Lineage Cell Therapeutics Inc (LCTX) 2026 Q1 法說會逐字稿

Welcome to the Lineage Cell Therapeutics first quarter 2026 conference call. (Operator Instructions)

歡迎參加 Lineage Cell Therapeutics 2026 年第一季財報電話會議。（接線員指示）

An audio webcast of this call is available on the Investors section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage, and recordings, reproductions or transmissions of this call without the expressed written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.

本次電話會議的音訊網路直播可於 Lineage 官網 www.lineagecell.com 的「投資人」專區收聽。本次電話會議受著作權保護，為 Lineage 之財產；未經 Lineage 明確書面同意，嚴禁錄音、重製或傳輸本次電話會議內容。提醒各位，今日會議將進行錄音。

I would now like to introduce your host for today's call, Ioana Hone, Head of Investor Relations at Lineage. Ms. Hone, please go ahead.

現在我想介紹今日會議的主持人：Lineage 投資人關係主管 Ioana Hone。Hone 女士，請開始。

Thank you, Demi. Good afternoon, and thank you for joining us. A press release reporting our first quarter 2026 financial results was issued earlier today, May 12, 2026, and can be found on the Investors section of our website.

謝謝你，Demi。各位下午好，感謝各位加入我們。我們已於今日（2026 年 5 月 12 日）稍早發布新聞稿，公告 2026 年第一季財務結果，並可於本公司官網的「投資人」專區查閱。

Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward-looking statements within the meaning of federal securities laws. Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements.

請注意，今日的發言及對各位提問的回覆僅反映管理階層截至今日的觀點，並將包含符合聯邦證券法定義之「前瞻性陳述」。在本次討論中所作、非屬歷史事實之陳述，均應視為前瞻性陳述，且可能受到重大風險與不確定性影響。本公司實際結果或表現可能與該等前瞻性陳述所示之預期存在重大差異。

For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K and in the Form 10-Q filed today. We caution you not to place undue reliance on any forward-looking statements, which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings. With us today are Brian Culley, our Chief Executive Officer; and Jill Howe, our Chief Financial Officer.

關於可能導致本公司結果或表現出現差異之若干因素，請參閱今日新聞稿中的前瞻性陳述章節，以及本公司向美國證券交易委員會（SEC）提交之文件，包括最近一期 Form 10-K 年報，以及今日提交的 Form 10-Q。我們提醒各位勿過度依賴任何前瞻性陳述；該等陳述僅截至今日有效，並受我們在 SEC 文件中所述之警示性聲明與風險因素所限制。今日與會者包括：執行長 Brian Culley，以及財務長 Jill Howe。

I will now hand the call over to Brian.

接下來我把電話交給 Brian。

Thank you, Ioana, and good afternoon, everyone. We appreciate you taking the time to join us today. We have a lot of great things to cover. I'm going to try and keep it short so that we can have plenty of time for analyst questions. I do definitely want to highlight the successful expansion of AlloSCOPE, our proprietary cell manufacturing platform, most notably because it led to the launch of COR1, our new wholly-owned corneal endothelial cell transplant program.

謝謝你，Ioana。各位下午好，感謝大家撥冗參與。我們今天有很多重點要分享。我會盡量簡短，讓我們有充足時間回答分析師提問。我確實想特別強調我們成功擴展 AlloSCOPE——我們的專有細胞製造平台——尤其是因為這促成了 COR1 的啟動；COR1 是我們全資擁有的全新角膜內皮細胞移植計畫。

We also successfully met our first internal milestone with our ILT1 manufacturing initiative. and established a new Scientific Advisory Board attracting and recognized and established cell therapy executive as its founding member.

我們也在 ILT1 製造計畫上成功達成第一個內部里程碑，並成立新的科學諮詢委員會（Scientific Advisory Board），吸引一位備受肯定且資深的細胞治療產業高階主管擔任創始成員。

But before I share those and other updates, I'll begin with the status of our lead clinical program, OpRegen. Data we reported several years ago from the OpRegen Phase I/IIa clinical study included improved anatomy of the retina, halting or reversal of atrophic progression and improved vision in patients with dry AMD. These are compelling data because they're not known to occur naturally in human beings. And since we made these initial reports, two additional and very important advancements have occurred in the field.

不過，在我分享上述及其他更新之前，我先從我們的主要臨床計畫 OpRegen 的進展談起。我們在數年前公布的 OpRegen 第 I/IIa 期臨床研究數據顯示：視網膜解剖結構改善、萎縮進展停止或逆轉，以及乾性 AMD 患者視力改善。這些數據相當引人注目，因為這些現象在人體中並不被認為會自然發生。自我們首次報告以來，該領域又出現了兩項額外且非常重要的進展。

The first of these is that three other companies have reported similar results with their own version of an RPE transplant, independently providing further evidence in support of the mechanism and its treatment effects.

第一項是，另有三家公司就其各自版本的 RPE（視網膜色素上皮）移植報告了類似結果，從獨立角度進一步提供支持該作用機制及其治療效果的證據。

And the second is that Roche and Genentech's long-term analysis of our data showed that vision gains persisted for at least three years following a single administration of cells among patients who received those cells to the target location.

第二項是，Roche 與 Genentech 對我們數據的長期分析顯示：在細胞成功投放至目標位置的患者中，單次給藥後的視力增益至少可持續三年。

Taken together, these data appear to us to be consistent with continued forward progress of the OpRegen program. And while we await a decision on the future of the OpRegen program, I'll note that while we've long believed that we may be seeing a potential functional cure for advanced dry AMD in the OpRegen program. This month's presentation by our partners, Roche and Genentech is the first time that they have used similar language to describe OpRegen as a potentially disease-modifying treatment.

綜合而言，這些數據在我們看來與 OpRegen 計畫持續向前推進的趨勢一致。在我們等待 OpRegen 計畫未來走向的決定之際，我也想指出：我們長期以來一直認為 OpRegen 計畫可能在晚期乾性 AMD 上呈現潛在的功能性治癒。而本月我們的合作夥伴 Roche 與 Genentech 的簡報，是他們首次使用類似措辭，將 OpRegen 描述為可能具疾病修飾（disease-modifying）效果的治療。

Obviously, even discussing disease modification and geographic atrophy is exceptionally promising because dry AMD is a common condition that has not been shown to self-resolve and only leads to worsening vision. So we find it notable that after adding only a single site in 2024, Genentech has now opened 11 new clinical sites starting in late 2025, bringing the ongoing study to a total of 17 unique locations.

顯然，即便只是討論在地理性萎縮（geographic atrophy, GA）上的疾病修飾，都極具前景，因為乾性 AMD 是常見疾病，尚未證實會自行緩解，且通常只會導致視力惡化。因此，我們認為值得注意的是：Genentech 在 2024 年僅新增一個研究中心後，自 2025 年底起已再開設 11 個新的臨床研究中心，使進行中的研究總計達到 17 個不同地點。

As I've explained on these calls before, we do not have a time frame to share when or whether a GAlette study data reveal and/or a public commitment to a multicenter controlled trial may occur. But we continue to be confident in our partners' commitment to the program. And we believe that the work that they are doing in the GAlette study to optimize surgical delivery will improve the product's profile and is intended to increase its probability of regulatory and commercial success, especially compared to the competition, which appeared to us to still be in the early stages and not as advanced as we are in the necessary aspects of manufacturing or delivery.

如我先前在電話會議中所說，我們無法提供時間表，說明 GAlette 研究何時或是否會揭露數據，以及/或何時或是否會公開承諾進行多中心對照試驗。但我們仍對合作夥伴對該計畫的投入保持信心。我們也相信，他們在 GAlette 研究中為優化手術投放方式所做的工作，將改善產品特性，並旨在提高其法規核准與商業成功的機率，特別是相較於競品——在我們看來，競品仍處於較早期階段，且在製造或投放等必要面向並未如我們般成熟。

Overall, we believe our powerful quartet of scalable manufacturing, proprietary delivery tools, long-term safety and efficacy data and a partnership providing world-class commercial capabilities make us bullish on the potential for OpRegen to capture a significant portion of a multibillion-dollar and still underserved GA market. And because all of our programs have certain features in common, we believe we can bring the same kinds of attributes to other cell transplant programs, but even more quickly, which should explain why we are eager to try and apply these learnings to other cell types.

整體而言，我們相信：可擴展的製造能力、專有投放工具、長期安全性與有效性數據，以及具備世界級商業化能力的合作夥伴——這四大優勢組合，使我們對 OpRegen 有望在規模達數十億美元、且仍未被充分滿足的 GA 市場中取得可觀市占，保持樂觀。此外，由於我們所有計畫在某些特徵上具有共通性，我們相信也能把同類型的優勢更快速地帶到其他細胞移植計畫上；這也解釋了為何我們迫切希望將這些經驗應用到其他細胞類型。

Now because development of cell therapies is very different than that of small molecules, we needed first to invest in our manufacturing capabilities to enable development of these other cell types. And that is because in cell therapy, the process is the product. Even seemingly insignificant changes to a process can impact your product's characteristics, including its efficacy. So you want to ensure that you have the right process in place before beginning clinical testing. Making those investments too late could be fatal to a program, analogous perhaps to changing the structure of a molecule.

由於細胞治療的開發與小分子藥物非常不同，我們首先必須投資製造能力，以支援其他細胞類型的開發。原因在於細胞治療中，「製程即產品」。即使看似微不足道的製程變更，也可能影響產品特性，包括療效。因此，在開始臨床測試之前，必須確保已建立正確的製程。若太晚才進行這些投資，可能對計畫造成致命影響；這或可類比為改變分子結構。

Some companies may feel pressured to rush into clinical testing without a robust, scalable manufacturing process and assume they can figure that part out later. We think that approach can create significant risks. We are choosing instead to invest in commercially viable process development before launching clinical trials so that if we do demonstrate compelling clinical activity, we believe we can be much more confident that the product which led to that activity can continue through approval and eventual commercialization. Otherwise, you may be delaying an inevitable and potentially critical shortcoming, which could cause you to go back to square one with the regulators.

有些公司可能因壓力而在缺乏穩健、可擴展製造製程的情況下匆忙進入臨床測試，並假設之後再把製造問題解決。我們認為這種作法可能帶來重大風險。我們選擇在啟動臨床試驗前，先投資於具商業可行性的製程開發；如此一來，若我們確實展現出具說服力的臨床活性，我們將更有信心：帶來該活性的產品能一路推進至核准並最終商業化。否則，你可能只是延後面對一個不可避免且可能關鍵的缺陷，導致你必須在法規機關面前回到原點。

Fortunately, while manufacturing may sometimes be an underappreciated or even overlooked area of cell therapy, it is nonetheless an integral factor in a product's success. And we believe we've made tremendous strides in this area. Our AlloSCOPE manufacturing platform utilizes a two-tiered banking system in which a master cell bank generates a working cell bank, which generates the clinical material.

所幸，雖然製造有時在細胞治療領域可能未被充分重視，甚至被忽略，但它仍是產品成功的關鍵因素之一。我們相信我們在此領域已取得巨大進展。我們的 AlloSCOPE 製造平台採用雙層細胞庫系統：由主細胞庫（master cell bank）建立工作細胞庫（working cell bank），再由工作細胞庫產生臨床用材料。

The production capability underlining this approach is easy to understand. A single vial from a master cell bank can generate an entirely new working cell bank and any vial from that working cell bank can generate the product. That means the amount of material you can mathematically generate is being multiplied at each step. So if each step has 100 vials, even just 100 times 100 times 100 is a 1 million vial production capability.

支撐此方法的產能概念很容易理解：主細胞庫中的單一小瓶（vial）即可建立全新的工作細胞庫，而工作細胞庫中的任何一瓶都能用來生產產品。這代表在每一步中，可數學式地生成的材料量都會被倍增。因此，若每一步各有 100 瓶，即便只是 100 乘以 100 乘以 100，也就是 100 萬瓶的生產能力。

And this is not a prophetic claim about large-scale production. We have performed these individual steps multiple times. And the final product from our banks has cleared the FDA requirements and been used in clinical testing. If we were to successfully perform these steps again and again using the full potential of our banks, we would produce many millions of vials of our product.

這並非對大規模生產的預言式宣稱。我們已多次執行這些個別步驟。而且，來自我們細胞庫的最終產品已符合 FDA 要求，並已用於臨床測試。若我們能一再成功地執行這些步驟並充分發揮細胞庫的全部潛力，我們將可生產數百萬瓶的產品。

Importantly, this kind of scale also means our cost per dose for particular program can potentially be in the hundreds of dollars, which we believe offers advantages in terms of patient access and affordability. And the potential for low-cost scale is one of the reasons we're so excited about the allogeneic off-the-shelf product candidates in our pipeline.

重要的是，這種規模也意味著：特定計畫的每劑成本可能有機會落在數百美元等級；我們認為這在病患可近性與可負擔性方面具有優勢。而低成本擴產的潛力，也是我們對產品線中同種異體、現成即用（off-the-shelf）候選產品感到興奮的原因之一。

I'll now turn my focus to how we apply our manufacturing success and lessons we've learned into our pipeline of cell-based assets for other medical conditions that arise from the loss of critical cellular function.

接下來我將把重點放在：我們如何將製造上的成功與所學到的經驗，應用到我們針對其他醫療狀況的細胞資產產品線——這些狀況源自關鍵細胞功能的喪失。

OPC1 is our second clinical stage program designed to increase mobility for people who suffered from a spinal cord injury by delivering new and functional oligodendrocyte progenitor cells to the site of injury. OPC1 has been administered to 30 individuals in two Phase I/II safety trials, and we believe the long-term safety and efficacy data collected in those trials is both promising and worthy of further investigation. This is a program that was created before the advent of modern cell therapy technologies and required some improvements to both the production process and product delivery.

OPC1 是我們第二個臨床階段計畫，旨在透過將新的、具功能性的少突膠質細胞前驅細胞（oligodendrocyte progenitor cells）輸送至受傷部位，提升脊髓損傷患者的活動能力。OPC1 已在兩項第一期/第二期安全性試驗中給予 30 位受試者，我們相信這些試驗所蒐集的長期安全性與療效數據既令人鼓舞，也值得進一步研究。此計畫是在現代細胞治療技術出現之前所建立，因此在生產流程與產品遞送方面需要一些改良。

We've previously reached our goals on the production process side, generating new cell banks and producing a cleaner, potent and uniform product on a commercially viable platform in our in-house GMP facility. We also overcame a major deficit with accessibility by inventing and introducing a new patented thaw-and-inject formulations, which we've developed for and then borrowed from the OpRegen program. That material has undergone in vivo comparability testing, and we expect to present that supporting data package to FDA later this year with the intention of introducing those cells, those new cells into the ongoing DOSED trial.

我們先前已在生產流程方面達成目標，在自有的 GMP 設施中建立新的細胞庫，並在具商業可行性的平台上生產出更潔淨、效力更佳且更一致的產品。我們也透過發明並導入一種新的、已申請專利的「解凍即注射」（thaw-and-inject）配方，克服了可近性方面的一大缺口；該配方是我們為 OpRegen 計畫所開發，並從該計畫借用而來。該材料已完成體內可比性測試（in vivo comparability testing），我們預期將於今年稍晚把這套支持性資料包提交給 FDA，目標是將這些細胞、這些新細胞導入正在進行的 DOSED 試驗。

DOSED is running in parallel to provide a separate analysis, which is to evaluate the safety and performance of a novel and proprietary delivery system for OPC1. Our goal with the new device is to deliver the cells to the area of injury without stopping patient ventilation, something that was required in prior studies. Once the cells and device have been adequately tested and a study design has been discussed with FDA, we expect we would be in a position to conduct a larger comparative study of OPC1 either alone or with a partner.

DOSED 與此同時平行進行，以提供另一項獨立分析，即評估一種新穎且專有的 OPC1 遞送系統之安全性與表現。我們的新裝置目標是在不停止病患通氣（ventilation）的情況下，將細胞送達受傷區域；而在先前研究中，停止通氣是必要步驟。一旦細胞與裝置完成充分測試，且與 FDA 討論完成研究設計後，我們預期將具備條件進行更大規模的 OPC1 比較性研究，可能由我們單獨進行或與合作夥伴共同進行。

Notably, the ongoing study is the first time OPC1 has been administered to patients with chronic injuries, which are injuries that may have occurred as long as 5 years prior to treatment. We have treated two such patients to date. And because we will be collecting functional assessments on all patients, we have the opportunity to investigate any signals of efficacy that may arise.

值得注意的是，這項正在進行的研究是 OPC1 首次用於慢性損傷患者；所謂慢性損傷，可能是在治療前最長達 5 年前發生的損傷。截至目前，我們已治療兩位此類患者。由於我們將對所有患者收集功能性評估，因此也有機會探查可能出現的任何療效訊號。

This is important, because unlike subacute patients, most chronic patients have reached a performance plateau where further spontaneous improvements are considered unlikely, and therefore, any functional improvements they gain may be easier to detect. And chronic injuries also represent a new and larger potential patient population for this experimental therapy.

這點很重要，因為不同於亞急性（subacute）患者，多數慢性患者已達到表現平台期，進一步自發性改善通常被認為不太可能；因此，他們若獲得任何功能性改善，可能更容易被偵測到。此外，慢性損傷也代表此一實驗性療法新的、且更大的潛在患者族群。

Importantly, the first chronic SCI participant is coming up on their one-year follow-up visit, so we expect to be able to provide an update on how they're doing on our next earnings call. And while the possibility of a treatment effect in chronic patients is an exciting topic, I don't want us to lose sight of the point that the DOSED study is designed to demonstrate the safety and performance of the novel delivery device. And to date, that device has performed as expected with no unexpected procedure, product or device-related adverse events or significant design changes required.

重要的是，第一位慢性脊髓損傷（SCI）受試者即將進行其一年期追蹤回診，因此我們預期能在下一次財報電話會議中提供其狀況更新。雖然慢性患者可能出現治療效果的可能性是令人振奮的議題，但我不希望我們忽略 DOSED 研究的重點：其設計目的在於證明這項新穎遞送裝置的安全性與表現。截至目前，該裝置表現符合預期，未出現任何非預期的手術、產品或裝置相關不良事件，也未需要重大設計變更。

DOSED also has recently been expanded to a second site, the Rancho Research Institute located in Downey, California in conjunction with the Rancho Los Amigos National Rehab Center. We are honored to have Dr. Charles Liu, the principal investigator and his team involved with the OPC1 program.

DOSED 近期也已擴展至第二個研究據點：位於加州唐尼（Downey, California）的 Rancho Research Institute，並與 Rancho Los Amigos National Rehab Center 合作。我們很榮幸由 Charles Liu 醫師擔任主要研究者，並由其團隊參與 OPC1 計畫。

Moving next to ReSonance. This is our first internally developed program using the modern technology available from the AlloSCOPE platform. This is an auditory neuronal cell transplant to treat hearing loss. ReSonance was built from the beginning on our AlloSCOPE platform. So it already has the features I discussed a few minutes ago. And last year, we announced a partnership for this program with William Demant Invest, which is expected to fully fund the planned preclinical development plan, leading to an IND filing.

接下來談 ReSonance。這是我們第一個使用 AlloSCOPE 平台現代技術、由內部開發的計畫。這是一種用於治療聽力損失的聽覺神經元細胞移植。ReSonance 從一開始即建立於我們的 AlloSCOPE 平台之上，因此已具備我在幾分鐘前提到的那些特性。去年，我們也宣布與 William Demant Invest 就此計畫建立合作夥伴關係，預期將全額資助規劃中的臨床前開發計畫，並推進至 IND 申請。

ReSonance is an important example that showed we could conceive of and successfully manufacture a completely new cell-based product candidate on our AlloSCOPE platform in a rapid and efficient way. From an initial investment of approximately $1 million, we generated new intellectual property and advanced ReSonance into preclinical testing in about one year. The speed and success of that project then led to a partnership with Demant, a world-leading hearing health care company, which brought us access to specialized technology, auditory expertise and a network of hearing health leaders.

ReSonance 是一個重要例證，顯示我們能在 AlloSCOPE 平台上，以快速且高效率的方式構思並成功製造一個全新的細胞基礎產品候選物。以約 100 萬美元的初始投入，我們在約一年內產生新的智慧財產並將 ReSonance 推進至臨床前測試。該專案的速度與成功，進而促成與 Demant 的合作；Demant 是全球領先的聽力健康照護公司，為我們帶來專業技術、聽覺領域專長，以及聽力健康領導者的人脈網絡。

And as shared previously, Demant also agreed to fund up to $12 million of preclinical activities, leading to a first-in-human regulatory filing, a portion of which has already been spent in support of the project, including as reimbursement to Lineage for our contributions. We believe this collaboration demonstrated the speed, efficiency and value creation that the AlloSCOPE platform can provide as well as highlighting productive dealmaking, and we hope to repeat this success with some of our other cell transplant programs.

此外，如先前所分享，Demant 也同意資助最高達 1,200 萬美元的臨床前活動，以推進至首次人體（first-in-human）的法規申報；其中一部分資金已用於支持該專案，包括對 Lineage 就我們貢獻所提供的費用補償。我們相信這項合作展現了 AlloSCOPE 平台可提供的速度、效率與價值創造，同時也凸顯了具生產力的交易合作能力；我們希望能在其他細胞移植計畫上複製這樣的成功。

Meanwhile, our collaboration with Demant has been progressing well. I'm happy to share for the first time today that we have successfully completed three engineering runs and preparations are underway to perform that process in our GMP suite. Successful manufacturing of GMP material will be an important next milestone as it's something we want to complete before speaking with the regulators about human testing. We've also established a novel model of deafening, which will enable the initiation of functional animal testing using the cells we produced under this important partnership.

同時，我們與 Demant 的合作進展良好。我很高興今天首次分享：我們已成功完成三次工程試產（engineering runs），並正準備在我們的 GMP 套房（GMP suite）中執行該製程。成功製造 GMP 材料將是下一個重要里程碑，因為這是我們在與監管機關討論人體試驗之前希望完成的事項。我們也建立了一種新的致聾模型（model of deafening），使我們能使用在此重要合作下所生產的細胞，啟動功能性動物測試。

Moving now into the rest of the pipeline. I want to provide some context regarding the next two programs, our islet cell and corneal endothelial cell initiatives. Human body is comprised of more than 200 discrete cell types. And because pluripotent cells can become any of those 200 cell types, we have many choices about where to deploy our resources into additional product candidates.

接著談管線其餘部分。我想先就接下來兩個計畫——我們的胰島細胞與角膜內皮細胞計畫——提供一些背景。人體由 200 多種不同的細胞類型所組成。由於多能幹細胞（pluripotent cells）可以分化成上述任何一種細胞類型，因此我們在將資源投入額外產品候選物方面有許多選擇。

After extensively evaluating where we might generate the greatest value from our process development and directed differentiation expertise, we announced two new initiatives: one, focused on addressing the issue of scale in type 1 diabetes; and a second one, focused on corneal endothelial disease.

在廣泛評估我們可在哪些領域，最能運用製程開發與定向分化（directed differentiation）專長以創造最大價值後，我們宣布兩項新計畫：第一，聚焦於解決第一型糖尿病的規模化（scale）問題；第二，聚焦於角膜內皮疾病。

One of the things we like about these two initiatives is that clinical evidence demonstrating that a cell transplant can address the respective diseases already exists. So unlike a small molecule program where you really have no idea about clinical efficacy or the translatability of animal models until you reach those steps, there already is established data showing that functional islet cells can lead to insulin independence and that functional corneal cells can treat Fuchs dystrophy.

我們喜歡這兩項計畫的一點是：已存在臨床證據顯示，細胞移植可以處理各自的疾病。因此，不同於小分子計畫——在進入那些階段之前，你其實無法確定臨床療效或動物模型的可轉譯性——在此已經有既有數據顯示，具功能性的胰島細胞可帶來脫離胰島素（insulin independence），而具功能性的角膜細胞可治療 Fuchs 角膜營養不良（Fuchs dystrophy）。

In these areas, the clinical risk may be reduced due to these precedents and thus, the business opportunity for Lineage resides where we perform best, on the process development and production side. And because islet and corneal cell transplants are currently performed using cadaver cells, we see a huge opportunity to try and develop a consistent and low-cost supply of these cells from our AlloSCOPE platform.

在這些領域，由於已有先例，臨床風險可能較低；因此，Lineage 的商業機會在於我們最擅長的部分——製程開發與生產端。並且，由於目前胰島與角膜細胞移植是使用屍體捐贈（cadaver）細胞進行，我們看見一個巨大的機會：嘗試透過 AlloSCOPE 平台開發這些細胞一致且低成本的供應來源。

Starting with COR1. This is a corneal endothelial cell or CEnC therapy program designed for the treatment of Fuchs and other corneal dystrophies. Fuchs corneal dystrophy is a progressive condition where cells on the inner layer of the cornea die off, causing swelling and vision loss. In the advanced setting of this disease, DMEK or Descemet membrane endothelial keratoplasty is a surgical option, consisting of replacing the diseased cells with a donor graft, often leading to improved vision.

先從 COR1 開始。這是一項角膜內皮細胞（corneal endothelial cell，CEnC）療法計畫，旨在治療 Fuchs 及其他角膜營養不良。Fuchs 角膜營養不良是一種進行性疾病，角膜內層的細胞逐漸死亡，導致角膜水腫與視力下降。在此疾病的晚期，DMEK（Descemet membrane endothelial keratoplasty，Descemet 膜內皮角膜移植術）是一種手術選項，作法是以捐贈者移植物替換病變細胞，通常可改善視力。

COR1 is an internally developed and wholly-owned preclinical cell transplant aimed at providing a consistent and affordable supply of corneal cells to these procedures. And I hope it isn't missed that COR1 can benefit from our ophthalmology and manufacturing expertise and highlights our approach by focusing on what we do best, large-scale, high-quality cell manufacturing.

COR1 是由內部開發且完全自有的臨床前細胞移植計畫，目標是為這些手術提供一致且可負擔的角膜細胞供應。我也希望大家不要忽略：COR1 可受益於我們在眼科與製造方面的專長，並凸顯我們的策略——聚焦於我們最擅長的事：大規模、高品質的細胞製造。

Millions of people are potential candidates for corneal transplants, but the current supply of CEnCs from cadaveric sources is limited by the low availability of organ donors, which, by their nature, have inconsistent yield and quality. Nevertheless, CEnC therapy from cadaveric sources has been approved in Japan and is in Phase III testing in the US, providing evidence for the mechanism of action and business opportunity.

數百萬人可能是角膜移植的候選者，但目前來自屍體來源的 CEnC 供應，受限於器官捐贈者數量不足；而且此類來源天生具有產量與品質不一致的問題。儘管如此，來自屍體來源的 CEnC 療法已在日本獲准，並在美國進行第三期試驗，為其作用機制與商業機會提供了證據。

But according to JAMA Ophthalmology, cadaver sources can only serve about 1 in 70 patients, highlighting the unmet need. The COR1 program aims to solve this limitation because existing approved CEnC transplant therapy not only relies on cadaveric tissue, which is limited and variable, but also requires cells to be transplanted within 30 hours of harvesting, creating barriers to patient access.

但根據《JAMA Ophthalmology》，屍體來源僅能服務約每 70 位患者中的 1 位，凸顯未被滿足的需求。COR1 計畫旨在解決此限制，因為現有已核准的 CEnC 移植療法不僅依賴有限且變異性高的屍體組織，還要求細胞必須在採集後 30 小時內完成移植，對患者可近性造成障礙。

We believe there is a terrific opportunity to address the unmet need for reliable, consistent, scalable and cryopreserved CEnCs. And again, CEnC transplant therapy is already clinically validated with preclinical models, endpoints and clinical and regulatory precedents that are well established and ready to be copied by an innovator with a superior cell source.

我們相信，在提供可靠、一致、可擴增（scalable）且可冷凍保存（cryopreserved）的 CEnC 方面，存在極佳的機會以滿足未被滿足的需求。再者，CEnC 移植療法已在臨床上獲得驗證，且其臨床前模型、終點，以及臨床與法規先例都已相當成熟；對於擁有更優細胞來源的創新者而言，這些都已準備好可加以複製。

From a manufacturing and formulation perspective, the anticipated therapeutic dose is small, fewer than 2 million cells per patient, which we believe is well within the capability of AlloSCOPE to deliver low cost of goods and an efficient production process. The differentiation pathway is well understood, and we believe we can utilize one of our existing differentiation methods to create a proprietary position as well as potentially accelerating and streamlining product development.

從製造與配方的角度來看，預期的治療劑量很小，每位患者少於200萬個細胞；我們相信這完全在AlloSCOPE具備的能力範圍內，可實現低製造成本（COGS）與高效率的生產流程。分化路徑已相當清楚，我們相信可運用既有的一種分化方法，建立專有優勢，並有望加速與精簡產品開發。

As a result, in just a matter of months, our team advanced the COR1 program from a little more than an idea into preclinical development and was able to successfully manufacture off-the-shelf corneal endothelial cells on our AlloSCOPE platform with the identity and morphological and functional characteristics that met our initial internal criteria and support further development. We plan to advance this program first into translational models and thereafter into initial human testing. And I hope at our next quarterly call that I'll be able to provide a timeline for initiation of a clinical trial of COR1.

因此，在短短數個月內，我們的團隊將COR1計畫從一個略高於概念的階段推進至臨床前開發，並能在我們的AlloSCOPE平台上成功製造可即用（off-the-shelf）的角膜內皮細胞，其身分特徵、形態與功能特性均符合我們最初的內部標準，並支持後續開發。我們計畫先將此計畫推進至轉譯模型，之後再進入初步人體測試。我也希望在下一次季度電話會議上，能提供COR1臨床試驗啟動的時間表。

Moving next to type 1 diabetes. We've been getting a lot of interest about our entry into this space. As with CEnCs, the clinical data show that islet cell transplants can work. Each year, dozens of patients are reported to be functionally cured using islet cells from cadavers, meaning they can regulate their blood sugar without daily disease management. However, islet supply is a major unsolved problem. Expansion of islets from cadaver sources cannot currently support a commercially viable source of these cells.

接下來談第一型糖尿病。我們進入此領域引起了許多關注。與角膜內皮細胞（CEnCs）相同，臨床數據顯示胰島細胞移植確實可行。每年都有數十名患者被報告在使用屍體捐贈來源的胰島細胞後達到功能性治癒，也就是他們能在不需每日疾病管理的情況下調節血糖。然而，胰島供應仍是一個尚未解決的重大問題。目前，來自屍體來源的胰島擴增無法支撐具商業可行性的細胞供應。

Immunosuppression, patient eligibility and hypoimmunity are all additional hurdles that need to be overcome, but we believe the hurdle with the least amount of progress to date is making islets at the scale required for commercial success. And we believe significant value in the islet cell transplant community should accrue to whomever solves the scale problem.

免疫抑制、患者適格性與低免疫性（hypoimmunity）都是需要克服的額外障礙，但我們認為迄今進展最少的關卡，是以達到商業成功所需的規模製造胰島。我們也相信，胰島細胞移植領域的重大價值將歸於能解決規模化問題的團隊。

One reason for the supply gap is that the required dose of islet cells may be as high as 1 billion cells per patient. For reference, the upper limit for an optimized bioreactor process might be 10 billion cells per liter. And that is still commercially inadequate for T1D patients even at 10- or 15-liter scale. And because mature islet cells do not expand readily in culture, these optimal calculations don't even apply.

供應缺口的一個原因是，胰島細胞所需劑量可能高達每位患者10億個細胞。作為參考，最佳化的生物反應器製程上限可能是每公升100億個細胞。即便在10或15公升規模下，對第一型糖尿病（T1D）患者而言仍不足以達到商業可行性。而且，由於成熟胰島細胞在培養中不易擴增，這些理想化的計算甚至不適用。

Our calculations suggest that you might begin to reach commercial viability at thousands of doses per batch, implying that production will have to occur on the scale of at least an 80-liter reactor. But carrying out a differentiation process in an 80-liter vessel requires feeding that vessel with many billions of undifferentiated pluripotent cells. You can't just rely on cells to divide endlessly. They have to retain their full pluripotency, their genetic stability and do so without losing their homogeneity and synchrony. And that is the fundamental problem.

我們的計算顯示，可能要在每批次達到數千個劑量時才開始接近商業可行性，這意味著生產至少必須在80公升反應器的規模進行。但在80公升容器中執行分化流程，需要以數十億個未分化多能性細胞來餵養該容器。你不能只依賴細胞無止盡分裂；它們必須保有完整多能性、基因穩定性，並且在不喪失均一性與同步性的情況下做到這一點。而這就是根本問題。

Conventional 3D expansion in aggregates introduces heterogeneity, leading to lower control, lower synchrony and higher dissociation requirements, resulting in more genetic aberrations and less effective differentiation. But generating billions of cells from conventional 2D approaches requires impractically large surface areas and high aseptic risk. There is an unavoidable conflict in islet cell production between reproducible control and sufficient scale, and there is no trade-off. You have to combine the best of both worlds in order to produce a commercially viable product.

傳統以聚集體進行的3D擴增會引入異質性，導致控制性較低、同步性較差且需要更高程度的解離處理，進而造成更多基因異常並降低分化效率。但若以傳統2D方法生成數十億個細胞，則需要不切實際的大面積培養表面，且無菌風險很高。胰島細胞生產在可重現的控制與足夠的規模之間存在不可避免的衝突，而且沒有取捨空間。要製造具商業可行性的產品，必須結合兩者的優點。

Our proposed solution to this problem is called ILT1, a new manufacturing initiative employing a modification of our AlloSCOPE platform into what we call AlloSCOPE 5D. AlloSCOPE 5D has the goal of generating large-scale production of predifferentiated cells with reduced manipulation and passaging so that you're capturing both 2D synchronization and control of differentiation with 3D environmental control and scalability, hence, 5D.

我們針對此問題提出的解決方案稱為ILT1，這是一項新的製造倡議，將我們的AlloSCOPE平台加以改造，形成我們所稱的AlloSCOPE 5D。AlloSCOPE 5D的目標是在降低操作與傳代的情況下，大規模生產預分化細胞，使你同時獲得2D的同步性與分化控制，以及3D的環境控制與可擴展性，因此稱為5D。

ILT1 is initially focused on producing a homogenized population of undifferentiated pluripotent cells ready for synchronized differentiation and which, if successful, could thereafter serve as the high feed source material for differentiation into islet cells. If we can develop a modality that can support an islet cell production process from expansion through differentiation in a dynamic culturing system, we could potentially solve a major hurdle to production and commercialization of an islet cell therapy product candidate.

ILT1最初聚焦於生產均質化的未分化多能性細胞族群，使其可進行同步分化；若成功，之後可作為分化成胰島細胞的高量投料來源材料。若我們能開發一種模式，支持在動態培養系統中從擴增到分化的胰島細胞生產流程，我們就可能解決胰島細胞治療候選產品在生產與商業化上的一項重大障礙。

With this initiative, we are inverting the traditional development paradigm by focusing on the scale-up of undifferentiated cells first because as I explained in the beginning of this call, once you've shown that you can actually produce your material while maintaining its quality at scale, we believe you may be materially reducing the risk profile for the remainder of the development project. That is because multiple independent groups have already shown that islets can clear preclinical and clinical testing and become an effective intervention for people with T1D.

透過這項倡議，我們正在顛覆傳統的開發典範，先聚焦於未分化細胞的放大（scale-up）。正如我在本次電話會議一開始所說，一旦你證明能在規模化生產下仍維持材料品質，我們相信你就能實質降低後續開發專案的風險輪廓。原因在於，已有多個獨立團隊證明胰島可通過臨床前與臨床測試，並成為T1D患者的有效介入方式。

Similarly, editing strategies and differentiation protocols already exist and can provide risk-reducing information in those respective areas, but no one to our knowledge has shown that they can scale islets to commercially relevant levels. For this reason, we think it's appropriate to focus on the unresolved scale problem rather than performing years of expensive preclinical and clinical studies while deferring the problem scale up for later.

同樣地，基因編輯策略與分化流程也已存在，並能在各自領域提供降低風險的資訊；但據我們所知，尚無人證明能將胰島規模化至具商業相關性的水準。因此，我們認為應把重點放在尚未解決的規模問題上，而不是在將規模化延後到更後期的同時，先投入多年昂貴的臨床前與臨床研究。

For some companies, advancing into clinical testing without a robust manufacturing process may even become a significant setback. We think the value is in establishing from the beginning, a process that can support downstream development. I previously reported that we met our first internal manufacturing milestone for this initiative by demonstrating what we believe is a highly homogenized, scalable and fully suspension-based process for generating undifferentiated pluripotent cells using one of our own proprietary cell lines.

對某些公司而言，在缺乏穩健製造流程的情況下推進臨床測試，甚至可能成為重大挫折。我們認為價值在於從一開始就建立能支援下游開發的流程。我先前已報告，我們已達成此倡議的第一個內部製造里程碑：使用我們自有的一條專有細胞株，展示出我們認為高度均質、可擴展且完全以懸浮培養為基礎的未分化多能性細胞生成流程。

After this work was successful at a 0.5 liter scale, we then moved into a larger multiliter format, which continues today. If we are successful at the larger scale, we would then seek to demonstrate AlloSCOPE 5D scalability with either an internally or externally sourced hypoimmune cell line, one that is suitable to support islet cell differentiation or we may proceed with a non-hypoimmune line or perhaps both. We don't need to generate islets yet. We first want to demonstrate the capability of being able to generate enough raw material that can become islets.

在0.5公升規模成功後，我們隨即轉入更大的多公升格式，並持續至今。若我們在更大規模上取得成功，接著將尋求以內部或外部來源的低免疫性細胞株來驗證AlloSCOPE 5D的可擴展性；該細胞株需適合支援胰島細胞分化，或者我們也可能採用非低免疫性細胞株，或兩者並行。我們目前不需要生成胰島；我們首先要證明具備產出足夠原料、可進一步成為胰島的能力。

As one final point on AlloSCOPE 5D, I will add that we don't yet know what the upper limit is for our approach, but we've already done it reproducibly at a small scale, and that allows us to apply insights, IP and process improvements to our other programs, such as by potentially making larger cell banks or driving our production costs even lower. We'll do our best to keep you informed on ILT1, but I can share today that we believe it's already paying off in other areas.

關於AlloSCOPE 5D的最後一點，我要補充的是，我們尚不清楚此方法的上限在哪裡，但我們已在小規模下可重現地完成，這使我們能將洞見、智慧財產（IP）與製程改良應用到其他計畫，例如可能建立更大的細胞庫，或進一步降低生產成本。我們會盡力持續向各位更新ILT1的進展；但我今天可以分享的是，我們相信它已在其他領域帶來回報。

Changing gears for just a moment, we recently announced the formation of our Scientific Advisory Board to provide strategic counsel and insights into the development of our pipeline. The SAB's founding member is Dr. Joachim Fruebis, a recognized and established biopharma executive who brings extensive experience across ophthalmology, neurology, diabetes and other areas of interest to us.

稍微轉換一下話題，我們近期宣布成立科學顧問委員會（Scientific Advisory Board, SAB），以就我們產品線的開發提供策略性建議與洞見。SAB的創始成員是Joachim Fruebis博士，他是備受認可且資深的生物製藥高階主管，為我們帶來涵蓋眼科、神經學、糖尿病及其他我們關注領域的豐富經驗。

Dr. Fruebis helped shape cell therapy development at Novo Nordisk and BlueRock and has led cross-functional global teams responsible for the late-stage development and commercialization of multiple approved products. We're excited to have been able to attract a leader of his caliber and look forward to providing updates on further appointments to our SAB throughout the year.

Fruebis博士曾協助塑造Novo Nordisk與BlueRock的細胞治療開發，並領導跨職能的全球團隊，負責多項已核准產品的後期開發與商業化。我們很高興能吸引到如此等級的領導者，並期待在今年內持續提供SAB後續任命的更新。

In addition, we also welcomed Dr. Priyantha Herath as our Senior Vice President and Head of Clinical. Dr. Herath is a Board-certified specialist neurologist with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase III clinical trial execution. He brings a broad clinical perspective suitable for our diverse pipeline and a deep understanding of disease penetration, progression and meaningful outcomes. We are pleased to have attracted the support and contributions of Dr. Fruebis and Herath to our growing and maturing company.

此外，我們也迎來Priyantha Herath博士擔任資深副總裁兼臨床部門主管。Herath博士為董事會認證的神經科專科醫師，擁有涵蓋早期轉譯開發、法規事務與臨床開發，並成功執行第三期（Phase III）臨床試驗的豐富經驗。他帶來適用於我們多元產品線的廣泛臨床視角，以及對疾病滲透率、進展與具意義終點的深刻理解。我們很高興能獲得Fruebis博士與Herath博士對我們這家持續成長與日益成熟的公司的支持與貢獻。

To wrap up these remarks, our business strategy aims to efficiently leverage our AlloSCOPE platform and create a pipeline of related but discrete cell-based assets, some of which we may advance internally toward commercialization and some of which we may seek to partner during early or late development. If you're wondering how we can manage such a broad pipeline, please keep in mind that our platform generates assets which share certain essential traits in common, such as each dollar we spend on innovation can apply across multiple programs.

總結以上說明，我們的商業策略旨在有效運用AlloSCOPE平台，建立一系列彼此相關但各自獨立的細胞資產；其中部分我們可能在內部推進至商業化，另一些則可能在早期或後期開發階段尋求合作夥伴。若你在想我們如何管理如此廣泛的產品線，請記住，我們的平台所產生的資產共享某些關鍵特徵，例如我們在創新上投入的每一美元，都可跨多個計畫發揮效益。

And while each product candidate is intended for a different condition and each cell line behaves in a unique manner and their respective development risks vary, the early steps of banking, process development and achieving controlled purity and scale have somewhat common features in the way we apply them, which allows us to broadly expand the scope of our pipeline without losing the focus required to succeed in each indication and using our capital in an efficient way.

雖然每個產品候選項目皆針對不同適應症、每條細胞株的表現方式各不相同，且其各自的開發風險亦有所差異，但在細胞庫建立、製程開發，以及達成可控的純度與放大量產等早期步驟上，我們在應用方式上仍具有一些共通特徵；這使我們得以在不失去各適應症成功所需專注度的前提下，廣泛擴展我們的產品線範疇，並以有效率的方式運用資本。

I hope that business update has been informative. And with that, I'll turn things over to Jill for a review of our financials.

希望這次的業務更新對各位有所助益。接下來我把時間交給 Jill，請她回顧我們的財務狀況。

Thanks, Brian. As of March 31, 2026, our overall cash position was $53.4 million. This capital is expected to support our planned operations into Q2 of 2028. In addition to our cash on hand, we may also receive approximately $32 million from the exercise of existing warrants, maturity date of which will be accelerated if the intent to advance OpRegen into a multicenter trial, which includes the control/comparator arm is publicly disclosed.

謝謝，Brian。截至 2026 年 3 月 31 日，我們的整體現金部位為 5,340 萬美元。預期這筆資金可支應我們的既定營運至 2028 年第二季。除手上現金外，我們也可能因既有認股權證被行使而再收到約 3,200 萬美元；若我們公開揭露有意將 OpRegen 推進至包含對照/比較組的多中心試驗，該等認股權證的到期日將會提前。

We also continue to remain eligible for a total of $615 million of developmental and commercial milestone payments under the Roche and Genentech collaboration agreement, and we continue to evaluate opportunities for additional partnerships similar to our Roche or Demant collaborations, which we could elect to enter into the future.

我們也仍符合資格，可依 Roche 與 Genentech 的合作協議獲得合計 6.15 億美元的開發與商業里程碑款項；同時，我們持續評估類似於與 Roche 或 Demant 合作的其他合作機會，未來我們也可選擇是否進一步締結此類合作。

Now I will review our first quarter results. Our revenue is generated primarily from collaboration revenues, royalties and other revenues. Total revenues were approximately $1.7 million, a net increase of $0.2 million as compared to $1.5 million for the same period in 2025. The increase was primarily driven by collaboration revenue recognized under our new research collaboration agreement with Demant.

接下來我將回顧第一季的業績。我們的營收主要來自合作收入、權利金及其他收入。總營收約為 170 萬美元，較 2025 年同期的 150 萬美元淨增加 20 萬美元。增加主要來自我們與 Demant 新研究合作協議下所認列的合作收入。

Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expenses were $9.3 million, an increase of $1.3 million as compared to $8 million for the same period in 2025. R&D expenses were $4.2 million, an increase of $1.1 million as compared to $3.1 million for the same period in 2025. The net increase was primarily driven by $0.3 million for our OPC1 program, $0.2 million for our ReSonance program and approximately $0.7 million for our preclinical and other undisclosed programs.

營運費用由研發費用以及一般與行政費用組成。總營運費用為 930 萬美元，較 2025 年同期的 800 萬美元增加 130 萬美元。研發費用為 420 萬美元，較 2025 年同期的 310 萬美元增加 110 萬美元。淨增加主要來自：OPC1 計畫 30 萬美元、ReSonance 計畫 20 萬美元，以及約 70 萬美元用於我們的臨床前與其他未揭露計畫。

G&A expenses were approximately $5.1 million, an increase of $0.2 million as compared to $4.9 million for the same period in 2025. The net increase is primarily driven by personnel costs, partially offset by services provided by third parties. Loss from operations was $7.6 million, an increase of $1.1 million compared to $6.5 million for the same period in 2025.

一般與行政費用約為 510 萬美元，較 2025 年同期的 490 萬美元增加 20 萬美元。淨增加主要由人事成本帶動，部分被第三方提供服務所抵銷。營運虧損為 760 萬美元，較 2025 年同期的 650 萬美元增加 110 萬美元。

Other income and expenses reflected other income of $2.8 million compared to other income of approximately $2.4 million for the same period in 2025. The net increase is primarily driven by exchange rate fluctuations related to Lineage's international subsidiaries and no warrant-related financing transaction costs incurred as compared to the prior year's quarters. Net loss attributable to Lineage of $4.8 million or $0.02 per share basic and $0.03 per share diluted compared to a net loss of $4.1 million or $0.02 per share for both basic and diluted for the same period in 2025.

其他收益與費用方面，本期其他收益為 280 萬美元，較 2025 年同期約 240 萬美元增加。淨增加主要來自與 Lineage 海外子公司相關的匯率波動，以及相較前一年度各季，本期未發生與認股權證相關的融資交易成本。歸屬於 Lineage 的淨損為 480 萬美元，或每股淨損（基本）0.02 美元、每股淨損（稀釋）0.03 美元；相較之下，2025 年同期歸屬於 Lineage 的淨損為 410 萬美元，基本與稀釋每股皆為 0.02 美元。

Our financial results continue to reflect our dedication to responsible fiscal management, and we remain focused on balancing our cost of capital with the investments we make to grow and strengthen our pipeline, as presented earlier in the call.

我們的財務結果持續反映我們對負責任財務管理的承諾；同時，我們仍專注於在資本成本與我們為成長及強化產品線所進行的投資之間取得平衡，如同先前在本次電話會議中所呈現。

I'll now hand the call back to Brian for concluding remarks.

接下來我把電話會議交回給 Brian，請他做結語。

Thanks, Jill. I'll quickly summarize by repeating some key themes. First, we continue to remain confident in the potential for OpRegen to advance into a multicenter controlled trial.

謝謝，Jill。我將快速總結並重申幾個關鍵主題。第一，我們仍對 OpRegen 推進至多中心對照試驗的潛力保持信心。

Second, with that confidence, we're making investments in our AlloSCOPE platform and launching new programs. In some cases, these new programs have a strong clinical precedent from cadaver cells such as using islet cells to achieve insulin independence or CEnCs to improve vision in patients with corneal endothelial disease.

第二，基於這份信心，我們正投資於 AlloSCOPE 平台並啟動新計畫。在某些情況下，這些新計畫具有來自屍體細胞的強力臨床先例，例如使用胰島細胞達成胰島素獨立，或使用 CEnCs 改善角膜內皮疾病患者的視力。

In other cases, the utility of replacing a cell is less established, but like OpRegen, it might reveal a remarkable new mechanism by which we can modify or even reverse the course of the disease. But in all of these programs, we believe establishing a robust manufacturing process early on with the purity, potency and scale capable of supporting a commercially attractive cost of goods is the right strategy for both long-term internal development and for creating partnership opportunities.

在其他情況下，以細胞替換的效用尚未被充分建立；但如同 OpRegen，它可能揭示一種顯著的新機制，使我們得以改變甚至逆轉疾病進程。然而，在所有這些計畫中，我們相信在早期即建立具備純度、效價與規模、並能支援具商業吸引力之銷貨成本的穩健製造流程，是同時有利於長期內部開發與創造合作機會的正確策略。

And then fourth, as our pipeline advances, we expect we will provide updates prior to as well as following any potential updates our partners may make on the OpRegen program. For example, we're looking forward to reporting initial OPC1 data, the outcome from the ReSonance annual go/no-go decision, COR1 development plans, ILT1 scale-up progress, announcing additional SAB members, a patent issuance update and whatever other news we might be able to generate in the second half of this very productive year.

第四，隨著我們的產品線推進，我們預期會在合作夥伴可能就 OpRegen 計畫發布任何更新之前以及之後提供最新進展。例如，我們期待報告 OPC1 的初步數據、ReSonance 年度 go/no-go 決策結果、COR1 的開發計畫、ILT1 的放大量產進度、宣布新增 SAB 成員、專利核發更新，以及在這個非常高產的一年下半年我們可能產出的其他消息。

Overall, we appreciate your support and your belief in our vision. And with that, operator, we are ready to take analyst questions.

總體而言，我們感謝各位的支持以及對我們願景的信任。接下來，主持人，我們準備開始回答分析師提問。

(Operator Instructions)

（主持人指示）

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Congrats on a lot of progress there. So on OpRegen, your understanding of that being characterized as disease-modifying relates to what data that was presented at the recent conference, the Foundation Fighting Blindness Summit. And how do you think of the photoreceptor recovery and some of the stratifying bleb coverage data that you have integrated as part of the GAlette trial, some of these learnings that you're having longer term? And then I have a follow-up.

恭喜你們取得許多進展。關於 OpRegen，你們將其描述為具疾病修飾（disease-modifying）效果的理解，是基於近期在 Foundation Fighting Blindness Summit 會議上所呈現的哪些數據？另外，你如何看待光感受器（photoreceptor）恢復，以及你們在 GAlette 試驗中整合的、用於分層的 bleb 覆蓋率數據；這些長期學到的經驗你們怎麼解讀？我還有一個追問。

Thank you for the question, Mayank. With regard to disease modification, my comments there, because we do not have access to the data in the ongoing GAlette study, we, just like our investors, look to other indicators of how things are going. A very clear indicator we had, for example, is the opening of 11 sites after initially only having six sites. We think that, that is consistent with planning for a larger campaign.

謝謝你的提問，Mayank。關於疾病修飾，我在那部分的評論是基於：由於我們無法取得正在進行中的 GAlette 研究數據，我們和投資人一樣，只能從其他指標來觀察進展。例如，一個非常明確的指標是：試驗中心從最初只有 6 個，後來擴增到 11 個。我們認為這與規劃更大規模的推進相一致。

My comments around disease modification are more nuanced. I'm speaking to the conclusion slide from the CTS data, which was very similar to the FFB data that came out nearly a year later. But the conclusion side at CTS, call it, 9 months ago, did not include any language about potentially modifying disease. That language has been presented for the first time in the recent FFB presentation.

我對疾病修飾的評論更為細緻。我指的是 CTS 數據的結論投影片，其內容與近一年後才發布的 FFB 數據非常相似。但在 CTS 的結論投影片（大約 9 個月前）中，並未包含任何關於可能修飾疾病的措辭。而這樣的措辭是首次出現在近期的 FFB 簡報中。

So it's small, but I highlight it because it is a change that I assume is intentional and purposeful, and I believe that it is positive to see that kind of language being used by a partner that is running an open-label study with a clinical benefit that never happens naturally. And even though we do not have access to those data, I think that there is some utility in paying attention to how the partners describe the data they have.

這是個小細節，但我特別提出來，因為這是一項我推測具有刻意與目的性的變化；我認為看到執行開放標籤研究、且觀察到自然情況下不會發生之臨床獲益的合作夥伴使用這類措辭，是正面的訊號。即便我們無法取得那些數據，我仍認為關注合作夥伴如何描述其手上數據，是有一定參考價值的。

And perhaps that also partly answers your second question. The insights that we have regarding bleb coverage and photoreceptor recovery comes entirely from our own Phase I/IIa as well as data that's been presented by other companies -- it does not include any specific insights that we have on the data from the ongoing GAlette study.

這也許也部分回答了你的第二個問題。我們對 bleb 覆蓋率與光感受器恢復的洞見，完全來自我們自己的第一/二期（Phase I/IIa）研究，以及其他公司所發表的數據——並不包含我們對正在進行中的 GAlette 研究數據的任何特定洞見。

So we form our opinions and we share those opinions, and we try to help direct investors to things that are out there available in the public, and then they can interpret them as they wish. But we're not able to provide any specific insights from the ongoing GAlette study because we do not have that information. And even if we did, we would not be able to share it with you at this time.

因此，我們形成自己的看法並分享這些看法，也嘗試引導投資人關注公開可得的資訊，讓大家自行解讀。但我們無法就正在進行中的 GAlette 研究提供任何具體洞見，因為我們沒有那些資訊。即便我們有，在此時點也無法與各位分享。

That's helpful. And then on the other eye programs that you have preclinical, the corneal endothelial cell, and I think you also disclosed the new PNC1, which is -- it looks like also photoreceptor cell targeted allogeneic. Maybe just on the corneal program, what's the internal criteria you may have met here? And what's sort of the work underway preclinically and sort of what things we should be watching for as you kind of do your next steps on manufacturing and also time to IND filing? If you could maybe just clarify that.

這很有幫助。接著關於你們其他仍在臨床前階段的眼科計畫，包括角膜內皮細胞計畫；我想你們也揭露了新的 PNC1，看起來也是針對光感受器細胞的同種異體（allogeneic）療法。就角膜計畫而言，你們內部可能已達成哪些評估標準？目前臨床前正在進行哪些工作？在你們推進下一步製造，以及距離 IND 申請的時間點上，我們應該關注哪些事項？可否請你再釐清一下。

And then just on ReSonance, if you may just remind us what are any partner-related milestones now that you've run the -- you had the three manufacturing runs completed? And where does that $12 million over sort of three-year period number kind of get -- start getting recognized as you get closer to IND?

另外關於 ReSonance，能否請你提醒我們：在你們完成三次製造批次（manufacturing runs）之後，目前還有哪些與合作夥伴相關的里程碑？以及那個約 1,200 萬美元、跨約三年期間的數字，會在你們更接近 IND 時如何開始被認列？

Yes. Thank you so much. So I guess first on -- I'll go in reverse order here. So for ReSonance, I think two things are important to us. Completing the engineering runs is a gateway to doing GMP runs, which itself is a gateway to having conversation with FDA. And I know that, that is something that people are going to be really interested in knowing when would we have our first FDA interaction for this program and what might be a timeline to clinical development.

是的。非常感謝。所以我想先從——我會用倒序來回答。就 ReSonance 而言，我認為有兩件事對我們很重要。完成工程批次（engineering runs）是進行 GMP 批次的門檻，而 GMP 批次本身又是與 FDA 展開對話的門檻。我知道這也是大家會非常關心的：這個專案我們何時會與 FDA 進行第一次互動，以及臨床開發可能的時間表會是什麼。

A second thing for ReSonance is, there is baked into that alliance a go/no-go decisions that occurs with the advancement of the program. So if the parties are not happy with how things are going, we can elect to conclude. either party has certain rights under those decisions. So we have coming up an annual go/no-go or call it, a continuation decision. I think in certain areas, we're running ahead of schedule, and I think we're really happy.

ReSonance 的第二點是，該合作聯盟的設計中內建了隨著專案推進而進行的 go/no-go（繼續/停止）決策。因此，如果各方對進展不滿意，我們可以選擇結束；在這些決策之下，任何一方都擁有特定權利。我們即將迎來一年一度的 go/no-go，或稱延續決策。我認為在某些方面我們的進度超前，而且我覺得我們非常滿意。

So I'm not particularly concerned, but I'm only speaking for 1/2 of the alliance. So we need to -- and we want to, and we frankly expect that we will go past an affirmative go/no-go decision based on the work that's been conducted to date.

所以我並不特別擔心，但我只能代表聯盟中的一半發言。因此我們需要——也希望，而且坦白說我們也預期——基於迄今為止所完成的工作，我們會在這次 go/no-go 決策中獲得肯定結果並繼續往前。

The $12 million, which is over an approximate three-year term of the agreement is roughly 2/3 reimbursement to Lineage and maybe 1/3 to Demant entities. So these will be third-party organizations that are providing various services.

這 1,200 萬美元是在協議約三年的期間內支付，其中約 2/3 是對 Lineage 的費用補償，約 1/3 可能支付給 Demant 相關實體。因此，這些將是提供各類服務的第三方機構。

Turning back to your question. Yes, hard to ignore that we have three ophthalmology programs, OpRegen for GA, the new one, COR1 and then the photoreceptor program. COR1, I think I covered fairly well in the script. In the photoreceptor program, we're keeping a close eye on the photoreceptor program that is under development at Bayer. We're really interested in seeing what they do.

回到你的問題。是的，很難忽視我們有三個眼科專案：用於 GA 的 OpRegen、新的 COR1，以及視受器（photoreceptor）專案。COR1 我想我在講稿中已經說得相當完整。至於視受器專案，我們正密切關注拜耳（Bayer）正在開發的視受器專案，我們非常有興趣看看他們會怎麼做。

And we also unencumbered some of the economics of the photoreceptor program from a third party. We did not wish to rely on that third party's intellectual property anymore. So we abandoned that work, terminated that agreement in order to unfetter that program from those unattractive economics.

此外，我們也把視受器專案的一部分經濟條款從某個第三方的束縛中解開。我們不希望再依賴該第三方的智慧財產權。因此我們放棄了那部分工作、終止了該協議，以便讓這個專案不再受那些不具吸引力的經濟條款所牽制。

I will be appropriate here to say that, that also means we cannot utilize the intellectual property that we were relying on. So it caused us to move the photoreceptor program a little bit back in time, a little bit earlier stage than where it was. But I think long term, having superior economics makes a lot of sense to us. Overall, and I think in part also addressing one of your questions, we perhaps look at value creation with these programs and cell therapy more broadly, a little bit differently than many others, especially with programs like COR1, where you know that there's a precedent.

在這裡我也應該說明，這同時意味著我們不能再使用先前所依賴的智慧財產權。因此這使得視受器專案在時間上稍微往後退了一點，回到比原先更早期的階段。但我認為從長期來看，擁有更優越的經濟性對我們而言非常合理。整體而言，而且也部分回應你其中一個問題，我們在這些專案以及更廣義的細胞治療上，對價值創造的看法可能與許多人不同，特別是像 COR1 這類你知道已有先例的專案。

We think the value is in what we've been doing recently, which is getting a very high-quality manufacturing process that is reproducible, that is not going to need to be changed during development. And when we have that accomplished, we feel like the risk profile from there forward is very different because we believe that a lot of companies have demonstrated that you can get exciting early clinical data. But then if you can't manufacture your product or you need to change your process, the FDA may tell you that it is not the same product anymore.

我們認為價值在於我們最近一直在做的事情：建立一個非常高品質、可重複、且在開發過程中不需要更改的製造流程。當我們完成這件事後，我們覺得從那一刻起的風險輪廓會非常不同，因為我們相信很多公司已經證明你可以取得令人振奮的早期臨床數據；但如果你無法製造你的產品，或你需要改變製程，FDA 可能會告訴你那已經不是同一個產品了。

For example, if you change a growth factor, you change a vessel, you may be altering the output of your product because it's so sensitive to the process. It's literally defined by the process that you employ. So we think that there is a lot of value in being able to manufacture a cell that has the identity markers, the morphology, the performance attributes that define your product.

例如，如果你更換一種生長因子、改變一個培養容器（vessel），你可能就會改變產品的產出，因為它對製程非常敏感。它幾乎就是由你所採用的製程所定義。因此我們認為，能夠製造出具有身分標記（identity markers）、形態（morphology）與性能屬性（performance attributes）來界定你產品的細胞，本身就具有很大的價值。

And if you can make that early, especially in indications where there's already a cadaver-sourced precedent for efficacy, we think these are programs that we are launching that offer a much more attractive overall probabilities of success than the conventional development where maybe you race into the clinic and you get a headline and then everyone figures out much later that you're not able to actually manufacture your product.

而如果你能在早期就做到這一點，特別是在那些已經有屍體來源（cadaver-sourced）療效先例的適應症上，我們認為我們正在啟動的這些專案，整體成功機率會比傳統開發模式更具吸引力；傳統模式可能是你衝進臨床、拿到一個頭條，然後很久之後大家才發現你其實無法真正製造你的產品。

We do not want to get into one of those situations. And so ,the criteria that we invite people to look at as we share these data are how reproducible is your material, how scalable? Do you have narrow specifications? What is your potency assay? And I feel that these are questions that are often not asked of some of the companies that work in this space, yet they are integral to a product's survival.

我們不想陷入那種情況。因此，我們希望大家在我們分享這些數據時關注的評估標準包括：你的材料可重複性如何？可擴展性如何？規格是否足夠狹窄？你的效力測定（potency assay）是什麼？我覺得這些問題常常沒有被拿來詢問在這個領域工作的某些公司，但它們卻是產品能否存活的關鍵。

So I hope that is helpful for how Lineage is perhaps a little different in thinking about our business strategy, our development strategy and how we can be able to be successful against what is an increase in companies working in cell therapy, which we otherwise welcome as I think this is a really important part of medicine going forward and is going to continue to grow and attract capital.

所以我希望這能有助於理解 Lineage 在思考我們的商業策略、開發策略，以及我們如何在細胞治療領域公司數量增加的情況下仍能成功方面，可能有哪些不同之處。我們其實也樂見更多公司投入，因為我認為這將是未來醫療非常重要的一部分，並且會持續成長、吸引資本。

Jack Allen, Baird.

Jack Allen，Baird。

Congrats on all the progress. I guess, I'll start with the RPE cell space and the geographic atrophy space. I just wanted to ask Brian and the team for their thoughts on some of the competitive data. I think that Astellas and iStem presented updated data from the RPE cells. And then I also saw at ARVO, there was an update from the complement inhibitor class, IZERVAY from Astellas had some data looking at continuation of driver eligibility at 24 months versus Sham. And I just wanted to kind of hear your thoughts on the broader space there. And then I have a follow-up question as well.

恭喜各項進展。我想我先從 RPE 細胞領域與地圖狀萎縮（geographic atrophy）領域開始。我想請教 Brian 與團隊對一些競爭數據的看法。我認為 Astellas 與 iStem 發表了 RPE 細胞的更新數據。然後我也在 ARVO 看到補體抑制劑（complement inhibitor）類別的更新，Astellas 的 IZERVAY 有一些數據在比較 24 個月時相較於假手術（Sham）的駕駛資格延續（driver eligibility）。我想聽聽你們對整體領域的看法。另外我也有一個追問。

I would start with Astellas. I consider their data update to be an important clearing event for Lineage. What I mean by that is that we haven't heard and we haven't known very much about what they have done. And I think it's normal that if you don't have information about a competitor, it's really easy to fill it in with scary thoughts.

我先從 Astellas 談起。我認為他們的數據更新對 Lineage 來說是一個重要的「釐清事件」（clearing event）。我的意思是，我們之前沒有聽到、也不太知道他們做了什麼。而且很正常的是，當你對競爭對手缺乏資訊時，很容易用一些令人害怕的想法去填補空白。

But then we saw the presentation, and I find myself comforted because I didn't see any information about manufacturing. I didn't see any information about delivery. I saw limited information about safety, and I saw information on one patient out of, I believe, 14 on anatomy. And I didn't find the information in the aggregate to be particularly worrisome or threatening. This is a program that they acquired in 2016, and it is now 2026, and the data in its totality is somewhat limited.

但我們看了那場簡報後，我反而感到安心，因為我沒有看到任何關於製造的資訊；我沒有看到任何關於給藥/遞送（delivery）的資訊；我看到的安全性資訊有限；而且在解剖學（anatomy）方面，我看到的是 14 位受試者中我相信只有 1 位病人的資訊。整體而言，我不覺得這些資訊特別令人擔憂或具威脅性。這個專案是他們在 2016 年取得的，現在已經是 2026 年，而其全部數據仍相對有限。

So I feel comforted that we are and will continue to be in a leading position, and I am thankful for the investments that our partners are making in optimizing this program because the more we know about what's going on with the competition, the more opportunities we have to develop a superior product profile. And when you're talking about a surgical procedure in the eye, I would assume that even relatively modest differences in safety profiles could turn into very significant decisions as to which product someone might choose if multiple products were approved.

因此我感到安心的是，我們目前、並且將持續處於領先位置；我也感謝我們的合作夥伴在優化這個專案上所做的投資，因為我們越了解競爭態勢，就越有機會打造更優越的產品特性（product profile）。而當你談的是眼內的外科手術程序時，我會假設即使安全性特徵只有相對小的差異，也可能轉化為非常重大的決策：若有多個產品獲批，臨床端可能會選擇哪一個。

So I think that the four items that I outlined in the call earlier are working together. And I hope that ultimately, those will lead to the best possible product profile and increase the probability of success of a product ultimately reaching these patients in this market.

所以我認為我在先前電話會議中概述的四個要素正在共同發揮作用。我希望最終它們能帶來最佳的產品特性，並提高產品最終能夠到達這些患者、進入這個市場的成功機率。

With respect to complement inhibitors, I view all of them largely the same. I think there is a treatment effect, but I think it is a very small treatment effect. And if I were in charge of a complement inhibitor, whether approved or in development, I would be working very hard to try to generate evidence that it has an effect on visual function because the data to date has suggested or been quite clear perhaps that these interventions do not have an effect on visual function.

至於補體抑制劑，我大致把它們都視為同一類。我認為確實有治療效果，但我認為那是非常小的治療效果。如果我是補體抑制劑（不論已獲批或仍在開發中）的負責人，我會非常努力去產生證據，證明它對視覺功能（visual function）有影響，因為迄今的數據已暗示——或許也相當清楚地顯示——這些介入並不會影響視覺功能。

And I don't think that post-hoc analyses are going to really convince people. I'd love to see an a priori designed study with a functional endpoint that's statistically demonstrated, but I'm not sure that we're going to see that. I have not seen the 24-month driving data. I think driving is really important. And if you're increasing someone's vision, such as with an RPE transplant, you may be able to get them a driver's license back. But if you do not increase someone's vision and they've lost their license, they will never get it back.

而我不認為事後分析（post-hoc analyses）真的能說服大家。我很希望看到一個事先設計（a priori designed）的研究，具有功能性終點，並且在統計上得到證實，但我不確定我們是否會看到。我還沒看過 24 個月的駕駛數據。我認為駕駛非常重要。如果你能提升一個人的視力，例如透過 RPE 移植，你可能讓他們重新拿回駕照。但如果你沒有提升一個人的視力，而他已經失去駕照，他將永遠不可能再拿回來。

So I don't know exactly what the various complement inhibitor strategies are, but I do feel comfortable that four companies now have shown that an RPE transplant can increase patients' vision. So if you want to measure impact on something like driving ability, I think RPE transplants are going to get more licenses into people's hands, whereas I don't think complement inhibitors can do anything but slow the number of licenses being taken away.

所以我不確定各種補體抑制策略具體是什麼，但我確實很有信心：現在已有四家公司顯示 RPE 移植可以提升患者視力。因此，如果你想衡量像駕駛能力這樣的影響，我認為 RPE 移植會讓更多人重新拿到駕照；而我不認為補體抑制劑能做的事情超過「減緩駕照被吊銷的人數」。

Awesome. That's very helpful comment. And then just to round it out on the RPE space. I did see from someone, a picture of the Roche boost at ARVO, I believe it was. And it seems like they are flagging the OpRegen program. I wasn't sure if you had any comments there.

太棒了。這個評論非常有幫助。然後再把 RPE 領域的部分補完整一點。我確實看到有人在 ARVO 上拍了一張 Roche 的展位照片，我想應該是在 ARVO。看起來他們正在強調 OpRegen 計畫。我不確定你對此是否有任何評論。

And then my other kind of follow-up question was on the DOSED study of OPC1 and if there were any updates surrounding the CIRM grant application there as well?

然後我另一個後續問題是關於 OPC1 的 DOSED 研究，以及那邊 CIRM 補助申請是否也有任何最新進展？

Thanks, Jack, for the question. Yes, Genentech did have space at ARVO, which is one of the major ophthalmology medical meetings of the year. That floor space on the exhibit hall, to my recollection, there were two areas. There was an area on one side that had a mention of a number of different product candidates, and that's where OpRegen lived.

謝謝你，Jack，提出這個問題。是的，Genentech 在 ARVO 確實有展位；ARVO 是一年當中主要的眼科醫學會議之一。就我記憶所及，他們在展覽館的那塊展區有兩個區域。一側有提到多個不同的產品候選項目，而 OpRegen 就在那裡。

There was another area that was dedicated to the science of RPE transplants. I don't think it was dedicated to OpRegen per se, but I'm not aware of any other RPE transplants in the program -- in their pipeline. So everyone can decide for themselves what it means that Genentech elected to utilize half of their booth space at ARVO in their ophthalmology section to communicating information about RPE transplants.

另一個區域則是專門介紹 RPE 移植的科學。我不認為那是專門為 OpRegen 而設，但我也不知道他們的研發管線中還有其他 RPE 移植項目。所以大家可以自行解讀：Genentech 選擇在 ARVO 的眼科展區中，用一半的攤位空間來傳達 RPE 移植相關資訊，這代表什麼。

My view of that is they're running an open-label study. We've got multiple independent examples that we can really have some positive effects in patients and that that's important to communicate to future users of this kind of technology. So I take it as an incredible positive. But others -- I don't know, I take it as a positive.

我對此的看法是：他們正在進行一項開放標籤研究。我們已經有多個獨立案例顯示，確實能在病患身上產生一些正向效果，而把這些資訊傳達給未來使用這類技術的人很重要。所以我把它視為非常正面的訊號。不過其他人——我不知道，我自己是把它當作正面。

Moving to DOSED and CIRM, we applied for a CIRM grant, reapplied rather for a CIRM grant. We did not receive one in the first cycle. We do not know if we will receive one in the second cycle, but we applied or reapplied rather in January. And later this summer, I believe CIRM will be getting together and having a decision.

談到 DOSED 和 CIRM，我們申請了 CIRM 補助，應該說是重新申請 CIRM 補助。我們在第一輪沒有拿到。我們不知道第二輪是否會拿到，但我們是在 1 月提出申請（或重新申請）。我相信今年夏天稍晚，CIRM 會開會並做出決定。

If we get the CIRM grant, that is a wonderful pickup. But as I shared after we did not receive the grant the first time, it does not have a material impact on this program. So I'm hopeful that we get it. If we do not, the program will continue, and we are looking forward to moving the DOSED study ahead and introducing our internally made cells into the ongoing DOSED trial.

如果我們拿到 CIRM 補助，那會是很棒的助力。但如同我在第一次未獲補助後分享過的，這對該計畫並不會造成實質性的影響。所以我希望能拿到；如果沒有，計畫也會繼續。我們期待推進 DOSED 研究，並把我們內部製造的細胞導入正在進行的 DOSED 試驗中。

Joe Pantginis, H.C. Wainwright.

Joe Pantginis，H.C. Wainwright。

So Brian, I wanted to start with the ILT1 program. And I know the answer is probably going to be, we just need to do the experiment. But you mentioned how you really need to scale up and be confident around your scale up around the baseline pluripotent cells. Now when you look to then take those cells and differentiate them into the ILT cells, what are the risks that, if any, I mean, a, you have to go through your differentiation process and any of those processes providing any risk with regard to, say, impacting scale up once you hit the ILT portion?

Brian，我想先從 ILT1 計畫開始。我知道答案可能會是「我們就是得做實驗」。但你提到你們確實需要放大規模，並且要對基礎的多能性細胞（pluripotent cells）的放大規模有信心。那當你把這些細胞再進一步分化成 ILT 細胞時，是否存在風險——如果有的話——也就是說，a，你必須走過分化流程，而這些流程是否會帶來任何風險，例如在進入 ILT 階段後影響放大規模？

Joe, it's an excellent question. And if it were easy to differentiate these cells into islets, we wouldn't -- we, the field, wouldn't have a problem with scale-up. Islet cells are unlike RPE, -- they are unlike auditory neurons. They do not like to expand in culture. So we can do a lot of expansion of our RPE after they've become RPE. They can continue to divide.

Joe，這是個非常好的問題。如果把這些細胞分化成胰島細胞很容易的話，我們——也就是整個領域——就不會在放大規模上遇到問題。胰島細胞不同於 RPE——也不同於聽覺神經元——它們不喜歡在培養中擴增。所以我們的 RPE 在成為 RPE 之後仍然可以做大量擴增，它們可以持續分裂。

Islet cells don't like to divide once they become islets. So you lose the ability to expand into greater numbers during differentiation, and again, post differentiation. So you have to focus on pre-differentiation. But there is absolutely risk at every step of the way. Everything that you might imagine as having an impact on your production is a valid risk, because cell production is so sensitive to the process.

胰島細胞一旦成為胰島後就不太願意分裂。因此在分化過程中、以及分化之後，你都失去了把數量擴增到更大規模的能力。所以你必須把重點放在分化之前。但在每一步都絕對存在風險。任何你能想像會影響產量的因素都是合理風險，因為細胞製造對流程非常敏感。

So it would be inaccurate of me to suggest that just because we could make a huge number of undifferentiated cells that I can pledge that those will easily and fully be converted into islet cells. Differentiation of pluripotent cells into specific cell types is very difficult.

所以，如果我因為能製造大量未分化細胞，就承諾這些細胞能夠輕鬆且完整地轉換成胰島細胞，那是不準確的。把多能性細胞分化成特定細胞類型是非常困難的。

But -- having said all of that, we've had a lot of success, more success than most. And I said a little bit about this about talking about AlloSCOPE and what we've done in a GMP environment, getting into the clinic. So we've gotten past FDA. These are things that I think a lot of companies talk about but haven't yet successfully done.

不過——話雖如此——我們已經取得很多成功，比大多數人更成功。我也稍微提到過，談到 AlloSCOPE 以及我們在 GMP 環境中所做的事情、並推進到臨床。所以我們已經通過 FDA。這些是我認為很多公司會談論、但尚未真正成功做到的事情。

So there's a lot of talk in the field. And I think we've been able to demonstrate some very credible success. We've reduced to practice, some very difficult things.

所以這個領域有很多討論。而我認為我們已經能夠展現一些非常可信的成功。我們把一些非常困難的事情落實到可操作的實務（reduced to practice）。

So I think that we've got confidence in the team's ability to be successful, but it simply doesn't matter. If you cannot generate enough starting material, you will never have a commercially viable product. So step one, I've been really clear about this once we launched the program. Step one is just showing that we can do a proof of concept at very small scale.

因此我認為我們對團隊成功的能力有信心，但這其實不重要：如果你無法產生足夠的起始材料，你就永遠不會有具商業可行性的產品。所以第一步——自從我們啟動這個計畫後我就講得很清楚——第一步就是在非常小的規模下證明概念可行。

Step two is moving up to a more moderate scale. That would be multiple leaders. That work is ongoing. And then step three would be to start to work with specific lines that we already know are capable of becoming islet cells.

第二步是提升到較中等的規模，也就是多個批次（multiple lots）。這項工作正在進行中。然後第三步則是開始使用我們已經知道具備分化成胰島細胞能力的特定細胞株來進行。

So it's a step-wise sequential risk-reducing approach that also is maintaining our investment in the program in an appropriate way. So these all represent go/no-go decision points that we could make. So if we run into a problem and we can't get somewhere, we can elect to stop the program, and we wouldn't be stuck with all this fixed investment and all of this infrastructure.

所以這是一種循序漸進、逐步降低風險的方法，同時也以適當方式維持我們在該計畫上的投入。這些都代表我們可以做出繼續/停止（go/no-go）的決策點。因此如果我們遇到問題、無法達到某個階段，我們可以選擇停止計畫，而不會被所有固定投入與基礎設施綁住。

So I think we're doing it in a really smart way. We've been very committed to trying to keep our spending in the neighborhood of $30 million a year, which we've done for multiple years now. And I think that's appropriate, because we are still waiting for an update that perhaps could change our share price. And until that occurs, we want to be really prudent and thoughtful about how we deploy our capital into these new initiatives.

所以我認為我們做得非常聰明。我們一直很致力於把支出控制在每年約 3,000 萬美元的範圍內，而我們也已經連續多年做到。我認為這是合適的，因為我們仍在等待某個更新，該更新或許能改變我們的股價。在那之前，我們希望在如何把資本投入這些新計畫上保持非常審慎與周全。

But again, as I said, we're able to manage multiple programs in part because they do have some similarity across them. The equipment that we do this in, the facility that we do this in, the team that we rely on, there are a lot of similarities here, and that's how we're able to manage five, six, seven, eight programs simultaneously.

但再說一次，如我所說，我們之所以能管理多個計畫，部分原因是它們之間確實有一些相似性。我們使用的設備、進行作業的設施、以及我們依賴的團隊，都有很多相似之處，這也是我們能同時管理五個、六個、七個、八個計畫的原因。

No, that's very helpful. And you took the words out of my mouth with regard to leveraging the successes that you've had. So I appreciate the answers.

不，這非常有幫助。而且你也把我想說的話講出來了——關於如何利用你們已經取得的成功。所以我很感謝你的回答。

And then with the ReSonance, and this is going into the scientific weeds again. ReSonance program, you did mention that you now have a novel model of deafening. So just curious any more details you could provide with this model? Are these genetically genetic-based deafness? Or is it chemically or environmentally induced deafness and why it might be relevant to the cells that you're going to be injecting?

然後關於 ReSonance，我又要深入科學細節了。你提到 ReSonance 計畫現在有一個新的致聾模型。想請教你能否提供更多關於這個模型的細節？這是基因／遺傳型的耳聾嗎？還是化學或環境誘導的耳聾？以及為什麼它可能與你們將要注射的細胞相關？

Yes. Thank you. We wouldn't be putting cells into humans that have got fully intact cellular capability. So we need to model disease condition, which means we need to destroy or cause the existing cells to be dysfunctional. There are multiple ways of doing that. Chemical induction is pretty standard. So there are different compounds and different concentrations and different times that people can use to essentially destroy a population of auditory neurons.

是的，謝謝。我們不會把細胞放進那些細胞功能仍然完全完整的人體中。所以我們需要建立疾病狀態的模型，也就是需要破壞或使既有細胞失能。有多種方式可以做到。化學誘導是相當標準的方法。所以人們可以使用不同化合物、不同濃度、不同時間，來基本上摧毀一群聽覺神經元。

And then you would take that model. And of course, you would then add your test article, you would deliver the cells and see if they are able to bring some of the hearing from your original baseline down to reduced capability, see if you can bring some of that capability back. These approaches, then the literature have largely been unsuccessful, but largely been performed using various mesenchymal stem cell preparations. So I don't know if those can work even under the best conditions.

然後你會使用那個模型。當然，接著你會加入你的測試品（test article），把細胞送入並觀察它們是否能把聽力從原本基線被降低後的狀態，恢復一部分能力，看看能否把部分能力帶回來。這些方法在文獻中大多未能成功，但多半是使用各種間質幹細胞（mesenchymal stem cell）的製備來做。所以我不知道那些在最佳條件下是否真的能奏效。

But we've needed to develop our own model, because this is very innovative work, and you can't go to one of the vendors and say, I'm going to send you my cells, please use them in your very well-established and regulatory familiar animal model of deafening. Even as to your selection of species, you've got different cochlea that are different sizes and anatomical changes. And it's actually difficult to develop a model that you feel is going to give you reliable information when you introduce the test article to that model.

但我們需要開發自己的模型，因為這是非常創新的工作，你無法去找某個供應商說：我要把我的細胞寄給你，請你用你那個非常成熟、且監管單位熟悉的動物致聾模型來測試。即便在物種選擇上，不同物種的耳蝸大小不同、解剖結構也有差異。而且要建立一個你覺得在把測試品導入後能提供可靠資訊的模型，其實是困難的。

But we think we have one now, and this has always been part of the plan. You establish a model and then you utilize your cells in the model. So we've, I guess, achieved an important, albeit relatively quiet milestone of creating a model of deafening that we can now use with our test article and see what occurs in response. And I think if we are successful in being able to affect hearing or at least minimally brain signaling from the ear in these models, I think that's an important finding and bodes well for future development and moving into human testing.

但我們認為現在已經有了，而且這一直都是計畫的一部分。你先建立一個模型，然後在模型中使用你的細胞。所以我們，我想，已經達成了一個重要但相對低調的里程碑：建立了一個失聰模型，現在我們可以用我們的測試品在這個模型中進行測試，看看會出現什麼反應。我認為如果我們成功在這些模型中影響聽覺，或至少在最低限度上影響從耳朵到大腦的訊號傳遞，那將是一個重要的發現，並且對未來的開發以及推進到人體試驗是個好兆頭。

Great. Thank you, Brian.

很好。謝謝你，Brian。

I think, Joe, it's just a follow-up that you didn't ask for. Many years ago, I remember working at this company where we had rat data using our RPE cells. And I'm quite sure at that time, I did not think that I was going to see the kinds of treatment effects that we've seen more recently. So it sounds preliminary to be talking about animal models and having to create your own models, but time goes by and then you find yourself with a nearly $700 million partnership with big pharma. And so I'm hopeful that some of the things that we are doing in hearing loss, while they don't have a precedent per se, there was no precedent for RPE cells either.

我想，Joe，這只是你沒有問到的一個補充。很多年前，我記得我在一家公司工作時，我們用我們的 RPE 細胞做過大鼠數據。我很確定在那個時候，我並不認為我會看到我們近來所看到的那種治療效果。所以，談到動物模型以及必須自己建立模型聽起來很初步，但時間一久，你就會發現自己與大型藥廠達成了將近 7 億美元的合作夥伴關係。因此我很期待，我們在聽力損失方面所做的一些事情，雖然本身沒有先例，但 RPE 細胞當時也同樣沒有先例。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

A couple from us. On OPC1, can you speak to the requisite safety waiting period and challenges identifying and getting patients into the DOSED study? Maybe what are your expectations for cadence of new patients to get enrolled and treated moving forward now that the second patient has been treated?

我們有兩個問題。關於 OPC1，你能談談所需的安全性等待期，以及在 DOSED 研究中辨識並讓病患入組所面臨的挑戰嗎？也許也請談談，在第二位病患已接受治療之後，你對未來新病患入組與接受治療的節奏有何預期？

And then just secondarily on COR1, can you speak to the currently available interventions for FECD in the US and the unmet need there, perhaps a sense for the low-hanging fruit for a cell therapy and key differences or limitations for the cell therapy approach relative to procedures like DMEK?

另外，關於 COR1，你能談談目前在美國針對 FECD 可用的介入方式與未被滿足的需求嗎？也請分享一下，對細胞治療而言有哪些「低垂的果實」，以及相較於像 DMEK 這類手術程序，細胞治療途徑的主要差異或限制是什麼？

Thank you, Sean. Good questions. With respect to OPC1, we've got two groups of patients that are part of this device study: chronic injuries, which are from 1 to 5 years; and subacute injuries, which are from 21 to 42 days. These patient journeys are very different from not just the anatomical or procedural changes, but emotional changes and where these individuals are in their lives. And you can imagine that they also represent an incredible spectrum of perspectives as to their interest in participating in clinical trials.

謝謝你，Sean。問題很好。就 OPC1 而言，這項器械研究包含兩組病患：慢性損傷，發生於 1 到 5 年；以及亞急性損傷，發生於 21 到 42 天。這兩類病患的就醫歷程非常不同，不僅在解剖或手術程序上的變化不同，在情緒變化以及這些人所處的人生階段也不同。你可以想像，他們對參與臨床試驗的興趣也呈現非常廣泛的光譜。

So for example, there are some individuals who have had chronic injuries, and for years, they have had no changes. And when they are presented with an opportunity to participate in a study like this, it sounds very exciting. There are other people who, when they find out that it involves a surgical intervention are not interested, because there is no amount of risk that they are willing to tolerate, which could change their function.

例如，有些人是慢性損傷，多年來都沒有任何變化。當他們被提供參與這樣研究的機會時，會覺得非常令人振奮。也有一些人，一得知需要外科介入就不感興趣，因為他們不願承擔任何可能改變其功能的風險。

And that is applicable also for a subacute patient. It's just that they are in a different situation because the injury is so new, it's just weeks old and the evaluation consideration is, I would say, even scarier because you're still sort of trying to reconcile.

這一點對亞急性病患也適用，只是他們處於不同情境，因為損傷非常新，才幾週而已；在評估與考量上，我會說甚至更令人害怕，因為你仍在某種程度上試著調適與接受。

Between those two groups, I would say that chronic is generally easier to enroll because these are individuals who are in the community and they can be reached more easily, whereas a subacute injury unfortunately requires a tragic incident to occur, and that incident has to happen near one of our sites, and then they have to qualify as well.

在這兩組之間，我會說慢性病患通常較容易入組，因為這些人已回到社區生活，也比較容易聯繫；而亞急性損傷不幸地需要一場悲劇事件發生，而且該事件必須發生在我們某個研究中心附近，之後他們還必須符合納入條件。

So it's always been very difficult to find subacute patients. And I assume that we will find our chronic patients before we find our subacute patients. It is helpful that we've opened a second site. And I think as we go forward and learn more, there can be additional sites that we can bring on and have a wider net. But it does not surprise me at all that the first two patients were chronic for the reasons that I shared.

因此，尋找亞急性病患一直都非常困難。我推測我們會先找到慢性病患，才會找到亞急性病患。開設第二個研究中心確實有幫助。我認為隨著我們持續推進並學到更多，還可以新增更多研究中心，擴大覆蓋範圍。但基於我分享的原因，前兩位病患是慢性個案，這完全不令我意外。

To try to address your second question around COR1, DMEK is utilizing cadaver sources of cells. So there are sort of multiple ways that you might envision the competitive landscape. One is we look at cadaver-sourced cells as being variable. You don't know who was in that car accident or whatever happened and they have an eyeball available.

針對你第二個關於 COR1 的問題，DMEK 是使用屍體來源的細胞。因此你可以用多種方式來想像競爭格局。其中一種是，我們認為屍體來源細胞具有變異性。你不知道那位捐贈者是遭遇車禍或其他什麼情況，才會有眼球可用。

And so you've got a variability concern, and you also have a temporal concern. You have to move quickly to acquire that donor material, prepare it, deliver it to a site. And so we don't -- and there's not enough supply. So we think that cadaver sources are not particularly useful.

所以你會有變異性的疑慮，也會有時間性的疑慮。你必須迅速取得捐贈材料、完成製備、再配送到研究或手術地點。而且供應量也不足。因此我們認為屍體來源並不是特別有用。

But there are some very interesting companies in the space, Aurion, Emmecell, Cellusion, these are three of them that we remain mindful of. Aurion is actually not even Aurion anymore. It's Alcon. Alcon acquired Aurion and they have an ongoing Phase III using cadaver cells. They just harvest the cadaver cells and then they passage them a number of times in order to increase the amount of supply.

不過在這個領域也有一些非常有意思的公司，例如 Aurion、Emmecell、Cellusion，這三家是我們持續關注的。Aurion 其實已經不再是 Aurion 了，而是 Alcon。Alcon 收購了 Aurion，他們正在進行一項使用屍體細胞的第三期試驗。他們採集屍體細胞，然後進行多次傳代，以增加供應量。

And while I don't know if the number was made public, our understanding is that it was quite an interesting acquisition for that company. So that's only a partial solution. I think if we are able to generate in the best case, an off-the-shelf low cost of production, cryopreserved formulation, we could essentially stockpile identical material that could be used for these procedures by schedule rather than being beholden to the unfortunate donor supply.

雖然我不知道相關數字是否公開，但我們的理解是，對那家公司而言這是一筆相當有意思的收購。因此那只是一個部分解方。我認為如果我們在最佳情況下能夠做出可即取即用、低生產成本、可冷凍保存的製劑，我們基本上就能囤積同質一致的材料，讓這些手術能依排程使用，而不是受制於不幸且有限的捐贈供應。

So it's quite exciting as a product profile. It is early. We are just now making these cells. But again, I really can't emphasize enough that perhaps value should be ascribed to companies when they are manufacturing the cells because we already know that these cells have been shown in others' hands to be successful, not just through preclinical testing, clinical testing, but even in commercial setting.

因此就產品輪廓而言相當令人振奮。當然目前仍在早期，我們才剛開始製造這些細胞。但我仍要強調，或許公司在「製造細胞」這件事上就應該被賦予價值，因為我們已經知道，這些細胞在他人手中已被證明是成功的，不僅在臨床前與臨床測試中，甚至在商業化環境中也是如此。

And there's an approved product in Japan using cadaver-sourced cells. So it's very exciting to know, and I put know in quotation marks for all the risks that obviously are inherent in product development. But we don't have mechanistic questions about whether CEnCs can improve vision in corneal endothelial diseases. That question has already been answered. And that is such a completely different risk profile than many years ago when I worked at a company like Neurocrine Biosciences, and we'd have an early-stage small molecule that hit a target really nicely, but you have absolutely no idea if it's going to be successful in preclinical testing, let alone clinical testing.

而且日本已有一個使用屍體來源細胞的核准產品。所以能夠知道這點非常令人振奮——我把「知道」加上引號，是因為產品開發顯然仍有其固有風險。但我們並沒有機轉上的疑問：CEnCs 是否能改善角膜內皮疾病的視力？這個問題已經被回答了。這與多年前我在 Neurocrine Biosciences 這類公司工作時的風險輪廓完全不同；當時我們可能有一個早期小分子藥物很漂亮地命中靶點，但你完全不知道它是否能在臨床前測試成功，更不用說臨床測試。

So it's one of the reasons that I love this area of medicine so much is that you have the opportunity to create so many changes and use precedent from other sources, but still provide an important and valuable solution by having an off-the-shelf alternative to donor cell material that is used in indications like endothelial diseases or type 1 diabetes.

這也是我如此熱愛這個醫療領域的原因之一：你有機會帶來許多改變，並利用其他來源的先例，同時仍能提供重要且有價值的解決方案——也就是提供一個可即取即用的替代方案，取代在內皮疾病或第一型糖尿病等適應症中所使用的捐贈細胞材料。

There are no further questions at this time. I will now turn the call back over to Brian Culley for any closing comments.

目前沒有其他問題。我現在把電話交回給 Brian Culley，請他做結語。

Yes. Thanks, everyone. Our focus on replacing cells that have become dysfunctional might someday reshape many treatment paradigms, and we really thank you for joining us on this mission. Have a great day.

好的。謝謝各位。我們專注於替換已失能的細胞，未來某一天可能會重塑許多治療典範，我們也非常感謝各位加入我們的使命。祝各位有美好的一天。

Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect.

各位女士先生，今天的電話會議到此結束。感謝各位參與，現在可以掛線。