Forte Biosciences Inc (FBRX) 2021 Q1 法說會逐字稿

Welcome to Forte Biosciences First Quarter 2021 Conference Call. My name is David, and I will be the operator for this call. On the call are Paul Wagner, Chairman and Chief Executive Officer of Forte Biosciences; Dan Burge, Forte's Chief Medical Officer; and Tony Riley, Forte's Chief Financial Officer.

歡迎參加 Forte Biosciences 2021 年第一季度電話會議。我叫大衛，我將擔任這次電話的接線員。參加電話會議的有 Forte Biosciences 董事長兼首席執行官 Paul Wagner； Dan Burge，Forte 首席醫療官；以及 Forte 首席財務官 Tony Riley。

Before I turn the call over to Paul and Tony to discuss the business and financial highlights of the first quarter, I would like to make a comment regarding forward-looking statements. Many of the statements made during the call today are forward-looking statements, including statements with respect to the company's cash position and the potential development time line of the company's product candidate. Actual results could differ materially from those contemplated by our forward-looking statements, and reported results should not be considered as an indication of future performance. Please look at our filings with the SEC for a discussion of the factors that could cause our results to differ materially. Additional information is also set forth in Forte's quarterly report on Form 10-Q for the quarter ended March 31, 2021, as filed today with the SEC and in Forte's annual report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on March 16, 2021.

在我打電話給保羅和托尼討論第一季度的業務和財務亮點之前，我想就前瞻性陳述發表評論。今天的電話會議中做出的許多聲明都是前瞻性聲明，包括有關公司現金狀況和公司候選產品的潛在開發時間表的聲明。實際結果可能與我們的前瞻性陳述中預期的結果存在重大差異，報告的結果不應被視為未來業績的指標。請查看我們向 SEC 提交的文件，了解可能導致我們的結果出現重大差異的因素的討論。今天向 SEC 提交的 Forte 截至 2021 年 3 月 31 日的季度 10-Q 表格季度報告以及截至 2020 年 12 月 31 日的 Forte 10-K 表格年度報告中還載有更多信息，如下：於2021 年3 月16 日向SEC 提交。

The forward-looking statements on this call are based on information available to us, and we disclaim any obligation to update these forward-looking statements, except as required by law. I will now turn this over to Tony, who will discuss the financial highlights of the first quarter of 2021.

本次電話會議中的前瞻性陳述基於我們掌握的信息，除法律要求外，我們不承擔更新這些前瞻性陳述的義務。我現在將把這個問題交給托尼，他將討論 2021 年第一季度的財務亮點。

Thank you. I will now give an update of our financial results for the first quarter of 2021.

謝謝。我現在將更新 2021 年第一季度的財務業績。

We ended the first quarter of 2021 with approximately $54.8 million in cash and cash equivalents, which we believe is sufficient to fund operations for at least the next 12 months as we continue to advance our lead product candidate, FB-401, through clinical trials. Cash utilization for the first quarter of 2021 was $4.0 million.

截至2021 年第一季度，我們擁有約5480 萬美元的現金和現金等價物，我們相信這足以為至少未來12 個月的運營提供資金，因為我們將繼續通過臨床試驗推進我們的主要候選產品FB-401 。 2021 年第一季度的現金利用率為 400 萬美元。

In terms of operating results, research and development expense were $3.3 million and $1.4 million for the first quarters of 2021 and 2022, respectively. The increases in 2021 were primarily due to manufacturing and clinical development costs and noncash stock-based compensation expense as we advanced FB-401 through Phase II clinical trials. We expect our research and development expenses to increase during the next 12 months as we continue the clinical development of FB-401.

就經營業績而言，2021年和2022年第一季度的研發費用分別為330萬美元和140萬美元。 2021 年的增長主要是由於製造和臨床開發成本以及我們通過 II 期臨床試驗推進 FB-401 時的非現金股票補償費用。隨著我們繼續進行 FB-401 的臨床開發，我們預計未來 12 個月的研發費用將會增加。

General and administrative expenses were $1.4 million and $0.7 million for the first quarters of 2021 and 2020, respectively. The increases in 2021 were primarily due to professional fees for legal, auditing and business consulting services and increases in head count expenses, including noncash stock-based compensation as we scale operations and became a public company on June 15, 2020.

2021 年和 2020 年第一季度的一般費用和管理費用分別為 140 萬美元和 70 萬美元。 2021 年的增長主要是由於法律、審計和商業諮詢服務的專業費用以及人員費用的增加，包括隨著我們擴大業務規模並於 2020 年 6 月 15 日成為上市公司而產生的非現金股票薪酬。

Losses per share were $0.36 and $0.97 for the quarters ended March 31, 2021, and 2020, respectively. Forte had 13.5 million shares of common stock outstanding at the end of the quarter.

截至2021年3月31日和2020年3月31日的季度每股虧損分別為0.36美元和0.97美元。截至本季度末，Forte 已發行普通股 1,350 萬股。

Additional details on our financial results for the first quarter of 2021 can be found in our Form 10-Q as filed today with the SEC. You can also find more information in the Investor Relations website at www.fortebiorx.com. I will now hand over to Paul.

有關我們 2021 年第一季度財務業績的更多詳細信息，請參閱今天向 SEC 提交的 10-Q 表格。您還可以在投資者關係網站 www.fortebiorx.com 上找到更多信息。現在我將把任務交給保羅。

Great. Thank you, Tony. We're going to keep today's call fairly short, but I wanted to give investors an opportunity to ask any questions that you may have.

偉大的。謝謝你，托尼。我們今天的電話會議將保持相當簡短，但我想讓投資者有機會提出你們可能有的任何問題。

Before we get to the Q&A, for those of you on the call that are not as familiar with Forte, we're developing FB-401, a live biotherapeutic, meaning that this therapy consists of living bacteria, for the treatment of inflammatory skin diseases. And the first focus is on atopic dermatitis. We've been working on FB-401 in collaboration with the National Institute of Health and the National Institute of Allergy and Infectious Diseases.

在我們進行問答之前，對於那些不熟悉 Forte 的人來說，我們正在開發 FB-401，一種活生物治療藥物，這意味著這種療法由活細菌組成，用於治療炎症性皮膚病。第一個焦點是特應性皮炎。我們一直在與美國國立衛生研究院和美國國家過敏和傳染病研究所合作開發 FB-401。

Atopic dermatitis is a disease that affects approximately 20 million people in the United States alone, with more than half of those being pediatrics. In fact, one of our thought leaders has suggested that number could be as high as 60% to 70% of the population being pediatrics. There's no cure for atopic dermatitis at present, and the treatment options for pediatrics in particular are very limited. We believe there's a significant unmet need for safe and effective therapies to treat these patients and are hopeful that FB-401 can meet that need. As we've highlighted previously, in October, FDA granted Fast Track designation to FB-401 based on that unmet need and the seriousness of the disease.

特應性皮炎是一種僅在美國就影響約 2000 萬人的疾病，其中一半以上是兒科疾病。事實上，我們的一位思想領袖表示，兒科醫生的數量可能高達 60% 到 70%。目前特應性皮炎無法治愈，尤其是兒科的治療選擇非常有限。我們相信，對治療這些患者的安全有效療法的需求尚未得到滿足，並希望 FB-401 能夠滿足這一需求。正如我們之前強調的，10 月份，FDA 基於未滿足的需求和疾病的嚴重性，授予 FB-401 快速通道資格。

We completed a Phase IIa study, and that data was published last year in Science Translational Medicine. Just as a quick recap, and I know we've talked about this before, but in that trial, the 20 pediatrics treated for 16 weeks in the IIa trial, FB-401 demonstrated a nearly 80% improvement from baseline in atopic dermatitis disease activity as measured by EASI. That's the Eczema Activity and Severity Index. And that effect was durable for between 3 and 8 months after stopping therapy.

我們完成了一項 IIa 期研究，該數據去年發表在《科學轉化醫學》雜誌上。快速回顧一下，我知道我們之前已經討論過這一點，但在該試驗中，20 名兒科患者在IIa 試驗中接受了16 週的治療，FB-401 表現出特應性皮炎疾病活動較基線改善了近80%由 EASI 測量。這就是濕疹活動度和嚴重程度指數。而且這種效果在停止治療後可持續 3 至 8 個月。

The proportion of patients that had at least a 50% improvement in disease, referred to as EASI 50, was 90%, while the EASI 75 was 70% and EASI 90 was 30%. In a subgroup of moderate to severe patients, all of them, 100%, achieved EASI 50, nearly 90% achieved EASI 75 and 1/3 achieved the EASI 90.

疾病改善至少 50%（稱為 EASI 50）的患者比例為 90%，而 EASI 75 為 70%，EASI 90 為 30%。在中度至重度患者亞組中，所有患者 100% 達到 EASI 50，近 90% 達到 EASI 75，1/3 達到 EASI 90。

As we announced last quarter, we have completed enrollment in the randomized controlled study. We originally targeted enrolling 124 subjects. But due to strong demand, we were able to enroll 154 subjects. Trial enrolled pediatrics, 2 years of age and older adolescents, and adults with mild to moderate atopic dermatitis. The majority of those subjects enrolled are under age 18, and the majority are also of moderate disease severity. We expect to announce the results of this trial in the third quarter.

正如我們上季度宣布的那樣，我們已經完成了隨機對照研究的招募。我們最初的目標是招收 124 名受試者。但由於需求強勁，我們最終招收了 154 名科目。試驗招募了患有輕度至中度特應性皮炎的兒科、2歲及以上青少年以及成人。大多數入組受試者年齡在 18 歲以下，而且大多數的疾病嚴重程度也為中等。我們預計將在第三季度公佈該試驗的結果。

In terms of our cash position. As Tony mentioned, at the end of the first quarter of 2021, we had $54.8 million, and our cash utilization rate positions us well. We expect to have cash sufficient for at least the next 12 months.

就我們的現金狀況而言。正如托尼提到的，截至 2021 年第一季度末，我們有 5480 萬美元，我們的現金利用率使我們處於有利地位。我們預計至少未來 12 個月的現金充足。

Lastly, I'm really pleased to announce that since our last conference call, we had 2 more patents issued, which brings our total patent portfolio up to 11 in the U.S., and we have similar filings progressing in greater than 15 ex U.S. countries.

最後，我非常高興地宣布，自上次電話會議以來，我們又發布了2 項專利，這使我們在美國的專利組合總數達到11 項，並且我們在美國以外的15 個以上國家/地區也有類似的申請正在進行。

So with that, David, we'll now open the call up for Q&A.

那麼，大衛，我們現在將開始問答環節。

(Operator Instructions) Our first question is from Mohit Bansal with Citigroup.

（操作員說明）我們的第一個問題來自花旗集團的 Mohit Bansal。

Congrats on the progress. A couple of questions. So one is regarding the use of EASI 50 as an end point in your Phase II trial versus IGA, which is used by dupil as well as Eucrisa. So any thoughts there on which end point is probably a better one for the kind of patient population you are going after?

祝賀取得的進展。有幾個問題。因此，我們考慮使用 EASI 50 作為 II 期試驗的終點，而不是使用 IGA，dupil 和 Eucrisa 都使用 IGA。那麼，對於您所追求的患者群體來說，哪種終點可能更好？有什麼想法嗎？

Mohit, thanks very much for that question. I appreciate it. Dan, do you want to address that? And I can maybe follow up with a few comments as well.

莫希特，非常感謝你提出這個問題。我很感激。丹，你想解決這個問題嗎？我也許還可以提出一些評論。

Sure. Sure. Clearly, the IGA is used in Phase III studies, and that's what we would plan for our Phase III as well. But when you do smaller Phase II trials, you're usually not powered for that end point so one usually uses alternative end points. So the EASI 50 is very common to use for a Phase II clinical trial like this.

當然。當然。顯然，IGA 用於 III 期研究，這也是我們為 III 期研究計劃的。但是，當您進行較小的第二階段試驗時，您通常沒有能力達到該終點，因此通常會使用替代終點。因此，EASI 50 非常常用於此類 II 期臨床試驗。

And then I'll just add. There's a number of secondary end points. Obviously, IGA is one of those end points and a variety of different EASIs. So the EASI 50 is one we've talked about before. Obviously, we're looking at improvement in EASI as well as EASI 75 and 90.

然後我就補充一下。有許多次要終點。顯然，IGA 是這些終點之一以及各種不同的 EASI。所以 EASI 50 是我們之前討論過的一個。顯然，我們正在考慮 EASI 以及 EASI 75 和 90 的改進。

Got it. Super helpful. And then one question we have been getting is that this division of the FDA you are seeking guidance from, is it the immunogenic division? Or is it -- given that yours is a live bacteria, so is it the one which takes care of the live bacteria? And does it matter who regulates this particular therapy?

知道了。超級有幫助。我們一直收到的一個問題是，您正在尋求指導的 FDA 的這個部門是免疫原部門嗎？或者是——既然你的細菌是活細菌，那麼它就是負責照顧活細菌的細菌嗎？誰來監管這種特殊療法重要嗎？

That's a really interesting question, Mohit. So it is being overseen by the division of vaccines and related products. I think the history of that might just go back to the fact that certain vaccines were actually living bacteria. Cholera vaccine in one of those. And so I think they've been given the mandate to review all of the living bacteria, so the biotherapeutics that consist of living bacteria, microbiome products. But they do have a call into or reach out to the therapeutic division for the indication of interest. So in our case, out to the derm division. I think there's a close collaboration between those 2.

這是一個非常有趣的問題，莫希特。因此它受到疫苗和相關產品部門的監管。我認為這一歷史可能可以追溯到這樣一個事實：某些疫苗實際上是活細菌。其中之一就是霍亂疫苗。因此，我認為他們已被授權審查所有活細菌，以及由活細菌、微生物組產品組成的生物治療藥物。但他們確實會致電或聯繫治療部門以徵求興趣。所以在我們的例子中，我們要轉向皮膚部門。我認為這兩個人之間有密切的合作。

In terms of whether there'd be any differences working with the division of vaccine-related product as opposed to the derm division, I don't know, but this division has been very responsive. And something I thought was interesting is that we did get that Fast Track designation really in the middle of the second wave of COVID, and I was a bit surprised about that. I would not have -- I would have thought that the division of vaccine-related product will be very focused on the COVID vaccines and maybe push our application out. But instead, we were granted that Fast Track designation. So I think that just shows the responsiveness of the division and the support for FB-401. Dan, did you have any other comments you wanted to add?

至於疫苗相關產品部門與皮膚部門的工作是否存在任何差異，我不知道，但該部門的反應非常靈敏。我認為有趣的是，我們確實在第二波新冠疫情期間獲得了快速通道稱號，對此我感到有點驚訝。我不會——我本以為疫苗相關產品的部門將非常關注新冠疫苗，可能會推遲我們的申請。但相反，我們被授予了快速通道稱號。所以我認為這恰恰顯示了該部門的響應能力和對 FB-401 的支持。丹，您還有其他要添加的評論嗎？

No. I think what you said is great. And I do think -- I would just emphasize the fact that the derm division is highly involved, as Paul mentioned, and they do bring a consultant in on our review from the derm division.

不，我覺得你說的很好。我確實認為 - 我只想強調一個事實，正如保羅提到的那樣，皮膚部門高度參與，他們確實從皮膚部門聘請了一名顧問來參與我們的審查。

Our next question is from Kumar Raja with Brookline Capital Markets.

我們的下一個問題來自 Brookline Capital Markets 的 Kumar Raja。

So with regard to the trial, what are your plans for an open-label extension once the trial is complete? And what are your thoughts on rolling over flexible patients to treatment in the open-label extension?

那麼關於試驗，試驗完成後您對開放標籤擴展有何計劃？您對將靈活的患者轉入開放標籤擴展治療有何想法？

Yes. That's a great question, Kumar, and thanks for joining the call. Dan, did you want to address that?

是的。這是一個很好的問題，庫馬爾，感謝您參加這次電話會議。丹，你想解決這個問題嗎？

Sure. Sure. So we have initiated an open-label extension for these Phase II subjects. So we'll allow the subjects to enroll into this open extension, including the placebo patients. This study will focus on safety and will be a year long.

當然。當然。因此，我們啟動了這些 II 期受試者的開放標籤擴展。因此，我們將允許受試者參加這個開放擴展，包括安慰劑患者。這項研究將重點關注安全性，為期一年。

Okay. And in terms of plans, Europe as well as ex U.S., how are you guys thinking about that?

好的。就計劃而言，歐洲以及美國以外的地區，你們對此有何看法？

Yes. That's a good question. I'll maybe make some comments then and turn it over to Dan if he's got any other insights here. Certainly, what we'd like to do is to be able to have an integrated global development plan that would include Europe as well as Asia. And those are things that we're thinking about right now. We're having discussions about how to do that, the potential pursuit of scientific advice in Europe. There are some unique aspects, I think, to European development, and we're working through those now. But Dan, did you have any other comments you wanted to make on that?

是的。這是個好問題。然後我可能會發表一些評論，如果丹有任何其他見解，我會將其轉交給他。當然，我們想要做的是能夠制定一個包括歐洲和亞洲在內的綜合全球發展計劃。這些都是我們現在正在考慮的事情。我們正在討論如何做到這一點，以及在歐洲尋求科學建議的可能性。我認為，歐洲的發展有一些獨特的方面，我們現在正在解決這些問題。但是丹，你對此還有什麼其他評論嗎？

Sure. As -- just to elaborate, I mean, we are focusing on, obviously, interactions with the FDA, and we'll continue to do so as we proceed from the Phase II into our Phase III program. As Paul already alluded to, we have begun the process with some consultants on approaching the EMA, obviously, looking for potential avenues for scientific advice. There are -- I'm going to say, again, there are a lot of little issues with Europe. We think we can work our way through those. And we would like to make sure that we have a program that involves both the U.S. and Europe.

當然。作為 - 只是為了詳細說明，我的意思是，我們顯然專注於與 FDA 的互動，並且當我們從第二階段進入第三階段計劃時，我們將繼續這樣做。正如保羅已經提到的，我們已經開始與一些顧問聯繫 EMA，顯然是為了尋找科學建議的潛在途徑。我要再說一遍，歐洲存在很多小問題。我們認為我們可以努力解決這些問題。我們希望確保我們有一個涉及美國和歐洲的計劃。

Okay. Great. And finally, you guys mentioned that majority of the patients in the trial, they are under 18. Can you give more color? Is it more closer to the 18 or is it much closer to the 2 or lower limit? And how does that impact compliance as well as your thoughts on the efficacy data from those patients?

好的。偉大的。最後，你們提到試驗中的大多數患者都在 18 歲以下。您能提供更多信息嗎？是更接近 18 還是更接近 2 或下限？這對依從性以及您對這些患者的療效數據的看法有何影響？

Yes. Good question, Kumar. Thank you. I'll make a few comments, and then Dan can provide his insights as well.

是的。好問題，庫馬爾。謝謝。我會發表一些評論，然後丹也可以提供他的見解。

So the breakdown, as we said, the majority are under 18. So about 75% of the subjects are under 18. 25% are adult very roughly. In terms of the compliance, I really don't see that much of an issue. For the very young patients, the 2- to 3-year olds, there is a caregiver, typically a parent, that's applying the therapy. And again, this is a therapy that has to be applied multiple times a day. It's -- other therapeutics, whether it's steroids or other therapies in development, oftentimes are creams that have to be applied multiple times a day or ointments that have to be applied multiple times a day.

正如我們所說，細分來看，大多數人都在 18 歲以下。所以大約 75% 的受試者在 18 歲以下。25% 是成年人。就合規性而言，我確實不認為有什麼大問題。對於非常年幼的患者，即 2 至 3 歲的患者，有一名護理人員（通常是父母）負責實施治療。再說一遍，這是一種必須每天多次應用的療法。它是 - 其他療法，無論是類固醇還是正在開發的其他療法，通常是必須每天多次使用的乳膏或必須每天多次使用的軟膏。

And again, just as a reminder, this therapy is a spray. So it's a water-based spray, and it's only applied 3 times a week. So I think from a compliance perspective, really, I don't think that that's an issue. We certainly haven't heard of that being an issue. It wasn't an issue in the IIa trial. Dan, did you have any other thoughts?

再次提醒一下，這種療法是一種噴霧劑。所以它是水基噴霧，每週只塗3次。所以我認為從合規的角度來看，我真的不認為這是一個問題。我們當然沒有聽說過這是一個問題。在 IIa 試驗中這不是一個問題。丹，你還有其他想法嗎？

Yes. I was just going to say, the nature of our product, the fact that it's a naturally occurring bacteria, again, though, it's highly selected strains that's applied to patients, the parents of the children are really -- they're really in love with this kind of idea. And so I think that's what's allowed us to over-enroll our trial. So there's a lot of excitement about a nonchemical drug therapy. So I think there's been a lot of interest by the parents to allow their patients or their children to be participating in this trial, and I think that will reflect in our compliance as we go forward.

是的。我只是想說，我們產品的本質，事實上它是一種天然存在的細菌，不過，它是經過精心挑選的菌株，應用於患者，孩子們的父母真的 - 他們真的很相愛帶著這樣的想法。所以我認為這就是我們能夠超額招募試驗的原因。因此，非化學藥物療法令人興奮。因此，我認為家長們非常有興趣允許他們的患者或他們的孩子參加這項試驗，我認為這將反映在我們今後的依從性上。

Our next question is from Michael Higgins with Ladenburg Thalmann.

我們的下一個問題來自邁克爾·希金斯和拉登堡·塔爾曼。

Congrats on the continued progress. I appreciate the opportunity to hear the -- ask some additional questions. You've been very forthcoming so far here. This is great. Just curious, in the ongoing Phase II, are you looking for anything specific by the different age groups, the younger kids, the older kids in the Phase II? Any secondaries that are based around that?

祝賀您不斷取得進步。我很高興有機會聽到——提出一些其他問題。到目前為止，你一直非常樂於助人。這很棒。只是好奇，在正在進行的第二階段中，您是否正在尋找第二階段中不同年齡組（年齡較小的孩子、年齡較大的孩子）的特定內容？有以此為基礎的輔助嗎？

Yes. I'll make a couple of comments, and then, Dan, if you want to provide any other insights. So there's a stratification. Age is one of those stratifications and so we are looking at that. Maybe even related to the previous question, I don't think -- we certainly didn't see any significant difference based on age, whether it was younger pediatrics or adolescents, in the IIa trial or even in the adults.

是的。我會發表一些評論，然後，丹，如果你想提供任何其他見解。所以有分層。年齡是這些分層之一，所以我們正在考慮這一點。我認為，甚至可能與前一個問題有關——我們當然沒有看到任何基於年齡的顯著差異，無論是年輕的兒科患者還是青少年，在 IIa 試驗中，甚至在成年人中。

Now the adults in the IIa trial were a little bit different. Again, they were only treated for 6 weeks and treated regionally. But no significance that we saw in terms of the overall activity. The consistency was there between the adults and the pediatrics and the adolescents. Dan, is there any other comments you want to provide?

現在，IIa 試驗中的成年人有點不同。同樣，他們只接受了 6 週的區域治療。但就整體活動而言，我們沒有看到任何意義。成人、兒科和青少年之間存在一致性。 Dan，您還有其他意見嗎？

No. No. I think we're looking at people very consistently because of what we observed previously.

不，不。我認為，由於我們之前觀察到的情況，我們對人們的觀察非常一致。

Second is more of a development question, I suppose. There's been some difficulties with others recently in their devices. If you could just remind us as to where you are with your device in terms of human factor studies that have been completed. Any other conversations with the FDA regarding the spray device?

我想第二個更多的是一個發展問題。最近其他人的設備出現了一些問題。您能否提醒我們，您的設備在已完成的人為因素研究方面處於什麼階段？與 FDA 就噴霧裝置還有其他對話嗎？

Yes, absolutely. Good question. So first of all, that spray device has a master file, and it's actually being used in an approved FDA product. So it's already in the market so we don't really expect many issues there. In terms of whether this is considered a device, again, we would say it's agnostic to the method of application. It could be a dropper, it could be a sprayer, it could be a foam to swipe. There are many different ways that the bacteria can be applied to the skin.

是的，一點沒錯。好問題。首先，該噴霧設備有一個主文件，並且它實際上被用於 FDA 批准的產品中。所以它已經在市場上，所以我們並不認為那裡會出現很多問題。至於這是否被視為設備，我們再次會說它與應用方法無關。它可以是滴管，可以是噴霧器，也可以是可擦拭的泡沫。有許多不同的方法可以將細菌應用於皮膚。

So with that said, you asked about human factor studies. And obviously, that's something that we're focused on. We're actually moving forward with human factor studies. But in the study that we've had ongoing now as well as the prior IIa study, the therapy is pretty straightforward. Again, it's just adding the water into the lyophilized bacteria, putting the pump sprayer on. And currently, just -- it reconstitutes almost instantaneously. So as soon as the diluent hits that lyophilized cake, it resolubilizes almost instantaneously. And then the pump sprayer is put on, and it's just primed and then pumped immediately after it's reconstituted. So, so far, pretty straightforward and no issues with the patients being able to use or apply the therapy.

話雖如此，您詢問了人為因素研究。顯然，這是我們關注的重點。我們實際上正在推進人為因素研究。但在我們現在正在進行的研究以及之前的 IIa 研究中，治療方法非常簡單。同樣，它只是將水添加到凍乾細菌中，然後打開泵式噴霧器。目前，它幾乎是立即重建的。因此，一旦稀釋劑接觸到凍乾餅，它幾乎立即重新溶解。然後裝上泵式噴霧器，只需將其灌注好，然後在重新配製後立即泵送。因此，到目前為止，非常簡單，患者能夠使用或應用該療法沒有任何問題。

Okay. That's great. Can you remind us on your milestone payments to DHHS, when those may begin?

好的。那太棒了。您能否提醒我們您向 DHHS 支付的里程碑付款何時開始？

Yes. I don't think we've given specific guidance on that, but they're late. So they would be after major value inflection points in the program.

是的。我認為我們沒有就此給出具體指導，但他們遲到了。因此，他們將追隨該計劃中的主要價值拐點。

Our next question is from Nicole Germino with Truist Securities.

我們的下一個問題來自 Truist Securities 的 Nicole Germino。

So for the Phase II coming up in the third quarter, if the data is positive and given that you're going after a broad label, can you give us a sense of how many patients across the age groups you would need for approval and to satisfy the safety database? And -- or will the cadence of the pivotal studies be focused on pediatric populations first and then adults? Or will these trials be run in parallel to achieve the broad label?

因此，對於第三季度即將進行的 II 期臨床試驗，如果數據是積極的，並且考慮到您正在追求廣泛的標籤，您能否讓我們了解您需要批准並需要多少跨年齡組的患者？滿足安全數據庫嗎？或者關鍵研究的節奏是否會首先關注兒童群體，然後關注成人？或者這些試驗會同時進行以實現廣泛的標籤嗎？

Dan can comment on this more. But just at a high level, I mean, what we've seen -- and certainly, we need to have discussions with FDA on this. But what we've seen with approved therapies for this type of indication is that one trial is sufficient for that broad label. In other words, pediatrics all the way through to adults and not looking too dissimilar from what our Phase II study looks like.

丹可以對此發表更多評論。但我的意思是，就高水平而言，我們所看到的——當然，我們需要與 FDA 就此進行討論。但我們在針對此類適應症的已批准療法中看到的是，一項試驗足以滿足該廣泛的標籤。換句話說，從兒科一直到成人，看起來與我們的二期研究並沒有太大不同。

And then in terms of that safety database, I always think it's good to have an extension study. It can encourage patients, particularly the placebo patients who may not be responding, to stay on study if they have a guarantee that they can go onto active after the end of the study. But as Dan highlighted, we do have an extension study also as part of the Phase II and hopeful that, that might be able to satisfy some of the safety questions that FDA might have. Dan, was there more that you wanted to add there?

然後就安全數據庫而言，我始終認為進行擴展研究是件好事。如果患者能保證在研究結束後可以繼續積極治療，它可以鼓勵患者，特別是可能沒有反應的安慰劑患者繼續進行研究。但正如 Dan 所強調的那樣，我們確實有一項擴展研究，作為第二階段的一部分，並希望這能夠解決 FDA 可能存在的一些安全問題。丹，您還有什麼要補充的嗎？

No. I -- Eucrisa got approved with adults, children and adolescence all with the single program. And again, we would aim to do the same, and we would expect that, that would be acceptable. And as Paul alluded to I think previously, we have been very satisfied with our interaction with the agency. And that when we finished our Phase II, we'll discuss with them our requirements for Phase III.

不。我——Eucrisa 通過單一程序獲得了成人、兒童和青少年的批准。再說一次，我們的目標是做同樣的事情，我們希望這是可以接受的。正如保羅之前提到的，我們對與該機構的互動非常滿意。當我們完成第二階段時，我們將與他們討論第三階段的要求。

And so our expectation would be that we wouldn't need to have separate studies for adults and pediatrics and again, that would just all be one study.

因此，我們的期望是，我們不需要對成人和兒科進行單獨的研究，而且這只是一項研究。

Great. And just one quick follow-up. Just to -- could you just elaborate a little bit more on a potential European or Asia filing? Would those geographies accept IGA scores readily? Or would you need to conduct separate studies and use different end points? Or what is the regulatory path forward for those geographies or what are their end points that they look more closely to?

偉大的。只需一個快速跟進。您能否詳細說明一下潛在的歐洲或亞洲申請？這些地區會輕易接受 IGA 分數嗎？或者您是否需要進行單獨的研究並使用不同的終點？或者這些地區的監管路徑是什麼，或者他們更關注的終點是什麼？

Dan, did you want to address that? Maybe I can add a few comments.

丹，你想解決這個問題嗎？也許我可以添加一些評論。

Sure. Sure. Again, crisaborole recently got approved with the EMA using their IGA and the studies they did in the United States. So clearly, they have different focuses than the U.S. does, but they have been -- they've obviously demonstrated there that the IGA is acceptable to them. So again, we'll be having some interactions with consultants and then potentially get some scientific advice to clarify what would be required for the EMA.

當然。當然。同樣，crisaborole 最近通過其 IGA 和在美國進行的研究獲得了 EMA 的批准。很明顯，他們的關注點與美國不同，但他們已經明顯地證明了 IGA 是他們可以接受的。同樣，我們將與顧問進行一些互動，然後可能會獲得一些科學建議，以澄清 EMA 的要求。

(Operator Instructions) Our next question is from Kalpit Patel with B. Riley.

（操作員說明）我們的下一個問題來自 Kalpit Patel 和 B. Riley。

Just a quick one on the ongoing study. Is there a specific delta that you're looking for in the trial that would be clinically meaningful in your view in addition to hitting stat sync? If there's a range, that would be super useful.

只是簡單介紹一下正在進行的研究。在您看來，除了達到統計同步之外，您在試驗中是否還需要尋找具有臨床意義的特定增量？如果有一個範圍，那將非常有用。

Yes. Great question. Thanks for joining the call, Kalpit. So that's a question that we've asked the thought leaders as well. And the answer that comes back is if the safety profile is clean, that the delta between active and placebo doesn't need to be very large. And what they've talked about is in terms of the EASI measure, somewhere between 10 and 15-point difference would be clinically significant to them. In other words, if with a clean safety profile and a 10- to 15-point difference in an EASI-based end point relative to placebo, that that's a therapy that would be used broadly. And I think there's precedent for that in the market. There's other therapies in psoriasis. And oral therapy in psoriasis, for example, where the activity isn't quite as great as some of the biologics, but the safety profile is very clean. And that has had a robust uptake in the market.

是的。很好的問題。感謝您加入通話，卡爾皮特。這也是我們向思想領袖提出的問題。得出的答案是，如果安全性良好，那麼活性藥物和安慰劑之間的差異不需要很大。他們所討論的是 EASI 衡量標準，10 到 15 點之間的差異對他們來說具有臨床意義。換句話說，如果具有明確的安全性，並且基於 EASI 的終點相對於安慰劑有 10 到 15 分的差異，那麼這就是一種將被廣泛使用的療法。我認為市場上有這樣的先例。牛皮癬還有其他療法。例如，牛皮癬的口服療法，其活性不如某些生物製劑那麼好，但安全性非常好。這在市場上得到了強勁的採用。

And I think in this indication, particularly going after the pediatrics, safety really is #1. The parents are very focused on safety. They want something that's natural, that they can be comfortable putting it on to their kids. It's not going to have any serious -- have a near or long-term issues to their kids' health. And that also has some effect. So I think the bar -- the highest bar really is on safety, followed by the activity. If some fraction of the patients don't respond to this therapy, I think then the parents would start moving them on to more aggressive therapies. But I really think that safety profile is paramount to getting uptake in the -- particularly in the pediatric market.

我認為在這個適應症中，特別是兒科，安全確實是第一位的。家長們非常注重安全。他們想要一些自然的東西，讓他們可以放心地把它戴在孩子身上。這不會對孩子的健康產生任何嚴重的近期或長期問題。這也有一定的效果。所以我認為最高的標準確實是安全，其次是活動。如果部分患者對這種療法沒有反應，我認為父母會開始讓他們接受更積極的療法。但我確實認為，安全性對於在尤其是兒科市場的普及至關重要。

Okay. I just had a quick follow-up actually on the IP related for -- the IP surrounding FB-401. I'm trying to understand, is the IP more related to the formulation of the drug? Or does it also include the bacterial species? I mean can you protect a bacterial species under IP like this? I'm just curious to hear your thoughts on that.

好的。我剛剛對 FB-401 周圍的 IP 相關的 IP 進行了快速跟進。我想了解一下，IP是否與藥物的配方更相關？或者它還包括細菌種類嗎？我的意思是，你能像這樣在知識產權下保護細菌物種嗎？我只是想听聽你對此的想法。

Sure, Kalpit. So as I mentioned, we just had 2 new patents issued. So we're up to 11 now, and it's really a broad range of intellectual property. I mean the starting -- our foundational patent is around culture and gram-negative bacteria off of the skin. So that was not trivial. And the NIH originally came up with that technique, and we were able to get a patent issued for that. And from there, it is the composition, so taking bacteria off of the skin and formulated into a drug product. It is use, using that product for the treatment of different diseases, including atopic dermatitis. It's formulating that into a kit. It's combining that with other potential therapeutics. So it's really broad.

當然，卡爾皮特。正如我提到的，我們剛剛發布了兩項新專利。現在我們已經有 11 個，這確實是一個廣泛的知識產權。我的意思是開始——我們的基礎專利是圍繞皮膚上的培養和革蘭氏陰性細菌。所以這並不是一件小事。美國國立衛生研究院最初提出了這項技術，我們因此獲得了專利。從那裡開始，就是組合物，從皮膚上去除細菌並配製成藥品。它是用途，使用該產品來治療不同的疾病，包括特應性皮炎。它正在將其製成套件。它將其與其他潛在的療法相結合。所以它真的很廣泛。

We've been very aggressive on the intellectual property for that very reason and have been really pleased with the number of patents that have issued. In fact, very early on, we went down track 1, which is a more accelerated path for patent issuances. And I wasn't sure we're going to be able to pursue that. But again, because there hadn't been much work done on gram-negatives broadly or specifically on Roseomonas mucosa, the prior art was fairly clean. Because again, before the NIH came up with this technique for culturing gram-negative bacteria, there really wasn't a way to separate this off of human skin and start to study them. So again, we'll have more patents coming. I think we're in a very solid position with the 11 that we have, and that will expand and be reflected internationally as well.

正是出於這個原因，我們在知識產權方面一直非常積極，並且對已頒發的專利數量感到非常滿意。事實上，很早就，我們走上了軌道 1，這是專利申請更加加速的路徑。我不確定我們是否能夠實現這一目標。但同樣，因為廣泛地或專門針對玫瑰單胞菌粘膜的革蘭氏陰性菌還沒有做太多工作，所以現有技術是相當乾淨的。因為，在美國國立衛生研究院提出這種培養革蘭氏陰性細菌的技術之前，確實沒有辦法將其與人類皮膚分離並開始研究它們。同樣，我們將獲得更多專利。我認為我們擁有 11 家公司，處於非常穩固的地位，而且這一地位也將擴大並在國際上得到體現。

Ladies and gentlemen, we have reached the end of the question-and-answer session. I'd like to turn the call back to Paul Wagner for closing remarks.

女士們、先生們，問答環節已經結束。我想將電話轉回給保羅·瓦格納（Paul Wagner）致閉幕詞。

Thanks, David. So we're really excited. We're looking forward to the readout, as all of you are as well, of the trial in a few months in the third quarter. So thank you again for dialing in. And if any of you have any questions, we're available after the call to take those. And have a good afternoon. Thank you again.

謝謝，大衛。所以我們真的很興奮。我們和大家一樣，期待著第三季度幾個月後的試驗結果。再次感謝您撥通電話。如果您有任何疑問，請在致電後我們隨時為您解答。祝你下午愉快。再次感謝你。

This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.

今天的會議到此結束。感謝您的參與。此時您可以斷開線路。