I have one for 2735. You mentioned about the flexibility to add another arm. I'm just curious about what considerations you'll be put in, in making that determination, especially in the context that some of -- when you dose escalate, especially in such short time intervals, sometimes, the magnitude of weight loss don't really separate. Instead, the difference is really where they plateau. So I'm curious about kind of the thinking into adding that additional arm.

所以我有一個 2735 的。您提到了添加另一隻手臂的靈活性。我只是好奇你在做出這個決定時會考慮哪些因素，特別是在某些情況下——當你劑量增加時，特別是在如此短的時間間隔內，有時，體重減輕的幅度並不大。真的分開了。相反，差異實際上在於它們處於穩定狀態。所以我很好奇添加額外手臂的想法。

And then in terms of oral dosing versus subcu, just curious if you have disclosed that and it will be helpful to kind of get an understanding of kind of the ratio between the subcu dosing normalize to weekly versus the oral dosing?

然後就口服劑量與 subcu 而言，只是好奇您是否已披露這一點，並且了解 subcu 劑量正常化為每週與口服劑量之間的比率是否會有幫助？

So with the oral dosing, we just have the flexibility in the protocol to add cohorts. It's not -- we have to make that decision based on the data and the data would be exposure, PK, tolerability data. Those would be kind of the primary drivers to understanding whether or not we want to add another cohort. With respect to the doses that are planned, I think we said previously, we're looking at 2.5 mgs per day of 5 milligrams per day, 10 milligrams per day and then 20 milligrams per day. And so those would be the planned doses. And then if we make any changes, we'll -- we have some flexibility there in the protocol.

因此，通過口服給藥，我們可以靈活地在方案中添加隊列。事實並非如此——我們必鬚根據數據做出決定，這些數據將是暴露、PK、耐受性數據。這些將是了解我們是否想要增加另一個群體的主要驅動因素。關於計劃的劑量，我想我們之前說過，我們正在考慮每天 2.5 毫克、每天 5 毫克、每天 10 毫克，然後是每天 20 毫克。這些就是計劃的劑量。然後，如果我們做出任何改變，我們將在協議中擁有一些靈活性。

And our next question will come from Yale Jen with Laidlaw & Company.

我們的下一個問題將來自 Yale Jen 和 Laidlaw & Company。

I've got 2 here. The first one is from the meeting -- the recent meeting that the triple G product, at least on the efficacy [side] seems to be very promising. My question to you is that with adding a glucagon agonist, is there something for you guys to consider? Or you feel this is probably not necessarily the best strategy forward? And I have another follow-up.

我這裡有2個第一個來自會議——最近的會議認為三G產品，至少在功效方面似乎非常有前途。我的問題是，添加胰高血糖素激動劑後，你們有什麼需要考慮的嗎？或者您認為這可能不一定是最好的策略？我還有另一個後續行動。

We have looked at the triple agonists here. And in our hands, we couldn't get them to outperform the dual agonist that target GLP-1 and GIP. What we do see from some of the data on the triple agonist compounds is that, the incremental benefit on weight loss is -- it's there. It's relatively modest, given the -- I think, significant change in the adverse event profile. So with elevated hypersensitivity and potentially concerns on cardiac safety, we'll see how those pan out long term, but those would be potential challenges that may or may not be worth it in every patient. So right now, we're looking at the GLP-1 GIP dual agonist. There may be other mechanisms outside of glucagon that could be layered on to those 2 and provide a very nice enhancement of the signal.

我們在這裡研究了三重激動劑。在我們手中，我們無法讓它們超越針對 GLP-1 和 GIP 的雙重激動劑。我們從三重激動劑化合物的一些數據中確實看到的是，減肥的增量好處是——它就在那裡。考慮到不良事件狀況的重大變化，我認為這個數字相對溫和。因此，隨著過敏症的升高和對心臟安全的潛在擔憂，我們將看到這些結果如何長期發揮作用，但這些將是潛在的挑戰，對於每個患者來說可能值得也可能不值得。現在，我們正在研究 GLP-1 GIP 雙重激動劑。胰高血糖素之外可能還有其他機制可以疊加在這兩種機制上，並提供非常好的信號增強。

And maybe just one more question here, which is for the Phase 2 subcu study you were going to start. Any color in terms of what level of longer duration or other aspects in the trial design you can reveal?

也許還有一個問題，即您要開始的第二階段 subcu 研究。您可以透露試驗設計中的較長持續時間或其他方面的任何顏色嗎？

So we're going up to 15 milligrams -- we plan to go up to 15 milligrams in this study. It's a 13-week study. And we would plan to titrate in 3-week blocks to move up to the 15-milligram dose level. So I believe at the end of the study, if you are randomized to the 15-milligram arm, you would be on that arm for about 4 weeks.

所以我們要增加到 15 毫克——我們計劃在這項研究中增加到 15 毫克。這是一項為期 13 週的研究。我們計劃以 3 週為一個週期進行滴定，以達到 15 毫克的劑量水平。因此，我相信在研究結束時，如果您被隨機分配到 15 毫克組，那麼您將在該組中呆大約 4 週。

And our next question will come from Thomas Smith with Leerink Partners.

我們的下一個問題將來自 Leerink Partners 的 Thomas Smith。

Just a couple on the obesity program. I think you've alluded to obesity week historically is a reasonable venue for presenting the detailed Phase I data. Can you just comment on whether that's still your expectation? And I guess, what additional data sets we should be looking forward to with the detailed presentation beyond the top line?

只有一對夫婦參加了肥胖計劃。我認為您曾經提到肥胖週曆史上是展示詳細第一階段數據的合理場所。您能否評論一下這是否仍然是您的期望？我想，在頂線之外的詳細演示中，我們應該期待哪些額外的數據集？

Yes, we did submit an abstract as a late breaker. And I don't know when those notifications will be sent out. We haven't notified yet. And we would hope to have -- we did collect a lot of different -- and we looked at plasma lipids -- I'm sorry (inaudible) and plasma glucose is what I meant to say. And we also looked at liver fat. So maybe some more color around some of those things as well as a little bit more on the PK side, we haven't talked a lot about PK, but probably expect to have a little bit more PK data.

是的，我們確實提交了一份摘要作為遲到的破壞者。我不知道這些通知什麼時候會發出。我們還沒有通知。我們希望——我們確實收集了很多不同的——我們研究了血漿脂質——對不起（聽不清），血漿葡萄糖就是我想說的。我們還觀察了肝臟脂肪。因此，也許圍繞其中一些事情以及 PK 方面有更多的色彩，我們還沒有談論太多有關 PK 的內容，但可能期望有更多的 PK 數據。

And just wondering if you could just elaborate a little bit on the regulatory progress with 2735 in the U.S. And I guess, specifically, if you could comment on whether you filed the IND and if you have it, I guess, what the gating factors to filing the IND would be?

只是想知道您是否可以詳細說明一下美國 2735 的監管進展。我想，具體來說，您是否可以評論一下您是否提交了 IND，如果您有，我想，限制因素是什麼提交IND會是什麼？

Yes, we have recently filed the IND and we hope to be able to start the study in the third quarter, but we have not -- we're still in that window right now. So there aren't any gating factors that we're aware of today that would preclude that, but we haven't heard back yet.

是的，我們最近提交了 IND，我們希望能夠在第三季度開始研究，但我們還沒有——我們現在仍處於這個窗口期。因此，據我們所知，目前沒有任何限制因素可以排除這種情況，但我們還沒有收到回复。

And just one last question, if I could, on the VOYAGE trial. And I know you've commented previously about using one pathologist to screen patients for entry. And I guess that they're on the board of F2, F3 or if they have an as equal to 4, they get referred on to a second pathology review. Maybe if you could just comment or give us your latest thoughts on how you're thinking about the biopsy evaluation for the 52-week biopsies? Are you considering adding additional pathologists or maybe changing to a consensus review methodology? Or just what are your latest thoughts on the histology efficacy evaluation?

如果可以的話，我想問最後一個關於 VOYAGE 試驗的問題。我知道您之前曾評論過使用一名病理學家來篩查患者的入境情況。我猜他們是 F2、F3 的董事會成員，或者如果他們的 A 等於 4，他們會被轉介進行第二次病理學審查。也許您可以發表評論或向我們提供您對 52 週活檢評估的最新想法？您是否正在考慮增加額外的病理學家或可能更改為共識審查方法？或者您對組織學療效評估的最新想法是什麼？

Yes, it's obviously, a lot has evolved since we initiated the study. We think we're best served now to sort of keep the 2 reader approach where you have a primary reader that sends things to a secondary reader when they are on the cusp of different radiations F2 versus F3 or anybody with an [NAS of 4] would still go to the second read. And they -- those 2 pathologists must reach consensus. And I'm not aware of any time thus far that they haven't reached consensus. So I think that it's working for us now in a Phase 3 trial, we would probably move to maybe a 3 reader approach. But right now, we're going to stick with what's currently in the protocol.

是的，很明顯，自從我們開始這項研究以來，已經發生了很多變化。我們認為，我們現在最好的辦法是保持2 個讀者的方法，其中您有一個主要讀者，當二級讀者處於不同輻射F2 與F3 或任何具有[NAS 為4] 的風口浪尖時，將信息發送給二級讀者。還是會去讀第二遍。他們——這兩位病理學家必須達成共識。到目前為止，我不知道他們有沒有達成共識。所以我認為它現在在第 3 階段試驗中對我們有效，我們可能會轉向 3 讀者方法。但現在，我們將堅持協議中當前的內容。

(Operator Instructions) Our next question here will come from Justin Zelin with BTIG.

（操作員說明）我們的下一個問題將來自 BTIG 的 Justin Zelin。

So Brian, we recently saw an acquisition in the obesity space. Could you give us the latest thinking on the BD strategy at Viking either bringing things into the company or likewise out?

布萊恩，我們最近看到了肥胖領域的一項收購。您能給我們介紹一下 Viking 的 BD 戰略的最新想法嗎？是把東西引入公司還是同樣退出？

Oh, yes. Thanks, Justin. Our plan today is to develop things really as far as we can. We don't see ourselves launching either a NASH or obesity product, but we will continue as aggressively as possible with the clinical development of our programs and be open-minded to opportunities as they arise, things that make sense for the company and our shareholders. But that's we're focused on is our own internal programs. Right now, I'd say bringing new things into the company, probably a lower priority given that we have our hands full.

哦是的。謝謝，賈斯汀。我們今天的計劃是盡可能地真正發展事物。我們不認為自己會推出 NASH 或肥胖產品，但我們將繼續盡可能積極地進行項目的臨床開發，並對出現的機會持開放態度，對公司和股東有意義的事情。但我們關注的是我們自己的內部計劃。現在，我想說的是，為公司帶來新事物，考慮到我們忙得不可開交，這可能是一個較低的優先級。

And our next question will come from Dylan Dupuis with Roth MKM.

我們的下一個問題將來自 Dylan Dupuis 和 Roth MKM。

Just one quick question on the Phase 2 obesity study that you guys are planning to start. Just around the dosing cohorts and at what point do you think you'll need to start implementing those situation strategies in the dosing curve? Thank you.

關於你們計劃開始的第二階段肥胖研究，我只想問一個簡單的問題。就劑量組而言，您認為您需要在什麼時候開始在劑量曲線中實施這些情況策略？謝謝。

Yes, we do plan to titrate the lowest dose in the Phase 2 study would be a 2.5 mg fixed dose but subsequent doses would be higher and will titrate into those doses in 3-week blocks. So for example, second cohort is a 5 milligram cohort. We plan to do 3 weeks at 2.5 mgs and then the remainder of the trial at the 5 milligram dose. So that's how we anticipate the titration scheme working.

是的，我們確實計劃在 2 期研究中滴定最低劑量為 2.5 毫克固定劑量，但後續劑量會更高，並將在 3 週內滴定到這些劑量。例如，第二組是 5 毫克組。我們計劃以 2.5 毫克的劑量進行 3 週的試驗，然後以 5 毫克的劑量進行剩餘的試驗。這就是我們預期滴定方案發揮作用的方式。

And this concludes our question-and-answer session. I'd 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。我想將會議轉回給斯蒂芬妮·迪亞茲（Stephanie Diaz）做總結髮言。

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

感謝大家的參與和對 Viking Therapeutics 的持續支持。我們期待在未來幾個月內再次為您提供最新消息。謝謝。

The conference is now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.

會議現已結束。非常感謝您參加今天的演講。您現在可以斷開線路。