Viking Therapeutics Inc (VKTX) 2023 Q4 法說會逐字稿

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2023 financial results conference call.

歡迎參加 Viking Therapeutics 2023 年第四季和全年財務業績電話會議。

At this time, all participants are in a listen only mode.

此時，所有參與者都處於只聽模式。

Following management's prepared remarks, we will hold a question and answer session to ask a question.

在管理階層準備好的發言之後，我們將舉行問答環節來提出問題。

At that time, please press the star key followed by one on your touchtone phone.

此時，請按按鍵式電話上的星號鍵，然後按 1。

If anyone has difficulty hearing the conference, please press star zero for operator assistance as a reminder, this conference call is being recorded today, February seventh, 2024.

如果有人在聽會議時遇到困難，請按星號零以獲得操作員協助作為提醒，本次電話會議將於今天（2024 年 2 月 7 日）錄製。

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

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

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 Xantic, Viking's CFO.

今天加入我的是 Viking 總裁兼執行長 Brian Lian 和 Viking 財務長 Greg Xantic。

Before we begin, I'd like to caution that comments made during this conference call today, February seventh, 2024, will contain forward-looking statements under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones.

在我們開始之前，我想提醒大家，今天（2024 年2 月7 日）的電話會議上發表的評論將包含根據1995 年美國私人證券訴訟改革法案的安全港條款做出的前瞻性聲明，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。

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and inversely 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差異，相反，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 fourth quarter and full year ended December 31st, 2023, and provide an update on recent progress with our clinical programs and operations. 2023 was an exciting year for Viking, highlighted by important data releases from two of our four clinical programs.

謝謝史蒂芬妮，今天透過電話或收聽網路廣播的大家下午好，我們將回顧截至 2023 年 12 月 31 日的第四季度和全年的財務業績，並提供我們臨床的最新進展程序和操作。 2023 年對 Viking 來說是令人興奮的一年，我們的四個臨床項目中的兩個項目發布的重要數據凸顯了這一點。

With respect to our obesity program, during the year, we announced positive results from a first-in-human Phase one clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors.

關於我們的肥胖計劃，今年，我們宣布了 VK2735（GLP-1 和 GIP 受體的雙重激動劑）的首次人體一期臨床試驗的積極結果。

In this study, subjects dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability.

在這項研究中，服用 VK2735 的受試者表現出統計上顯著的體重減輕，並且具有良好的安全性和耐受性。

Following these results, we initiated the Phase 2 trial called venture to further revamp evaluate VK2735 in patients with obesity.

根據這些結果，我們啟動了名為 Venture 的 2 期試驗，以進一步改善評估肥胖患者的 VK2735。

We expect to report top line results from this study later this quarter.

我們預計將在本季稍後報告這項研究的主要結果。

During the year, we also initiated a Phase 1 clinical trial evaluation evaluating an oral formulation of VK2735.

年內，我們也啟動了1期臨床試驗評估，評估VK2735的口服製劑。

We expect to report results from this study later this quarter.

我們預計將在本季稍後報告這項研究的結果。

Viking made good progress with other pipeline pipeline programs during the year as well.

今年，維京公司在其他管道項目上也取得了良好進展。

In May, we announced positive top line results from the Phase IIb VOYAGE study of our thyroid hormone receptor beta agonist VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis.

今年 5 月，我們宣布了甲狀腺激素受體 β 激動劑 VK2809 在活檢確診的非酒精性脂肪性肝炎和纖維化患者中進行的 IIb 期 VOYAGE 研究取得了積極的頂線結果。

This trial met its primary endpoint with patients receiving VK2809, demonstrating statistically significant reductions in liver fat as well as other important measures compared with patients treated with placebo.

該試驗在接受 VK2809 治療的患者中達到了主要終點，與接受安慰劑治療的患者相比，肝臟脂肪以及其他重要指標均出現了統計上顯著的減少。

We look forward to reporting the 52-week biopsy data from this study in the first half of 2024.

我們期待在 2024 年上半年報告這項研究的 52 週活檢數據。

On the financial side, we completed 2023 with a strong balance sheet.

在財務方面，我們以強勁的資產負債表結束了 2023 年。

Thanks to our continued diligence in managing expenses, along with a successful public offering of common stock, which resulted in gross proceeds of approximately $288 million.

由於我們在管理費用方面的持續努力，以及普通股的成功公開發行，總收益達到約 2.88 億美元。

These funds will be used to support the continued advancement of our pipeline programs through multiple clinical milestones.

這些資金將用於支持我們的管道項目通過多個臨床里程碑的持續推進。

I'll provide further details on our operations and development activities after we review our financial results for the fourth quarter and full year 2023.

在我們審查第四季度和 2023 年全年的財務業績後，我將提供有關我們營運和開發活動的更多詳細資訊。

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

為此，我將把電話轉給 Viking 財務長 Greg Xantic。

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 K filing with the Securities and Exchange Commission, which we expect to file today, and I'll now go over our results for the fourth quarter and full year ended December 31st, 2023.

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 K 表格，我們預計今天將提交該表格，現在我將回顧我們第四季度的業績和全面的業績。截至2023 年12月31 日的年度。

Beginning with the results for the quarter.

從本季的業績開始。

Our research increase (technical difficulty) in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022.

我們先前提到的研發費用以及一般和管理費用的研究增加（技術難度），部分被利息收入與 2022 年同期相比的增加所抵銷。

I'll now go over the results for the 12 months ended December 31st, 2023.

我現在將回顧截至 2023 年 12 月 31 日的 12 個月的結果。

Our research and development expenses for the year ended December 31st, 2023 were $63.8 million compared to $54.2 million for the same period in 2022.

截至 2023 年 12 月 31 日止年度，我們的研發費用為 6,380 萬美元，而 2022 年同期為 5,420 萬美元。

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

這一增長主要是由於與臨床前研究、股票薪酬、候選藥物生產、第三方顧問提供的工資和福利以及服務相關的費用增加，但部分被臨床研究相關費用的減少所抵消。

Our general and administrative expenses for the year ended December 31st, 2023 were $37 million compared to $16.1 million for the same period in 2022.

截至 2023 年 12 月 31 日止年度，我們的一般及管理費用為 3,700 萬美元，而 2022 年同期為 1,610 萬美元。

The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, third party consultants and salaries and benefits.

這一增長主要是由於與法律和專利服務、股票薪酬、第三方顧問以及工資和福利相關的費用增加。

For the year ended December 31st, 2023, Viking reported a net loss of $85.9 million or $0.91 per share compared to a net loss of $68.9 million or $0.9 per share in the corresponding period in 2022.

截至 2023 年 12 月 31 日的年度，Viking 報告淨虧損 8,590 萬美元，即每股 0.91 美元，而 2022 年同期淨虧損為 6,890 萬美元，即每股 0.9 美元。

The increase in net loss for the year ended December 31st, 2023, was primarily due to the increase 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 2022.

截至2023年12月31日止年度的淨虧損增加，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2022年同期相比的增加所抵銷。

Turning to the balance sheet.

轉向資產負債表。

At December 31st, 2023, Viking held cash, cash equivalents and short-term investments of $362 million compared to $155 million as of December 31st, 2022.

截至2023年12月31日，Viking持有現金、現金等價物及短期投資3.62億美元，截至2022年12月31日為1.55億美元。

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, Gregg.

謝謝，格雷格。

And as I mentioned in my opening comments, in 2023, Viking made significant progress with each of our four clinical programs, positioning the Company for an exciting year ahead.

正如我在開場白中提到的，2023 年，Viking 在我們的四個臨床項目中都取得了重大進展，為公司未來的一年奠定了激動人心的基礎。

I'll now briefly review our 2023 accomplishments and preview key objectives for 2024.

我現在將簡要回顧我們 2023 年的成就並預覽 2024 年的主要目標。

I'll begin with an update on our VK2735 program for obesity.

我將首先介紹我們針對肥胖的 VK2735 計劃的最新情況。

The VK2735 is Viking's newest clinical stage compound and is a dual agonist of the glucagon-like peptide one or GLP-1 receptor and the glucose dependent insulin Tropic polypeptide or GIP. receptor.

VK2735是Viking最新的臨床階段化合物，是胰高血糖素樣勝肽1或GLP-1受體和葡萄糖依賴性胰島素Tropic多肽或GIP的雙重激動劑。受體。

In the first quarter of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735.

2023 年第一季度，我們宣布了 VK2735 的 1 期單次劑量遞增和多次劑量遞增研究的正面結果。

This study was designed to evaluate the compound's initial safety, tolerability and pharmacokinetic profile as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.

本研究旨在評估該化合物的初始安全性、耐受性和藥物動力學特徵及其對探索性代謝指標（包括體重和肝臟脂肪）的潛在影響。

Single ascending dose portion of the study enrolled healthy men and women and demonstrated that single subcutaneous doses of VK2735 were safe and well tolerated and displayed favorable pharmacokinetics.

研究的單次劑量遞增部分招募了健康男性和女性，並證明單次皮下劑量的 VK2735 是安全的、耐受性良好，並顯示出良好的藥物動力學。

VK2735 demonstrated a half-life of approximately 178 hours to 250 hours and excellent therapeutic exposures.

VK2735 表現出約 178 小時至 250 小時的半衰期和出色的治療暴露。

The multiple ascending dose portion of this study enrolled healthy men and women with the minimum body mass index of 30 kilograms per meter squared.

本研究的多劑量遞增部分招募了最低體重指數為每平方公尺 30 公斤的健康男性和女性。

These subjects received subcutaneous doses of VK2735 once weekly for 28 days as in the single ascending dose study multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity.

這些受試者每週一次皮下注射 VK2735，持續 28 天，因為在單次劑量遞增研究中，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臨床活性的積極跡象。

All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline ranging up to 7.8% cohorts receiving the VK2735 also demonstrated reductions in 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 with respect to safety and tolerability. 98% of observed adverse events in the multiple ascending dose portion of the study were reported as mild or moderate and 99% of gastrointestinal related adverse events were reported as mild or moderate.

所有接受VK2735 治療的隊列均表現出平均體重較基線降低高達7.8%，與安慰劑相比，接受VK2735 治療的隊列也表現出體重降低高達6%，與安慰劑相比，體重的統計學顯著差異也得以維持或改善就安全性和耐受性而言，在最後一次給予 VK2735 劑量後 21 天後的第 43 天追蹤時間點。在研究的多次劑量遞增部分中觀察到的不良事件中，98% 報告為輕度或中度，99% 胃腸道相關不良事件報告為輕度或中度。

This study also demonstrated VK2735 encouraging impact on liver fat and plasma lipids, specifically after four weekly subcutaneous doses of VK2735 subjects in the Phase one trial reported liver fat reductions of up to 47% from baseline among subjects with nonalcoholic fatty liver disease.

這項研究也證明了VK2735 對肝臟脂肪和血漿脂質具有令人鼓舞的影響，特別是在第一階段試驗中，每週皮下注射VK2735 受試者四次後，報告稱患有非酒精性脂肪肝疾病的受試者的肝臟脂肪較基線減少了高達47%。

Placebo-adjusted reductions in liver fat reached approximately 59%.

安慰劑調整後肝臟脂肪減少量達約 59%。

These results indicate VK2735 potential benefit in patients with various forms of fatty liver disease.

這些結果表明 VK2735 對患有各種形式的脂肪肝疾病的患者俱有潛在的益處。

With respect to plasma lipids treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL-cholesterol of up to 23%.

就血漿脂質而言，VK2735 治療使總膽固醇較基線降低高達 21%，LDL 膽固醇降低高達 23%，令人鼓舞。

Plasma levels of APRIL lipoprotein B were also reduced by 21%.

APRIL 脂蛋白 B 的血漿濃度也降低了 21%。

These data are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline plasma lipid levels.

這些數據特別有趣，因為這些健康志願者在開始研究時血脂基線水平正常。

These study results were featured in an oral presentation last October at Obesity Week and served as the basis for our decision to continue to advance this program further in clinical development to this end, in the third quarter of last year, Viking initiated the Phase 2 venture trial to evaluate VK2735 in patients with obesity.

這些研究結果在去年 10 月的肥胖週上進行了口頭報告，並作為我們決定繼續進一步推進該計畫的臨床開發的基礎，為此，去年第三季度，Viking 啟動了 2 期計畫評估肥胖患者VK2735 的試驗。

The venture trial is a randomized, double-blind, placebo-controlled, multicenter study that is evaluating the safety, tolerability, pharmacokinetics and weight loss efficacy of BK. two seven three five administered subcutaneously once weekly for 13 weeks.

此風險試驗是一項隨機、雙盲、安慰劑對照、多中心研究，旨在評估 BK 的安全性、耐受性、藥物動力學和減肥功效。二七三五每週一次皮下注射，持續 13 週。

This trial was designed to enroll approximately 125 adults with obesity for adults who are overweight with at least one weight-related co-morbid condition due to higher than expected clinician and patient interest.

該試驗旨在招募約 125 名肥胖成年人，由於臨床醫生和患者的興趣高於預期，因此患有至少一種體重相關共病的超重成年人。

This trial's enrollment was increased to 176 patients and completed ahead of schedule.

本試驗入組患者增至176名，並提前完成。

The venture trial is evaluating weekly subcutaneous doses of VK2735 of up to 15 milligrams compared to the 10 milligram top dose evaluated in the prior Phase one multiple ascending dose study.

此風險試驗正在評估 VK2735 每週皮下注射劑量高達 15 毫克，而先前的一期多次遞增劑量研究中評估的最高劑量為 10 毫克。

The primary endpoint of the study will assess the percent change in body weight from baseline to week 13 among patients treated with VK2735 as compared with placebo.

研究的主要終點將評估接受 VK2735 治療的患者與安慰劑相比，從基線到第 13 週的體重變化百分比。

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

次要和探索性終點將評估一系列額外的安全性和有效性措施。

We expect to report the top-line results from this study in the first quarter of this year.

我們預計將在今年第一季報告這項研究的主要結果。

In addition to the subcutaneous formulation of VK2735 in the first quarter of last year, Viking announced the initiation of a Phase o1ne clinical study evaluating a novel tablet formulation of this molecule.

除了去年第一季VK2735的皮下製劑外，Viking還宣布啟動一項臨床研究，評估該分子的新型片劑製劑。

This study as an extension of the Phase 1 single-ascending dose and multiple-ascending dose study discussed a moment ago, 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 in this portion of the study will receive once daily oral doses of VK2735 for 28 days.

這項研究作為剛才討論的一期單次劑量遞增和多次劑量遞增研究的延伸，該研究的口服部分是一項隨機、雙盲、安慰劑對照研究，受試者為具有最低體重的健康志願者。在這部分研究中，體重指數為每平方公尺 30 公斤的受試者將每天口服一次 VK2735，持續 28 天。

The primary objective of the study is to evaluate the safety tolerability and pharmacokinetics of DK. two seven three five following 28, 28 days of oral dosing.

研究的主要目的是評估 DK 的安全耐受性和藥物動力學。二七三五以下28、28天口服給藥。

Exploratory endpoints include changes in body weight and other pharmacodynamic markers.

探索性終點包括體重和其他藥效學標記的變化。

We expect to report the results from this study in the first quarter of this year.

我們預計將在今年第一季報告這項研究的結果。

I'll now provide an update on our VK. two L. nine program for the treatment of NASH and fibrosis.

我現在將提供有關我們的 VK 的更新。兩個L.九方案用於治療NASH和纖維化。

DK. 29 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 last May, we announced positive top-line results from the ongoing Phase IIb VOYAGE study of VK. two L. nine.

DK。 29 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。去年 5 月，我們宣布了正在進行的 VK IIb 期 VOYAGE 研究的積極頂線結果。兩個左九。

The VOYAGE study is a randomized double-blind, placebo-controlled multi-centered international trial designed to assess the efficacy, safety and tolerability of DK. to eight or nine in patients with biopsy-confirmed NASH and fibrosis.

VOYAGE 研究是一項隨機雙盲、安慰劑對照的多中心國際試驗，旨在評估 DK 的有效性、安全性和耐受性。活檢證實患有 NASH 和纖維化的患者有 8 到 9 名。

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.

入組患者的肝臟脂肪含量至少為 8%（以磁振造影、質子密度、脂肪分數以及 F2 和 F3 纖維化測量）。

As we reported in May, this study successfully achieved its primary endpoint with patients receiving VK. 2.9, demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared to placebo.

正如我們在 5 月報導的那樣，這項研究成功地實現了接受 VK 治療的患者的主要終點。 2.9，顯示與安慰劑相比，從基線到第 12 週，肝臟脂肪含量在統計上顯著降低。

The median relative change from baseline in liver fat ranged from 38% to 55% among patients receiving VK.

接受 VK 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%。

2.9. Importantly, up to 85% of patients receiving DK. 29 experienced at least a 30% relative reduction in liver fat.

2.9.重要的是，高達 85% 的患者接受 DK。 29 人的肝臟脂肪相對減少了至少 30%。

This level of efficacy is associated with a greater likelihood of histologic benefit in NASH.

這種療效水準與 NASH 的組織學獲益的可能性更大相關。

As in prior studies, VK. 29 treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic proteins.

如同先前的研究一樣，VK. 29 名接受治療的患者的 LDL 膽固醇、三酸甘油酯和致動脈粥樣硬化蛋白也實現了統計學上的顯著降低。

We believe these results indicate that VK. 2009 has the potential to provide long-term cardiovascular benefits.

我們相信這些結果顯示 VK. 2009 年有可能提供長期的心血管益處。

The initial wage data also served to further establish PK to it aligns promising safety and tolerability profile. 94% of treatment related adverse events among patients receiving DK. 29 were reported as mild or moderate discontinuations due to adverse events were low and balanced among placebo and treatment arms.

初始薪資數據還有助於進一步建立 PK，使其與有希望的安全性和耐受性概況保持一致。接受 DK 治療的患者中 94% 的不良事件與治療相關。 29 例因不良事件而輕度或中度停藥，安慰劑組和治療組的比例較低且平衡。

In particular, VK. 2009 demonstrated excellent gastrointestinal tolerability.

特別是，VK. 2009年表現出優異的胃腸道耐受性。

In the VOYAGE study, the rates of nausea, diarrhea, stool frequency and vomiting were similar among VK., 2.9 treated patients compared to placebo in November.

在 VOYAGE 研究中，11 月 VK., 2.9 治療組患者的噁心、腹瀉、大便次數和嘔吐發生率與安慰劑組相似。

Viking presented new data from this study at the annual meeting of the American Association for the Study of Liver Disease.

維京在美國肝病研究協會年會上展示了這項研究的新數據。

These new data demonstrated robust liver fat reductions among patients with or without type-2 diabetes as well as those having F2 or F3 fibrosis among patients with type two diabetes.

這些新數據表明，患有或不患有第2型糖尿病的患者以及患有F2或F3纖維化的第2型糖尿病患者的肝臟脂肪顯著減少。

At week 12, reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions reported among patients without type two diabetes.

在第 12 週時，肝臟脂肪較基線減少了 36% 至 54%，與非二型糖尿病患者報告的減少量相當。

These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat in the presence of an important metabolic co-morbidity commonly observed in patients with NASH treatment with VK. 29 also demonstrated potent reductions in liver fat among patients with F2 or F3 fibrosis.

這些數據表明，在接受 VK 治療的 NASH 患者中常見的重要代謝併發症存在的情況下，甲狀腺激素 β 受體的活化仍然可以有效減少肝臟脂肪。 29 也證明 F2 或 F3 纖維化患者的肝臟脂肪有效減少。

Thus neither the presence of type two diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted VK. two airlines efficacy in reducing liver fat as steatosis and local toxicity are believed to be underlying drivers in NASH.

因此，二型糖尿病的存在以及 F2 或 F3 纖維化的存在都不會顯著影響 VK。兩家航空公司在減少肝臟脂肪方面具有功效，因為脂肪變性和局部毒性被認為是 NASH 的潛在驅動因素。

These results suggest important long-term benefits across key subgroups.

這些結果顯示關鍵亞組具有重要的長期利益。

We recently completed the final biopsies in the VOYAGE study and look forward to reporting data on histologic changes assessed after 52 weeks of treatment in the first half of 2024.

我們最近完成了 VOYAGE 研究的最終活檢，並期待在 2024 年上半年報告 52 週治療後評估的組織學變化數據。

Moving to our orphan disease program, our second thyroid hormone receptor beta agonist.

轉向我們的孤兒疾病項目，我們的第二種甲狀腺激素受體β激動劑。

VKO. two one four is currently being evaluated in a Phase Ib trial in patients with X-linked adrenoleukodystrophy or X-ALD likely K to eight or nine detail to one four is also an orally available, small molecule that is selective for the beta isoform of the thyroid hormone receptor.

VKO。二一四目前正在 X 連鎖腎上腺腦白質營養不良或 X-ALD 患者的 Ib 期試驗中進行評估，可能 K 至八或九細節一四也是一種口服小分子，對 β 亞型具有選擇性甲狀腺激素受體。

X-ald is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a proximal 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，是由基因突變導致長鏈脂肪酸近端轉運蛋白功能喪失而引起的。

As a result, patients are unable to efficiently metabolized very long-chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD in a prior Phase one study VKO. two one four demonstrated dose-dependent exposures, no evidence of accumulation and the half-life consistent with anticipated once daily dosing subject to receipt detail two one four experienced reductions in LDL cholesterol, triglycerides, April like for protein B and lipoprotein A. detail too, on four 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, the ongoing Phase Ib study of DKr two, one fours being conducted in patients with the adrenal myelin neuropathy or AM. end form of X-ALD, which is the most common form of the disorder.

因此，患者無法有效地代謝極長鏈脂肪酸，並且在先前的一期研究 VKO 中，這些化合物的累積被認為有助於 X-ALD 的發生和進展。二一四顯示劑量依賴性暴露，沒有累積的證據，半衰期與預期每天一次給藥一致，取決於收據細節二一四經歷了LDL 膽固醇、甘油三酯的降低，四月就像蛋白B 和脂蛋白A 一樣。細節也, on four 也表現出令人鼓舞的安全性和耐受性概況，沒有報告嚴重不良事件，也沒有觀察到胃腸道副作用、生命體徵或心血管措施的治療或劑量相關訊號，正在進行的DKr 2, 1 fours 的Ib 期研究正在進行中患有腎上腺髓鞘神經病變或 AM 的患者。 X-ALD 的最終形式，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 AMM.

該試驗是一項針對 AMM 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 VKO. two one four administered orally once daily for 28 days.

研究的主要目的是評估 VKO 的安全性、耐受性和藥物動力學。二一四口服，每日一次，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 expect to report the top line results from this study in the first half of 2024.

我們預計在 2024 年上半年報告這項研究的主要結果。

In conclusion, 2023 was an exciting and productive year for Viking with the Company achieving significant progress with each of our clinical programs.

總而言之，2023 年對 Viking 來說是令人興奮且富有成效的一年，公司的每個臨床計畫都取得了重大進展。

During the year, we reported the results from the first Phase one trial of DK. two seven three five, which demonstrated early signals of efficacy as well as promising safety and tolerability.

在這一年裡，我們報告了 DK 的第一個一期試驗的結果。二七三五，顯示出療效的早期訊號以及有希望的安全性和耐受性。

We also initiated the Phase one clinical evaluation of a novel oral formulation of VK2735, which we believe may expand the market opportunity for this compound.

我們也啟動了 VK2735 新型口服製劑的第一期臨床評估，我們相信這可能會擴大該化合物的市場機會。

In the fall of 2023, we initiated and completed the upsized enrollment of the venture Phase two trial to evaluate VK2735 longer-term clinical benefit in patients with obesity.

2023 年秋季，我們啟動並完成了此風險二期試驗的擴大招募，以評估 VK2735 對肥胖患者的長期臨床益處。

We look forward to reporting the results from the venture Phase two study later this quarter, along with the Phase one data from the oral formulation study.

我們期待在本季稍後報告該計畫第二階段研究的結果，以及口服製劑研究的第一階段數據。

We also look forward to reporting data from the voyage Phase 2b study of our thyroid beta receptor agonist VK. oh two to 0 eight oh nine in biopsy-confirmed NASH and fibrosis.

我們也期待報告我們的甲狀腺 β 受體激動劑 VK 的航行 2b 期研究的數據。哦二到零八哦九在活檢證實的 NASH 和纖維化中。

The initial data from this study successfully achieved the primary endpoint and affirmed to DK. to eight or nine best in class effect on liver fat, along with its favorable tolerability and safety profile.

本研究的初始數據成功達到了主要終點並確認為 DK。對肝臟脂肪的效果達到八到九個同類最佳，並且具有良好的耐受性和安全性。

We expect to report the 52 week biopsy data from this study in the first half of 2024.

我們預計在 2024 年上半年報告研究的 52 週活檢數據。

The Phase Ib study of VKO. two one four for the treatment of adrenal mild neuropathy also continues.

VKO 的 Ib 期研究。二一四對於腎上腺輕度神經病變的治療也持續進行。

And we look forward to announcing the results from this trial later in the first half.

我們期待在上半年稍後宣布該試驗的結果。

Finally, we completed 2023 with a strong balance sheet and a cash position that will support our objectives for 2024 and beyond.

最後，我們以強勁的資產負債表和現金狀況結束了 2023 年，這將支持我們實現 2024 年及以後的目標。

All of us at Viking are optimistic about the year ahead, and we'd like to extend our thanks to our shareholders, partners, investigators and importantly, the patients participating in our clinical trials for their continued support.

Viking 的所有人都對未來的一年感到樂觀，我們要感謝我們的股東、合作夥伴、研究人員，更重要的是，感謝參與我們臨床試驗的患者的持續支持。

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？

Joon Lee, Truist.

李俊，真理主義者。

Regarding to subcutaneous 5275, you reminded us that you are in phase one.

關於皮下5275，您提醒我們您正處於第一階段。

You sub 6% placebo-adjusted weight loss in just four weeks.

根據安慰劑調整，您在短短 4 週內體重減輕了 6%。

So with longer dosing of up to 13 weeks using up to 50% higher dose, but a reasonable expectation of weight loss in the upcoming entry trial?

那麼，如果使用長達 ​​13 週的較長劑量，使用高出 50% 的劑量，但在即將到來的入門試驗中，體重減輕的預期合理嗎？

Yes, Adrian, thanks for the questions, Tom.

是的，阿德里安，謝謝你的提問，湯姆。

So we are really using a around an 8% hurdle for the for the venture study.

因此，我們實際上使用了大約 8% 的門檻來進行風險研究。

I think if we showed that, that would be sufficient for us to move forward, some think it could be competitive at 13 weeks.

我認為如果我們能證明這一點，就足以讓我們繼續前進，有些人認為 13 週後可能會具有競爭力。

And that just a quick follow-up on one of their safety and efficacy measures?

這只是對其安全性和有效性措施之一的快速跟進？

Are you tracking that we should be looking out for interventional trial?

您是否認為我們應該關注介入試驗？

I'm sorry.

對不起。

What other safety and what?

還有什麼安全什麼的？

Efficacy measures.

功效措施。

Well, Alex, it's yes, we're looking at obviously, plasma lipids.

嗯，亞歷克斯，是的，我們顯然正在研究血漿脂質。

We're looking at plasma glucose insulin, a standard battery of lab assessments and clinical chemistry from cardiovascular safety as well.

我們正在研究血漿葡萄糖胰島素，這是一組標準的實驗室評估和心血管安全的臨床化學。

But it's free free stand, nothing unusual or exotic in the in the safety analysis.

但它是獨立的，在安全分析中沒有任何異常或異國情調。

Great.

偉大的。

And then one last quick one on for the oral VK2735, are you able to disclose whether you've dosed higher than 20 milligrams in that respect.

最後一個關於口服 VK2735 的快速問題，您是否能夠透露您在這方面的劑量是否超過 20 毫克。

As you know, we're not going to get into the details of the of the cohorts.

如您所知，我們不會深入了解該群體的詳細資訊。

We'll disclose all those details when we disclose the data if you're fortunate data.

如果您的數據幸運的話，我們會在披露數據時披露所有這些詳細資訊。

Next question comes from Steven Seedhouse of Raymond James.

下一個問題來自 Raymond James 的 Steven Seedhouse。

Please go ahead.

請繼續。

Steven, your line is open or you made it clear and sorry about that guys.

史蒂文，你的線路是開放的，或者你已經明確表示對那些人表示歉意。

Can you hear me now this weekend?

這個週末你聽得到我說話嗎？

Well, so my apologies, I appreciate you taking the question.

嗯，很抱歉，我很感謝你提出這個問題。

I wanted to first ask about venture for the higher dose arms, particularly the 15 milligram cohort.

我想先詢問高劑量組的風險，特別是 15 毫克組。

If you were just following the tirzepatide titration schema like 2.5 milligrams titrated in this case, every three weeks, you still wouldn't get to the high dose.

如果您只是遵循替澤帕肽滴定方案，例如在本例中每三週滴定 2.5 毫克，您仍然無法達到高劑量。

So I'm curious if you can just clarify like what are the dose increments and sort of schema for the titration arm in that study?

所以我很好奇你是否能澄清一下該研究中滴定臂的劑量增量和模式是什麼？

Yes.

是的。

We use a three week blocks on the lowest doses, 2.5 mg for 13 weeks, the second doses, it's for three weeks and then 5 mg for 10 weeks.

我們使用最低劑量的三週療程，2.5 毫克，持續 13 週，第二個劑量，持續三週，然後 5 毫克，持續 10 週。

The 10 milligram dose is 2.5 for three weeks, 5 mg for three weeks and then 10 mg for seven weeks, and then the 15 milligram dose starts at 5 mg.

10毫克劑量為2.5毫克三週，5毫克三週，然後10毫克七週，然後15毫克劑量從5毫克開始。

So it's a 5 milligrams for three weeks, 7.5 milligrams for three weeks, 10 milligrams for three weeks and then 15 milligrams for four weeks.

因此，三週服用 5 毫克，三週服用 7.5 毫克，三週服用 10 毫克，然後四週服用 15 毫克。

Perfect.

完美的。

Appreciate appreciate that detail.

欣賞欣賞這個細節。

And then just wanted to ask also is that there's a four week follow-up period in this study off-drug, and I'm curious if that's are we waiting for that four week off-drug follow-up to conclude before analyzing the top-line data?

然後我想問的是，這項研究有一個為期四週的停藥追蹤期，我很好奇我們是否要等待為期四周的停藥期追蹤得出結論，然後再分析頂部線數據？

Or would the release just include the 13 weeks on drug?

還是釋放只包含 13 週的藥物治療？

Well, yes, it's a good question.

嗯，是的，這是一個好問題。

It's a six week follow-up period.

這是一個六週的追蹤期。

We might evolve earlier at four weeks mistakenly, but I guess the six week follow-up window, and I believe we'll be through that when we report the top-line data.

我們可能會錯誤地提前四個星期進行進化，​​但我猜六週的隨訪窗口，我相信當我們報告頂線數據時我們會完成這個任務。

Okay.

好的。

And I mean on those will be the first to ask that is what is the sequencing of the subcu and the oral data, which comes first?

我的意思是，在這些問題上，首先要問的是 subcu 和口語資料的順序是什麼，哪個先出現？

Or would they be announced together?

還是一起公佈？

Steve, I know not going to be announced together and that they'll both be this quarter.

史蒂夫，我知道不會一起宣布，而且都將在本季宣布。

I think that's about all the granularity we're going to give the core is not very long.

我認為這就是我們要給核心的所有粒度，不是很長。

Thanks a lot.

多謝。

Thanks, Dave.

謝謝，戴夫。

Next question comes from Jay Olson of Oppenheimer.

下一個問題來自奧本海默的傑伊·奧爾森。

Please go ahead.

請繼續。

Hey, congrats on the progress and thanks for that.

嘿，祝賀您取得的進展，並為此表示感謝。

Adaytum.

阿達圖姆。

Can you just talk about through the oral Phase one data?

您能透過口頭的一期數據來談談嗎？

And since you have the option to add cohorts on how many cohorts of data should we?

既然您可以選擇新增群組，那麼我們應該增加多少群組資料呢？

Thanks for the question.

謝謝你的提問。

Yes, I mentioned to June, we're not going to get into the details of numbers of cohorts until we actually released the data from the trial was originally designed to enroll four cohorts, but we maintain flexibility to add cohorts, but we'll have all the details on that when we release the data.

是的，我向六月提到過，在我們實際發布試驗數據之前，我們不會詳細了解隊列數量，該試驗最初設計用於招募四個隊列，但我們保持添加隊列的靈活性，但我們會當我們發布數據時，我們會提供所有詳細資訊。

Okay, great.

好的，太好了。

Thank you.

謝謝。

And then I guess since Novo is planning to acquire catalyst.

然後我想既然 Novo 正計劃收購 Catalyst。

Can you just talk about on your manufacturing plans and any impact you might expect that acquisition goes through?

您能否談談您的製造計劃以及您預計收購會產生的任何影響？

Yes, thanks.

對了謝謝。

Good question.

好問題。

Shouldn't impact us at all at least definitely not in the near term.

根本不該影響我們，至少在短期內絕對不會。

And I don't believe because as far as future plans as well, I think we're all set to supply of all of the clinical studies that would be required to do receive approval.

我不相信，因為就未來的計劃而言，我認為我們都準備好提供獲得批准所需的所有臨床研究。

Great, thanks.

萬分感謝。

And can you just talk big picture about the current landscape for oral weight-loss drugs?

能談談目前口服減肥藥的整體情況嗎？

And where do you think of CORAL drugs will fit in the grand scheme of DLBCL landscape?

您認為 CORAL 藥物將在 DLBCL 的宏偉計劃中發揮怎樣的作用？

Yes, that's a big question, but I know we're 20 years into the GLP-1 era and there's one approved oral agent that's a very, very difficult challenge that the industry faces.

是的，這是一個大問題，但我知道我們已經進入 GLP-1 時代 20 年了，並且有一種經批准的口服藥物，這是該行業面臨的一個非常非常困難的挑戰。

So we're working on a program we're excited about, but it's very, very difficult.

所以我們正在開發一個我們很興奮的項目，但這非常非常困難。

I think orals have multiple different commercial positions.

我認為口頭有多種不同的商業地位。

One would be as a lead into a to a subcu therapeutic for someone who doesn't want to maybe start with an injection from a second one would be in the maintenance setting and we think that's a really important setting because if you come off such a large amount of weight loss and you don't want to continue to take the subcu transitioning to an oral would be a potentially really attractive option.

對於不想從第二個注射開始的人來說，一個將是進入 subcu 治療的先導，可能會在維持環境中，我們認為這是一個非常重要的環境，因為如果你離開這樣一個大量減肥並且您不想繼續服用subcu 過渡到口服將是一個潛在的真正有吸引力的選擇。

And in that sense to you maybe wouldn't require the same level of efficacy as a subcu to maintain a certain target body weight we think the other potential opportunity would be in that the temporary use.

從這個意義上說，對您來說，也許不需要與 subcu 相同水平的功效來維持一定的目標體重，我們認為另一個潛在的機會是臨時使用。

Do you have an event coming up in six months or whatever, and you want to lose some weight ahead of that.

您是否有六個月後即將舉行的活動，並且您想在此之前減肥。

And so you wouldn't necessarily need the magnitude of weight loss that could be provided by a subcu dosage form and an oral would be suitable there.

因此，您不一定需要 subcu 劑型所能提供的減肥效果，口服劑型就適合。

So a lot of different opportunities.

所以有很多不同的機會。

We see the subcu as the meat of the market, but we see the the oral opportunity is a really important incremental opportunity.

我們將 subcu 視為市場的核心，但我們認為口頭機會是一個非常重要的增量機會。

Great.

偉大的。

Thank you so much.

太感謝了。

For taking the questions.

為了回答問題。

Thanks, Jay.

謝謝，傑伊。

Next question comes from Lars Robin of Maxim Group.

下一個問題來自 Maxim 集團的 Lars Robin。

Please go ahead.

請繼續。

Hi, everyone, and congrats on the progress.

大家好，祝賀你們的進展。

And just a couple of questions from me.

我只問幾個問題。

So you obviously have a very, very busy first half with the Phase IIb VOYAGE and the venture results on if both studies were to succeed and you see what you want to see on.

因此，您顯然在 IIb 期 VOYAGE 上度過了非常非常忙碌的上半場，並且該專案的結果取決於兩項研究是否成功以及您是否看到了您想要看到的結果。

Could you provide some color context around how much it would cost or what it would take to advance these programs into the next clinical trial?

您能否提供一些關於將這些項目推進到下一個臨床試驗的成本或需要什麼的背景資訊？

Yes, there are obviously very large and expensive studies of more than easily more than EUR100 million per study.

是的，顯然有非常龐大且昂貴的研究，每項研究的花費很容易超過 1 億歐元。

Probably not going to give detailed guidance on the precise expenses of those studies.

可能不會對這些研究的確切費用提供詳細指導。

But the it suffice to say, I think Erez, where these are, these are very expensive Phase three programs.

但只要說，我認為埃雷茲，這些都是非常昂貴的第三階段計畫。

Got you.

明白你了。

And now on your on injectable, could you talk a little bit about the current, I guess, delivery MegaSIM.

現在關於您的注射劑，您可以談談當前的，我猜，交付的 MegaSIM。

Is it just on patients on use of vial and syringe?

是否僅適用於使用小瓶和注射器的病人？

You have like an auto-injector or plans for like an autoinjector device for on your injectable.

您有一個自動注射器或計劃在您的注射劑上安裝一個自動注射器裝置。

Is any of that in the works?

正在開發中嗎？

Yes, it is.

是的。

The Phase two venture study is using a vial and syringe, but we will be using a different device in future studies.

第二階段的風險研究使用小瓶和注射器，但我們將在未來的研究中使用不同的設備。

Is that something we might get an update on Fisher was that we might get an update on more like 25?

我們可能會得到關於費雪的更新，我們可能會得到更多類似 25 的更新嗎？

We'll probably provide an update on that when we start the next study.

當我們開始下一項研究時，我們可能會提供最新情況。

And the timing of that is TBD data.

具體時間待定。

Thank you.

謝謝。

Thanks for taking my questions.

感謝您回答我的問題。

Andy Shay of William Blair.

威廉布萊爾的安迪謝伊。

Please go ahead.

請繼續。

Great.

偉大的。

Thanks for taking the question and congratulations on all the progress in 2023 and look forward to a very productive 2024.

感謝您提出問題，祝賀 2023 年的所有進展，並期待 2024 年取得豐碩成果。

I've a question about the oral administration.

我有一個關於口服給藥的問題。

If you look at the results is label, there's some restrictions about timing of the two volumes of water.

如果您查看標籤上的結果，您會發現兩份水的時間有一些限制。

I'm just curious about the the gastric absorption technology baked into the oral formulation?

我只是好奇口服製劑中加入了胃吸收技術？

And do you think that there's a potential that you can engineer away these restrictions?

您認為您有可能消除這些限制嗎？

Yes.

是的。

Thanks.

謝謝。

We haven't disclosed, you know that the technology or anything regarding patient behavior, you know, in their subject favor in this in this study.

我們還沒有透露，技術或任何有關患者行為的信息，在這項研究中對他們的受試者有利。

We will discuss that when we when we disclose the data from.

當我們披露數據時，我們將討論這一點。

But I have to say now per per many Phase one trials.

但我現在必須根據許多第一階段試驗說。

These people are fasted as they when they take their doses in the morning.

這些人與早上服藥時一樣禁食。

But we haven't disclosed any additional requirements or suggestions.

但我們還沒有透露任何額外的要求或建議。

Got it.

知道了。

Okay.

好的。

And then staying in the same OBC field, obviously, there's an increase in interest and perhaps evaluation of clinical assets that could boost lean body mass and looking at the or signed a deal recently.

然後，顯然，留在同一個 OBC 領域，人們對可以增加瘦體重的臨床資產的興趣和評估可能有所增加，並且最近正在考慮或簽署一項協議。

So in your pipeline 50 to 11, obviously that has demonstrated potential for that.

因此，在您的管道 50 到 11 中，顯然這已經證明了這方面的潛力。

So I'm curious about potentially any change in prioritization or perhaps increased external inbound on that and that you can share with us?

因此，我很好奇優先順序可能會發生任何變化，或者可能會增加外部入站，您可以與我們分享嗎？

Yes.

是的。

Thanks, Andy.

謝謝，安迪。

It's a it's an interesting question.

這是一個有趣的問題。

And you're right, the VK. 5 to one one of the most potent oral agents, I believe that we've ever seen and certainly to our knowledge, there's nothing more potent on the oral side in hip fracture study, we saw very significant increases in lean body mass and at all doses and a beautiful dose response.

你是對的，VK。 5 是最有效的口服藥物之一，我相信我們見過，當然據我們所知，在髖部骨折研究中，沒有什麼比口服藥物更有效的了，我們看到瘦體重有非常顯著的增加劑量和美麗的劑量反應。

So we report those data in 2017 and 18.

所以我們報告了 2017 年和 18 年的數據。

And to the extent a loss of muscle from these agents is clinically relevant and then maybe adding muscle building agents could be a reasonable approach.

在某種程度上，這些藥物造成的肌肉流失與臨床相關，那麼添加肌肉增強劑可能是合理的方法。

It's not clear that it is clinically relevant.

目前尚不清楚它是否具有臨床相關性。

The change in lean body mass.

去脂體重的變化。

I know, it sounds great.

我知道，聽起來很棒。

And it's an easy clean story to tell.

這是一個簡單乾淨的故事。

But we do have some experience in muscle drugs.

但我們在肌肉藥物方面確實有一些經驗。

And we I've experience with what the FDA considers important and it's not just increase in muscle mass.

我對 FDA 認為重要的事情有經驗，這不僅僅是增加肌肉質量。

So it is an interesting area.

所以這是一個有趣的領域。

We have got a very potent compound, but the the medical necessity is a little bit murky to us that's fair.

我們已經找到了一種非常有效的化合物，但其醫療必要性對我們來說有點模糊，這是公平的。

Thank you very much.

非常感謝。

And maybe last quick one in terms of R&D, a little uptick this quarter, just thinking about how do you foresee that trend going forward?

也許最後一個快速的研發方面，本季略有上升，只是想一下您如何預見未來的趨勢？

Thank you and Andy, I think our yields will go up a bit this year versus last year or not radically, but it will be up a bit focused on advancing all of our programs and assuming success.

謝謝你們和安迪，我認為今年我們的產量將比去年有所上升，或者不會大幅上升，但會有所上升，重點是推進我們所有的項目並取得成功。

So yes, I think you could think about it increasing a bit, but not not way way up for sure.

所以是的，我認為你可以考慮增加一點，但肯定不會大幅增加。

Great.

偉大的。

Appreciate it.

欣賞它。

Thanks, Andy.

謝謝，安迪。

Yes, next question comes from Thomas Smith of Leerink Partners.

是的，下一個問題來自 Leerink Partners 的托馬斯史密斯。

Please go ahead.

請繼續。

Hey, guys, good afternoon and thanks for taking the questions.

嘿，夥計們，下午好，感謝您提出問題。

Maybe one, just the picture.

也許有一個，只是一張照片。

We've seen a young, obviously very active environment and seems like there's a lot of strategic interest in the obesity space.

我們看到了一個年輕、看起來非常活躍的環境，似乎對肥胖的領域有許多策略的興趣。

Can you just some comment on what you're seeing on the business development front in terms of partnership interest on your programs, both obesity and NASH, and just remind us how you're thinking about next steps of development across both programs.

您能否就您在肥胖和非酒精性脂肪性肝炎（NASH）計畫的合作夥伴興趣方面所看到的業務發展方面發表一些評論，並提醒我們您如何考慮這兩個項目的下一步發展。

Thanks, Tom.

謝謝，湯姆。

We can't comment too much on that I would just say you're correct in saying that it's an active area and an area of high awareness.

我們不能對此發表太多評論，我只想說你說這是一個活躍的領域和一個高度認知的領域是正確的。

So I'd say across the industry based on the and the magnitude of success that we're seeing and the clinical benefit that these therapies provide.

因此，我想說的是，基於我們所看到的成功程度和這些療法提供的臨床益處，整個行業都是如此。

So makes sense that there would be interest from potential partners, and I would be happy to have engage in those discussions.

因此，潛在合作夥伴對此感興趣是有道理的，我很樂意參與這些討論。

Got it.

知道了。

That's helpful.

這很有幫助。

Thanks.

謝謝。

And then maybe just one on VOYAGE.

然後也許只有 VOYAGE 上的一個。

You mentioned having just completed the last patient biopsies recently.

您提到最近剛完成最後一次患者切片檢查。

Maybe you could just remind us on how you're thinking about evaluating those biopsies in VOYAGE, whether using single pathologist or multi path review.

也許您可以提醒我們您如何考慮在 VOYAGE 中評估這些活檢，無論是使用單一病理學家還是多路徑審查。

And I'm just kind of walk us through the gating factors there to reporting the top line dataset?

我只是引導我們了解報告頂線資料集的門控因素？

Yes, I think so.

是的，我想是這樣。

The biopsies are the slower element there, um, it is a single reader that we're using and the single reader goes to a second reader when there's a patient whose biopsy is right on the cusp of something like F2, F3 fibrosis or and Apple's activity score for things like that, go to a second reader and then the first and second reader must reach a consensus before the final assessment of the slide is made.

活檢是那裡較慢的元素，嗯，我們使用的是單一讀取器，當患者的活檢正好處於F2、F3 纖維化或Apple 的疾病的尖端時，單個讀取器會轉到第二個讀取器對於此類事情的活動分數，請交給第二位讀者，然後第一位和第二位讀者必須在對幻燈片進行最終評估之前達成共識。

So I think we started the study really before the three rater approach had become more widely used.

所以我認為我們在三評估者方法得到更廣泛使用之前就開始了這項研究。

And so that's why we have the single reader.

這就是我們擁有單一讀者的原因。

Yes.

是的。

Got it.

知道了。

That's helpful.

這很有幫助。

Thanks for taking the questions.

感謝您提出問題。

Thanks, Tom.

謝謝，湯姆。

Next question comes from Yale Jen of Laidlaw & Company.

下一個問題來自 Laidlaw & Company 的 Yale Jen。

Please go ahead.

請繼續。

Good afternoon and thanks for taking the questions.

下午好，感謝您提出問題。

Just two quick ones here.

這裡只有兩個快速的。

The first is that the giving the reason Lilly reporting about the synergy match beta.

首先是禮來公司報告協同配對測試版的原因。

And you guys actually mentioned earlier that the in terms of 2735 have impact on the liver.

你們實際上之前提到2735對肝臟有影響。

I wonder whether there's additional thought or any other thing you guys were thinking of in your overall strategic are planning or thinking?

我想知道你們在整體策略規劃或思考中是否有額外的想法或任何其他想法？

Yes, things are not really.

是的，事情並非如此。

We have a NASH program already and not interested at this point.

我們已經有一個 NASH 計劃，但目前不感興趣。

And really pursuing NASH with the the K. two seven three five program.

並透過 K.二七三五計劃真正追求 NASH。

I do think it's encouraging to see that the dual agonist mechanism appears to be effective at NASH resolution.

我確實認為雙激動劑機制在 NASH 解決方面似乎有效是令人鼓舞的。

I think that's exciting, but we're going to stick with obesity for the time being with that program.

我認為這很令人興奮，但我們將暫時透過該計劃來解決肥胖問題。

Okay.

好的。

Maybe one more a follow-up here, which is that and Jin recently published their RMG. was 33 Phase one data.

也許還有一個後續，那就是 Jin 最近發布了他們的 RMG。為 33 第一階段數據。

Was there any is there any comment and thought that that will go forward for the your programs as well?

有沒有任何意見並認為這也將適用於您的計劃？

Yes, that's a good question.

是的，這是一個好問題。

We haven't had a chance to really get into the evaluation of those data is pretty fresh, um, but yes, I guess we'll evaluate those data moving forward, but good question for Amgen.

我們還沒有機會真正評估這些數據，嗯，但是，是的，我想我們會繼續評估這些數據，但這對安進來說是個好問題。

Well, thanks a lot and congrats on the progress and look for all the data in this half of the year.

嗯，非常感謝，恭喜你取得了進展，尋找這半年的所有數據。

Thanks a lot.

多謝。

Yes.

是的。

Next question comes from Joe Pantginis of H.C. Wainwright.

下一個問題來自 H.C. 的 Joe Pantginis。溫賴特。

Please go ahead.

請繼續。

Hey, guys, good afternoon.

嘿，夥計們，下午好。

Thanks taking the question on.

感謝您提出問題。

So Brian, first, I just wanted to start at the back end of your question and answer commentary, maybe push the envelope a little bit on business development.

所以布萊恩，首先，我只想從你的問答評論的後端開始，也許在業務發展方面稍微挑戰一下極限。

You said you'd be happy to engage in discussions.

您說過您很樂意參與討論。

And I was just curious if I may, are you able to discuss the levels of maturities of any potential discussions that may be ongoing?

我只是好奇，如果可以的話，您是否能夠討論任何可能正在進行的潛在討論的成熟度？

Yes, John, I wouldn't want to mischaracterize that statement or mislead or I think we've always been open to partnering discussions since since day one.

是的，約翰，我不想曲解該聲明或誤導，或者我認為從第一天起我們就一直對合作討論持開放態度。

So we're always opportunistically evaluating opportunities whatever is presented to us.

因此，無論出現什麼機會，我們總是會機會主義地評估。

So I can't really characterize to any discussions.

所以我無法真正描述任何討論的特徵。

Got it.

知道了。

Got it.

知道了。

And then up to the earlier question, a very earlier question was asked about venture.

然後到前面的問題，一個很早的問題被問到關於創投。

I'll ask the same regarding the oral study, and that is what do you consider the benchmark to success for the oral study?

關於口語學習，我也會問同樣的問題，這就是您認為口語學習成功的基準是什麼？

Yes, we've always considered some of it could look on well.

是的，我們一直認為其中一些看起來不錯。

So obviously, it's a safety and PK and tolerability study.

顯然，這是一項安全性、PK 和耐受性研究。

So we look for safety, tolerability and a clean, predictable PK profile on body weight.

因此，我們尋求安全性、耐受性和明確的、可預測的體重 PK 曲線。

If we could look like a an injectable GLP-1 after a month, that would be, I think, encouraging.

如果我們能在一個月後看起來像是可注射的 GLP-1，我認為那將是令人鼓舞的。

And so what's the magnitude there.

那麼那裡的規模有多大呢？

It's a little bit variable, but we look at 1% to 2% as being a something that would probably warrant the further development.

雖然有一點變化，但我們認為 1% 到 2% 可能值得進一步開發。

Okay.

好的。

Very fair.

很公平。

And then my last question.

然後是我的最後一個問題。

Obviously, this goes into a later 2024 and beyond.

顯然，這將持續到 2024 年晚些時候及以後。

Are you willing to take any first passes now with regard to a pivotal study plans or even designs, four for obesity for obesity for NASH in general?

您現在是否願意就一項關鍵的研究計劃甚至設計（四個針對肥胖和 NASH 的肥胖問題）進行初步設計？

For the Company?

為了公司？

Yes.

是的。

With both of these programs, we plan to speak with the FDA following the data analysis.

對於這兩個項目，我們計劃在數據分析後與 FDA 進行交談。

So we'd like to have a Type C meeting with the FDA on the IBK. two seven three five program and outline potential next steps there.

因此，我們希望與 FDA 就 IBK 舉行 C 類會議。二七三五計劃並概述了下一步可能採取的步驟。

And then with the the NASH program have an end of Phase two meeting, and I wish we knew we know what the guidance is for both indications, but it would be nice to talk with the FDA to learn any any recommendations or new comments that they have regarding trial design.

然後，NASH 計劃第二階段會議結束，我希望我們知道這兩種適應症的指南是什麼，但如果能與 FDA 交談以了解他們提出的任何建議或新評論，那就太好了有關於試驗設計。

But we do have a pretty good idea on what those trials will look like.

但我們確實對這些試驗的情況有一個很好的了解。

Thanks for the color, Brian.

謝謝你的顏色，布萊恩。

Next question comes from Jack part of Anno of Stifel.

下一個問題來自 Stifel 的 Anno 的 Jack。

Please go ahead.

請繼續。

Jack Padawano calling in for Annabel Samimy.

傑克·帕達瓦諾打電話給安娜貝爾·薩米米。

Thanks for taking the question.

感謝您提出問題。

And so again, just wanted to touch briefly on the NASH resolution data from tirzepatide SYNERGY NASH trial.

再次強調，我只是想簡單介紹一下 tirzepatide SYNERGY NASH 試驗的 NASH 解決數據。

Just curious if those results change on where you view THR beta receptor agonist kind of fitting into the treatment paradigm given the more on similar upstream liver fat intact and both mechanisms have?

只是好奇這些結果是否會改變您認為 THR β 受體激動劑是否適合治療範式，因為更多類似的上游肝臟脂肪完整且兩種機制都有？

Yes.

是的。

Thanks, Jack.

謝謝，傑克。

It doesn't really change our view of the role of a targeted agent.

它並沒有真正改變我們對目標代理角色的看法。

We do think there's going to be a lot of different therapies used in this population.

我們確實認為這個人群將會使用許多不同的療法。

The population is very heterogeneous and to begin with and different patients will be better suited for different therapies.

人群非常異質，首先，不同的患者將更適合不同的治療。

So we do see the targeted agents is remaining relevant for sure.

因此，我們確實看到目標代理仍然具有相關性。

That said, I think it would be naive to think that GLP-1 type therapeutics won't be important in the treatment paradigm potentially as a sort of a backbone in the in the overweight or the diabetic patient, Tom, but we still see theirs up.

也就是說，我認為認為 GLP-1 型療法在治療範式中不重要，可能作為超重或糖尿病患者的支柱，這種想法是天真的，但我們仍然看到他們的向上。

It's a nice opportunity for targeted agents.

對於目標代理商來說，這是一個很好的機會。

Great.

偉大的。

Thanks for the color.

謝謝你的顏色。

Thanks, Jeff.

謝謝，傑夫。

Next question comes from Justin Zimmerman of BTIG.

下一個問題來自 BTIG 的 Justin Zimmerman。

Please go ahead.

請繼續。

Thanks for taking the question and congrats on the progress of Brian, but wanted to ask then to the earlier guidance for Q. formulation of two seven three five here being released.

感謝您提出問題並祝賀 Brian 的進步，但想詢問此處發布的早期關於 Q. 公式的指導。二七三五。

I had a guidance into a level of interest or demand on behalf of patients for a subcu rather than oral?

我代表患者對 subcu 而不是口服的興趣或需求程度進行了指導？

Or just how should we should be thinking about that?

或者我們應該如何思考這個問題？

No, it's just I think just and it was just that the trial was enrolled more quickly than expected.

不，這只是我認為只是試驗的註冊速度比預期的要快。

And and there were no hiccups during the course of the study.

而且在研究過程中沒有出現任何問題。

And so we think we should have the data this quarter going to the demand.

因此，我們認為本季的數據應該符合需求。

I mean, it just it was just the demand is reflected in the speed and size of the trial.

我的意思是，這只是需求反映在試驗的速度和規模。

It was set.

就這樣定下來了。

It's really pretty pretty easy to enroll that makes sense to me.

註冊真的非常容易，這對我來說很有意義。

And is it possible we could get the the oral and the subcu data at the same time, understand it?

我們是否可以同時取得口語和 subcu 數據，懂嗎？

No, probably not.

不，可能不會。

And we haven't disclosed the sequence just other than to say both both will be this quarter.

我們還沒有透露具體的順序，只是說兩者都將在本季進行。

Great.

偉大的。

Thanks for taking my questions.

感謝您回答我的問題。

Thanks, Justin.

謝謝，賈斯汀。

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 again for your participation and continued support of Viking Therapeutics.

再次感謝您對 Viking Therapeutics 的參與和持續支持。

We look forward to updating you again in the coming months.

我們期待在未來幾個月內再次為您提供最新消息。

Have a great afternoon.

祝你有個愉快的下午。

The conference has now concluded.

會議現已結束。

Thank you for attending today's presentation, and you may now.

感謝您參加今天的演示，現在就可以參加。