Alpine Immune Sciences Inc (ALPN) 2022 Q4 法說會逐字稿

Welcome to the Alpine Immune Sciences fourth-quarter 2022 earnings call. (Operator Instructions) As a reminder, this event is being recorded.

歡迎來到 Alpine Immune Sciences 2022 年第四季度財報電話會議。 （操作員說明）作為提醒，正在記錄此事件。

I would now like to introduce Temre Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, I'll now turn the call over to you.

我現在想介紹一下 Alpine 的投資者關係和企業傳播高級總監 Temre Johnson。約翰遜女士，我現在將電話轉給您。

Thank you, Terri. Good afternoon and thank you for joining us. With me on the call today are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer; Dr. Stanford Peng, President and Head of Research and Development; and Paul Rickey, Chief Financial Officer.

謝謝你，特麗。下午好，感謝您加入我們。今天和我一起打電話的是執行主席兼首席執行官 Mitchell Gold 博士；總裁兼研發主管 Stanford Peng 博士；首席財務官 Paul Rickey。

Before I turn the call over to Mitch, I would like to remind you that we'll be making forward-looking statements during today's call. These forward-looking statements are based on our current expectations and inherently involve significant risk and uncertainty. Actual results and the timing of events, potential publications of clinical data, and expectations regarding the sufficiency of cash and investment could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You may refer to the most recent SEC filing regarding the risk factors associated with these statements.

在我把電話轉給米奇之前，我想提醒你，我們將在今天的電話會議上發表前瞻性陳述。這些前瞻性陳述基於我們當前的預期，並且固有地涉及重大風險和不確定性。由於這些風險和不確定性，實際結果和事件發生的時間、臨床數據的潛在發布以及對現金和投資充足性的預期可能與此類前瞻性陳述中的預期存在重大差異。您可以參考美國證券交易委員會最近提交的有關與這些聲明相關的風險因素的文件。

Mitch, please go ahead.

米奇，請繼續。

Thank you, Temre. Alpine is off to a strong start in 2023, driven by progress in the development of povetacicept, a potentially best-in-class dual inhibitor of the BAFF and APRIL cytokines with a convenient once-every-four-week subcutaneous dosing regimen that we believe has the potential to benefit patients living with multiple types of autoimmune or inflammatory diseases.

謝謝你，泰姆雷。在 povetacicept 開發取得進展的推動下，Alpine 在 2023 年取得了良好的開端，povetacicept 是一種潛在的同類最佳的 BAFF 和 APRIL 細胞因子雙重抑製劑，我們相信每 4 週一次的皮下給藥方案非常方便有可能使患有多種自身免疫性疾病或炎症性疾病的患者受益。

I'm pleased to announce that we recently achieved a significant milestone for povetacicept with the initiation of the RUBY-3 basket study, our first patient-based study for the program, which will study povetacicept in autoimmune glomerulonephritis indications, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy. Although still early in development, investigator enthusiasm for the program and interest in participating in the RUBY-3 study is highly encouraging.

我很高興地宣布，我們最近通過啟動 RUBY-3 籃子研究實現了 povetacicept 的一個重要里程碑，這是我們針對該項目的第一個基於患者的研究，該研究將研究 povetacicept 在自身免疫性腎小球腎炎適應症中的作用，包括 IgA 腎病、狼瘡腎炎和原發性膜性腎病。儘管仍處於開發初期，但研究人員對該計劃的熱情和參與 RUBY-3 研究的興趣非常令人鼓舞。

In addition to RUBY-3, we are planning to initiate the RUBY-4 BAFF study in autoimmune cytopenias in the second quarter of 2023. This includes autoimmune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease. We expect to share initial data from both the RUBY-3 and RUBY-4 BAFF studies by the end of this year.

除了 RUBY-3，我們還計劃在 2023 年第二季度啟動針對自身免疫性血細胞減少症的 RUBY-4 BAFF 研究。這包括自身免疫性血小板減少症、溫性自身免疫性溶血性貧血和冷凝集素病。我們希望在今年年底前分享 RUBY-3 和 RUBY-4 BAFF 研究的初始數據。

We see broad development potential for povetacicept in multiple indications beyond the BAFF studies, including our RUBY-2 study in systemic lupus erythematosus, as well as neurologic, dermatologic, and other rheumatic disease indications.

我們看到 povetacicept 在 BAFF 研究之外的多種適應症中具有廣泛的發展潛力，包括我們在系統性紅斑狼瘡中的 RUBY-2 研究，以及神經系統、皮膚病和其他風濕病適應症。

We recently signed a collaboration with Truveta to help accelerate the broad development of povetacicept across these multiple indications. With an increasingly competitive and sometimes challenging clinical trial environment, Truveta gives us access to its 28 partner members who provide 16% of patient care in the United States. In addition to our own efforts, we will leverage Truveta's platform and analytics capabilities to more quickly identify and recruit study participants for RUBY-3 and RUBY-4 with the potential to benefit most from povetacicept.

我們最近與 Truveta 簽署了一項合作協議，以幫助加速 povetacicept 在這些多種適應症中的廣泛開發。隨著競爭日益激烈且有時充滿挑戰的臨床試驗環境，Truveta 讓我們可以接觸到其 28 名合作夥伴成員，他們在美國提供 16% 的患者護理。除了我們自己的努力之外，我們還將利用 Truveta 的平台和分析能力來更快地識別和招募 RUBY-3 和 RUBY-4 的研究參與者，他們有可能從 povetacicept 中獲益最多。

We believe povetacicept has the potential to be a pipeline and a product. With our strong balance sheet and promising preclinical and Phase 1 healthy volunteer data, we are rapidly moving forward with a robust development plan for povetacicept.

我們相信 povetacicept 有潛力成為一種管道和產品。憑藉我們強大的資產負債表和有前途的臨床前和第一階段健康志願者數據，我們正在迅速推進 povetacicept 的穩健發展計劃。

I'll now hand the call over to Stanford to review our progress, provide updates on our broad development plans for pove in more detail. Stanford?

我現在將把電話轉給斯坦福大學來審查我們的進展，更詳細地提供我們廣泛的 pove 發展計劃的更新。斯坦福？

Thank you, Mitch. As a reminder, povetacicept is an Fc fusion of a variant TACI domain engineered to inhibit more potently the APRIL and BAFF cytokines than wild-type TACI-Ig fusion proteins. The clinical relevance of these cytokines continues to grow in multiple autoimmune diseases, with proof of concept and/or encouraging [clinical] data with various agents in this class in diseases such as systemic lupus, lupus nephritis, IgA nephropathy, Sjogren's syndrome, and myasthenia gravis.

謝謝你，米奇。提醒一下，povetacicept 是一種變體 TACI 結構域的 Fc 融合體，經過改造可比野生型 TACI-Ig 融合蛋白更有效地抑制 APRIL 和 BAFF 細胞因子。這些細胞因子在多種自身免疫性疾病中的臨床相關性不斷增強，在系統性狼瘡、狼瘡性腎炎、IgA 腎病、乾燥綜合徵和肌無力等疾病中，此類各種藥物的概念證明和/或令人鼓舞的[臨床]數據重症。

In preclinical studies, povetacicept appears superior to wild-type TACI-Ig comparators, as well as inhibitors of only APRIL or BAFF. It demonstrates potent activity in multiple disease-relevant animal models.

在臨床前研究中，povetacicept 似乎優於野生型 TACI-Ig 比較劑，以及僅 APRIL 或 BAFF 的抑製劑。它在多種疾病相關動物模型中顯示出強大的活性。

In a Phase 1 first-in-human study in adult healthy volunteers, povetacicept has been well tolerated. It has demonstrated excellent PK and PD, including dose-related reductions in circulating antibody- secreting cells and serum immunoglobulins, as well as the IgA nephropathy-relevant biomarker, galactose-deficient IgA1.

在成人健康志願者的第一階段首次人體研究中，povetacicept 具有良好的耐受性。它已證明具有出色的 PK 和 PD，包括循環抗體分泌細胞和血清免疫球蛋白以及 IgA 腎病相關生物標誌物半乳糖缺陷型 IgA1 的劑量相關減少。

In the initial multi-dose experience in disease populations, we are initially focusing on two basket studies. The first is RUBY-3, an open-label basket study in autoimmune glomerulonephritis. This study has just recently begun enrollment. Second to shortly follow is RUBY-4, an open-label basket study in autoimmune cytopenias.

在疾病人群的最初多劑量經驗中，我們最初專注於兩項籃子研究。第一個是 RUBY-3，一項針對自身免疫性腎小球腎炎的開放標籤籃子研究。這項研究最近剛剛開始招募。其次是 RUBY-4，這是一項針對自身免疫性血細胞減少症的開放標籤籃子研究。

With the initial data from these studies, we anticipate the ability next year to begin multiple Phase 2 studies, including one in systemic lupus erythematosus, known as RUBY-2. Additional studies in other disease areas are of great interest, including nephrology or hematology, neurology, dermatology, as well as rheumatology besides lupus. Some of these we envision could proceed via an accelerated approval pathway.

根據這些研究的初步數據，我們預計明年能夠開始多項 2 期研究，包括一項針對系統性紅斑狼瘡的研究，稱為 RUBY-2。其他疾病領域的其他研究也很有趣，包括腎髒病學或血液學、神經病學、皮膚病學，以及狼瘡以外的風濕病學。我們設想其中一些可以通過加速批准途徑進行。

In summary, povetacicept potently targets both the APRIL and BAFF cytokines in a unique, highly differentiated way. It has just begun patient-based studies and has broad development potential. We look forward to sharing additional data as the program progresses.

總之，povetacicept 以一種獨特的、高度分化的方式有效地靶向 APRIL 和 BAFF 細胞因子。它剛剛開始以患者為基礎的研究，具有廣闊的發展潛力。隨著項目的進展，我們期待分享更多數據。

I'll now turn the call over to Paul.

我現在將電話轉給保羅。

Thank you, Stanford. I will now provide an overview of our financials for the fourth quarter ended December 31, 2022. Revenue recognized under our collaboration programs for the quarter ended December 31, 2022, was $2.8 million compared to $4.5 million in 2021. The decrease primarily relates to lower revenue recognized under our collaboration with AbbVie, partially offset by revenue recognized for services performed in connection with our collaboration with Horizon, which was executed in late 2021.

謝謝你，斯坦福。我現在將概述我們截至 2022 年 12 月 31 日的第四季度的財務狀況。截至 2022 年 12 月 31 日的季度，根據我們的合作計劃確認的收入為 280 萬美元，而 2021 年為 450 萬美元。減少主要與較低的收入有關根據我們與 AbbVie 的合作確認的收入，部分被我們與 Horizon 合作執行的服務確認的收入所抵消，該合作於 2021 年底執行。

Research and development expenses for the fourth quarter ended December 31, 2022, were $18.8 million compared to $15.4 million in 2021. The increase was primarily attributable to higher personnel-related expenses due to increased headcount to support our ongoing and planned clinical development programs.

截至 2022 年 12 月 31 日的第四季度研發費用為 1880 萬美元，而 2021 年為 1540 萬美元。這一增長主要是由於為支持我們正在進行和計劃中的臨床開發項目而增加的員工人數導致的人事相關費用增加。

General and administrative expenses for the fourth quarter ended December 31, 2022, were $4.4 million compared to $4.5 million for 2021. Company recorded net losses of $18.9 million and $15.2 million for the fourth quarter ended 2022 and 2021, respectively.

截至 2022 年 12 月 31 日的第四季度的一般和行政費用為 440 萬美元，而 2021 年為 450 萬美元。公司在截至 2022 年和 2021 年的第四季度分別錄得淨虧損 1890 萬美元和 1520 萬美元。

As of December 31, 2022, Alpine's cash and investments totaled $273.4 million, which we anticipate should be sufficient to fund our planned operations through 2025.

截至 2022 年 12 月 31 日，Alpine 的現金和投資總額為 2.734 億美元，我們預計這足以為我們到 2025 年的計劃運營提供資金。

I'll now hand the call back to Mitch.

我現在將電話轉回給米奇。

Thanks, Paul. As Stanford highlighted, we are highly encouraged by the progress of povetacicept, a molecule that we believe is the only truly potent dual APRIL/BAFF inhibitor. As a result, we believe in the broad potential for the program may become an important new disease-modifying therapy across multiple B cell-mediated autoimmune and inflammatory diseases.

謝謝，保羅。正如斯坦福強調的那樣，我們對 povetacicept 的進展感到非常鼓舞，我們認為這種分子是唯一真正有效的雙重 APRIL/BAFF 抑製劑。因此，我們相信該項目的廣泛潛力可能成為跨越多種 B 細胞介導的自身免疫性疾病和炎症性疾病的重要新疾病緩解療法。

Closing, we believe we have laid a strong foundation to launch into the next phase of Alpine as we progress throughout the course of this year and into next year. Operator, we'll now open the phone to questions.

最後，我們相信隨著我們在今年和明年的整個過程中取得進展，我們已經為進入下一階段的 Alpine 奠定了堅實的基礎。接線員，我們現在打開電話提問。

(Operator Instructions) Mike Ulz, Morgan Stanley.

（操作員說明）Mike Ulz，摩根士丹利。

Hey, guys. Thanks for taking the question, and congrats on getting the RUBY-3 study going here. Maybe just a question in terms of both basket studies, and maybe you can comment on how you're currently thinking about dosing and if there's any additional dosing work you plan to do before getting into the indication-specific cohorts in the basket studies. And I guess part of why I'm asking, I looked on clinicaltrials.gov, and I noticed some differences in the dosing that you're using for RUBY-3 and RUBY-4. Thanks.

大家好。感謝您提出這個問題，並祝賀 RUBY-3 研究進展順利。也許只是關於兩個籃子研究的問題，也許你可以評論你目前是如何考慮劑量的，以及在進入籃子研究中的適應症特定隊列之前你是否計劃做任何額外的劑量工作。我想我問的部分原因是，我查看了 clinicaltrials.gov，我注意到您用於 RUBY-3 和 RUBY-4 的劑量存在一些差異。謝謝。

Yeah. Maybe I'll take the first part of that, Mike. Thanks for the question. Then I'll ask Stanford, I [don't know] if you want to.

是的。邁克，也許我會做第一部分。謝謝你的問題。然後我會問斯坦福大學，我 [不知道] 你是否願意。

So just as a reminder, RUBY-3 has two different dose escalations that we'll be going through, both an 80-milligram cohort and a 240-milligram cohort. And RUBY-4 will be going directly into a 240-milligram dosing group, so there will be no 80-milligram cohort in that group.

因此，提醒一下，RUBY-3 有兩個不同的劑量遞增，我們將經歷兩個劑量遞增，一個是 80 毫克隊列，另一個是 240 毫克隊列。 RUBY-4 將直接進入 240 毫克劑量組，因此該組中不會有 80 毫克劑量組。

That's correct. And so there's no pre-indication sort of phase of the study. We'll be going directly into all three diseases in both trials at the doses that Mitch mentioned.

這是正確的。因此，研究階段沒有預兆。我們將以 Mitch 提到的劑量直接研究這兩項試驗中的所有三種疾病。

Got it. That's helpful. And maybe just one more question from me. I noticed in the press release for RUBY-2, you plan to start that study in mid-2024, and you make a comment based on some enabling data from RUBY-3 and RUBY-4 studies. Maybe you can just clarify what you're hoping to learn from those studies that will enable you to start RUBY-2.

知道了。這很有幫助。也許我還有一個問題。我在 RUBY-2 的新聞稿中註意到，您計劃在 2024 年年中開始這項研究，並且您根據 RUBY-3 和 RUBY-4 研究的一些支持數據發表了評論。也許您可以澄清您希望從那些使您能夠啟動 RUBY-2 的研究中學到什麼。

It's primarily multi-dose data. As you know, the Phase 1 study we ran is a single ascending dose study. In addition, it will give us greater confidence in the dose selection for the Phase 2 since that's a large study.

它主要是多劑量數據。如您所知，我們進行的 1 期研究是一項單劑量遞增研究。此外，這將使我們對第 2 階段的劑量選擇更有信心，因為這是一項大型研究。

Yep. Got it. Thanks so much.

是的。知道了。非常感謝。

Thanks, Mike.

謝謝，邁克。

Tara Bancroft, Cowen.

塔拉班克羅夫特，考恩。

Hi, guys, and thanks for taking the question. So, I'm wondering what do you expect the rate of enrollment to be in the basket studies now, especially given the Truveta collaboration, and when do you think that you might reach full enrollment? Thanks.

嗨，伙計們，謝謝你提出這個問題。所以，我想知道您預計現在籃子研究的入學率是多少，特別是考慮到 Truveta 的合作，您認為什麼時候可以達到全面入學率？謝謝。

Well, what I'll say is that enrollment in general, it has been a challenging clinical trial environment to enroll patients. That being said, I'm pretty pleased with the way RUBY-3 has started. We're getting a lot of investigator interest and a lot of patient interest, and I think you saw that in our comments in the press release today. So that, in and of itself, is encouraging, but I would say it's early on in the start of that trial, but if that trend continues, we expect that it'll enroll fairly rapidly.

好吧，我要說的是，總的來說，招募患者一直是一個具有挑戰性的臨床試驗環境。也就是說，我對 RUBY-3 的啟動方式感到非常滿意。我們得到了很多研究者的興趣和很多患者的興趣，我想你在今天的新聞稿中的評論中看到了這一點。因此，就其本身而言，這是令人鼓舞的，但我會說它在試驗開始的早期，但如果這種趨勢繼續下去，我們預計它會相當迅速地註冊。

The Truveta collaboration, I'll talk a little bit about. Tara, I appreciate you bringing that up. I think we've always enrolled trials in a very traditional way. We work with CROs, and we engage investigators in a really active way to identify patients and bring them into trials. I think one of the things as an industry that we've done fairly poorly is using some of the new electronic medical record systems and large cohorts of patients across multiple centers to identify them quickly and then recruit patients into clinical trials.

Truveta 合作，我會談一點。塔拉，感謝你提出這個問題。我認為我們一直以非常傳統的方式註冊試驗。我們與 CRO 合作，我們以一種非常積極的方式讓研究人員參與進來，以識別患者並將他們帶入試驗。我認為作為一個行業，我們做得相當糟糕的一件事是使用一些新的電子病歷系統和跨多個中心的大量患者來快速識別他們，然後招募患者進行臨床試驗。

Obviously, Truveta is a Seattle-based company. We know them well and we work with them to enable their member partners to identify patients that are relevant to RUBY-3 and RUBY-4 to enroll them in our clinical trials.

顯然，Truveta 是一家位於西雅圖的公司。我們非常了解他們，我們與他們合作，使他們的成員合作夥伴能夠識別與 RUBY-3 和 RUBY-4 相關的患者，以便讓他們參加我們的臨床試驗。

Okay, thanks.

好的謝謝。

Thomas Smith, SVB Securities.

托馬斯·史密斯，SVB 證券。

Good afternoon. This is [Brian Connolly] on for Tom. I believe you just responded to a question about Truveta, but just curious if there are any other gating factors or any other obstacles or challenging factors you're encountering as you're progressing the basket trials. Thanks.

下午好。這是湯姆的 [Brian Connolly]。我相信您剛剛回答了一個關於 Truveta 的問題，但只是想知道您在進行籃子試驗時是否遇到任何其他門控因素或任何其他障礙或挑戰因素。謝謝。

Yeah, thanks, Brian. No, I mean, the reason we put Truveta in place was to be proactive at the start of the study. These are things that you want to be in front of. I would say our traditional efforts are looking as good as I've seen the trial get started in terms of launch. I think it's because awareness on the targets and strong awareness in the space, and we have a great group of investigators that we've brought in.

是的，謝謝，布賴恩。不，我的意思是，我們使用 Truveta 的原因是為了在研究開始時積極主動。這些是您想在前面的事情。我會說我們的傳統努力看起來和我看到的試驗在發布方面開始一樣好。我認為這是因為對目標的認識和對該領域的強烈認識，而且我們引進了一批優秀的調查人員。

The reason we brought Truveta on board is we didn't want to have to add it on later on. We wanted to, number one, do it at the beginning of the trial. And, two, as we push into Phase 2 studies next year, that could result in accelerated approval, and we wanted the collaboration between us and Truveta to be fully integrated so we can leverage it as we move into bigger studies.

我們將 Truveta 加入的原因是我們不想在以後添加它。第一，我們想在試驗開始時就這樣做。第二，當我們明年推進第二階段研究時，這可能會導致加速批准，我們希望我們和 Truveta 之間的合作能夠完全整合，這樣我們就可以在進入更大的研究時利用它。

Yep. Great. Thanks so much.

是的。偉大的。非常感謝。

Mark Breidenbach, Oppenheimer.

馬克·布雷登巴赫，奧本海默。

Hey, good afternoon, guys. Thanks for taking our questions. Just a quick couple for me. First, on the Truveta collaboration, have you specified what they're getting in return for helping optimize enrollment of RUBY-3 and RUBY-4?

嘿，下午好，伙計們。感謝您回答我們的問題。對我來說只是快速的一對。首先，關於 Truveta 合作，您是否指定了他們幫助優化 RUBY-3 和 RUBY-4 註冊的回報？

I'm sorry, Mark. I lost you that one second there. Can you say that one more time?

對不起，馬克。我在那一秒鐘失去了你。你能再說一遍嗎？

Yeah. Sorry. What's Truveta getting in return for helping you guys enroll in RUBY-3 and RUBY-4?

是的。對不起。 Truveta 幫助你們註冊 RUBY-3 和 RUBY-4 的回報是什麼？

It's a traditional services agreement, so there's kind of a baseline fee that we pay them. And then as they enroll a certain number of patients, they have certain objectives that they need to meet to be able to generate service fees as a result of that. So it's not any different than a traditional services agreement.

這是一項傳統的服務協議，因此我們向他們支付了某種基準費用。然後，當他們招收一定數量的患者時，他們有特定的目標，他們需要滿足這些目標才能因此產生服務費。所以它與傳統的服務協議沒有任何不同。

Okay. Got it. And with regard to the upcoming presentation at WCN from RUBY-1, is there anything in that presentation that we haven't already seen? What's going to be the focus of that upcoming presentation next week?

好的。知道了。關於 RUBY-1 即將在 WCN 上進行的演示，該演示中有什麼我們還沒有看到的嗎？下週即將舉行的演講的重點是什麼？

Our main goal is to reiterate awareness. We didn't present there last year, as I'm sure you're aware, but make sure that -- just build awareness about the target and the molecule with that audience. There will be updated Phase 1 data with regard to additional follow-up with some of the subjects, although the general conclusions have not changed, which you can tell from some of our preceding comments.

我們的主要目標是重申意識。我們去年沒有在那裡展示，我相信你知道，但要確保——只是讓觀眾了解目標和分子。關於一些受試者的額外跟進，將更新第一階段數據，儘管一般結論沒有改變，您可以從我們之前的一些評論中看出這一點。

Okay. Got it. And maybe one last one from me. I know you mentioned the 80-milligram and 240-milligram dosing cohorts in RUBY-3. Can you just comment on the dosing schedules and how those compare to, let's say, if we use telitacicept as the closest equivalent or competing drug, how the dosing schedules compare between your drug and RemeGen's? Thank you.

好的。知道了。也許是我的最後一個。我知道您提到了 RUBY-3 中的 80 毫克和 240 毫克劑量組。你能評論一下給藥方案嗎？如果我們使用 telitacicept 作為最接近的等效藥物或競爭藥物，那麼這些方案與我們的給藥方案相比如何？你們的藥物與 RemeGen 的給藥方案相比如何？謝謝。

Yeah. Our trials both are dosing at a Q4 week dose regimen, and that's at all doses -- or both doses being tested. As far as we are aware, RemeGen is 160 milligrams sub-Q weekly, and that appears to be their doses for all of their clinical trials. So in comparison, we're Q4 versus Q1 week.

是的。我們的試驗都在第 4 週的劑量方案中給藥，而且是所有劑量——或兩種劑量都在接受測試。據我們所知，RemeGen 每週服用 160 毫克 sub-Q，這似乎是他們所有臨床試驗的劑量。所以相比之下，我們是第四季度和第一季度。

As you know, Mark, that's one of the key -- when we start to talk about best-in-class potential for pove, one of the key things that differentiate us is, one, that when we're [posting to Q], that we have a much more convenient dosing schedule. And the fact that we cover both cytokines more completely than either of the wild-type TACIs out there allows us to take a pretty broad development plan going forward.

正如你所知，馬克，這是關鍵之一——當我們開始談論 pove 的一流潛力時，使我們與眾不同的關鍵因素之一是，當我們 [發佈到 Q] ，我們有一個更方便的給藥時間表。事實上，我們比現有的任何一種野生型 TACI 更全面地涵蓋了這兩種細胞因子，這使我們能夠制定一個相當廣泛的發展計劃。

Got it. Thanks for taking our questions.

知道了。感謝您回答我們的問題。

Joe Pantginis, HC Wainwright.

喬·潘吉尼斯，HC 溫賴特。

Hey, everybody. Good afternoon. Thanks for taking the question. Wanted to get a little more color, if you can, regarding the end-of-year initial data from both RUBY-3 and RUBY-4. Is this going to be essentially early-response type of data for each type of indication, or can we get more than that initially with regard to, say, any translational or PD data?

大家好下午好。感謝您提出問題。關於 RUBY-3 和 RUBY-4 的年終初始數據，如果可以的話，希望獲得更多的顏色。對於每種類型的適應症，這基本上都是早期反應類型的數據，還是我們可以獲得比最初更多的關於任何轉化或 PD 數據的數據？

Yeah, we'll be focusing quite a bit on both traditional endpoints as well as biomarker-related data. So, PD endpoints, including immunoglobulin target, cytokine targets, as well as -- and then, what I mean by biomarkers are things like IgE, IgA1, and IgA nephropathy, and each of those indications has their respective antibody that we'll be looking at. So, we'll be looking at all that and look forward to being able to report toward the end of the year.

是的，我們將重點關注傳統端點以及與生物標誌物相關的數據。所以，PD 終點，包括免疫球蛋白靶點、細胞因子靶點，以及——然後，我所說的生物標誌物是 IgE、IgA1 和 IgA 腎病，這些適應症中的每一個都有各自的抗體，我們將看著。因此，我們正在研究所有這些，並期待能夠在年底前報告。

That's great. And do you think you could just remind, I mean, since it's a basket concept, how many per indication you're looking for and how many you think that might deliver for the initial data?

那太棒了。你是否認為你可以提醒一下，我的意思是，因為它是一個籃子概念，你正在尋找每個跡象的數量，以及你認為可以為初始數據提供多少？

It's a basket trial, Joe, so we'll see how many patients we can -- I can tell you that we're getting interest. At least in RUBY-3 so far, we're getting interest across all the different subtypes, that being IgAN, lupus nephritis, and primary membranous nephropathy. Exactly how that mix is going to shake out, I think it's too early to say right now, but early on, we're pretty pleased with the mix of interest that's coming into the trial.

這是一個籃子試驗，喬，所以我們會看看我們能有多少病人——我可以告訴你我們正在引起興趣。至少到目前為止，在 RUBY-3 中，我們對所有不同的亞型都感興趣，即 IgAN、狼瘡性腎炎和原發性膜性腎病。究竟這種組合將如何擺脫困境，我認為現在說還為時過早，但在早期，我們對進入試驗的興趣組合感到非常滿意。

Sure. Got it. Thanks a lot.

當然。知道了。多謝。

There are no further questions, Dr. Gold. I'll turn the call back over to you.

Gold 博士，沒有其他問題了。我會把電話轉給你。

Thank you, operator. I'd like to thank you all for taking part in today's call. We look forward to seeing many of you at upcoming investor and medical meetings and providing updates in the months ahead. Thank you and have a great afternoon.

謝謝你，運營商。我要感謝大家參加今天的電話會議。我們期待在即將舉行的投資者和醫療會議上見到你們中的許多人，並在未來幾個月提供最新消息。謝謝你，祝你下午愉快。

Thank you, ladies and gentlemen. This concludes our call today. You may now disconnect.

謝謝你們，女士們，先生們。我們今天的電話會議到此結束。您現在可以斷開連接。