Invivyd Inc (IVVD) 2025 Q3 法說會逐字稿

Good morning, everyone, and welcome to the Q3 2025 Invivyd earnings conference call. (Operator Instructions)

各位早安，歡迎參加 Invivyd 2025 年第三季財報電話會議。（操作說明）

Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Katie Falzone, Senior Vice President of Finance. Please go ahead.

請注意，今天的活動正在錄影。現在，我想把發言權交給財務高級副總裁凱蒂·法爾佐內。請繼續。

Thank you, operator. A short while ago, we issued a press release announcing our Q3 2025 financial results in recent business highlights. That press release and the slides that are being used on today's webcast can be found in the investors section of the Invivyd website under the press release and events and presentation sections respectively. Today's discussion will be led by Mark Elia, Chairman of Invivyd's Board of Directors. He is joined by Tim Lee, Chief Commercial Officer; and Bill Duke, Chief Financial Officer.

謝謝接線生。不久前，我們在近期業務亮點中發布了一份新聞稿，宣布了我們 2025 年第三季的財務表現。新聞稿和今天網路直播中使用的幻燈片分別可以在 Invivyd 網站的投資者部分、新聞稿部分和活動及簡報部分找到。今天的討論將由 Invivyd 董事會主席 Mark Elia 主持。與他一同出席的還有首席商務官蒂姆·李和首席財務官比爾·杜克。

During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today.

在今天的討論中，我們將就公司和商業策略、研發活動、監管計劃、某些財務預期、未來前景以及其他非歷史事實的陳述作出前瞻性聲明。這些前瞻性陳述屬於《私人證券訴訟改革法案》的定義範圍，並受到各種風險、假設和不確定性的影響，這些風險、假設和不確定性可能會隨著時間的推移而變化，並導致我們的實際結果與今天表達或暗示的結果有重大差異。

These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the US Securities and Exchange Commission, including our most recent Form 10-K and 10-Q, which are also available on our website.

這些前瞻性聲明僅代表截至本次電話會議之日的情況，Invivyd 不承擔更新此類陳述的義務。有關可能影響 Invivyd 業務的風險因素的更多信息，請參閱我們向美國證券交易委員會提交的文件，包括我們最新的 10-K 表格和 10-Q 表格，這些文件也可在我們的網站上找到。

I will now turn the call over to Mark.

現在我將把通話轉給馬克。

Thank you, Katie, and good morning, everyone. The third quarter for Invivyd marked a turning point in our company's history, and we hope, also marked the beginning of substantial change in how we may prevent COVID for vulnerable Americans in the near future.

謝謝你，凱蒂，大家早安。Invivyd 第三季標誌著公司歷史上的轉折點，我們希望，這也標誌著在不久的將來，我們將在預防弱勢美國人感染 COVID 方面發生實質性的改變。

In the third quarter, in addition to growing our PEMGARDA commercial franchise, we received feedback from the US FDA to develop our vaccine alternative antibody, VYD2311, for broad populations that continue to suffer from COVID and who are not adequately served by current COVID vaccines. This feedback and our next steps at Invivyd are the result of years of Invivyd innovation and dialogue on that innovation with the FDA.

第三季度，除了擴大我們的 PEMGARDA 商業特許經營權外，我們還收到了美國 FDA 的反饋，要求我們開發疫苗替代抗體 VYD2311，以服務於繼續遭受 COVID 折磨且目前 COVID 疫苗未能充分滿足其需求的廣大群體。Invivyd 的這些回饋和我們接下來的步驟，是 Invivyd 多年來不斷創新以及與 FDA 就這些創新進行對話的結果。

By focusing on molecular evolution and by demonstrating the clinical benefits of our medicines in prospective, randomized placebo-controlled clinical trials, we believe we and the FDA are working within the same highly robust intellectual framework for evaluating new medicines, all for the benefit of vulnerable populations and the American public.

透過專注於分子演化，並透過前瞻性、隨機安慰劑對照臨床試驗證明我們藥物的臨床益處，我們相信我們和 FDA 正在同一個高度穩健的知識框架內評估新藥，所有這些都是為了弱勢群體和美國公眾的利益。

Following receipt of FDA feedback, we immediately moved in late summer to raise capital to power our intended studies, and in total raised approximately $87 million in capital in the quarter and shortly thereafter. This infusion of capital leaves Invivyd well funded to execute our pivotal clinical program, as well as to expand our current commercial organization in anticipation of VYD2311 launch, all while staying highly disciplined on our operating expenditures.

在收到 FDA 的回饋後，我們在夏末立即採取行動籌集資金，以支持我們計劃的研究，並在本季度及之後不久總共籌集了約 8700 萬美元的資金。此次資金注入使 Invivyd 擁有充足的資金來執行我們的關鍵臨床項目，並擴大我們目前的商業組織，以迎接 VYD2311 的上市，同時保持對營運支出的高度自律。

As a reminder, we have anticipated launch quantities of VYD2311 and a route to scaling manufacturing and supply further as we approach launch. The next 12 to 18 months promises to be an extraordinary time for Invivyd.

再次提醒大家，我們已經預計了 VYD2311 的首發數量，並且隨著上市日期的臨近，我們制定了進一步擴大生產和供應規模的方案。接下來的 12 到 18 個月對於 Invivyd 來說將是非凡的時期。

On today's call, I'll briefly review some aspects of our upcoming pivotal program for VYD2311, which is on track to initiate around year-end and deliver top-line data in mid 2026. And then Tim Lee will walk through recent progress with PEMGARDA and comment on the future commercial landscape for VYD2311. Finally, Bill Duke will review our financials and then we will be happy to take your questions.

在今天的電話會議上，我將簡要回顧我們即將開展的 VYD2311 關鍵項目的一些方面，該項目預計將於年底左右啟動，並在 2026 年年中提供主要數據。然後，Tim Lee 將介紹 PEMGARDA 的最新進展，並評論 VYD2311 的未來商業前景。最後，比爾·杜克將審核我們的財務報表，之後我們將很樂意回答您的問題。

We recently conducted a webinar that contains substantial detail on our work with monoclonal antibodies and our plans for moving forward with our pivotal declaration and Liberty clinical studies. I will briefly touch on some design elements and background logic for those studies today, but recommend that for more detail, listeners revisit our investor event webcast from last week.

我們最近舉辦了一場網路研討會，其中包含了關於我們在單株抗體方面的工作以及我們推進關鍵聲明和 Liberty 臨床研究的計劃的大量詳細資訊。今天我將簡要介紹這些研究的一些設計元素和背景邏輯，但建議聽眾如需了解更多詳情，請回顧我們上週的投資人活動網路直播。

To start, it's important to remember that the category of COVID prevention was born with mRNA vaccines during the 1st year of the COVID pandemic. At that time, speed to market was prized over the collection of long-term placebo-controlled clinical data. As a result, the placebo-controlled efficacy data we have from COVID vaccination is principally from the two original major studies of mRNA vaccines, each with a relatively short efficacy follow-up of seven to eight weeks, at which point the efficacy data was unblinded and the vaccines were authorized.

首先，需要記住的是，COVID 預防這個類別是在 COVID 大流行的第一年隨著 mRNA 疫苗的出現而誕生的。當時，人們更重視的是產品上市速度，而不是收集長期的安慰劑對照臨床數據。因此，我們目前所掌握的 COVID 疫苗安慰劑對照療效數據主要來自兩項最初的 mRNA 疫苗主要研究，每項研究的療效追蹤期都相對較短，只有七到八週，之後療效數據被揭盲，疫苗也獲得了批准。

These studies were, of course, conducted then in immunologically naive humans rather than in today's seropositive human population, and were conducted at a time of immunologically responsive original SARS-CoV-2 virus, rather than against the immunologically evasive viruses we face today. So other than measuring modern antibody titers that may not relate particularly to past observed protection in RCTs, there is very little controlled data on the efficacy of COVID vaccines beyond this original two-month look to inform current clinical protection and overall risk benefit.

當然，這些研究當時是在免疫力低下的人類身上進行的，而不是在如今血清陽性的人群中進行的；而且是在針對具有免疫反應性的原始 SARS-CoV-2 病毒進行的，而不是針對我們今天面臨的具有免疫逃避能力的病毒進行的。因此，除了測量可能與過去在 RCT 中觀察到的保護作用沒有特別關聯的現代抗體滴度之外，除了最初兩個月的觀察之外，關於 COVID 疫苗的有效性的受控數據非常少，無法為當前的臨床保護和總體風險收益提供資訊。

The FDA has used those original data and various real world data sets and immunologic data to construct labeling language for the vaccines in our current environment. Both mRNA vaccines are indicated for use at least two months after the last dose of COVID-19 vaccine. But that statement does not provide any information on likely protection in a modern context if used maximally, for example, every two months, or if used, as most people use it, once a year. Finally, CDC and ACIP recommendations have generally been consistent with FDA language, recommending vaccine utilization once or twice per year, or no more than every two months for certain vulnerable populations.

FDA 已利用這些原始數據、各種真實世界數據集和免疫學數據，為我們當前環境下的疫苗建立了標籤語言。兩種mRNA疫苗均建議在接種最後一劑COVID-19疫苗至少兩個月後使用。但該聲明並未提供任何關於在現代環境下，如果以最大限度使用（例如每兩個月一次）或像大多數人那樣每年使用一次，可能獲得的保護方面的信息。最後，美國疾病管制與預防中心 (CDC) 和免疫實踐諮詢委員會 (ACIP) 的建議與美國食品藥物管理局 (FDA) 的說法基本一致，建議每年接種一到兩次疫苗，或者對於某些弱勢群體，每兩個月接種不超過一次。

The point is that while COVID vaccines remain a blockbuster medical category despite widespread skepticism, as a society, we do not have any modern randomized data describing current or long-term vaccine efficacy. We do not have any placebo-controlled prospective clinical trials demonstrating the safety and efficacy profile of repeat vaccine dosing. And we do not have any prospectively designed placebo-controlled information on the relationship between vaccine-induced antibody titers and clinical protection over either the short or long-term.

關鍵在於，儘管新冠疫苗在普遍存在懷疑的情況下仍然是一個重磅醫療產品，但作為一個社會，我們沒有任何現代隨機數據來描述當前或長期的疫苗有效性。我們目前沒有任何安慰劑對照的前瞻性臨床試驗來證明重複接種疫苗的安全性和有效性。我們沒有任何前瞻性設計的安慰劑對照訊息，來了解疫苗誘導的抗體滴度與短期或長期臨床保護之間的關係。

We designed the declaration study to address several of these issues in a compact fashion in order to advance our knowledge around COVID protection, while rapidly moving VYD2311 to BLA submission if the study is successful. By using a single dose of VYD2311 with a three-month measurement, and by evaluating in parallel the safety and efficacy of monthly repeat dosing, we believe Invivyd can, in one single study, provide more information on the extent, durability, and quantitative predictability of protection from COVID than we have had from COVID vaccines over the past five years.

我們設計了這項聲明研究，旨在以簡潔的方式解決其中幾個問題，從而增進我們對 COVID 防護的了解，同時如果研究成功，則迅速將 VYD2311 提交至 BLA 申請。透過使用單劑 VYD2311 並進行三個月的測量，同時平行評估每月重複給藥的安全性和有效性，我們相信 Invivyd 可以在一項研究中提供比過去五年新冠疫苗更多的關於 COVID 保護程度、持久性和定量可預測性的信息。

We are also evaluating currently our options for evaluating longer-term protection with VYD2311, as our modeling suggests that meaningful protection following a single dose would last for a year. More, in the LIBERTY study, we plan to assess in a head-to-head study the safety and tolerability profile of VYD2311 versus active comparator mRNA vaccines. Why? The single most important reason Americans avoid COVID vaccination for is fear of safety and we see a critical opportunity to avoid the weaknesses of cross-trial comparison, and by contrast, simply demonstrate what we expect to be the major safety advantage of antibody-based prophylaxis.

我們目前也在評估 VYD2311 的長期保護效果，因為我們的模型顯示，單劑接種後可產生有意義的保護效果，持續時間可達一年。此外，在 LIBERTY 研究中，我們計劃透過頭對頭研究評估 VYD2311 與活性對照 mRNA 疫苗的安全性和耐受性。為什麼？美國人避免接種新冠疫苗的最重要原因是擔心安全性，我們看到了一個關鍵的機會，可以避免交叉試驗比較的缺點，而是直接證明我們預期的基於抗體的預防的主要安全優勢。

Based on our prior studies of low-dose intramuscular antibodies, we expect a highly favorable side effect profile that reflects the absence of inflammation and immune engagement that can be uniquely offered by antibodies. Antibodies in vivid makes draw directly from normal human immune biology and do not require inflammation like a vaccine boost might. And so a clear demonstration of safety and tolerability advantage may be a critical piece for educating HCPs, vulnerable populations, and policymakers on the merits of our approach.

根據我們先前對低劑量肌注抗體的研究，我們預期其副作用特徵非常有利，這反映了抗體所特有的不會引起發炎和免疫反應。Vivid 製劑中的抗體直接來自正常的人體免疫生物學，且不需要像疫苗加強劑那樣引發發炎。因此，清楚地展現安全性和耐受性優勢，對於教育醫護人員、弱勢群體和政策制定者了解我們方法的優點至關重要。

Net, we believe the Declaration of Liberty provide an incredible opportunity to demonstrate the power of our antibodies in protecting people from COVID, and we anticipate that our data, expected mid-2026, will add to our growing body of information that can provide major confidence in a potentially superior medical approach to protection compared to COVID vaccines. Our clinical and regulatory groups have been moving quickly to stand up these studies, and we will look forward to updating you on our progress in the coming weeks and months.

總而言之，我們相信《自由宣言》提供了一個絕佳的機會來展示我們的抗體在保護人們免受 COVID 侵害方面的力量，我們預計，我們的數據（預計在 2026 年年中）將為我們不斷增長的信息庫增添新的內容，從而為這種可能比 COVID 疫苗更優越的醫療保護方法提供更大的信心。我們的臨床和監管團隊一直在迅速推進這些研究，我們期待在接下來的幾週和幾個月向您報告我們的進展。

I will now turn the call over to Tim Lee, our Chief Commercial Officer, to talk about our progress with PEMGARDA and our expectations for the VYD2311 commercial environment.

現在我將把電話轉交給我們的商務長 Tim Lee，讓他談談我們在 PEMGARDA 方面的進展以及我們對 VYD2311 商業環境的期望。

Thank you, Marc. Last week in our investor webcast, I said that we believe there is an enormous near-term opportunity for Invivyd. Now, I'll get into the future that we see.

謝謝你，馬克。上週在我們的投資者網路直播中，我說過，我們認為 Invivyd 在近期內有巨大的發展機會。現在，我將展望我們所看到的未來​​。

It is said that Thomas Jefferson quipped, I'm a great believer in luck. The harder I work, the more I have of it. We are able to help certain immunocompromised people avoid COVID today, while planning to (technical difficulty) a broad swath of Americans avoid COVID in the future with our next generation antibody. There's a lot to digest here from this slide, because we are taking the actions that I told you that we take during our Q1 earnings call, and they are working.

據說托馬斯·傑斐遜曾戲言：“我非常相信運氣。”我越努力，得到的就越多。我們目前能夠幫助某些免疫功能低下的人避免感染新冠病毒，同時計劃（由於技術困難）在未來利用我們的下一代抗體幫助廣大美國人避免感染新冠病毒。這張投影片的資訊量很大，因為我們正在採取我在第一季財報電話會議上提到的措施，而且這些措施正在奏效。

I told you we're beginning to make progress on contracting. Today, we have more than 15,000 contracted GPO sites. I told you that we're refining messaging, and today, we have more than 1,200 sites offering infusion, and 76% of those accounts are reordering. I told you that we're beginning to be seen as a leader in COVID, and we're acting as leaders, and that means that we've been to more than 125 conferences. And all of these is enabling us to move from helping a smaller patient population today via infusion to a potential vaccine replacement with our next generation antibody, if approved.

我告訴過你，我們在合約簽訂方面已經開始取得進展。目前，我們擁有超過 15,000 個簽約的 GPO 站點。我告訴過你們，我們正在改進宣傳訊息，如今，我們有超過 1200 個網站提供輸液服務，其中 76% 的帳戶正在重新訂購。我告訴過你們，我們在應對新冠疫情方面開始被視為領導者，我們也正在發揮領導者的作用，這意味著我們已經參加了超過 125 場會議。所有這些都使我們能夠從目前透過輸液幫助較小規模的患者群體，發展到如果獲得批准，用我們的下一代抗體取代疫苗。

In our Q1 call, I shared that the IDSA guidelines and the NCCN guidelines for B cell lymphomas included PEMGARDA. As you can see here on this slide, today, numerous medical societies and guidelines make that recommendation. And it's important that the medical community is recognizing the importance of antibodies in preventing COVID, because the long-term impact of the disease continues to be dire.

在我們的第一季電話會議上，我提到 IDSA 指南和 NCCN 指南中都包含了 PEMGARDA 方案，用於治療 B 細胞淋巴瘤。正如你在這張投影片上看到的，如今許多醫學協會和指南都提出了這個建議。醫學界認識到抗體在預防新冠肺炎方面的重要性非常重要，因為疾病的長期影響仍然十分嚴重。

From the impact on children exposed to COVID-19 in utero, to our brains, to our cardiovascular systems, we should all want to avoid getting sick with COVID. We see a future that needs a widely available and accessible option to prevent COVID for most Americans. Current options simply are not enough, and we need to provide patient choice.

從胎兒時期接觸新冠病毒對兒童的影響，到對我們的大腦和心血管系統的影響，我們都應該避免感染新冠病毒。我們看到，未來需要為大多數美國人提供一種廣泛可用且易於使用的預防新冠病毒的方法。目前的選擇遠遠不夠，我們需要為患者提供選擇權。

The (technical difficulty) for HDPs and the immunocompromised people, can scale to a much bigger market share should VYD2311 be approved. We have found that people do not want to miss out on life because of COVID. They are on social media, and they are receptive to learning more.

如果 VYD2311 獲得批准，那麼對於 HDP 和免疫功能低下的人群來說，（技術上的困難）可能會擴大到更大的市場份額。我們發現，人們不希望因為新冠疫情而錯過生活。他們活躍於社群媒體，並且樂於學習更多知識。

I've talked about the number of conferences we've been at, and I wanted to share where we are from a commercial perspective. We're meeting HDPs who are most interested in keeping their immunocompromised patients protected against COVID and understand the damage that COVID continues to cause for the immunocompromised people who are in their care.

我之前談到了我們參加過的會議數量，現在我想從商業角度分享我們目前的狀況。我們正在與醫療專業人員會面，他們最關心的是保護免疫功能低下的患者免受 COVID 的侵害，並且了解 COVID 對他們照顧的免疫功能低下的人造成的持續損害。

As we consider the size of the potential commercial opportunity at this point in 2025, COVID vaccine uptake is substantially below that of influenza vaccine uptake, despite people being more concerned about getting COVID than they are about getting the flu. As we've seen the CDC data, the reason why people do not get the COVID mRNA vaccine is a concern about side effects.

當我們考慮 2025 年的潛在商業機會規模時，儘管人們更擔心感染新冠病毒而不是流感，但新冠疫苗的接種率遠低於流感疫苗的接種率。從美國疾病管制與預防中心的數據來看，人們不接種新冠mRNA疫苗的原因是擔心副作用。

We see extraordinary medical value to create a business to scale. So our goal is simple. Not easy, but simple. We want to provide people with a choice as they seek protection against COVID, and we believe that this has blockbuster potential because there are so many people that we can help.

我們看到了其在醫療領域的巨大價值，並希望以此打造一個可以規模化發展的企業。所以我們的目標很簡單。不容易，但很簡單。我們希望為人們提供對抗新冠病毒的保護措施，我們相信這將具有巨大的潛力，因為我們可以幫助很多人。

We see an enormous near-term commercial opportunity for Invivyd. Last year in the US, COVID vaccine sales totaled $3.8 billion. And yet, as we reviewed, the vaccine appears to be less than an ideal solution. We believe we may substantially (technical difficulty) safety, efficacy and durability of efficacy of protection from COVID, and we're looking forward to getting started, should VYD2311 be approved.

我們看到 Invivyd 在近期內擁有巨大的商業機會。去年美國新冠疫苗銷售額總計38億美元。然而，正如我們所分析的，疫苗似乎並非理想的解決方案。我們相信，如果 VYD2311 獲得批准，我們可能會大幅提高其在預防 COVID 方面的安全性、有效性和持久性（技術難度），我們期待著開始這項工作。

With that, I'll turn it over to Bill Duke.

接下來，我將把麥克風交給比爾‧杜克。

Thanks, Tim. I will quickly review our financials and then we'll be opening the line for your questions. Our PEMGARDA revenues continue to grow in the third quarter, up to 11% quarter on quarter and 41% year over year, reflecting our continued efforts on driving awareness in the market. We also substantially improved our cash position, not just from our underwritten public offering in August, but also by a reverse inquiry through our initial ATM facility, now effectively exhausted and at much better prices than our August 2025 financing.

謝謝你，提姆。我將快速瀏覽我們的財務狀況，然後我們將開通熱線回答您的問題。第三季度，我們的 PEMGARDA 營收持續成長，季增高達 11%，年成長高達 41%，這反映了我們不斷努力提高市場認知度。我們也大幅改善了現金狀況，這不僅得益於 8 月的承銷公開發行，還得益於透過我們最初的 ATM 融資管道進行的反向詢價，該管道目前已基本耗盡，而且價格比我們 2025 年 8 月的融資價格要好得多。

Invivyd is now well capitalized through anticipated pivotal data for VYD2311 in mid-2026, and depending upon continued PEMGARDA growth and continued operational discipline, potentially well beyond. With that, we will take your questions.

Invivyd 目前資金充足，預計 VYD2311 將於 2026 年中期公佈關鍵數據，並且根據 PEMGARDA 的持續成長和持續的營運紀律，未來發展潛力巨大。接下來，我們將回答您的問題。

(Operator Instructions) Josh Schimmer, Cantor Fitzgerald.

（操作說明）Josh Schimmer，Cantor Fitzgerald。

Hi. This is Alexa Deemer on for Josh Schimmer, and congrats on a great and exciting quarter. So my first question is, do you plan on winding down PEMGARDA once the next gen product is approved? And if so, over how much time? Thanks. And then I have another question.

你好。這裡是 Alexa Deemer，代 Josh Schimmer 為您報道，恭喜您度過了一個精彩而令人興奮的季度。所以我的第一個問題是，一旦下一代產品獲得批准，你們是否打算逐步停止使用 PEMGARDA？如果屬實，持續時間有多長？謝謝。我還有一個問題。

Hey, Alexa. Good morning and thanks for the question. I think the easiest answer right now is simply no. PEMGARDA is as you know, perhaps, a medicine that has some slightly less attractive properties in terms of scalability and accessibility, but it does remain a differentiated medicine at the molecular level. And while the market may someday pass it by, we would have no plans to actively sunset it.

嘿，Alexa。早安，謝謝你的提問。我認為目前最簡單的答案就是「不」。如您所知，PEMGARDA 在可擴展性和可及性方面可能存在一些不太吸引人的特質，但它在分子層面上仍然是一種差異化的藥物。雖然市場將來可能會忽略它，但我們目前沒有主動終止它的計劃。

Awesome. Thanks. And then my second question is, can you please clarify the coordination between (inaudible) that is required for the LIBERTY study? Thanks.

驚人的。謝謝。那麼我的第二個問題是，您能否解釋一下 LIBERTY 研究所需的（聽不清楚）之間的協調？謝謝。

Thanks. Great. Well, I can certainly tell you what we know, but I think that sort of insight is best left as a question to the FDA. I think what you are simply observing in our work is that by virtue of a law that I think dates back all the way to 2002, there are differing responsibilities as between (inaudible), and therapeutic monoclonal antibodies have traditionally been handled by law by (inaudible).

謝謝。偉大的。當然，我可以告訴你我們所知道的情況，但我認為這類見解最好留給美國食品藥物管理局（FDA）來解答。我認為您在我們工作中觀察到的現像是，根據一項我認為可以追溯到2002年的法律，不同機構（聽不清楚）的責任有所不同，而治療性單株抗體歷來由法律規定…（聽不清楚）

And so, when we, in effect, commingle these sorts of prophylactic medicines in a study, I would imagine that there would be some level of dialogue between those two centers on the nature and boundary sets of our study. Of course, I can't tell you what they're going to talk about with one another, but I think from our perspective, it's all about, essentially getting confidence and alignment on what to us looks like a relatively straightforward inquiry, right?

因此，當我們在研究中實際混合使用這些預防性藥物時，我想這兩個中心之間會就我們研究的性質和界限設定進行一定程度的對話。當然，我不能告訴你他們會談論什麼，但我認為從我們的角度來看，這本質上是為了就一個在我們看來相對簡單的問題達成共識和一致，對吧？

So there are mechanistic and fundamental questions that so far have only been answered in animal systems. For example, what does happen if you concomitantly administer both a vaccine and a monoclonal antibody? It wouldn't be crazy to imagine they might interact. Now, the meaning of such an interaction, I don't know that we see a particular issue one way or the other, right? Animal work suggests that applying a monoclonal is almost like putting a little piece of masking tape on an antigen, and so you redirect some of the immune response to vaccine, but it's not clear to us that it'll change it one way or the other.

因此，有一些機制性和基本性的問題，迄今為止只有在動物系統中才得到了解答。例如，如果同時接種疫苗和注射單株抗體會發生什麼事？設想他們可能會互動也並非異想天開。至於這種互動的意義，我不知道我們是否從中看到了某個具體問題，對吧？動物實驗表明，使用單株抗體幾乎就像在抗原上貼上一小塊遮蔽膠帶，這樣就能將部分免疫反應轉向疫苗，但我們尚不清楚這是否會改變免疫反應的方向。

I think our suspicion would be that in seeking to advance a broadly labeled, broadly indicated monoclonal, we would want to do this sort of experiment and the FDA would wish to reflect on such an experiment to support labeling language and you know, a description that is useful to HCPs and vulnerable populations about what is the nature of such a combination. So again, I think it's really just from our standpoint a logistical step that will involve a slightly unusual coordination at their end because, to my knowledge, nobody of late has actually sought to combine such assets in one single clinical study.

我認為，我們懷疑，在尋求推進一種廣泛適用、適應症廣泛的單株抗體藥物時，我們會想要進行這類實驗，而FDA也希望能夠參考這類實驗，以支持標籤語言的製定，並提供一種對醫護人員和弱勢群體有用的描述，讓他們了解這種組合藥物的性質。所以，我認為從我們的角度來看，這真的只是一個後勤步驟，需要他們那邊進行一些不尋常的協調，因為據我所知，最近還沒有人真正嘗試將這些資源結合到一個臨床研究中。

But that's a very different statement than us thinking it involves any particular risk one way or the other and any particular extraordinary process. I think we just wanted to flag it because I think it's an unusual study in a really good and interesting way. And we're very much looking forward to conducting it. Does that help?

但這與我們認為它涉及任何特定風險或任何特殊過程的說法截然不同。我認為我們只是想提一下這項研究，因為它非常獨特，而且很有趣。我們非常期待進行這次活動。這樣有幫助嗎？

Super helpful. Thank you so much.

非常有用。太感謝了。

Patrick Trucchio, H.C. Wainwright.

派崔克·特魯基奧，H.C. 溫賴特。

Hi. This is (inaudible) on for Patrick Trucchio. Thank you. Thank you for taking the question and congrats on all the progress. Could you please discuss the commercial team's current reach and any plans to expand beyond infusion centers as you transition towards intramuscular delivery for VYD2311? And then I have one more question. Thank you.

你好。這是派崔克·特魯基奧的（聽不清楚）演講。謝謝。感謝您回答這個問題，並祝賀您取得的所有進展。請您介紹一下商業團隊目前的業務範圍，以及在向肌肉注射給藥方式過渡的過程中，是否有計劃將業務拓展到輸液中心以外的領域？我還有一個問題。謝謝。

Yeah, great question. I think as you note, right, it is certainly a foundation that we've been building out around an infused specialty medication. What we're starting to do is build upon that broad foundation to meet the specialists who currently care for immunocompromised patients as well as those who will be the right target audience for 2311 should it be approved. And so the foundation we've built is scalable. I think you'll see more from us around some air cover around digital assets and reach into the community, and then an increase in field presence as we go forward through the next year.

嗯，問得好。正如你所指出的，沒錯，這確實是我們圍繞輸注特藥而建立的基礎。我們現在要做的，就是以此為基礎，為目前照顧免疫功能低下患者的專家以及如果 2311 獲得批准將成為其目標受眾的人群提供服務。因此，我們建構的基礎是可擴展的。我認為，在接下來的這一年裡，你會看到我們在數位資產和社群影響力方面投入更多精力，然後增加實地投入。

Great. Thank you so much. And then also you mentioned early-stage discovery efforts in RSV and measles. How do you intend to differentiate those programs and what's the realistic timeline for development candidate nomination?

偉大的。太感謝了。然後您也提到了呼吸道合胞病毒和麻疹的早期發現工作。您打算如何區分這些項目？候選人提名發展計畫的合理時間表是什麼？

Great. Well, these are programs that are in the discovery space right now. And in fact, they have very different contours. Differentiation for a measles antibody is, at this point, relatively easy to claim because there aren't any. And so we are approaching that virus with the same philosophical construct we would use for most of our discovery work in COVID and beyond.

偉大的。嗯，這些都是目前處於探索階段的項目。事實上，它們的輪廓非常不同。目前來說，區分麻疹抗體相對容易，因為還沒有麻疹抗體。因此，我們採用與研究 COVID 及其他病毒時相同的哲學框架來研究這種病毒。

So by that, I mean, we want to look at virus variation, we want to look at the druggable targets that are on that virus, and we want to use the platform we have to try to create the highest potency, broadest coverage, most attractive biophysical medicine we can. Now, the same is true in the RSV space with one distinction, of course, which is there are already relatively, if not very high-quality antibodies that are blockbuster commercial medicines.

所以我的意思是，我們想研究病毒變異，我們想研究病毒上的可成藥靶點，我們想利用我們現有的平台，努力創造出效力最高、覆蓋範圍最廣、最具吸引力的生物物理藥物。現在，RSV 領域的情況也是如此，當然，有一個區別，那就是已經有一些相對高品質（即使不是非常高品質）的抗體，它們是暢銷的商業藥物。

And so in all of these opportunities, I think we look at potential differentiation through a couple of different lenses. The first one we would think of is a differential resistance profile. Because when we get out of the discovery space and into the commercial market, viral resistance, just like an antibiotics is a principal concern. And so it is advantageous if we can bring something to the world that can be a backstop or an important addition to an existing armamentarium just different in terms of the risk profile the medicine presents to vulnerable populations in HCP. So resistance can be thought of as one of the first key things.

因此，在所有這些機會中，我認為我們可以從幾個不同的角度來看待潛在的差異化。我們首先想到的是差分電阻曲線。因為當我們從研發領域進入商業市場時，病毒抗藥性就像抗生素抗藥性一樣，是一個主要問題。因此，如果我們能為世界帶來一些可以作為後備措施或現有武器庫的重要補充的東西，而只是在藥物對醫療保健專業人員中的弱勢群體帶來的風險方面有所不同，那麼這將是有利的。因此，阻力可以被認為是首要的關鍵因素之一。

Now, after that, there are any number of biophysical properties from overall potency to cost of goods and expression yields, advantages in dose and delivery that get to sort of more fine tuning at the molecular level. And so I think we are interested in providing an update on both of those programs before the end of the year. And after we have sort of polished up something and found something we're happy with, our suspicion would be that they would both be candidates for relatively rapid advancement into the clinical space.

之後，還有許多生物物理特性，從整體效力到產品成本和表達產量，劑量和輸送方面的優勢，這些都需要在分子層面上進行更精細的調整。因此，我認為我們有興趣在年底前向大家報告這兩個項目的最新進展。當我們對某些東西進行潤色，並找到我們滿意的東西之後，我們懷疑它們倆都將成為相對快速地進入臨床領域的候選者。

After which, for example, RSV and measles will diverge. RSV is relatively well understood clinical development territory. Measles, as you might imagine, is not. And so they could end up being pretty different looking development campaigns with pretty different looking use cases, in effect, but we are just excited about the progress we're making in the discovery space and we'll look forward to giving you all an update as soon as we can.

之後，例如，呼吸道合胞病毒和麻疹病毒將分化。RSV 的臨床開發領域相對來說較為成熟。正如你可能想像的那樣，麻疹並非如此。因此，它們最終可能會成為外觀截然不同的開發活動，並具有截然不同的用例，但我們對我們在探索領域的進展感到興奮，我們期待盡快向大家提供最新進展。

Great. Thank you so much. That was super helpful.

偉大的。太感謝了。那真是太有幫助了。

Ladies and gentlemen, with that, we'll conclude today's question-and-answer session. I'd like to turn the floor back over to Mark Elia for any closing remarks.

女士們、先生們，今天的問答環節到此結束。我想把發言權交還給馬克·埃利亞，讓他做最後的總結發言。

All right. Thank you all for joining us this morning and for helping us keep it nice and tight. We and the team will be around for the rest of the day to follow up with any questions you might have. Thanks very much.

好的。感謝各位今天早上參與我們的節目，也感謝你們幫助我們保持現場的良好秩序。我們和團隊今天餘下的時間都會在，隨時解答您可能提出的任何問題。非常感謝。

And with that, everyone, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.

各位，今天的電話會議和演示就到此結束。非常感謝您的參與。現在您可以斷開線路了。