Vir Biotechnology Inc (VIR) 2025 Q3 法說會逐字稿

Hello and welcome to Vir Biotechnology third quarter 2025 financial results and corporate update call. As a reminder, this conference call is being recorded.

大家好，歡迎參加 Vir Biotechnology 2025 年第三季財務業績及公司最新進度電話會議。再次提醒，本次電話會議正在錄音。

(Operator Instructions)

（操作說明）

I will now turn the call over to Jason O'Byrne, Chief Financial Officer. Please go ahead.

現在我將把電話轉交給財務長傑森·奧伯恩。請繼續。

Thank you and good afternoon. With me today are Dr. Marianne De Backer, our Chief Executive Officer, and Dr. Mark Eisner, our Chief Medical Officer.

謝謝，下午好。今天陪同我的是我們的執行長瑪麗安·德·貝克博士和我們的首席醫療官馬克·艾斯納博士。

Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including forms 10K, 10Q, and 8K.

在開始之前，我想提醒大家，我們今天所作的一些陳述屬於證券法意義上的前瞻性陳述。這些前瞻性聲明涉及重大風險和不確定性，可能導致我們的臨床開發計劃、未來結果、業績或成就與此類前瞻性聲明中明示或暗示的內容有重大差異。這些風險和不確定性以及與我們業務相關的風險已在公司向美國證券交易委員會提交的報告中進行了描述，包括 10K 表格、10Q 表格和 8K 表格。

I will now turn the call over to our CEO, Marianne De Backer. Please go ahead.

現在我將把電話交給我們的執行長瑪麗安·德·貝克爾。請繼續。

Good afternoon, everyone, and thank you for joining us for Vir Biotechnology third quarter 2025 earnings call. Today's call will highlight the significant progress we've made and a clear path forward as an organization. We'll provide guidance on our VIR-5500 program timeline, discuss the upcoming solstice data presentation, and highlight how our clinical execution this quarter positions us for the significant value creating opportunities ahead.

各位下午好，感謝各位參加 Vir Biotechnology 2025 年第三季財報電話會議。今天的電話會議將重點介紹我們所取得的重大進展，以及我們作為組織未來發展的明確方向。我們將提供有關 VIR-5500 項目時間表的指導，討論即將舉行的年度數據發布會，並重點介紹我們本季度的臨床執行情況如何使我們為未來創造重大價值的機會做好準備。

The third quarter has been marked by important achievements across both our Hepatitis Delta and T-cell engager programs that demonstrate our ability to execute on critical milestones. Our team remains committed to powering the immune system to transform patients' lives, and today we'll outline how our recent accomplishments set the stage for what we believe will be a pivotal period for Vir Bio.

第三季度，我們在C型肝炎和T細胞銜接器專案方面都取得了重要成就，這證明了我們有能力實現關鍵里程碑。我們的團隊始終致力於增強免疫系統，進而改變患者的生活。今天，我們將概述我們最近的成就如何為我們認為對 Vir Bio 至關重要的時期奠定基礎。

I will now highlight the key accomplishments from this quarter that demonstrate this accelerating momentum. First, we completed enrollment in Eclipse 1, our first registrational Phase 3 study for Hepatitis Delta. Second, we're excited to provide guidance that we plan to share a comprehensive data update for the 5500, a pro extant masked PSMA targeted T-cell engager in the first quarter of 2026. And third, we dosed the first patient in our first line metastatic castration resistant prostate cancer combination study with androgen receptor phosphate inhibitors. Collectively, these achievements represent an acceleration in our development trajectory and provide clear line of sight to multiple value creating catalysts ahead. We're executing with precision while advancing towards multiple important data readouts and regulatory milestones.

接下來，我將重點介紹本季所取得的主要成就，這些成就體現了這種加速發展勢頭。首先，我們完成了 Eclipse 1 的入組，這是我們第一個針對丁型肝炎的註冊性 3 期研究。其次，我們很高興地宣布，我們計劃在 2026 年第一季分享 5500 的全面數據更新，5500 是一種針對現有掩蔽 PSMA 靶向 T 細胞的銜接器。第三，我們在針對轉移性去勢抵抗性前列腺癌的第一線聯合治療研究中，對第一位患者使用了雄性激素受體磷酸酯抑制劑。總而言之，這些成就代表著我們發展軌跡的加速，並為未來多個創造價值的催化劑提供了清晰的指引。我們正在精準執行各項工作，同時朝著多個重要的數據解讀和監管里程碑邁進。

I will now provide more detail on our Hepatitis Delta program where we've made exceptional progress this quarter. The completion of Eclipse 1 enrollment represents a pivotal step towards bringing our differentiated combination regimen to patients with Hepatitis Delta in the United States and beyond. This achievement, accomplished ahead of our internal projections, reflects both strong investigator confidence and the substantial unmet medical need in this devastating disease.

接下來我將詳細介紹我們的丁型肝炎防治項目，本季我們取得了顯著進展。Eclipse 1 招募工作的完成標誌著我們向美國及其他地區的C型肝炎患者推出差異化聯合治療方案邁出了關鍵一步。這項成就比我們內部的預期提前完成，既反映了研究人員的強烈信心，也反映了這種毀滅性疾病方面尚未得到充分滿足的醫療需求。

With Eclipse 1 enrollment complete, we now expect primary completion in the fourth quarter of 2026, with topline data for all three eclipse studies expected by the first quarter of 2027. This accelerated timeline positions us well for regulatory submissions and demonstrates our operational excellence in executing registrational studies.

隨著 Eclipse 1 的招募工作完成，我們現在預計將在 2026 年第四季度完成主要工作，所有三項 Eclipse 研究的初步數據預計將在 2027 年第一季公佈。這項加快的時間表使我們在監管申報方面處於有利地位，並展現了我們在執行註冊研究方面的卓越營運能力。

Eclipse 2 continues to involve well across European sites and remains on track. Together, Eclipse 1 and Eclipse 2 are designed to form the backbone of our regulatory filing package. Eclipse 3, or Phase 2B head-to-head comparison against lever tide, is progressing ahead of schedule with strong enrollment momentum and will provide valuable comparative data to support access and reimbursement discussions, particularly in European markets.

Eclipse 2 繼續在歐洲各地順利進行，並按計劃推進。Eclipse 1 和 Eclipse 2 共同構成了我們監理申報包的主體。Eclipse 3（或 2B 期與 Lever Tide 的頭對頭比較）進展順利，入組勢頭強勁，並將提供有價值的比較數據，以支持准入和報銷方面的討論，尤其是在歐洲市場。

The Hepatitis Delta market represents a compelling commercial opportunity with approximately 61,000 RNA positive patients in the United States and 113,000 in EU markets. The patient population's geographic concentration, particularly in major US urban centers, supports an efficient commercial approach with the target specialty sales organization focused on hepatenologists and infectious disease specialists.

丙型肝炎市場蘊藏著巨大的商業機會，美國約有 61,000 名 RNA 陽性患者，歐盟市場約有 113,000 名 RNA 陽性患者。患者群體的地理集中性，尤其是在美國主要城市中心，有利於採取高效的商業策略，目標專業銷售組織應專注於肝病學家和傳染病專家。

Looking ahead to this month, we're preparing to present the complete 48-week solstice data set at ASLD on November 9th. This presentation will provide important insights into the safety and efficacy profile of our combination regimen and is expected to provide supportive data that reinforces confidence in our registration program.

展望本月，我們準備在 11 月 9 日的 ASLD 會議上展示完整的 48 週冬至資料集。本次報告將提供有關我們聯合治療方案的安全性和有效性的重要見解，並有望提供支持性數據，從而增強人們對我們註冊計劃的信心。

Turning to our oncology portfolio, we are excited to provide guidance that we plan to share a data update for VIR-5500, our PSMA targeted T-cell engager in the first quarter of 2026. We've made substantial progress in our dose escalation across both weekly and every three weeks schedules, and this data set is expected to provide important insights into the program's potential. We are enthusiastic about this program and the differentiated PRO-XTEN dual masking approach.

談到我們的腫瘤產品組合，我們很高興地宣布，我們計劃在 2026 年第一季分享 VIR-5500（一種針對 PSMA 的 T 細胞銜接器）的數據更新。我們在每周和每三週的劑量遞增方案方面都取得了實質進展，預計該資料集將為該專案的潛力提供重要的見解。我們對這個專案和PRO-XTEN獨特的雙重遮蔽方法感到非常興奮。

As I mentioned, we recently dosed the first patient in our first line metastatic castration resistant prostate cancer combination study with ERPRs, a first step towards addressing a significant unmet need for patients in earlier treatment lines. For VIR-5818, our PRO-XTEN masked HER2 targeted T-cell engagers, we are continuing dose escalation in combination with embrolizumab, which is actively enrolling. For VIR-5525, our PRO-XTEN masked EGFR targeted T-cell engager, our program continues to advance with enrollment in our Phase 1 study progressing as expected. We are leveraging the extensive learnings from both VIR-5818 and VIR-5500 to enable efficient development and accelerate decision making.

正如我之前提到的，我們最近在針對轉移性去勢抵抗性前列腺癌的第一線聯合治療研究中，對第一位患者使用了 ERPRs，這是解決早期治療患者重大未滿足需求的第一步。對於 VIR-5818（我們的 PRO-XTEN 掩蔽 HER2 標靶 T 細胞銜接器），我們正在繼續與 embrolizumab 聯合進行劑量遞增試驗，目前正在積極招募患者。對於我們的 PRO-XTEN 掩蔽 EGFR 靶向 T 細胞銜接器 VIR-5525，我們的計畫正在繼續推進，1 期研究的入組工作也按預期進行。我們正在利用從 VIR-5818 和 VIR-5500 中汲取的豐富經驗，以實現高效開發並加快決策。

The clinical experience we're gaining across three distinct targets, PSMA, HER2, and EGFR is building evidence for the versatility of the PRO-XTEN universal masking platform. This emerging clinical validation gives us confidence as we advance our pre-clinical pipeline of additional T-cell engager candidates targeting various tumor associated antigens whether through internal development or strategic partnerships that leverage our platform technology.

我們在 PSMA、HER2 和 EGFR 這三個不同的標靶上累積的臨床經驗，正在為 PRO-XTEN 通用掩蔽平台的通用性提供證據。這項新興的臨床驗證讓我們更有信心推進更多針對各種腫瘤相關抗原的 T 細胞銜接器候選藥物的臨床前研發，無論是透過內部開發還是利用我們平台技術的策略合作。

Finally, we ended the third quarter with approximately $810.7 million in cash, cash equivalents and investments. Based on our current operating plan, we continue to project our cash runway expanding into mid 2027. This strong financial foundation enables us to advance our registration on Hepatitis Delta program and our oncology pipeline with confidence.

最後，截至第三季末，我們持有約 8.107 億美元的現金、現金等價物和投資。根據我們目前的營運計劃，我們預計現金流將持續到 2027 年年中。雄厚的財務基礎使我們能夠充滿信心地推進丙型肝炎計畫的註冊和腫瘤治療產品線。

With that, I'll now turn the call over to Mark to provide a more detailed update on our clinical development program.

接下來，我將把電話交給馬克，讓他更詳細地介紹我們的臨床開發項目。

Thank you, Marianne. I'm pleased to provide detailed updates on our clinical development programs. Starting with our Hepatitis Delta program, Eclipse 1 enrollment was successfully completed with approximately 120 participants randomized 2 to 1 to our combination therapy versus deferred treatment. This achievement was accomplished approximately two months ahead of our aggressive internal enrollment assumptions, demonstrating exceptional execution by our study teams and reflecting the significant unmet medical need in this patient population.

謝謝你，瑪麗安。我很高興向大家詳細介紹我們的臨床開發項目的最新進展。從我們的C型肝炎計畫開始，Eclipse 1 的招募工作已成功完成，約有 120 名參與者以 2:1 的比例隨機分配到我們的聯合治療組或延遲治療組。這項成就比我們積極的內部招募預期提前了大約兩個月完成，證明了我們研究團隊的出色執行力，也反映了該患者群體中尚未滿足的重大醫療需求。

The strength of our enrollment reflects multiple factors. First, the robust solstice Phase 2 study results. Second, strong engagement with our clinical investigator community. Third, the absence of FDA approved treatments for Hepatitis Delta in the United States and limited options globally. And fourth, the urgent need for more effective and convenient therapies for this devastating disease.

我們的招生實力反映了多種因素。首先，是 Solstice 2 期研究的可靠結果。第二，與我們的臨床研究人員群體保持密切聯繫。第三，美國沒有FDA核准的C型肝炎治療方法，全球治療選擇也有限。第四，迫切需要更有效、更方便的治療方法來應對這種毀滅性疾病。

Study team engagement throughout startup led to accelerated country and site activation, allowing us to complete study enrollment faster than originally projected. This was further reinforced by consistent enrollment momentum across regions with investigators actively identifying and referring patients.

研究團隊在整個啟動過程中積極參與，加快了國家和站點的啟動速度，使我們能夠比原計劃更快地完成研究招募。各地區持續不斷的招募動能進一步強化了這一點，研究人員積極尋找並推薦患者。

Eclipse 2 continues with enrollment progressing well across multiple European sites [demonstrating] in treatment naive patients and based on the strength of enrollment we're seeing is tracking toward a similar completion timeline as Eclipse 1 and 2. Eclipse 3 enrollment has progressed ahead of our projections, and this study will provide critical comparative data for access and reimbursement discussions with topline data expected in the first quarter of 2027 alongside the other eclipse studies.

Eclipse 2 的招募工作正在多個歐洲地點順利進行，[顯示]在未經治療的患者中，根據我們看到的招募力度，其完成時間表與 Eclipse 1 和 2 類似。Eclipse 3 的註冊進展比我們預期的要快，這項研究將為准入和報銷討論提供關鍵的比較數據，預計將於 2027 年第一季度與其他 Eclipse 研究一起公佈主要數據。

Regarding our upcoming AASLD presentation, the complete solstice 48-week data set for the combination regimen of [Tovivabar and losaran] represents an important clinical milestone. This additional follow-up provides important safety and efficacy insights and builds on our previously reported compelling Phase 2 results that demonstrated 64% of patients achieving HDV RNA target not detected at week 36 with our monthly combination regimen.

關於我們即將向 AASLD 發表的報告，[Tovivabar 和 losaran] 聯合治療方案的完整 48 週 Solstice 數據集代表了一個重要的臨床里程碑。這項額外的後續研究提供了重要的安全性和有效性見解，並建立在我們先前報告的令人信服的 2 期結果之上，該結果表明，使用我們的每月聯合治療方案，64% 的患者在第 36 週達到了 HDV RNA 未檢出的目標。

Turning to our oncology programs, we continue to advance our pro extend mass T-cell engager portfolio across multiple targets. For VIR-5500, our masked PSMA targeted T-cell engager, dose escalation is advancing in both weekly and every three weeks schedules. We have not reached a maximum tolerated dose, and escalation continues as planned.

轉向我們的腫瘤學項目，我們將繼續推進我們的大規模 T 細胞銜接器產品組合，以覆蓋多個目標。對於我們的掩蔽型 PSMA 標靶 T 細胞銜接器 VIR-5500，劑量遞增正在每周和每三週的方案中推進。我們尚未達到最大耐受劑量，劑量遞增將按計劃繼續進行。

The half-life of 8 to 10 days potentially supports our every 3-week dosing evaluation with the potential for even longer dosing intervals. As Marianne mentioned, we achieved an important milestone this quarter with the first patient dose in our first line metastatic castration resistant prostate cancer combination study with androgen receptor pathway inhibitors. This earlier line expansion offers the potential to address significant unmet need for patients earlier in their treatment journey.

8 至 10 天的半衰期可能支持我們每 3 週進行一次給藥評估，並且有可能延長給藥間隔。正如 Marianne 所提到的，本季度我們取得了重要的里程碑，在針對轉移性去勢抵抗性前列腺癌的一線聯合治療研究中，我們首次對患者使用了雄激素受體通路抑制劑。更早擴展產品線，預計在患者治療早期階段滿足其重要的未滿足需求。

We're planning for a comprehensive data update in the first quarter of 2026 with a meaningful data set across dose levels in late line patients. We expect this will include safety assessments and efficacy measures including PSA responses and kinetics, imaging, and resist evaluations.

我們計劃在 2026 年第一季進行全面的數據更新，屆時將獲得晚期患者不同劑量水平的有意義的數據集。我們預計這將包括安全性評估和療效指標，包括 PSA 反應和動力學、影像和抗藥性評估。

The program is designed to leverage the potential advantages of the PRO-XTEN platform, including a favorable safety profile and extended half-life. Our approach seeks to maximize the therapeutic index of solid tumor T-cell engagers through selective tumor activation while minimizing systemic activity.

該計劃旨在利用 PRO-XTEN 平台的潛在優勢，包括良好的安全性和較長的半衰期。我們的方法旨在透過選擇性活化腫瘤來最大限度地提高實體瘤 T 細胞銜接器的治療指數，同時最大限度地減少全身活性。

For VIR-5818, our HER2 targeted T-cell engager, combination dose escalation with pembrolizumab is actively enrolling and progressing according to plan. For VIR-5525, our EGFR targeted T-cell engager, Phase 1 steady enrollment is also progressing as expected. The study design incorporates learnings from VIR-5818 and VIR-5500 to enable efficient dose escalation. We are evaluating both monotherapy and combination with pembrolizumab across multiple EGFR expressing tumor types.

對於我們的 HER2 標靶 T 細胞銜接器 VIR-5818，與帕博利珠單抗聯合劑量遞增試驗正在積極招募患者，並按計劃進展。對於我們的 EGFR 標靶 T 細胞銜接器 VIR-5525，1 期臨床試驗的穩定入組也如預期進行。研究設計融合了 VIR-5818 和 VIR-5500 的經驗，以實現有效的劑量遞增。我們正在評估單藥治療和與帕博利珠單抗聯合治療在多種表達 EGFR 的腫瘤類型中的療效。

As we've discussed on our second quarter call, we believe this program has the potential to address significant unmet need for patients across multiple solid tumor types where current EGFR targeted approaches have important limitations. We also continue to advance multiple preclinical T-cell engager candidates targeting various tumor associated antigens.

正如我們在第二季電話會議上討論的那樣，我們相信該計畫有潛力解決多種實體瘤患者尚未滿足的重大需求，而目前針對 EGFR 的方法在這些方面存在重要的局限性。我們也將持續推進多個針對各種腫瘤相關抗原的臨床前 T 細胞銜接器候選藥物的研發。

The clinical experience from our current programs is informing the development of these pre-clinical candidates, and we're taking a strategic approach that combines internal advancement with potential partnership opportunities to accelerate development and advance a broader pipeline that addresses unmet need across multiple cancer types.

我們目前計畫的臨床經驗正在指導這些臨床前候選藥物的開發，我們正在採取策略性方法，將內部進展與潛在的合作機會相結合，以加速開發並推進更廣泛的產品線，以滿足多種癌症類型中尚未滿足的需求。

We've made exceptional progress across our entire clinical portfolio during the third quarter. Eclipse 1 enrollment completion provides a clear path to pivotal data in early 2027 for all three Eclipse studies. Our upcoming VIR-5500 data update will provide important insights into our oncology pipeline's potential, and our platform leaves us well positioned to efficiently advance multiple future candidates.

第三季度，我們在整個臨床產品組合中都取得了卓越的進展。Eclipse 1 招募工作的完成為所有三項 Eclipse 研究在 2027 年初獲得關鍵數據提供了明確的途徑。我們即將發布的 VIR-5500 數據更新將為我們腫瘤產品線的潛力提供重要的見解，而我們的平台使我們能夠有效地推進多個未來的候選藥物。

With that, I'll now hand the call over to Jason for a financial update.

接下來，我會把電話交給傑森，讓他報告一下財務狀況。

Thank you, Mark. I am pleased to share our third quarter financial performance and overall financial position.

謝謝你，馬克。我很高興與大家分享我們第三季的財務表現和整體財務狀況。

R&D expense for the third quarter of 2025 was $151.5 million which included $5.5 million of non-cash stock-based compensation, and a $75 million milestone payment triggered by first in human dosing of VIR-5525. This compares to $195.2 million for the same period in 2024, which included $8.9 million of stock-based compensation and a $102.8 million upfront payment made to Sanofi at the closing of our exclusive worldwide license agreement.

2025 年第三季的研發費用為 1.515 億美元，其中包括 550 萬美元的非現金股票補償金，以及因 VIR-5525 首次人體給藥而觸發的 7,500 萬美元里程碑付款。相較之下，2024 年同期為 1.952 億美元，其中包括 890 萬美元的股票選擇權補償金，以及在與賽諾菲簽訂獨家全球授權協議時支付的 1.028 億美元預付款。

The year over year decrease was primarily driven by lower license expense. And cost savings from previously announced restructuring initiatives, partially offset by increased clinical development expenses associated with our Hepatitis Delta and oncology programs.

年比下降的主要原因是許可證費用降低。此外，先前宣布的重組計劃也帶來了成本節約，但部分被與我們的丙型肝炎和腫瘤項目相關的臨床開發費用增加所抵消。

SG&A expense for the third quarter of 2025 was $22.2 million which included $5.8 million of stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

2025 年第三季的銷售、一般及行政費用為 2,220 萬美元，其中包括 580 萬美元的股票選擇權費用；而 2024 年同期為 2,570 萬美元，其中包括 780 萬美元的股票選擇權費用。這一下降主要是由於先前宣布的重組計劃提高了效率並節省了成本。

Our third quarter of 2025 operating expenses totaled $173.7 million, representing a $46.2 million decrease from the same period in 2024. Net loss for the third quarter of 2025 was $163.1 million compared to a net loss of $213.7 million for the same period last year.

2025 年第三季營運支出總計 1.737 億美元，比 2024 年同期減少了 4,620 萬美元。2025 年第三季淨虧損為 1.631 億美元，去年同期淨虧損為 2.137 億美元。

Turning to cash, our net change in cash and investments in the third quarter was approximately $81.4 million. During the third quarter, we also made certain cash payments from restricted cash, including a $75 million payment to former Aminex shareholders.

就現金而言，我們第三季的現金和投資淨變動約為 8,140 萬美元。第三季度，我們也從受限現金中支付了一些款項，其中包括向 Aminex 前股東支付的 7,500 萬美元。

As described earlier, this payment was triggered by dosing the first patient in our VIR-5525 study and was fully anticipated. Having been held in escrow as restricted cash since we signed the Sanofi agreement last year. As a reminder, restricted cash is excluded from our reported balances of cash, cash equivalents, and investments. As such, disbursements from restricted cash accounts do not affect our projected cash runway.

如前所述，這筆款項是由於我們在 VIR-5525 研究中給第一位患者用藥而觸發的，並且完全在預料之中。自去年與賽諾菲簽署協議以來，這筆資金一直作為受限現金存放在第三方託管帳戶中。再次提醒，受限現金不計入我們報告的現金、現金等價物和投資餘額。因此，從受限現金帳戶中支出不會影響我們預期的現金儲備。

We ended the third quarter with approximately $810.7 million in cash, cash equivalents, and investments. Based on our current operating plan, we continue to project our cash runway extending into mid 2027. Our capital deployment strategy remains focused on our most promising programs.

第三季末，我們擁有約 8.107 億美元的現金、現金等價物和投資。根據我們目前的營運計劃，我們預計現金流將持續到 2027 年年中。我們的資金部署策略仍然集中在最有前景的項目上。

We're advancing our Hepatitis Delta eclipse registrational program, while also advancing our T-cell engager programs, including VIR-5500, VIR-5818, and VIR-5525.

我們正在推進丙型肝炎病毒 eclipse 註冊計劃，同時也在推進我們的 T 細胞銜接器計劃，包括 VIR-5500、VIR-5818 和 VIR-5525。

We continue to deploy capital strategically, prioritizing investments and programs with the greatest potential for both meaningful patient impact and value creation, while also advancing business development opportunities that can further optimize our resource allocation.

我們將繼續進行策略性資本部署，優先考慮對患者產生重大影響和創造價值潛力最大的投資和項目，同時推進能夠進一步優化資源配置的業務發展機會。

This concludes our prepared remarks. We will now initiate the Q&A session. Please limit questions to two per person so that we can get to all of our covering analysts. I'll turn it over to you, operator.

我們的發言稿到此結束。現在開始問答環節。請每人提問不超過兩個問題，以便我們能向所有負責通報的分析師提問。剩下的交給你，操作員。

(Operator Instructions)

（操作說明）

Gina Wong, Barclays.

吉娜·王，巴克萊銀行。

Hello, can you hear me? Thank you for taking our questions. This is [Kong Wong] on behalf of Gina Wong from Barclays. We have two questions. First one for the PSMA, the [Ja] actually setting higher bar for the PSA50. However, the durability doesn't seem good. So how do you think the PSMA could show actually differentiation of your assets and we know the QLs we spoke to actually focus on durability of the PSA control and more importantly, durability of the durable tumor response. The second question actually for the HDV for the history readout, what's your clinical bar as the key differentiation? Thank you.

你好，你聽得到我說話嗎？感謝您回答我們的問題。我是孔王，代表巴克萊銀行的吉娜·王。我們有兩個問題。PSMA 的第一個冠軍，[Ja] 實際上為 PSA50 設定了更高的標準。然而，其耐用性似乎不太好。那麼，您認為PSMA如何真正展現您資產的差異化優勢呢？我們知道，我們交談過的QL實際上關注的是PSA控制的持久性，更重要的是，是腫瘤反應的持久性。第二個問題實際上是針對 HDV 的歷史讀數，您的臨床標準是什麼，作為關鍵區分標準是什麼？謝謝。

Yeah, thank you for those questions. So maybe on PSMA, I will just start by saying that we're really excited to provide the guidance and share a comprehensive data update for our lead asset VIR-5500 in the first quarter of 2026. And of course, at that point we will have a really meaningful data set across multiple dose levels [in the late] time patient setting. We will have data on both weekly and every three weeks dosing, and there will be certainly sufficient numbers to provide robust insights.

是的，謝謝你的提問。所以，關於PSMA，我首先要說的是，我們非常高興能在2026年第一季提供指導意見，並分享我們主要資產VIR-5500的全面數據更新。當然，到那時，我們將擁有一個真正有意義的數據集，涵蓋多個劑量水平的後期患者情況。我們將獲得每週給藥和每三週給藥的數據，而且數據量肯定足夠大，可以提供可靠的見解。

Maybe I'll ask Mark to add anything.

或許我會請馬克補充一些內容。

Thanks Marianne. Well, we do think we have a differentiated approach with the [platform] and in particular for VIR-5500 PSMA. I'll comment on the fact that we use a steric hindrance mechanism for masking both the [CD3] and the PSMA side of the molecule. We have a dual masking approach which is unique in the mask PSMA space. It's a clinically validated approach. There's a product on the market called Eltuvio that uses the PRO-XTEN mask, so we know we know it's safe in that setting, and we think we can get to a really exceptional therapeutic index which would include both depth and durability of PSA response but stay tuned for our Q1 update.

謝謝你，瑪麗安。我們認為，我們在[平台]方面，特別是對於VIR-5500 PSMA，採取了差異化的方法。我要說明的是，我們使用空間位阻機制來遮蔽分子的 [CD3] 側和 PSMA 側。我們採用了一種在掩模 PSMA 領域獨一無二的雙重掩模方法。這是一種經過臨床驗證的方法。市面上有一款名為 Eltuvio 的產品使用了 PRO-XTEN 面罩，所以我們知道在這種環境下它是安全的，我們認為我們可以達到非常出色的治療指數，包括 PSA 反應的深度和持久性，但請繼續關注我們的第一季更新。

Your other question is about HDV and the eclipse program and what we think the bar is, particularly for Eclipse 1. Just to remind people, we showed in the solstice trial, 64% viral suppression target not detected at week 36. That was in week 36 that we presented before and we are going to be presenting the complete 48-week solstice Phase 2 data at ASLD very shortly. In terms of the bar, we think the combination of our [gloves are] have exceptional ability to suppress HDV viral RNA and achieve target not detected. We can hit HP surface antigen down by 3 logs. So I'm not going to give you a specific number today, but you know we are we are expecting to have a very exceptional efficacy in terms of the virologic outcomes that I mentioned.

您的另一個問題是關於 HDV 和 Eclipse 程序，以及我們認為的門檻是什麼，特別是對於 Eclipse 1 而言。提醒大家一下，我們在 Solstice 試驗中發現，第 36 週時未檢測到 64% 的病毒抑制目標。那是我們之前展示的第 36 週的數據，我們很快就會在 ASLD 上展示完整的 48 週冬至第二階段數據。就檢測範圍而言，我們認為我們的[手套]組合具有抑制HDV病毒RNA並實現未檢測到目標的卓越能力。我們可以將HP表面抗原濃度降低3個數量級。所以我今天不會給你們一個具體的數字，但是你們知道，我們預計在病毒學結果方面會取得非常卓越的療效，正如我所提到的。

Mike [Os], Morgan Stanley.

麥克（奧斯），摩根士丹利。

Hi, this is [Roon from Mike]. Thanks for taking our questions. In terms of the VIR-5500 data, will that be presented at a conference in early January, or do you think later in the quarter? And then secondly, is there anything you can point to that we should focus on the upcoming presentations at AASLD? Thank you.

您好，這裡是[來自 Mike 的 Roon]。謝謝您回答我們的問題。關於 VIR-5500 數據，您認為會在 1 月初的會議上公佈，還是會在本季稍後公佈？其次，您能否指出一些我們應該重點關注的AASLD即將發表的演講內容？謝謝。

So sure, so the first question is about the update and exactly the timing in quarter one and the setting for quarter one. We haven't provided that guidance exactly what month or what it will be the setting. I mean it could be a company event, it could be an academic conference, that's to be announced at a subsequent time. In terms of the focus for ASLD and the solstice, we will be showing the complete 48-week data for [Tard the Lesam and Tard] monotherapy arms. So, this will provide a complete update for target not detected, for HP surface antigens safety, so you'll get a complete picture there which I think will be a meaningful update from what we've shown before.

好的，第一季度是關於更新，以及第一季的具體時間和第一季的設定。我們尚未提供具體月份或活動安排的指導意見。我的意思是，這可能是公司活動，也可能是學術會議，時間待定。就 ASLD 和冬至的重點而言，我們將展示 [Tard the Lesam 和 Tard] 單藥治療組的完整 48 週數據。因此，這將提供關於未檢測到目標、HP 表面抗原安全性的完整更新，您將獲得一個完整的圖景，我認為這將是我們之前展示的內容的一個有意義的更新。

Thank you.

謝謝。

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

Hi, good afternoon, and thank you for taking our questions. My first is on 5500 as well. Can you please clarify if your planned update in the first quarter of next year will be just the monotherapy patients, or will you have any data with regard to the combination group that are being tested with ERPIs? And my second question is on Hep D. Gilead announced that they're filing [Volverittide], but at a 10 mg dose versus the 2 mg dose that is currently approved in Europe. Can you comment on how you think that might change the landscape here in the US as progress with your program? And also, any potential regulatory implications, if any, if you think that there are any there.

您好，下午好，感謝您回答我們的問題。我的第一台也是5500台。請問您能否澄清一下，您計劃在明年第一季發布的更新數據是否僅包含單藥治療患者的數據，還是也會有關於接受 ERPI 聯合治療組的數據？我的第二個問題是關於C型肝炎的。吉利德公司宣布他們正在申請[Volverittide]的上市許可，但劑量為10毫克，而目前歐洲批准的劑量為2毫克。您能否談談隨著您的專案在美國取得進展，您認為這將如何改變美國的現狀？此外，如果您認為有任何潛在的監管影響，也請一併提出。

Thank you very much.

非常感謝。

Thank you. Yeah, thank you, Paul. Maybe just on your first question, yeah, as we only recently started the first line and CRPC combination study with ERPIs, so that data will not be part of the first quarter 2026 update.

謝謝。謝謝你，保羅。或許只針對你的第一個問題，是的，因為我們最近才開始使用 ERPI 進行一線治療和 CRPC 聯合治療的研究，所以該數據不會包含在 2026 年第一季的更新中。

Yeah, so your question Paul is about the Gilead announcement that they effect approval in H2 2026 and your question specifically about the 10 mg dose. I mean, we actually think it's a very net positive for Vir Bio that Gilead will launch [blubbertide] ahead of us. We think that they will help to drive disease awareness. We think that they will help to focus on testing, HTV testing, which would make prepare the landscape for our launch. We don't see the 10 mg or 2 mg. We see those similarly. I mean, we still think our regimen of [Tobiard and Leon] can achieve really strong virologic suppression compared to [On Blover tied] with either dose. In terms of regulatory implications, we feel very confident that our program is designed to secure regulatory approval with Eclipse 1 and Eclipse 2 as being the core of the regulatory package, and the Eclipse 3 is providing really strong head-to-head information which will bolster the value proposition for patients and in particular for pairs in the EU.

是的，保羅，你的問題是關於吉利德宣布將在 2026 年下半年批准該藥物，而你的問題具體是關於 10 毫克劑量的。我的意思是，我們實際上認為吉利德公司搶在我們之前推出[blubbertide]對Vir Bio來說是一個非常積極的利好因素。我們認為它們將有助於提高人們對疾病的認識。我們認為這將有助於我們專注於測試，特別是 HTV 測試，這將為我們的發布做好準備。我們沒看到10毫克或2毫克的劑量。我們認為這些情況類似。我的意思是，我們仍然認為，與 [On Blover 方案] 相比，我們的 [Tobiard 和 Leon 方案] 在任何劑量下都能實現非常強的病毒抑制效果。就監管影響而言，我們非常有信心，我們的方案旨在獲得監管部門的批准，其中 Eclipse 1 和 Eclipse 2 是監管方案的核心，而 Eclipse 3 提供了非常強大的頭對頭訊息，這將增強對患者的價值主張，特別是對歐盟患者的價值主張。

Cory Kasimov, Evercore ISI.

Cory Kasimov，Evercore ISI。

Hi, thank you for taking our question. This is Josh Jazar on for Cory Kasimov. Based of your PK and PD modeling data, are you surprised that you have not reached the maximum tolerated dose for 5500? And can you share on whether you have seen any great 3 CRS events? Thank you.

您好，感謝您回答我們的問題。這裡是 Josh Jazar 代 Cory Kasimov 為您報道。根據您的 PK 和 PD 模型數據，您是否對尚未達到 5500 的最大耐受劑量感到驚訝？您能否分享一下您是否看過任何精彩的3CRS活動？謝謝。

So are we surprised that we have not reached the maximum tolerated dose? Well, we've been going through dose escalation systematically, and that's been going very well. I'm not really prepared to share any further details about dose escalation or results today, so stay tuned for our event in quarter one next year. And regarding more updated information on safety, again, we will be discussing that in quarter one next year at our data release.

所以，我們是否應該對尚未達到最大耐受劑量感到驚訝？我們一直有條不紊地進行劑量遞增，而且進展非常順利。今天我還不方便透露有關劑量遞增或結果的更多細節，敬請關注我們明年第一季的活動。至於安全方面的最新信息，我們將在明年第一季的數據發布會上再次進行討論。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Hey guys, this is Matthew on for Alec. Appreciate you taking our questions. In terms of the 48-week HDV data, can you maybe speak to how meaningful this data is for physician education ahead of a potential launch and any reason to think that there would be a significant change from week 36 to 48?

大家好，我是Matthew，代Alec報道。感謝您回答我們的問題。關於 48 週 HDV 數據，您能否談談這些數據對於在潛在上市前進行醫生教育的意義有多大，以及是否有任何理由認為從第 36 週到第 48 週會有重大變化？

So great question. I do think that the data will be meaningful for educating physicians, clinicians, and others who are interested in HDV about what our regimen can deliver at week 48. In terms of what we expect to show you, I would just say it's not going to be a long time, so stay tuned for our presentation. But you know we've been seeing deepening of responses over time to date. So, you know we're excited to have the presentation and look forward to sharing it with you.

問得好。我認為這些數據對於教育醫生、臨床醫生以及其他對 HDV 感興趣的人，讓他們了解我們的治療方案在第 48 週能達到的效果，將具有重要意義。至於我們打算向大家展示的內容，我只能說不會花很長時間，敬請期待我們的簡報。但你知道，隨著時間的推移，我們已經看到各方反應不斷加深。所以，我們非常興奮能進行這次演講，並期待與您分享。

Ellen Horst, TD Cowen.

艾倫·霍斯特，TD Cowen。

Hi guys, thanks for taking my question. Just to drill down a little bit more on the TCE update, can you talk little bit more about how you're prioritizing the three TC programs? Is there a world where you take all three of them forward or are you imagining that this will be a no go go decision, for all three such that, you only move forward with the best data and maybe talk about the [seven] points that you think are most important for that no go go decision whether it's response rate or durability, safety, etc. Thank you.

大家好，感謝你們回答我的問題。為了更深入地了解 TCE 更新，您能否再詳細談談您是如何確定三個 TC 專案的優先順序的？是否存在一種可能，讓這三個方案都繼續前進？或者您是否設想過，這三個方案最終都會被否決，也就是說，您只會基於最佳數據推進，並討論您認為對否決決定最重要的七個方面，例如響應率、耐用性、安全性等等。謝謝。

Thank you, Ellen. I'll start by saying our capital allocation priorities as we have said are really based on progressing our registrational study for Hepatitis Delta and then certainly accelerating as much as we can our VIR-5500 prostate cancer program. Our other T-cell engager programs obviously are gated based on data, it's typical. And as we have also shared before, we have a number of preclinical programs that have garnered a lot of external interest, so we're also looking at potential business development opportunities across our pipeline.

謝謝你，艾倫。首先我要說的是，正如我們之前所說，我們的資本分配重點實際上是推進丙型肝炎的註冊研究，然後當然要盡可能加快我們的 VIR-5500 前列腺癌計畫。我們其他的 T 細胞活化程序顯然都是根據數據進行篩選的，這是很常見的。正如我們之前分享過的，我們有許多臨床前計畫引起了外界的廣泛關注，因此我們也關注我們產品線中潛在的業務發展機會。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

Thanks for the question. So how are you thinking about the optimal setting for the TCE program in prostate cancer? We got the results from PSM addition, I'll be at a [tepid] reaction of us, but a lot more patients [PSMA radio ligand] exposed in the coming years. I know you've started the pre-taxing cohort, that's up and running, but should we expect some proof of conflict results post-PSMA [radio ligand] from your next update with more US patient role? Thanks.

謝謝你的提問。那麼，您認為前列腺癌TCE方案的最佳設定是什麼？我們從PSM添加中得到了結果，我對此反應冷淡，但未來幾年會有更多患者接受PSMA放射性配體治療。我知道你們已經開始了稅前隊列研究，而且研究進展順利，但是，如果你們下次更新中納入更多美國患者，我們是否可以期待在PSMA（放射性配體）治療後獲得一些衝突結果的證據呢？謝謝。

Sure, so in terms of what exactly expect in terms of the patient population for our update, just as a reminder, we are currently doing those escalation in both in both [Q Week] and Q3 week in the third line plus MCRPC setting that would you know include post-RLT patients as a population.

當然，那麼就我們此次更新的患者群體而言，具體預期是什麼，需要提醒的是，我們目前正在[Q Week]和Q3週對三線治療以及MCRPC患者進行升級，其中包括接受過RLT治療的患者群體。

We also started, as Marianne said, the frontline taxing naive, although we won't have that data for the update. In terms of we're ultimately in position, this outset in terms of the patient population, we are interrogating the full gamut and intent to the patient populations from late line to earlier line to hormone sensitive. So, this will ultimately be a data driven decision about how we ultimately position the molecule. But just to get back to the update in Q1, that will be the later line patients that were the part one or our part one of the Phase 1 program.

正如瑪麗安娜所說，我們也開始對一線徵稅，儘管我們在更新時不會有這些數據。就我們最終所處的位置而言，就患者群體而言，我們正在全面考察從晚期治療到早期治療再到激素敏感型治療的患者群體及其治療意圖。因此，最終我們將根據數據來決定如何定位該分子。但回到第一季的更新，那將是後期患者，也就是我們 1 期計畫的第一部分。

Joseph Stringer, Needham & Company.

Joseph Stringer，Needham & Company。

Hi, thanks for taking our question. You've shown that your HDV combo therapy can reduce the Hep D surface antigen level over time. I guess how well does this data resonate with KOLs and physicians? Is this something that you believe could be beneficial and potentially differentiator given the long-term chronic treatment paradigm for HDV? Or is it not nearly as important as say ALT and neurological response?

您好，感謝您回答我們的問題。你已經證明，HDV聯合療法可以隨著時間的推移降低C型肝炎表面抗原水平。我想知道這些數據在意見領袖和醫生群體中的反應如何？鑑於 HDV 的長期慢性治療模式，您認為這可能是有益的，並且有可能成為差異化因素嗎？或者說，它遠沒有ALT和神經反應那麼重要？

Thanks for the question. I mean, firstly, I would state that the most important objective of our program with [Rivergarden] is to suppress the virus to target, not detected in a large proportion of patients because we know that suppressing delta virus to TND will translate into better outcomes for patients in terms of progression of the underlying liver disease. But you think that the fact that we can reduce Hepatitis D surface antigen levels by about 3 logs is important and does resonate with KOLs because as you recall, the surface antigen is critically important for some for the viral life cycle of delta. It needs the surface antigen to form its own viral code. So the fact that we are starving the delta virus of the surface antigen is another mechanism by which we suppress the virus with our combination regimen. So we do think that is important in differentiating.

謝謝你的提問。首先，我想說明的是，我們與[Rivergarden]合作開展的計畫最重要的目標是抑制病毒至目標水平，即在很大一部分患者中檢測不到的水平，因為我們知道，將丁型肝炎病毒抑製到TND水平將轉化為患者在潛在肝病進展方面獲得更好的治療效果。但您認為，我們可以將丁型肝炎表面抗原水平降低約 3 個數量級這一事實非常重要，並且確實引起了關鍵意見領袖的共鳴，因為正如您所記得的，表面抗原對於某些人而言，對丁型肝炎病毒的生命週期至關重要。它需要表面抗原來形成自己的病毒代碼。因此，我們透過聯合療法抑制病毒的另一種機制是，透過剝奪丁型病毒的表面抗原。所以我們認為這對於區分彼此很重要。

Patrick Trucchio, H. C. Wainwright.

派崔克·特魯基奧，H·C·溫賴特。

Thanks. Just a follow-up question on HDV. First, in terms of the addressable patients in the US that you believe the combination of [Tabevaar and the labs] could be relevant for at the time of launch. I'm wondering if that would include the 61,000 patients estimated in the US [by remic] with HDV? Or is there a subgroup of patients who would be best for treatment at the time of launch? And separately, what efforts are ongoing to identify these patients? I mean, I appreciate that Eclipse 1 enrolled two months ahead of schedule, so just curious if particularly [as you know Bulvertide] maybe gets approved if there's just going to be more awareness and how you'll actually go about discovering those patients and ultimately how many patients you think you can reach at the time of launch?

謝謝。關於高清視頻，還有一個後續問題。首先，就您認為 [Tabevaar 和實驗室] 的組合在上市時可能與美國哪些潛在患者相關而言，您認為哪些患者群體可能適用？我想知道這是否包括美國估計的 61,000 名 HDV 患者（根據 remic 估計）？或者，是否存在某個特定患者群體，最適合在產品上市時接受治療？另外，目前正在進行哪些工作來辨識這些患者？我的意思是，我很欣賞 Eclipse 1 提前兩個月完成了招募，所以只是好奇，如果（您知道 Bulvertide）獲得批准，是否會提高人們對它的認知度，以及您將如何實際找到這些患者，最終您認為在上市時可以接觸到多少患者？

So excellent question. So, in terms of the HDV addressable population at launch, I mean, we're estimating approximately 60,000 patients in the US who are viremic with HDV. We really think the patients will be eligible for a regimen broadly because we can treat patients effectively with high viral loads or lower viral loads. We can treat patients with compensated cirrhosis or non-cirrhotic, so we expect to be able to treat a very broad population of patients who are viremic with HDV. So, we don't feel that that will be constrained to any kind of subgroup at all, we feel like it will be a broad population.

問得好。所以，就上市時HDV可治療族群而言，我的意思是，我們估計美國大約有60,000名HDV病毒血症患者。我們認為，無論病毒量高低，患者都有資格接受這種治療方案，因為我們可以有效治療病毒量高的患者。我們可以治療代償性肝硬化或非肝硬化患者，因此我們期望能夠治療非常廣泛的HDV病毒血症患者族群。所以，我們認為這不會局限於任何特定的群體，而會波及廣泛的人群。

In terms of how are we approaching the launch. Well, first of all, I would note [that you] agree with you that the [enrollment] of Eclipse 1 really speaks to the high medical need for a regimen that can meaningfully address the delta virus patient, the patients with HDV and there are viremia and the liver disease that follows.

關於我們如何進行產品發布。首先，我想指出，您同意我的觀點，即 Eclipse 1 的招募確實表明，對於能夠有效治療丁型肝炎病毒感染者、丁型肝炎病毒感染者以及出現病毒血症和隨之而來的肝病的患者來說，治療方案具有很高的醫療需求。

We also think that Gilead launching [Bulvertide] ahead of us like I said before, would be a real advantage because it'll drive disease awareness, drive testing and those things. We are in active discussions with KOLs, with advocacy groups, diagnostic companies, etc. about the best way forward to make driving awareness ourselves. And back to an earlier question, in terms of what will be the impact of our solstice presentation ASLD this year? And I think it's going to be very significant because this is the first time, we'll present the 48-week complete data for the combination which really undergirds our clips program and provides further confidence in what we're trying to achieve with the clips, which is really high rates of target not detected, HPV surface and suppression. And you know really hopefully driving good outcomes for patients.

我們也認為，正如我之前所說，吉利德搶在我們前面推出[Bulvertide]將是一個真正的優勢，因為它將提高人們對疾病的認識，推動檢測等等。我們正在與 KOL、倡議團體、診斷公司等積極討論如何更好地提高我們自身的駕駛意識。回到先前的問題，今年我們的夏至演講 ASLD 會產生什麼影響？我認為這意義重大，因為這是我們首次公佈該組合療法的 48 週完整數據，這真正鞏固了我們的夾子療法計劃，並進一步增強了我們對夾子療法目標的信心，即實現非常高的目標未檢出率、HPV 表面感染率和抑制率。而且，你真的希望能為患者帶來良好的治療效果。

Patrick, as I mean both from an efficacy perspective and also from a patient convenience perspective, our regimen being monthly dosing, that is a very big differentiator.

帕特里克，我的意思是，無論從療效角度還是從患者便利性角度來看，我們的治療方案是每月一次給藥，這是一個非常大的優勢。

This concludes the Q&A session of the call.

本次電話會議的問答環節到此結束。

Thank you for participating. I'll now turn the call back over to Marianne.

感謝您的參與。現在我將把電話轉回給瑪麗安。

Thank you, operator, and thank you all for joining us today. We look forward to updating you on our progress in the coming months. Operator, you may end the call.

謝謝接線員，也謝謝各位今天收看我們的節目。我們期待在接下來的幾個月向您報告我們的進展。接線員，您可以結束通話了。

This concludes our call today.

今天的通話到此結束。

Thank you for joining. You may now disconnect.

感謝您的參與。您現在可以斷開連線了。