Viking Therapeutics Inc (VKTX) 2024 Q1 法說會逐字稿

Welcome to the Viking Therapeutics First Quarter 2024 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, April 24, 2024.

歡迎參加 Viking Therapeutics 2024 年第一季財務業績電話會議。 （操作員說明）謹此提醒，本次電話會議於今天（2024 年 4 月 24 日）錄製。

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

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

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

大家好，感謝大家參加今天的電話會議。今天加入我的是 Viking 總裁兼執行長 Brian Lian 和 Viking 財務長 Greg Zante。

Before we begin, I'd like to caution that comments made during this conference call today, April 24th, 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. 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. And I'll now turn the call over to Brian Lian for his initial comments.

在我們開始之前，我想提醒大家，在今天（2024 年4 月24 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。前瞻性陳述存在風險和不確定性，可能導致實際結果出現重大不利差異，且報告的結果不應被視為未來績效的指標。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。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。現在我將把電話轉給 Brian Lian，徵求他的初步意見。

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast today will review our financial results for the first quarter ended March 31st, 2024, and provide an update on recent progress with our clinical programs and operations during the first quarter Viking announced positive results from two of the company's key pipeline programs. First, our Phase two venture study evaluating our dual GLP-1 and GIP. receptor agonist VK. two seven three five in patients with obesity successfully achieved its primary endpoint and all secondary endpoints demonstrating statistically significant reductions in body weight at all doses as compared to placebo. Also during the quarter, the company announced results from a Phase one clinical trial evaluating an oral tablet formulation of VK. two seven three five. This study demonstrated encouraging safety and tolerability as well as promising weight loss following 28 days of once daily dosing. The Company plans to advance both of both of these programs into further development later this year.

謝謝斯蒂芬妮，今天透過電話或網路廣播收聽的大家下午好，我們將回顧我們截至 2024 年 3 月 31 日的第一季度的財務業績，並提供第一季度臨床項目和運營的最新進展維京公司宣布了公司兩項關鍵管道項目的積極成果。首先，我們的第二階段風險研究評估了我們的雙重 GLP-1 和 GIP。受體激動劑VK。肥胖患者的二七三五成功地達到了其主要終點，所有次要終點均顯示與安慰劑相比，所有劑量下的體重均出現統計上顯著的減輕。同樣在本季度，該公司公佈了評估 VK 口服藥錠配方的一期臨床試驗結果。二七三五。這項研究證明了令人鼓舞的安全性和耐受性，以及在每日一次給藥 28 天後有望減輕體重。該公司計劃在今年稍後將這兩個項目推向進一步開發。

In addition, during the first quarter, the Company completed the final biopsies in the Phase IIb VOYAGE study evaluating the novel thyroid hormone receptor beta agonist VK. two eight oh nine in patients with NASH and fibrosis. We expect to report the biopsy results from this study later this quarter.

此外，在第一季度，該公司完成了評估新型甲狀腺激素受體β激動劑VK的IIb期VOYAGE研究的最終活檢。 NASH 和纖維化患者的二八零九。我們預計將在本季稍後報告這項研究的活檢結果。

Finally, during the quarter, Viking completed a public offering of common stock raising gross proceeds of approximately $630 million. These funds substantially strengthen the Company's balance sheet and will support our plans to aggressively develop our pipeline. I'll provide further details on our operations and development activities after we review our financial results for the first quarter of 2024.

最後，Viking 在本季完成了普通股公開發行，籌集了約 6.3 億美元的總收益。這些資金大大增強了公司的資產負債表，並將支持我們積極開發管道的計劃。在我們審查 2024 年第一季的財務業績後，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 Zante, Viking's Chief Financial Officer.

為此，我將把電話轉給 Viking 財務長 Greg Zante。

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 Q filing with the Securities and Exchange Commission, which we expect to file later 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，我們預計將在今天晚些時候提交該文件。

I'll now go over our results for the first quarter ended March 31st, 2024. Research and development expenses were $24.1 million for the three months ended March 31st, 2024, compared to $11 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, preclinical studies, clinical studies, stock-based compensation, salaries and benefits and services provided by third-party consultants.

現在，我將回顧截至2024 年3 月31 日的第一季的業績。主要原因是由於與我們的候選藥物製造、臨床前研究、臨床研究、股票補償、工資和福利以及第三方顧問提供的服務相關的費用增加。

General and administrative expenses were $10 million for the three months ended March 31st, 2024, compared to $9.5 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services.

截至2024 年3 月31 日的三個月，一般及行政費用為1,000 萬美元，而2023 年同期為950 萬美元。增加。

For the three months ended March 31st, 2024 Viking reported a net loss of $27.4 million or $0.26 per share compared to a net loss of $19.5 million or $0.25 per share in the corresponding period in 2023. The increase in net loss for the three months ended March 31st, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023.

截至2024 年3 月31 日的三個月，Viking 報告淨虧損2,740 萬美元，即每股0.26 美元，而2023 年同期淨虧損為1,950 萬美元，即每股0.25 美元。增加2024年3月31日，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，部分被利息收入較2023年同期增加所抵銷。

Turning to the balance sheet. At March 31st, 2024, Viking held cash, cash equivalents and short-term investments of $963 million compared to $362 million as of December 31st, 2023, first quarter balance reflects receipt of gross proceeds of $630 million from the company's public offering, which closed on March fourth, 2024.

轉向資產負債表。截至2024 年3 月31 日，Viking 持有現金、現金等價物和短期投資為9.63 億美元，而截至2023 年12 月31 日為3.62 億美元，第一季餘額反映從公司公開發行中收到的總收益為6.3 億美元，該公開發行已結束2024 年 3 月 4 日。

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. The first quarter of 2024 was an eventful quarter as we received and reported the results from two cleat key clinical trials, our Phase two venture trial evaluating subcutaneous VK. two seven three five in patients with obesity and our Phase one clinical trial evaluating an oral tablet formulation of DK. two seven three five in healthy volunteers. Both studies were successful, demonstrating promising weight loss and favorable safety and tolerability and we look forward to advancing both of these programs into further development later this year as we have recently reviewed the results from each of these studies on separate conference calls, I'll briefly review key takeaways in my prepared comments and refer you to our February 27th and March 26th press releases for more details. In addition, I'm happy to provide further detail in the Q&A portion of the call.

謝謝，格雷格。 2024 年第一季是一個多事的季度，我們收到並報告了兩項關鍵臨床試驗的結果，即評估皮下 VK 的第二期風險試驗。二七三五在肥胖患者中進行，我們的一期臨床試驗評估了 DK 口服片劑配方。二七三五為健康志工。這兩項研究都取得了成功，證明了有希望的減肥效果以及良好的安全性和耐受性，我們期待在今年晚些時候將這兩個項目推進到進一步開發，因為我們最近在單獨的電話會議上審查了每項研究的結果，我將請簡要回顧一下我準備好的評論中的要點，並請您參閱我們 2 月 27 日和 3 月 26 日的新聞稿以了解更多詳細資訊。此外，我很高興在電話問答部分提供更多詳細資訊。

I will first provide an update on our subcutaneous formulation of VK. two seven three five for obesity VK. two seven three five is a dual agonist of the glucagon-like peptide one or GLP-1 receptor and the glucose dependent insulin Tropic polypeptide or GIP. receptor in the first quarter of 2023, we announced positive results from a Phase one single ascending dose and multiple ascending dose study of VK. to 75. This study demonstrated the promising safety, tolerability and pharmacokinetics of VK. two seven three five when administered as a weekly subcutaneous injection for four weeks. In addition, subjects in the study demonstrated up to 7.8% weight weight loss from baseline after 28 days with no signs of plateau. Based on these positive results, Viking initiated a Phase two trial called the venture trial to evaluate DK. two seven three five in patients with obesity. The venture trial was a randomized double blind placebo controlled multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of DK. two seven three five administered subcutaneously once weekly for 13 weeks. In the first quarter, Viking announced positive top line results from the venture study. This trial successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK. two seven three five, demonstrating reductions in body weight at all doses compared with placebo for the primary endpoint patients receiving VK. two seven three five demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% as well as statistically significant reductions in mean body weight relative to placebo ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all VK. two seven three five doses starting at week one and were maintained throughout the course of the study. Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing. We believe this suggests that further weight loss could be achieved through extended dosing beyond the 13 week treatment period of this study. Additionally, the venture study showed VK. to 75 treatment to be safe and well-tolerated over a 13-week trial with the majority of treatment emergent adverse events being characterized as mild or moderate based on the Phase two venture results as well as prior Phase one results, making plans to meet with the FDA later this quarter to discuss next steps in the development of VK. two seven three five. In addition to the subcutaneous formulation, the company is also developing a novel oral tablet formulation of VK. two 75. We believe a tablet formulation could represent an attractive treatment option for patients with obesity, and we see this as an important potential expansion of the overall opportunity for the program.

我將首先介紹我們的 VK 皮下注射配方的最新情況。二七三五為肥胖VK。二七三五是胰高血糖素樣勝肽一或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。 2023 年第一季度，我們宣布了 VK 的一期單次劑量遞增和多次劑量遞增研究的積極結果。至 75。每週皮下注射一次，持續四週，二七三五。此外，研究中的受試者在 28 天後體重較基線減輕了 7.8%，且沒有出現平台期跡象。基於這些積極的結果，Viking 啟動了一項名為風險試驗的第二階段試驗來評估 DK。二七三五肥胖患者。這項風險試驗是一項隨機雙盲安慰劑對照多中心研究，評估了 DK 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。第一季度，維京宣布了風險研究的積極頂線結果。該試驗成功實現了接受 VK 治療的患者的主要終點和所有次要終點。二七三五，顯示接受 VK 的主要終點患者與安慰劑相比，所有劑量的體重均減輕。二七三五的平均體重較基線顯著降低了 14.7%，相對於安慰劑，平均體重降低了 13.1%。與安慰劑相比，所有 VK 均觀察到統計學上的顯著差異。從第一週開始服用二七三五劑，並在整個研究過程中維持。所有治療組的體重減輕在 13 週內都在進展，並且沒有表現出穩定的跡象。我們相信這表明在本研究的 13 週治療期之後延長給藥可以實現進一步的體重減輕。此外，風險研究顯示 VK。在為期13 週的試驗中，75 種治療方法被認為是安全且耐受性良好的，根據第二階段風險結果以及先前的第一階段結果，大多數治療中出現的不良事件被定性為輕度或中度，並制定計劃以滿足FDA 將在本季稍後討論 VK 開發的後續步驟。二七三五。除了皮下製劑外，該公司也正在開發VK的新型口服錠劑製劑。 2 75. 我們相信，片劑配方對於肥胖患者來說可能是一種有吸引力的治療選擇，我們認為這是該計劃總體機會的重要潛在擴展。

Last year, we initiated an extension of the previously reported subcutaneous Phase one study to incorporate an evaluation of our tablet formulation. The oral portion of this study is a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. Primary objective is to evaluate the safety and tolerability of VK. two seven three five administered as a tablet once daily for 28 days. Secondary and exploratory objectives include an evaluation of the pharmacokinetics of orally administered VK. two seven three five, as well as various pharmacodynamic measures, including changes in body weight and other metrics.

去年，我們啟動了先前報導的皮下一期研究的擴展，以納入對我們的片劑配方的評估。本研究的口服部分是一項隨機、雙盲、安慰劑對照研究，對象為體重指數最低為每平方公尺 30 公斤的健康成年人。主要目的是評估 VK 的安全性和耐受性。二七三五以片劑形式每天服用一次，持續 28 天。次要和探索性目標包括評估口服 VK 的藥物動力學。二七三五，以及各種藥效學測量，包括體重和其他指標的變化。

During the first quarter, we reported the initial data from this study with respect to safety and tolerability, oral DK. two seven three five was shown to be safe and well-tolerated following once-daily dosing for up to 28 days at doses that were titrated up to 40 milligrams among subjects receiving the say two seven, three five. All treatment-emergent adverse events were reported as mild or moderate in severity with the majority 76% reported as mild overall, no clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with DK. two seven three five compared with placebo. And importantly, to date, no serious adverse events have been reported in this study.

在第一季度，我們報告了本研究有關口服 DK 安全性和耐受性的初步數據。在接受「二七三五」治療的受試者中，每日一次給藥長達 28 天，劑量逐漸增加至 40 毫克，二七三五被證明是安全且耐受性良好的。所有治療中出現的不良事件的嚴重程度均報告為輕度或中度，其中大多數（76%）總體報告為輕度，在接受DK 治療的受試者中，胃腸道不良事件沒有報告有臨床意義的差異。與安慰劑相比，二七三五。重要的是，迄今為止，這項研究中尚未報告嚴重不良事件。

In addition to safety and tolerability and exploratory assessment of change in body weight was conducted subjects receiving oral DK. two seven three five demonstrated dose-dependent reductions in body weight ranging up to 5.3% from baseline. Placebo-adjusted reductions in bodyweight reached up to 3.3% from baseline body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated. In addition, weight loss during the 28 day window of this study was progressive at the 20 milligram and 40 milligram dose levels with no plateau observed, given the promising weight loss signal observed in this study, along with the excellent tolerability profile thus far, Viking is pursuing further dose escalation. In addition, based on the encouraging trajectory of weight loss and the lack of a plateau at 28 days for the higher dose cohorts. We believe that further benefits might be anticipated from longer dosing periods. To this end, we are proceeding with plans for a Phase two trial in patients with obesity and we expect to initiate this study later this year. Details on study design will be provided as we get closer to study initiation.

除了安全性和耐受性以及體重變化的探索性評估之外，還對接受口服 DK 的受試者進行了評估。二七三五表現出劑量依賴性的體重減輕，較基線高達 5.3%。與基線相比，安慰劑調整後的體重下降幅度高達 3.3%，且安慰劑在評估的最高劑量下具有統計學顯著性。此外，考慮到本研究中觀察到的有希望的減肥訊號以及迄今為止出色的耐受性，在本研究的28 天窗口期間，體重減輕在20 毫克和40 毫克劑量水平下呈漸進式，沒有觀察到平台期。此外，基於令人鼓舞的體重減輕軌跡以及高劑量組在 28 天時沒有達到平台期。我們相信更長的給藥時間可能會帶來更多的好處。為此，我們正在計劃對肥胖患者進行第二階段試驗，並預計在今年稍後啟動這項研究。當我們接近研究啟動時，將提供有關研究設計的詳細資訊。

I will now turn to our most advanced clinical program VK. two eight or nine for the treatment of NASH and fibrosis. 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.

我現在將談談我們最先進的臨床項目 VK。二八九用於治療NASH和纖維化。 DK。 29 是一種口服的甲狀腺激素受體小分子激動劑。它對肝組織以及受體的β亞型具有選擇性。

Last May, we announced positive top line results from the Phase IIb VOYAGE study of DK. two eight oh nine. The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter international trial designed to assess the efficacy, safety and tolerability of VK. to eight or nine in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat as measured by magnetic resonance imaging, proton density, fat fraction as well as F2 and F3 fibrosis.

去年 5 月，我們宣布了 DK IIb 期 VOYAGE 研究的正面頂線結果。兩點八點九點。 VOYAGE 研究是一項隨機、雙盲、安慰劑對照、多中心國際試驗，旨在評估 VK 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。透過磁振造影、質子密度、脂肪分數以及 F2 和 F3 纖維化測量，納入的患者肝臟脂肪含量至少為 8%。

Last May we reported that this study had 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 with placebo. The median relative change from baseline in liver fat among patients treated with BK. 2.9 ranged from 38% to 55% after 12 weeks. In addition, up to 85% of patients receiving VK. 2.9 experienced at least a 30% reduction in liver fat. This level of efficacy is associated with a greater likelihood of histologic benefit in NASH. As in prior studies, VK. to eight or nine treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic lipoproteins. We believe these results indicate that VK. to eight or nine has the potential to provide longer-term cardioprotective benefits. The initial voyage data also served to further establish the K. two L. nine's promising safety and tolerability profile. 94% of treatment related adverse events among patients receiving DK. to eight or nine were reported as mild or moderate discontinuations due to adverse events were low and balanced among placebo and treatment arms. In particular, VK. 2.9 demonstrated at excellent gastrointestinal tolerability with similar rates of nausea, diarrhea stool frequency and vomiting observed among DK. 29 treated patients compared to placebo last November. Viking presented additional data from this study at the annual meeting of the American Association for the Study of Liver Diseases. These new data demonstrated robust liver fat reductions among patients with or without type two diabetes as well as those having either F2 or F3 fibrosis among patients with type two diabetes. At week 12, reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions observed among patients without type-2 diabetes treatment with BK. 2.9 also demonstrated potent reductions in liver fat among patients with either F2 or F3 fibrosis with liver fat reductions ranging up to approximately 58% from baseline. Thus, these results indicate that neither the presence of type two diabetes nor the presence of F2 or F3 fibrosis, meaningfully impact VK. 2.9 to efficacy in reducing liver fat. During the first quarter, we completed the final biopsies in the VOYAGE study and remain on track to report the histology data from this study later this quarter.

去年 5 月，我們報告說，這項研究已成功實現了接受 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。使用 BK 治療的患者肝臟脂肪相對於基線的中位數相對變化。 12 週後，2.9 的範圍從 38% 到 55%。此外，高達85%的患者接受VK治療。 2.9 的肝臟脂肪減少了至少 30%。這種療效水準與 NASH 的組織學獲益的可能性更大相關。如同先前的研究一樣，VK.八到九名接受治療的患者的低密度脂蛋白膽固醇、三酸甘油酯和致動脈粥樣硬化脂蛋白也實現了統計學上的顯著降低。我們相信這些結果顯示 VK.八到九歲有可能提供長期的心臟保護作用。最初的航行數據也進一步確定了 K.2 L.9 的安全性和耐受性。接受 DK 治療的患者中 94% 的不良事件與治療相關。據報道，有八到九個因不良事件而輕度或中度停藥的患者比例較低，並且在安慰劑組和治療組之間保持平衡。特別是，VK. 2.9 表現出良好的胃腸道耐受性，在 DK 中觀察到噁心、腹瀉、大便頻率和嘔吐的發生率相似。去年 11 月，29 名接受治療的患者與安慰劑進行了比較。維京公司在美國肝病研究協會年會上展示了這項研究的更多數據。這些新數據表明，患有或不患有二型糖尿病的患者以及患有 F2 或 F3 纖維化的二型糖尿病患者的肝臟脂肪顯著減少。在第 12 週時，肝臟脂肪較基線減少了 36% 至 54%，與未接受 BK 治療的 2 型糖尿病患者中觀察到的減少程度相當。 2.9 也證明了 F2 或 F3 纖維化患者的肝臟脂肪有效減少，肝臟脂肪較基線減少高達約 58%。因此，這些結果表明，二型糖尿病的存在和 F2 或 F3 纖維化的存在都不會顯著影響 VK。 2.9 降低肝臟脂肪的功效。在第一季度，我們完成了 VOYAGE 研究的最終活檢，並繼續在本季度稍後報告研究的組織學數據。

I'll now provide a brief update on our second thyroid hormone receptor beta agonist PKO. two one four, which is currently being evaluated in a Phase Ib trial in patients with X-linked adrenoleukodystrophy or X-ALD like VK. two L. nine VKO. two one four is also an orally available, small molecule that is selective for the beta isoform of the thyroid hormone receptor X-ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of the proximal transporter of very long-chain fatty acids. 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 in healthy volunteers, VKO. two one four demonstrated dose-dependent exposures, no evidence of accumulation and a half-life consistent with anticipated once daily dosing subjects who received VKO. two one for experienced reductions in LDL cholesterol, triglycerides, April, April, protein B and lipoprotein A. DKr two and 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 detailed two one four is being conducted in patients with the adrenal myelin neuropathy or AMN. form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multicenter study in adult male patients with AMM. 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. The study also includes an exploratory assessment of changes in plasma levels of very long-chain fatty acids. The Company expects to report the top-line results from this trial in mid 2024.

現在我將簡要介紹我們的第二種甲狀腺激素受體 β 激動劑 PKO。 2 1 4，目前正在 Ib 期試驗中對 X 連鎖腎上腺腦白質營養不良或 VK 等 X-ALD 患者進行評估。二L.九VKO。二一四也是一種口服小分子，對甲狀腺激素受體的β亞型有選擇性X-ALD 是一種罕見且使人衰弱的代謝性疾病，由基因突變引起，該突變使極長的近端轉運蛋白功能喪失β-鏈脂肪酸。因此，患者無法有效地代謝極長鏈脂肪酸，並且在先前針對健康志願者的一期研究 VKO 中，這些化合物的累積被認為有助於 X-ALD 的發生和進展。二一四表現出劑量依賴性暴露，沒有累積的證據，半衰期與接受 VKO 的預期每日一次給藥受試者一致。兩個一的LDL 膽固醇、三酸甘油酯、April、April、B 蛋白和脂蛋白A 的降低。觀察到GI 的治療或劑量相關訊號副作用、生命徵像或心血管措施。正在進行的詳細二一四 Ib 期研究正在腎上腺髓鞘神經病變 (AMN) 患者中進行。 X-ALD 的一種形式，這是該疾病最常見的形式。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。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。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。公司預計將於 2024 年中期報告該試驗的主要結果。

Finally, during the first quarter, the Company successfully completed an underwritten public offering of common stock. The gross proceeds to Viking from this offering were approximately $630 million. As Greg indicated a few moments ago, these funds have strengthened our balance sheet, which as of the end of the quarter held approximately $963 million in cash, significantly extending our runway. This provides the company with the resources to aggressively develop our programs through important clinical milestones in conclusion, during the first quarter, Viking reported positive data from two key clinical trials of our lead obesity program. VK. two seven three five Phase two venture study demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection as well as promising safety and tolerability. The Phase one study of the oral tablet formulation of VK. two seven three five demonstrated excellent safety and tolerability and positive signs of clinical activity with subjects reporting mean weight loss of up to 5.3% from baseline following 28 days of oral dosing. We plan to meet with regulators to discuss the path forward for each of these programs, and we expect to initiate further clinical trials with each later this year. We also plan to report data from the Phase IIb VOYAGE study of our thyroid hormone beta receptor agonist VK. to eight or nine in biopsy-confirmed NASH and fibrosis later this quarter. The initial data from this study successfully achieved the primary endpoint and affirmed the VK. 2.9 potent efficacy in reducing liver fat, along with its favorable tolerability and safety profile. 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 later this quarter.

最終，該公司在第一季成功完成了普通股的承銷公開發行。 Viking 此次發行的總收益約為 6.3 億美元。正如格雷格不久前指出的那樣，這些資金增強了我們的資產負債表，截至本季末，我們的資產負債表持有約 9.63 億美元現金，顯著延長了我們的營運範圍。這為公司提供了資源，透過重要的臨床里程碑積極開發我們的專案。 VK。二七三五二期風險研究表明，每週皮下注射給藥 13 週後，體重較基線減少約 15%，且安全性和耐受性良好。 VK口服藥錠配方的一期研究。二七三五表現出優異的安全性和耐受性以及臨床活性的積極跡象，受試者報告口服給藥 28 天後平均體重較基線減輕高達 5.3%。我們計劃與監管機構會面，討論每個項目的前進道路，並預計在今年稍後啟動進一步的臨床試驗。我們也計劃報告甲狀腺激素 β 受體激動劑 VK 的 IIb 期 VOYAGE 研究的數據。本季度晚些時候，活檢證實的 NASH 和纖維化病例增加到八到九個。本研究的初始數據成功實現了主要終點並確認了 VK。 2.9 減少肝臟脂肪的有效功效，以及良好的耐受性和安全性。我們最近完成了 VOYAGE 研究的最終活檢，並期待在本季度晚些時候報告 52 週治療後評估的組織學變化數據。

Finally, we expect to announce data from our Phase Ib study of detailed two one four for the treatment of adrenal myelin neuropathy midyear to support our maturing pipeline. The Company ended the quarter with a strong balance sheet of 963 million.

最後，我們預計在年中公佈治療腎上腺髓鞘神經病變的詳細二一四 Ib 期研究的數據，以支持我們成熟的產品線。該公司本季末的資產負債表強勁，達 9.63 億美元。

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

我們今天準備的評論到此結束。非常感謝您加入我們，我們現在開始提問。

(Operator Instructions) Joon Lee, Truist.

（操作員指示）Joon Lee，真理論者。

Hey, congrats on the quarter and thanks for taking our questions. Sarcopenia is getting a lot of attention these days and some companies are talking about adding a storm to GLP. You certainly have your share of experiences with storm and sober opinion in general. Any thoughts on bringing back 5 to one one as an add-on strategy? And I have a follow-up.

嘿，恭喜本季度，感謝您回答我們的問題。最近，肌少症引起了很多關注，一些公司正在討論在 GLP 中加入風暴。總的來說，你當然也有過風暴和清醒觀點的經驗。對於將 5 比 1 恢復為附加策略有什麼想法嗎？我有一個後續行動。

Hey, Joon. Yes, thanks, for the question. Yes, it is, I think, getting to be more popular in the conversation. What we have kind of always said and hasn't really changed is it's hard to understand the the clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what are typically used for approval. But it's a good point that 5 to one one compound is the most potent arm that we're aware of. And to the extent muscle loss is considered to be clinically relevant more. So in the pharmacologic setting versus the regular diet and exercise setting, it could be something that's a that's really useful.

嘿，瓊。是的，謝謝你的提問。是的，我認為它在談話中越來越受歡迎。我們總是說但沒有真正改變的是，很難理解肌肉損失的臨床意義，以及這是否真的對功能、感覺或生存產生影響，而這些通常是用於批准的。但值得指出的是，5 比 1 的化合物是我們所知的最有效的藥物。在某種程度上，肌肉損失被認為與臨床相關。因此，與常規飲食和運動相比，在藥理學環境中，它可能是真正有用的東西。

Okay. I'm looking forward to your update on that. Can you update us on where you are with the oral BK. two, 7.35 dosing and what the it's like the stopping criteria or the maximum dose that you tend to test for the oral?

好的。我期待您的更新。您能否向我們介紹一下您在口服 BK 方面的進展？二、7.35 劑量以及您傾向於測試口服的停止標準或最大劑量是什麼？

Yes. Thanks, Joon. It's ongoing still and we are planning to continue dose escalation until we either get to some sort of a some reason for stopping it or maybe a plateau on the exposures or a plateau on the on the weight change or some tolerability issue. And so we'll probably have more to say about that around the middle of the year when we have data from the additional cohorts.

是的。謝謝，瓊。它仍在繼續，我們計劃繼續劑量遞增，直到我們找到某種停止劑量的原因，或者可能是暴露水平或體重變化或某些耐受性問題達到穩定水平。因此，當我們獲得更多隊列的數據時，我們可能會在今年年中對此進行更多討論。

Great. And one final question. Any steady state and around your markets, is it your expectation that VK. two seven, three five would drive percent weight loss greater than tirzepatide? Or would it be similar to first peptide and what is the basis for your thinking? Thank you.

偉大的。最後一個問題。您期望 VK. 圍繞您的市場處於任何穩定狀態嗎？二七、三五會比替澤帕肽帶來更大的減肥效果嗎？或者它會類似於第一個勝肽嗎？謝謝。

Sorry, are you talking about the oral or --what?

抱歉，您是在談論口頭還是—什麼？

Yeah, injectable and let's say, subcutaneous.

是的，可以注射，可以說是皮下注射。

So for the subcutaneous, um, well, it seems that that at any given dose, the exposures are significantly higher, um, and so and whether it would be better or comparable hard to say, but I think at any given dose, we should have a greater load onboard without in our view it out without a meaningful change in the tolerability profile. So how that translates, I think we'd have to see a longer study before making a call on that.

因此，對於皮下注射，嗯，似乎在任何給定的劑量下，暴露量都明顯更高，嗯，所以，很難說它是否會更好或相當，但我認為在任何給定的劑量下，我們應該在我們看來，在沒有對耐受性進行有意義的改變的情況下，船上有更大的負載。因此，我認為在做出決定之前我們必須進行更長的研究。

Roger Song, Jefferies.

羅傑·宋，杰弗里斯。

Hi, team. This is Kambiz on for Roger. Maybe on VK. two eight zero nine, what's the general translatability of kind of the 12 week MRI PDFF result into later histology endpoints and on are you planning to move the program into mass program into Phase three yourself? Or do you intend to partner? And then maybe as a third and final question, how do you think that thyroid beta agonist market will develop. There's kind of been some recent evidence that GLP ones, both dual GLP-1 and GIP. and dual GLP-1 glucagon agonist have shown potentially by process improvement. So just your thoughts on how that market will develop and will be really helpful. Thank you.

大家好。這是 Kambiz 為 Roger 做的節目。也許在VK上。二八零九，12 週 MRI PDFF 結果到後來的組織學終點的一般可轉化性是什麼？或是有合作的打算嗎？然後也許作為第三個也是最後一個問題，您認為甲狀腺β激動劑市場將如何發展。最近有一些證據顯示 GLP 是雙重的 GLP-1 和 GIP。和雙重 GLP-1 胰高血糖素激動劑已透過製程改進顯示出潛力。因此，您對這個市場將如何發展的想法將會非常有幫助。謝謝。

Yes. Thanks, Kambiz. So with the translatability for liver fat to histologic improvement. Generally, it has been shown that reducing liver fat, particularly above that 30% relative reduction threshold has led to improved odds of histologic benefit. There are some exceptions to that but generally there are more examples of that proving out than not. And I think it's more of a compound by compound situation when you when you tried to translate the precise liver fat reduction to histologic improvement. I think the best comparator for us would be the other thyroid agonist that was recently approved. It showed in the somewhere in the 10s range for a NASH resolution and it did show some improvement in fibrosis. So to the extent we have a similar or better liver fat reduction, I think that would be sort of the range we would be looking at for NASH resolution and fibrosis improvement.

是的。謝謝，坎比茲。因此，肝臟脂肪可轉化為組織學改善。一般來說，研究表明，減少肝臟脂肪，特別是高於 30% 的相對減少閾值，可以提高組織學獲益的幾率。雖然也有一些例外，但一般來說，證明這一點的例子比沒有證明的例子更多。我認為當你試圖將精確的肝臟脂肪減少轉化為組織學改善時，這更像是一種複合情況。我認為對我們來說最好的比較是最近批准的另一種甲狀腺激動劑。它顯示 NASH 解析度在 10 秒範圍內，且纖維化確實有所改善。因此，如果我們的肝臟脂肪減少程度相似或更好，我認為這將是我們尋求 NASH 解決和纖維化改善的範圍。

And with respect to the overall market, yes, it does seem like there is a rapid expansion of the GLP-1 utilization. And so that probably does create some some some headwind on the uptake of new NASH drugs, but we've not had an approved drug for NASH. So now that we do. I think it's going to be really important to see how the first few quarters and mature there. And maybe there is a backlog of people waiting to trial and a backlog of clinicians waiting to do I prescribe It's so unknown right now, it's hard to hard to project, but it is true that the GLP ones are getting more and more utilization. And there's a middle question in there, I think I skipped.

就整個市場而言，GLP-1 的利用率似乎確實在快速擴大。因此，這可能確實會給新 NASH 藥物的使用帶來一些阻力，但我們還沒有批准治療 NASH 的藥物。所以現在我們這樣做了。我認為了解前幾個季度的發展非常重要。也許有大量的人在等待試驗，還有大量的臨床醫生在等我開處方。中間有一個問題，我想我跳過了。

Yes, just some plans on Phase three for your management program, kind of intended to it solar or maybe a search for a partner?

是的，只是您管理計劃第三階段的一些計劃，有點是為了太陽能還是尋找合作夥伴？

Yes. Yes, great. So the odd we plan to do is receive the data from the VOYAGE study, and then we'll schedule an end-of-Phase two meeting with the FDA later this year and yet the current view of registration endpoints and any trial design suggestions might the agency might have. And I think we'll have to see what the data look like, but we'll be probably looking for a partner with the program, but hard to say without having a look at the data first.

是的。對，很好。因此，我們計劃要做的奇怪事情是接收 VOYAGE 研究的數據，然後我們將安排今年稍後與 FDA 舉行第二階段結束會議，但目前對註冊終點的看法和任何試驗設計建議可能會有所不同。該機構可能有。我認為我們必須看看數據是什麼樣的，但我們可能會尋找該計劃的合作夥伴，但如果不先查看數據就很難說。

Annabel Samimy, Stifel.

安娜貝爾·薩米米，斯蒂菲爾。

Hi, and thanks for taking my questions. I have two on on the oral. So when you think about the additional doses for the oral, which you know already has shown some pretty respectable weight loss metrics. How are you balancing how you push the dose versus the manufacturing capacity issues. We are getting a lot of questions around that given the supply problems that current manufacturers have with their own therapies right now. So I just wanted to know if you're going into this on with that thought in mind.

您好，感謝您回答我的問題。我有兩個在口頭上。因此，當您考慮口服的額外劑量時，您知道已經顯示出一些相當可觀的減肥指標。您如何平衡推動劑量與生產能力問題。鑑於目前製造商自己的療法存在供應問題，我們對此提出了許多問題。所以我只是想知道你是否會帶著這個想法進入這個主題。

And on the second is, I guess, given some of the additional benefits that we lost drugs are having, whether it's on CV risk or hypertension or kidney disease and sleep apnea? And are there any additional trials or subpopulations that you can be baking into your later-stage development programs to sort of position yourself competitively on even at a minimum from a payer perspective as this space evolves without having to do Phase four trials on, but at least have some kind of idea or a metric in the late-stage trials that you're already designing. So those are my questions for now.

我想，第二個問題是，考慮到我們失去的藥物所帶來的一些額外好處，無論是心血管風險、高血壓、腎臟疾病和睡眠呼吸中止症？隨著這個領域的發展，是否有任何額外的試驗或子群體可以融入到後期開發計劃中，以便至少從付款人的角度使自己具有競爭力，而無需進行第四階段試驗，但至少可以從付款人的角度來看。這些都是我現在的問題。

Thanks, Annabel. For the second question, we'll probably focus mostly on obesity as the primary or early indication. But all of that, the subsets that you just mentioned and the successes in those populations are really important. So to the extent we could add a cohort with that dyslipidemia or something like that to look at the effects on plasma lipids that might have a read through to cardiovascular benefit that maybe we were primarily though, looking at the weight loss indication for the Phase three program with respect to manufacturing, it's an area that, yes, we're acutely aware of it. And you know, I think a couple of things we're right now in this very acute stage where these compounds have just been recently approved for weight loss and there is just overwhelming demand and the supply isn't quite there. We don't consider that to be a terminal state. We do see from the existing companies in the space, it ramp up in manufacturing capacity. We know on the contractor side, there is a massive attention being paid paid to this this issue. And so I think the supply dynamics will probably evolve over the next few years, still going to be a difficult challenge, but I think we're not in a permanent shortage state, we don't think.

謝謝，安娜貝爾。對於第二個問題，我們可能主要關注肥胖作為主要或早期跡象。但所有這些，您剛才提到的子集以及這些人群中的成功都非常重要。因此，在某種程度上，我們可以添加一個患有血脂異常或類似疾病的隊列來觀察對血漿脂質的影響，這可能會對心血管有益，也許我們主要是在觀察第三階段的減肥跡象是的，我們非常清楚這一領域。你知道，我認為我們現在正處於一個非常緊急的階段，這些化合物最近剛剛被批准用於減肥，需求量巨大，但供應不足。我們不認為這是一個最終狀態。我們確實從該領域的現有公司中看到，它的製造能力有所提高。我們知道承包商方面對此問題給予了極大的關注。因此，我認為供應動態可能會在未來幾年內發生變化，這仍然是一個艱鉅的挑戰，但我認為我們並沒有處於永久短缺狀態，我們不這麼認為。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Oh, hey, congrats on all the progress and thank you for providing this update for subcu VK. two, seven, three five. What kind of data should we expect in 2Q? And do you think you'll have enough data to support less frequent dosing? And then what are your latest thoughts on a Phase IIb study? And then I had a follow-up question, if I could.

哦，嘿，祝賀所有的進展，並感謝您為 subcu VK 提供此更新。二、七、三、五。第二季我們應該期待什麼樣的數據？您認為您有足夠的數據來支持較低的給藥頻率嗎？那麼您對 IIb 期研究的最新想法是什麼？然後我有一個後續問題，如果可以的話。

Yes. Thanks, Jay. So we'll we haven't received the final data from the study. And so we would be looking for the lipid data, some of the PK data, the exposure data after in oh four and six weeks after the last dose that that sort of thing I think would be important for us to understand and what's the proper forum for presentation you'll make maybe some of it would trickle into earnings updates or corporate presentations, but probably later in the year, we would have a presentation at a medical conference.

是的。謝謝，傑伊。所以我們還沒有收到這項研究的最終數據。因此，我們將尋找血脂數據、一些 PK 數據、最後一次給藥後四周和六週後的暴露數據，我認為這類事情對於我們了解非常重要，以及什麼是合適的論壇對於演示，您可能會做一些演示，其中一些會滲透到收益更新或公司演示中，但可能在今年晚些時候，我們會在醫學會議上進行演示。

And with respect to less-frequent dosing, I mean, that's part of the PK data that we will receive. If it looks like we're in a therapeutic range at some period after the last dose, maybe that will be feasible. Our strategy and we would look to incorporate that into a subsequent trial. So the really important data coming out of the PK dataset.

我的意思是，關於不太頻繁的給藥，這是我們將收到的 PK 數據的一部分。如果看起來我們在最後一次給藥後的某個時期處於治療範圍內，也許這是可行的。我們的策略以及我們希望將其納入後續試驗中。所以真正重要的數據來自 PK 數據集。

Okay, great. Thanks.

好的，太好了。謝謝。

And latest thoughts on that Phase IIb study?

關於 IIb 期研究的最新想法？

Phase IIb study, yes, we're going to have a Type C meeting with the FDA later this quarter. And so we would hope to be able to start the next study a Phase IIb study seems seems likely of, but we would look to start to that later in the year. Probably fourth quarter would be the timing for that study.

IIb 期研究，是的，我們將在本季稍後與 FDA 舉行 C 類會議。因此，我們希望能夠開始下一項似乎有可能進行的 IIb 期研究，但我們希望在今年稍後開始。這項研究的時間可能是第四季。

Okay. Great, thanks.

好的。萬分感謝。

And if I could ask one more question. Given the positive data you've already presented for both injectable and oral VK. two, seven, three five, what additional cards would you like to turnover before seeking or partner or potential strategic transactions?

如果我可以再問一個問題嗎？鑑於您已經提供了注射和口服 VK 的積極數據。二、七、三、五，在尋求合作夥伴或潛在的策略交易之前，您還想翻哪些牌？

Well, I think more data is always helpful to potential partners, but we don't view it as a gating for us to have meaningful conversations. And I'm not sure it's necessarily gating for others to have meaningful conversations with us. But and generally, the larger partners like to see more data as programs evolve. But again, that's not a I don't think that's a mandatory requirement right now.

嗯，我認為更多的數據總是對潛在的合作夥伴有幫助，但我們並不認為它是我們有意義的對話的大門。我不確定這是否一定會妨礙其他人與我們進行有意義的對話。但一般來說，隨著專案的發展，較大的合作夥伴希望看到更多的數據。但同樣，這不是一個我認為現在不是強制性要求的情況。

Andrew Hsieh, William Blair.

安德魯謝，威廉布萊爾。

Great, guys. Thanks for taking our questions. Tom. So the first one I have is really on the potential framework for duration for the Phase two subcutaneous study and maybe from two directions. One is really on and maybe the GLP tox. Maybe you could provide us with an update regarding how long you can dose of this upcoming study based on? Well, the GLP tox we've done to date. And then secondarily, it's mostly like a so I'll go question one on how you view the importance of seeing a pretty consistent plateauing just to give the maximum weight loss data and just in terms of derisking program is important just to see that, sorry?

太棒了，夥計們。感謝您回答我們的問題。湯姆.因此，我的第一個實際上是關於第二階段皮下研究持續時間的潛在框架，可能來自兩個方向。其中一個確實存在，也許是 GLP 毒素。也許您可以向我們提供有關您可以根據這項即將進行的研究服用多長時間的最新資訊？好吧，我們迄今為止已經完成了 GLP 毒理學。其次，它基本上就像一個，所以我會問一個問題，你如何看待看到一個相當一致的平台期的重要性，只是為了提供最大的減肥數據，並且就去風險計劃而言，看到這一點很重要，抱歉？

Yes, thanks, Andy, for the flat to bottom, you know, from from what we've seen right now, the Phase two B studies that were performed with the semaglutide Enterra's appetite had not plateaued prior to the registration studies being initiated. So it's hard to hard to really know how the FDA will judge the assessment of a plateau when the currently approved drugs did not reach that in there in their Phase 2b studies or so. That's that's one of the things we hope to learn a little bit about in the upcoming Type C meeting with the tox coverage, we're can we're finished with the chronic tox. So we don't have a limitation toxicity wise or GLP tox study limitation on duration. So we could dose as long as we'd like. And I think probably six months or nine months would be the two most likely candidates for duration of the Phase IIb.

是的，謝謝，安迪，從持平到底部，你知道，從我們現在所看到的情況來看，用索馬魯肽 Enterra 進行的二期 B 研究在註冊研究開始之前並沒有達到穩定水平。因此，當目前核准的藥物未達到 2b 期研究中的穩定水平時，很難真正知道 FDA 將如何判斷穩定期的評估。這是我們希望在即將召開的 Type C 毒物報道會議上了解的事情之一，我們可以結束慢性毒物。因此，我們沒有毒性方面的限製或 GLP 毒性研究的持續時間限制。所以我們可以隨心所欲地服用。我認為 6 個月或 9 個月可能是 IIb 期持續時間最有可能的兩個候選人。

Got it. That's helpful. Since we're talking about the upcoming discussion with the FDA. I'm just curious if you have any lingering questions or actually items you'd like to discuss with the agency around midyear.

知道了。這很有幫助。因為我們正在談論即將與 FDA 進行的討論。我只是好奇您是否有任何揮之不去的問題或實際上想在年中與該機構討論的項目。

Well, we're not going to disclose the nature of the conversations, but we're interested in study design and duration. And going back to your question about it, understanding that the ideal duration prior to Phase three. So those are those are our key questions.

好吧，我們不會透露對話的性質，但我們對研究設計和持續時間感興趣。回到你的問題，了解第三階段之前的理想持續時間。這些都是我們的關鍵問題。

Got it. Okay. And lastly, the mechanics, this huge, obviously, we're expecting NASH data coming up. And so curious if there's any sort of procedural things that we should anticipate with the IP dispute there?

知道了。好的。最後是機制，很明顯，我們期待 NASH 資料的出現。很好奇我們是否應該在智慧財產權糾紛中預見任何程序問題？

Yes. And so we would expect a ruling on the dispute sometime this quarter, but it's hard to speculate since it's a ongoing litigation.

是的。因此，我們預計本季某個時候會對爭議做出裁決，但很難推測，因為這是一項正在進行的訴訟。

Steve Seedhouse, Raymond James.

史蒂夫席德豪斯，雷蒙德詹姆斯。

Hi, thank you. This is Nick on for Steve on we have a question related to animals on manufacturing. Are you able to specify what materials or factors are most gaining to ramp up commercial supply of two seven three five? And would this only be a potential issue for the higher doses of the oral formulation? Thank you.

嗨，謝謝你。這是尼克替史蒂夫回答的問題，我們有一個與動物生產相關的問題。您能否具體說明哪些材料或因素最有利於增加二七三五的商業供應？這是否只是高劑量口服製劑的潛在問題？謝謝。

Yes, I think it's an issue for all doses. When we look at the currently approved drugs, they're difficult to start of because of shortages of. So I think all doses it's relevant to up today.

是的，我認為這對於所有劑量都是一個問題。當我們看看目前批准的藥物時，它們由於短缺而很難啟動。所以我認為今天的所有劑量都與此相關。

With respect to overall, what is the where the greatest shortage. I mean there throughout the supply chain of solvents, whatever is needed for solid phase synthesis, a fill-and-finish materials. So it's a pretty of zero shortfall right now. But again, we don't think that's going to be a terminal state for for this class of compounds. When you look at the market opportunity, that incentive is pretty high to figure out these problems.

就整體而言，最大的不足是什麼地方。我的意思是在整個溶劑供應鏈中，無論固相合成所需的是什麼，填充和完成材料。所以現在缺口幾乎是零。但同樣，我們認為這不會成為此類化合物的最終狀態。當你看到市場機會時，你會發現解決這些問題的動力相當高。

(Operator Instructions) Thomas Smith, Leerink Partners.

（操作員說明）Thomas Smith，Leerink Partners。

Hey, guys, good afternoon. Thanks for taking the questions. Just ahead of the VOYAGE study readout, can you remind us what your expectations are on the two histology endpoints, fibrosis improvement and NASH resolution? And can you comment on what data you expect to have available at the top line versus data sets that you expect to receive later or perhaps say for presentation at a medical meeting?

嘿，夥計們，下午好。感謝您提出問題。在 VOYAGE 研究結果公佈之前，您能否提醒我們您對纖維化改善和 NASH 解決這兩個組織學終點的期望是什麼？您能否評論一下您希望在頂線獲得哪些數據以及您希望稍後收到或可能在醫學會議上演示的數據集？

Yes. Thanks, Tom. So on the on the hurdles of what we've always thought is if we can show a NASH resolution delta in that in that low to mid 10s rate for treated versus <unk> placebo and for the proportion of patients with a one point improvement without worsening of NASH and similarly sort of low double digits, although with fibrosis, I would be I would not be expecting statistical significance just because the numbers are smaller, but those would be the the key hurdles that we're looking for with that dataset.

是的。謝謝，湯姆。因此，我們一直認為的障礙是，我們是否能夠顯示 NASH 解決率增量，即治療組與安慰劑相比，NASH 解決率在 10 秒左右，並且在沒有治療的情況下改善 1 分的患者比例NASH的惡化和類似的低兩位數，儘管有纖維化，我不會僅僅因為數字較小而期望統計顯著性，但這些將是我們在該數據集中尋找的關鍵障礙。

With respect to what would be available and when will that those are the primary components of the data that we'll receive. We will be receiving probably little later data on paired biopsy reads, you know, what is someone's NASH, better, unchanged or worse at the end of the treatment period that that kind of thing since those take a little bit longer to evaluate.

關於可用的內容以及何時可用，這些是我們將收到的數據的主要組成部分。我們可能稍後會收到關於配對活檢讀數的數據，你知道，在治療期結束時某人的 NASH 是更好、不變還是更差，這類事情需要更長的時間來評估。

Understood. That's helpful.

明白了。這很有幫助。

And then just Tom, for oral 27 35, can you just clarify, do you expect to report data from the ongoing higher-dose cohort once that's available? Or is it possible that you could add some additional higher dose cohorts before we see any incremental data from the study?

然後，湯姆，對於口頭 27 35，您能否澄清一下，一旦獲得正在進行的高劑量隊列的數據，您是否期望報告這些數據？或者，在我們看到研究的任何增量數據之前，您是否可以添加一些額外的更高劑量的隊列？

Probably more the latter. So we don't just kind of drip data out. We would probably want to report what we have when the study is completed rather than cohort by cohort.

恐怕更多的是後者。所以我們不只是滴出數據。我們可能希望在研究完成後報告我們所得到的結果，而不是逐一報告。

Yale Jen, Laidlaw & Co.

耶魯仁萊德勞公司

Good afternoon and thanks for taking the questions.

下午好，感謝您提出問題。

Brian,, you're talking about that the 27 35 of LiDAR will be presented at medical conferences. Just curious anything in mind at this point that you're thinking?

Brian，你說的是 LiDAR 的 27 35 將在醫學會議上展示。只是好奇此時你在想什麼？

Yes. Thanks, Yale. Last year, we presented the Phase one data at Obesity Week and so that would seem like a good candidate we have submitted. I think that that would seem like a good candidate for for data presentation.

是的。謝謝，耶魯。去年，我們在肥胖週上展示了第一階段的數據，因此這似乎是我們提交的一個不錯的候選數據。我認為這似乎是數據呈現的一個很好的選擇。

Okay, that's helpful. And though a follow-up question here is that for the subcu version, do you think that here one is the auto injector? Are you guys already working on that? And secondly, is that do you anticipate any kind of bridging PK study in between before you're heading to a more pivotal study?

好的，這很有幫助。雖然這裡的後續問題是 subcu 版本，但您認為這裡是自動注射器嗎？你們已經在做這件事了嗎？其次，在進行更關鍵的研究之前，您是否預期會進行任何類型的橋接 PK 研究？

Yes, great question. Yes, we will be using the pen type device, and we would hope that's available prior to initiation of the next clinical study. But we're not going to let that be a gating factor. So that and the device is not ready. We would plan to start the study with vial and syringe and then transition on to the auto-injector.

是的，很好的問題。是的，我們將使用筆型設備，我們希望在下一次臨床研究開始之前可以使用該設備。但我們不會讓它成為一個限制因素。所以設備還沒準備好。我們計劃從小瓶和注射器開始研究，然後過渡到自動注射器。

But do you anticipate at one point even whether you thought earlier before that or later that you need a bridging study for that or you think that PK data could be supportive?

但是，您是否在某一時刻預計到，甚至您之前或之後認為您需要為此進行一項橋接研究，或者您認為 PK 數據可能會提供支援？

Well, no, I don't think we would need a bridging study at this point. That's not that's not we're contemplating. I mean, if we have to do one, we would, but I don't think that's going to be requirement. We would transition people.

嗯，不，我認為我們目前不需要進行橋接研究。這不是我們沒有考慮的。我的意思是，如果我們必須這樣做，我們會這樣做，但我認為這不會成為要求。我們會轉變人員。

Okay, great. Thanks. And congrats on all the profit this quarter.

好的，太好了。謝謝。並恭喜本季所有利潤。

Thanks, Elisha.

謝謝，以利沙。

Justin Zelin, BTIG.

賈斯汀·澤林，BTIG。

Thanks for taking the questions and congrats on the progress. Brian, you just mentioned for the VOYAGE study for fibrosis. You mentioned that there might be a few patients here. And can you just remind us if the study is powered to show a difference in fibrosis in the study and have a follow-up.

感謝您提出問題並祝賀取得的進展。 Brian，您剛剛提到了纖維化的 VOYAGE 研究。你提到這裡可能有一些病人。您能否提醒我們，這項研究是否有動力顯示研究中纖維化的差異並進行追蹤。

Yes, thanks, Justin. It wasn't powered on fibrosis.

是的，謝謝，賈斯汀。它不是由纖維化驅動的。

It was powered on NASH resolution rates, and I'm not sure we ever disclosed apparent in the 80% range to show approximately at a 20% delta on NASH resolution. But it was up not designed around fibrosis as that generally requires quite a bit larger than we have in this study.

它以 NASH 分辨率為動力，我不確定我們是否曾公開過在 80% 的範圍內明顯顯示 NASH 分辨率大約有 20% 的增量。但它並不是圍繞著纖維化而設計的，因為這通常需要比我們在本研究中更大的尺寸。

Understood. That's helpful. And maybe I'll ask you. I don't think any others have asked yet. Just expectations on the 0 to one four for X-ALD what would be a success here in your view for the Phase Ib?

明白了。這很有幫助。也許我會問你。我認為還沒有其他人問過。只是對 X-ALD 的 0 到 1 4 的期望，您認為 Ib 階段會取得什麼成功？

Yes, yes. So we have previously shown with that compound somewhere in the in the 20% range on LDL reduction and in the 20% range for APOB. and LBLA. So we know it's effective at lipid reduction and we also looked very long-chain fatty acids in the healthy volunteers. That's kind of tough to look because they're there healthy volunteers. They don't really have abnormalities of very long-chain fatty acids, but we did see some reductions in very long-chain fatty acids in that prior Phase one experience. So if we can see somewhere in the mid to high 10s on the very long-chain fatty acid reduction that would be a pretty interesting, hopefully more than that. But that would be probably that the gating factor to consider further development in X-linked adrenoleukodystrophy.

是的是的。因此，我們先前已經證明，該化合物可以使 LDL 降低 20%，使 APOB 降低 20%。和LBLA。所以我們知道它可以有效降低脂質，我們也在健康志願者中觀察了長鏈脂肪酸。這看起來有點困難，因為他們都是健康的志工。它們實際上並沒有長鏈脂肪酸異常，但我們在先前的第一階段經驗中確實看到了長鏈脂肪酸的一些減少。因此，如果我們能看到長鏈脂肪酸減少量在 10 左右，那將是非常有趣的，希望不止於此。但這可能是考慮 X 連鎖腎上腺腦白質營養不良進一步發展的門控因素。

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

我們的問答環節到此結束。我想將會議轉交給斯蒂芬妮·迪亞茲（Stephanie Diaz）發表閉幕詞。

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

再次感謝您對 Viking Therapeutics 的參與和持續支持。我們期待在未來幾個月內再次為您提供最新消息。祝你下午好。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。