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Operator
Operator
Welcome to the Viking Therapeutics first quarter 2026 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, April 29, 2026.
歡迎參加 Viking Therapeutics 2026 年第一季財務業績電話會議。(接線員指示) 提醒各位,本電話會議於今日 2026 年 4 月 29 日錄音。
I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Thank you, and over to you.
現在我想把會議交給 Viking 投資人關係經理 Stephanie Diaz。謝謝,交給您。
Stephanie Diaz - Manager of Investor Relations
Stephanie Diaz - Manager of Investor Relations
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.
各位好,感謝大家參與今天的電話會議。今天與我一同出席的有 Viking 總裁暨執行長 Brian Lian,以及 Viking 財務長 Greg Zante。
Before we begin, I'd like to caution that comments made during this conference call today, April 29, 2026, 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.
在開始之前,我想提醒各位,今天(2026 年 4 月 29 日)本電話會議中的評論將包含《1995 年美國私人證券訴訟改革法》安全港條款所定義的前瞻性陳述,包括關於 Viking 對其研發活動、時程與里程碑之預期的陳述。前瞻性陳述存在風險與不確定性,可能導致實際結果出現重大且不利的差異;已揭露之結果不應被視為未來表現的指標。這些前瞻性陳述僅截至今日有效,公司不承擔修訂或更新今日任何陳述之義務。我鼓勵各位查閱公司向美國證券交易委員會提交的所有文件,以了解上述及其他相關事項。
I'll now turn the call over to Brian Lian for his initial comments.
接下來我把電話交給 Brian Lian,請他先發表開場評論。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended March 31, 2026, and review recent progress with our pipeline programs and operations.
謝謝 Stephanie,也向所有透過電話或網路直播收聽的各位致意。今天我們將回顧截至 2026 年 3 月 31 日止第一季的財務結果,並更新我們在產品線計畫與營運方面的最新進展。
During the first quarter, we made significant progress with our obesity franchise, highlighted by our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors. As we have previously reported, in June 2025, following the positive results from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program evaluating VK2735 dosed as a weekly subcutaneous injection.
第一季期間,我們在肥胖領域產品線取得重大進展,重點包括我們的主力化合物 VK2735——一種 GLP-1 與 GIP 受體的雙重致效劑。如先前所報告,於 2025 年 6 月,在第二期 VENTURE 研究取得正面結果後,Viking 啟動第三期 VANQUISH 臨床計畫,評估以每週一次皮下注射方式給藥的 VK2735。
The Phase III VANQUISH program includes two studies: VANQUISH-1 evaluating the treatment of adults with obesity and VANQUISH-2 evaluating the treatment of adults with obesity and type 2 diabetes. Enrollment in the VANQUISH-1 trial was completed in the fourth quarter of last year. And during the first quarter of 2026, we were pleased to announce the completion of enrollment in the VANQUISH-2 trial. Both studies continue to proceed on track.
第三期 VANQUISH 計畫包含兩項研究:VANQUISH-1 評估成人肥胖治療;VANQUISH-2 評估成人肥胖合併第二型糖尿病的治療。VANQUISH-1 試驗已於去年第四季完成收案。而在 2026 年第一季,我們很高興宣布 VANQUISH-2 試驗也已完成收案。兩項研究皆持續按計畫推進。
Also in the first quarter, the company made progress with its oral VK2735 program. Following an end of Phase II meeting with the FDA, and based on the positive top line results reported in our Phase II VENTURE-Oral dosing study, the company elected to advance oral VK2735 into Phase III clinical development, which we plan to initiate later this year.
同樣在第一季,公司也推進了口服 VK2735 計畫。在與 FDA 召開第二期結束(End-of-Phase II)會議後,並基於我們在第二期 VENTURE-Oral 口服給藥研究所公布的正面主要結果,公司決定將口服 VK2735 推進至第三期臨床開發,並計畫於今年稍晚啟動。
Concurrent with the planning and execution of our subcutaneous and oral registration programs in October 2025, Viking initiated a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly, every other week or weekly dosing. This trial has advanced rapidly with enrollment completed in the first quarter of this year, less than three months after initiation. We expect to report the results of this study in the third quarter.
在規劃與執行皮下與口服註冊性試驗的同時,Viking 於 2025 年 10 月啟動 VK2735 維持劑量研究,以評估不同維持方案的效果,包括每月一次、每兩週一次或每週一次給藥。該試驗進展迅速,於今年第一季完成收案,距離啟動不到三個月。我們預期將於第三季公布此研究結果。
Finally, in the first quarter, we filed an IND with our novel amylin receptor agonist and pending clearance are on track to initiate the clinical development of this compound later this quarter. I'll have additional comments on our operations and development activities following a review of our financial results for the first quarter ended March 31.
最後,在第一季我們就一款新型胰淀素(amylin)受體致效劑提交了 IND 申請;在等待核准之際,我們仍按計畫於本季稍晚啟動該化合物的臨床開發。在回顧截至 3 月 31 日止第一季財務結果後,我將就我們的營運與研發活動提供更多評論。
For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
接下來我把電話交給 Viking 財務長 Greg Zante。
Greg Zante - Chief Financial Officer
Greg Zante - Chief Financial Officer
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 shortly.
謝謝 Brian。配合我的說明,我建議與會者參考 Viking 向美國證券交易委員會提交的 Form 10-Q,我們預計將於近期提交。
I'll now go over our results for the first quarter ended March 31, 2026. Research and development expenses were $115.2 million for the three months ended March 31, 2026, and compared to $41.4 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, consultants, salaries, and benefits and preclinical studies, partially offset by a decrease in expenses related to stock-based compensation.
我現在說明截至 2026 年 3 月 31 日止第一季的業績。截至 2026 年 3 月 31 日止三個月,研發費用為 1.152 億美元,較 2025 年同期的 4,140 萬美元增加。增加主要來自臨床研究、候選藥物製造、顧問費用、薪資與福利以及臨床前研究相關支出上升;部分被以股份為基礎之酬勞費用下降所抵銷。
General and administrative expenses were $14 million for the three months ended March 31, 2026, compared to $14.1 million for the same period in 2025. The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation, partially offset by increased expenses related to consulting, salaries and benefits, and scientific and disease education.
截至 2026 年 3 月 31 日止三個月,一般及行政費用為 1,400 萬美元,較 2025 年同期的 1,410 萬美元略降。下降主要因法律與專利服務以及以股份為基礎之酬勞相關支出減少;部分被顧問費用、薪資與福利,以及科學與疾病教育相關支出增加所抵銷。
For the three months ended March 31, 2026, Viking recorded a net loss of $158.3 million or $1.37 per share compared to a net loss of $45.6 million or $0.41 per share in the corresponding period in 2025. The increase in net loss for the three months ended March 31, 2026, was primarily due to increased research and development expenses partially offset by decreased general and administrative expenses compared to the same period in 2025.
截至 2026 年 3 月 31 日止三個月,Viking 錄得淨損 1.583 億美元,或每股淨損 1.37 美元;相較之下,2025 年同期淨損為 4,560 萬美元,或每股淨損 0.41 美元。截至 2026 年 3 月 31 日止三個月淨損增加,主要因研發費用增加,部分被一般及行政費用較 2025 年同期下降所抵銷。
Turning to the balance sheet. At March 31, 2026, Viking (inaudible) cash, cash equivalents, and short-term investments of $603 million compared to $706 million as of December 31, 2025. This concludes my financial review. And I'll now turn the call back over to Brian.
接著看資產負債表。截至 2026 年 3 月 31 日,Viking(聽不清)現金、約當現金及短期投資為 6.03 億美元,較 2025 年 12 月 31 日的 7.06 億美元下降。以上為我的財務回顧。接下來我把電話交回 Brian。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Thanks, Greg. I'll now provide an update on Viking's clinical and operational progress, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulin atrophic polypeptide, or GIP receptor that has demonstrated promising efficacy, safety, and tolerability across multiple clinical trials.
謝謝 Greg。接下來我將更新 Viking 的臨床與營運進展,先從我們的主力肥胖計畫 VK2735 開始。VK2735 是一種胰高血糖素樣胜肽-1(GLP-1)受體與葡萄糖依賴性胰島素促泌多胜肽(GIP)受體的雙重致效劑,已在多項臨床試驗中展現具前景的療效、安全性與耐受性。
As I mentioned in my opening comments, Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity as well as evaluating a novel maintenance dosing protocol to support long-term weight management. During the first quarter, Viking made substantial progress in each of these areas.
如我在開場時提到,Viking 正在開發 VK2735 的注射劑型與口服劑型,用於治療肥胖,並評估一項新型維持給藥方案,以支持長期體重管理。第一季期間,Viking 在上述各領域皆取得實質進展。
With respect to the subcutaneous VK2735 program, Viking's prior Phase I and Phase II trial successfully achieved their primary and secondary endpoints, demonstrating significant weight loss compared with placebo as well as an impressive safety, tolerability, and pharmacokinetic profile. In the Phase I subcutaneous study, subjects receiving VK2735 achieved up to approximately 8% weight loss from baseline after four weekly doses with no signs of plateau.
就皮下 VK2735 計畫而言,Viking 先前的第一期與第二期試驗均成功達成主要與次要終點,顯示相較安慰劑具有顯著減重效果,並展現令人印象深刻的安全性、耐受性與藥物動力學特性。在第一期皮下研究中,受試者在每週一次、連續四次給藥後,相較基線最高可達約 8% 的體重下降,且未見平台期跡象。
In the Phase II VENTURE study, patients demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses, again with no signs of plateau. Importantly, the VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek Conference last November. The final results were also published in January 2026 in obesity, the peer-reviewed Journal of the Obesity Society.
在第二期 VENTURE 研究中,患者在每週一次、共 13 次給藥後,平均體重相較基線的下降幅度達到具統計顯著性的降低,最高可達 14.7%,同樣未見平台期跡象。重要的是,VENTURE 研究亦顯示 VK2735 在 13 週給藥期間安全且耐受性良好,多數治療期間出現的不良事件屬輕度或中度,且很快緩解。這些結果已於去年 11 月在 2025 年 ObesityWeek 大會的報告中重點呈現。最終結果亦於 2026 年 1 月發表於《Obesity》(肥胖),即 Obesity Society 的同儕審查期刊。
Following the VENTURE Phase II study, Viking held a Type C meeting with the FDA and subsequently an end of Phase II meeting with the agency. Based on feedback from these meetings in June of last year, the company initiated the VANQUISH Phase III registration program, evaluating subcutaneous VK2735 in patients with obesity.
在 VENTURE 第二期研究之後,Viking 與 FDA 舉行了 Type C 會議,並隨後與該機構召開了第二期結束(end of Phase II)會議。根據去年 6 月這些會議的回饋,公司啟動了 VANQUISH 第三期註冊計畫,在肥胖患者中評估皮下注射 VK2735。
The VANQUISH program consists of two clinical trials, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.
VANQUISH 計畫由兩項臨床試驗組成,一項針對肥胖成人,另一項針對肥胖合併第 2 型糖尿病的成人。每項研究皆為隨機、雙盲、安慰劑對照的多中心試驗,旨在評估以皮下注射每週一次、連續 78 週給藥之 VK2735 的療效與安全性。
Enrollment in each of these trials was rapid with the VANQUISH-1 study enrolling approximately 4,500 patients by November 2025, approximately five months after trial initiation. Enrollment in the VANQUISH-I study was completed in the first quarter, enrolling approximately 1,000 patients. Participants in each trial are being randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams, or placebo.
這兩項試驗的收案速度都很快,其中 VANQUISH-1 研究在 2025 年 11 月前收納約 4,500 名患者,約為試驗啟動後 5 個月。VANQUISH-I 研究的收案已於第一季完成,共收納約 1,000 名患者。各試驗受試者將被隨機分派至每週 7.5 毫克、12.5 毫克、17.5 毫克或安慰劑。
Primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% weight loss.
VANQUISH 試驗的主要終點為:與安慰劑相比,接受 VK2735 的受試者在治療 78 週後相較基線的體重百分比變化。次要與探索性終點將評估其他一系列安全性與療效指標,包括達到至少 5%、10%、15% 與 20% 減重的患者比例。
Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period.
每項研究都將包含延伸期,讓受試者在完成主要給藥期間後仍有機會繼續接受治療,包括在最初 78 週治療期間被隨機分派至安慰劑的患者。
Another important achievement during the first quarter for both the VANQUISH-1 and VANQUISH-2 studies was the successful introduction of an auto-injector device into the trials. As a reminder, both VANQUISH-1VANQUISH and VANQUISH-2 were initiated using a vial and syringe for administration of VK2735.
第一季期間,VANQUISH-1 與 VANQUISH-2 兩項研究的另一項重要里程碑,是成功將自動注射器裝置導入試驗。提醒一下,VANQUISH-1VANQUISH 與 VANQUISH-2 在啟動時,皆使用藥瓶與注射器來施打 VK2735。
In the fourth quarter of 2025, Viking conducted a bioequivalent study to facilitate the introduction of an auto-injector, which we believe will add optionality to treatment and may represent a more convenient method of administration for patients.
在 2025 年第四季,Viking 進行了一項生體相等性研究,以促成自動注射器的導入;我們相信這將為治療提供更多選擇,並可能為患者帶來更便利的給藥方式。
This study was successfully completed, and in the first quarter of 2026, participants in both VANQUISH studies began transitioning to the auto-injector device. This transition has been proceeding smoothly, and we are very pleased to now have both VANQUISH studies advancing with our state-of-the-art auto-injector.
該研究已成功完成,並於 2026 年第一季,兩項 VANQUISH 研究的受試者開始轉換至自動注射器裝置。此一轉換進行順利,我們非常高興目前兩項 VANQUISH 研究都能以我們最先進的自動注射器持續推進。
I would now like to provide an update on Viking's oral tablet formulation of VK2735. I referenced a moment ago that we believe the auto-injector device in our subcutaneous VANQUISH studies will provide optionality and treatment.
接下來我想就 Viking 的 VK2735 口服錠劑配方提供最新進展。我剛才提到,我們相信在皮下 VANQUISH 研究中使用自動注射器裝置,將為治療提供更多選擇與彈性。
The concept of optionality is becoming increasingly important based on our conversations with physicians and KOLs about treatment regimens. Every patient's weight loss journey is unique, and we consistently hear from health care providers about the need for flexible treatment and administration options.
根據我們與醫師及關鍵意見領袖(KOL)就治療方案的交流,「選擇性」的概念正變得愈來愈重要。每位患者的減重旅程都各不相同,我們也持續從醫療照護提供者那裡聽到,需要更具彈性的治療與給藥選項。
We have long believed that an oral tablet formulation has the potential to be an attractive option for those who prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved via weekly injection. Providing this optionality has been an important driver for the development of our oral program.
我們長期以來相信,口服錠劑配方有潛力成為一個具吸引力的選項:適用於偏好以口服療法開始治療者,或適用於希望在每週注射已達成減重後維持成果者。提供這種選擇性一直是我們推動口服計畫開發的重要動力。
Given the recent success of another oral peptide for obesity, we are even more optimistic about the promise of oral administration. Viking's prior Phase I and Phase II studies evaluating oral VK2735 successfully achieved their objectives, in addition to excellent safety and tolerability, our Phase I study demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 daily doses.
鑑於近期另一款用於肥胖的口服胜肽取得成功,我們對口服給藥的前景更加樂觀。Viking 先前評估口服 VK2735 的第一期與第二期研究皆成功達成目標;除具備優異的安全性與耐受性外,我們的第一期研究亦顯示相較基線的平均體重呈劑量依賴性下降,在每日給藥 28 次後降幅最高達 8.2%。
In addition, the Phase II VENTURE-Oral dosing study of VK2735 achieved its primary and secondary endpoints with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline.
此外,VK2735 的第二期 VENTURE-口服給藥研究達成其主要與次要終點;接受每日一次錠劑配方的受試者在 13 週後的平均體重相較基線呈現具統計顯著的下降,降幅最高達 12.2%。
Statistically significant differences compared to both baseline and placebo were observed for all doses above 15 milligrams starting at week 1 and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks compared with only 5% of placebo-treated subjects.
自第 1 週起,所有高於 15 毫克的劑量在整個 13 週治療期間,皆觀察到相較基線與安慰劑的統計顯著差異。在 13 週後,VK2735 治療組中最多有 80% 的受試者達到至少 10% 減重,而安慰劑組僅為 5%。
The tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once daily dosing. The vast majority, 98% and of drug-related treatment emergent adverse events were characterized as mild or moderate in severity.
VK2735 的錠劑配方在每日一次、持續 13 週給藥下,也展現出令人鼓舞的安全性與耐受性。絕大多數(98%)與藥物相關的治療期間新發不良事件(treatment emergent adverse events)被評估為輕度或中度。
Importantly, in the dose range we plan to explore in future studies we believe the data show no meaningful difference in GI-related adverse events between subjects treated with VK2735 and placebo. The tolerability data from the VENTURE-Oral dosing study also suggests that future titration regimens, starting at lower doses and utilizing longer titration intervals, are likely to further improve oral VK2735's tolerability profile.
重要的是,在我們計畫於未來研究中探索的劑量範圍內,我們認為數據顯示 VK2735 與安慰劑在腸胃道(GI)相關不良事件方面沒有實質差異。VENTURE-口服給藥研究的耐受性數據亦顯示,未來的滴定方案(從較低劑量開始並採用較長的滴定間隔)很可能進一步改善口服 VK2735 的耐受性特徵。
As with our subcutaneous program, following the completion of the VENTURE-Oral dosing study, we held an end of Phase II meeting with the FDA. Based on feedback from this meeting, the company plans to advance oral VK2735 into Phase III development for the treatment of obesity. We currently expect to initiate this program in the fourth quarter of this year, and we'll provide more details on study design at that time.
與我們的皮下計畫相同,在完成 VENTURE-口服給藥研究後,我們與 FDA 召開了第二期結束(end of Phase II)會議。根據該會議的回饋,公司計畫推進口服 VK2735 進入用於治療肥胖的第三期開發。我們目前預期將於今年第四季啟動此計畫,並將於屆時提供更多研究設計細節。
As part of our goal to create an optimal treatment experience for patients on their weight loss journey, Viking is actively engaged with KOLs and health care providers and advocates who are focused on improving the lives of those living with obesity.
作為我們為患者減重旅程打造最佳治療體驗之目標的一部分,Viking 正積極與 KOL、醫療照護提供者以及致力於改善肥胖患者生活的倡議者合作。
Through these relationships, we have the opportunity to listen to a range of stakeholders in the community and to work towards solutions that best meet their treatment needs. Viking's efforts at developing a novel maintenance dosing strategy emerged as a result of these conversations.
透過這些合作關係,我們得以傾聽社群中各類利害關係人的意見,並共同推動最能滿足其治療需求的解決方案。Viking 開發新型維持劑量策略的努力,正是源自這些對話。
In approaching how the best design a maintenance study, we consider the unique characteristics of the VK2735 molecule, namely its potency and unique PK profile. We believe these features may allow the development of maintenance regimens that utilize less frequent dosing than the weekly regimens used by existing agents. This could be an attractive option for those patients who have achieved their weight loss goals and are seeking to maintain that weight loss going forward.
在思考如何最佳設計維持期研究時,我們會考量 VK2735 分子的獨特特性,亦即其效力與獨特的藥物動力學(PK)特徵。我們相信這些特性可能使得維持方案得以採用比現有藥物每週給藥方案更低頻率的給藥。對於已達成減重目標並希望在未來維持減重成果的患者而言,這可能是一個具吸引力的選項。
By using the same therapeutic agent for both the induction and the longer-term maintenance phase of weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents.
透過在體重管理的誘導期與較長期維持期皆使用同一治療藥物,我們相信相較於需要在不同治療藥物之間切換的選項,患者可能會經歷較少的副作用。
By reducing side effects, we believe adherence to treatment may be improved, allowing patients to ultimately realize the long-term benefits of weight loss and maintenance, including improved cardiovascular health enhanced physical function, and increased quality of life.
透過降低副作用,我們相信可提升治療依從性,使患者最終得以實現減重與維持的長期效益,包括改善心血管健康、提升身體功能,以及提高生活品質。
With these goals in mind, in the fourth quarter of 2025, we initiated a Phase I study to explore a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735, followed by a transition to a range of maintenance regimens or placebo.
基於上述目標,我們於 2025 年第四季啟動了一項第一期研究,以探索一系列維持期給藥方案。在此研究中,所有受試者將先接受 VK2735 的初始每週劑量,之後再轉換至一系列維持方案或安慰劑。
The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will assess the change in body weight from baseline as well as the change in body weight from the time of transition to the end of the study.
本研究的目標是評估 VK2735 在上述各種給藥方案下的安全性、耐受性以及藥物動力學特徵。探索性終點將評估相較於基線的體重變化,以及自轉換時點至研究結束期間的體重變化。
The timing of this study is particularly important to our broader development program as we believe the results from these maintenance regimens could be utilized in the upcoming 52-week VANQUISH extension studies.
本研究的時程對我們更廣泛的開發計畫尤為重要,因為我們相信這些維持治療方案的結果可用於即將進行的 52 週 VANQUISH 延伸研究。
As a result of this timing, and the importance of selecting doses for immediate use in the subcutaneous extension studies, we have bifurcated the study to focus first on the subcutaneous maintenance cohorts followed by the oral maintenance cohorts.
基於此一時程安排,以及為皮下延伸研究即時選擇劑量的重要性,我們將本研究分為兩部分:先聚焦皮下維持治療隊列,之後再進行口服維持治療隊列。
To this end, we've expanded the number of subcutaneous dosing arms in this study from four to eight. This increase in cohorts will provide a broad and robust data set from which to choose for inclusion in the VANQUISH extension study.
為此,我們已將本研究中的皮下給藥組別數量由四組擴增至八組。隊列數的增加將提供廣泛且具韌性的資料集,以供選擇納入 VANQUISH 延伸研究。
Following the completion of the subcutaneous maintenance cohorts, we will continue the study to evaluate a similarly wide range of oral cohorts. We expect to report the results of the subcutaneous portion of the study in the third quarter of this year and expect to report the oral maintenance results in the first half of next year.
在完成皮下維持治療隊列後,我們將持續進行本研究,以評估同樣廣泛範圍的口服隊列。我們預期於今年第三季公布本研究皮下部分的結果,並預期於明年上半年公布口服維持治療結果。
Moving to our other pipeline programs. Viking is also evaluating a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor is an important potential mechanism for regulating appetite and body weight making this program an excellent addition to our obesity franchise.
接著談我們其他的研發管線計畫。Viking 也正在評估一系列新型胰淀素(amylin)受體致效劑。早期資料顯示,活化胰淀素受體是調控食慾與體重的重要潛在機制,使該計畫成為我們肥胖產品線的極佳補強。
In 2025, we made significant progress with our lead amylin agonist VK3019, and we recently filed an IND for this program. Pending clearance, we expect to initiate a Phase I clinical trial for VK3019 later this quarter. As VK2735 advances through Phase III development and toward potential approval and commercialization, we continue to thoughtfully grow our organization to meet the opportunities and challenges that lie in the not-too-distant future. Key recent additions to our team include staffing across a range of scientific and operational roles, including supply chain management, manufacturing and quality.
在 2025 年,我們在主力胰淀素致效劑 VK3019 上取得重大進展,並已於近期就此計畫提交 IND。待核准後,我們預期於本季稍晚啟動 VK3019 的第一期臨床試驗。隨著 VK2735 推進至第三期開發並邁向潛在核准與商業化,我們也持續審慎擴充組織,以因應不久將來的機會與挑戰。近期團隊的重要增補包括多項科學與營運職能的人才配置,涵蓋供應鏈管理、製造與品質等領域。
To coalesce these functions into an efficient and effective commercialization strategy, the company announced in the first quarter the appointment of Neil Aubuchon as its first Chief Commercial Officer. Neil brings to Viking more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions in the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735. We are excited to have him on board to lead this critical operation.
為將上述職能整合為高效率且有效的商業化策略,公司於第一季宣布任命 Neil Aubuchon 為首任商務長(Chief Commercial Officer)。Neil 為 Viking 帶來超過 20 年的產業經驗,其中近 17 年任職於禮來(Eli Lilly)。他曾在心臟代謝領域的全球商業與行銷職能擔任領導職務,使其具備獨特資格來領導我們 VK2735 的商業策略。我們很高興他加入團隊,領導這項關鍵營運。
As always, Viking remains vigilant in managing the company's balance sheet to ensure we're able to successfully execute our objectives. As Greg reported a few minutes ago, the company held approximately $600 million in cash at the end of the first quarter, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials as well as to pursue development of our additional programs.
一如既往,Viking 持續謹慎管理公司的資產負債表,以確保我們能成功執行各項目標。如 Greg 幾分鐘前所報告,公司於第一季末持有約 6 億美元現金,使我們得以達成重要的公司里程碑,包括完成目前進行中的第三期肥胖臨床試驗,以及推進其他計畫的開發。
In conclusion, I'm happy to report that the advances and momentum of 2025 have continued through the first quarter of 2026. Looking ahead, we plan to have both our subcutaneous and oral VK2735 programs in Phase III registration trials during the year.
總結而言,我很高興報告 2025 年的進展與動能已延續至 2026 年第一季。展望未來,我們計畫在今年讓 VK2735 的皮下與口服兩項計畫皆進入第三期註冊性試驗。
Our maintenance dosing trial continues, and we look forward to reporting data from this study in the third quarter. With respect to our earlier stage pipeline, we expect to initiate a Phase I trial for our amylin agonist VK3019, shortly. Operationally, as our programs continue to progress toward potential approval and commercialization.
我們的維持劑量試驗仍在進行中,並期待於第三季公布本研究數據。就較早期的研發管線而言,我們預期將於近期啟動胰淀素致效劑 VK3019 的第一期試驗。在營運面,隨著各項計畫持續朝向潛在核准與商業化推進。
Our organization continues to evolve as well. Our team is focused on executing a timely and strategic expansion plan that ensures that Viking has the partnerships, vendors, and in-house expertise required to succeed in all areas including clinical, regulatory, manufacturing, and commercialization.
我們的組織也持續演進。團隊專注於執行及時且具策略性的擴張計畫,以確保 Viking 在臨床、法規、製造與商業化等各領域,具備成功所需的合作夥伴、供應商與內部專業能力。
And finally, we expect to offer industry-leading options with respect to administration, dosing, and maintenance that physicians and patients need to optimize the path to individual weight loss goals and long-term health. We look forward to reporting our advances on these fronts in the coming months.
最後,我們預期在給藥方式、劑量與維持治療方面提供業界領先的選項,滿足醫師與病患的需求,以最佳化達成個人減重目標與長期健康的路徑。我們期待在未來幾個月就這些面向的進展進行報告。
This concludes our prepared comments for today. Thanks for joining, and we'll now open the call for questions. Operator?
以上為我們今天預先準備的發言。感謝各位參與,接下來我們將開放提問。接線員?
Operator
Operator
(Operator Instructions)
(接線員指示)
Steve Seedhouse, Cantor.
Steve Seedhouse,Cantor。
Steven Seedhouse - Analyst
Steven Seedhouse - Analyst
First is just on the change from four to eight subcu maintenance cohorts in the ongoing study. I was hoping you could just elaborate on what like doses and intervals, the new eight cohorts are testing. And then also, if you wouldn't mind just quickly commenting on R&D just for our modeling, maybe connecting the dots between the like $160 million-ish or so net loss versus about $100 million in net cash change. And I think folks specifically were expecting R&D to come down a bit this quarter from some onetime Phase III start-up costs. So I just would hope if you could clarify if you're expecting R&D cost to come down next quarter or if this is maybe the new run rate?
第一個問題是關於目前進行中的研究,皮下維持治療隊列由四組增加到八組的變更。我想請你們進一步說明新增的八個隊列正在測試哪些劑量與給藥間隔。另外,如果不介意的話,也請快速評論一下研發費用(R&D),以利我們建模:大約 1.6 億美元左右的淨損與約 1 億美元的淨現金變動之間,如何對得起來。我想市場上特別預期本季研發費用會因部分一次性第三期啟動成本而在本季後略為下降。因此也想請你們釐清:你們是否預期下季研發費用會下降,或這可能就是新的費用水準(run rate)?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Thanks, Steve. This is Brian. I'll take the clinical question, and Greg will take the cash question. So on the maintenance study, just given the importance of this study for implementation into the VANQUISH extensions, we decided to extend the cohorts and then defer the oral dosing to a second part. So we'll retain those first four cohorts that we had earlier, which were 22.5, 20 -- 17.5 mg monthly as well as 7.5 mg every other week.
謝謝你,Steve。我是 Brian。我來回答臨床問題,Greg 會回答現金的問題。關於維持治療研究,鑑於此研究對導入 VANQUISH 延伸研究的重要性,我們決定擴增隊列,並將口服給藥延後到第二部分。因此我們會保留先前的前四個隊列,分別為每月 22.5、20、17.5 mg,以及每兩週 7.5 mg。
But we've added 15 monthly, 10 monthly, 10 every other week, and 5 every other week. So we got a nice range of every other week and a broader range of monthly doses.
另外我們新增了每月 15、每月 10、每兩週 10,以及每兩週 5。因此我們涵蓋了不錯的每兩週給藥範圍,並擴大了每月劑量的範圍。
Greg Zante - Chief Financial Officer
Greg Zante - Chief Financial Officer
Yes. And Steve, on the OpEx and cash, for one, the disconnect on that a bit is really timing, a function of timing. They just were higher expenses and cash usage and that stuff evens out over time. But over the -- looking ahead in this next quarter, I think our cash usage and expense will be around where we were at quarter 1, maybe a bit lower. But toward the second half of this year, I would expect this to taper down a little bit.
是的。Steve,關於營業費用(OpEx)與現金,首先兩者之間看起來有些落差主要是時點因素,也就是時間點的影響。只是費用與現金使用在某些期間較高,隨時間推移會趨於平衡。但展望下一季,我認為我們的現金使用與費用大致會與第一季相當,可能略低一些。不過到了今年下半年,我預期會稍微趨緩下降。
So the overall usage is still in line with our projections from our last call. And we would anticipate having cash into '28 and through the catalysts we've talked about, including the oral Phase III data points. So we remain funded as we expected, but we probably used a little bit more in the first quarter than I anticipated, but we are on track.
因此整體使用情況仍與我們上次電話會議所提供的預估一致。我們預期現金可支應至 2028 年,並涵蓋我們所談到的各項催化事件(catalysts),包括口服第三期的數據節點。因此我們的資金狀況如預期般充足;只是第一季的使用略高於我原先預估,但整體仍在軌道上。
Operator
Operator
Thomas Smith, Leerink Partners.
Thomas Smith,Leerink Partners。
Nathanael Charoensook - Analyst
Nathanael Charoensook - Analyst
This is Nathanael on for Tom Smith. We have a couple of questions. So the first one now that both VANQUISH-1 and VANQUISH-2 full enrolled, what baseline characteristics are you seeing? And are they consistent with your expectations? Are you seeing any difference of enthusiasm, seen failure rates or retention between VANQUISH-1 and VANQUISH-2?
我是 Nathanael,代替 Tom Smith 提問。我們有幾個問題。第一個問題是,既然 VANQUISH-1 與 VANQUISH-2 都已完成全數收案(full enrolled),你們看到的基線特徵為何?是否與你們的預期一致?在 VANQUISH-1 與 VANQUISH-2 之間,你們是否看到熱度(enthusiasm)差異、篩選失敗率(screen failure rates)或留存率(retention)的差異?
And we have a follow-up.
我們還有一個追問。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes, sure. So we're actually going to present the baseline demographics at two conferences this year. I think in the European Congress of obesity, we'll have the VANQUISH-1 demographics. And then at EASD, we'll have VANQUISH-2 demographics. So I'll defer to those conferences for the demographic disclosures.
是的,當然。所以我們今年其實會在兩個會議上發表基線人口統計資料。我想在歐洲肥胖大會上,我們會公布 VANQUISH-1 的人口統計資料。然後在 EASD 上,我們會公布 VANQUISH-2 的人口統計資料。所以人口統計資料的揭露我就留待這些會議上再公布。
But I don't think anything is kind of out of the ordinary with respect to the population relative to other studies that are kind of down the middle of the fairway.
但我不認為就受試人群而言,有什麼相較於其他同類型研究特別不尋常之處;整體看起來相當典型。
Nathanael Charoensook - Analyst
Nathanael Charoensook - Analyst
Got it. Yes. And the second one, how should investors think about the expected weight loss in type 2 diabetic versus nondiabetic OBC patients?
了解。是的。第二個問題,投資人應該如何看待第二型糖尿病 OBC 病患相較於非糖尿病 OBC 病患的預期減重幅度?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Hard to know. It's obviously the individual investor to make that estimation. But generally, type 2 patients are a little bit more resistant to weight loss than non-type 2 patients. So I don't think that would be surprising to see in the weight loss data from these studies.
是的。很難說。顯然這需要個別投資人自行做出估計。但一般而言,第二型糖尿病患者相較於非第二型患者,對減重會稍微更具抗性。所以在這些研究的減重數據中看到這種情況,我不會覺得意外。
I think probably see more robust effect in the straight obesity and maybe a little bit lower efficacy in type 2 diabetics, just like everybody else has shown.
我想在單純肥胖族群可能會看到更強的效果,而在第二型糖尿病患者身上療效可能會稍低一些,就像其他人所呈現的結果一樣。
Nathanael Charoensook - Analyst
Nathanael Charoensook - Analyst
And finally, on the Phase II initiation of oral VK2735, which is now expected in 4Q '26, what changed versus prior expectation for [2226].
最後,關於口服 VK2735 的第二期試驗啟動時間,目前預期在 2026 年第四季,這與先前對[2226] 的預期相比,有什麼改變?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Nothing really changed. We're moving incredibly fast and scaling up dramatically here. And as you do that, you learn a lot about the process and efficiencies, making 100 tablets is different than making 1 million tablets. And so you learn a little bit more about engineering processes and et cetera, that get optimized along the way just to ensure you got the most efficient and cost-effective methods in place. And all of that takes some time.
其實沒有什麼改變。我們推進速度非常快,且正在大幅擴張規模。在這個過程中,你會對流程與效率學到很多;製作 100 顆錠劑和製作 100 萬顆錠劑是不同的。因此你會更了解工程製程等等,並在過程中加以最佳化,以確保採用最有效率且最具成本效益的方法。而這些都需要一些時間。
We feel good about the supply chain and the capacity and efficiencies and where we're at in the development cycle. So I look forward to initiating as early as possible in the fourth quarter.
我們對供應鏈、產能、效率以及目前在開發週期中的進度都很有信心。所以我期待能在第四季儘早啟動。
Operator
Operator
Mike Ulz, Morgan Stanley.
Morgan Stanley 的 Mike Ulz。
Michael Ulz - Analyst
Michael Ulz - Analyst
Maybe just a follow-up on the maintenance study. Obviously, you're testing a number of different regimens, subcu, oral, et cetera. Just curious, early in the study, if you're getting a sense of which one of those options that's sort of resonating most with the patients? And could it be the monthly dosing? Or is that a wrong interpretation?
也許追問一下維持期研究。顯然你們在測試多種不同方案,皮下(subcu)、口服等等。想請教在研究早期,你們是否已經感覺到哪一種選項最能引起病患共鳴?會不會是每月一次給藥?還是這樣解讀不正確?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes, we're not really getting that level of feedback, Mike, and it would be hard to interpret because it's a placebo-controlled study. But we made the addition of the subcu cohorts before anybody had transitioned to the maintenance setting. So no one had actually entered into the oral maintenance portion. We made the decision and expanded the subcu portions. We'll do the oral then in a separate part of the study.
是的,Mike,我們其實沒有收到那種層級的回饋,而且也很難解讀,因為這是一項安慰劑對照研究。不過,我們是在任何人轉入維持期設定之前,就新增了皮下給藥的隊列。所以當時還沒有人真正進入口服維持期的部分。我們做了決定並擴增了皮下部分。口服部分我們會在研究的另一個獨立部分進行。
Operator
Operator
Ryan Deschner, Raymond James.
Raymond James 的 Ryan Deschner。
Ryan Deschner - Analyst
Ryan Deschner - Analyst
What were the key factors that went in selecting the 19-week period as the subcu induction time period for the maintenance study? And then I have a follow-up.
在維持期研究中,選擇 19 週作為皮下(subcu)誘導期的關鍵因素是什麼?然後我還有一個追問。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Ryan. It was really driven by the time to titrate to the 22.5 mg dose. That was the highest dose, and we wanted to put people -- first get people up there and then keep them there for I think it's a 3-week treatment time there and then transition everybody to the maintenance at the same time point. So that was sort of the rate-limiting factor, the time it took to titrate to the highest dose.
是的。謝謝你,Ryan。主要是由滴定到 22.5 mg 劑量所需的時間所驅動。那是最高劑量,我們希望先讓受試者升到那個劑量,然後我記得在那裡維持大約 3 週的治療時間,接著在同一個時間點讓所有人轉入維持期。所以這算是限制因素,也就是滴定到最高劑量所需的時間。
Ryan Deschner - Analyst
Ryan Deschner - Analyst
Got it. That's helpful. And I guess I just wanted to kind of feel out what the odds might be. Would you add an additional oral cohorts potentially later on in the maintenance study. Is that something that could be on the table?
了解。這很有幫助。我想我只是想探探可能性。你們是否可能在維持期研究後期再新增額外的口服隊列?這是否有可能納入考量?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes, absolutely. Great question. Yes, we will be adding more cohorts to the oral portion of the study. So we'll probably look at a few more doses as well as potentially alternative regimens.
是的,絕對會。問得很好。是的,我們會在研究的口服部分新增更多隊列。因此我們可能也會再看幾個不同劑量,以及可能的替代給藥方案。
Operator
Operator
Anna Samimy, Stifel.
Stifel 的 Anna Samimy。
Annabel Samimy - Equity Analyst
Annabel Samimy - Equity Analyst
So obviously, with the addition of new cohorts or maintenance studies seems to have gotten a little bit more involved. And I guess I'm trying to figure out what the various possibilities are for that extension trial? Are you going to select one of these cohorts? Are you going to give the option for multiple cohorts going into the extension study? Like what is the purpose of having all these eight additional cohorts.
所以很明顯,隨著新增隊列,維持期研究似乎變得更複雜了一些。我想釐清的是,對於那個延伸試驗(extension trial)有哪些不同的可能性?你們會選擇其中一個隊列嗎?還是會提供多個隊列進入延伸研究的選項?新增這八個額外隊列的目的到底是什麼?
I'm just trying to understand exactly what you intend to do with these cohorts going forward? Is it just for information purposes and their selection in the extension study? And then I guess taking it forward, are you going to develop it any further past this extension study for possible inclusion in the label? Or is it just developing a wealth of data for physicians to draw and sort of use the data as an art rather than a very prescriptive formula for maintenance for these patients.
我只是想更清楚了解,你們接下來打算如何運用這些隊列?是僅供資訊用途,並用於延伸研究中的選擇嗎?再往後看,你們是否會在這個延伸研究之後進一步開發,以便可能納入標籤(label)?還是只是建立大量數據,讓醫師可以參考,並把這些數據當作一種「藝術」來運用,而不是非常制式、規定式的維持治療公式?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Annabel. Two great questions. I think with the second question, at a minimum, we would hope to be able to publish the extension data from the VANQUISH extension, utilizing some of these maintenance cohorts. So that would provide valuable information in the form of publications to clinicians and patients.
是的。謝謝你,Annabel。兩個都問得很好。我想就第二個問題而言,至少我們希望能夠發表 VANQUISH 延伸研究的延伸數據,並運用其中一些維持期隊列。因此,這將以論文發表的形式,為臨床醫師與病患提供有價值的資訊。
And what do we expect to learn from the maintenance cohorts? So really, the best maintenance strategy to employees is every other week dosing preferable. It seems like a lot of people are doing that now just out in the real world. is monthly going to be the better strategy. And if so, what dose.
那我們期望從維持期隊列學到什麼?也就是說,最佳的維持策略是什麼:隔週給藥是否更理想?看起來現在很多人在真實世界中就是這樣做。每月一次是否會是更好的策略?如果是,那應該用什麼劑量?
And so we had only three monthly doses and one every other week dose in the prior study. And so we thought to better inform the cohorts that would go into the extension of VANQUISH, and there will be more than one dosing arm in the extension studies for maintenance and Vanquish. It just made sense to expand the subcu cohorts and then defer the oral since we went as time sensitive on the oral to a separate part of the study.
因此在先前的研究中,我們只有三個每月一次的劑量,以及一個隔週一次的劑量。所以我們認為,為了更好地為將進入 VANQUISH 延伸研究的隊列提供資訊,而且在 VANQUISH 的維持期延伸研究中會有不只一個給藥組別,擴增皮下隊列是合理的;而口服部分因為時間敏感度較高,我們就延後到研究的另一個部分來做。
Annabel Samimy - Equity Analyst
Annabel Samimy - Equity Analyst
Okay. Got it. So just to clarify, you will have a very defined set of cohorts in that extension study. Drawing from this data, the Phase I data?
好的。了解。所以確認一下,你們在那個延伸研究中會有一組非常明確定義的隊列,是根據這些數據、第一期數據來挑選的?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Oh, sure. Yes, definitely. It will be multiple maintenance cohorts there that will be drawn from these data. Yes. Thanks, Annabel.
喔,當然。是的,肯定會。那裡會有多個維持期隊列,會從這些數據中挑選出來。是的。謝謝你,Annabel。
Operator
Operator
Biren Amin, Piper Sandler.
Biren Amin,Piper Sandler。
Biren Amin - Analyst
Biren Amin - Analyst
Brian, I guess just on the VANQUISH expansion, when will the maintenance doses be introduced for the subcu? Will that be at week 78 or week 84? And how long will you be evaluating those subcu doses? And I guess just a follow-on question for the VANQUISH dose cohorts in the treatment phase of 7.5 and 12.5 weekly, how do you think about the transition of those patients to maintenance doses given the maintenance trials evaluating 15 milligrams weekly and higher in that 19-week induction period.
Brian,我想就 VANQUISH 擴展試驗來問一下,皮下(subcu)的維持劑量會在什麼時候導入?會是在第 78 週還是第 84 週?你們會評估這些皮下劑量多久?另外一個延伸問題是,VANQUISH 在治療期每週 7.5 與 12.5 的劑量隊列,你們如何看待這些病人轉換到維持劑量?因為維持試驗在那個 19 週誘導期中正在評估每週 15 毫克及更高劑量。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Well, we'll -- for the first question, we'll transition people at 78 weeks won't be a sort of a washout or anything like that out and we plan to run the extension for 52 weeks. As far as the transition from $17.5 million to whatever the maintenance dose might be.
是的。嗯——針對第一個問題,我們會在 78 週時讓受試者轉換,不會有任何洗脫期之類的安排,我們計畫將延伸期進行 52 週。至於從 17.5 毫克轉換到不論最終維持劑量為何。
Yes, if you were to go from 17.5% to a higher 22.5 mg dose or something like that, there could be some incremental adverse events. That's not really what you see after a prolonged exposure like this, but those are all the things that we'll find out during the trial.
是的,如果你從 17.5 毫克提高到 22.5 毫克或類似更高劑量,可能會出現一些額外的不良事件增量。在這種長期暴露之後,通常不太會看到那樣的情況,但這些都是我們會在試驗中釐清的事情。
Thanks, Biren.
謝謝你,Biren。
Operator
Operator
Jay Olson, Oppenheimer.
Jay Olson,Oppenheimer。
Jay Olson - Analyst
Jay Olson - Analyst
Congrats on all the progress. Just a follow-up on some of the factors that informed your decision to initiate the Phase III oral study in the fourth quarter. Did you want to see the results of the Phase I maintenance study in the third quarter before starting the Phase III oral study in the fourth quarter? Or were there other factors involved -- and then we also had a question on 3019. Could you just talk about your plans for the Phase I amylin program?
恭喜你們取得所有進展。我想追問一下,哪些因素促成你們決定在第四季啟動第三期口服研究?你們是否想先在第三季看到第一期維持研究的結果,再於第四季啟動第三期口服研究?還是有其他因素——另外我們也有一個關於 3019 的問題。你能談談你們第一期 amylin(胰澱素)計畫的規劃嗎?
Are you thinking about induction, maintenance combination, I guess, what's kind of on the table there for your amylin program.
你們是在考慮誘導、維持或合併治療嗎?我想問的是,你們的胰澱素計畫目前有哪些選項在評估中。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Jay. For the oral study, no, we weren't planning to wait for the data. They're just independent factors, the maintenance data and the initiation of the oral studies that were not related. With the 3019 molecule, the first study will be -- before you think about combos and that sort of thing, first, you want to understand the compounds basic properties.
是的。謝謝,Jay。關於口服研究,不,我們並沒有打算等那些數據。維持數據與啟動口服研究是彼此獨立的因素,兩者沒有關聯。至於 3019 這個分子,在你考慮合併用藥等事情之前,首先你要先了解該化合物的基本特性。
And so the first two studies will be a SAD study and then a MAD study. We are initiating combo talks with the 2735 compound. So longer term, I think that's a really promising area to look at. But the initial studies will just be single agent. And it would be kind of the playbook we used for 2735 with a (inaudible) followed by a 28-day mat.
因此前兩個研究會是一個 SAD(單次遞增劑量)研究,接著是一個 MAD(多次遞增劑量)研究。我們正在就 2735 這個化合物啟動合併用藥的討論。所以從長期來看,我認為那是一個非常有前景、值得探索的領域。但初期研究將只會是單藥。而且會大致沿用我們在 2735 上採用的策略:先做(聽不清)接著做 28 天的 MAD。
Nice opportunity with this mechanism to potentially target people who are a little lower BMI, 32 to 34, 35 or people who can't maybe can't tolerate the GLP-1 and want to try something different, but both are very significant opportunities for the amylin program.
這個機轉帶來一個很好的機會,可能可以鎖定 BMI 稍低的人群,例如 32 到 34、35,或是一些可能無法耐受 GLP-1、想嘗試不同療法的人;但對胰澱素計畫而言,兩者都是非常重大的機會。
Operator
Operator
Andy Hsieh, William Blair.
Andy Hsieh,William Blair。
Andy Hsieh - Equity Analyst
Andy Hsieh - Equity Analyst
Just for the extension portion of the VANQUISH study, I'm curious about maybe the patient's ability to select just given the open-label nature of the study? And also do you allow patients to maybe down titrate if you're they're at a higher monthly dose or up titrate if they actually see like a weight regain -- just maybe from a practical protocol-related nation.
關於 VANQUISH 研究的延伸部分,我想了解在研究採取開放標籤的情況下,病人是否能夠自行選擇?另外,你們是否允許病人在每月較高劑量時下調滴定,或如果他們出現體重回升時上調滴定——主要是從實務與方案設計相關的角度來問。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Andy. Great question. It's not really an open-label study. And so people -- if you were on placebo, you will be randomized to active agents, but you don't know which dose level you'll be at -- and we're not going to, I think, discuss many design details otherwise until we actually start the study, but you can imagine some people staying on their current therapy and some people transitioning maybe to a maintenance regimen.
是的。謝謝,Andy。問得很好。這其實不算是一個開放標籤研究。因此受試者——如果你原本在安慰劑組,你會被隨機分派到有效藥,但你不知道自己會在哪個劑量層級——此外,在我們真正啟動研究之前,我想我們不會討論太多設計細節;但你可以想像,有些人會維持目前治療,有些人可能會轉換到維持療程。
So different groups of people might be randomized to different cohorts. I think it's a very elegant and nice study design, but we probably won't discuss too many details until we actually start it. Thanks, Andy.
因此不同族群的受試者可能會被隨機分派到不同隊列。我認為這是一個非常精巧且很好的研究設計,但在我們真正開始之前,可能不會透露太多細節。謝謝,Andy。
Operator
Operator
Roger Song, Jefferies.
Roger Song,Jefferies。
Roger Song - Equity Analyst
Roger Song - Equity Analyst
Great. To put a final point on the VANQUISH extension regimen from the maintenance data you will report. I understand that you want to expand every two weeks dosing. And then is that fair to say you want to pick one monthly on for every two weeks. And how much delta among those dosing regimens you will take multiple within those two frequency?
很好。就你們將公布的維持數據來看,想對 VANQUISH 延伸療程做個最後確認。我理解你們想擴展到每兩週一次的給藥。那麼是否可以說,你們也想在每兩週一次的方案中挑選一個每月一次的方案?而在這兩種給藥頻率之內,你們會納入多少不同方案之間的差異(delta),也就是會在各頻率下選多個方案嗎?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Thanks, Roger. Yes. So I think more generally, we want to select the most effective arms and doses. So not wedded to a certain number of every other week or a certain number of monthly just whatever seems to be the most effective. So we would look at multiple arms to come forward, and those will be based on whatever seems to look best in this initial 102 maintenance study.
謝謝,Roger。是的。我想更一般地說,我們希望選出最有效的治療組別與劑量。因此我們不會拘泥於一定要有多少個隔週一次的組別或多少個每月一次的組別,而是以看起來最有效者為準。所以我們會評估多個組別以決定後續推進,而這些選擇將以最初這項 102 維持研究中看起來最佳的結果為依據。
Thanks, Roger.
謝謝,Roger。
Operator
Operator
William Wood, B. Riley Securities.
William Wood,B. Riley Securities。
William Wood - Analyst
William Wood - Analyst
Very nice progress you've been making. So two from us, one upfront and then a follow-up. I'm just curious in terms of your maintenance trial with the additions of the new subcu and then also it sounds like the new additions of the oral. Should we expect any delay in timing throughout the third quarter, maybe from the beginning to the end and/or should we expect sort of multiple data cuts throughout the third quarter in terms of whether it's at the 19-week and then the final maintenance or we'll get the subcu first and then the oral. Maybe just if you could clarify on that?
你們的進展非常不錯。我們有兩個問題,一個先問,然後再追問。我想了解你們的維持試驗,新增了新的皮下(subcu)隊列,另外聽起來也新增了口服隊列。我們是否應該預期第三季的時程會有任何延後,例如從季初延到季末?以及/或我們是否應該預期第三季會有多次數據釋出,例如 19 週時先釋出一次,然後最終維持期再釋出一次;或是先拿到皮下數據,再拿到口服數據?能否請你澄清一下?
And then I have a follow-up.
然後我還有一個追問。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, William. It will probably be two data releases, one for the subcu cohorts and then subsequently for the oral cohorts. But the subcu will be in the third quarter, and we don't anticipate there being a substantial difference in the timing for the data to be available. Maybe a little bit, but nothing significant.
是的。謝謝,William。很可能會有兩次數據發布,一次是皮下隊列,之後再發布口服隊列。但皮下的數據會在第三季,我們不預期可取得數據的時間點會有實質差異。可能會有一點點差,但不會很顯著。
William Wood - Analyst
William Wood - Analyst
Right. That's very helpful. And then on your VK3019. You've mentioned in the past that, that asset has shown better efficacy or potentially weight loss than your 2735, at least preclinically. I was curious if you could provide some of those comparative parameters of the two drugs, maybe Cmax, Tmax or half-life or even weight loss understanding it all be preclinical and how this might have compared to tirzepatide or even per amylin, if you've done any of those studies.
了解。這很有幫助。接著關於你們的 VK3019。你們過去提到,至少在臨床前,該資產顯示出比 2735 更好的療效或潛在減重效果。我想請問你是否能提供一些兩個藥物的比較參數,例如 Cmax、Tmax 或半衰期,甚至是減重效果——我理解這些都會是臨床前資料——以及若你們做過相關研究,它與 tirzepatide 或甚至與其他胰澱素(amylin)藥物相比表現如何。
Just sort of trying to get a better understanding of what stood out on this particular asset that decided for you to bring it to the clinic.
只是想更深入了解一下,這個特定資產有哪些突出的地方,讓你們決定把它推進臨床。
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, William. Yes, unfortunately, I don't carry a lot of those data around in my head. There's too much other junk up there. But it was very potent on the receptors, very good PK profile that would be amenable to weekly dosing, we think, and that marries up nicely with the 2735-PK profile.
是的。謝謝你,William。是的,很遺憾,我腦子裡沒有隨時記著很多那類數據。裡面還塞了太多其他雜七雜八的東西。但它對受體的效力非常強,PK(藥物動力學)特性也非常好,我們認為適合每週給藥,而且這與 2735 的 PK 特性非常契合。
When we looked at data in rodents, it seemed to be better than cagrilintide. When we looked in obese monkeys, it seemed to provide better weight loss than VK2735. But I don't have those numbers off the top of my head, these are just general comments. Thanks, William.
當我們看齧齒類動物的數據時,它看起來比 cagrilintide 更好。當我們看肥胖猴的數據時,它似乎能帶來比 VK2735 更好的減重效果。但我一時想不起具體數字,這些只是概括性的評論。謝謝你,William。
Operator
Operator
Hardik Parikh, JPMorgan.
JPMorgan 的 Hardik Parikh。
Hardik Parikh - Analyst
Hardik Parikh - Analyst
Just a couple of questions on the oral program. So just one is I know in the past, you've talked about you're working on reducing the number of tablets you have to take at a dose. I was wondering if you have any updates there on where you are in that progress? And then just a high-level question on -- you mentioned the launch of another oral peptide -- just what are you -- how are you -- where do you think the takeaways from that launch in terms of just what it says about the overall market and then the role of oral peptides in general?
關於口服項目有幾個問題。第一個是,我知道過去你們提過正在努力減少每個劑量需要服用的錠數。想請問這方面目前進展到哪裡?有沒有更新?另外一個高層次的問題是——你們提到另一款口服胜肽的上市——你們認為從那次上市可以得到哪些重點啟示?就整體市場而言它代表什麼,以及口服胜肽整體扮演的角色是什麼?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Hardik. So we would want to have no more than two tablets as the higher dose option lower doses would be one tablet. So in the Phase II trial, everybody took four tablets and the feedback we received was that's just people weren't real satisfied with that -- so no more than two tablets. And we generally don't comment too much about competitive dynamics.
是的。謝謝你,Hardik。我們希望高劑量選項最多不超過兩錠;較低劑量則是一錠。因此在第二期試驗中,每位受試者都服用四錠,而我們收到的回饋是大家對此並不太滿意——所以最多不超過兩錠。另外,我們通常不會對競爭態勢做太多評論。
But I think the launch of the current oral peptide has been very robust, and it supports this real, I think, high interest level in the oral modality. And interestingly, it's represented more of a market expansion than any sort of cannibalization of the injectable market. So it's been, I think, a very, very impressive launch.
但我認為目前這款口服胜肽的上市表現非常強勁,這也支持了市場對口服劑型確實有很高的興趣。而且有趣的是,它更多代表市場擴張,而不是對注射市場的任何蠶食。所以我認為這是一個非常、非常令人印象深刻的上市。
And Neil Aubuchon is our Chief Commercial Officer. He's here as well. Neil, do you have any additional color on that?
另外,Neil Aubuchon 是我們的首席商務官。他也在現場。Neil,你能否再補充一些看法?
Neil Aubuchon - Chief Commercial Officer
Neil Aubuchon - Chief Commercial Officer
Yes. Brian, I think you characterized it well, Hardik, this is Neil here. Yes, I think what we're seeing is this is growing the market. So it just goes to show that there's significant opportunities still -- it's too early to comment on the latest launch. I think it's just several weeks in.
好的。Brian,我想你描述得很到位。Hardik,我是 Neil。是的,我認為我們看到的是它正在擴大市場。所以這也顯示仍然存在顯著的機會——但要評論最新這次上市還太早。我想目前也才過了幾週。
So we wouldn't have commented in any way, but it's awfully early. It's going to be quite competitive dynamic between these two companies, as you would expect. The only thing I would also just remind you is that both the orals on the market are GLP-1s, where ours is going to be a dual agonist oral. So we expect to have the first dual agonist oral on the market. And I don't know if that's fully appreciated by folks in the ecosystem.
所以我們不會以任何方式做出評論,但確實還非常早。如你所預期,這兩家公司之間的競爭態勢會相當激烈。我另外想提醒的一點是,市面上兩款口服產品都是 GLP-1,而我們將會是一款雙重致效劑(dual agonist)的口服產品。因此我們預期會成為市場上第一個口服雙重致效劑。而我不確定生態系中的各方是否已充分意識到這一點。
So we're pretty excited about the opportunity for oral. Thanks, Hardik.
所以我們對口服機會感到非常興奮。謝謝你,Hardik。
Operator
Operator
Yale Jen, Laidlaw & Company.
Laidlaw & Company 的 Yale Jen。
Yale Jen - Analyst
Yale Jen - Analyst
In terms of the VANQUISH expansion study, would that also include both VANQUISH-1 and VANQUISH-2 in terms of the type 2 diabetes patients as well as if you will incorporate some maintenance regimen into those -- in that study, would that also include type 2 diabetes patients as well.
就 VANQUISH 擴展研究而言,是否也會涵蓋 VANQUISH-1 與 VANQUISH-2 中的第二型糖尿病患者?另外,如果你們會在該研究中納入某種維持治療方案,那是否也會包含第二型糖尿病患者?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes, it will. Yes.
是的,會。是的。
Operator
Operator
Our final question will come from Jeet Mukherjee from BTIG.
我們最後一個問題來自 BTIG 的 Jeet Mukherjee。
Unidentified Participant
Unidentified Participant
This is [Blake] on for Jeet. In regards to the subcu maintenance data coming in the third quarter, what does good look like to you guys in -- are you comfortable reporting a modest (inaudible)? If so, is there a BARDA standard that qualifies as weight to retention?
我是 [Blake],代 Jeet 提問。關於第三季將公布的皮下(subcu)維持治療數據,對你們而言「好的結果」長什麼樣子——你們是否能接受報告一個溫和的(聽不清)?如果可以,是否有一個 BARDA 的標準可用來界定何謂體重維持(weight retention)?
Brian Lian - President, Chief Executive Officer, Director
Brian Lian - President, Chief Executive Officer, Director
Yes. Thanks, Blake. It's a good question. I guess the way we look at it is best case scenario is you see a continuation of weight loss when you transition to the maintenance regimen, just slope might change a little bit. I think our base case is -- which is a great outcome.
是的。謝謝你,Blake。這是個好問題。我想我們的看法是,最佳情境是在轉換到維持治療方案後仍能持續減重,只是斜率可能會稍微改變。我認為我們的基本情境是——而這其實就是很好的結果。
It's just a real maintenance, less than really a few percent either way up or down. And then the worst case would be you see a sharp rebound. So those are kind of the general scenarios that we're looking at. And I think a flat lining or relatively flat after the transition would be a really great outcome for us.
也就是確實維持住,體重上下變動不超過幾個百分點。最糟的情境則是看到明顯反彈。所以這些大致是我們在觀察的幾種情境。我認為在轉換後呈現持平或相對持平,對我們而言會是非常好的結果。
Operator
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
問答環節到此結束。我想把電話會議交回給 Stephanie Diaz,請她做結語。
Stephanie Diaz - Manager of Investor Relations
Stephanie Diaz - Manager of Investor Relations
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.
再次感謝各位的參與,以及對 Viking Therapeutics 的持續支持。我們期待在未來幾個月再次向各位更新。祝各位下午愉快。
Operator
Operator
Thank you. The conference has now concluded. Thank you for attending.
謝謝。本次電話會議到此結束。感謝各位出席。