(ELDN) 2022 Q2 法說會逐字稿

Greetings and welcome to the Eledon Pharmaceuticals second-quarter financial results conference call. (Operator Instructions) As a reminder, this conference call is recorded today, August 11, 2022.

問候並歡迎參加 Eledon Pharmaceuticals 第二季度財務業績電話會議。 （操作員說明）提醒一下，本次電話會議錄製於今天，2022 年 8 月 11 日。

I now would like to turn the conference over to Paul Little, Chief Financial Officer of Eledon. Please go ahead, sir.

我現在想把會議交給 Eledon 的首席財務官 Paul Little。請繼續，先生。

Good afternoon, everyone, and thank you for joining Eledon's second-quarter 2022 operating and financial results conference call. I am joined on today's call by David-Alexandre Gros, Chief Executive Officer; and Jeff Bornstein, Chief Medical Officer. Steve Perrin, our President and Chief Scientific Officer, will not be joining today's call because he is attending a funeral.

大家下午好，感謝您參加 Eledon 的 2022 年第二季度運營和財務業績電話會議。首席執行官 David-Alexandre Gros 加入了今天的電話會議；和首席醫療官傑夫伯恩斯坦。我們的總裁兼首席科學官 Steve Perrin 將不會參加今天的電話會議，因為他正在參加葬禮。

Earlier today, Eledon issued a press release announcing financial results for the second quarter ended June 30, 2022. You may access the release under the Investors tab on our company's website at eledon.com.

今天早些時候，Eledon 發布了一份新聞稿，宣布了截至 2022 年 6 月 30 日的第二季度財務業績。您可以在我們公司網站 eledon.com 的“投資者”選項卡下訪問該新聞稿。

I would like to remind everyone that statements made during this conference call relating to Eledon's expected future performance, future business prospects, or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All such forward-looking statements are intended to be subject to the Safe Harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of Eledon.

我想提醒大家，本次電話會議期間有關 Eledon 預期未來業績、未來業務前景或未來事件或計劃的聲明可能包括 1995 年《私人證券訴訟改革法案》所定義的前瞻性聲明。所有此類前瞻性聲明外觀聲明旨在受改革法案提供的安全港保護。由於 Eledon 無法控制的許多因素的影響，實際結果和結果可能與這些預測存在重大差異。

Eledon expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to risk factors set forth in Eledon's reports filed with the US Securities and Exchange Commission.

Eledon 明確表示不承擔任何義務為其前瞻性陳述提供更新，無論是由於新信息、未來事件或其他原因。參與者將被引導到 Eledon 提交給美國證券交易委員會的報告中列出的風險因素。

Now I would like to pass the call to Eledon's CEO, Dr. David-Alexandre Gros. DA?

現在我想將電話轉給 Eledon 的首席執行官 David-Alexandre Gros 博士。達？

Thank you, Paul, and thank you all for joining the call today. The second quarter marked the beginning of an exciting period for Eledon as we reported the first of four distinct clinical readouts from our tegoprubart pipeline with positive Phase 2a results in ALS. This year, we have been focused on the execution across our four clinical trials: kidney transplantation, ALS, IgA nephropathy or IgAN, and islet cell transplantation. I am very encouraged by the progress we have made in each of these areas.

謝謝你，保羅，謝謝大家今天加入電話會議。第二季度標誌著 Eledon 一個激動人心的時期的開始，因為我們報告了來自我們的 tegoprubart 管道的四個不同臨床讀數中的第一個，在 ALS 中具有積極的 2a 期結果。今年，我們一直專注於執行我們的四項臨床試驗：腎移植、ALS、IgA 腎病或 IgAN 以及胰島細胞移植。我對我們在這些領域取得的進展感到非常鼓舞。

In renal transplantation, we recently announced the first patient dosed in a Phase 1b open-label study of tegoprubart in Canada, United Kingdom, and Australia. We look forward to the continued enrollment of the study through the remainder of the year. And based on the timing of our first patient enrolled, we aim to provide initial three- and six-month open-label data across available transplant participants in the first quarter of 2023.

在腎移植方面，我們最近宣布了在加拿大、英國和澳大利亞進行的 tegoprubart 1b 期開放標籤研究中的第一位患者。我們期待在今年餘下時間繼續招募該研究。根據我們第一位患者入組的時間，我們的目標是在 2023 年第一季度為可用的移植參與者提供最初的 3 個月和 6 個月的開放標籤數據。

Additionally, we announced that the FDA has cleared Eledon's investigational new drug application or IND application for a larger controlled Phase 2a trial of tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant, thereby allowing us to expand our development and efforts for this important indication into the United States. Jeff will go into the trial design in more detail, but I'll note that this will be a superiority study versus standard of care with calcineurin inhibitors or CNIs.

此外，我們宣布 FDA 已批准 Eledon 的研究性新藥申請或 IND 申請，以進行更大規模的 tegorubart 對照 2a 期試驗，以預防接受腎移植的患者的器官排斥，從而使我們能夠擴大我們的開發和努力進入美國的重要標誌。 Jeff 將更詳細地介紹試驗設計，但我會指出，這將是一項優於鈣調神經磷酸酶抑製劑或 CNI 護理標準的研究。

As I mentioned, we were excited to report positive topline data in a Phase 2a study of tegoprubart in adults with ALS in May. Tegoprubart not only successfully met the primary endpoint of safety and tolerability, but showed dose-dependent target engagement and a level of reduction in pro-inflammatory biomarkers associated with the trends in slowing down of disease progression as measured by ALSFRS slope.

正如我所提到的，我們很高興在 5 月份的 ALS 成人 tegoprubart 2a 期研究中報告了積極的頂線數據。 Tegorubart 不僅成功地達到了安全性和耐受性的主要終點，而且顯示出劑量依賴性靶標參與度和與疾病進展減緩趨勢相關的促炎生物標誌物的降低水平，這由 ALSFRS 斜率測量。

Additionally, we observed a reduction in a number of biomarkers also associated with both IgAN and kidney allograft transplant rejection, which we believe provides significant validation of tegoprubart's broad therapeutic potential. With an eye to further progressing ALS clinical developments, we will be working with opinion leaders, the patient community, and regulators on potential next steps as well as looking at different approaches to fund a potential future trial.

此外，我們觀察到一些與 IgAN 和同種異體腎移植排斥反應相關的生物標誌物的減少，我們認為這為 tegoprubart 的廣泛治療潛力提供了重要的驗證。著眼於進一步推進 ALS 臨床開發，我們將與意見領袖、患者社區和監管機構就潛在的後續步驟進行合作，並尋找不同的方法來資助未來的潛在試驗。

Next, our Phase 2a study of tegoprubart in adults with IgAN continues to enroll, and we are expanding the enrollment landscape from our current 9 countries with 17 sites into another 3 additional countries, including the United States and China. Based on enrollment progress to date, we expect to fully enroll the high-dose cohort in the first half of 2023. Our goal is to provide meaningful insights into tegoprubart's clinical activity after 24 weeks of therapy in this indication. And we thus anticipate reporting initial six-month open-label data from this study in the first quarter of 2023.

接下來，我們在 IgAN 成人患者中進行的 tegoprubart 2a 期研究繼續招募，我們正在將招募範圍從我們目前擁有 17 個站點的 9 個國家擴展到另外 3 個國家，包括美國和中國。根據迄今為止的註冊進展，我們預計將在 2023 年上半年全面註冊高劑量隊列。我們的目標是在治療 24 週後對 tegorubart 的臨床活動提供有意義的見解。因此，我們預計在 2023 年第一季度報告這項研究的最初六個月的開放標籤數據。

Turning to islet cell transplantation, in June, tegoprubart was granted orphan drug designation by the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation. This represents a significant regulatory milestone for this program as we plan to open a clinical site at the University of Chicago in the coming month. We believe that this will be a major catalyst in the enrollment process going forward.

談到胰島細胞移植，6 月，tegorubart 被 FDA 授予孤兒藥指定，用於預防胰島細胞移植中的同種異體移植排斥。這代表了該計劃的一個重要監管里程碑，因為我們計劃在下個月在芝加哥大學開設一個臨床站點。我們相信這將成為未來招生過程的主要催化劑。

With the planned opening of the Chicago clinical site and in order to more efficiently focus our resources, we made a decision to close the existing clinical site in Alberta, Canada. We believe the new clinical site in Chicago will be sufficient to enroll the study of up to six participants with type 1 diabetes, and we anticipate reporting initial three-month open-label data from this study in the first quarter of 2023.

隨著芝加哥臨床中心的計劃開放，為了更有效地集中我們的資源，我們決定關閉加拿大阿爾伯塔省現有的臨床中心。我們相信芝加哥的新臨床中心將足以招募多達 6 名 1 型糖尿病參與者的研究，我們預計將在 2023 年第一季度報告該研究的初始三個月開放標籤數據。

I'll now turn over the call to Jeff Bornstein, our Chief Medical Officer to provide additional details on our development program. Jeff?

我現在將電話轉給我們的首席醫療官 Jeff Bornstein，以提供有關我們開發計劃的更多詳細信息。傑夫?

Thank you, DA. I'd like to begin by discussing our recent kidney transplant efforts. The cornerstone for the prevention of transplant rejection is the utilization of CNIs, even though CNIs are associated with significant side effects, including beta cell toxicity causing new onset diabetes, neurotoxicity causing neurological symptoms, including tremors and decreased cognitive function, as well as an increased risk of heart disease.

謝謝你，達。我想首先討論一下我們最近的腎移植工作。預防移植排斥反應的基石是使用 CNI，儘管 CNI 與顯著的副作用有關，包括導致新發糖尿病的 β 細胞毒性、引起神經系統症狀的神經毒性，包括震顫和認知功能下降，以及增加心髒病的風險。

Additionally, a chronic utilization of CNIs to prevent graft rejection has been associated with significant nephrotoxicity, which can impair graft function and even shortened graft survival in the same organs where CNIs are being taken to protect. By improving the safety and tolerability of first-line immunosuppression, tegoprubart has the potential to both improve patient quality of life and reduce overall morbidity in the near term as well as ultimately improved graft survival rate in the long term.

此外，長期使用 CNI 來預防移植物排斥與顯著的腎毒性有關，這可能會損害移植物功能，甚至會縮短移植物在接受 CNI 保護的器官中的存活率。通過提高一線免疫抑制的安全性和耐受性，tegorubart 有可能在短期內改善患者的生活質量和降低總體發病率，並最終提高移植物的長期存活率。

We are particularly enthused about our kidney transplant efforts because of the large amount of non-human primate data generated both by ourselves with tegoprubart as well as with historic anti-CD40 ligand antibodies. In these studies, non-human primates treated with anti-CD40 ligand antibody as monotherapy demonstrated protection from rejection for month at a time versus only days in untreated animals.

我們特別熱衷於我們的腎移植工作，因為我們自己使用 tegoprubart 以及歷史上的抗 CD40 配體抗體生成了大量非人類靈長類動物數據。在這些研究中，用抗 CD40 配體抗體作為單一療法治療的非人靈長類動物證明了一次可以在一個月內避免排斥反應，而在未治療的動物中僅幾天。

As DA mentioned, we recently dosed the first patient in our Phase 1b clinical trial of tegoprubart in kidney transplantation. Its 52-week open-label study with sites in Canada, the United Kingdom and Australia is enrolling up to 12 patients undergoing renal transplant with primary endpoints of safety and pharmacokinetics as well as exploratory endpoints, including biopsy-proven acute rejection, change in eGFR, and biomarkers of inflammation and kidney rejection.

正如 DA 所提到的，我們最近在腎移植 tegoprubart 的 1b 期臨床試驗中為第一位患者給藥。其在加拿大、英國和澳大利亞開展的為期 52 週的開放標籤研究正在招募多達 12 名接受腎移植的患者，主要終點為安全性和藥代動力學以及探索性終點，包括活檢證實的急性排斥反應、eGFR 的變化，以及炎症和腎排斥的生物標誌物。

Our goal is to demonstrate that tegoprubart can be safely utilized to replace CNI as part of first-line immunosuppressive therapy and solid organ transplantation and prevent acute and long-term solid organ transplant rejection without the use of CNIs. With enrollment ongoing, we aim to provide initial three-month and six-month open-label data across multiple transplant participants in the first quarter of 2023. These time points are relevant since acute rejection most often occurs within the first 90 days of the transplant, and new onset diabetes post-transplant often begin to be seen at six months.

我們的目標是證明 tegorubart 可以安全地用於替代 CNI，作為一線免疫抑制治療和實體器官移植的一部分，並在不使用 CNI 的情況下預防急性和長期實體器官移植排斥。隨著招募的進行，我們的目標是在 2023 年第一季度為多名移植參與者提供最初的三個月和六個月的開放標籤數據。這些時間點是相關的，因為急性排斥反應最常發生在移植的前 90 天內，並且移植後新發的糖尿病通常在六個月時開始出現。

In addition, we were pleased to recently announce a regulatory milestone with the clearance of tegoprubart US IND application to evaluate tegoprubart for the prevention of rejection in kidney transplant recipients. The IND opening Phase 2 study will be a multi-center, open-label, two-arm, active comparator, safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants, 50 per arm undergoing kidney transplants.

此外，我們很高興最近宣布了一項監管里程碑，即 tegoprubart 美國 IND 申請的批准，以評估 tegoprubart 預防腎移植受者排斥反應的作用。 IND 開始的第 2 期研究將是一項多中心、開放標籤、雙臂、主動比較、安全性、藥代動力學和療效研究，將招募大約 120 名參與者，每組 50 名接受腎移植。

Participants will receive tegoprubart or the active comparator, tacrolimus as part of an immunosuppressive regimen, including corticosteroids and mycophenolate mofetil or mycophenolate sodium. The study's primary objective is to assess whether graft function at 12 months post-transplant in tegoprubart-treated participants is superior to tacrolimus-treated participants. And the primary endpoint will compare the mean estimated glomerular filtration rate, eGFR, at 12 months for tegoprubart versus current standard of care.

參與者將接受 tegoprubart 或活性比較劑他克莫司作為免疫抑制方案的一部分，包括皮質類固醇和黴酚酸酯或黴酚酸鈉。該研究的主要目的是評估 tegoprubart 治療的參與者在移植後 12 個月的移植功能是否優於他克莫司治療的參與者。主要終點將比較 tegoprubart 與當前護理標准在 12 個月時的平均估計腎小球濾過率 eGFR。

Graft function as assessed by eGFR at 12 months post-transplant is associated independently with subsequent graft failure. GFR has been established as an indicator of kidney function in both pre- and post-transplant patients. And lower levels are associated with need for dialysis and transplantation or re-transplantation.

移植後 12 個月通過 eGFR 評估的移植物功能與隨後的移植物失敗獨立相關。 GFR 已被確定為移植前和移植後患者腎功能的指標。較低的水平與透析和移植或再移植的需要有關。

Secondary objectives include safety, incidence of new onset diabetes, biopsy-proven acute rejection, and participants in graft survival. We will provide further information on the timing of this study later this year.

次要目標包括安全性、新發糖尿病的發病率、活檢證實的急性排斥反應和移植物存活率。我們將在今年晚些時候提供有關這項研究的時間安排的更多信息。

Of note, the Phase 2 program includes an open-label extension study, allowing for the collection of long-term efficacy and safety from both this study as well as the ongoing Phase 1b study. We expect to run both the Phase 1b and the Phase 2 studies in parallel, so we can continue to report data and insights on tegoprubart from the Phase 1b study while the Phase 2 is running.

值得注意的是，第 2 階段計劃包括一項開放標籤擴展研究，允許從本研究以及正在進行的第 1b 階段研究中收集長期療效和安全性。我們希望同時進行 1b 期和 2 期研究，因此我們可以在第 2 期運行期間繼續報告來自 1b 期研究的 tegoprubart 數據和見解。

Next, I'll move on to ALS and recap the positive topline data we announced from our Phase 2a trial evaluating tegoprubart in ALS. This was a significant milestone for Eledon as it demonstrated the safety and tolerability of tegoprubart, provided insights into the role and potential impact of tegoprubart in ALS, and also help furnace some potential read throughs for tegoprubart to other indications with overlapping biomarkers.

接下來，我將繼續討論 ALS，並回顧我們在 2a 期試驗中宣布的積極的頂線數據，該試驗評估 tegoprubart 在 ALS 中的作用。這對 Eledon 來說是一個重要的里程碑，因為它證明了 tegoprubart 的安全性和耐受性，提供了對 tegoprubart 在 ALS 中的作用和潛在影響的見解，還有助於將 tegoprubart 的一些潛在通讀轉化為具有重疊生物標誌物的其他適應症。

The study was an open-label, multiple ascending dose study that sequentially evaluated 1 milligram per kilogram, 2 milligrams per kilogram, 4 milligrams per kilogram, and 8 milligrams per kilogram of tegoprubart administered every two weeks via IV infusion for a total of six infusions. In the two lower-dose cohorts, we enrolled nine participants per group. And as we dose escalated, we move to 18 participants per cohort as the higher two doses were where we had projected to see the biomarker effect.

該研究是一項開放標籤、多劑量遞增研究，依次評估 1 毫克/千克、2 毫克/千克、4 毫克/千克和 8 毫克/千克的 tegoprubart，每兩週通過靜脈輸注給藥，共 6 次輸注.在兩個低劑量隊列中，我們每組招募了 9 名參與者。隨著劑量的增加，我們將每個隊列轉移到 18 名參與者，因為較高的兩個劑量是我們預計會看到生物標誌物效應的地方。

We collected blood samples of screening and just prior to first infusion for each participant as well as prior to each subsequent infusion, so that each participant can serve as their own control in the study. The primary endpoint of the study was safety and tolerability with a range of secondary and exploratory endpoints, measuring biomarker activity for target engagement, changes in pro-inflammatory chemokine and cytokine upregulated in people living with ALS, and changes in ALS functional rating scale or the ALSFRS.

我們在每個參與者的第一次輸注之前以及每次後續輸注之前收集了篩查的血液樣本，以便每個參與者都可以在研究中作為他們自己的對照。該研究的主要終點是安全性和耐受性，具有一系列次要和探索性終點，測量目標參與的生物標誌物活性、ALS 患者中促炎趨化因子和細胞因子上調的變化，以及 ALS 功能評定量表或ALSFRS。

The data showed that tegoprubart successfully met the primary endpoint of safety and tolerability with no serious or severe adverse events related to study drug and adverse events being generally consistent with what is expected in the population of ALS participants. Importantly, there were no signs of platelet activation or thrombosis in the participants. And anti-drug antibodies were present in less than 5% of samples, all of which were up low titer and did not impact tegoprubart drug levels.

數據顯示，tegorubart 成功地達到了安全性和耐受性的主要終點，沒有與研究藥物相關的嚴重或嚴重不良事件，並且不良事件與 ALS 參與者人群的預期基本一致。重要的是，參與者沒有血小板活化或血栓形成的跡象。並且抗藥物抗體存在於不到 5% 的樣本中，所有這些樣本的滴度都很低，並且不影響 tegoprubart 藥物水平。

Tegoprubart target engagement as measured by a statistically significant reduction in CD40 ligand, a marker of T-cell activity and CXCL13, a marker of B-cell activity, was achieved in a dose-dependent fashion. With the largest mean reductions occurring in the two higher dose cohorts, in addition, we also observed an increase in the percentage of participants who showed a reduced level of these biomarkers in a dose-dependent manner.

通過 CD40 配體（T 細胞活性標誌物和 CXCL13（B 細胞活性標誌物）的統計學顯著降低來衡量）以劑量依賴性方式實現了 Tegorubart 靶標參與。此外，隨著兩個較高劑量組的平均下降幅度最大，我們還觀察到以劑量依賴性方式顯示這些生物標誌物水平降低的參與者百分比增加。

Prior to launching the trial, we identified six pro-inflammatory proteins that have been described in the literature to be elevated in people with ALS, including TNF-alpha, MCP1, IL-6, IL-1, EN-RAGE, and CRP. We were highly encouraged to see significant reduction in four of the six of these pro-inflammatory markers, including TNF-alpha, MCP1, EN-RAGE, and CRP. In addition to these ALS-associated biomarkers, we observed a total reduction in 23 of the 32 pro-inflammatory proteins we detected, including myeloid markers, CXCL9, and CXCL10, as well as complement C3 and the B-cell markers, IgA, IgE, and IgM.

在啟動試驗之前，我們確定了文獻中描述的六種促炎蛋白在 ALS 患者中升高，包括 TNF-α、MCP1、IL-6、IL-1、EN-RAGE 和 CRP。我們很高興看到這六種促炎標誌物中的四種顯著減少，包括 TNF-α、MCP1、EN-RAGE 和 CRP。除了這些與 ALS 相關的生物標誌物外，我們還觀察到我們檢測到的 32 種促炎蛋白中的 23 種總減少，包括骨髓標誌物 CXCL9 和 CXCL10，以及補體 C3 和 B 細胞標誌物 IgA、IgE ，和 IgM。

These additional biomarkers are of note since they play an important role in our other disease programs. IgA, C3, and CD40 ligand have been associated with disease progression and proteinuria in patients with IgAN; while CXCL9, CXCL10, IgM, and C3 have been associated with kidney transplant rejections.

這些額外的生物標誌物值得注意，因為它們在我們的其他疾病項目中發揮著重要作用。 IgA、C3 和 CD40 配體與 IgAN 患者的疾病進展和蛋白尿有關；而 CXCL9、CXCL10、IgM 和 C3 與腎移植排斥反應有關。

Lastly, as part of the exploratory endpoints, we reported that tegoprubart's target engagement and level of reduction in pro-inflammatory biomarkers are associated with the trend in slowing down of disease progression as measured by ALSFRS slope when compared to a cohort from the ALS PRO-ACT database. This database is a publicly available data collection from historical ALS clinical trials, containing demographic data as well as clinical outcome measures, including ALSFRS.

最後，作為探索性終點的一部分，我們報告說，與 ALS PRO 的隊列相比，tegoprubart 的靶標參與和促炎生物標誌物的減少水平與通過 ALSFRS 斜率測量的疾病進展減緩趨勢相關。行動數據庫。該數據庫是歷史 ALS 臨床試驗的公開數據集合，包含人口統計數據和臨床結果測量，包括 ALSFRS。

We found that participants with positive target engagement, defined as those who had at least a 10% decrease in CXCL13 trended toward a greater slowing of ALSFRS slope when compared to those who did not achieve target engagement. These data taken together suggest that inhibition of CD40 ligand signaling by tegoprubart results in a decrease in pro-inflammatory biomarkers that may result in a slowing of disease progression.

我們發現，具有積極目標參與度的參與者（定義為 CXCL13 至少降低 10% 的參與者）與未實現目標參與度的參與者相比，ALSFRS 斜率的減緩趨勢更大。這些數據綜合起來表明，tegoprubart 對 CD40 配體信號傳導的抑制導致促炎生物標誌物的減少，這可能導致疾病進展的減慢。

We are very encouraged by these results, which further demonstrate the safety and tolerability of tegoprubart through the highest dose cohort. We also believe that showing a relationship between target engagement, reduction in pro-inflammatory markers, and change in disease progression measured by ALSFRS has an important signal in this devastating disease that further validates our competence in tegoprubart's immunomodulatory potential in ALS. Finally, we look forward to presenting our data at an upcoming ALS conference later this year.

我們對這些結果感到非常鼓舞，這些結果通過最高劑量隊列進一步證明了 tegorubart 的安全性和耐受性。我們還認為，通過 ALSFRS 測量，顯示靶標參與、促炎標誌物減少和疾病進展變化之間的關係在這種破壞性疾病中具有重要信號，進一步驗證了我們在 tegoprubart 在 ALS 中的免疫調節潛力方面的能力。最後，我們期待在今年晚些時候即將召開的 ALS 會議上展示我們的數據。

Moving to IgAN, we believe in the strong mechanistic rationale for pursuing CD40 ligand inhibition in IgAN due to tegoprubart's potential ability to show beneficial effects on both the upstream and downstream pathophysiology of IgAN. While the current standard of care and other drugs in development generally aim to either reduce production of antibodies or to alter kidney hemodynamics to reduce protein loss and tissue damage.

轉向 IgAN，我們相信在 IgAN 中追求 CD40 配體抑制的強大機制原理是因為 tegoprubart 對 IgAN 的上游和下游病理生理學均顯示有益影響的潛在能力。雖然目前的護理標準和其他正在開發的藥物通常旨在減少抗體的產生或改變腎臟血流動力學以減少蛋白質損失和組織損傷。

Tegoprubart has the potential to impact multiple steps in the pathophysiology -- in fact, multiple steps in the pathophysiology by reducing production of IgA antibodies, reducing the production of anti-IgA, IgG antibody, reducing immune complex formation, and reducing cellular inflammation in the glomerulus itself.

Tegoprubart 有可能影響病理生理學中的多個步驟——事實上，通過減少 IgA 抗體的產生、減少抗 IgA、IgG 抗體的產生、減少免疫複合物的形成和減少細胞炎症來影響病理生理學中的多個步驟腎小球本身。

We are happy to report that we continue to dose patients in our open-label Phase 2a clinical trial in patients with IgAN. We have been actively engaged with regulators across the world and now have approval for clinical trial sites in nine countries with plans to expand into up to three additional countries, including United States and China. This global study is a 96-week open-label trial that will include 42 total participants in high-dose and a low-dose cohort.

我們很高興地報告，我們繼續在 IgAN 患者的開放標籤 2a 期臨床試驗中對患者進行給藥。我們一直在與世界各地的監管機構積極合作，目前已獲准在九個國家設立臨床試驗地點，併計劃擴展到另外三個國家，包括美國和中國。這項全球研究是一項為期 96 週的開放標籤試驗，將包括 42 名高劑量和低劑量隊列的參與者。

The primary endpoint is change in the urinary protein to creatinine ratio or UPCR at week 24. Secondary endpoints include change in estimated glomerular filtration rate at week 96, as well as safety and tolerability.

主要終點是第 24 週尿蛋白與肌酐比或 UPCR 的變化。次要終點包括第 96 週估計腎小球濾過率的變化，以及安全性和耐受性。

Based on enrollment trends to date, we anticipate fully enrolling the first cohort of this study in the first half of 2023. We believe it is important to accumulate 24 weeks of clinical data across multiple patients in this indication in order to properly evaluate tegoprubart's potential. And therefore, we anticipate reporting initial six-month open-label data from this study late in the first quarter of 2023.

根據迄今為止的入組趨勢，我們預計在 2023 年上半年完全入組本研究的第一批隊列。我們認為，在這一適應症中積累多位患者的 24 週臨床數據非常重要，以便正確評估 tegorubart 的潛力。因此，我們預計在 2023 年第一季度末報告這項研究的最初六個月的開放標籤數據。

I'll wrap up my update by turning to islet cell transplantation and our Phase 2a trial for the prevention of allograft rejection where we are about to open our US site at the University of Chicago. We believe this new site will be a critical step to jump-start the enrollment process of this study by allowing us to concentrate resources and close our Canadian site. A key advantage of the Chicago site is it's focused on these novel types of approaches since islet cell transplantation is considered experimental in the United States. And we are confident that the new clinical site in Chicago will be sufficient to enroll the study of up to six participants.

最後，我將轉向胰島細胞移植和預防同種異體移植排斥反應的 2a 期試驗，我們即將在芝加哥大學開設我們的美國網站。我們相信這個新網站將成為啟動本研究註冊過程的關鍵一步，讓我們能夠集中資源並關閉我們的加拿大網站。芝加哥站點的一個關鍵優勢是它專注於這些新型方法，因為胰島細胞移植在美國被認為是實驗性的。我們相信芝加哥的新臨床中心將足以招收多達六名參與者的研究。

This site will be actively screening for type 1 diabetic patients with hypoglycemic unawareness to experience significant swings in glucose levels that are associated with serious risk and comorbidities. Our goal is to evaluate tegoprubart as the backbone of maintenance anti-rejection therapy similar to the design for kidney transplantation. In ICT specifically, we are also evaluating the ability of patients to achieve insulin independence as well as the number of islet cell transplants required to achieve independence.

該站點將積極篩查沒有低血糖意識的 1 型糖尿病患者，以發現與嚴重風險和合併症相關的血糖水平顯著波動。我們的目標是評估 tegorubart 作為維持性抗排斥治療的支柱，類似於腎移植的設計。特別是在 ICT 領域，我們還在評估患者實現胰島素獨立的能力以及實現獨立所需的胰島細胞移植數量。

We believe that by removing CNIs, which are directly toxic to the islet cells and replacing with tegoprubart, more patients may be able to achieve better glycemic control with fewer islet cell transplants. With the opening of our first US site, we are looking to enroll the first patient in this Phase 2a islet cell transplantation trial and aim to provide available three-month data in the first quarter of 2023.

我們相信，通過去除對胰島細胞有直接毒性的 CNI 並用 tegoprubart 代替，更多的患者可能能夠通過更少的胰島細胞移植來實現更好的血糖控制。隨著我們第一個美國站點的開放，我們希望在這項 2a 期胰島細胞移植試驗中招募第一位患者，並旨在在 2023 年第一季度提供可用的三個月數據。

With that, I'll now turn the call over to Paul for our financial update.

有了這個，我現在將電話轉給 Paul 以獲取我們的財務更新。

Thank you, Jeff. In addition to the financial results summarized in our press release, you can find additional information in our Form 10-Q, which we will file later today.

謝謝你，傑夫。除了我們新聞稿中總結的財務業績外，您還可以在我們將於今天晚些時候提交的 10-Q 表格中找到更多信息。

The company reported a net loss of $9.2 million or $0.65 per share for the three months ended June 30, 2022, compared to a net loss of $7.4 million or $0.50 for the same period in 2021. Research and development expenses were $5.7 million for the three months ended June 30, 2022, compared to $4.2 million for the comparable period in 2021, which was an increase of $1.5 million.

該公司報告稱，截至 2022 年 6 月 30 日止三個月淨虧損 920 萬美元或每股 0.65 美元，而 2021 年同期淨虧損 740 萬美元或 0.50 美元。三者的研發費用為 570 萬美元截至 2022 年 6 月 30 日的月份，與 2021 年同期的 420 萬美元相比，增加了 150 萬美元。

The increase was primarily due to an increase in clinical development costs of $600,000, primarily with external CROs as we advanced our tegoprubart programs and an increase in consulting expenses of $800,000, as well as personnel costs of $200,000 due to an increase in headcount and stock-based compensation costs. G&A expenses were $3.5 million for the three months ended June 30, 2022, compared to $3.7 million for the comparable period in 2021, a decrease of $200,000.

增加的主要原因是臨床開發成本增加了 600,000 美元，主要是隨著我們推進 tegorubart 項目的外部 CRO 增加，諮詢費用增加了 800,000 美元，以及人員成本增加了 200,000 美元，原因是員工人數和庫存增加 -基於補償成本。截至 2022 年 6 月 30 日止三個月的 G&A 費用為 350 萬美元，而 2021 年同期為 370 萬美元，減少了 20 萬美元。

Looking at the cost side of our business, we continue to remain diligent in the control of our discretionary spending, and this reduction in year-over-year G&A spend is a reflection of these ongoing efforts. As of June 30, 2022, Eledon had $70.5 million in cash and cash equivalents, which we expect to be sufficient to fund our clinical trial operations as currently planned into 2024.

從我們業務的成本方面來看，我們繼續努力控制我們的可自由支配支出，而 G&A 支出的同比減少反映了這些持續的努力。截至 2022 年 6 月 30 日，Eledon 擁有 7050 萬美元的現金和現金等價物，我們預計這將足以為我們目前計劃到 2024 年的臨床試驗業務提供資金。

Our cash runway allows us to initiate the Phase 2 trial of tegoprubart for the prevention of organ rejection in patients receiving their kidney transplant, but additional financing will be required to fund any future ALS clinical trials.

我們的現金跑道使我們能夠啟動 tegoprubart 的 2 期試驗，以預防接受腎移植的患者的器官排斥，但需要額外的資金來資助任何未來的 ALS 臨床試驗。

With that financial update, let me turn the call back over to DA.

通過該財務更新，讓我將電話轉回給 DA。

Thanks, Paul. As we discussed today, we are encouraged by the progress we made this quarter throughout our pipeline, and we are excited to continue the positive momentum generated in the first half of this year. We believe the first of our four tegoprubart clinical readouts demonstrated not only the potential to treat ALS, but also a broader range of inflammation-related indications by targeting the CD40 ligand pathway.

謝謝，保羅。正如我們今天所討論的，我們對本季度在整個管道中取得的進展感到鼓舞，我們很高興能夠繼續保持今年上半年產生的積極勢頭。我們相信，我們四個 tegorubart 臨床讀數中的第一個不僅證明了治療 ALS 的潛力，而且還通過靶向 CD40 配體途徑證明了更廣泛的炎症相關適應症。

Through the remainder of the year, we will be focused on enrollments across our three ongoing trials as well as preparing for the launch of our larger Phase 2 kidney transplantation study. We look forward to providing meaningful data updates for each program starting in the first quarter of 2023.

在今年剩下的時間裡，我們將專注於我們正在進行的三項試驗的註冊，並為啟動我們更大的 2 期腎移植研究做準備。我們期待從 2023 年第一季度開始為每個項目提供有意義的數據更新。

I'll now ask the operator to begin our Q&A session. Operator?

我現在請接線員開始我們的問答環節。操作員？

(Operator Instructions) Thomas Smith, SBV Securities.

（操作員說明）Thomas Smith，SBV 證券。

Hey, guys. Good afternoon. Thanks for taking the questions. Just I guess first on the updated data timelines, yeah, I understand there are a lot of moving parts here, but can you provide any thoughts on how many patients we can expect to see across each of these initial datasets in Q1 2023?

大家好。下午好。感謝您提出問題。只是我想首先在更新的數據時間表上，是的，我知道這裡有很多移動部分，但是您能否提供關於我們在 2023 年第一季度可以在每個初始數據集中看到多少患者的想法？

Hey, Tom, and thanks for the question. We expect to get the same number of patients that we've been discussing in the past. And it's really just a slight change. So as you know, beforehand, we have been talking about late this year with the timing of when we started enrollment in transplant and in IgAN, in order to make sure that we have sufficient patients that just delays us slightly into the first quarter. So we should have -- the target is to have a few patients in the transplant indications and then a handful of patients with six months of data in IgAN.

嘿，湯姆，謝謝你的問題。我們希望獲得與我們過去討論過的相同數量的患者。這實際上只是一個輕微的變化。因此，如您所知，此前我們一直在討論今年年底開始註冊移植和 IgAN 的時間，以確保我們有足夠的患者，這只會稍微推遲我們進入第一季度。所以我們應該有 - 目標是讓少數患者適應移植適應症，然後讓少數患者在 IgAN 中有 6 個月的數據。

Okay. Got it. And then on islet cell transplant, can you just talk a little bit more about the team at the University of Chicago? And I guess just give us a sense, are they actively performing these procedures today as part of other clinical studies? And if they are, kind of what the volume of that might be. And then I guess your thoughts around potentially expanding out to other centers in the US? I think there are 15 to 20 other academic centers that are performing these procedures, but just curious how you guys are thinking about expansion of this program?

好的。知道了。然後關於胰島細胞移植，你能多談談芝加哥大學的團隊嗎？我想只是給我們一個感覺，他們今天是否積極執行這些程序作為其他臨床研究的一部分？如果是的話，那可能是多少。然後我猜你對可能擴展到美國其他中心的想法？我認為有 15 到 20 個其他學術中心正在執行這些程序，但只是好奇你們是如何考慮擴展這個程序的？

Sure. So maybe I'll start with the second part, and then Jeff, I'll turn it over to you to talk about the first part of the question on the University of Chicago. But to answer your question about expanding right now, we're looking to focus on the University of Chicago. And because our IND includes cell manufacturing right now, that's specific to this site. So the goal is to see if -- and we believe we'll be able to begin to enroll and to get traction in Chicago. And then over time, of course, we can revisit and think about where else we may go.

當然。所以也許我會從第二部分開始，然後是傑夫，我會把它交給你來談談芝加哥大學問題的第一部分。但要回答您關於現在擴展的問題，我們希望專注於芝加哥大學。因為我們的 IND 現在包括細胞製造，所以這是特定於這個站點的。所以我們的目標是看看是否——我們相信我們將能夠開始註冊並在芝加哥獲得關注。當然，隨著時間的推移，我們可以重新審視並考慮我們還可以去哪裡。

Now, Jeff, I'll turn the call over to you in terms of the site.

現在，傑夫，我將根據網站將電話轉給您。

Yeah. All right. Thank you, DA. Thanks, Tom. The University of Chicago is very active. They've been involved in islet cell transplant for many years. They've done it in their own -- under their own experimental protocol as well as protocols with other sponsors. They are active right now. And so they are very confident that they can enroll on our study and we've enjoyed working with them and their collaborative spirit and their enthusiasm. So we are very confident in them.

是的。好的。謝謝你，達。謝謝，湯姆。芝加哥大學非常活躍。他們多年來一直參與胰島細胞移植。他們自己完成了——根據他們自己的實驗協議以及與其他贊助商的協議。他們現在很活躍。因此，他們非常有信心可以參加我們的研究，我們很享受與他們一起工作以及他們的協作精神和熱情。所以我們對他們很有信心。

The PI is the same person. There's the same person who presented at our R&D Day.

PI是同一個人。在我們的研發日上展示的人是同一個人。

Okay, great. Got it. And then just lastly on the renal transplant program -- and congrats on the progress here with the first patient dosed and the recent IND clearance. Can you share any feedback on your engagement with FDA and maybe just some of the thought process behind running the larger Phase 2 program in parallel with the ex-US open-label program?

好，太棒了。知道了。最後是腎移植計劃——祝賀第一位患者給藥和最近 IND 清除的進展。您能否分享您與 FDA 合作的任何反饋，或者只是與前美國開放標籤計劃並行運行更大的第 2 階段計劃背後的一些思考過程？

Sure. So we can't share much about the discussions, but perhaps what we can do is talk about how we ended up opting for superiority study.

當然。所以我們不能分享太多關於討論的內容，但也許我們能做的就是談談我們最終是如何選擇優勢研究的。

Jeff, why don't I turn that over to you?

傑夫，我為什麼不把它交給你呢？

Sure. Yeah. Thank you, DA. So the thought process behind the design of the study was that it provides certain advantages. Superiority will allow us to design a smaller study, but also at the same time, perhaps have some longer-term commercial advantages there.

當然。是的。謝謝你，達。因此，研究設計背後的思考過程是它提供了某些優勢。優勢將使我們能夠設計一個較小的研究，但同時，也許在那裡有一些長期的商業優勢。

The agency did give us feedback around trial design and did guide us in that direction. And from our point of view, regardless of what Phase 3 looks like, this study is going to be big enough and inform on the right endpoint to enable the correct design, whether that's a confirmatory trial that confirmed this design or whether we have to switch to a different endpoint. We believe that this is the time to inform all of it.

該機構確實向我們提供了有關試驗設計的反饋，並指導我們朝那個方向發展。從我們的角度來看，無論第三階段是什麼樣子，這項研究都將足夠大，並在正確的終點提供信息以實現正確的設計，無論是確認該設計的驗證性試驗，還是我們是否必須轉換到不同的端點。我們相信現在是通知所有這一切的時候了。

Okay, great. That's super helpful.

好，太棒了。這非常有幫助。

And then to your question about the Phase 1b study, we plan to run, as we discussed, both in parallel. And the advantage of doing that is that it's going to allow us to continue learning about tegoprubart. And it will also give us a way to continue to report data about the performance of tegoprubart in kidney transplant, while the larger study is running.

然後對於您關於 1b 階段研究的問題，我們計劃同時運行，正如我們所討論的那樣。這樣做的好處是可以讓我們繼續了解 tegoprubart。它還將為我們提供一種方法來繼續報告有關 tegoprubart 在腎移植中的表現的數據，同時更大的研究正在進行中。

Got it. Understood. All right, guys, thanks for taking the questions. Appreciate it.

知道了。明白了。好的，伙計們，感謝您提出問題。欣賞它。

Thanks, Tom.

謝謝，湯姆。

Rami Katkhuda, LifeSci Capital.

Rami Katkhuda，生命科學資本。

Hey, guys. Congrats on the recent updates and thanks for taking my questions. Two quick ones for me. First, to clarify on a previous point, is mean eGFR potentially an approvable endpoint in a potential Phase 3 study? Or are you still going to have to focus on kind of graft survival long term?

大家好。恭喜最近的更新，感謝您提出我的問題。給我兩個快速的。首先，為了澄清前一點，平均 eGFR 是否可能是潛在的第 3 階段研究中的一個可批准的終點？還是您仍將不得不長期關注移植物存活率？

Sure. So, Jeff, why don't I turn that over to you?

當然。那麼，傑夫，我為什麼不把它交給你呢？

Yeah, sure. Thank you. So as you're probably aware, the precedent in this space has been noninferiority in Phase 3, focusing on graft rejection and patient graft survival. The mean change in eGFR has not been used to support approval, but that doesn't necessarily mean that it can't be in the future. And so our plan is to look at the data we have and keep engaging with the agency. And like I said, on the response to previous question, we'll be ready with the data from this trial, whichever pathway that takes us down.

好，當然。謝謝你。因此，您可能已經知道，該領域的先例是第 3 階段的非劣效性，重點關注移植物排斥和患者移植物存活率。 eGFR 的平均變化尚未用於支持批准，但這並不一定意味著它不能在未來出現。因此，我們的計劃是查看我們擁有的數據並繼續與該機構合作。就像我說的，在回答之前的問題時，我們將準備好從這次試驗中獲得的數據，無論哪種方式讓我們失望。

Got it. That makes a lot of sense. And then tacrolimus is obviously nephrotoxic as we talked on the past. But can you quantify how much the treatment usually affect eGFR patients receiving a kidney transplant in the first year?

知道了。這很有意義。正如我們過去所說，他克莫司顯然具有腎毒性。但是你能量化治療通常對第一年接受腎移植的 eGFR 患者的影響有多大嗎？

Jeff?

傑夫?

Yeah, I can take that, DA. Yeah, thanks. So it's variable, of course, patient to patient and also depends somewhat on the quality of the graft that they got. But looking at datasets from published data and also from head-to-head trials with, for example, the belatacept trial, the mean GFR in CNI-treated patients typically is lower and tends to decline. And that rate of decline again is different in different individual patients. But it is predictive.

是的，我可以接受，DA。是的，謝謝。所以它是可變的，當然，病人對病人，也取決於他們得到的移植物的質量。但是從已發表的數據以及與 belatacept 試驗等頭對頭試驗的數據集來看，接受 CNI 治療的患者的平均 GFR 通常較低並且趨於下降。而且這種下降速度在不同的個體患者中是不同的。但它是預測性的。

There is data showing that if the eGFR at one year is below a threshold of 50 ml per minute per body surface area, that is predictive of poor graft function in the long run and even graft loss. And the lower you go, the worse, the higher the risk of that bad outcome. And so it is predictive and that's not surprising because it's predictive and it's used as a validated surrogate in non-transplant indications, right?

有數據顯示，如果一年時的 eGFR 低於每體表面積每分鐘 50 毫升的閾值，則從長遠來看，這預示著移植物功能較差，甚至移植物丟失。而且你走得越低，越糟糕，這種糟糕結果的風險就越高。所以它是預測性的，這並不奇怪，因為它是預測性的，並且在非移植適應症中被用作經過驗證的替代物，對嗎？

If you look at the IgAN program, the ultimate endpoint is GFR and proteinuria is the surrogate that's reasonably likely to predict. And the reason that GFR was the ultimate endpoint is that it's known as an effective stand-in for the clinical outcomes of dialysis and kidney failure. So it's not surprising that the GFR can predict that and consistently calcineurin-exposed patients do have lower GFRs and their GFRs decline over time.

如果您查看 IgAN 計劃，最終終點是 GFR，而蛋白尿是可以合理預測的替代指標。 GFR 是最終終點的原因是它被稱為透析和腎衰竭臨床結果的有效替代品。因此，GFR 可以預測並且持續暴露於鈣調磷酸酶的患者確實具有較低的 GFR 並且隨著時間的推移他們的 GFR 下降，這並不奇怪。

Got it. Thanks so much.

知道了。非常感謝。

Matt Kaplan, Ladenburg Thalmann.

馬特·卡普蘭，拉登堡·塔爾曼。

Hi, this is [Raymond] in for Matt. Thanks for taking our questions. Congrats on getting the FDA on board with a two-transplant study. Very impressive. Just wanted to ask this, have -- how your view of the Phase 1b that you've already started, did that change in light of interactions for the Phase 2 program?

嗨，我是 Matt 的 [Raymond]。感謝您提出我們的問題。恭喜 FDA 參與了一項兩次移植研究。非常令人印象深刻。只是想問一下，您對已經開始的第 1b 階段的看法如何，是否根據第 2 階段計劃的互動而改變？

Thanks for the question, [Raymond]. Let me turn that over to Jeff.

謝謝你的問題，[雷蒙德]。讓我把它交給傑夫。

Yeah, thank you. So if I'm understanding the question correctly, you're asking if our thinking around the 1b study has changed in light of getting the IND open for 2a, is that right?

是的，謝謝。因此，如果我正確理解了這個問題，您是在問我們對 1b 研究的看法是否隨著 IND 對 2a 開放而發生了變化，對嗎？

Yeah, yeah, I was wondering if there's potential and maybe the FDA is trying to evolve in their thinking or perhaps -- yeah.

是的，是的，我想知道是否有潛力，也許 FDA 正試圖改變他們的想法，或者——是的。

Right. Okay. So I can't speak for the FDA and what they're thinking. But for us, nothing's changed. We are executing our ongoing trial. We think that that trial is going to provide very meaningful data on the safety and efficacy in a pilot program for sure, but still very meaningful data on what tegoprubart can do in this population.

正確的。好的。所以我不能代表 FDA 和他們的想法。但對我們來說，一切都沒有改變。我們正在執行我們正在進行的試驗。我們認為，該試驗肯定會在試點項目中提供非常有意義的安全性和有效性數據，但對於 tegorubart 在這一人群中的作用仍然是非常有意義的數據。

And as I mentioned on the call, our intent is to add a long-term extension trial to the program, not just to the Phase 2a study, but would also allow for those 1b patients, have the opportunity to continue long term should they be so inclined and they're doing well.

正如我在電話會議中提到的那樣，我們的目的是為該計劃增加一項長期擴展試驗，不僅是在 2a 期研究中，而且還允許那些 1b 患者，如果他們有機會長期繼續下去如此傾向，他們做得很好。

And this will allow us to gain additional information over time on durability, on long-term outcomes in that sentinel cohort, where we're very committed to that patient population and the participants in that trial. Nothing's changed for us with the new study also coming on in terms of with the existing study.

隨著時間的推移，這將使我們能夠獲得更多關於耐用性、哨點隊列長期結果的信息，我們非常致力於該患者群體和該試驗的參與者。新的研究也與現有的研究相提並論，對我們來說沒有任何改變。

I appreciate that. I guess -- yeah.

我很感激。我猜——是的。

Yeah. Just one addition, just to clarify, the 1b is ex-US. So while the Phase 2 is where the IND was just cleared, the 1b will remain ex-US. And as you might recall, a year ago when we went ex-US with the trial, the agency had asked us at that time to do a non-human primate study. So what's changed has been really the completion of that non-human primate study and then the agency clearing our IND.

是的。只是為了澄清一點，1b 是前美國的。因此，雖然第 2 階段是 IND 剛剛被清除的地方，但 1b 仍將保留在美國以外。您可能還記得，一年前，當我們去美國進行試驗時，該機構當時要求我們進行一項非人類靈長類動物研究。所以真正改變的是非人類靈長類動物研究的完成，然後是該機構批准我們的 IND。

Okay, I appreciate it. And I guess just one more question on the islet cell program, congrats on making progress on opening -- preparing the US site. I was wondering if there's any lessons perhaps from the Canadian site experience that you might transfer over. Any insight would be helpful. Thanks.

好的，我很感激。我想還有一個關於胰島細胞計劃的問題，恭喜在開放方面取得進展——準備美國網站。我想知道您是否可以從加拿大網站的經驗中吸取教訓。任何見解都會有所幫助。謝謝。

Jeff?

傑夫?

Yeah. It's a very fair question to ask. But it's a difficult one to answer because there were multiple circumstances that contributed to that, not going the way we had hoped in Canada. And it wasn't just one thing. There was definitely an impact of COVID. There was also some changing almost geopolitical landscape and how islet cell is covered across Canada and changing -- as I said, the changing dynamic of who was referred to the site. So there was a lot of different factors that contributed to it.

是的。這是一個非常公平的問題。但這是一個很難回答的問題，因為有多種情況導致了這種情況，而不是像我們在加拿大所希望的那樣。這不僅僅是一件事。肯定有COVID的影響。幾乎地緣政治格局也發生了一些變化，以及胰島細胞在加拿大各地的覆蓋方式和變化——正如我所說，誰被稱為該站點的動態變化。所以有很多不同的因素促成了它。

It's a fair question to ask, but I unfortunately don't have a great answer for you. There is not enough one great takeaway that we had that we're going to say, aha. If we do this different, that's going to go better. We do feel very confident in Dr. Witkowski and the team at University of Chicago, and we do believe it's going to go different there. But there isn't really one key takeaway that we've taken from that that we can apply going forward.

這是一個公平的問題，但不幸的是，我沒有給你一個很好的答案。我們沒有足夠的一個很棒的外賣，我們要說，啊哈。如果我們這樣做不同，那會更好。我們確實對 Witkowski 博士和芝加哥大學的團隊充滿信心，我們相信那裡會有所不同。但是，我們並沒有真正從中得到一個可以應用的關鍵要點。

[The key are] -- what Jeff just mentioned, so here, the focus is the site. Since islet cell transplants are considered experimental procedure in the US, all of the patients that are going through the site are focused on getting an experimental procedure. So that allows for a slightly different conversation to be had with potential participants in the study.

[關鍵是] -- Jeff 剛才提到的，所以這裡的重點是網站。由於胰島細胞移植在美國被認為是實驗性程序，因此通過該站點的所有患者都專注於獲得實驗性程序。因此，這允許與研究中的潛在參與者進行稍微不同的對話。

And as well, it allows for some different coverage and a different role in terms of our being able to support the program versus a program where parts of the cost could have been covered by the Canadian authorities.

而且，它允許一些不同的覆蓋範圍和不同的角色，因為我們能夠支持該計劃，而不是加拿大當局可能承擔部分費用的計劃。

Yeah. Appreciate that color. Thanks.

是的。欣賞那個顏色。謝謝。

Thank you. And this concludes the question-and-answer session. And I would like to turn the call to DA Gros for any closing comments.

謝謝你。問答環節到此結束。我想將電話轉給 DA Gros，以徵求任何結束意見。

Right. Thank you very much for your assistance, operator, and thank you all for joining us on today's call.

正確的。非常感謝您的幫助，接線員，並感謝大家加入我們今天的電話會議。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

謝謝你。會議現已結束。感謝您參加今天的演講。您現在可以斷開線路。