Viridian Therapeutics Inc (VRDN) 2023 Q1 法說會逐字稿

Welcome to the Viridian Therapeutics First Quarter 2023 Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to hand the call over to Ms. Louisa Stone, Manager of Investor Relations for Viridian. Please go ahead.

歡迎來到 Viridian Therapeutics 2023 年第一季度電話會議。 （操作員說明）提醒一下，正在錄製此會議。我現在想把電話轉給 Viridian 投資者關係經理 Louisa Stone 女士。請繼續。

Thank you, and welcome, everyone, to our first quarter 2023 earnings conference call. The press release reporting our financial results and corporate updates is available on the Investors page of our corporate website at www.viridiantherapeutics.com.

謝謝大家，歡迎大家參加我們 2023 年第一季度的收益電話會議。報告我們的財務業績和公司更新的新聞稿可在我們公司網站 www.viridiantherapeutics.com 的投資者頁面上找到。

Joining me on the call this afternoon are Scott Myers, our President and Chief Executive Officer; Kristian Humer, our Chief Financial and Business Officer; Dr. Deepa Rajagopalan, our Chief Product and Strategy Officer; Dr. Thomas Ciulla, our Chief Development Officer; and Todd James, Senior Vice President, Corporate Affairs and Investor Relations.

今天下午和我一起參加電話會議的是我們的總裁兼首席執行官斯科特·邁爾斯 (Scott Myers)；我們的首席財務和商務官 Kristian Humer；我們的首席產品和戰略官 Deepa Rajagopalan 博士；我們的首席開發官 Thomas Ciulla 博士；以及公司事務和投資者關係高級副總裁 Todd James。

Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements regarding our financial outlook in addition to regulatory, product development and commercialization plans and research activities. These statements are subject to risks and uncertainties that could cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q and 10-K on file with the SEC. I would now like to turn the call over to Scott Myers, our President and CEO.

在我們開始之前，我想提醒大家，除了監管、產品開發和商業化計劃以及研究活動之外，本次電話會議和網絡廣播還將包含有關我們財務前景的前瞻性陳述。這些陳述受風險和不確定因素的影響，可能導致實際結果與預測結果存在重大差異。這些風險的描述可以在我們最近提交給美國證券交易委員會的 10-Q 和 10-K 表格中找到。我現在想把電話轉給我們的總裁兼首席執行官斯科特邁爾斯。

Thank you, Louisa. Good afternoon, everyone. Thanks for joining us today. We had a productive quarter, and I'm excited to report on our progress today after completing my first 3 months as Viridian's President and CEO. 2023 is an important year for Viridian, a year that includes key milestones in all of our clinical programs. I am proud of all the progress our company has made thus far and looking forward to continuing our work to bring potential best-in-class therapies to patients with thyroid eye disease and additional disease areas in the future.

謝謝你，路易莎。大家下午好。感謝您今天加入我們。我們有一個富有成效的季度，在我擔任 Viridian 總裁兼首席執行官的頭 3 個月後，我很高興今天報告我們的進展。 2023 年對 Viridian 來說是重要的一年，這一年包括我們所有臨床項目的關鍵里程碑。我為我們公司迄今取得的所有進展感到自豪，並期待著繼續我們的工作，為甲狀腺眼病患者和未來其他疾病領域的患者帶來潛在的一流療法。

Our team has grown rapidly throughout the first quarter, and we made several key hires on our senior leadership team, helping to strategically position us for future success. Additional details can be found in the press release we issued earlier today, but these hires include Tony Casciano, Viridian's first Chief Commercial Officer; Dr. Tom Ciulla, Chief Development Officer; Dr. Felix Geissler, Senior Vice President of Medical Affairs; and Dr. Erik Kupperman, Vice President, Program leadership. Each of these individuals have already made valuable contributions to the organization and will be integral leaders for our company as we continue to expand our teams, mature as an organization and prepare for future success.

我們的團隊在整個第一季度發展迅速，我們在高級領導團隊中聘用了幾名重要人員，幫助我們在戰略上定位未來的成功。更多詳細信息可以在我們今天早些時候發布的新聞稿中找到，但這些僱員包括 Viridian 的第一任首席商務官 Tony Casciano；首席開發官 Tom Ciulla 博士；醫學事務高級副總裁 Felix Geissler 博士；和項目領導副總裁 Erik Kupperman 博士。這些人中的每一個人都已經為組織做出了寶貴的貢獻，並且隨著我們繼續擴大我們的團隊、成熟為一個組織並為未來的成功做準備，他們將成為我們公司不可或缺的領導者。

I'll now review the progress we made in our clinical programs during the first quarter, and Kristian Humer, our CFO, will discuss our financial results before we take your questions. Let's begin with our TED programs, starting with our lead asset, VRDN-001, a humanized monoclonal antibody administered intravenously once every 3 weeks, which acts as a full antagonist of insulin-like growth factor I receptor, or IGF-1R.

我現在將回顧第一季度我們在臨床項目中取得的進展，我們的首席財務官 Kristian Humer 將在我們回答您的問題之前討論我們的財務結果。讓我們從我們的 TED 項目開始，從我們的主要資產 VRDN-001 開始，這是一種人源化單克隆抗體，每 3 周靜脈注射一次，作為胰島素樣生長因子 I 受體或 IGF-1R 的完全拮抗劑。

In the second half of 2022 and at the beginning of this year, we reported a series of positive topline clinical data announcements from 3 dose cohorts of the Phase I/II clinical trial, evaluating the safety and efficacy of VRDN-001 in patients with active TED. In December 2022, our team initiated the global Phase III THRIVE trial, which will evaluate the efficacy and safety of VRDN-001 in patients with active TED. Based on our recent discussions with key stakeholders in the TED community, there is particular enthusiasm for our shortened 5-dose 12-week treatment regimen of VRDN-001 compared with the 8-dose 21-week regimen of FDA approved TEPEZZA.

在 2022 年下半年和今年年初，我們報告了來自 I/II 期臨床試驗的 3 個劑量組的一系列正面頂線臨床數據公告，評估 VRDN-001 在活動性患者中的安全性和有效性泰德。 2022 年 12 月，我們的團隊啟動了全球 III 期 THRIVE 試驗，該試驗將評估 VRDN-001 在活動性 TED 患者中的療效和安全性。根據我們最近與 TED 社區主要利益相關者的討論，與 FDA 批准的 TEPEZZA 的 8 劑 21 周方案相比，我們對 VRDN-001 的縮短 5 劑 12 周治療方案特別感興趣。

Success in the 5-dose arm has the potential to provide welcome convenience to patients by shortening their treatment course and eliminating 3 trips to an infusion center. Enrollment is ongoing, and we continue to anticipate reporting top line results from THRIVE in the middle of 2024. Moving to chronic TED, we are excited to announce that our proof-of-concept study evaluating VRDN-001 IV in patients with chronic TED is fully enrolled. As a reminder, the trial design in chronic TED is similar to our proof-of-concept design that we used in active TED. Two infusions of VRDN-001, one at day 1 and the second at day 21 with evaluation of safety and clinical activity at week 6.

5 劑量組的成功有可能通過縮短治療療程和減少 3 次前往輸液中心的次數，為患者提供受歡迎的便利。招募工作正在進行中，我們繼續期待在 2024 年年中報告 THRIVE 的頂級結果。轉向慢性 TED，我們很高興地宣布，我們在慢性 TED 患者中評估 VRDN-001 IV 的概念驗證研究是完全註冊。提醒一下，慢性 TED 的試驗設計類似於我們在活躍 TED 中使用的概念驗證設計。兩次輸注 VRDN-001，第 1 天輸註一次，第 21 天輸注第二次，並在第 6 週評估安全性和臨床活性。

There are 2 dose cohorts, 10 mg per kg and 3 mg per kg will target enrollment of 8 patients in each cohort. Randomized 3:1 in favor of VRDN-001 versus placebo. Inclusion criteria include any clinical activity score at baseline. We expect to report results from both dose cohorts of this proof-of-concept trial in either June or July.

有 2 個劑量組群，10 mg/kg 和 3 mg/kg，目標是每個組群招募 8 名患者。隨機化 3:1 支持 VRDN-001 與安慰劑。納入標準包括基線時的任何臨床活動評分。我們預計將在 6 月或 7 月報告該概念驗證試驗的兩個劑量隊列的結果。

Following the results, we plan to start our second global Phase III trial, THRIVE-2, to evaluate the safety and efficacy of VRDN-001 in patients with chronic TED. Topline results from THRIVE-2 are expected by the end of 2024. I'd now like to move to our subcutaneous programs, which include VRDN-001, VRDN-002 and VRDN-003. All 3 candidates have the potential to be developed for delivery with a patient-friendly self-administered pen device, which could significantly increase access, reduce burden and expand treatment options for patients living with TED.

根據結果，我們計劃開始我們的第二個全球 III 期試驗 THRIVE-2，以評估 VRDN-001 在慢性 TED 患者中的安全性和有效性。 THRIVE-2 的頂線結果預計到 2024 年底。我現在想轉到我們的皮下項目，包括 VRDN-001、VRDN-002 和 VRDN-003。所有 3 名候選人都有可能被開發為使用對患者友好的自我管理筆設備進行分娩，這可以顯著增加 TED 患者的可及性、減輕負擔並擴大治療選擇。

We plan to select one of these candidates as our lead subcutaneous program before the end of the year. With our many learnings from VRDN-001 IV preclinical and clinical work, we believe that the differentiated mechanisms of action with full antagonism of IGF-1R achieved by VRDN-001 and VRDN-003 make either of them the most likely to bring a best-in-class subcutaneous product to patients. As a result, a trial evaluating VRDN-002 in patients with TED will only proceed in 2024 if VRDN-002 is selected as the lead subcutaneous program at the end of the year. This allows us to keep VRDN-002 as a potential backup while steadfastly focusing on advancing our efforts with VRDN-003 and VRDN-001.

我們計劃在年底前選擇其中一名候選人作為我們的主要皮下項目。憑藉我們從 VRDN-001 IV 臨床前和臨床工作中學到的許多知識，我們相信 VRDN-001 和 VRDN-003 實現的具有完全拮抗 IGF-1R 的差異化作用機制使它們中的任何一個最有可能帶來最佳-為患者提供一流的皮下產品。因此，如果 VRDN-002 在年底被選為主要皮下項目，那麼在 TED 患者中評估 VRDN-002 的試驗只會在 2024 年進行。這使我們能夠將 VRDN-002 作為潛在的備份，同時堅定地專注於推進 VRDN-003 和 VRDN-001 的工作。

I will now highlight the upcoming priorities to get the subcutaneous lead program selection by year-end. For VRDN-001, Phase I results in healthy volunteers are expected in the fourth quarter of 2023. For VRDN-002, we continue to generate data from the ongoing Phase I healthy volunteer trial. For VRDN-003, our plans remain on track to file the investigational new drug application with the FDA during the second quarter. We expect Phase I results in healthy volunteers in the fourth quarter of 2023. After the lead subcutaneous candidates selected, we expect to advance the program to a pivotal Phase II/III trial, which is planned for the middle of 2024.

我現在將強調即將到來的優先事項，以便在年底前選擇皮下先導計劃。對於 VRDN-001，第一階段健康志願者的結果預計將在 2023 年第四季度獲得。對於 VRDN-002，我們將繼續從正在進行的第一階段健康志願者試驗中生成數據。對於 VRDN-003，我們的計劃仍在按計劃在第二季度向 FDA 提交新藥研究申請。我們預計第一階段的結果將在 2023 年第四季度在健康志願者中產生。在選定主要皮下候選人後，我們預計將該項目推進到計劃於 2024 年年中進行的關鍵 II/III 期試驗。

Last month, our team was thrilled to present multiple abstracts at the 2023 Association of Research in Vision and Ophthalmology Annual Meeting. A platform presentation featured data from our Phase I/II trial of VRDN-001 in patients with active TED, while the poster presentations featured new clinical and preclinical research on VRDN-002 and VRDN-003. This marked the company's first presentation of VRDN-003 research at a medical congress, an exciting milestone that programs development. Our team looks forward to presenting at additional medical congresses and further engaging with TED patient and physician communities throughout this year.

上個月，我們的團隊很高興在 2023 年視覺與眼科研究協會年會上展示了多篇摘要。平台展示展示了我們在活動性 TED 患者中進行的 VRDN-001 I/II 期試驗的數據，而海報展示展示了 VRDN-002 和 VRDN-003 的新臨床和臨床前研究。這標誌著該公司首次在醫學大會上展示 VRDN-003 研究成果，這是一個令人興奮的程序開發里程碑。我們的團隊期待今年在更多的醫學大會上發表演講，並進一步與 TED 患者和醫生社區進行交流。

Finally, we continue to advance our earlier-stage preclinical pipeline and will expand our disease focus beyond TED and into the rare and autoimmune space. Our preclinical programs include VRDN-004, 005 and 006. Yesterday, we announced a partnership with Enable Injections to utilize their enFuse on-body drug delivery system for one of our preclinical programs. We plan to provide additional information on at least one of the programs later this year. With that, I will turn the call over to Kristian, who will provide a financial review for the first quarter of 2023. Kristian?

最後，我們繼續推進我們早期的臨床前管道，並將我們的疾病重點從 TED 擴展到罕見和自身免疫領域。我們的臨床前項目包括 VRDN-004、005 和 006。昨天，我們宣布與 Enable Injections 合作，將他們的 enFuse 體內給藥系統用於我們的一項臨床前項目。我們計劃在今年晚些時候提供至少一個項目的更多信息。有了這個，我將把電話轉給克里斯蒂安，他將提供 2023 年第一季度的財務審查。克里斯蒂安？

Thank you, Scott. Good afternoon, everyone. I'd like to refer you to our press release issued earlier today for a detailed summary of our financial results for the first quarter 2023 and take this opportunity to review a few items. We ended the first quarter with approximately $373.9 million in cash, cash equivalents and short-term investments compared with $424.6 million as of December 31, 2022. We believe that our current cash, cash equivalents and short-term investments, excluding our $75 million credit facility will be sufficient to fund our operations into the second half of 2025.

謝謝你，斯科特。大家下午好。我想向您推薦我們今天早些時候發布的新聞稿，以詳細了解我們 2023 年第一季度的財務業績，並藉此機會回顧一些項目。第一季度結束時，我們的現金、現金等價物和短期投資約為 3.739 億美元，而截至 2022 年 12 月 31 日為 4.246 億美元。我們認為，我們目前的現金、現金等價物和短期投資，不包括我們的 7500 萬美元信貸設施將足以為我們到 2025 年下半年的運營提供資金。

Research and development expenses were $50.7 million during the first quarter of 2023 compared with $17.7 million for the same period last year. Research and development expenses for the first quarter of 2023 include a one-time $15 million upfront payment to Enable in consideration for the rights granted to Viridian to utilize Enable Injections' enFuse on-body drug delivery system. Other drivers for the increase in research and development expenses include higher CMC expenses in preparation for the IND application for VRDN-003 as well as development activities.

2023 年第一季度的研發費用為 5070 萬美元，而去年同期為 1770 萬美元。 2023 年第一季度的研發費用包括一次性支付給 Enable 的 1500 萬美元預付款，以考慮授予 Viridian 使用 Enable Injections 的 enFuse 體內給藥系統的權利。研發費用增加的其他驅動因素包括為準備 VRDN-003 的 IND 申請以及開發活動而增加的 CMC 費用。

Higher personnel costs due to an increase in headcount, higher preclinical costs due to early-stage collaboration expenses. As of May 1, 2023, Viridian had approximately 58 million shares of common stock outstanding on an as-converted basis. With that, I'll ask the operator to open the call for questions. Operator?

人員增加導致人員成本增加，早期合作費用導致臨床前成本增加。截至 2023 年 5 月 1 日，Viridian 擁有約 5800 萬股已發行普通股（按轉換後的基礎計算）。有了這個，我會要求接線員打開問題電話。操作員？

(Operator Instructions) Your first question is from the line of Derek Archila with Wells Fargo.

（操作員說明）您的第一個問題來自富國銀行的 Derek Archila。

Congrats on the progress. Maybe just two questions from us. Maybe just first, can you just talk about the variables that could lead the chronic data coming out in July versus in the second quarter? And then also, just your thinking on the TED market opportunity given what we saw from Horizon recently in their quarter results. I mean do you think anything has changed in the market? Or do you kind of chalk that up to deal-related things going -- with the ongoing Amgen deal?

祝賀進步。也許我們只有兩個問題。也許只是首先，您能否談談可能導致 7 月與第二季度出現長期數據的變量？然後，根據我們最近從 Horizon 的季度業績中看到的情況，您對 TED 市場機會的看法。我的意思是你認為市場有什麼變化嗎？還是您將其歸因於與交易相關的事情——正在進行的安進交易？

This is Scott. We're expecting a real high probability that we're going to see clinical activity in chronic TED because it's been confirmed by the recent Horizon data. They were able to post a 62% and very meaningful response with a 2-millimeter reduction in proptosis. Our trial is evaluating the activity with only 2 doses of VRDN-001 to establish the proof of concept and reduction in proptosis of less than 2 millimeters, excuse me, would be -- still be very meaningful because we still plan to evaluate the longer doses in THRIVE-2. We're very pleased with what's happened in that trial. We've actually overenrolled the 3 mg per kg cohort. So once we get the process rolling where we bring in all the information from the CRO, from the sites, the MRIs, we're going to need some time to really look through that and make sure it's right. And then we'll be ready to announce either June or July.

這是斯科特。我們期待在慢性 TED 中看到臨床活動的可能性非常大，因為最近的 Horizon 數據已經證實了這一點。他們能夠發布 62% 的非常有意義的反應，突出減少 2 毫米。我們的試驗正在評估僅用 2 劑 VRDN-001 的活動，以建立概念證明和減少小於 2 毫米的眼球突出，抱歉，仍然非常有意義，因為我們仍計劃評估更長的劑量在 THRIVE-2 中。我們對該試驗中發生的事情感到非常滿意。我們實際上已經超額註冊了每公斤 3 毫克的隊列。因此，一旦我們開始從 CRO、網站、MRI 獲取所有信息的流程，我們將需要一些時間來真正審視並確保它是正確的。然後我們準備好宣布 6 月或 7 月。

And then with regard to your second question was about what we saw in the Horizon data. We thought it was actually very good data for patients suffering from chronic TED, and there's still a very large unmet need in that population because surgical intervention is really all they have left, unless they use a systemic treatment. We look forward to seeing some more of their information when they are able to release around patient baseline characteristics, the efficacy end points and some of the safety because this was the first placebo-controlled data in this chronic population. And then we look forward to reporting our data in June or July of this year.

然後關於你的第二個問題是關於我們在 Horizon 數據中看到的。我們認為這對於患有慢性 TED 的患者來說實際上是非常好的數據，並且該人群中仍然存在大量未滿足的需求，因為除非他們使用全身治療，否則手術干預真的是他們所剩下的一切。當他們能夠發布患者基線特徵、療效終點和一些安全性時，我們期待看到他們的更多信息，因為這是該慢性人群中的第一個安慰劑對照數據。然後我們期待在今年 6 月或 7 月報告我們的數據。

And as a reminder, though, we were -- our study was set up slightly differently. It was for patients with proptosis of greater than or equal to 3 millimeters above normal values and then symptoms that had presented themselves after 1 year of study screening -- excuse me, prior to study screening. And just a reminder, we did not have a cash requirement whereas Horizon used a 0 or 1 for cash. We are enrolling 2 cohorts, as I mentioned before, with VRDN-001, there's a 10 mg per kg cohort and a 3 mg per kg cohort randomized at 3:1 versus placebo, and there was staggered enrollment, the 10 mg per kg arm enrolled first with the 3 to follow as I said it was overenrolled.

不過提醒一下，我們的研究設置略有不同。它適用於眼球突出大於或等於正常值 3 毫米，然後在研究篩選 1 年後出現症狀的患者——對不起，在研究篩選之前。提醒一下，我們沒有現金要求，而 Horizon 使用 0 或 1 現金。正如我之前提到的，我們正在招募 2 個隊列，使用 VRDN-001，有一個 10 mg/kg 隊列和一個 3 mg/kg 隊列以 3:1 隨機分配給安慰劑，並且有交錯的註冊，10 mg/kg 組首先註冊了 3 個，正如我所說的那樣，它已經超額註冊了。

So there's only 2 infusions in each of those at day 1 and then again at day 21, which is q.3 weekly. And then the results will be at day 42 and week 6. So good news from the Horizon data. We think that their result will play well in the marketplace with that 2-millimeter reduction and that will help them hopefully get more coverage decisions from insurance companies and with their broader label that, that will create a really nice tailwind for the market.

因此，在第 1 天和第 21 天（每週 3 次）再次輸注 2 次。然後結果將在第 42 天和第 6 週出現。來自 Horizon 數據的好消息。我們認為他們的結果將通過減少 2 毫米在市場上發揮良好作用，這將有助於他們有希望從保險公司獲得更多的承保決定，以及他們更廣泛的標籤，這將為市場創造一個非常好的順風。

Derek, this is Todd. As far as things that could be potentially impacting sales or what was potentially driving a reduction from Q4 to Q1, we think as far as how Horizon was investing in the market as far as expanding their sales force the direct-to-consumer advertising as well as the patient and physician support around trying to expedite new market access and reimbursement for patients is absolutely great places to invest in. But I think to your point, around potential distraction around an M&A process as that was taking place in the public headlines, certainly not helpful when you're trying to make in-flight operational changes to impact the sales trajectory of a drug.

德里克，這是托德。至於可能影響銷售或可能導致第四季度減少到第一季度的因素，我們認為 Horizon 如何投資市場以及擴大直接面向消費者的廣告的銷售隊伍因為患者和醫生在嘗試加快新市場准入和患者報銷方面的支持絕對是投資的好地方。但我認為，就你的觀點而言，圍繞併購過程的潛在干擾，正如公眾頭條新聞所發生的那樣，當然當您嘗試進行飛行中的操作更改以影響藥物的銷售軌跡時，這無濟於事。

The chronic data that Scott just described will certainly help as far as being able to have educate and aware physicians and payers to hopefully drive additional sales in the chronic marketplace. But I'd also just point out that integration isn't easy either. And so people should probably expect some additional impact over the next couple of quarters as Amgen is integrating the Horizon team. And then with chronic, those changes that were being made, I think we should be able to return to growth either later this year or early next year and see the TEPEZZA sales pick up again.

斯科特剛剛描述的慢性病數據肯定會有所幫助，因為它能夠教育和了解醫生和付款人，從而有望在慢性病市場上推動額外的銷售。但我還要指出，集成也不容易。因此，隨著 Amgen 正在整合 Horizon 團隊，人們可能會在接下來的幾個季度中期待一些額外的影響。然後隨著慢性變化，我認為我們應該能夠在今年晚些時候或明年初恢復增長，並看到 TEPEZZA 的銷售再次回升。

Your next question is from the line of Alex Thomson with Stifel.

你的下一個問題來自 Stifel 的 Alex Thomson。

I guess a couple for me. Maybe could you talk about whether the path forward with 001 subcu to bridge PK if you have successful IV trials potentially in the market faster? And then maybe as a follow-up to Derek's question, what are your current expectations around your label? Do you expect to get sort of the old TEPEZZA label? Or do you expect the path forward for you to get the new label upon approval? And if so, how that might impact the commercial opportunity?

我猜對我來說是一對。也許你能談談如果你有可能更快地在市場上進行成功的 IV 試驗，那麼 001 subcu 的前進道路是否可以橋接 PK？然後也許作為 Derek 問題的後續，你目前對你的品牌有什麼期望？您希望得到某種舊的 TEPEZZA 標籤嗎？或者您是否希望在獲得批准後獲得新標籤？如果是這樣，這將如何影響商業機會？

So for the second one, both the THRIVE and the THRIVE-2 study are going to be supportive of the BLA. And so then we would expect then that to translate into a broad TED label similar to what you're seeing today with the TEPEZZA label. And sorry, could you repeat your first question?

因此，對於第二個，THRIVE 和 THRIVE-2 研究都將支持 BLA。因此，我們希望它能轉化為廣泛的 TED 標籤，類似於您今天看到的 TEPEZZA 標籤。抱歉，你能重複你的第一個問題嗎？

With the 001 subcu.

與 001 subcu。

So the current way that we're thinking about it is really separate programs of IV versus subcu. And so we're moving ahead with THRIVE and THRIVE-2 to set up for an approval with the IV, and then we're going to select the lead candidate in subcu, which based off of everything that we're seeing today, 003 looks like it would have the best profile from the binding affinity of 001 along with the half-life extension of 002. If there were a way for us to bridge from 001 subcu -- from IV to subcu, that's certainly something we'll evaluate in the future. But currently, no plans to update you on that right now.

因此，我們目前考慮的方式實際上是 IV 與 subcu 的獨立程序。因此，我們正在推進 THRIVE 和 THRIVE-2 以準備獲得 IV 的批准，然後我們將根據我們今天看到的一切來選擇 subcu 的主要候選人，003從 001 的結合親和力和 002 的半衰期延長來看，它看起來具有最佳配置文件。如果我們有辦法從 001 subcu 橋接——從 IV 到 subcu，那肯定是我們要評估的東西將來。但是目前，沒有計劃立即向您更新。

Your next question is from the line of Gavin Clark-Gartner.

你的下一個問題來自 Gavin Clark-Gartner。

I had two. First, I just wanted to make sure that if you do select 003, there's nothing else that could potentially slow you down, specifically wondering about any formulation manufacturing or preclinical toxicology work. And I'll come back for my second question.

我有兩個。首先，我只是想確保如果您確實選擇了 003，沒有其他可能會減慢您的速度，特別是想知道任何配方製造或臨床前毒理學工作。我會回來回答我的第二個問題。

Yes. No. All three programs are right on track, and we're going to continue to evaluate them through the end of the year. And as of now, there's no issues with formulation or the preclinical work. The healthy volunteer studies will be underway and will complete by the end of the year.

是的。不會。這三個項目都在正常軌道上，我們將在年底前繼續評估它們。截至目前，配方或臨床前工作沒有任何問題。健康志願者研究將在今年年底前完成。

And then we should be on track, Gavin -- this is Todd. We should be on track to start a Phase II/III pivotal then for what other program is selected as the lead in the middle of next year.

然後我們應該走上正軌，加文——這是托德。我們應該按計劃開始第二階段/第三階段的關鍵，然後在明年年中選擇其他項目作為主導。

All right. That's super helpful. And then separately, on the partnership for the on-body system that was announced yesterday. I just wanted to clarify, was that for the next preclinical program that's going to be unveiled? Or is that for an earlier preclinical program that is still to be discussed?

好的。這非常有幫助。然後分別是關於昨天宣布的人體系統的合作夥伴關係。我只是想澄清一下，這是為了下一個即將公佈的臨床前項目嗎？或者這是一個仍有待討論的早期臨床前項目？

That's for 1 of the 3 programs we're currently developing, and it will have nothing to do with TED whatsoever. So it will be for 1 of those 3.

這是我們目前正在開發的 3 個項目中的一個，它與 TED 沒有任何關係。所以這將適用於這 3 個中的 1 個。

Your next question is from the line of Thomas Smith with SVB Securities.

你的下一個問題來自 SVB 證券公司的 Thomas Smith。

A couple on our end. I was wondering if you could provide any additional color on how the THRIVE trial is enrolling at this point and how that enrollment is tracking relative to your initial modeling? And then secondly, I understand the difference between the inclusion criteria between your study and the Horizon study, but I was just wondering if you have any visibility into the baseline characteristics of the chronic character of a concept cohort and whether this is tracking towards more of a sort of a low CAS population or kind of mid CAS patient population?

我們這邊的一對夫婦。我想知道你是否可以提供任何額外的顏色來說明 THRIVE 試驗在這一點上是如何註冊的，以及該註冊是如何相對於你的初始建模進行跟踪的？其次，我了解您的研究與 Horizon 研究的納入標準之間的差異，但我只是想知道您是否了解概念隊列慢性特徵的基線特徵，以及這是否正在追踪更多一種低 CAS 人群或一種中等 CAS 患者人群？

Yes. So with regard to the THRIVE study, we're really pleased that we can announce the first placement that was enrolled back in December. And we have more than 30 sites activated globally, but we're not giving any interim updates on the enrollment. And the second question was around -- that we don't -- we have not unblinded our baseline characteristics. I believe they have, but we have not.

是的。因此，關於 THRIVE 研究，我們真的很高興我們可以宣布 12 月份登記的第一個安置。我們在全球範圍內激活了 30 多個站點，但我們不會提供有關註冊的任何臨時更新。第二個問題是——我們沒有——我們沒有公開我們的基線特徵。我相信他們有，但我們沒有。

Your next question is from the line of Laura Chico with Wedbush Securities.

你的下一個問題來自 Wedbush Securities 的 Laura Chico。

I just have two. Just kind of following up on the enFuse delivery system, understanding this is for other programs outside of TED, but just kind of curious why the rationale for the program and executing on this right now. Just any advantages or criteria you were looking for in terms of selecting this particular partner? And then secondarily, on the cash runway, just any commentary or additional color there on levers to extend that. I think R&D picked up a little bit if I'm reading things correctly here. I'm just trying to understand the expectations on the burn for the remainder of the year.

我只有兩個。只是跟進 enFuse 交付系統，了解這是針對 TED 之外的其他程序，但只是好奇為什麼現在要執行該程序的基本原理。在選擇這個特定合作夥伴時，您是否有任何優勢或標準？其次，在現金跑道上，只需在槓桿上添加任何評論或附加顏色即可擴展它。如果我在這裡正確閱讀內容，我認為 R&D 有所回升。我只是想了解對今年剩餘時間的燒錢預期。

Yes. So I'll take the -- this is Scott. I'll take the first question and Kristian will answer your second question. So the first one really goes around the hallmark and the philosophy of the company is if we can improve in a market that's been created around efficacy or potentially safety or mode of delivery. Those are the three criteria that we take care of near and dear and look hard to do that, and we believe this technology will help that compound that this is going to be put within our preclinical pipeline. Kristian?

是的。所以我會 - 這是斯科特。我會回答第一個問題，克里斯蒂安會回答你的第二個問題。因此，第一個真正圍繞著標誌和公司的理念是，如果我們能夠在圍繞功效或潛在安全性或交付方式創建的市場中進行改進。這些是我們密切關注並努力做到這一點的三個標準，我們相信這項技術將有助於將其放入我們的臨床前管道中的化合物。克里斯蒂安？

So look, we've got cash a little bit under $374 million. We continue to guide cash runway into the second half of 2025, but it funds -- on a program-by-program basis, it funds basically both THRIVE and THRIVE-2, all the way through data at the end of '24 and a little bit into '25. Our subcu program is funded through to what we're calling the date of decision point at the end of this year, where we will select the program to move forward into pivotal trials. Most importantly, pivotal trial prep is funded so that we can move expeditiously at the end of '23 into pivotal trials.

所以看，我們的現金略低於 3.74 億美元。我們繼續指導現金跑道進入 2025 年下半年，但它資助——在逐個項目的基礎上，它基本上為 THRIVE 和 THRIVE-2 提供資金，一直通過 24 年底的數據和一點點進入'25。我們的 subcu 計劃的資金一直持續到我們稱之為今年年底的決策點日期，屆時我們將選擇該計劃以進入關鍵試驗。最重要的是，關鍵的試驗準備工作得到了資助，這樣我們就可以在 23 年底迅速進入關鍵試驗。

Our non-TED pipeline is all funded either through to candidate selection or IND filing, and you should expect us to unveil these programs one by one, and we'll let the market decide what they want to fund. We have committed to unveiling at least 1 of the 3 programs on our pipeline -- one of our non-TED programs on our pipeline chart over the course of the rest of 2023. Kind of -- our cash operating expenses in Q1 were slightly higher than they usually are mostly due to kind of the enabled payment of $15 million. You should expect slightly elevated expenses again in Q2 as we initiate kind of THRIVE-2. And after that should normalize again back to kind of a steady state of somewhere between $35 million and $45 million.

我們的非 TED 管道全部通過候選人選擇或 IND 申請獲得資金，您應該期待我們一個接一個地公佈這些項目，我們將讓市場決定他們想要資助什麼。我們已承諾在 2023 年剩餘時間里至少公佈 3 個計劃中的 1 個——我們計劃表上的非 TED 計劃之一。有點——我們第一季度的現金運營支出略高比通常情況下多的原因主要是由於啟用了 1500 萬美元的付款。隨著我們啟動 THRIVE-2，您應該預計第二季度的支出會再次略有增加。之後應該再次正常化，回到 3500 萬到 4500 萬美元之間的穩定狀態。

Your next question is from the line of Kalpit Patel with B. Riley Securities.

你的下一個問題來自 B. Riley Securities 的 Kalpit Patel。

Maybe one more on the market opportunity here for thyroid eye disease. I guess, based on your conversations with KOLs in the space, is there a backlog of chronic TED patients that are waiting to be treated? And do you think that it will sort of be a rapid uptake in this setting like we saw in the acute setting? Or would it be a slow build given the lower severity of the disease?

也許這裡還有一個關於甲狀腺眼病的市場機會。我想，根據你與該領域 KOL 的對話，是否有積壓的慢性 TED 患者等待治療？你認為它會像我們在急性環境中看到的那樣在這種環境中快速吸收嗎？或者考慮到疾病的嚴重程度較低，它會慢慢形成嗎？

This is Scott. I'll take the first part and maybe Tom Ciulla will add a little color because we've actually been out in the field quite a bit lately at the different conferences and visiting with our PIs and KOLs, and learning about that. I think the belief is that there was a low-hanging fruit situation with the actives. But in the words of some of the physicians I spoke with, there are lines of chronic patients. I think the recent data that's been put out there bodes well with their broad label now and that they can take forward, as I mentioned before, to get coverage decision.

這是斯科特。我將參加第一部分，也許 Tom Ciulla 會添加一點色彩，因為我們實際上最近在不同的會議上已經在該領域進行了相當多的嘗試，並拜訪了我們的 PI 和 KOL，並了解了這一點。我認為人們相信活性成分是唾手可得的果實。但用我採訪過的一些醫生的話來說，有很多慢性病患者。我認為最近發布的數據預示著他們現在的廣泛標籤，正如我之前提到的，他們可以向前推進，以獲得覆蓋範圍的決定。

But I think we see there's really significant opportunity out there for market potential and to grow the market especially when we think about our 5-dose regimen that's -- as part of our THRIVE study. The physicians are really excited about that, even versus the 8-dose that's already available. And I think we really have the opportunity to grow the market with our subcu offering. So we'll have a very broad approach to treating this diseases -- disease, excuse me, with whether people want to use an IV or a subcu.

但我認為我們看到了市場潛力和發展市場的巨大機會，特別是當我們考慮我們的 5 劑量方案時——作為我們 THRIVE 研究的一部分。醫生們對此感到非常興奮，即使與已經可用的 8 劑相比也是如此。而且我認為我們真的有機會通過我們的 subcu 產品來發展市場。所以我們將有一個非常廣泛的方法來治療這種疾病——疾病，對不起，人們是想使用 IV 還是 subcu。

And then there's also the future of a lot of physicians are telling us around it's still 8 doses with TEPEZZA, sort of an acute treatment for what appears now to be a chronic disease because the TEPEZZA data definitely showed that these chronic patients do present themselves even after having the disease and their criteria 2 to 10 years, and we've even heard longer than that, and they are getting relief. But Tom, I don't know if you want to add some color?

然後還有很多醫生告訴我們的未來，它仍然是 8 劑 TEPEZZA，這是一種針對現在看來是慢性疾病的急性治療方法，因為 TEPEZZA 數據明確表明這些慢性患者甚至會出現在患上這種疾病和他們的標準 2 到 10 年後，我們甚至聽說過比這更長的時間，他們正在得到緩解。但是湯姆，我不知道你是否想添加一些顏色？

Sure. This is Tom Ciulla. So we -- as Scott mentioned, we've been through a variety of congresses recently. We were at the Association for Research in Vision and Ophthalmology, the North America Neuro-Ophthalmology Society and the North American Society of Academic Orbital Surgeons, where we had multiple presentations at each of these congresses. Scott actually has attended and has met with several of the investigators and KOLs. And uniformly, they're very enthusiastic about our multiple ascending dose proof-of-concept study in acute TED.

當然。這是湯姆·丘拉。所以我們 - 正如斯科特提到的那樣，我們最近參加了各種大會。我們參加了視覺和眼科研究協會、北美神經眼科學會和北美眼眶外科醫師協會，我們在這些大會上分別做了多次演講。斯科特實際上已經參加並會見了幾位調查員和 KOL。一致地，他們對我們在急性 TED 中的多次遞增劑量概念驗證研究非常熱情。

I think we've gotten a lot of positive feedback about that data. We've also gotten a lot of positive feedback about Horizon's recent data in chronic TED, and we see this as a win for patients suffering from chronic TED. What the KOLs and investigators have told us is that they do indeed have a backlog of patients and they -- many of them have asked to take part in our clinical trial as investigators. So we think there is a groundswell of optimism, not only for active TED, but for chronic TED, where there's a backlog, just as you asked about.

我認為我們已經收到了很多關於該數據的積極反饋。我們也得到了很多關於 Horizon 近期慢性 TED 數據的積極反饋，我們認為這是慢性 TED 患者的勝利。 KOL 和調查人員告訴我們的是，他們確實有大量患者，他們中的許多人要求作為調查人員參加我們的臨床試驗。因此，我們認為樂觀情緒正在高漲，不僅對於活躍的 TED，對於長期的 TED，正如您所問的那樣，那裡存在積壓。

Okay. Got it. And can you give us a little more -- maybe more color between the selection of the right subcu candidate and the timing of the start of that pivotal trial in mid-2024. What steps are remaining to start that trial?

好的。知道了。你能不能給我們多一點——也許在選擇合適的 subcu 候選人和 2024 年年中開始關鍵試驗的時間之間有更多的顏色。還需要哪些步驟才能開始該試驗？

Yes. So there are -- a couple of the 002 healthy volunteer studies is ongoing right now, and we've even reported some of that information out at one of the more recent conferences. And then the 003 and 001 healthy volunteer studies, which will be looking at bioavailability and safety. Those will be completed early enough to have by the end of the year, and then we'll wind up all that information, make the decision about which one of the candidates we would move forward with. And then based on that information, we would then seek input from the stakeholders and plan to start the trial midyear.

是的。因此，目前正在進行一些 002 健康志願者研究，我們甚至在最近的一次會議上報告了其中一些信息。然後是 003 和 001 健康志願者研究，將研究生物利用度和安全性。這些將儘早完成，以便在今年年底之前完成，然後我們將收集所有這些信息，決定我們將推進哪一位候選人。然後根據這些信息，我們會徵求利益相關者的意見，併計劃在年中開始試驗。

Your next question is from the line of Jason Butler with JMP Securities.

您的下一個問題來自 JMP 證券公司的 Jason Butler。

Scott, you pointed to before the importance of the shortened treatment duration in the THRIVE study for the IV. Can you just talk about how that thinking rolls over to your planning for the subcu pivotal program and I guess, also the chronic TED program?

斯科特，你之前在 IV 的 THRIVE 研究中指出了縮短治療時間的重要性。你能談談這種想法是如何影響到你對 subcu 關鍵項目的規劃的嗎，我猜，還有長期的 TED 項目？

Yes. So we are learning a lot about what's going on in the marketplace. And I would say the market has changed pretty dramatically over the launch of TEPEZZA and how physicians are actually using these drugs, as I mentioned before, the way that it's kind of an acute treatment paradigm today where you give 8 doses and then at least that's how the label read and you see how it goes. But what you realize is if the thyroid is not being controlled well and the pathway is uncovered and not blocked by using a TEPEZZA-like compound, the symptoms of TED return.

是的。因此，我們正在學習很多關於市場上正在發生的事情。我想說隨著 TEPEZZA 的推出以及醫生實際使用這些藥物的方式，市場已經發生了相當大的變化，正如我之前提到的，今天它是一種急性治療範例，你給予 8 劑，然後至少是這樣標籤是怎麼讀的，你就知道它是怎麼回事了。但是你會意識到，如果甲狀腺沒有得到很好的控制，並且使用類似 TEPEZZA 的化合物發現並且沒有阻斷該通路，那麼 TED 的症狀就會再次出現。

And so one of the things -- and one of the reasons we have the 5-dose regimen in there is, one, it's quicker to enroll in the patients when they -- if they see a result or not, they'll be able to roll over after their doses on to an active as we've seen before. But the physicians just really like the idea that you maybe able to treat and induce a response with TED at a lower number of doses, and we also point to some of the side effects that show up on TEPEZZA in those higher dose numbers and the flattening of the curve.

因此，其中一件事——也是我們採用 5 劑方案的原因之一，其中之一，當他們——無論他們是否看到結果，他們都能夠更快地登記患者就像我們之前看到的那樣，在服藥後翻滾到活躍狀態。但是醫生們真的很喜歡這樣的想法，即您可能能夠以較低的劑量使用 TED 治療和誘導反應，我們還指出了 TEPEZZA 在較高劑量和扁平化中出現的一些副作用的曲線。

So we actually believe we will start to see a couple of people would call it a treat and retreat or it could be an induction in maintenance way and where we think we're very well positioned, both with our infused product line that will -- once it's approved, obviously, but all of the subcu, so then you put the treatment in the hands of the patient, obviously, after being diagnosed and you just have a lot more flexibility and a lot better experience for the patients who don't have to go to infusion centers to be treated.

所以我們實際上相信我們會開始看到一些人會稱之為治療和撤退，或者它可能是維護方式的歸納，我們認為我們處於非常有利的位置，我們注入的產品線將 -一旦它被批准，顯然，但是所有的子單元，然後你就把治療交給病人，顯然，在被診斷之後，你就會有更多的靈活性和更好的體驗必須去輸液中心接受治療。

So we actually see a pretty significant paradigm shift that you could have sort of an induction phase where you get the acute signs and symptoms under control, and then you go to a real maintenance paradigm where there are potentially with our technology, you could get to a q.4 weekly or once a month dosing in the hands of the patient and not seeing the caregiver, which we think is differentiated from at least the way we understand TEPEZZA is going.

所以我們實際上看到了一個非常重要的範式轉變，你可以有一個誘導階段，在那裡你可以控制急性體徵和症狀，然後你進入一個真正的維護範式，我們的技術有可能，你可以a q.4 每週或每月一次在患者手中給藥並且看不到護理人員，我們認為這至少與我們了解 TEPEZZA 的方式不同。

Got it. And I guess just a follow-up to that then. Are you hearing from physicians yet that there they're employing that treat and retreat with TEPEZZA. So patients are getting treatment in the acute phase and then either retreated in a chronic phase? Or is it just too early to say that?

知道了。我想這只是後續行動。您是否從醫生那裡聽說他們正在使用 TEPEZZA 進行治療和撤退。那麼患者是在急性期接受治療，然後在慢性期接受治療嗎？還是說現在還為時過早？

So I think you pretty much hit it right on the head, actually. So what we start to hear anecdotally and then multiple times from physicians who were treating during the pandemic, they couldn't get their full 8 doses because TEPEZZA had been sidelined for the COVID vaccines. So they were given limited number of doses, and what they would do is give a few doses and then watch and see the result and have the patient return and then they still had a few more doses to give them or sometimes we've heard of they'll give people up to 5, basically send them home and say, stay in touch.

所以我認為你幾乎一針見血，實際上。因此，我們開始聽到軼事，然後多次從在大流行期間接受治療的醫生那裡聽到，他們無法獲得完整的 8 劑疫苗，因為 TEPEZZA 已被排除在 COVID 疫苗之外。所以他們只給了有限的劑量，他們會做的是給幾劑，然後觀察結果，讓病人回來，然後他們還有幾劑給他們，或者有時我們聽說過他們會給最多 5 個人，基本上是讓他們回家，然後說，保持聯繫。

And if you start to hear these -- excuse me, feel these results, you can come back and we can infuse you again. So no, it is almost turning into -- I heard from one physician. It's like give a few doses and then turn it into a PRN as the patient needs it. So we're picking up that intel, and we do have the benefit of foresight versus hindsight and so we can use this Intel to adjust how we go to market.

如果你開始聽到這些——對不起，感受這些結果，你可以回來，我們可以再次為你注入。所以不，它幾乎變成了——我從一位醫生那裡聽說過。這就像給一些劑量，然後根據患者的需要將其轉化為 PRN。所以我們選擇了那個英特爾，我們確實有先見之明和後見之明的優勢，所以我們可以使用這個英特爾來調整我們進入市場的方式。

(Operator Instructions) Your next question is from the line of Rami Katkhuda with LifeSci.

（操作員說明）你的下一個問題來自 Rami Katkhuda 與 LifeSci 的合作。

Two quick ones for me. I guess, first, is there anything specific that you're looking out for in the proven concept chronic TED study that can influence the THRIVE-2 protocol? And then secondly, in your conversations with physicians and payers, have market access or reimbursement considerations changed with TEPEZZA after the chronic data?

兩個快速的給我。我想，首先，您是否正在尋找可以影響 THRIVE-2 協議的經過驗證的概念長期 TED 研究的具體內容？其次，在您與醫生和付款人的對話中，在長期數據之後，TEPEZZA 的市場准入或報銷考慮因素是否發生了變化？

Yes. So specific to the chronic data and how that could impact the THRIVE-2 Phase III design. So we have, of course, some preliminary thinking of what that Phase III design could look like prior to the data. We recently got some very high-level topline results from Horizon. That was kind of helpful for us to think about how we can think about clinical activity. We will then also be informed by the activity that we see in our trial and then not one specific thing that I would kind of call out today, but we'll be fully informed by that data and kind of relative to that preliminary thinking make any necessary considerations and impacts to the trial design, if it's necessary to seek either KOL and/or health authority feedback before we kick off the trial. Of course, we'll do that as well.

是的。如此具體到慢性數據以及它如何影響 THRIVE-2 III 期設計。因此，我們當然對 III 期設計在數據之前的樣子有一些初步的想法。我們最近從 Horizon 獲得了一些非常高水平的頂線結果。這有助於我們思考如何思考臨床活動。然後，我們還將了解我們在試驗中看到的活動，而不是我今天要說的具體事情，但我們將充分了解該數據以及與初步想法相關的任何信息對試驗設計的必要考慮和影響，如果有必要在我們開始試驗之前尋求 KOL 和/或衛生當局的反饋。當然，我們也會這樣做。

As far as market access decisions following that chronic data from Horizon just -- now 4 weeks ago, I think it's really too early for us to be getting intelligence around that. And so that's something we'll definitely be listening to as far as for intelligence that we're getting from the marketplace and the survey work that we do. And of course, if we start to take care of things, then it would be more appropriate to give you that intel as we're hearing in real time.

至於根據 Horizon 的長期數據做出的市場准入決策——現在是 4 週前，我認為我們現在就獲得有關這方面的情報還為時過早。因此，就我們從市場獲得的情報和我們所做的調查工作而言，我們肯定會聽取這些意見。當然，如果我們開始處理事情，那麼向您提供我們實時聽到的情報會更合適。

Your next question is from the line of Gavin Clarke-Gartner.

你的下一個問題來自 Gavin Clarke-Gartner。

I just wanted to circle back on the extended duration or retreatment dynamic that you just mentioned. Because today, a lot of the payer policies explicitly don't allow for more than 8 TEPEZZA doses. I'm wondering how you approach pricing and also what clinical data you need to show to allow for this dynamic in the future?

我只是想回顧一下您剛才提到的延長持續時間或撤退動態。因為今天，許多付款人政策明確不允許超過 8 劑 TEPEZZA。我想知道您如何處理定價以及您需要顯示哪些臨床數據才能在未來實現這種動態？

Yes. So this would be obviously post-approval approach we would take. But when you're going -- when you could shift out of -- from a treat to retreat to induction and the maintenance, the pricing could be very different because you have -- you might be using the subcu the whole time that way. So today, they are at 8. But with their broader label now and a retreatment, they could get -- they can resubmit for reimbursement on the next bid. And instead of going 8 and 8 is what I've been referring to and have heard from a lot of the physicians is this is a chronic disease, and the label is basically now at any time you have TED, you can be treated with the drug.

是的。所以這顯然是我們將採取的批准後方法。但是當你要去的時候——當你可以離開——從治療到撤退到歸納和維護時，定價可能會非常不同，因為你有——你可能一直以這種方式使用 subcu。所以今天，他們在 8 點。但現在有了更廣泛的標籤和撤退，他們可以獲得 - 他們可以在下一次投標時重新提交報銷。而不是去 8 和 8 是我一直提到的，並且從很多醫生那裡聽說這是一種慢性疾病，現在標籤基本上是在你有 TED 的任何時候，你可以用藥品。

So it's -- I think people are struggling with using 8 and then 8 and 8 and then also with that very high dose, you could maybe -- if you use smaller doses like with our full antagonism, we are about 1/3 at the 5-dose cohort and not quite about half of where they'll be with their 150 mg per kg. So being able to dose with different dose regimens, whether it's subcu or treat or retreat with a lower number of infusion doses seems to be a preferred approach.

所以它——我認為人們正在努力使用 8，然後是 8 和 8，然後是非常高的劑量，你也許可以——如果你使用更小的劑量，就像我們完全對抗一樣，我們大約有 1/3 5 劑組，而不是他們每公斤 150 毫克劑量的一半。因此，能夠採用不同的劑量方案進行給藥，無論是亞皮下注射還是治療或以較少的輸注劑量撤退似乎是一種首選方法。

At this time, we have reached the conclusion of the question-and-answer session. I would now like to turn the call back over to Viridian's President and CEO, Scott Myers, for closing remarks.

至此，我們的問答環節已經接近尾聲。我現在想把電話轉回給 Viridian 的總裁兼首席執行官斯科特邁爾斯，讓他發表結束語。

Thank you, operator, and thanks, everyone, for your time this afternoon. Please feel free to reach out to Todd or Louisa if you have any follow-up questions, and we are happy to touch base with you. Thanks again, and have a great evening.

謝謝接線員，也謝謝大家今天下午的時間。如果您有任何後續問題，請隨時聯繫 Todd 或 Louisa，我們很樂意與您聯繫。再次感謝，祝您度過一個愉快的夜晚。

This concludes the conference call today. You may now disconnect your lines. Thank you for participating.

今天的電話會議到此結束。您現在可以斷開線路。感謝您的參與。