Dbv Technologies SA (DBVT) 2024 Q2 法說會逐字稿

Welcome to the DBV second quarter financial results and business update conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note this event is being recorded.

歡迎參加 DBV 第二季財務業績和業務更新電話會議。所有參與者將處於僅聽模式。[操作員說明] 請注意此事件正在被記錄。

I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

我現在想將會議交給投資者關係部門的凱蒂·馬修斯 (Katie Matthews)。請繼續。

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the three and six months ended June 30, 2024. This press release is available in the Press Releases section of the DBV Technologies website. Before we begin, please note that today’s call may include a number of forward-looking statements including, but not limited to comments regarding our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our cash runway and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies.

謝謝。今天下午，DBV Technologies 發布了一份新聞稿，概述了我們截至 2024 年 6 月 30 日的三個月和六個月的財務表現。本新聞稿可在 DBV Technologies 網站的新聞稿部分取得。在我們開始之前，請注意，今天的電話會議可能包括許多前瞻性陳述，包括但不限於有關我們的臨床和監管開發計劃、我們預期的臨床試驗的設計、相互作用的時間和結果的評論與監管機構合作，我們對現金跑道的預測以及我們任何候選產品（如果獲得批准）改善食物過敏患者生活的能力。

These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company’s actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company’s filings with the SEC and the French AMF for information concerning risk factors that could cause the company’s actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call.

這些前瞻性陳述所基於的假設存在風險和不確定性，這些風險和不確定性可能導致公司的實際結果與這些陳述所暗示的結果有顯著差異。鑑於這些風險和不確定性，您不應過度依賴這些前瞻性陳述。請參閱該公司向 SEC 和法國 AMF 提交的文件，以了解可能導致該公司實際業績與預期存在重大差異的風險因素的信息，包括本次電話會議中所做的任何前瞻性聲明。除法律要求外，本公司不承擔公開更新或修改任何前瞻性陳述以解釋或反映本次電話會議後發生的事件或情況的義務。

Joining me on the call today are Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV’s Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer.

今天和我一起參加電話會議的是 DBV 執行長 Daniel Tassé 博士； DBV 首席醫療官 Pharis Mohideen 博士；以及我們的財務長 Virginie Boucinha。

I will now pass the call over to Daniel. Daniel?

我現在將把電話轉給丹尼爾。丹尼爾？

Thank you Katie, and thank you everyone for joining our call this evening to review DBV's second quarter and first half 2024 financial results. For those of you who may be less familiar with our business, DBV is developing Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy, including food allergy. Viaskin is based on epicutaneous immunotherapy, we refer to it as EPIT, and it is our method of delivering biologically active compounds to the immune system through intact skin to progressively induce immune tolerance.

謝謝凱蒂，也謝謝大家今晚參加我們的電話會議，回顧 DBV 2024 年第二季和上半年的財務表現。對於可能不太熟悉我們業務的人來說，DBV 正在開發 Viaskin，這是一個研究性專有技術平台，在免疫療法（包括食物過敏）方面具有廣泛的潛在應用。Viaskin 基於表皮免疫療法，我們稱之為 EPIT，它是我們透過完整皮膚向免疫系統輸送生物活性化合物以逐步誘導免疫耐受的方法。

Our most advanced candidate is Viaskin Peanut, which we are developing for peanut allergic children, ages one through seven, where there exists a significant unmet medical need in the U.S. and around the world, and critically, is an age group where the immune system is particularly malleable. It is also where there is the most risk to these children from accidental exposure to peanut. Moreover, 75% to 80% of children with a peanut allergy will not outgrow their peanut allergy over their lifetime.

我們最先進的候選藥物是Viaskin Peanut，我們正在為1 至7 歲的花生過敏兒童開發該產品，這些兒童在美國和世界各地都存在未得到滿足的重大醫療需求，最重要的是，該年齡組的免疫系統處於低水平。這也是這些兒童意外接觸花生的風險最大的地方。此外，75% 到 80% 的花生過敏兒童在其一生中都不會擺脫花生過敏。

And today we are pleased to provide updates on our two Viaskin Peanut development program – programs sorry, one in children aged four to seven years of age using the modified larger circular patch, and one in toddlers age one to three using the original square patch. As you know, we plan on filing two separate biological license applications or BLAs, one for each age group.

今天，我們很高興提供有關Viaskin Peanut 開發計劃的最新信息- 抱歉，一項計劃針對4 至7 歲的兒童，使用修改後的較大圓形貼片，另一項針對1 至3 歲的幼兒，使用原始的方形貼片修補。如您所知，我們計劃提交兩份單獨的生物許可申請或 BLA，每個年齡組一份。

There are three key highlights we wish to share with you today. Beginning with the program in children four to seven years old, let's remember that we are running the VITESSE Phase 3 pivotal trial of the modified Viaskin Peanut patch in that population. Results from this trial, together with the COMFORT Children supplemental safety study, will form the basis of a BLA for this age group. Since the middle of last year, we have seen very good momentum enrolling the VITESSE trial patients and we are unchanged in our expectation that the final subject will be screened by the end of the third quarter of this year.

今天我們想與大家分享三個重要亮點。從針對 4 至 7 歲兒童的計劃開始，讓我們記住，我們正在該人群中進行改良 Viaskin 花生貼片的 VITESSE 第 3 期關鍵試驗。該試驗的結果與 COMFORT Children 補充安全性研究一起，將構​​成該年齡組 BLA 的基礎。自去年年中以來，我們看到了招募 VITESSE 試驗患者的良好勢頭，我們對最終受試者將在今年第三季末篩選的預期沒有改變。

Turning to our other program in toddlers one to three years of age, let's recall that we announced successful results from the Phase 3 efficacy study, or pivotal study known as EPITOPE, which clearly met its primary endpoint and was published in the New England Journal of Medicine last year. Also recall that the FDA requested that we conduct a supplemental safety study, which we'd call COMFORT, COMFORT Toddlers, to increase the number of subjects on treatment in the one- to three-year-old safety database in support of that BLA.

轉向我們針對一到三歲幼兒的其他項目，讓我們回想一下，我們宣布了3 期療效研究或稱為EPITOPE 的關鍵研究的成功結果，該研究顯然達到了其主要終點，並發表在《新英格蘭雜誌》上。請同時記住，FDA 要求我們進行一項補充安全性研究，我們稱之為 COMFORT，COMFORT 幼兒，以增加一到三年安全資料庫中接受治療的受試者數量，以支持該 BLA。

We submitted the COMFORT Toddlers protocol to the FDA in November of last year, and the agency responded in March. Since then, we have been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study, and the dialogue has mainly focused on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time.

我們在去年 11 月向 FDA 提交了 COMFORT Toddlers 方案，該機構於 3 月做出了回應。從那時起，我們一直與 FDA 就 COMFORT Toddlers 補充安全性研究進行持續對話，對話主要集中在貼片佩戴時間體驗上，包括處方者如何建議父母和護理人員管理貼片的日常變化。時間。

I will let Pharis, our Chief Medical Officer, get into the details in a bit more of a moment here, but let me state, firstly, that we recognize the importance of that question, and we believe the right answer to that question resides in the result of our existing trial, EPITOPE.

我會讓我們的首席醫療官 Pharis 稍後詳細介紹，但首先讓我聲明，我們認識到這個問題的重要性，我們相信這個問題的正確答案在於我們現有試驗的結果，EPITOPE。

And in an effort to seek alignment with FDA, we have recently submitted to the agency a draft labeling proposal, with comprehensive supportive data and analyses that were informed by the EPITOPE pivotal data, focused on the user experience during the first 90 days of treatment, so the first three months of treatment, to address agency's queries about patch wear time.

為了尋求與 FDA 的一致，我們最近向該機構提交了一份標籤提案草案，其中包含根據 EPITOPE 關鍵數據提供的全面支持數據和分析，重點關注治療前 90 天的用戶體驗，因此在治療的前三個月，要解決機構關於貼片佩戴時間的詢問。

The agency asked us for more details and analysis about that proposal, which we provided to FDA on June 28. And while we are awaiting a response from FDA on this labeling proposal, we continue to advance study preparation activities to be able to initiate the study once we have protocol alignment. Finally, the third update is the result of continued cost-saving measures. Through that, we have extended our cash runway into Q1 2025, and I will let Virginie, our CFO, give more details on that shortly.

該機構要求我們提供有關該提案的更多細節和分析，我們已於 6 月 28 日向 FDA 提供了這些細節和分析。在我們等待 FDA 對此標籤提案的回應的同時，我們將繼續推進研究準備活動，以便在協議一致後能夠啟動研究。最後，第三次更新是持續採取節約成本措施的結果。透過這項舉措，我們已將現金跑道延長至 2025 年第一季度，我將讓我們的財務長 Virginie 盡快提供更多相關細節。

At this point, I would like to turn the call over to our Chief Medical Officer, Dr. Pharis Mohideen, for a more detailed update on our clinical programs. Pharis?

此時，我想將電話轉給我們的首席醫療官 Pharis Mohideen 博士，以獲取有關我們臨床計劃的更詳細的最新資訊。法里斯？

Thank you, Daniel. First, let's start with the tests. If you recall, this is a 600-patient study in 4 to 7 year olds with peanut allergy using the modified Viaskin Peanut patch. We have 86 sites across the U.S., Canada, Europe, UK, and Australia. The study is assessing the efficacy and safety of Viaskin Peanut over the course of 12 months of treatment. I'm really pleased with the progress that we have made.

謝謝你，丹尼爾。首先，讓我們從測試開始。如果你還記得的話，這是一項針對 600 名患有花生過敏的 4 至 7 歲兒童的研究，使用改良的 Viaskin 花生貼片。我們在美國、加拿大、歐洲、英國和澳洲設有 86 個站點。該研究正在評估 Viaskin Peanut 在 12 個月治療過程中的功效和安全性。我對我們所取得的進展感到非常滿意。

The test has been a company-wide priority, and it's taken a coordinated effort within DBV to get to this point. For example, our medical affairs team is small in numbers, but they are incredibly diligent and never fail to engage our multiple stakeholders at medical conferences.

該測試一直是全公司的優先事項，DBV 內部透過協調努力才達到這一目標。例如，我們的醫療事務團隊人數很少，但他們非常勤奮，並且在醫療會議上總是能夠吸引我們的多個利害關係人。

And of course, our investigators and their staff did a fantastic job. And we really appreciate the support that we have received from the patient advocacy groups and the academic societies.

當然，我們的調查人員及其工作人員做得非常出色。我們非常感謝病患權益團體和學術協會給予我們的支持。

I must also thank our study participants, the parents, caregivers and subjects for their tremendous contributions. As we said in the press release, we anticipate to close recruitment by the end of the third quarter of this year. We estimate that top line results would follow approximately 12 months after the last patient is screened. We will certainly provide more detailed updates along the way.

我還必須感謝我們的研究參與者、家長、照顧者和受試者的巨大貢獻。正如我們在新聞稿中所說，我們預計將在今年第三季末結束招募。我們估計最終結果將在最後一位患者接受篩檢後約 12 個月得出。我們肯定會一路提供更詳細的更新。

Let’s move now to the status of the COMFORT Toddlers supplemental safety study protocol. The FDA asked us to do a supplemental safety study in the one to three-year old patient population to add to the EPITOPE safety database in this age group. Following a Type C protocol meeting, we submitted the Toddlers safety protocol to the FDA in November 2023.

現在讓我們討論 COMFORT Toddlers 補充安全研究計畫的現況。FDA 要求我們對一到三歲的患者群體進行補充安全性研究，以添加到該年齡組的 EPITOPE 安全資料庫中。在 C 類協議會議之後，我們於 2023 年 11 月向 FDA 提交了幼兒安全協議。

The agency responded with comments in March of this year. Since then, DBV and FDA have been engaged in ongoing dialogue. These exchanges largely focused on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time.

該機構於今年 3 月做出回應並發表評論。從那時起，DBV 和 FDA 一直在進行持續的對話。這些交流主要集中在貼片佩戴時間體驗上，包括處方者如何建議父母和照顧者管理貼片佩戴時間的日常變化。

On June 28, DBV submitted a proposed draft labeling approach with comprehensive supportive data and analyses intended to address the agency’s concerns related to patch wear time experience. We are now waiting for the FDA’s feedback on this labeling proposal.

6 月 28 日，DBV 提交了一份擬議的標籤方法草案，其中包含全面的支援數據和分析，旨在解決該機構對貼片佩戴時間體驗的擔憂。我們現在正在等待 FDA 對此標籤提案的回饋。

Let me explain the labeling proposal that we submitted to the FDA. The agency’s questions we believe are best answered with the data from our pivotal trial EPITOPE. We are still in discussion with the agency and awaiting feedback, but I can give you an overview of the concept.

讓我解釋一下我們向 FDA 提交的標籤提案。我們認為，我們的關鍵試驗 EPITOPE 的數據可以最好地回答該機構的問題。我們仍在與該機構進行討論並等待反饋，但我可以向您提供該概念的概述。

Based on our analysis of the EPITOPE data, we have identified two groups within the Viaskin Peanut treatment arm. We call the two groups the label in and label out subjects. The baseline immunological characteristics of the label in and label out subjects such as peanut-specific IgE, Skin Prick Test, and eliciting dose are similar.

根據我們對 EPITOPE 數據的分析，我們在 Viaskin Peanut 治療組中確定了兩組。我們將這兩組稱為「標籤內」和「標籤外」主題。標記受試者和標記受試者的基線免疫學特徵（例如花生特異性 IgE、皮膚點刺試驗和引發劑量）相似。

So there is clearly a difference in the sensitivity to the locally applied peanut allergen that drive differences in patch wear time experience. This is what we refer to as differences in immune physiology in the press release. Within the first 90 days on treatment, it is possible to identify and separate subjects into those that are very likely to have a robust efficacy response relative to those who are less likely to have a robust efficacy response.

因此，對局部應用的花生過敏原的敏感性顯然存在差異，從而導致貼片佩戴時間體驗的差異。這就是我們在新聞稿中所說的免疫生理學差異。在治療的前 90 天內，可以識別受試者並將其分為很可能具有穩健療效反應的受試者和不太可能具有穩健療效反應的受試者。

All of this can be done with just the patch wear time experience during the first 90 days on treatment. Subjects that are very likely to have a robust efficacy response are called label in. The proposed prescribing information, the label would recommend that these subjects continue Viaskin Peanut treatment.

所有這一切都可以透過治療前 90 天的貼片佩戴時間體驗來完成。很可能具有強烈功效反應的受試者稱為標籤。根據建議的處方訊息，標籤將建議這些受試者繼續 Viaskin Peanut 治療。

Alternatively, subjects that are less likely to have a robust efficacy response are called label out and the proposed prescribing information would recommend a shared decision making process between the healthcare provider and the parent or caregiver to determine if treatment should be discontinued.

或者，不太可能產生強烈療效反應的受試者被標記出來，並且提議的處方資訊將建議醫療保健提供者和父母或照護者之間進行共享決策過程，以確定是否應該停止治療。

In other words, for subjects identified as label out, the proposed label indicates that clinical efficacy is less likely and discontinuation of treatment should be discussed. If Viaskin Peanut is approved, we believe this labeling proposal would give prescribers a pragmatic, data driven way to discuss and provide guidance on patch wear time experience to parents and caregivers.

換句話說，對於被確定為標籤外的受試者，提議的標籤表明臨床療效不太可能，並且應討論停止治療。如果 Viaskin Peanut 獲得批准，我們相信該標籤提案將為處方者提供一種務實的、數據驅動的方式來討論貼片佩戴時間體驗並為父母和照顧者提供指導。

At this point, I'd like to invite Virginie to cover financial highlights.

現在，我想邀請維吉妮來報道財務亮點。

Thank you very much, Pharis. So we'll now briefly review financial highlights for the first semester of 2024. And there are two highlights I would like to elaborate on, our cash run rate and our P&L, in particular operating expenses. So number one, we close H1 with €66.2 million of cash on hand and our cash runway now takes us into first quarter of 2025, which is an extension from prior communication where our cash runway was sufficient to fund operations until 2024 year-end.

非常感謝你，法里斯。現在，我們將簡要回顧 2024 年第一學期的財務亮點。我想詳細說明兩個亮點，我們的現金運行率和損益表，特別是營運費用。因此，第一，我們在上半年結束時手頭上有6620 萬歐元現金，我們的現金跑道現在將我們帶入2025 年第一季度，這是之前溝通的延伸，之前溝通中我們的現金跑道足以為2024年之前的營運提供資金 -結尾。

This extension is due to cost saving measures we have implemented and that we will continue to drive. There's another point I would like to highlight as we consider cash consumption in H1 of 2024. In the first semester, cash used in operations totaled $70 million, largely for ongoing clinical trials and for CMC and regulatory activities. It is important to note that H1 cash consumption includes $24 million of non-recurring costs such as comfort study, startup costs, move projects, supply chain activities.

此次延期是由於我們已經實施並將繼續推動的成本節約措施。當我們考慮 2024 年上半年的現金消費時，我想強調另一點。第一季度，營運中使用的現金總額為 7,000 萬美元，主要用於正在進行的臨床試驗以及 CMC 和監管活動。值得注意的是，上半年現金消耗包括 2,400 萬美元的非經常性成本，例如舒適度研究、啟動成本、搬遷專案、供應鏈活動。

I will now elaborate briefly on our financials in terms of P&L. Our operating income amounts to $2.6 million for the semester and it is now exclusively composed of the research tax credit, the CIF French scheme following the termination of the collaboration agreement with Nestle Health Sciences.

我現在將簡要闡述我們的損益表財務狀況。我們本學期的營業收入為 260 萬美元，目前完全由研究稅收抵免、與雀巢健康科學合作協議終止後的 CIF 法國計劃組成。

Operating expenses total $65 million that's plus 28% on last year, but it is driven by what really matters. That's Viaskin Peanut clinical and CMC activities, and again a third of it are non-recurring expenses. So for the semester we book a net loss of $60.5 million.

營運費用總計 6500 萬美元，比去年增加 28%，但它是由真正重要的事情驅動的。這就是 Viaskin Peanut 的臨床和 CMC 活動，其中三分之一是非經常性費用。因此，本學期我們的淨虧損為 6,050 萬美元。

So I'd like to reiterate that we continue to maximize the efficiency of our spend and remain highly disciplined in our cash management.

因此，我想重申，我們將繼續最大限度地提高支出效率，並在現金管理方面保持嚴格的紀律。

That concludes the financial overview, and I'll turn the call back to Daniel for closing remarks.

財務概覽到此結束，我將把電話轉回給丹尼爾做結束語。

Danielle?

丹妮爾？

Merci, Virginie. Before bringing the call for your questions, I would like to take a moment to recap. Our anticipated milestones the remainder of 2024, which is a critical year for DBV. So first, by the end of the third quarter, reiterating that we anticipate completing enrollment in our ongoing VITESSE Phase 3 efficacy trial in children age four to seven years of age, and obviously that's something that we will communicate once that's done.

謝謝，維吉妮。在致電詢問您的問題之前，我想花點時間回顧一下。我們預計 2024 年剩餘時間將實現里程碑，這對 DBV 來說是關鍵的一年。因此，首先，到第三季末，我們重申，我們預計將完成針對 4 至 7 歲兒童正在進行的 VITESSE 3 期療效試驗的註冊，顯然，一旦完成，我們將對此進行溝通。

Secondly, we believe that DBV's proposed labeling approach is a pragmatic solution backed with robust analyses and data from EPITOPE. Importantly, and I wish to add that on April 29, the Office of Vaccine Research and Review, which is known as OVRR, which is the regulatory division within FDA that has responsibility for Viaskin Peanut, stated that non-COVID related backlogs, the products such as ours were behind them now, and that the agency would have more bandwidth for interaction with sponsors.

其次，我們相信 DBV 提出的標記方法是一種實用的解決方案，有可靠的分析和來自 EPITOPE 的資料支援。重要的是，我想補充一點，4 月 29 日，疫苗研究和審查辦公室（OVRR）（即 FDA 內負責 Viaskin Peanut 的監管部門）表示，與新冠病毒無關的積壓產品，像我們這樣的機構現在已經落後於他們了，該機構將有更多的頻寬與贊助商互動。

And we are seeing that firsthand in our interactions with the agency in the last few months for both CMC questions as well as clinical related questions. And it's obviously we're encouraged by that. And later this year, we anticipate having the year three results from our ongoing open-label extension EPITOPE, our successful Phase 3 trial in toddlers. Recall that we had saw further statistical, further and significant improvements across all efficacy parameters in desensitization year two. We look forward to sharing with you later this year, the year three results, as well as the publication of the year two results of the open label extension in a medical journal.

我們在過去幾個月與該機構就 CMC 問題以及臨床相關問題的互動中親眼目睹了這一點。顯然我們對此感到鼓舞。今年晚些時候，我們預計我們正在進行的開放標籤擴展 EPITOPE（我們在幼兒中成功的 3 期試驗）將在第三年獲得結果。回想一下，我們在脫敏第二年看到了所有功效參數的進一步統計、進一步和顯著改善。我們期待在今年稍後與您分享第三年的結果，以及在醫學期刊上發表開放標籤擴展的第二年的結果。

With that, I want to thank everyone on the phone and webcast for joining us today. I will now ask Pharis and Virginie to join me for the Q&A.

在此，我要感謝今天透過電話和網路直播加入我們的所有人。我現在請 Pharis 和 Virginie 和我一起參加問答。

At this time, we will conduct a question and answer session. (Operator Instructions)

這時候，我們將進行問答環節。（操作員說明）

Jon Wolleben with Citizens GMP.

Jon Wolleben 與公民 GMP。

Hey, good afternoon. Thanks for the update and taking the questions. Maybe just one quick clarification on the label-in, label-out, and then I have some follow-ups on that. When you say patch wear time experience, do you mean how long the kids are wearing the patch or the experience they have while wearing the patch or an interplay between those two concepts?

嘿，下午好。感謝您的更新並提出問題。也許只是對標籤輸入、標籤輸出做一個快速澄清，然後我對此進行一些跟進。當您說貼片佩戴時間體驗時，您的意思是孩子們佩戴貼片的時間有多長，還是他們在佩戴貼片時的體驗，或者這兩個概念之間的相互作用？

Yeah, good question Jonathan, thanks for asking. No it’s the former. It’s the fact that some kids wear the patch easily 24 hours a day. Other kids it varies more from one day to the other. So that patch wear time experience measured in hours of wear varies in some patients, and that’s the data that is rich to identify patients will be best responders in a nutshell.

是的，喬納森，這個問題問得好，謝謝你的提問。不，是前者。事實上，有些孩子可以輕鬆地 24 小時佩戴貼片。其他孩子每一天的變化更大。因此，以佩戴小時數衡量的貼片佩戴時間體驗因某些患者而異，簡而言之，透過豐富的數據來識別患者將是最佳反應者。

Pharis, is that a good way to put it?

Pharis，這樣說好嗎？

Yeah, that’s a good way, Daniel. The other way I like to think about it, Jonathan, is it’s kind of like a holistic experience, right? So not just is the patch there or not like an adhesion type of assessment, but it’s the day-to-day variability in the wear time. It’s the individual sensitivity, tolerability, itching, what kind of experience did they have? Was it difficult to wear it all day long or was it easy? There may be some lifestyle components in that that’s a little harder to tease out, but it’s not just one element. And as Daniel said, you can look at average daily wear time, but that doesn’t always tell you the story in terms of day-to-day variability. So I like to think of it as more of a holistic experience with the product. Does that help to kind of fill in some of the gaps there?

是的，這是個好方法，丹尼爾。喬納森，我喜歡從另一個角度思考它，這是否有點像整體體驗，對吧？因此，不僅僅是補丁是否存在，就像粘附類型的評估一樣，而且是佩戴時間的日常變化。是個人的敏感度、耐受力、癢感，他們有什麼樣的體驗？整天佩戴它是困難還是容易？其中可能有一些生活方式的組成部分——有點難以梳理，但它不僅僅是一個因素。正如丹尼爾所說，您可以查看平均每日佩戴時間，但這並不總是告訴您日常變化的情況。所以我更喜歡將其視為產品的整體體驗。這是否有助於填補那裡的一些空白？

Yeah. Well, does that make it harder to quantify them, though, than a simple number of hours worn?

是的。那麼，這是否比簡單的佩戴小時數更難量化它們？

No, not necessarily. We have – we just – it’s kind of the opposite. We have a lot of data, and we can look at a lot of different parameters. And with all of that data, you can get a pretty good sense of the type of experience the patient’s having. Obviously, we can’t talk to the patients, right. But there's so much data that we collect in our trials, that you can get a pretty good characteristic of these patients, and there's really quite a clear differentiation between those who are labeled and labeled out based on this whole accumulated data set that we have on them.

不，不一定。我們有——我們只是——有點相反。我們有很多數據，我們可以查看很多不同的參數。透過所有這些數據，您可以很好地了解患者的體驗類型。顯然，我們不能與患者交談，對吧。但是我們在試驗中收集瞭如此多的數據，您可以很好地了解這些患者的特徵，並且根據我們積累的整個數據集，那些被標記和被標記的患者之間確實存在相當明顯的區別。 。

Got it. Okay. And then you guys said there's an association between a robust clinical efficacy response. I'm wondering if you could put some parameters around what you define as a robust response, and then what percentage of the EPITOPE patients were label and label out based on this criteria?

知道了。好的。然後你們說強大的臨床療效反應之間有相關性。我想知道您是否可以圍繞您定義的穩健反應設定一些參數，然後根據此標準標記和標記多少百分比的 EPITOPE 患者？

Daniel you want to take it or want me to take it.

丹尼爾，你想接受還是希望我接受。

Yeah, I can, I can take it. Yes. So, at this point, because we're still in dialogue with the FDA, we are. It's probably not the best idea to throw out specific numbers and details, but we know this data set really, really well, and those numbers are robust in terms of what you've seen in the past from the EPITOPE results. And it is a pretty good separation between the two in terms of the size of those who are labeled in versus labeled out. I know that's kind of vague, but at this point, until we have final agreement with the FDA and have wrestled this down, it's probably nothing the right time to discuss it. But obviously, as we move forward, we'll present all of this in a public fashion.

是的，我可以，我可以接受。是的。所以，在這一點上，因為我們仍在與 FDA 對話，所以我們正在這樣做。拋出具體的數字和細節可能不是最好的主意，但我們非常非常了解這個資料集，而且這些數字對於您過去從 EPITOPE 結果中看到的內容來說是穩健的。就被標記的人和被標記的人的規模而言，兩者之間有很好的區別。我知道這有點模糊，但在這一點上，在我們與 FDA 達成最終協議並解決這個問題之前，現在可能不是討論它的合適時機。但顯然，隨著我們的前進，我們將以公開的方式呈現所有這些。

Fair enough.

很公平。

There's a reference point, I would add here, Jonathan, if I may. We have 67% overall response rate, so, obviously, the label lens would have a better response rate than that. By definition, it's a traditional enrichment strategy here, so. But the quantification will come down to the agreement we come to with the agency. If we can come to that agreement, the details will be shared at that point in time.

如果可以的話，喬納森，我想在這裡添加一個參考點。我們的整體反應率為 67%，因此，顯然，標籤鏡頭的反應率會比這更好。根據定義，這是一種傳統的豐富策略。但量化將取決於我們與該機構達成的協議。如果我們能夠達成協議，屆時將分享詳細資訊。

Got it. And one last one for me. Update on COMFORT Children, you guys don't have any expectations for feedback timing there it doesn't seem. Wondering, do you think that any progress with COMFORT Toddlers would help with COMFORT Children, or are there different issues and feedback from FDA there.

知道了。最後一張是給我的。關於 COMFORT 的更新 孩子們，你們對回饋時間似乎沒有任何期望。想知道，您認為 COMFORT Toddlers 方面的任何進展是否會對 COMFORT Children 有所幫助，或者 FDA 是否有不同的問題和回饋。

Yeah, I'll take that one, Ferris. The two were intertwined. The ability to get to the right protocol design for COMFORT Toddlers was an element, obviously of COMFORT Children. So we wanted to solve for toddlers first, children will come next year as the next step in our discussions with the agency. But job one is to get to agreement in one year to three year olds.

是的，我要那個，費里斯。兩人糾纏在一起。為 COMFORT Toddlers 制定正確的協議設計的能力顯然是 COMFORT Children 的一個要素。因此，我們想先解決幼兒問題，作為我們與該機構討論的下一步，孩子們將在明年到來。但首要任務是在一歲到三歲的孩子內達成一致。

Got it. Okay. Thanks again for taking the questions.

知道了。好的。再次感謝您提出問題。

Please. Thank you.

請。謝謝。

[Operator Instructions] And it appears there are no further questions. Mr. Tassé, I'll turn the conference back to you.

[操作員說明] 看來沒有其他問題了。塔塞先生，我將把會議轉回給你。

I’m sure I'm not on mute, I'm not. Well, that concludes our call for this afternoon. Again, thank you. We are pleased with our progress the first half of the year. We look forward to achievement of the additional value creating milestones that I described this year and next. As always, we will keep you posted on our progress and I wish you all a very good evening.

我確信我沒有靜音，我沒有。好了，我們今天下午的電話會議就到此結束。再次感謝您。我們對上半年的進展感到滿意。我們期待實現我今年和明年所描述的額外價值創造里程碑。一如既往，我們將隨時向您通報我們的進展情況，並祝大家度過一個美好的夜晚。

This concludes today's conference call. Thank you for attending.

今天的電話會議到此結束。感謝您的出席。