Dbv Technologies SA (DBVT) 2023 Q4 法說會逐字稿

Apologies for the late start of our conference. Welcome to the DBV full-year 2023 financial results and business update conference call. (Operator Instructions)

對於我們的會議開始較晚表示歉意。歡迎參加 DBV 2023 年全年財務業績和業務更新電話會議。（操作員說明）

Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

請注意此事件正在被記錄。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. And again, our sincere apologies for the delay in starting today. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 2023. This press release is available in the press releases section of the DBV Technologies website.

謝謝。再次，我們對今天延遲開始表示誠摯的歉意。今天下午，DBV Technologies 發布了一份新聞稿，概述了我們截至 2023 年 12 月 31 日的 12 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。

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.

在我們開始之前，請注意，今天的電話會議可能包括一些前瞻性陳述，包括但不限於有關我們的臨床和監管開發計劃、我們預期臨床試驗的設計、與監管機構互動的時間和結果的評論、我們對現金跑道的預測，以及我們的任何候選產品（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.

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建議的結果有顯著差異。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。

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.

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 Daniel Tasse, 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 Tasse； DBV 首席醫療官 Pharis Mohideen 博士；以及我們的財務長 Virginie Boucinha。

Before handing the call over to Daniel, for those of you who may be new to DBV, we are developing Viaskin, an investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies and other immunological disorders, with Viaskin Peanut as our lead candidate.

在將電話轉交給Daniel 之前，對於那些可能不熟悉DBV 的人，我們正在開發Viaskin，這是一個研究性專有技術平台，具有廣泛的潛在應用，可作為治療食物過敏和其他免疫性疾病的免疫療法，與Viaskin Peanut 一起使用作為我們的主要候選人。

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？

Katie, thank you, and thank you, everyone. Again, I need to add my apologies. We were waiting for confirmation that the [key] had been uploaded. It usually takes a minute. It took much longer today. We will obviously dig into this and make sure it doesn't happen again. So my apologies for having you on hold for 30 minutes.

凱蒂，謝謝你，謝謝大家。再次，我需要表達我的歉意。我們正在等待[密鑰]已上傳的確認。通常需要一分鐘。今天花了更長的時間。我們顯然會深入研究此事並確保不再發生。非常抱歉讓您等了 30 分鐘。

Today, we'll obviously give you an update on our progress when it comes to Viaskin Peanut programs and regulatory pathway. And then Virginie will share with us a financial update. But before we do that, I'd like to share with you a few perspectives about Viaskin Peanut and the peanut allergy market, things that we have not discussed in a while.

今天，我們顯然會向您介紹 Viaskin Peanut 計劃和監管途徑的最新進展。然後維吉妮將與我們分享財務最新情況。但在此之前，我想與您分享一些關於 Viaskin 花生和花生過敏市場的觀點，這些是我們已經有一段時間沒有討論過的事情了。

Starting with the fact that last week, DBV attended the American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting, which was held in Washington, DC. The meeting, which is known as AAAAI is regarded as the premier event in the allergy immunology community. And every year, we have a lot of booths on the ground at AAAAI to listen and engage with other key stakeholders, allergists, and patient advocacy groups at very top of that list.

從上週開始，DBV 參加了在華盛頓特區舉行的美國過敏、氣喘和免疫學會年度科學會議。這次會議被稱為 AAAAI，被認為是過敏免疫學界的首要活動。每年，我們都會在 AAAI 現場設立許多展位，用於傾聽其他主要利益相關者、過敏專家和患者權益團體的意見並與之互動。

One of the highlights of AAAAI this year was the fact that the product theaters -- if you've been to AAAAI, the product theaters are big deal and attract a lot of traffic. The one we hosted was called Importance of Early Intervention for Peanut Allergy. And I'm very proud of the fact that it had an unprecedented attendance. In fact, we're told that we broke the record for AAAAI event and the best attended product theater ever.

今年AAAI的一大亮點就是產品劇院－如果你去過AAAI，產品劇院是件大事，吸引了許多人潮。我們主辦的一場名為「花生過敏早期介入的重要性」。我感到非常自豪的是，它的出席人數是空前的。事實上，我們被告知我們打破了 AAAI 活動的記錄和有史以來參與人數最多的產品劇院。

Their room held 125 people; 230 allergists or more showed up. The point here being that intervening early in peanut allergy is important. Our technology is important, creating much interest. And obviously, that's the most validating feedback that there is on the hard work that's been going in, which I'd like to use to just, again, reinforce our commitment to the space and to the importance and the benefit of generating plenty of data and plenty of long-term data. We understand the huge responsibility we have of establishing the long-term safety and clinical benefits of Viaskin Peanut, because treating children is an important responsibility.

他們的房間可容納 125 人； 230 名或更多過敏症專家到場。這裡的重點是，早期介入花生過敏很重要。我們的技術很重要，引起了很多興趣。顯然，這是對我們一直在努力工作的最有效的回饋，我想用它來再次加強我們對這個領域以及產生大量數據的重要性和好處的承諾以及大量的長期數據。我們了解建立 Viaskin Peanut 的長期安全性和臨床效益所肩負的巨大責任，因為治療兒童是一項重要的責任。

Our open-label extension commitment to patients, while it takes time and effort and financial resources, ensures a rich population of subjects on Viaskin Peanuts to guide treatment, inform options, and optimize outcomes for patients. And we do have extensive follow-up of our subjects.

我們對患者的開放標籤擴展承諾，雖然需要時間、精力和財政資源，但確保了 Viaskin Peanuts 上豐富的受試者群體，以指導治療、告知選擇並優化患者的結果。我們確實對我們的研究對象進行了廣泛的追蹤。

You may recall, we recently reported back in November our interim year-two data from our open-label extension study in toddlers. And obviously, we cannot wait to see what the year-three data will look like when we share it later on this year.

您可能還記得，我們​​最近在 11 月報告了我們針對幼兒的開放標籤擴展研究的第二年中期數據。顯然，我們迫不及待地想看看今年稍後分享的第三年數據會是什麼樣子。

In 2024, we will continue to work towards creating a robust data package in toddlers and children. We have a lot of work cut for us, but we're enthusiastic about it. For the next year, we expect to have approximately 1,400 children aged one to seven enrolled globally in our Phase 3 trials. All our Phase 3 studies have an open-label extension, which as I mentioned just now, is key to understanding long-term treatments and the benefits of our therapy.

2024 年，我們將繼續努力為幼兒和兒童創建強大的資料包。我們還有很多工作要做，但我們對此充滿熱情。明年，我們預計全球將有約 1,400 名 1 至 7 歲的兒童參加我們的 3 期試驗。我們所有的 3 期研究都有開放標籤擴展，正如我剛才提到的，這是了解長期治療和我們治療的益處的關鍵。

And it goes without saying we will have the largest cumulative exposure to investigational product ever in pediatric food allergy. It's going to be a massive safety database. For our one- to seven-year-old, we will have, in fact, close to 1,700 subjects on active treatment. And if we combine that with the data from our prior Phase 3 trials, to break this down, approximately 600 toddler patients -- 600 toddlers age one to three and about 1,100 patients age four to seven will have been on immunotherapy for up to three years.

不用說，我們將在兒科食物過敏方面累積有史以來最大的研究產品累積暴露。這將是一個龐大的安全資料庫。事實上，對於我們一到七歲的孩子，我們將有近 1,700 名受試者接受積極治療。如果我們將其與先前 3 期試驗的數據結合起來，那麼大約 600 名幼兒患者（600 名 1 至 3 歲的幼兒和約 1,100 名 4 至 7 歲的患者）將接受免疫治療長達三年。 。

And let's not forget all the work we've done in 4 to 11 before that, where some of those children were treated with Viaskin Peanut for up to five years. In fact, some of that data was shared at AAAAI last weekend.

我們不要忘記我們在 4 到 11 之前所做的所有工作，其中一些孩子接受了 Viaskin Peanut 長達五年的治療。事實上，其中一些數據已於上週末在 AAAAI 上共享。

To sum it all up and put this in perspective, over 1 million Viaskin patches have been applied to children age 1 through 11 in our clinical development program. That's obviously more than 1 million days of therapy that makes up the safety database of this product's -- safety and efficacy database of this product. And it is, as I said, the most comprehensive research in children with peanut allergy.

總而言之，在我們的臨床開發計畫中，超過 100 萬片 Viaskin 貼片已應用於 1 至 11 歲的兒童。顯然，超過 100 萬天的治療構成了該產品的安全性資料庫——該產品的安全性和有效性資料庫。正如我所說，這是針對花生過敏兒童最全面的研究。

We have a well-studied product that demonstrate efficacy and consistently favorable safety profile. We're proud of that, and we keep on building that database.

我們擁有經過充分研究的產品，該產品具有良好的功效和一貫良好的安全性。我們對此感到自豪，並且我們將繼續建立該資料庫。

The second point I wish to touch on today is the disease-modifying potential of Viaskin Peanut. I'd like to share with you data that's been discussed in the past, but put together, I think, as an important perspective here.

我今天想談的第二點是 Viaskin 花生的疾病緩解潛力。我想與大家分享過去討論過的數據，但我認為這些數據放在一起是一個重要的觀點。

Let's start with our recent and striking observation in toddlers from year two, our ongoing open-label extension study. Data showed that approximately three out of five toddlers could consume almost 3.5 grams of peanut protein without triggering stopping symptoms during the food challenge. That is the equivalent of 12 to 14 peanuts, way beyond what we anticipated during accidental exposure and a massive jump from what was a median eliciting dose at baseline of 100 milligrams.

讓我們從最近對二年級幼兒的驚人觀察開始，這是我們正在進行的開放標籤擴展研究。數據顯示，大約五分之三的幼兒在食物挑戰期間可以消耗近 3.5 克花生蛋白而不會引發停止症狀。這相當於 12 到 14 粒花生，遠遠超出了我們在意外接觸期間的預期，並且比基線 100 毫克的中位誘發劑量大幅躍升。

These data suggest that Viaskin Peanut is potentially rewiring immune systems, and we suspect that is due to a plasticity immune system in this age group.

這些數據表明，Viaskin Peanut 可能會重新連接免疫系統，我們懷疑這是由於該年齡層的可塑性免疫系統所致。

We also have two other data sets from prior studies showing that Viaskin Peanut can induce what is known as sustained unresponsiveness to the allergen in older children, who, after two to three years of treatment, 80% of participants maintained desensitization of 1,000 milligrams or more two months after stopping treatment.

我們還有先前研究中的另外兩個資料集，顯示Viaskin 花生會導致年齡較大的兒童對過敏原持續無反應，經過兩到三年的治療，80% 的參與者保持了1,000 毫克或更多的脫敏。停止治療兩個月後。

And thirdly, we know from our studies in animal models that the data suggests the Viaskin Peanut induces sustained unresponsiveness of the allergen by modulating the epigenetic signature, a specific T-cell compartments. Remember, Viaskin Peanut has a unique mode of action that leverages the skin's immune properties, induce tolerance. And there's no other product out there that shows that mode of action.

第三，我們從動物模型研究中得知，數據顯示 Viaskin 花生透過調節表觀遺傳特徵（特定的 T 細胞區室）來誘導過敏原持續無反應。請記住，Viaskin 花生具有獨特的作用模式，可以利用皮膚的免疫特性，誘導耐受性。目前還沒有其他產品能夠顯示出這種作用模式。

With all this in mind, while this is not the indication we'll be pursuing at approval, we fully intend post-approval. And as part of our long-term commitment to these children, to explore the Viaskin peanut is fundamentally disease modifying after a few years of treatment.

考慮到所有這些，雖然這不是我們在批准時追求的跡象，但我們完全打算在批准後進行。作為我們對這些兒童長期承諾的一部分，探索 Viaskin 花生可以在幾年的治療後從根本上改變疾病。

With that as background on our commitment to science and to our patients, I'll turn the call over to Pharis, our Chief Medical Officer, for a detailed update on our two Viaskin Peanut programs.

以此作為我們對科學和病人承諾的背景，我將把電話轉給我們的首席醫療官 Pharis，以了解我們兩個 Viaskin Peanut 計畫的詳細最新情況。

Thank you, Daniel. As a reminder, we intend to submit two separate BLAs for the treatment of peanut allergy. In the one to three year olds, we are using the original square patch. The 12-month efficacy study EPITOPE is completed, and the results were published in the New England Journal of Medicine.

謝謝你，丹尼爾。提醒一下，我們打算提交兩份單獨的花生過敏治療 BLA。對於一到三歲的孩子，我們使用原始的方形貼片。為期12個月的療效研究EPITOPE已完成，結果發表在《新英格蘭醫學雜誌》。

In the pre-BLA meeting held in April of 2023, the FDA did not request any additional efficacy data, but did request a supplemental safety study to increase exposure on active product to close to 600 subjects per ICH guidelines. To be clear, the FDA was not looking for a specific safety signal or a specific safety concern. We call this six-month safety study COMFORT Toddlers.

在 2023 年 4 月舉行的 BLA 前會議上，FDA 沒有要求任何額外的療效數據，但確實要求進行補充安全性研究，以根據 ICH 指南將活性產品的暴露量增加到近 600 名受試者。需要明確的是，FDA 並不是在尋找特定的安全訊號或特定的安全問題。我們將這項為期六個月的安全研究稱為「COMFORT Toddlers」。

In parallel, we are running the four-to-seven-year-old indication with the modified circular path. We started this program last year with a 12-month VITESSE study. Recruitment is ongoing at this time. This indication will also have a six-month supplemental safety study, which we call COMFORT Children. The two studies combined will have 600 subjects on active treatment to meet the ICH guideline.

同時，我們正在使用修改後的圓形路徑運行四到七年的指示。我們去年透過一項為期 12 個月的 VITESSE 研究啟動了該計劃。目前招聘正在進行中。該適應症還將進行為期六個月的補充安全性研究，我們稱之為 COMFORT Children。這兩項研究合計將有 600 名受試者接受積極治療，以滿足 ICH 指南的要求。

So our attention this year will be focused on completing recruitment for the VITESSE and starting our two supplemental safety studies.

因此，我們今年的注意力將集中在完成 VITESSE 的招募並開始我們的兩項補充安全研究。

As Daniel mentioned, DBV has always been committed to generating the most robust data sets possible in our clinical trials. VITESSE is no exception. We recently submitted an amendment to extend the open-label phase so that every subject enrolled in the trial has the opportunity to receive Viaskin Peanut for up to three years.

正如 Daniel 所提到的，DBV 始終致力於在我們的臨床試驗中產生最可靠的資料集。維特斯也不例外。我們最近提交了一項修正案，以延長開放標籤階段，以便參加試驗的每個受試者都有機會接受 Viaskin Peanut 長達三年。

And remember, we also have our expanded access program for subjects that have completed in treatment in a DBV clinical trial and want to continue to receive Viaskin Peanut. So that test is set up to provide another large, robust dataset, unmatched by any other peanut allergy study in this age group.

請記住，我們也針對已完成 DBV 臨床試驗治療並希望繼續接受 Viaskin Peanut 的受試者制定了擴展准入計劃。因此，該測試的目的是提供另一個大型、可靠的數據集，這是該年齡層任何其他花生過敏研究無法比擬的。

Recall that the population in VITESSE is considered to be more sensitive than subjects in our previous studies, with the inclusion eliciting dose set at 100 milligrams. This is aligned with a younger 47-year-old age group where we believe Viaskin Peanut can provide great clinical benefit.

回想一下，VITESSE 中的族群被認為比我們先前研究中的受試者更敏感，納入誘發劑量設定為 100 毫克。這與 47 歲的年輕年齡組相符，我們相信 Viaskin Peanut 可以提供巨大的臨床益處。

In VITESSE, we have 86 clinical centers spread across the US, Canada, Australia, and Europe. Sites in every country are open and actively recruiting subjects. Like other sponsors, we were set back by the new European clinical trials directive, which significantly delayed our opening of our European sites. However, that's behind us now, and we expect to build momentum and complete screening by Q3 this year.

在 VITESSE，我們擁有 86 個臨床中心，遍佈美國、加拿大、澳洲和歐洲。每個國家的站點都是開放的並積極招募受試者。與其他申辦者一樣，我們受到了新的歐洲臨床試驗指令的阻礙，這大大推遲了我們歐洲站點的開放。然而，這一切現在已經過去了，我們預計將在今年第三季之前建立勢頭並完成篩選。

That brings me to the COMFORT Children supplemental safety study in four to seven year olds. This will have a six-month core period, followed by an open-label extension that will provide an additional six months of treatment for subjects randomized to active product and 12 months of treatment for subjects randomized to placebo. Every subjects will have the opportunity to receive Viaskin Peanut for a full year.

這讓我想到了 4 至 7 歲兒童的 COMFORT Children 補充安全研究。這將有一個為期6 個月的核心期，隨後是開放標籤擴展，為隨機接受活性產品的受試者提供額外6 個月的治療，為隨機接受安慰劑的受試者提供12 個月的治療。每個受試者都有機會獲得一整年的 Viaskin Peanut。

This will be a 270-subject study, randomized three to one active to placebo. The main inclusion criteria will be based on skin prick test and peanut-specific IgE levels. These criteria are sufficient to ensure a similar patient population relative to VITESSE. Thus, there is no need for a food challenge as part of the inclusion criteria.

這將是一項 270 名受試者的研究，隨機分為 3 比 1 的活性藥物組和安慰劑組。主要納入標準將基於皮膚點刺測試和花生特異性 IgE 水平。這些標準足以確保與 VITESSE 相似的患者群體。因此，沒有必要將食物挑戰作為納入標準的一部分。

One of the differences in COMFORT Children relative to VITESSE is the use of a simplified instructions for use. The safety study IFU states each DBV712 250-microgram epicutaneous system is intended to be worn for a full day, 24 hours. This is a shift away from the 24, plus minus 4 hours per day and the minimum wear time used in previous studies.

COMFORT Children 相對於 VITESSE 的差異之一是使用簡化的使用說明。安全研究 IFU 指出，每個 DBV712 250 微克表皮系統適合全天 24 小時配戴。這與 24 小時不同，加上每天負 4 小時以及先前研究中使用的最短配戴時間。

This new IFU more accurately reflects allergen immunotherapy and how we expect our product to be labeled if approved. Based on a past similar safety study we conducted in 4 to 11 year olds, we believe COMFORT Children would be on attractive study with potential subjects and at research centers. Be assured that study start-up activities with our CRO have already begun so that we will be in a good position to initiate the study at an optimal time.

這種新的 IFU 更準確地反映了過敏原免疫療法以及我們期望我們的產品在獲得批准後如何進行標記。根據我們過去在 4 至 11 歲兒童中進行的類似安全性研究，我們相信 COMFORT Children 將在潛在受試者和研究中心進行有吸引力的研究。請放心，我們的 CRO 的研究啟動活動已經開始，因此我們將能夠在最佳時間啟動研究。

Okay. Let's move to the toddler program. The results from the first 12 months of the EPITOPE study were published last year in the New England Journal of Medicine. The open-label extension to EPITOPE is ongoing. Recall that all subjects have the option to receive Viaskin Peanut for up to three years.

好的。讓我們轉向幼兒計畫。EPITOPE 研究前 12 個月的結果於去年發表在《新英格蘭醫學雜誌》。EPITOPE 的開放標籤擴充正在進行中。回想一下，所有受試者都可以選擇接受 Viaskin Peanut 長達三年。

For subjects or originally randomized to active treatment, we have data for two years on treatment. And for those randomized to placebo, we have the one-year crossover data from placebo to active. These data were presented as the very first-ever late-breaker at the American College of Allergy, Asthma, and Immunology Annual Meeting last November.

對於受試者或最初隨機接受積極治療的受試者，我們有兩年的治療數據。對於那些隨機接受安慰劑的患者，我們有從安慰劑到活性藥物的一年交叉數據。這些數據是在去年 11 月的美國過敏、氣喘和免疫學會年會上首次提出的。

In the interim data from the open-label extension to EPITOPE, we observed continued improvement and treatment response following the second year of treatment, which is consistent with our previous open-label extension data in 4 to 11 year olds. Using the responder criteria in EPITOPE, the response rate increased from 67% to almost 84%; and four out of five subjects, 81% consumed an eliciting dose of greater than or equal to 1,000 milligrams. To put this into perspective, the median eliciting dose at baseline was 100 milligrams. That's a tenfold increase.

在 EPITOPE 開放標籤延伸的中期數據中，我們觀察到治療第二年後持續改善和治療反應，這與我們先前在 4 至 11 歲兒童中的開放標籤延伸數據一致。使用 EPITOPE 中的應答者標準，反應率從 67% 增加到近 84%；五分之四的受試者中，81% 的攝取劑量大於或等於 1,000 毫克。為了正確看待這一點，基線時的中位誘發劑量為 100 毫克。這是十倍的成長。

Finally, participants consumed -- sorry, 56% of participants consumed the entire food challenge of nearly 3.5 grams, or about 14 peanut kernels, without meeting the food challenge stopping criteria. We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical dataset.

最後，參與者吃了——抱歉，56% 的參與者食用了近 3.5 克的整個食物挑戰，大約 14 粒花生仁，但沒有達到食物挑戰停止標準。我們相信這些結果確實令人印象深刻，這些結果繼續建立在我們廣泛而強大的 Viaskin Peanut 臨床數據集的基礎上。

During the second year of treatment, the safety results in toddlers were entirely consistent with trials in older children, which demonstrated a well-tolerated, predictable safety profile. Local application site reactions were the most commonly reported adverse events, though, notably, the frequency of such reactions decreased in the second year of treatment with Viaskin Peanut. No subjects had treatment-related serious, treatment-emergent adverse events during the second year of treatment with Viaskin Peanut, and no treatment-related permanent study discontinuations occurred.

在治療的第二年，幼兒的安全性結果與年齡較大兒童的試驗完全一致，證明了該藥物具有良好的耐受性、可預測的安全性。局部應用部位反應是最常見的不良事件，但值得注意的是，在使用 Viaskin Peanut 治療的第二年，此類反應的頻率有所下降。在使用 Viaskin Peanut 治療的第二年中，沒有受試者出現與治療相關的嚴重的、治療引起的不良事件，也沒有發生與治療相關的永久研究中斷。

Furthermore, there were no treatment-related anaphylactic events during the second year of treatment with Viaskin Peanut. And remember, our studies used a very broad definition of anaphylaxis purposefully behind to set a very low bar in reporting anaphylactic events.

此外，在使用 Viaskin Peanut 治療的第二年，沒有出現與治療相關的過敏事件。請記住，我們的研究故意使用了非常廣泛的過敏反應定義，從而在報告過敏事件方面設定了非常低的標準。

Overall, we were extremely pleased with the results of the second year of treatment from an efficacy point as well as from a safety point. We didn't present the placebo crossover data in the slides today, but it was discussed at the college meeting in November.

總的來說，我們對第二年的治療結果從療效和安全性方面都非常滿意。我們今天沒有在幻燈片中展示安慰劑交叉數據，但在 11 月的大學會議上對此進行了討論。

And the placebo crossover efficacy and safety appeared to be virtually identical to the first 12-month data set in EPITOPE that was published in the New England Journal. This confirms what was observed previously and also provides reassurance that slightly older subjects, the three year olds in EPITOPE that crossed over as four year olds in the open-label extension still had a robust treatment effect. This bodes well for the VITESSE study.

安慰劑交叉療效和安全性似乎與《新英格蘭雜誌》上發表的 EPITOPE 第一個 12 個月資料集幾乎相同。這證實了先前觀察到的情況，並且還保證了年齡稍大的受試者，即 EPITOPE 中的三歲兒童在開放標籤擴展中跨越為四歲兒童，仍然具有強大的治療效果。這對 VITESSE 研究來說是個好兆頭。

Let me wrap up with the COMFORT Toddler study. This is a six-month study that will include 400 subjects, randomized three to one, active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to one year. COMFORT Toddlers will use the same IFU as COMFORT Children. So there will be consistency between the two studies. This study will use the same square patch as the EPITOPE study.

讓我以 COMFORT Toddler 研究作為結束語。這是一項為期六個月的研究，將包括 400 名受試者，隨機分為三對一，分別服用活性藥物和安慰劑。與 COMFORT Children 研究一樣，受試者將有機會接受長達一年的積極治療。COMFORT 幼兒將使用與 COMFORT 兒童相同的 IFU。因此這兩項研究之間會有一致性。本研究將使用與 EPITOPE 研究相同的方形補丁。

One of the differences between COMFORT Toddlers and COMFORT Children other than the obvious difference in age range and patch is that the toddler study was used a double-blind, placebo-controlled food challenge as part of the inclusion criteria. We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that as EPITOPE as possible. We believe in food challenge was the best way to ensure that outcome.

除了年齡範圍和斑塊上的明顯差異之外，COMFORT Toddlers 和 COMFORT Children 之間的差異之一是，幼兒研究採用雙盲、安慰劑對照食物挑戰作為納入標準的一部分。我們選擇納入食物挑戰，以確保安全性研究中的研究人群與 EPITOPE 盡可能緊密匹配。我們相信食物挑戰是確保這一結果的最佳方式。

Peanut-specific IgE is more reliable as a biomarker of peanut allergy in older children but is less reliable in toddlers. Our EPITOPE data shows that half of our subjects had peanut-specific IgE levels at or below 14, but still tested positive for peanut allergy by a food challenge. That is, they had low IgE levels, but were still allergic, whereas the older subjects in the middle and far-right figures on the slide, had much fewer subjects with low IgE that were peanut allergic.

花生特異性 IgE 作為花生過敏的生物標記對於年齡較大的兒童來說更可靠，但對於幼兒來說不太可靠。我們的抗原決定位數據顯示，我們一半的受試者的花生特異性 IgE 水平等於或低於 14，但仍透過食物挑戰檢測出花生過敏呈陽性。也就是說，他們的 IgE 水平較低，但仍然過敏，而幻燈片中間和最右邊的老年受試者中，IgE 水平較低且對花生過敏的受試者要少得多。

We appreciate that this adds a bit of complexity to the study and they have a small impact on recruitment, but we believe this will allow us to best replicate the EPITOPE study population for a BLA submission in the future.

我們意識到這增加了研究的複雜性，並且對招募影響很小，但我們相信這將使我們能夠最好地複製 EPITOPE 研究群體，以便將來提交 BLA。

As we have stated previously, we will initiate COMFORT Toddlers after we received FDA feedback on the protocol, which was submitted in November last year. The DBV clinical team has been gearing up with our CRO for study initiation. We believe we are in position to initiate the study in a short period of time, pending FDA feedback on the protocol.

正如我們之前所說，在收到 FDA 對去年 11 月提交的方案的回饋後，我們將啟動 COMFORT Toddlers。DBV 臨床團隊一直在與我們的 CRO 合作啟動研究。我們相信，我們有能力在短時間內啟動這項研究，等待 FDA 對方案的回饋。

With that, back to you, Daniel.

說到這裡，回到你身邊，丹尼爾。

Thank you, Pharis. Before turning the call over to Virginie to review the financials, I'd like to cover a corporate update. During the fourth quarter, we further strengthened our leadership team in advance of our two BLA submissions and anticipated commercialization, so that we are best positioned for long-term success.

謝謝你，法里斯。在將電話轉給維吉妮查看財務狀況之前，我想先介紹一下公司的最新情況。在第四季度，我們在兩次 BLA 提交和預期商業化之前進一步加強了我們的領導團隊，以便我們為長期成功做好準備。

On top of our new CFO, Virginie, who joined us in November, we appointed Dr. Kevin Malobisky, PhD, as our new Chief Operations Officer. Kevin has an extensive track record of more than 35 years in biopharmaceutical, strategic, and operational leadership roles, including roles that span both research, as well as drug development and drug approval. Kevin will be instrumental for successful BLA submission, and I couldn't be more thrilled that he has joined our leadership team.

除了 11 月加入我們的新財務長 Virginie 之外，我們還任命 Kevin Malobisky 博士為我們新的營運長。Kevin 在生物製藥、策略和營運領導職位方面擁有超過 35 年的豐富經驗，包括研究、藥物開發和藥物批准。Kevin 將為成功提交 BLA 發揮重要作用，對於他加入我們的領導團隊，我感到無比興奮。

I would like to have the opportunity to formally welcome Kevin to our team, and he's already making a very positive impact. So really delighted to have both Virginie and Kevin joining us. Without further ado, I will invite Virginie to cover briefly our financial highlights.

我希望有機會正式歡迎凱文加入我們的團隊，他已經產生了非常積極的影響。非常高興維吉妮和凱文加入我們。言歸正傳，我將邀請 Virginie 簡要介紹我們的財務亮點。

Thank you very much, Daniel, and I will now provide a brief overview of our financials for the year 2023, which I invite you to further review in our press release and phone.

非常感謝您，丹尼爾，我現在將簡要概述我們 2023 年的財務狀況，我邀請您在我們的新聞稿和電話中進一步查看。

There are three highlights I would like to point out for your 2023. Number one, we closed the year with $141 million in cash. Number two, we dedicated over 90% of the cash we used in operations to progressing Viaskin Peanut clinical development and preparing for BLA filing. Number three, our 2023 P&L includes the favorable impact of the termination of our collaboration with Nestlé.

我想為您指出 2023 年的三個亮點。第一，我們以 1.41 億美元的現金結束了這一年。第二，我們將營運中使用的超過 90% 的現金用於推進 Viaskin Peanut 臨床開發和準備 BLA 備案。第三，我們的 2023 年損益表包括終止與雀巢合作的有利影響。

As you may be aware, in Q4 of last year 2023, we terminated a collaboration agreement with Nestlé, which was meant to develop and commercialize a diagnostic marker for cow's milk allergy. This contract was draining resources and attention away from our priority Viaskin Peanut, with neither tangible nor medium-term income. Terminating the contract was a financially sound decision with material positive impact on our '23 financials expenses and net loss.

如您所知，2023 年第四季度，我們終止了與雀巢的合作協議，該協議旨在開發牛奶過敏診斷標記並將其商業化。該合約耗盡了我們優先生產的 Viaskin Peanut 的資源和注意力，既沒有有形收入，也沒有中期收入。終止合約在財務上是一個明智的決定，對我們 23 年的財務費用和淨虧損產生了重大正面影響。

One more word on our financials and resources allocation, if you consider our financial statements without the impact of the Nestlé collaboration agreement, our operating expenses increased by 25% in 2023 to support the VP clinical -- Viaskin Peanut clinical studies, CMC preparation, regulatory activities and getting ready from the manufacturing site, in view of all of this for the approval and launch of [Viaskin].

關於我們的財務和資源分配，如果你考慮我們的財務報表，沒有受到雀巢合作協議的影響，我們的營運費用在 2023 年增加了 25%，以支持 VP 臨床——Viaskin Peanut 臨床研究、CMC 準備、監管活動並從生產現場做好準備，考慮到所有這些，以便批准和推出[維亞斯金]。

Back over to you, Daniel.

回到你身邊，丹尼爾。

Thanks, Virginie. Now, before I communicate DBV's upcoming milestones, I would be amiss if I did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and that we believe Viaskin Peanut will serve that community.

謝謝，維吉妮。現在，在我傳達 DBV 即將到來的里程碑之前，如果我沒有在這裡花一點時間了解過去幾年食物過敏狀況發生了多大變化，並且我們相信 Viaskin Peanut 將為該社區服務，那我就錯了。

There's nothing we hea more clearly from the food allergy community that this therapeutic area desperately needs treatment alternatives. The recent FDA approval of omalizumab, which was the brand name XOLAIR, for the treatment of food allergy in adult is a welcome addition. We see treatment for food allergy requiring a range of options just like other immunological conditions, such as asthma, atopic dermatitis or inhalant allergies.

我們從食物過敏界得到的最清楚訊息是，這個治療領域迫切需要替代治療方案。最近 FDA 批准奧馬珠單抗（商品名 XOLAIR）用於治療成人食物過敏，這是一個受歡迎的補充。我們認為食物過敏的治療需要一系列的選擇，就像其他免疫性疾病，如氣喘、異位性皮膚炎或吸入性過敏。

And I'm asking you here to imagine the position of a parent with a young child just diagnosed with peanut allergy at the pediatricians office or the allergist's office until they recently stopped there. The only option available to concerned parents and caregivers was avoidance and diligent readiness with an epinephrine autoinjector.

我在這裡請您想像一下，一位家長帶著剛被診斷出患有花生過敏的幼兒在兒科醫生辦公室或過敏症專家辦公室，直到他們最近停在那裡。對於相關的父母和照顧者來說，唯一的選擇是避免並使用腎上腺素自動注射器做好準備。

Today is a different story, and over time, we'll keep on getting different and better. Children are now channeled to the allergist's office where they and their families can have real conversations, as illustrated here, about all the conditions and all the circumstances that surround the life of that child and that family. And that was another topic that we picked up in talking with KOLs and experts at AAAAI.

今天是一個不同的故事，隨著時間的推移，我們將不斷變得不同、變得更好。現在，孩子們被引導到過敏症專家辦公室，在那裡他們和他們的家人可以進行真正的對話，如下圖所示，討論圍繞該孩子和該家庭生活的所有條件和所有情況。這是我們在與 AAAAI 的 KOL 和專家交談時提到的另一個主題。

Having a range of treatment options available only fuels that conversation. And for the 670,000 children in the US, ages one through seven currently living with a daily burn of a peanut allergy, every patient's story in situation is unique, requires a bespoke solution, and that's what's needed here. Simply put, one size will not fit all.

擁有一系列可用的治療方案只會促進這種對話。對於目前美國 67 萬名 1 至 7 歲的兒童來說，他們每天都患有花生過敏，每個患者的情況都是獨一無二的，需要客製化的解決方案，而這正是這裡所需要的。簡而言之，一種尺寸並不適合所有人。

In an ever-evolving market, and we want to be very much part of that evolution, Viaskin Peanut will always be a very important product. In fact, it will be, as the opinion of most, a foundational product as was evident after speaking with hundreds of allergists attending the AAAAI Conference.

在不斷發展的市場中，我們希望成為這一發展的重要組成部分，Viaskin Peanut 將永遠是一個非常重要的產品。事實上，正如大多數人所認為的那樣，它將成為一種基礎產品，在與參加 AAAI 會議的數百名過敏症專家交談後，這一點顯而易見。

Before I open up the call for questions, I would like to take a moment to share our anticipated milestones for 2024. And this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT Toddlers trial, the six-month supplemental safety trial in support of a BLA.

在開始提問之前，我想花點時間分享我們 2024 年的預期里程碑。對 DBV 來說，今年是關鍵的一年。我們預計將啟動 COMFORT Toddlers 試驗的第一個主題，即為期六個月的補充安全試驗，以支持 BLA。

We also anticipate completing enrollment of our ongoing VITESSE Phase 3 efficacy trial in children aged four through seven years of age. And once VITESSE enrollment is close to completion, we'll initiate recruitment for our six-month COMFORT Children trial in support of that BLA. Recruitment, as Pharis touched on, will be carefully timed, so as not to compete for the same study subjects across two different clinical trials.

我們也預計將完成針對 4 至 7 歲兒童正在進行的 VITESSE 3 期療效試驗的招募。一旦 VITESSE 註冊接近完成，我們將啟動為期六個月的 COMFORT Children 試驗的招募，以支持該 BLA。正如 Pharis 所提到的，招募將仔細安排時間，以免在兩個不同的臨床試驗中爭奪相同的研究對象。

During the second quarter, we also plan to host an Investor Day, and we will share those details as soon as possible. We hope many of you will be able to join us. We also plan to announce the three-year results from our ongoing Phase 3 open-label extension of the EPITOPE trial earlier on this year.

在第二季度，我們還計劃舉辦投資者日，我們將盡快分享這些細節。我們希望你們中的許多人能夠加入我們。我們還計劃在今年稍早公佈正在進行的 EPITOPE 試驗第三階段開放標籤擴展的三年結果。

And finally, the publication and science and medical affairs machine at DBV continues to be operating very actively. We anticipate publication of additional manuscripts, which includes publications of the results of the year-two open-label extension of EPITOPE, which Pharis showed a few minutes ago, and additional invite review with a peer-reviewed scientific journal, as well as submitting abstracts of new results for presentation in upcoming conferences. So we'll keep on publishing a lot of data on our technology and its benefits.

最後，DBV 的出版、科學和醫療事務機構繼續非常活躍地運作。我們預計會發表更多手稿，其中包括幾分鐘前 Pharis 展示的 EPITOPE 第二年開放標籤擴展結果的發表，以及同行評審科學期刊的額外邀請評審，以及提交摘要在即將召開的會議上展示的新成果。因此，我們將繼續發布有關我們的技術及其優勢的大量數據。

With that, we'll now ask Pharis and Virginie to join me for the Q&A. And operator, if you could open up the lines for questions, that'd be great.

現在，我們將邀請 Pharis 和 Virginie 加入我的問答環節。接線員，如果您可以開放提問線路，那就太好了。

(Operator Instructions) Jon Wolleben, Citizens JMP.

（操作員說明）Jon Wolleben，Citizens JMP。

Hey, good afternoon and thanks for taking the questions. But first, I was hoping you could give a little bit more color on this EU directive. And then also, can you comment how many of the 600 expected patients in VITESSE you've already enrolled to date?

嘿，下午好，感謝您提出問題。但首先，我希望您能為這項歐盟指令提供更多的資訊。另外，您能否評論 VITESSE 迄今為止已登記的 600 名預期患者中有多少人？

I'll have Pharis answer the question on the directive.

我會讓 Pharis 回答有關該指令的問題。

Hey, Jon, it's Pharis. So this EU directive is a little bit different from how things were done in the past. So you have to submit your dossier, your protocol. And the countries that you've selected in Europe, all are banded together essentially as one country. So in the past, you could go one off to Germany, Italy, Spain, whichever countries you wanted. In this case, they're all bundled into one. So if any country has any objection, it has to go all the way to be resolved, and that process can continue almost indefinitely.

嘿，喬恩，我是法里斯。因此，這項歐盟指令與過去的做法有些不同。所以你必須提交你的檔案、你的協議。您在歐洲選擇的國家基本上都作為一個國家/地區聯合在一起。所以在過去，你可以一次去德國、義大利、西班牙，無論你想去哪個國家。在這種情況下，它們都捆綁在一起。因此，如果任何國家有任何反對意見，都必須全力解決，而這個過程幾乎可以無限期地持續下去。

And the big difference here is if one country protests and has an issue, all of the countries are stuck. They can't participate. And you can't pull out and one off, bill separately to all the different countries. So it is a bit different.

這裡最大的區別是，如果一個國家提出抗議並出現問題，所有國家都會陷入困境。他們不能參加。而且您無法一次向所有不同的國家/地區單獨計費。所以有點不同。

And I think the challenge here was we were one of the first Phase 2 protocols that went through. And so the system wasn't quite worked out. And I think there was just a glitch here and there. And as these new things come through, they're not always well oiled. So that's the nature of the difference in the directive now versus how it was in the past.

我認為這裡的挑戰是我們是最早通過的第二階段協議之一。所以這個系統還沒有完全完善。我認為只是到處都有一個小故障。當這些新事物出現時，它們並不總是順利進行。這就是現在的指令與過去的指令的本質差異。

Got it. Can you comment how many -- yes, can you comment on how many of the expected 600 patients have been enrolled so far?

知道了。您能否評論一下目前有多少患者 - 是的，您能否評論一下目前預計的 600 名患者中有多少人已經入組？

We don't provide that clarity of guidance for competitive reasons here. The study is progressing well against the forecast we had in place, assuming that the sales were up and running. They've been up and running later than expected.

出於競爭原因，我們在此不提供明確的指導。假設銷售正常進行，這項研究的進展與我們的預測相比進展順利。他們的啟動和運行時間比預期要晚。

What I can share is we expected 60 to 90 days would be sufficient to get through the new directive process. It took us closer to -- actually to exactly nine months to go through it. And that explains why we are out of abundance of prudence, pushing the expectation of last patient screen from a first half of 2000 -- Q2 of 2024 to Q3 of 2024.

我可以分享的是，我們預計 60 到 90 天就足以完成新指令流程。我們花了將近九個月的時間才完成它。這解釋了為什麼我們過於謹慎，將最後一次患者篩檢的預期從 2000 年上半年（2024 年第二季）推遲到 2024 年第三季。

Got it. Okay. And any timing guidance on when COMFORT Toddlers will be starting? And then how do you think about the parallel programs? Do you want them to be exactly parallel with BLA submissions in the same time period? Does that make it easier for you or potentially the review division? Or could there be staggering and one coming before the other?

知道了。好的。關於 COMFORT Toddlers 何時開始有任何時間指導嗎？那麼您如何看待並行程序？您是否希望它們與同一時間段內的 BLA 提交完全平行？這是否會讓您或潛在的審核部門變得更容易？或者是否會出現令人震驚的情況，一個先於另一個？

Yes. So I'll have Pharis answer the first question on COMFORT Toddlers and I'll talk about the benefits of having the two programs being parallel here.

是的。因此，我將讓 Pharis 回答關於 COMFORT Toddlers 的第一個問題，並且我將在這裡討論兩個程式並行的好處。

Yeah, Jon, as we've always said, we will start our Phase 3 programs when we have FDA feedback. So we're waiting for the FDA feedback. We've done all the preparations we can in terms of the team and the CRO being ready to go once we get that feedback. So we believe it will be a short period turnaround from a NAV standpoint. So again, I think it's the right thing to do for Phase 3 trials, get FDA feedback in alignment before we start to run.

是的，喬恩，正如我們一直說的，當我們收到 FDA 的回饋時，我們將啟動我們的第三階段計劃。所以我們正在等待 FDA 的回饋。我們已經做好了一切準備工作，團隊和 CRO 在收到回饋後就可以開始工作。因此，我們認為從資產淨值的角度來看，這將是一個短期的轉變。所以，我再次認為，對於 3 期試驗來說，在開始運行之前獲得 FDA 的回饋是正確的。

And we're in communication with them and they reinforce to us. And we believe from the pace of response e-mails, everything else that they are, they face a top priority. We very much see that. But we're just waiting for that final sign-off before starting the study out of, again, common sense prudence.

我們正在與他們溝通，他們也會向我們提供幫助。我們相信，從回覆電子郵件的速度來看，無論是其他什麼，他們都面臨著首要任務。我們非常看到這一點。但我們只是在等待最終的簽署，然後再出於常識性的謹慎而開始研究。

And then the other question --

然後是另一個問題--

Yeah, to come back to the benefits of the two doses in parallel. So your other question, I guess?

是的，讓我們同時回顧一下兩種劑量的好處。我想你的另一個問題是？

Yes, please.

是的，請。

Yeah. Look, both markets are huge. So if it was essentially coming down to a race to commercial potential, read them even, quite simply. Obviously, the program in toddlers is more straightforward. There's only one study to run, while we have two to run with -- in four to seven year olds.

是的。看來，這兩個市場都很大。因此，如果這本質上是一場商業潛力的競賽，那麼甚至簡單地閱讀它們。顯然，幼兒的計劃更加簡單。只有一項研究需要進行，而我們有兩項研究需要進行──針對的是四到七歲的孩子。

But that was why we were very happy when the agency agreed that these would be two separate BLAs, making not one to be junior to the other by being the BLA and the supplemental BLA. And thus, whichever one can file for us, we will file first, and making us as a commercial matter indifferent to which one is ready first. That makes sense?

但這就是為什麼當該機構同意這將是兩個獨立的 BLA 時，我們非常高興，因為 BLA 和補充 BLA 不會使一個 BLA 低於另一個 BLA。因此，無論誰可以為我們提出申請，我們都會先提出申請，這使得我們在商業問題上對誰先準備好並不關心。這就說得通了？

And then just -- yeah. Last one for me, Daniel. You touched on this, the XOLAIR approval. Can you discuss how allergists you speak to are thinking about Viaskin Peanuts use versus XOLAIR use? Do you think there's an overlap between the patients that may like both? Or do you think these are going to be separate addressable markets based on product profiles? And I'll jump back in the queue. Thanks.

然後只是——是的。我的最後一個，丹尼爾。您談到了 XOLAIR 的批准。您能否討論一下與您交談過的過敏症專家如何看待 Viaskin Peanuts 的使用與 XOLAIR 的使用？您認為兩者都喜歡的患者之間是否有重疊？或者您認為這些將是基於產品概況的單獨的可尋址市場？我會插回隊列中。謝謝。

Yeah, I'll have Pharis give you more detail because we've all talked a bunch of allergists at AAAAI. But no, there's very little overlap between the two markets, which is why XOLAIR's approval is important here by offering options. The populations are pretty significantly different. So Pharis, you want to share what you've learned from the --?

是的，我會讓 Pharis 給你更多細節，因為我們都在 AAAI 討論過一群過敏症專家。但事實並非如此，兩個市場之間幾乎沒有重疊，這就是為什麼 XOLAIR 的批准通過提供選擇在這裡很重要。人口差異非常顯著。所以 Pharis，你想分享你從——？

Sure. So we spend quite a bit of time at AAAAI talking to our different sites. And the take-home message we're getting from them is that XOLAIR had been approved a long time and it had been used off-label with OIT in certain situations. And there hasn't been huge, huge off-label use for peanut allergy as a standalone indication, or even multiple food allergies.

當然。因此，我們在 AAAAI 上花了相當多的時間與我們的不同站點進行交流。我們從他們那裡得到的重要資訊是，XOLAIR 已獲得批准很長時間，並且在某些情況下已與 OIT 一起超說明書使用。而且花生過敏作為獨立適應症，甚至多種食物過敏，還沒有大量超說明書使用。

And the reason for our one to seven year olds, the way we've been told is -- especially in the toddlers one to three, none of the investigators we spoke to would use it as sort of monotherapy for multiple food allergies or single food allergies because it's a target population. It's unknown what it would do for a immune system that is still evolving, very immature. And of course, it's an injectable.

我們被告知的原因是，對於一到七歲的孩子，尤其是一到三歲的幼兒，我們採訪過的研究人員都不會使用它作為多種食物過敏或單一食物的單一療法。過敏，因為它是目標人群。目前尚不清楚它會對仍在進化、非常不成熟的免疫系統產生什麼作用。當然，它是注射劑。

In the older patients, maybe six or seven, what we've heard was there could be extreme, extreme cases of patients that are ultra, ultra sensitive. So the anecdote that was told to me was practitioner has a patient who could go to Chuck E. Cheese, and this patient so allergic to milk that any of the residual pizza cheese grease that's on there, and if they had touched their mouth or their eyes, they would go into an anaphylactic reaction. And this is just almost straight verbatim what this investigator told me.

在老年患者中，可能是六、七歲，我們聽說可能有極端非常敏感的患者病例。因此，醫生告訴我的軼事是，醫生有一位患者可以去 Chuck E. Cheese，這位患者對牛奶過敏，以至於那裡殘留的披薩奶酪油脂，如果他們觸摸了自己的嘴或身體，眼睛，他們會產生過敏反應。這幾乎是這位調查員告訴我的原話。

And for a case like that, where it's well documented that the sensitivity is just extreme and they've tried to avoid and done everything they can, that patient might be a candidate for omalizumab. But again, it's a pretty extreme case, and they don't tend to overlap with our patients very much at all.

對於這樣的病例，有充分證據表明敏感性非常高，並且他們已盡力避免並盡其所能，該患者可能是奧馬珠單抗的候選者。但同樣，這是一個非常極端的案例，他們與我們的患者根本沒有太多重疊。

I don't know if that helps, Jonathan, but that's just what we've gathered as anecdotes talking to as many of the investigators as we can to get an understanding of how the product may be used.

我不知道這是否有幫助，喬納森，但這正是我們與盡可能多的調查人員交談時收集的軼事，以了解如何使用該產品。

No, that's consistent with what we're hearing as well. So good to hear. And thanks for the feedback and color, guys.

不，這也與我們聽到的一致。很高興聽到。謝謝你們的回饋和顏色，夥計們。

Sure. The formal market research also decides that it was KOL shows, yeah, to be used in older kids and adolescents or young adults who are multi-allergic at times in their lives where you want to make sure that their behavior or whatever they're experiencing is covered. It's not the population that we wish to help with our product.

當然。正式的市場研究還決定，KOL 節目適用於年齡較大的孩子和青少年或年輕人，他們在生活中有時會出現多種過敏症，您想確保他們的行為或他們正在經歷的任何事情被覆蓋。我們希望透過我們的產品幫助的不是大眾。

(Operator Instructions) Sushila Hernandez, Van Lanschot Kempen.

（操作員說明）Sushila Hernandez、Van Lanschot Kempen。

Yes, thank you for taking my question. Could you just walk us through the steps ahead to get to the BLA filing for the toddlers? And a second question, does your cash runway until the end of '24 include the start of both safety studies? Thank you.

是的，謝謝您回答我的問題。您能否引導我們完成為幼兒進行 BLA 備案的步驟？第二個問題，到 24 年底您的現金跑道是否包括開始兩項安全研究？謝謝。

Good question. So the answer to the second part of your question is yes. Our forecasts have always been, as you know, rather smart and conservative. So this assumes the -- not only the initiation of those two studies, a continuation of VITESSE. A lot of work we're doing also when it comes to regulatory dossier, CMC and billing up inventory also. So there's -- a lot of our expenses this year are going to that.

好問題。所以你問題的第二部分的答案是肯定的。如您所知，我們的預測一直相當明智和保守。因此，這不僅是這兩項研究的啟動，也是 VITESSE 的延續。在監管檔案、CMC 和庫存計費方面，我們也做了很多工作。所以今年我們的很多開銷都花在這方面了。

As far as next steps for the toddler dossier, sign off from the FDA on the protocol and then initiation of the trial. As Pharis said, we've been in dialogue with many of the investigator sites. We can turn that around pretty quickly.

至於幼兒檔案的下一步，FDA 會在方案上簽字，然後開始試驗。正如 Pharis 所說，我們一直在與許多調查站點進行對話。我們可以很快扭轉局面。

What we don't know is how quickly this study will enroll. We know there's a lot of enthusiasm for that study. We know that food challenges, especially only one at entry in toddlers, is easier to do, much easier to do than food challenges in older children. So we're confident this study will enroll at a good pace.

我們不知道這項研究的招募速度有多快。我們知道人們對這項研究抱持著很大的熱情。我們知道，食物挑戰，尤其是幼兒入門時的食物挑戰，比年齡較大的孩子更容易完成。因此，我們相信這項研究將以良好的速度進行。

But we have no analogs here. And for that reason, we're going to leave that as an open question until we have more data to guide more precisely to study completion BLA filing. We expect also that once we have the clinical data to move to filing a BLA, we'll move rather quickly. The CMC work will be done by then, and it's not a complex dossier, by the way, so it's pretty straightforward when it comes to the clinical data that we have to pull and analyze.

但我們這裡沒有類似物。基於這個原因，我們將把這個問題當作一個懸而未決的問題，直到我們有更多數據來更準確地指導研究完成 BLA 歸檔。我們也預計，一旦我們獲得臨床數據以提交 BLA，我們將很快採取行動。CMC 工作將在那時完成，順便說一句，這並不是一個複雜的檔案，因此當涉及到我們必須提取和分析的臨床數據時，它非常簡單。

Thank you.

謝謝。

I hope that answer your questions, Sushila.

我希望能回答你的問題，蘇西拉。

Yes, thank you.

是的，謝謝。

Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tasse for any closing remarks.

謝謝。我們的問答環節到此結束。我想將會議轉回丹尼爾·塔斯（Daniel Tasse）發表閉幕詞。

Covered a lot today and thanks for those questions. So to recap, we're continuing to advance the VITESSE, our Phase 3 study in peanut allergy children four to seven. In parallel, the successful completion of the supplemental COMFORT safety studies are important.

今天涵蓋了很多內容，感謝您提出這些問題。回顧一下，我們正在繼續推進 VITESSE，這是我們針對 4 至 7 歲花生過敏兒童的 3 期研究。同時，成功完成補充 COMFORT 安全研究也很重要。

And as I shared with our colleagues asking questions here, we have two BLAs that are distinct and in parallel. And thus, one is not relating to the other one. And the moment we have signed off on the protocol in toddlers, we will initiate that study. It's well lined up.

正如我與在這裡提問的同事分享的那樣，我們有兩個不同且並行的 BLA。因此，一個與另一個沒有關係。一旦我們簽署了針對幼兒的協議，我們就會啟動這項研究。排列得很好。

We are very confident or remain very confident this work will support BLAs in both age groups. And as we've picked up from dialogues with allergists at AAAAI, what we pick up when it comes to talking to investigators, what we have a pickup in our market research, families want treatment options. The more treatment options are available, the more dynamic the market will be. And we all benefit from that.

我們非常有信心或仍然非常有信心這項工作將為兩個年齡層的 BLA 提供支援。正如我們從與 AAAAI 過敏症專家的對話中、在與調查人員交談時得到的資訊、在市場研究中得到的信息，家庭想要治療選擇。可用的治療方案越多，市場就越活躍。我們都從中受益。

And this concludes the call for today. Again, we hope that we will keep on conveying the success of our programs to 2023 to 2024. We're laser focus on execution. And lastly, I want to apologize, again, profusely for a call that started later than expected. I thank you all. Wish you a good evening.

今天的電話會議到此結束。再次，我們希望我們能夠在 2023 年至 2024 年繼續將我們的計劃取得成功。我們非常注重執行力。最後，我想再次為比預期晚開始的通話深表歉意。我謝謝大家。祝您有個美好的夜晚。

The conference has now concluded, and thank you for attending today's presentation. You may now disconnect.

會議現已結束，感謝大家參加今天的報告。您現在可以斷開連線。