Vir Biotechnology Inc (VIR) 2024 Q3 法說會逐字稿

Hello, welcome to Veer Biotechnologies third quarter, 2024 financial results and business update call as a reminder, this conference call is being recorded at this time. All participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If you would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again and then I'll turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin Mr. Lepke.

您好，歡迎參加 Veer Biotechnologies 2024 年第三季財務業績和業務更新電話會議，謹此提醒，本次電話會議目前正在錄製中。所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節。如果您想在此期間提問，只需按星號鍵，然後按電話鍵盤上的數字 1 即可。如果您想撤回問題，請再次按星號 1，然後我會將電話轉給投資者關係高級總監 Rich Lepke。您可以開始了，萊普克先生。

Thank you. And good afternoon with me today our Dr Marianne De Backer, our Chief Executive Officer, Dr Mark Eisner, our Chief Medical Officer, and Jason O'Byrne, our Chief Financial Officer.

謝謝。今天下午好，我們的執行長 Marianne De Backer 博士、我們的首席醫療官 Mark Eisner 博士和我們的財務長 Jason O'Byrne。

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.

在開始之前，我想提醒大家，我們今天發表的一些聲明屬於證券法規定的前瞻性聲明。這些前瞻性陳述涉及重大風險和不確定性，可能導致我們的臨床開發計畫、未來結果、績效或成就與此類前瞻性陳述明示或暗示的內容有顯著差異。

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 10-K 10-Q and AK, I will now turn the call over to our CEO Marianne De Backer.

這些風險、不確定性以及與我們業務相關的風險在公司向證券交易委員會提交的報告中進行了描述，包括表格10-K 10-Q 和AK，我現在將把電話轉給我們的首席執行官Marianne De Backer。

Thank you, Rich. Good afternoon, everyone and thank you for joining us today.

謝謝你，里奇。大家下午好，感謝您今天加入我們。

I'm pleased to provide an update on the significant progress we've made this quarter beginning with the successful closing of our exclusive worldwide licensing agreement with Sanofi. This landmark agreement includes three clinical stage masked T cell engagers and the use of Sanofi's proprietary Pro Xten protease cleavable masking platform for oncology and infectious diseases.

我很高興向您介紹我們本季取得的重大進展的最新情況，首先是我們與賽諾菲成功簽署了全球獨家授權協議。這項具有里程碑意義的協議包括三個臨床階段的掩蔽 T 細胞接合器，以及賽諾菲專有的 Pro Xten 蛋白酶可切割掩蔽平台在腫瘤學和傳染病領域的使用。

This strategic move aligns seamlessly with our mission to use the power of the immune system to fight disease.

這項策略性舉措與我們利用免疫系統的力量對抗疾病的使命完美契合。

We believe that the three dual masked T cell engagers veer 5,818 for her two veer, 5,500 for he ma and veerf 5,525 for Egfr have the potential to be best in class therapies.

我們相信，她的兩個 veer 的三個雙掩蔽 T 細胞接合器 veer 5,818、he ma 的 5,500 和 Egfr 的 veerf 5,525 有潛力成為同類最佳療法。

These investigational treatments aim to minimize toxicity challenges typically associated with T cell engager, allowing for higher dosing and thereby enhancing efficacy.

這些研究性治療旨在最大限度地減少通常與 T 細胞接合器相關的毒性挑戰，從而允許更高的劑量，從而提高療效。

As part of this agreement, we have welcomed key employees from Sanofi which bring extensive scientific and development expertise in oncology and the pro xent masking platform technology.

作為協議的一部分，我們迎來了賽諾菲的關鍵員工，他們帶來了腫瘤學和 pro xent masking 平台技術的廣泛科學和開發專業知識。

These talented individuals have quickly proven to be an excellent fit within our organization.

這些才華橫溢的人很快就被證明非常適合我們的組織。

We believe that their expertise combined with our deep understanding of T cell immunology, our robust infrastructure and leading machine learning and antibody engineering capabilities will create significant synergies.

我們相信，他們的專業知識與我們對 T 細胞免疫學的深刻理解、我們強大的基礎設施以及領先的機器學習和抗體工程能力相結合，將產生顯著的協同效應。

Moving on to our mid-stage clinical pipeline. We are making strong progress across our Hepatitis programs with important upcoming data readouts.

繼續我們的中期臨床管道。隨著即將公佈的重要數據，我們的肝炎計畫正在取得巨大進展。

I'll now highlight our recent progress in the ongoing phase two solstice trial in patients with chronic hepatitis delta. Hepatitis delta represents a highly promising growth opportunity for viewer. Marking the next significant inflection point in our journey to becoming a fully integrated and sustainable commercial company, much like other orphan disease markets. The HPV market is characterized by significant unmet medical needs and severe clinical outcomes for patients.

現在我將重點介紹我們在慢性丁型肝炎患者中正在進行的第二階段至日試驗的最新進展。對觀眾來說，丁型肝炎代表著一個非常有前途的成長機會。這標誌著我們成為一家完全一體化、可持續發展的商業公司的旅程中的下一個重要轉折點，就像其他孤兒疾病市場一樣。HPV 市場的特徵是醫療需求顯著未被滿足，病患的臨床結果也很嚴重。

This underscores an opportunity for innovative and impactful therapies that address critical health challenges and offer substantial value to both patients and the healthcare system.

這強調了創新和有影響力的療法的機會，這些療法可以解決關鍵的健康挑戰，並為患者和醫療保健系統提供巨大的價值。

We estimate there are approximately 100,000 people living with Hepatitis Delta in the United States and approximately 200,000 in Europe.

我們估計，美國約有 10 萬名丁型肝炎患者，歐洲約有 20 萬人。

Despite the severe and often life-threatening impact of HPV, patients currently have very limited treatment options. There are no approved therapies in the US and in Europe, the only available treatment requires daily self-administered subcutaneous injections, presenting challenges for long term patient compliance and quality of life.

儘管 HPV 造成嚴重且常常危及生命的影響，但患者目前的治療選擇非常有限。美國和歐洲沒有批准的治療方法，唯一可用的治療方法需要每天自行皮下注射，這對患者的長期依從性和生活品質提出了挑戰。

Based on the preliminary phase two clinical data we have shared to date; we believe our combination regimen of to bear and (inaudible) is highly differentiated compared to the current standard of care and has the potential to be a transformative treatment option for these patients in need.

基於我們迄今為止分享的初步二期臨床數據；我們相信，與目前的護理標準相比，我們的「忍受」和「（聽不清楚）」聯合治療方案具有高度差異化，並且有可能成為這些有需要的患者的變革性治療選擇。

As we continue to advance this promising treatment, we anticipate an increase in both diagnosis and treatment rates. Feedback from physicians and advocacy groups has highlighted a growing interest in reflex testing for Hepatitis delta.

隨著我們繼續推進這種有希望的治療方法，我們預計診斷率和治療率都會增加。醫生和倡導團體的回饋凸顯了人們對丁型肝炎反射測試越來越感興趣。

Reflex testing involves automatically testing for hepatitis Delta in patients who test positive for hepatitis B without requiring a separate order from the healthcare provider.

反射檢測涉及對乙型肝炎檢測呈陽性的患者自動檢測丁型肝炎，無需醫療保健提供者單獨下令。

This proactive approach ensures early identification of HPV infections even in regions like the United States where treatment options are currently limited by identifying patients early. We can help ensure they receive timely treatment once a therapy is approved. While we are at the early stages of driving this awareness, we aim to improve early diagnosis and pave the way for effective treatment outcomes for patients with Hepatitis Delta. As our HPV program advances closer towards a potential approval.

這種積極主動的方法確保了 HPV 感染的早期識別，即使在美國等目前治療選擇受到早期識別患者限制的地區。一旦治療方法獲得批准，我們可以幫助確保他們得到及時的治療。雖然我們正處於推動這種認識的早期階段，但我們的目標是改善三角洲肝炎患者的早期診斷並為有效治療結果鋪平道路。隨著我們的 HPV 計畫越來越接近潛在的批准。

We are committed to partnering with key stakeholders across the health care landscape to advocate for and adopt these testing practices.

我們致力於與醫療保健領域的主要利益相關者合作，倡導並採用這些測試實踐。

Looking ahead, we will present data from the solstice trial at the AASLD conference taking place November 15th to 19th in San Diego.

展望未來，我們將在 11 月 15 日至 19 日在聖地牙哥舉行的 AASLD 會議上展示冬至試驗的數據。

We are making excellent progress, advancing this program in the clinic and have engaged with the FDA to discuss our planned registrational program in HPV, which is expected to begin next year.

我們正在取得顯著進展，在臨床上推進該計劃，並已與 FDA 合作討論我們計劃的 HPV 註冊計劃，預計將於明年開始。

Next, I'd like to address our functional cure program for chronic hepatitis B which represents another substantial opportunity for a combination regimen of the beard and (inaudible) with or without regulated Interferon alpha.

接下來，我想談談我們針對慢性乙型肝炎的功能性治療計劃，該計劃代表了鬍鬚和（聽不清楚）有或沒有受監管的干擾素 α 的聯合治療方案的另一個重大機會。

Our goal is a functional cure in this setting, defined as a sustained loss of detectable hepatitis B surface antigen and hepatitis B virus DNA. After a finite course of treatment, there are an estimated $1.6 million hepatitis B patients in the United States alone and approximately $254 million globally. We are looking forward to reporting end of treatment data from the March part B trial in a late breaking presentation at the upcoming ASLD meeting in November.

我們的目標是在這種情況下實現功能性治愈，即可檢測到的乙型肝炎表面抗原和乙型肝炎病毒 DNA 持續喪失。經過有限療程的治療後，光在美國就有約 160 萬美元的B型肝炎患者，全球約有 2.54 億美元。我們期待在 11 月即將舉行的 ASLD 會議上的最新重大報告中報告 3 月份 B 部分試驗的治療結束數據。

This end of treatment data will be followed by the functional cure data readout in the second quarter of 2025.

治療數據結束後，將在 2025 年第二季讀出功能性治癒數據。

Based on KOL feedback, our target for a functional cure is 30% for the interferon containing regimen and 20% for the regimen excluding interferon.

根據 KOL 的回饋，我們的功能性治癒目標是含幹擾素方案的功能性治癒率為 30%，不含幹擾素的方案為 20%。

Before I close, I would like to provide an update on our upcoming events and reaffirm our commitment to keeping you informed about our progress.

在結束之前，我想介紹我們即將舉行的活動的最新情況，並重申我們致力於讓您隨時了解我們的進展。

While we had initially planned to host an R&D Day in the fourth quarter, we will instead conduct an in-depth investor event focused on our Hepatitis franchise in November.

雖然我們最初計劃在第四季度舉辦研發日活動，但我們將在 11 月舉辦一場專注於我們的肝炎特許經營權的深入投資者活動。

Given the addition of the T cell engagers to our portfolio and the subsequent reprioritization of our pipeline. We have adjusted our plans. We now intend to discuss our T cell engager programs at a dedicated investor event in the first quarter of 2025. This timing also allows us to present initial clinical results ensuring we provide insights into our progress and the future prospects of these programs.

鑑於我們的產品組合中添加了 T 細胞接合劑，並且隨後重新調整了我們的產品線優先順序。我們已經調整了計劃。我們現在打算在 2025 年第一季的一次專門投資者活動中討論我們的 T 細胞參與計劃。這個時機也使我們能夠展示初步的臨床結果，確保我們能夠深入了解這些項目的進展和未來前景。

As mentioned, we will host an exclusively Hepatitis focused investor event immediately following the ASLD conference in November.

如前所述，我們將在 11 月的 ASLD 會議之後立即舉辦一場專門針對肝炎的投資人活動。

During this event, we will provide detailed updates on both the March and solstice programs.

在此活動期間，我們將提供三月和夏至計畫的詳細更新。

This focused approach will allow us to delve deeply into these two critical development programs and their implications for patients and our broader clinical strategy.

這種重點突出的方法將使我們能夠深入研究這兩個關鍵的開發計劃及其對患者和我們更廣泛的臨床策略的影響。

We understand the importance of clear and timely communication with our investors, and we are committed to keeping you updated on all the significant developments.

我們了解與投資者進行清晰、及時溝通的重要性，我們致力於讓您隨時了解所有重大進展。

Finally, I'm thrilled to have welcomed Jason O'Byrne as our new executive Vice President and Chief Financial Officer. Earlier this month, Jason is an accomplished executive with more than 20 years of experience in finance and operations and a proven track record in financial strategy across public companies.

最後，我很高興歡迎傑森·奧伯恩 (Jason O'Byrne) 擔任我們的新執行副總裁兼財務長。本月早些時候，Jason 是一位卓有成就的高階主管，在財務和營運方面擁有 20 多年的經驗，並且在上市公司的財務策略方面擁有良好的業績記錄。

His exceptional leadership and focus on excellence and execution make him a perfect fit as we embark on the next chapter for our organization since joining veer, one of Jason's key priorities has been to ensure continued disciplined capital deployment and financial stewardship.

自從加入 veer 以來，他卓越的領導力以及對卓越和執行力的關注使他成為我們組織開啟新篇章的完美人選，Jason 的主要優先事項之一是確保持續嚴格的資本部署和財務管理。

As we recently announced, we have implemented a strategic restructuring initiative to prioritize our clinical stage pipeline opportunities and streamline our operations. These efforts are allowing us to allocate our resources more efficiently and focus on our core programs.

正如我們最近宣布的那樣，我們實施了一項策略重組計劃，以優先考慮我們的臨床階段管道機會並簡化我們的營運。這些努力使我們能夠更有效地分配資源並專注於我們的核心專案。

In closing, I couldn't be more optimistic about fear's future and the potential impact of our innovative therapies. We have a strong balance sheet which allows us to fund operations through our next major inflection points. We are prudently managing our expenses with a focus on our most promising programs and maximizing shareholder value.

最後，我對恐懼的未來以及我們創新療法的潛在影響感到非常樂觀。我們擁有強大的資產負債表，使我們能夠為下一個主要拐點的營運提供資金。我們正在審慎地管理我們的開支，重點關注我們最有前途的項目和最大化股東價值。

I would like to thank our dedicated team, including our new colleagues for their hard work and our investors for their continued support. And with that, I'll now turn the call over to our executive Vice President and Chief Medical Officer, Mark Eisner to provide an update on our clinical development programs and pipeline.

我要感謝我們敬業的團隊，包括新同事的辛勤工作，以及投資者的持續支持。現在，我將把電話轉給我們的執行副總裁兼首席醫療官馬克·艾斯納 (Mark Eisner)，以提供有關我們臨床開發計劃和管道的最新資訊。

Thank you, Marianne and good afternoon, everyone. Let's begin with the solstice trial in Hepatitis Delta. As a reminder, we presented strong preliminary data from our phase two solstice trial in HPV at the EASL Congress in June.

謝謝瑪麗安，大家下午好。讓我們從三角洲型肝炎的至日試驗開始。提醒一下，我們在 6 月的 EASL 大會上展示了 HPV 第二階段至日試驗的強有力的初步數據。

In our rollover cohort of six non (inaudible) participants, we reported that all six achieve virologic suppression below the lower limit of quantification and five out of six achieved targets not detected indicating no measurable presence of HDVRN. A additionally, three out of six achieved a LT normalization, durable virologic suppression was observed in the combination role of cohort suggesting the potential for sustained antiviral activity.

在我們的六名非（聽不清楚）參與者的輪換隊列中，我們報告說，所有六名參與者都實現了低於量化下限的病毒學抑制，並且六分之五達到了未檢測到的目標，表明沒有可測量的HDVRN 存在。此外，六分之三的人實現了 LT 正常化，在隊列的組合作用中觀察到持久的病毒學抑制，表明持續抗病毒活性的潛力。

There are 32 participants in the de novo combination cohort and 33 participants are in the monotherapy cohort at the time of the analysis. 11 participants in the de Novo Combination cohort and seven participants in the monotherapy cohort had reached 24 weeks of treatment.

在分析時，從頭聯合隊列中有 32 名參與者，單一療法隊列中有 33 名參與者。 de Novo 組合群組中的 11 名參與者和單一療法群組中的 7 名參與者已達到 24 週的治療時間。

There were no discontinuations in the combination cohort.

聯合治療組中沒有出現停藥的情況。

After 24 weeks of treatment, all11 participants in the de Novo combination cohort achieved virologic suppression below the lower limit of quantification and six out of 11 achieved targets not detected.

經過 24 週的治療後，de Novo 聯合隊列中的所有 11 名參與者均達到了低於量化下限的病毒學抑制，並且 11 名參與者中有 6 名達到了未檢測到的目標。

Seven out of 11 also achieved alt normalization.

11 人中有 7 人也實現了替代正常化。

From a safety perspective, we observed no treatment related serious adverse events or a LT flare in either the monotherapy or de novo combination treatment regimens.

從安全角度來看，我們在單一療法或從頭聯合治療方案中均未觀察到與治療相關的嚴重不良事件或 LT 耀斑。

The majority of adverse events were transient and mild grade one or two with a low incidence of injection site reactions taken together. These preliminary data are extremely promising as all three cohorts demonstrated rapid and sustained virologic responses.

大多數不良事件是短暫的、輕微的一二級反應，同時注射部位反應的發生率較低。這些初步數據非常有希望，因為所有三個隊列都表現出快速且持續的病毒學反應。

We'll be sharing the full data set for both cohorts of approximately 30 participants at 24 weeks of treatment as well as available data for participants beyond 24 weeks of treatment at AASLD, we are pleased to have received fast track designation from the US FDA for a combination of Tibar and LPSN.

我們將分享大約 30 名參與者在 24 週治療時的兩個隊列的完整數據集，以及 AASLD 治療超過 24 週的參與者的可用數據，我們很高興獲得美國 FDA 的快速通道指定Tibar 和LPSN 的組合。

We're also actively exploring all possible acceleration pathways to bring this promising investigational therapy to patients as quickly as possible.

我們也正在積極探索所有可能的加速途徑，以盡快將這種有前景的研究療法帶給患者。

We have recently engaged with health authorities to line on our clinical development strategy for Hepatitis Delta. Based on these discussions, we are actively working to expedite the initiation of our registrational program. We look forward to sharing more information at our Hepatitis focused investor event following the ASLD conference.

我們最近與衛生當局合作，制定了 Delta 型肝炎的臨床開發策略。基於這些討論，我們正在積極努力加快啟動我們的註冊計劃。我們期待在 ASLD 會議之後的以肝炎為重點的投資者活動中分享更多資訊。

Moving on to our phase two program for chronic hepatitis B at AASLD. We look forward to sharing the end of treatment data from the March part B trial which evaluates our doublet and triplet regimens the data will include approximately 50 participants receiving our combination treatment and approximately 30 participants receiving the combination therapy plus interferon.

繼續我們 AASLD 慢性B型肝炎的第二階段計劃。我們期待分享3 月份B 部分試驗的治療結束數據，該試驗評估我們的雙聯和三重療法，該數據將包括大約50 名接受我們聯合治療的參與者和大約30 名接受聯合治療加乾擾素的參與者。

This readout will be followed by posttreatment data in the second quarter of 2025 which will allow us to assess functional cure for both regimens.

此讀數之後將在 2025 年第二季提供治療後數據，這將使我們能夠評估兩種治療方案的功能性治癒。

Now let's transition to oncology and discuss the T cell engager programs as we described in our second quarter. Call the agreement with Sanofi provided us with a robust portfolio of assets targeting clinically validated antigens and oncology. I'll briefly touch on the status of each program.

現在讓我們轉向腫瘤學並討論我們在第二季度中描述的 T 細胞參與計劃。與賽諾菲的協議為我們提供了針對臨床驗證抗原和腫瘤學的強大資產組合。我將簡要介紹每個程序的狀態。

Vera 5,818 or dual mass, her two CD three T cell engager. It's a highly differentiated asset with the potential to address significant needs in her two expressing cancers as the only massed her two T cell engager currently in clinical development. veier 5,818 is designed to offer lower off tumour toxicity allowing for higher doses and potentially improved efficacy. Compared to existing her two targeted therapies.

Vera 5,818 或雙質量，她的兩個 CD 三個 T 細胞接合器。這是一項高度差異化的資產，有可能滿足她的兩種表達癌症的重大需求，因為它是目前臨床開發中唯一聚集了她的兩種 T 細胞接合劑的資產。 veier 5,818 旨在提供較低的腫瘤毒性，從而允許更高的劑量並可能提高療效。與現有的兩種標靶療法相比。

There is a significant unmet need in her two positive cancers, particularly in metastatic breast cancer and metastatic colorectal cancer.

她的兩種陽性癌症，特別是轉移性乳癌和轉移性大腸癌，有顯著的未滿足需求。

The phase one study is ongoing evaluating VIR 5,818 is both a monotherapy and in combination with Pampero Liz IAB initially in a basket of solid tumour indications.

第一期研究正在進行中，評估 VIR 5,818 既是單一療法，也是與 Pampero Liz IAB 聯合治療的一籃子實體瘤適應症。

The study is currently being conducted at 10 active sites in Europe and Australia and we are making good progress with continued dose escalation.

該研究目前正在歐洲和澳洲的 10 個活動中心進行，隨著劑量的持續增加，我們正在取得良好進展。

We anticipate sharing preliminary monotherapy data in the first quarter. Of 2025.

我們預計在第一季分享初步的單一療法數據。2025 年。

veer 5,500 is a dual mass PS ma directed T cell engager. Currently in phase one clinical trials, prostate cancer represents a significant disease burden with many patients in need of more effective and well tolerated treatment options.

veer 5,500 是一種雙質量 PS ma 定向 T 細胞接合劑。目前正處於第一階段臨床試驗中，攝護腺癌是一種重大的疾病負擔，許多患者需要更有效且耐受性良好的治療方案。

As the only dual mass PSMA directed T cell engager. Currently in clinical development, veer 5,500 is designed to offer lower off tumour toxicity allowing for higher doses and potentially improved efficacy compared to existing PSMA targeted therapies.

作為唯一的雙質量 PSMA 定向 T 細胞接合器。目前正處於臨床開發階段，veer 5,500 旨在提供較低的腫瘤毒性，與現有的 PSMA 標靶療法相比，可以使用更高的劑量，並可能提高療效。

The study is currently ongoing evaluating V 5,500 as a monotherapy in a step up dose escalation design with the potential to expand into combination therapy.

該研究目前正在評估 V 5,500 作為劑量遞增設計中的單一療法，並有可能擴展到聯合療法。

The phase one study for veer 5,500 is earlier in its progression with fewer participants compared to veer 5,818.

與 veer 5,818 相比，veer 5,500 的第一階段研究進展較早，參與者較少。

We anticipate sharing early monotherapy data in the first quarter of 2025.

我們預計在 2025 年第一季分享早期單一療法數據。

Finally veer 5,525 a dual mass EGFR CD three T cell engager has a cleared IND and we're preparing to initiate the phase one clinical study. Despite available treatments, the need for patients with EGFR expressing tumours remains high. The initial target tumour types for VR 5,525 are metastatic head and neck squamous cell carcinoma, metastatic squamous non-small cell lung cancer and metastatic colorectal cancer.

最後，veer 5,525 雙質量 EGFR CD 三 T 細胞接合劑已獲得批准的 IND，我們正準備啟動第一階段臨床研究。儘管有可用的治療方法，但表達 EGFR 的腫瘤患者的需求仍然很高。VR 5,525的初始目標腫瘤類型是轉移性頭頸鱗狀細胞癌、轉移性鱗狀非小細胞肺癌和轉移性大腸直腸癌。

We believe that veer 5,525 has the potential to provide a safe and tolerable treatment option for patients in the second line and beyond settings for these difficult to treat cancers. We are on track to initiate enrollment in a phase one clinical study in the first quarter of 2025. With that, I'll now hand the call over to Jason.

我們相信 veer 5,525 有潛力為第二線及其他難以治療的癌症患者提供安全且可耐受的治療選擇。我們預計在 2025 年第一季啟動一期臨床研究的招募。現在，我將把電話轉給傑森。

Thank you, Mark and thank you Marianne for the warm welcome.

謝謝馬克，謝謝瑪麗安的熱情歡迎。

It's an honor to join the talented veer team at this important time in the company's evolution.

我很榮幸能夠在公司發展的這個重要時刻加入才華橫溢的轉向團隊。

I have long admired vir's commitment to preventing and treating serious infectious disease and the team's impressive history of proven successful execution today. As Mark just shared. Veer continues its focus on infectious disease while also expanding into oncology with the addition of three T cell engager assets and the underlying pro extend masking platform.

我長期以來一直欽佩 vir 對預防和治療嚴重傳染病的承諾，以及該團隊今天被證明成功執行的令人印象深刻的歷史。正如馬克剛剛分享的。Veer 繼續專注於傳染病，同時也透過增加三個 T 細胞參與資產和基礎的專業擴展屏蔽平台擴展到腫瘤學。

In my role as CFO I look forward to working alongside the executive team and all the dedicated beer employees to deliver meaningful benefit to patients and to create shareholder value.

作為首席財務官，我期待與執行團隊和所有敬業的啤酒員工一起工作，為患者帶來有意義的利益並創造股東價值。

As Mary Ann mentioned, one of my early focus areas will be disciplined, capital deployment and financial stewardship.

正如瑪麗安所提到的，我早期關注的領域之一是紀律、資本部署和財務管理。

I am confident that with our strong financial position, compelling clinical programs, an exceptional team, we are well positioned to deliver veer's mission.

我相信，憑藉我們強大的財務狀況、引人注目的臨床項目和出色的團隊，我們有能力實現 veer 的使命。

I will now share highlights of the third quarter, 2024. Financial results.

現在我將分享 2024 年第三季的亮點。財務業績。

R&D expenses for the third quarter of 2024 were approximately $195 million compared to $145 million. For the same period. In 2023 the increase was primarily driven by approximately $103 million of expense related to the Sanofi transaction. This quarter partially offset by reduced clinical development and manufacturing costs associated with the discontinued full asset veer 2,482 SG&A expenses for the third quarter of 2024 were $25.7 million compared to $40.9 million for the same period in 2023 the decrease was largely related to cost saving initiatives announced at the end of 2023 restructuring, long lived asset impairment and related charges for the third quarter of 2024 were $12.7 million compared to $3.4 million for the same period last year.

2024 年第三季的研發費用約為 1.95 億美元，去年同期為 1.45 億美元。同一時期。2023 年，這一成長主要是由與賽諾菲交易相關的約 1.03 億美元費用所推動的。本季部分被與終止全資產轉向相關的臨床開發和製造成本減少所抵銷。成本節約措施有關截至 2023 年重組結束，2024 年第三季的長期資產減損及相關費用為 1,270 萬美元，去年同期為 340 萬美元。

The increase was primarily driven by our August 2024 restructuring, severance charges and asset impairment charges related to the closing of our Portland Oregon facility.

這一增長主要是由於我們 2024 年 8 月的重組、遣散費和與關閉俄勒岡州波特蘭工廠相關的資產減損費用所致。

We ended the third quarter with cash cash equivalents and investments of approximately $1.19 billion compared to $1.43 billion at the end of the second quarter, excluding the effects of the Sanofi transaction. The decrease in cash and investments during the third quarter was approximately $66 million including the effects of the Sanofi Agreement. The total decrease in cash and investments during the quarter was approximately $245 million which included $104 million in cash payments made to Sanofi at closing plus a $75 million escrowed milestone payment. The escrowed $75 million milestone is subject to veer 5,525 achieving first in human dosing by 2026 and that amount was reclassified to restricted cash in the quarter.

第三季末，我們的現金等價物和投資約為 11.9 億美元，而第二季末為 14.3 億美元，不包括賽諾菲交易的影響。第三季現金和投資減少約 6,600 萬美元，其中包括賽諾菲協議的影響。本季現金和投資減少總額約為 2.45 億美元，其中包括交易結束時向賽諾菲支付的 1.04 億美元現金以及 7,500 萬美元託管里程碑付款。託管的 7,500 萬美元里程碑取決於 2026 年 5,525 名患者首次實現人體給藥，該金額在本季度被重新分類為限制性現金。

As we approach the latter part of the year, we are adjusting our GAAP full year 2024 expense guidance to a range of 660 to $680 million which includes the Santa transaction expenses, stock based compensation expense and restructuring charges, excluding those three items. Our updated net guidance is now modestly lower at a range of 430 to $470 million compared to our second quarter guidance of 450 to $500 million. With that, I'll turn the call back over to Rich to begin the Q&A session.

隨著今年下半年的臨近，我們將 GAAP 2024 年全年費用指引調整為 660 至 6.8 億美元，其中包括聖誕老人交易費用、股票補償費用和重組費用，但不包括這三項。與第二季 4.5 至 5 億美元的指引相比，我們更新後的淨指引目前略有下降，為 4.3 至 4.7 億美元。之後，我會將電話轉回給 Rich，開始問答環節。

Thank you, Jason.

謝謝你，傑森。

This concludes our prepared remarks and we will now start the Q&A section.

我們準備好的演講到此結束，現在我們將開始問答部分。

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.

請將問題限制為每人兩個，以便我們能夠聯繫到所有覆蓋的分析師。我會把它交給你的接線生。

Thank you. At this time, we will begin conducting our analyst Q&A session for analysts. Please raise your hand by pressing star one to indicate you would like to join the queue if you've not done so already. Once you hear the operator announce your name, you can unmute your line and ask your question.

謝謝。此時，我們將開始為分析師進行分析師問答環節。如果您還沒有加入隊列，請按一號星舉手以表示您想加入隊列。一旦聽到接線員報出您的名字，您就可以取消線路靜音並提出問題。

We'll go first to Paul Choi at Goldman Sachs.

我們先請教高盛的 Paul Choi。

Hi, good afternoon and thank you for taking our questions. My first question is can you just update us on the status of your plans and of phase two meeting with the FDA apologies if I missed a mention of it in the press release. So I was just curious what the status of your regulatory discussions was. And my second question is for your new key cell Engager program for 5,818. Can you maybe comment on how you're thinking about the relative measures you're looking for for both the monotherapy versus the plumber luzum combination? Thank you very much.

您好，下午好，感謝您回答我們的問題。我的第一個問題是，您能否向我們介紹一下您的計劃和第二階段會議的最新情況，如果我在新聞稿中沒有提到這一點，FDA 深表歉意。所以我只是好奇你們的監管討論進展如何。我的第二個問題是針對 5,818 人的新關鍵單元參與計畫。您能否評論一下您如何考慮單一療法與水管工 luzum 組合療法所尋找的相對措施？非常感謝。

Okay, thank you very much for the question, Paul, I'll give it to to mark our CMO to answer those questions.

好的，非常感謝你提出這個問題，Paul，我會請我們的 CMO 來回答這些問題。

Yeah. Thanks for the question, Paul. We have engaged with the FDA as you, as you mentioned, we are just putting the very finishing touches on our clinical development program and we expect to be able to share further details about that at our Hepatitis focused investor meeting on November 19th in terms of the T Cell Engager program in the 5,818.

是的。謝謝你的提問，保羅。正如您所提到的，我們已經與 FDA 進行了接觸，我們剛剛完成了我們的臨床開發計劃的最後階段，我們希望能夠在 11 月 19 日的肝炎重點投資者會議上分享更多細節： 5,818 中的T 細胞參與計劃。

Her two C three program in particular, your question about efficacy is a good one.

特別是她的兩個C三個程序，你關於功效的問題是一個很好的問題。

We are planning to share preliminary monotherapy data from that program also the PS MA program in quarter one next year. And at that time, we'll be able to provide a bit more perspective on, on you know, on the data.

我們計劃在明年第一季分享該計劃以及 PS MA 計劃的初步單一療法數據。到那時，我們將能夠提供更多關於數據的觀點。

Okay, thank you.

好的，謝謝。

Next, we'll move to Eric Joseph at JP Morgan.

接下來，我們將請來摩根大通的艾瑞克‧約瑟夫 (Eric Joseph)。

Oh, thanks. If I remember correctly, just in terms of the pivotal path forward in HPV, you, you previously outlined a randomized study with Helix as a comparator arm, I guess, based on your you know, latest regulatory interactions, should we still kind of carry that expectation? And, and I guess within that, how should be thinking about sort of the continued inclusion of or evaluation of combination or monotherapy with TTBU five? thanks.

哦，謝謝。如果我沒記錯的話，就 HPV 的關鍵前進道路而言，您之前概述了一項以 Helix 作為比較臂的隨機研究，我想，根據您知道的最新監管相互作用，我們是否應該繼續進行那個期望？而且，我想在此範圍內，應該如何考慮繼續納入或評估 TTBU 5 的聯合或單一療法？謝謝。

Yeah, thanks. Thanks for the question. So, as we've stated before, we are committed to going forward with the combination of to bear and the LERO because we achieve deep and sustained viral logic responses with the combination regimen and remind everyone, we got fast track designation for the combination regimen for the FDA in terms of further details of the program. You know, we do plan on discussing this in more detail in our investor event around the ASLD.

是的，謝謝。謝謝你的提問。因此，正如我們之前所說，我們致力於推進 to bear 和 LERO 的組合，因為我們透過組合方案實現了深入且持續的病毒邏輯反應，並提醒大家，我們獲得了組合方案的快速通道指定向FDA 提供該計劃的進一步細節。您知道，我們確實計劃在圍繞 ASLD 的投資者活動中更詳細地討論這個問題。

Okay, great. Thanks very much.

好的，太好了。非常感謝。

We'll move next to Mike Ulz at Morgan Stanley.

我們將接替摩根士丹利的麥克烏爾茲 (Mike Ulz)。

Yes. Good afternoon. Thanks for taking the question as well. Maybe I could just ask a follow up on, on the phase three trial design and your interactions with the FDA. I'm just curious if you're getting any feedback that might be unexpected at this point or are things just on track and you're going to sort of reveal the final details at your investor event. Thanks.

是的。午安.也感謝您提出這個問題。也許我可以詢問第三階段試驗設計以及您與 FDA 的互動的後續情況。我只是好奇您是否收到了任何可能在此時出乎意料的反饋，或者事情是否正在步入正軌，並且您將在投資者活動中透露最終細節。謝謝。

Yeah,Thank you for the question. I will say we had a very productive meeting with the FDA. I think we aligned with them very closely on the plan. And you know, we'll, we'll, we'll be prepared to share more details at the investor around ASLP.

是的，謝謝你的提問。我想說的是，我們與 FDA 進行了一次非常有成效的會議。我認為我們在計劃上與他們非常一致。你知道，我們將準備向投資者分享更多關於 ASLP 的細節。

Great. Thank you.

偉大的。謝謝。

Next, we'll go to Gina Wang at Barclays.

接下來，我們將採訪巴克萊銀行的吉娜·王 (Gina Wang)。

Thank you for taking my questions. I have two questions. The first one is regarding the HPV data. Thank you very much to you know, putting the data together from the prior study. So slide 21 you lay out the several data points here. But I assume the key focus for us, it should be the target not detectable rate and also AP normalization should we expect? You know, those are the benchmark and that should be the the level minimum level should achieve with more patient data. Now, 32 patients, 33 patients at the week 24. And my second question is regarding the T cell engager. And I remember Marianne, you said you saw some initial phase one data when you know the center of the deal discussion was ongoing. So now with, you know, the the next year data update, have you seen the more patient data and with the more patient does the monotherapy activity hold as your initial expectation?

感謝您回答我的問題。我有兩個問題。第一個是關於 HPV 數據。非常感謝您將先前研究的數據匯總在一起。因此，您在投影片 21 中列出了幾個數據點。但我認為我們的重點應該是目標不可偵測率以及我們應該期望的 AP 標準化嗎？您知道，這些是基準，這應該是更多患者數據應達到的最低水準。現在有 32 名患者，第 24 週有 33 名患者。我的第二個問題是關於 T 細胞接合器。我記得瑪麗安，你說當你知道交易討論的中心正在進行時，你看到了一些最初的第一階段數據。那麼現在，您知道，明年的數據更新後，您是否看到了更多的患者數據以及更多的患者，單一療法活動是否符合您的最初預期？

Okay, thank you very much. Gina, Mark you want to comment on the HPV?

好的，非常感謝。吉娜、馬克，你想對 HPV 發表評論嗎？

Absolutely. So, to source the study of HPV, we are going to have an oral presentation at the A SLD meeting which I think will give a lot more information, particularly all the patients need it through week 24 of the study and some of the patients beyond that. So we're going to be presenting those data in terms of your question around TND. Yes, absolutely. I mean, getting below the limit of quantification target not detected means there's undetectable delta viral levels. So that is, you know, kind of the, the most rigorous measurement that's out there, you know, our combination regimen that, that what we revealed that easel is a very, very profound reduction in the viral load and achieving high rates of target not detected above 50% a week 24. In terms of a LT normalization, that's also important and those data will be included. You know, the FDA guidance includes a composite end point of T&D plus A LT normalization. So that will be data we will also present at the ASLD meeting coming up.

絕對地。因此，為了獲取HPV 研究的來源，我們將在A SLD 會議上進行口頭報告，我認為這將提供更多信息，特別是在研究的第24 週內所有患者都需要它，以及一些超出研究週期的患者。因此，我們將根據您關於 TND 的問題來展示這些數據。是的，絕對是。我的意思是，低於未檢測到的定量目標極限意味著存在無法檢測到的 Delta 病毒水平。所以，你知道，這是最嚴格的測量，你知道，我們的組合方案，我們發現，畫架可以非常非常深刻地減少病毒載量並實現高目標率每週未檢測到超過 50% 24.就 LT 標準化而言，這也很重要，並且將包含這些數據。您知道，FDA 指南包括 T&D 加上 LT 正常化的複合終點。因此，我們也將在即將召開的 ASLD 會議上展示這些數據。

Yeah. And then on your question related to the T cell engagers, Gina, remember that our agreement with Sany closed on September 9th. So we are in the midst of transitions, for example, trial sponsorship and so on. Obviously, you know, we have all the the data available on on the programs. And as I mentioned, we will be in a position to share the initial data on the monotherapy of both the 5,500 and 5518, 5818 assets in the first quarter of 2025.

是的。然後，關於您與 T 細胞接合者相關的問題，Gina，請記住我們與三一重工的協議於 9 月 9 日結束。所以我們正處於過渡之中，例如試驗贊助等等。顯然，你知道，我們擁有該程式的所有可用數據。正如我所提到的，我們將能夠在 2025 年第一季分享 5,500 和 5518、5818 資產單一療法的初始數據。

We'll move next to Alex Shanahan at Bank of America.

我們將搬到美國銀行的亞歷克斯·沙納漢（Alex Shanahan）旁邊。

Hey guys, thanks for taking my questions. 22 from me as well. I was hoping you could help frame the sort of data we should expect for 5,818 and 5,500 in the first quarter will be mostly focusing on, on maybe safety and dosimetry or could we see some initial efficacy metrics as well? And if you could speak to how the dual mask for your assets might benefit your ability to to reach a higher target dose. Is this baked into the dose escalation or it's driving to reach AM TD? Maybe not even the right way to be thinking about things here. Thank you.

嘿夥計們，謝謝你回答我的問題。 22 也來自我。我希望你能幫助建立我們預計第一季 5,818 和 5,500 的數據，這些數據將主要關注安全性和劑量測定，或者我們是否也可以看到一些初步功效指標？如果您能談談您資產的雙重面罩如何有利於您達到更高目標劑量的能力。這是劑量遞增的結果還是正在推動達到 AM TD？也許這甚至不是思考問題的正確方式。謝謝。

Sure. So, in terms of your first question, we, as we stated, we are planning to share preliminary monotherapy data from the ongoing phase one studies, both for your 5,818, her two program and your 5,500 the PSAT Cell Engager program. At this point, we're not really providing more color on that, but we, we will be providing those data updates in quarter one of next year.

當然。因此，就您的第一個問題而言，正如我們所說，我們計劃分享正在進行的第一階段研究的初步單藥治療數據，包括您的5,818、她的兩個項目和您的5,500 PSAT Cell Engager 計畫。目前，我們並沒有真正提供更多信息，但我們將在明年第一季提供這些數據更新。

And then your question about the dual masking I think is important. You know, all of our programs do have do have the dual masking. So we're masking both the C three T cell engager part of the molecule and the to antigen part of binding part of the molecule. So, you know, the working hypothesis here is that that will allow us to achieve a better therapeutic index. So higher levels of safety, I mean higher levels of levels of efficacy with, with good safety. As we mentioned before, for her two program were the only dual mask program in clinical development for PSMA. You know, the gene X program masks the C three part, but at least the PS ma unmasked. So, we think we may have a differentiated asset in terms of our dual masking of the PSMA molecule.

然後你關於雙重掩蔽的問題我認為很重要。您知道，我們所有的程式都確實具有雙重屏蔽。因此，我們掩蓋了該分子的 C 3 T 細胞接合部分和該分子的結合部分的抗原部分。所以，你知道，這裡的工作假設是，這將使我們能夠實現更好的治療指數。所以更高程度的安全性，我的意思是更高水準的功效和良好的安全性。正如我們之前提到的，她的兩個項目是 PSMA 臨床開發中唯一的雙面膜項目。要知道，X基因程式掩蓋了C三部分，但至少PS ma暴露了。因此，我們認為我們在 PSMA 分子的雙重掩蔽方面可能擁有差異化資產。

Thank you.

謝謝。

We'll go next to Roana Rez at Lein Partners.

接下來我們將前往 Lein Partners 的 Roana Rez。

Hey, this is Nick Lein. Thanks for taking our questions. Maybe first on the HPV phase three trial design, just thinking about the target patient population. Are you going to be focusing on both cros and non cros? And I guess are there any specific baseline characteristics, you know, you could enrich for here a quick follow up on HPV after that?

嘿，這是尼克·萊恩。感謝您回答我們的問題。也許首先是關於 HPV 第三階段試驗設計，只考慮目標患者族群。你會同時關注 cros 和非 cros 嗎？我想是否有任何具體的基線特徵，您知道，您可以在此之後豐富 HPV 的快速跟進嗎？

Sure. So thanks for the question in terms So, in solstice, we presented data including both cirrhotic and non cirrhotic patients, CPTAS. And you know, back in easel when we presented these data, you'll recall that the efficacy antiviral efficacy effect on A LT was very, very good in both cros and non cros. If anything, they're not, if anything, the cirrhotic patients fared a little bit better. So you, you know, clearly we want to base our phase three program on the observations from the phase two program. So we would include both scorad and non cirrhotic patients. In terms of baseline characteristics, that kind of predict response and any enrichment, you know, I think we'll be able to provide more color on that at our investor focused hepatitis that presentation around a sld. So stay tuned for more detail there.

當然。因此，感謝您提出的問題。你知道，當我們在畫架上展示這些數據時，你會記得 A LT 的抗病毒功效在 cros 和非 cros 中都非常非常好。如果有什麼不同的話，那就是肝硬化患者的情況要好一些。所以，你知道，顯然我們希望我們的第三階段計畫是基於第二階段計畫的觀察。因此，我們將包括肝硬化患者和非肝硬化患者。就基線特徵而言，這種預測反應和任何豐富性，你知道，我認為我們將能夠在圍繞 sld 的投資者重點關注的肝炎中提供更多的色彩。因此，請繼續關注那裡的更多細節。

Got it that's helpful. And then an HBV. You know, looking ahead what sort of it's a read through to the 48 week end of treatment data, add to the possible functional cure data in the second quarter of 25. And just, you know, curious what sort of HPS age of depression rates, you know, you could see at the 48 weeks, you know how that might mature adding into the off treatment data into Q. Thanks.

明白了，很有幫助。然後是B肝病毒。你知道，展望未來，要通讀 48 週結束的治療數據，添加到 25 週第二季可能的功能性治癒數據。只是，你知道，好奇 HPS 年齡的憂鬱症發生率是多少，你知道，你可以在 48 週時看到，你知道這可能如何成熟，將治療數據添加到 Q 中。

Yeah. No, that, that's a really good question. So just to summarize, we'll have the end of treatment data for the doublet of garden and the left and the triplet with pegulated interferon. In addition, at the upcoming liver meeting in San Diego, the functional cure data, as you said comes in Q2 next year. So really what we said before for functional cures, we're looking for a minimum of a 30% in the triplet, functional cure 20% in the doublet. I mean, in terms of end of treatment data, you know, it's clear that there is going to be at least based on prior programs of various mechanism of action. There's a drop off between end of treatment in 24 weeks, post treatment to a functional cure. But you know, predicting that drop off is is not not straightforward and you know, you know, clearly established markers to do that. So what I'd say just in summary is, you know, we will have the treatment data soon. You know that the functional cure rate will take a little bit longer to you next year and taken together that will give a very complete picture of the regimens and what they can achieve for HPV patients.

是的。不，這是一個非常好的問題。總而言之，我們將獲得花園雙聯體和左側以及聚乙二醇幹擾素三聯體的治療結束數據。此外，在即將於聖地牙哥舉行的肝臟會議上，正如您所說，功能性治癒數據將在明年第二季公佈。因此，正如我們之前所說的功能性治愈，我們正在尋找三聯體中至少 30% 的功能性治愈，雙聯體中至少 20% 的功能性治愈。我的意思是，就治療結束數據而言，很明顯，至少將基於各種作用機制的先前計劃。治療結束後 24 週內，從治療後到功能性治愈，病情有所下降。但你知道，預測下降並不簡單，而且你知道，你知道，有明確的標記來做到這一點。所以我總結來說就是，我們很快就會得到治療數據。您知道，明年的功能性治癒率將需要更長的時間，綜合起來，您將能夠非常全面地了解治療方案以及它們可以為 HPV 患者帶來的效果。

We'll move next to fill no doubt at TD Cowen.

接下來我們將消除 TD Cowen 的疑問。

Good afternoon. Thanks for taking our questions. Two from us. So, first on the HPV pivotal program, you've suggested you'll be able to give us an update at the A sld endless meeting. Will you have the final trial design at that time? And would you be able to disclose the, the design and timelines at the meeting. That's the first question and the second question just broadly on the T CE S, you've mentioned the potential for differentiation versus either other T CS in development or, or just broadly in the spaces of her two and P MS A to begin. Do you need to see differentiation in order to move those beyond phase one or is simply safe and effective? Good enough at this point with, with additional differentiation to be established in future studies.

午安.感謝您回答我們的問題。我們兩個。因此，首先關於 HPV 關鍵計劃，您建議您能夠在 A sld 無休止的會議上向我們提供最新情況。到時候你們會有最終的試用設計嗎？您能否在會議上透露設計和時間表？這是關於T CE S 的第一個問題和第二個問題，您已經提到了與正在開發的其​​他T CS 相比的差異化潛力，或者只是在她的兩個和P MS A 的空間中廣泛地開始。您是否需要看到差異化才能使這些產品超越第一階段，或者只是安全有效？在這一點上已經足夠好了，在未來的研究中還需要建立額外的差異。

Thanks.

謝謝。

So for the HPV question, we are planning, you know, that is to disclose more information about the final trial design, the phase three designs that so you'll be able to see that at the investor event around the sld so that, you know, more, more coming there in terms of time lines right now, we're not disclosing additional information about that. And we will look to do that when we have full clarity on on timelines in terms of the T ce question Marianne, would you like me to?

因此，對於 HPV 問題，我們正在計劃，您知道，那就是披露有關最終試驗設計、第三階段設計的更多信息，以便您能夠在 sld 周圍的投資者活動中看到這一點，以便您要知道，現在還有更多、更多的時間安排，我們不會透露更多相關資訊。當我們完全明確 T ce 問題瑪麗安的時間表時，我們會考慮這樣做，你願意我這樣做嗎？

Sure?

當然？

Okay. So your question is around, you know, what we would need to see to move these programs forward for her to and PS ma to be H1st, that's really something that is going to be a data driven decision. I think, you know, we are looking at this very early stage, of course to look at you know, proof of concept and the you know, preliminary mono therapy data that we'll present in quarter one. I think we'll give start to give a picture of what the the programs look like in terms of, you know, the, the more specific answer to your question. I don't think we're quite ready to reply on that yet, but we will look to provide more color on that at a future time point.

好的。所以你的問題是，你知道，我們需要看到什麼才能推動這些項目，讓她和 PS ma 成為 H1st，這確實是一個數據驅動的決定。我認為，我們正在研究這個非常早期的階段，當然是要研究概念驗證以及我們將在第一季提供的初步單一療法數據。我想我們將開始根據您的問題的更具體的答案來描繪這些程序的樣子。我認為我們還沒有準備好對此做出回應，但我們將在未來的某個時間點提供更多相關資訊。

Perfect. Thanks for taking our questions.

完美的。感謝您回答我們的問題。

And we'll go next to Patrick Trucchio at HC Wainwright.

接下來我們將採訪 HC Wainwright 的 Patrick Trucchio。

Thanks. Good afternoon. Just a couple of follow up questions for me first in the HPV program. Can you discuss more how the combination of ALEOR and to BEVA Bar would be expected to be differentiated from boliver tide including at higher doses and the level of confidence that patients would maintain a lt normalization and vi violo responses switch from bot to the combination treatment regimen based on what we've seen in the clinical data so far. And then separately with the HBV program, regarding the 20% functional cure rate without interferon and 30% functional cure rate with Interferon. Can you tell us if these rates would be anticipated in all commerce or is it in the low S antigen at baseline patients? And if we look ahead to a potential phase three pivotal program, can you talk about or tell us more if you're thinking about maybe stratifying based on s antigen? A baseline? Would it make sense to explore combination? This combination in patients with low s antigen a baseline.

謝謝。午安.首先請教我幾個有關 HPV 計劃的後續問題。您能否更多地討論一下ALEOR 和BEVA Bar 的組合預計將如何與牛肝潮區分開來，包括在較高劑量下，以及患者保持lt 正常化和vi violo 反應從bot 切換到聯合治療方案的信心程度根據迄今為止我們在臨床數據中看到的情況。然後與HBV方案分開，關於不使用乾擾素的20％功能治癒率和使用乾擾素的30％功能治癒率。您能否告訴我們這些比率是否在所有商業中都是預期的，還是在基線患者的低 S 抗原中？如果我們展望一個潛在的第三階段關鍵計劃，如果您正在考慮根據 s 抗原進行分層，您能否談談或告訴我們更多？基線？探索組合有意義嗎？這種組合在具有低 s 抗原的患者中具有基線。

Okay. So your first question about HPV. The first part of that was about the combination of Tebi and Love Saran versus Glover Tide. We do you know with the 2 mg approved dose, you know, we do expect to get much higher levels of target not detected. Based on our data we presented at Diesel then the lever which is tw 12% at 48 week. Your your question about the higher dose, I mean that that dose isn't really isn't approved anywhere.

好的。你的第一個問題是關於 HPV 的。第一部分是關於 Tebi 和 Love Saran 與 Glover Tide 的組合。我們知道，在 2 毫克批准劑量下，我們確實期望獲得更高水平的未檢測到的目標。根據我們在 Diesel 上提供的數據，第 48 週時槓桿為 12%。您關於更高劑量的問題，我的意思是該劑量實際上並未在任何地方獲得批准。

So you know, but, but even so I think, you know, the level of T and the efficacy that we expect to have should be superior to the lever type. Just thinking about what we're likely to see in terms of the level of confidence for the lever type switch. Yeah, I mean, in terms of the patient population who's been on Bloco who is likely to enter such a trial or, or in a clinical practice, you know, we would expect to be much higher in terms of our vlog response with our combination and continued treatment with forever type in terms of your HBD question. Fundamentally, I think your question around, you know, is this going to be an all commerce versus a stratified population based on baseline surface antigen? I guess I just ask you to stay tuned for the data and that those questions should become much clearer at the March presentation at the live meeting.

所以你知道，但是，但即便如此我認為，你知道，T的水平和我們期望的功效應該優於槓桿式。想想我們可能會看到對槓桿式開關的信心程度。是的，我的意思是，就使用 Bloco 的患者群體而言，他們可能會參加此類試驗，或者在臨床實踐中，您知道，我們預計我們的組合在視頻博客反應方面會更高並根據您的HBD 問題繼續使用永久類型進行治療。從根本上說，我認為你的問題是，你知道，這將是一個全商業還是一個基於基線表面抗原的分層群體？我想我只是請您繼續關注數據，並且這些問題應該在三月的現場會議演示中變得更加清晰。

Great. Thank you so much.

偉大的。太感謝了。

And this concludes the Q&A session of the call. Thank you for participating and I'll turn the call back over to rich.

電話問答環節到此結束。感謝您的參與，我會將電話轉回給 Rich。

Thank you all for your interest in beer and for participating in today's earnings call. We appreciate your continued support and look forward to providing further updates on our progress in the future. Audra, This concludes our call. Thank you.

感謝大家對啤酒的興趣並參加今天的財報電話會議。我們感謝您的持續支持，並期待在未來提供有關我們進展的進一步更新。奧德拉，我們的通話到此結束。謝謝。

You.

你。

Make.

製作。

You may close the call. Thank you. And that does conclude today's conference call. Thank you for your participation. You may now disconnect.

您可以關閉通話。謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。