Lineage Cell Therapeutics Inc (LCTX) 2025 Q4 法說會逐字稿

Welcome to the Lineage Cell Therapeutics third-quarter (sic – "fourth-quarter") 2025 conference call. (Operator Instructions) An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. And recordings, reproductions or transmission of this call without the express written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.

歡迎參加 Lineage Cell Therapeutics 2025 年第三季（原文為「第四季」）電話會議。（操作說明）本次電話會議的音訊網路直播可在Lineage公司網站www.lineagecell.com的投資者關係版位收聽。本次電話會議受版權保護，版權歸Lineage公司所有。未經 Lineage 的明確書面同意，嚴禁錄製、複製或傳播此通話。再次提醒，今天的通話將會被錄音。

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.

現在我謹向大家介紹今天電話會議的主持人，Lineage 投資者關係主管 Ioana Hone。霍恩女士，請繼續。

Thank you, Jamie. Good afternoon, and thank you for joining us. A press release reporting our fourth quarter and full year 2025 financial results was issued earlier today, March 5, 2026, and can be found on the Investors section of our website. 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.

謝謝你，傑米。下午好，感謝各位的參與。我們於今天（2026 年 3 月 5 日）早些時候發布了 2025 年第四季度和全年財務業績的新聞稿，該新聞稿可在我們網站的投資者關係部分找到。請注意，今天發表的演講和對您問題的回答僅反映管理層截至今天的觀點，並且包含聯邦證券法意義上的前瞻性陳述。

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.

本次討論中所作的非歷史事實陳述應視為前瞻性陳述，這些陳述存在重大風險和不確定性。本公司的實際業績或表現可能與此類前瞻性聲明所暗示的預期有重大差異。

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 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.

有關可能導致公司業績或表現出現差異的某些因素的討論，請參閱今天新聞稿中的前瞻性聲明部分以及公司向美國證券交易委員會提交的文件，包括今天提交的最新年度報告（10-K 表格）。我們提醒您不要過度依賴任何前瞻性陳述，這些陳述僅代表截至今日的觀點，並受我們向美國證券交易委員會提交的文件中所述的警示性聲明和風險因素的限制。

With us today are Brian Culley, our Chief Executive Officer; and Jill Howe, our Chief Financial Officer. I'll now hand the call over to Brian.

今天陪同我們出席的有我們的執行長布萊恩·庫利和財務長吉爾·豪。現在我將把電話交給布萊恩。

Thank you, Ioana, and good afternoon, everyone. We appreciate you taking the time to join us on the call today. We have a great call planned, highlighted by recent warrant exercises that further extend our runway, and a positive result for our initial go/no-go development milestone in our Islet cell research initiative.

謝謝你，伊奧娜，大家下午好。感謝您今天抽空參加我們的電話會議。我們計劃召開一次非常棒的電話會議，重點是最近的認股權證行使進一步延長了我們的資金儲備，以及我們在胰島細胞研究計劃的初步推進/終止開發里程碑取得了積極成果。

I want to start by reminding everyone that we have a significant number of employees who live and work in Israel. And while our manufacturing facility is not located near a metropolitan center, some of our staff do commute from larger cities. Their safety is our top priority, and we are, of course, monitoring the situation.

首先我想提醒大家，我們有相當數量的員工在以色列生活和工作。雖然我們的生產設施不在大都會中心附近，但我們的一些員工確實從大城市通勤過來。他們的安全是我們的首要任務，我們當然會密切關注事態發展。

To date and as expected, a few employees and employee spouses have been called into military service, which is similar to what we've experienced and successfully navigated in 2023. We cannot know what the future holds, but thanks to the incredible dedication of the team we've hired, our operations are continuing, and we expect things will continue to progress. Thank you also for the many messages of concern and support I've received from our colleagues and shareholders alike

到目前為止，正如預期的那樣，一些員工和員工配偶已被徵召入伍，這與我們 2023 年經歷並成功應對的情況類似。我們無法預知未來，但由於我們聘請的團隊的卓越奉獻精神，我們的營運得以繼續，我們預計事情會繼續取得進展。也感謝各位同事和股東發出的眾多關心與支持的訊息。

Moving ahead, as many of you know, cell therapy has revolutionized oncology, saving lives and creating tremendous shareholder value. But the use of cell therapy in oncology is maturing. While the application of cell therapy to fields outside of cancer remains in the early stages. For this reason, we are focused on delivering the next wave of innovation and value creation in this emerging branch of medicine.

展望未來，正如你們許多人所知，細胞療法徹底改變了腫瘤學，拯救了生命，並創造了巨大的股東價值。但細胞療法在腫瘤學的應用正在日趨成熟。雖然細胞療法在癌症以外的領域的應用仍處於早期階段。因此，我們致力於在這個新興醫學領域帶來下一波創新和價值創造。

We'll begin with the exciting results seen from our lead program in geographic atrophy as a testimonial to what cell therapy is capable of. And as that program matures, we have begun turning our focus to how we can apply our manufacturing success and the lessons we have learned from the OpRegen program to evaluate other medical conditions that also arise from the loss of critical cellular function. Our focus on replacing cells that have become dysfunctional or destroyed may fundamentally reshape many treatment and recovery paradigms.

我們將首先介紹我們在地理萎縮症治療領域取得的令人振奮的成果，以此證明細胞療法的潛力。隨著該專案的成熟，我們開始將重點轉向如何將我們在製造方面的成功經驗以及從 OpRegen 專案中學到的經驗教訓應用於評估其他因關鍵細胞功能喪失而引起的疾病。我們專注於替換功能失調或被破壞的細胞，這可能會從根本上改變許多治療和復健模式。

And based on our conviction that the OpRegen program has the potential to drive future value, we believe we are uniquely positioned to capitalize on opportunities to develop other kinds of mature differentiated cells for patients, which, in our view, could lead to clinical outcomes currently beyond the reach of conventional approaches.

基於我們對 OpRegen 計畫具有推動未來價值的信念，我們相信我們擁有獨特的優勢，能夠抓住機遇，為患者開發其他類型的成熟分化細胞，我們認為，這些細胞有望帶來目前傳統方法無法企及的臨床療效。

Our work was productive last year, highlighted by us achieving the first milestone under our Roche Genentech alliance, entering into a funded research collaboration for preclinical development of ReSonance, which is our first internally developed product candidate, and more recently, the launch of our new Islet cell research initiative, something which I will provide an update on later in the call. But first, I want to discuss two developments in particular from last year that reinforce our confidence in the company's long-term outlook and which helped shape our plans for 2026.

去年我們的工作成果豐碩，亮點包括：在與羅氏基因泰克的聯盟下實現了第一個里程碑；開展了一項資助的研究合作，用於ReSonance的臨床前開發，ReSonance是我們第一個自主研發的候選產品；最近，我們啟動了新的胰島細胞研究計劃，稍後我將在電話會議中對此進行更新。但首先，我想重點討論去年兩項進展，這兩項進展增強了我們對公司長期前景的信心，並幫助我們制定了 2026 年的計劃。

First, after relying on just seven clinical sites for more than two years, Roche and Genentech have somewhat suddenly opened 10 new clinical sites in the GAlette study in the past nine months, including one announced earlier this week at Duke Eye Center.

首先，在兩年多的時間裡，羅氏和基因泰克一直依靠七個臨床中心進行 GAlette 研究，但在過去九個月裡，他們突然開設了 10 個新的臨床中心，其中包括本週早些時候在杜克眼科中心宣布開設的一個中心。

While we don't have any guidance to share on the timing of any additional trials or data disclosures, we view this surge of site openings as a favorable sign because this activity could support preparations for later-stage trials. And as I've shared on prior calls, there are other actions and readouts that have occurred in the past year that similarly suggest positive forward progress of OpRegen could be underway.

雖然我們目前沒有關於其他試驗或資料揭露時間的指導意見，但我們認為這次試驗點開放數量激增是一個好兆頭，因為這項活動可能有助於為後期試驗做好準備。正如我在之前的電話會議中分享的那樣，過去一年中發生的其他一些行動和結果也同樣表明 OpRegen 可能正在取得積極的進展。

The second item we enjoyed last year were the enhancements and milestones we hit with our manufacturing platform, AlloSCOPE. AlloSCOPE purposefully stands for allogeneic, scalable, consistent, off-the-shelf, Ppluripotent cell engineering. This acronym highlights the key elements of our core technology.

去年我們享受到的第二件大事是我們的製造平台 AlloSCOPE 的改進和里程碑。AlloSCOPE 刻意代表同種異體、可擴展、一致、現成的多能細胞工程。這個縮寫突顯了我們核心技術的關鍵要素。

Many of you are familiar with the challenges of autologous cell therapy, such as its high manufacturing cost and donor variability. But with AlloSCOPE, we address those challenges by using the same source cell line for all patients built on a platform we believe is capable of scaling into millions of doses and trillions of cells.

你們中的許多人都熟悉自體細胞療法的挑戰，例如其高昂的生產成本和捐贈者差異性。但透過 AlloSCOPE，我們利用相同的來源細胞系來應對這些挑戰，該細胞系建立在一個我們認為能夠擴展到數百萬劑和數萬億個細胞的平台上。

This is something that has long been aspired to or sometimes even promised by the field of allogeneic cell therapy. But to our knowledge, very few companies possibly none have actually shown that they can perform a large-scale pluripotent cell production process in a GMP setting and use that resulting material in an FDA-cleared clinical trial.

這是異體細胞治療領域長期以來一直渴望實現，有時甚至是承諾實現的目標。但據我們所知，很少有公司（可能沒有）真正證明他們能夠在符合 GMP 標準的環境下進行大規模多能幹細胞生產過程，並將所得材料用於 FDA 批准的臨床試驗。

But here at Lineage, we successfully established a GMP master cell bank from which we established a GMP working cell bank and generated product that has been used in the clinic. And because the hundreds of vials, which comprise those banks are identical, we are confident that we can successfully repeat the process as many times as needed.

但是，在 Lineage，我們成功建立了 GMP 主細胞庫，並由此建立了 GMP 工作細胞庫，並生產了臨床中使用的產品。由於組成這些庫的數百個小瓶子都是相同的，我們有信心根據需要多次成功重複這個過程。

We believe this achievement provides credible evidence that the AlloSCOPE cell banking system we built is capable of generating millions of vials of our product candidate. This is no small achievement because it's easy to say you plan to rely on the self-renewing capability of pluripotent cells to generate Phase 1 trial material. But with complex biologics like cell therapies, the process is the product.

我們相信，這項成就提供了可信的證據，證明我們建立的 AlloSCOPE 細胞庫系統能夠生產數百萬瓶我們的候選產品。這並非一項小成就，因為很容易說你計劃依靠多能幹細胞的自我更新能力來產生 1 期試驗材料。但對於細胞療法等複雜的生物製劑而言，過程本身就是一種產品。

So if your early clinical process isn't capable of satisfying commercial scale, then you're developing product candidate that won't be able to supply the market. This is an essential but often overlooked aspect of cell therapy product development and requires certain investments and commitments to occur in the early stages.

因此，如果你的早期臨床過程無法滿足商業規模的要求，那麼你開發的候選產品將無法供應市場。這是細胞治療產品開發中至關重要但經常被忽視的方面，需要在早期階段進行一定的投資和承諾。

As a company with many years of experience in this field, we have had the time to make these investments. This also explains why we embrace the mantra of better from the beginning. We strive to only initiate programs that have a clear line of sight to commercial scale and other critical product features.

作為一家在該領域擁有多年經驗的公司，我們有時間進行這些投資。這也解釋了為什麼我們始終秉持「一開始就做得更好」的理念。我們力求只啟動那些能夠清楚展現商業規模和其他關鍵產品特性的專案。

And from these two significant developments, specifically, the evidence supporting OpRegen's potential advancement by Genentech, along with the successful demonstration of commercially viable pluripotent cell production, we have developed the conviction to apply our platform to the furtherance of developing other cell-based products with the potential to treat various diseases and conditions.

基於這兩項重大進展，特別是基因泰克公司支持 OpRegen 潛在進展的證據，以及商業上可行的多能幹細胞生產的成功證明，我們確信可以將我們的平台應用於進一步開發其他基於細胞的產品，這些產品有可能治療各種疾病和病症。

I will say a few things about our recent and planned pipeline development later in the call. But first, I want to briefly review the status of our lead programs, OpRegen for dry AMD with geographic atrophy, OPC1 for spinal cord injury and ReSonance for hearing loss.

稍後我會在電話會議中談談我們近期和計劃中的管道開發項目。但首先，我想簡要回顧我們的主要項目進展情況，包括用於治療乾性老年黃斑部病變伴隨地圖狀萎縮的 OpRegen、用於治療脊髓損傷的 OPC1 以及用於治療聽力損失的 Resonance。

OpRegen is the most advanced program in our pipeline and serves as a critical case study for our approach to cell transplantation. Dry-AMD with GA is an increasingly established indication but suffers from underwhelming treatment options. Initial reports from our Phase 1/2a clinical study included improved anatomy, halting of atrophic progression and improved vision in patients with dry AMD and were unprecedented at the time.

OpRegen 是我們研發管線中最先進的項目，也是我們細胞移植方法的重要案例研究。乾性老年黃斑部病變伴隨地圖狀萎縮是一種日益確立的適應症，但治療選擇卻不盡人意。我們 1/2a 期臨床研究的初步報告顯示，乾性 AMD 患者的解剖結構得到改善，萎縮進展得到阻止，視力得到提高，這在當時是前所未有的。

And from Roche and Genentech's additional analysis of our Phase 1/2a data, it has been observed in a single dose of OpRegen cells can provide visual improvement lasting for at least three years among patients who received the cells at the target location. This is an exceptionally promising finding because dry AMD is a condition that has not been shown to self resolve and only leads to worsening vision.

羅氏和基因泰克對我們 1/2a 期數據的進一步分析表明，單次注射 OpRegen 細胞即可為接受標靶細胞治療的患者帶來至少持續三年的視覺改善。這是一個非常有希望的發現，因為乾性老年黃斑部病變是一種尚未被證實能夠自愈，只會導致視力惡化的疾病。

Equally importantly, three independent groups pursuing RPE transplants have recently reported short-term outcomes similar to ours, providing further evidence in support of this novel mechanism. Although data remains forthcoming from GAlette, Roche, and Genentech's ongoing Phase 2a study, it is encouraging to see that our partners have continued to expand the retinal communities exposure and experience with OpRegen.

同樣重要的是，最近有三個獨立的 RPE 移植研究小組報告了與我們類似的短期結果，為這種新機制提供了進一步的證據。儘管 GAlette、羅氏和基因泰克正在進行的 2a 期研究的數據尚未公佈，但令人鼓舞的是，我們的合作夥伴一直在不斷擴大視網膜社區對 OpRegen 的了解和體驗。

As a reminder, GAlette is a surgical optimization study designed for approximately 60 patients. This study has been running for three years and is an open-label study for which all primary and secondary outcome measures are captured in 90 days. So we infer that Roche has collected and reviewed long-term data from patients treated in that trial, which we expect has informed their recent site expansion decisions.

提醒一下，GAlette 是一項外科優化研究，設計對象約 60 名患者。這項研究已經進行了三年，是一項開放標籤研究，所有主要和次要結果指標均在 90 天內收集。因此，我們推斷羅氏公司已經收集並審查了該試驗中接受治療的患者的長期數據，我們認為這些數據為他們最近的試驗點擴展決策提供了依據。

Specifically, after adding only a single site in 2024, Genentech suddenly increased its pace and opened nine new clinical sites in 2025, bringing this study to a total of 17 unique locations, including the new site just added last week. In addition, Genentech previously acquired novel and proprietary surgical delivery devices from a competitor and sought and received RMAT designation for OpRegen.

具體來說，在 2024 年僅新增一個試驗點後，基因泰克公司突然加快了步伐，在 2025 年開設了九個新的臨床試驗點，使這項研究的試驗點總數達到 17 個，其中包括上週剛新增的試驗點。此外，基因泰克先前從競爭對手那裡收購了新型專有外科輸送裝置，並尋求並獲得了 OpRegen 的 RMAT 認證。

We believe these are all positive indicators that support our expectation of Roche and Genentech's continued advancement of the OpRegen program. And in December, Lineage received its first $5 million payment from the achievement of a development milestone, highlighting our contribution to this process.

我們認為這些都是正面的訊號，支持我們對羅氏和基因泰克繼續推進 OpRegen 計畫的預期。12 月，Lineage 因實現了開發里程碑而獲得了第一筆 500 萬美元的款項，這凸顯了我們對這一過程的貢獻。

When you aggregate these and other publicly available actions, we believe they point to a positive future. And while OpRegen reflects a new technology, we believe we have a set of attributes including scalable manufacturing, proprietary delivery tools, long-term safety and efficacy data, and a world-class partnership that adds abundant clinical insights and commercial capabilities. For these reasons and others, I hope you'll appreciate why we are so bullish on the potential for OpRegen to capture the multibillion and still largely unaddressed GA market. And also, while we are taking steps to try to recreate this promise with other cell types.

綜合這些以及其他公開訊息，我們相信它們預示著一個積極的未來。雖然 OpRegen 代表了一種新技術，但我們相信我們擁有一系列優勢，包括可擴展的生產、專有的輸送工具、長期的安全性和有效性數據，以及世界一流的合作夥伴關係，從而增加了豐富的臨床見解和商業能力。基於這些原因以及其他原因，我希望您能理解為什麼我們如此看好 OpRegen 能夠佔領數十億美元且仍未充分開發的 GA 市場。同時，我們也採取措施，嘗試用其他細胞類型重現這項成果。

Moving to our next cell type, oligodendrocyte progenitors. We are developing OPC1 an off-the-shelf cell transplant designed to increase mobility for people who suffered from a spinal cord injury. OPC1 has been administered in two Phase 1/2a -- 1/2 safety trials in sub-acute patients and the long-term safety and efficacy data we have collected so far is both promising and worthy of further investigation.

接下來我們來看看下一個細胞類型：少突膠質細胞祖細胞。我們正在開發 OPC1，這是一種現成的細胞移植產品，旨在提高脊髓損傷患者的活動能力。OPC1 已在兩項 1/2a 期 - 1/2 安全性試驗中用於亞急性患者，我們目前收集到的長期安全性和有效性數據既令人鼓舞，又值得進一步研究。

We currently are enrolling patients in the DOSED study, the third clinical study of OPC1 which is evaluating the safety of a novel and proprietary system to deliver ourselves to the area of injury without stopping patient ventilation. In addition to testing the safety and performance of the new device, we also will be collecting functional assessments on all patients, giving us the opportunity to investigate any signals of efficacy that may arise.

我們目前正在招募患者參與 DOSED 研究，這是 OPC1 的第三項臨床研究，旨在評估一種新型專有系統的安全性，該系統能夠在不停止患者通氣的情況下將我們輸送到受傷區域。除了測試新設備的安全性和性能外，我們還將收集所有患者的功能評估數據，以便我們有機會調查可能出現的任何療效訊號。

This is important because last year, we treated our first ever chronic SCI patient. That was an important milestone because chronic injuries represent an additional and larger potential addressable population for this experimental therapy. And unlike subacute patients many chronic patients have reached a functional plateau, making any physical improvement easier to detect and rely upon.

這很重要，因為去年我們治療了首例慢性脊髓損傷患者。這是一個重要的里程碑，因為慢性傷害代表著這項實驗性療法需要額外且更大的潛在目標族群。與亞急性患者不同，許多慢性患者的功能已經達到穩定期，因此任何身體上的改善都更容易被發現和重視。

DOSED is an open-label study and that first participant, I mentioned recently had their six-month safety follow-up visit with no significant safety events reported following treatment. Equally important, the device performed as planned, which provides significant derisking of the device that we plan to employ in a larger trial.

DOSED 是一項開放標籤研究，我最近提到的第一位參與者進行了六個月的安全隨訪，治療後沒有報告任何重大安全事件。同樣重要的是，該設備按計劃運行，這大大降低了我們計劃在更大規模的試驗中使用該設備的風險。

Last month, we expanded DOSED to the Greater Los Angeles area by opening our second clinical site at the Rancho Research Institute in conjunction with Rancho Los Amigos National Rehab Center. Jill and I have the pleasure of hosting Dr. Charles Liu, the principal investigator and his team for dinner a few weeks ago, and we are extremely excited to have their group involved with the OPC1 program.

上個月，我們與 Rancho Los Amigos 國家復健中心合作，在 Rancho Research Institute 開設了第二個臨床站點，將 DOSED 擴展到了大洛杉磯地區。幾週前，我和吉爾有幸招待了首席研究員查爾斯·劉博士及其團隊共進晚餐，我們非常高興他們的團隊能夠參與到 OPC1 項目中來。

Moving next to ReSonance. This is an auditory neuronal cell transplant being developed to treat hearing loss and also marks our first internally developed program. One of our goals during 2025 was to strike deals which partly are completely funded existing product candidates. We accomplished this goal through the partnership we announced with William Demant Invest, which is expected to fund all planned preclinical development for the AMP 1 program up to the IND stage.

接下來是 Resonance。這是正在研發的一種用於治療聽力損失的聽覺神經元細胞移植技術，也是我們第一個自主研發的計畫。我們在 2025 年的目標之一是達成部分或全部由現有候選產品提供資金的交易。我們透過與 William Demant Invest 宣布的合作關係實現了這一目標，預計該合作關係將為 AMP 1 計畫的所有計畫臨床前開發提供資金，直至 IND 階段。

ReSonance was an important test for our business model because it demonstrated that we could conceive of and successfully manufacture a completely new cell-based product candidate on our AlloSCOPE platform in a rapid and efficient way.

ReSonance 對我們的商業模式來說是一次重要的考驗，因為它證明了我們可以在 AlloSCOPE 平台上快速高效地構思並成功製造出一種全新的基於細胞的候選產品。

With a modest investment, we were able to generate new intellectual property and advanced ReSonance into preclinical testing within one year. This early data was sufficient to establish a partnership with a world-leading hearing health care company, which also brought us access to specialized technology, auditory experience and a network of hearing health leaders. We believe this collaboration was an important demonstration of the speed, efficiency and return on investment that the AlloSCOPE platform can provide and evidence of our ability to replicate our OpRegen collaboration success with another cell transplant program.

我們僅投入少量資金，就在一年內創造了新的智慧財產權，並將 Resonance 推進到臨床前測試階段。這些早期數據足以讓我們與一家世界領先的聽力保健公司建立合作關係，這也讓我們獲得了專業技術、聽覺經驗和聽力保健領導者網絡。我們相信，此次合作充分展現了 AlloSCOPE 平台的速度、效率和投資回報率，也證明了我們有能力將 OpRegen 合作的成功經驗複製到另一個細胞移植專案中。

I next will spend just a moment on AlloSCOPE to provide context to my upcoming remarks about our new Islet cell initiative. AlloSCOPE describes a platform on which we can bank and scale pluripotent cells to great numbers before differentiating those cells into discrete types of cells of the human body. It delivers what we consider to be the table stakes necessary to create a commercially successful allogeneic cell therapy, and it is being applied by us across multiple programs and cell lines.

接下來，我將花一點時間介紹 AlloSCOPE，以便為我即將談到的關於我們新的胰島細胞計劃提供一些背景資訊。AlloSCOPE 描述了一個平台，我們可以在該平台上儲存和大規模擴增能幹細胞，然後再將這些細胞分化成人體內各種類型的細胞。它具備我們認為創造商業上成功的同種異體細胞療法所需的基本條件，我們正在將其應用於多個項目和細胞系。

AlloSCOPE is a proprietary differentiation and production platform on which our cell-based products are derived from a single initial cell line, conferring consistent, cost-effective and scalable production. These features should enable us to support the production of millions of doses of a consistent and cost-effective cell-based product.

AlloSCOPE 是一個專有的分化和生產平台，我們的細胞產品均源自單一初始細胞系，從而實現了穩定、經濟高效且可擴展的生產。這些特性應該能夠支持生產數百萬劑穩定且經濟高效的細胞產品。

Using AlloSCOPE, we have successfully completed a cGMP production run from our two-tiered cell banking system for two of our product candidates, one of which has been utilized in the clinic. This achievement is notable because it demonstrates our ability to scale a process with the purity, potency, and regulatory quality required to support clinical use, a standard, which we believe sits beyond the reach of many companies and which can become a valuable differentiator for Lineage.

利用 AlloSCOPE，我們已成功完成了兩款候選產品的 cGMP 生產，其中一款已在臨床中使用。這項成就意義非凡，因為它證明了我們有能力以所需的純度、效力和監管品質來擴大生產規模，以支持臨床應用。我們認為，這項標準是許多公司無法企及的，並且可以成為 Lineage 的一項寶貴的差異化優勢。

With that background provided, I'll remind you that the human body is comprised of about 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 the development of additional potential product candidates.

有了這些背景知識，我提醒大家，人體由大約 200 種不同的細胞類型組成。由於多能幹細胞可以分化成這 200 種細胞類型中的任何一種，因此我們在將資源投入其他潛在候選產品的開發方面有很多選擇。

When thinking about where we might generate the greatest value from our process development and directed differentiation expertise, we recently announced a new research initiative in Type 1 diabetes and specifically, an opportunity we saw to address a major obstacle to a successful Type 1 diabetes cell transplant treatment.

在思考如何利用我們的製程開發和定向差異化專業知識創造最大價值時，我們最近宣布了一項針對 1 型糖尿病的新研究計劃，特別是我們看到的一個機會，即解決 1 型糖尿病細胞移植治療成功面臨的一個重大障礙。

We've been getting a lot of questions about our entry into this space. So I'm going to take your time today to walk you through our plans in some detail. The headline is that we met our initial internal go/no-go development milestone, which means we will continue to our next phase of internal development. Now I need to explain why that's important. We already know that Islet cell transplants can work.

我們收到了很多關於我們進軍這個領域的問題。所以今天我會花點時間，詳細地向你介紹我們的計劃。標題是：我們達到了最初的內部開發可行性/不可行性里程碑，這意味著我們將繼續進入下一階段的內部開發。現在我需要解釋為什麼這很重要。我們已經知道胰島細胞移植是可行的。

Dozens of patients are functionally cured each year using Islet cells from cadavers, meaning they can regulate -- patients can regulate their blood sugar without proactive and daily disease management. However, a major unsolved problem is supply. Cadavers cannot support a commercially viable source of Islet cells.

每年有數十名患者透過移植屍體中的胰島細胞而得到功能性治愈，這意味著他們可以調節血糖——患者無需主動進行日常疾病管理即可調節血糖。然而，供應問題仍然是一個尚未解決的重大難題。屍體無法作為具有商業可行性的胰島細胞來源。

Immunosuppression, patient eligibility and hypoimmunity are all additional hurdles that need to be overcome, but we believe the elephant in the room is that we know of no company that can make Islet at the scale required for a commercial product. And we believe the greatest value in the Islet cell transplant space will accrue to whoever solves that scale problem.

免疫抑制、病患資格和免疫力低下都是需要克服的額外障礙，但我們認為最大的問題是，我們不知道有哪家公司能夠以商業產品所需的規模生產胰島。我們相信，在胰島細胞移植領域，誰能解決規模問題，誰就能獲得最大的價值。

The explanation for this gap is that the required dose of Islet cells may be as high as 1 billion cells per patient, but mature Islet do not expand readily in culture. Meanwhile, our calculations indicate that commercial viability begins in the range of thousands of doses per batch, implying that commercially relevant processes will have to be done on the scale of at least an 80-liter bioreactor. But carrying out a differentiation process in an 80-liter vessel requires feeding that vessel with billions of undifferentiated stem cells, which retain their full flurry potency capability and their genetic stability. And that is the problem.

造成這種差距的原因是，每位患者所需的胰島細胞劑量可能高達 10 億個細胞，但成熟的胰島細胞在培養中不容易擴增。同時，我們的計算表明，商業可行性始於每批次數千劑的規模，這意味著具有商業意義的製程至少需要在 80 公升的生物反應器規模上進行。但是，要在 80 公升的容器中進行分化過程，需要在該容器中添加數十億個未分化的幹細胞，這些幹細胞保留了其全部的增殖能力和遺傳穩定性。這就是問題所在。

Conventional 3D expansion introduces excessive passaging risking loss of control and genetic aberrations but generating billions of cells required from conventional 2D approaches demands in practical surface areas and high aseptic risk. There is unavoidable conflict and trade-off between having reproducible control and scale.

傳統的 3D 擴增引入了過多的傳代，存在失去控制和遺傳異常的風險，但傳統的 2D 方法需要產生數十億個細胞，這要求實際表面積較大，且無菌操作風險較高。可重複控制和規模化之間存在不可避免的衝突和權衡。

Our strategy has two aspects. The first is to use the AlloSCOPE platform to combine the control advantages of 2D culture with the volumetric efficiency of 3D systems or what we refer to as 5D engineering. And I'm proud to report today for the first time that we have actually achieved this milestone and reduced it to practice multiple times at 0.5 liter scale, successfully reaching our first go/no-go decision point with this initiative. We're now evaluating whether we can translate this capability to the next step up into a multi leader vessel.

我們的策略包含兩個面向。首先，利用 AlloSCOPE 平台，將 2D 培養的控制優勢與 3D 系統的體積效率結合，也就是我們所謂的 5D 工程。今天，我很自豪地宣布，我們首次實現了這一里程碑，並在 0.5 升規模下多次實踐，成功地達到了這項計劃的第一個成功/失敗的決策點。我們現在正在評估是否可以將這種能力轉化為更高級的多領航艦艇。

Demonstrating reproducible performance at an even larger scale is the next step on the path to feeding 80-liter bioreactors of scale, which should be capable of producing thousands of therapeutic doses of Islet cells per run. Importantly, this work is all being done pre differentiation, which means this stage of development is not dependent on finalizing our immune suppression strategies.

在更大的規模上證明可重複的性能是通往 80 公升規模生物反應器的下一步，該反應器每次運行應該能夠生產數千劑治療劑量的胰島細胞。重要的是，所有這些工作都是在分化之前完成的，這意味著該發展階段並不依賴我們最終確定免疫抑制策略。

The second important aspect of our strategy is that we are looking to tackle the bioreactor feeding problem first. We are inverting the traditional development paradigm by focusing on the scale-up of undifferentiated cells, first, because once you've shown that you can actually produce your material at scale, we believe the risk profile for the rest of the Islet cells project changes materially. That's because we already know that Islet can be an effective intervention and have been shown by multiple groups to be successful in preclinical and clinical settings.

我們策略的第二個重要面向是，我們首先要解決生物反應器進料問題。我們正在顛覆傳統的開發模式，首先專注於未分化細胞的規模化生產，因為一旦你證明你可以大規模生產你的材料，我們相信胰島細胞計畫其餘部分的風險狀況將會發生實質變化。這是因為我們已經知道 Islet 可以是一種有效的干預措施，而多個研究小組已經證明它在臨床前和臨床環境中都取得了成功。

Similarly, editing strategies and differentiation protocols already exist and provide risk-reducing information in those areas. And we may be able to leverage that information if our scale initiative is successful. But no one yet has shown that they can scale Islets. We think it's far more prudent to focus first on the unresolved scale problem rather than performing years of expensive studies and deferring the issue of scale for later.

同樣，編輯策略和差異化協議已經存在，並提供了這些領域的風險降低資訊。如果我們的規模化計劃成功，我們或許可以利用這些資訊。但目前還沒有人證明他們能夠攀登這些島嶼。我們認為，與其花費數年時間進行昂貴的研究並將規模問題推遲到以後解決，不如先集中精力解決尚未解決的規模問題，這樣要明智得多。

Our strategy doesn't fit easily onto a bumper sticker. But if we wanted to print one, it might say better from the beginning. That is how I describe our development philosophy. We enter fields only when we can see the entire path from cell banking through commercial delivery. We look to identify clear go, no-go decision points along the way and we strive to include improvements or solutions to existing methods, processes, delivery or to the cells themselves in order to have the best overall product profile.

我們的策略無法簡單地用一張車貼來概括。但如果我們想印一份，最好從一開始就寫得更好。這就是我對我們發展理念的描述。只有當我們能夠看到從細胞庫建立到商業交付的整個路徑時，我們才會進入該領域。我們力求在過程中明確判斷是否可行或不可行，並努力改進現有方法、流程、交付方式或細胞本身，以獲得最佳的整體產品特性。

I'll conclude by saying that our platform generates assets which share certain essential traits in common, so that each dollar we spend on innovation may apply across multiple programs. While each product candidate is, of course, intended for a different condition and each cell line behaves in a unique manner, the early steps of banking, process development, control purity and scale have somewhat common features in the way we apply them, which allows us to expand the scope of our pipeline without losing the focus required to succeed in each indication, and uses our capital in an efficient way. I hope that it helps explain our exciting business update. And with that, I'll turn things over to Jill for a review of our financials.

最後我想說的是，我們的平台產生的資產具有某些共同的基本特徵，因此我們花在創新上的每一美元都可以應用於多個專案。當然，每個候選產品都針對不同的病症，每個細胞系的表現也各不相同，但我們在細胞庫建立、工藝開發、純度控制和規模化等方面的應用方式有一些共同的特點，這使我們能夠在不失去針對每種適應症取得成功所需專注力的情況下，擴展我們的產品線範圍，並以高效的方式利用我們的資金。希望這能幫助您了解我們令人興奮的業務最新進展。接下來，我將把財務報表交給吉爾進行審核。

Thanks, Brian. Before presenting our financial results, I want to address some points that may have caught your attention. The reported net loss for the full year is approximately $45 million higher than in 2024, this increase is mainly due to non-cash charges linked to our rising stock price over the year, which resulted in higher warrant liability. Additionally, we incurred a noncash charge relating to an asset we acquired in 2019, which we elected to no longer develop.

謝謝你，布萊恩。在公佈財務業績之前，我想先談談一些可能引起大家注意的重點。報告顯示，全年淨虧損比 2024 年高出約 4,500 萬美元，這一增長主要是由於與公司股價在一年內上漲相關的非現金支出，導致認股權證負債增加。此外，我們也產生了一筆與 2019 年收購的資產相關的非現金支出，我們選擇不再開發該資產。

You may have also noticed that the reported cost for option costs are higher this year. This is due to a standard accounting treatment applied when recording the expense associated with our downstream obligations after we received the first milestone from Roche Genentech. If you look at the expenses without this cost, the OpRegen developmental expenses were lower year-over-year.

您可能也注意到，今年報告的選擇權成本較高。這是由於在收到羅氏基因泰克公司的第一筆里程碑款項後，記錄與我們的下游義務相關的費用時採用了標準的會計處理方法。如果排除這項成本，OpRegen 的研發費用較去年同期降低。

As of December 31, 2025, our overall cash position was $55.8 million, which, together with the approximate $5.4 million in proceeds from warrants exercised this March is expected to support our planned operations into Q2 of 2028. This is a significantly higher runway than we guided to during our last call, with the biggest contributors being the $21 million in gross proceeds received from an ATM block trade in November, the warrant exercise of $5.4 million this week along with the achievement of the first $5 million milestone under our Roche collaboration.

截至 2025 年 12 月 31 日，我們的現金總額為 5,580 萬美元，加上今年 3 月行使認股權證所得的約 540 萬美元，預計將足以支持我們計劃營運至 2028 年第二季。這比我們上次電話會議中給出的預期要高得多，其中最大的貢獻者是 11 月透過 ATM 大宗交易獲得的 2,100 萬美元總收益、本週行使認股權證獲得的 540 萬美元，以及我們在與羅氏合作下實現的第一個 500 萬美元里程碑。

This revised guidance also does not take into account any other potential sources of funding, including additional milestone payments we are eligible for under our Roche collaboration, or any additional partnerships, which we may elect to enter into in the future.

這項修訂後的指導意見也沒有考慮到任何其他潛在的資金來源，包括我們根據與羅氏的合作有資格獲得的額外里程碑付款，或者我們將來可能選擇建立的任何其他合作夥伴關係。

Separately, a large additional source of potential capital is the approximately $32 million remaining of underlying warrants priced at $0.91 per share which is below our current trading price and which gets accelerated if Roche or Genentech publicly disclosed their intent to advance OpRegen into a clinical trial with the comparator arm.

此外，還有一大筆潛在的額外資金來源，即剩餘約 3,200 萬美元的基礎認股權證，每股價格為 0.91 美元，低於我們目前的交易價格。如果羅氏或基因泰克公開揭露其將 OpRegen 推進到與對照組進行臨床試驗的意圖，則這筆資金將加速成長。

Now I will review our fourth-quarter and full-year results. Total revenues for the fourth quarter were approximately $6.6 million, a net increase of $3.7 million as compared to the same period in 2024. The increase was primarily driven by higher collaboration revenue recognized under our collaboration and license agreement with Roche, following the achievement of the first milestone, along with the new research collaboration agreement with WDI.

現在我將回顧我們第四季和全年的業績。第四季總營收約 660 萬美元，比 2024 年同期淨成長 370 萬美元。成長主要得益於我們與羅氏的合作與授權協議在實現第一個里程碑後確認的更高合作收入，以及與 WDI 達成的新研究合作協議。

Total operating expenses for the fourth quarter were $13.2 million, an increase of $5.2 million as compared to the same period in 2024. R&D expenses for the fourth quarter were $8.2 million, an increase of $4.8 million as compared to the same period in 2024. The net increase was primarily driven by $2.1 million for our OpRegen program expenses and $2.7 million for our preclinical and other undisclosed programs.

第四季總營運支出為 1,320 萬美元，比 2024 年同期增加了 520 萬美元。第四季研發費用為 820 萬美元，比 2024 年同期增加了 480 萬美元。淨成長主要由 OpRegen 項目支出 210 萬美元和臨床前及其他未公開項目支出 270 萬美元推動。

G&A expenses for the fourth quarter were approximately $4.8 million, an increase of $0.4 million as compared to the same period in 2024. The net increase was primarily driven by personnel costs. Loss from operations for the fourth quarter was $6.5 million, an increase of $1.4 million as compared to the same period in 2024.

第四季一般及行政費用約 480 萬美元，比 2024 年同期增加了 40 萬美元。淨成長主要由人員成本驅動。第四季營運虧損為 650 萬美元，比 2024 年同期增加了 140 萬美元。

Other income expenses for the fourth quarter reflected other income of $2.2 million compared to other income of approximately $1.9 million for the same period in 2024. The net increase is primarily driven by exchange rate fluctuations related to Lineage's international subsidiaries. No warrant-related financing transaction costs incurred as compared to the prior year's quarter, and this was partially offset by the non-cash quarterly fair value remeasurement expenses of the warrant liabilities.

第四季的其他收入支出反映了其他收入為 220 萬美元，而 2024 年同期其他收入約為 190 萬美元。淨成長主要受 Lineage 國際子公司匯率波動的影響。與去年同期相比，未發生與認股權證相關的融資交易成本，但部分被認股權證負債的非現金季度公允價值重估費用所抵銷。

The net income loss attributable to Lineage for the 3 months ended December 31 with a net income of $0.9 million or $0.04 per share compared to a net loss of $3.3 million or $0.02 per share for the same period in 2024. Next, I'll spend a few minutes reviewing the full year operating results.

截至 2024 年 12 月 31 日止的三個月，歸屬於 Lineage 的淨收入為 90 萬美元，即每股 0.04 美元，而 2024 年同期淨虧損為 330 萬美元，即每股 0.02 美元。接下來，我將花幾分鐘時間回顧全年的經營績效。

Total revenues for the year were $14.6 million, an increase of $5.1 million as compared to the same period in 2024. This increase was primarily driven by higher collaboration revenue recognized under the Roche agreement following the achievement of the first milestone along with new research collaboration agreement with WDI.

本年度總收入為 1,460 萬美元，比 2024 年同期增加了 510 萬美元。這一增長主要是由於在實現第一個里程碑後，根據與羅氏的協議確認了更高的合作收入，以及與 WDI 達成了新的研究合作協議。

Total operating expenses for the full year were $51.2 million, an increase of $20.2 million as compared to the same period in 2024. This increase is primarily driven by $14.8 million of expenses recognized during the year for the loss on impairment of the intangible asset related to the VAC platform. R&D expenses for the full year were $17.7 million, an increase of approximately $5.2 million as compared to the same period in 2024. The increase is primarily driven by $1.6 million for our OpRegen program, $0.7 million increase for ANP1 program, and $0.2 million for our OPC1 program, and $2.8 million for our preclinical programs and other undisclosed programs.

全年營運總支出為 5,120 萬美元，比 2024 年同期增加了 2,020 萬美元。這一增長主要是由於本年度確認了與 VAC 平台相關的無形資產減損損失的 1,480 萬美元支出。全年研發費用為 1,770 萬美元，比 2024 年同期增加了約 520 萬美元。此次成長主要得益於 OpRegen 專案增加 160 萬美元，ANP1 專案增加 70 萬美元，OPC1 專案增加 20 萬美元，以及臨床前專案和其他未公開專案增加 280 萬美元。

G&A expenses for the full year were $18.5 million, an increase of approximately $0.3 million as compared to the same period in 2024. The net increase was primarily driven by $0.2 million in personnel costs and $0.1 million for services provided by third parties.

全年一般及行政費用為 1,850 萬美元，比 2024 年同期增加了約 30 萬美元。淨成長主要由人員成本增加 20 萬美元和第三方提供的服務成本增加 10 萬美元。

Loss from operations for the full year was $36.6 million, an increase of $15.1 million as compared to the same period in 2024. Other income expenses for the full year reflected other expenses of $32 million compared to other income of $2.9 million for the same period in 2024. The net change of $34.9 million was largely attributable to the non-cash fair value measurement expense of the warrant liabilities of $37.9 million, primarily due to an increase in our share price as compared to the prior year period.

全年營運虧損為 3,660 萬美元，比 2024 年同期增加了 1,510 萬美元。全年其他收入支出反映出其他支出為 3,200 萬美元，而 2024 年同期其他收入為 290 萬美元。淨變動 3,490 萬美元主要歸因於認股權證負債的非現金公允價值計量費用 3,790 萬美元，主要是由於與去年同期相比，我們的股價上漲所致。

This increase in expense was partially offset by exchange rate fluctuations related to Lineage's international subsidiaries and lower warrant-related transaction costs incurred as compared to the prior year in connection with the November 2024 financing. The net loss attributable to Lineage for the year ended December 31, 2025, was $63.5 million or $0.28 per share compared to a net loss of $18.6 million or $0.09 per share for 2024. The difference was primarily driven by the noncash fair value remeasurement of the warrant liabilities and the loss on impairment expense related to a 2019 acquisition.

支出增加的部分被 Lineage 國際子公司的匯率波動以及與前一年相比，2024 年 11 月融資中產生的認股權證相關交易成本降低所抵銷。截至 2025 年 12 月 31 日止年度，歸屬於 Lineage 的淨虧損為 6,350 萬美元，即每股虧損 0.28 美元，而 2024 年的淨虧損為 1,860 萬美元，即每股虧損 0.09 美元。差異主要源自於認股權證負債的非現金公允價值重新計量以及與 2019 年收購相關的減損費用損失。

Our financial results continue to reflect our ongoing 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. Let me hand the call back to Brian for concluding remarks.

我們的財務表現繼續反映了我們對負責任的財務管理的持續承諾，我們將繼續專注於平衡資本成本與我們為發展和加強產品線所做的投資。讓我把電話交還給布萊恩，請他做總結發言。

Thanks, Jill. I'll quickly summarize by repeating two key themes. First, we continue to remain confident in the potential for OpRegen to drive positive clinical outcomes in dry AMD and we're encouraged by our partner signs of commitment to the program. We also believe the independent evidence generated by others RPE cell transplant trials supports and elevates our replace and restore philosophy.

謝謝你，吉爾。我將透過重申兩個關鍵主題來快速總結。首先，我們仍然對 OpRegen 在乾性 AMD 治療中取得積極臨床療效的潛力充滿信心，並且我們對合作夥伴對該計畫的承諾表示鼓舞。我們也認為，其他 RPE 細胞移植試驗產生的獨立證據支持並提升了我們的替換和修復理念。

Second, we're preparing for a successful future by making new investments in our cell transplant platform and using our recent manufacturing innovations as a foundation from which additional pipeline programs can be advanced either by a funded partnerships or independently.

其次，我們正在為未來成功做好準備，對細胞移植平台進行新的投資，並以我們最近的製造創新為基礎，透過資助合作或獨立推進其他研發項目。

We believe our approach offers powerful optionality, which we consider essential for a company at our stage of growth and development. We appreciate your support and belief in our vision. With that operator, we are prepared to take analyst questions.

我們相信，我們的方法提供了強大的選擇權，我們認為這對於處於我們成長和發展階段的公司來說至關重要。我們感謝您對我們願景的支持與信任。有了這位操作員，我們就能夠回答分析師的問題了。

(Operator Instructions) Joe Pantginis, HC Wainwright.

（操作說明）Joe Pantginis，HC Wainwright。

Hey everybody, good afternoon. Thanks for taking the question. Actually, Brian, I have three questions, a strategic one, a technical one, and probably a question you can't answer. So first, on the strategic question, I mean, you have many ongoing programs now with specific cell types, and you also have this broader AlloSCOPE program with pluripotent cells ready to go. How do you look to potentially translate, say, over the longer term with regard to business development strategy around all your various options?

大家好，下午好。感謝您回答這個問題。實際上，布萊恩，我有三個問題，一個策略性問題，一個技術性問題，還有一個你可能回答不了的問題。首先，關於策略問題，我的意思是，你們現在有很多針對特定細胞類型的正在進行的項目，而且你們還有更廣泛的 AlloSCOPE 項目，其中多能幹細胞已經準備就緒。從長遠來看，您如何看待圍繞各種選擇的業務發展策略的轉換應用？

Thank you, Joe, for the first of those three questions. Again, excellent business development team. Clearly, I can point to the Roche Genentech transaction. I can point to the Demant deal. And of course, these are just things that you've seen, it is normal and common for us to have other interactions, maybe deals that could come together but don't for various reasons. So they're a reliable and productive group.

喬，謝謝你提出的第一個問題。再次強調，這是一支非常優秀的業務拓展團隊。顯然，我可以指出羅氏與基因泰克的交易。我可以指出Demant的交易。當然，這些只是你所看到的一些事情，我們之間還有其他互動，也許有些交易本來可以達成，但由於各種原因最終未能達成，這都是正常且常見的。所以他們是一個可靠且有效率的團隊。

What we can do, what we have the opportunity to do is to take the AlloSCOPE platform and apply it in different ways to generate a basket of assets. And then we can make some decisions that are good for the company in terms of partnering or retaining. We don't have a particular objective to launch any of the products we manufacture, although that's certainly not off the table either. We are really being mindful of our cost of capital, the spending, the risk and our own capability to make decisions about what and whether to partner and what time, assuming that there is an appropriate economic arrangement to be struck at all.

我們能夠做的，或者說我們有機會做的，就是利用 AlloSCOPE 平台，以不同的方式應用它來產生一籃子資產。然後，我們可以在合作或續約方面做出一些對公司有利的決定。我們目前並沒有推出任何我們生產的產品的具體目標，儘管這當然也不排除在外。我們非常重視資金成本、支出、風險以及我們本身在決定是否與誰合作以及何時合作方面的能力，前提是能夠達成合適的經濟安排。

So I think the way to maximize the value of the platform that we have developed is in part to generate new assets that can be partnered fairly early and to use some of that capital to offset our needs to rely on traditional capital markets. And through that mix of creating assets that are funded by others as well as adding programs and taking them a little bit further, I think we may be solving to optimize for the best return on invested capital that we can with the technology that we have developed here at Lineage.

所以我認為，最大化我們開發的平台價值的方法之一，是創造可以儘早合作的新資產，並利用其中的一些資金來抵消我們對傳統資本市場的依賴。透過創造由他人資助的資產，以及增加專案並將其進一步推進，我認為我們或許能夠利用我們在 Lineage 開發的技術，找到實現最佳投資回報的方法。

That's extremely helpful. And then I guess my technical question is without giving away the secret sauce here. For the ILT cell component that you're working on here, what would you consider to be the rate-limiting step or steps with regard to moving beyond the 0.5 liter scale?

這非常有幫助。那麼，我想問的技術問題是，在不洩漏核心技術的前提下。對於您正在研究的ILT電池組件，您認為在突破0.5升規模方面，限速步驟是什麼？

That's an excellent question and the very nature of the exploratory work is that we do not know. So we cannot predict the linearity of going from half liter to multi liter to ultimately up in the neighborhood of 80-liter or 300 liters. There are incredible new technologies that are available that help companies with this work, but it's very difficult to say.

這是一個很好的問題，而探索性工作的本質就在於我們不知道答案。因此，我們無法預測從半升到幾公升，最終達到 80 公升或 300 公升左右的線性成長規律。有許多令人驚嘆的新技術可以幫助公司完成這項工作，但很難說哪種技術最有效。

I would say this, though, I do think going from 0 to a 0.5 liter was a much larger achievement than what I expect going from a 0.5 liter to 2, 3, 4 liters will be. And the reason for that is that it hadn't been done before and as I explained earlier on the call. It's very hard to get the control that you want from a 2D process and apply it into the scale of a 3D process.

不過，我想說的是，我認為從 0 升到 0.5 升的成就遠比從 0.5 升到 2 升、3 升、4 升的成就要大得多。原因在於之前從未有人這樣做過，正如我之前在電話中解釋的那樣。很難將二維製程所獲得的控制效果應用到三維製程。

So to be clear about one thing here, AlloSCOPE describes our basic platform, our banking or manufacturing. AlloSCOPE 5.0 is the application where we're essentially tricking cells to think that they're being grown in a 2D environment while actually putting them in a 3D environment. So quite simply two plus three equals five, perhaps the additional dimensions our scale and cost in that situation.

所以，首先要明確一點，AlloSCOPE 描述的是我們的基本平台，也就是我們的銀行或製造平台。AlloSCOPE 5.0 是一款應用程序，它本質上是欺騙細胞，讓它們以為是在 2D 環境中生長，而實際上將它們置於 3D 環境中。所以簡單來說，二加三等於五，也許額外的維度是指在這種情況下我們的規模和成本。

But I think what's really exciting about the next step is that if you do have control in the lower mid-leader scale, you really could begin to have discussions about pooling that output and feeding maybe an 80-liter reactor or it could give you some insights and confidence about the linearity as you scale. Not every cell line is going to be amenable and can adapt to these larger scales and perhaps some of the technologies don't fit well depending on the cell type that you plan to differentiate. So it's very much unexplored territory, which is why I wanted to spend a lot of time talking about it today.

但我認為下一步真正令人興奮的是，如果你能夠控制中低階領導者的規模，你就可以開始討論如何匯集這些產出，並將其輸送到一個 80 公升的反應器中，或者它可以讓你對規模擴大過程中的線性關係有一些見解和信心。並非每一種細胞係都適合併能適應這種更大規模的培養，而且根據你計劃分化的細胞類型，某些技術可能並不適用。所以這完全是一個未知的領域，這也是為什麼我今天想花很多時間談論它的原因。

Very helpful. And then I think we're essentially done because I think the next one is unanswerable, as I said. But with regard to the GAlette study, I'm sure you get questions on this all the time. But is there any visibility or anecdotes you could provide with regard to the types of deliveries that Roche might be testing or methods?

很有幫助。然後我覺得我們基本上就結束了，因為正如我所說，我認為下一個問題是無法回答的。但關於 GAlette 研究，我相信你肯定經常被問到這個問題。但是，您能否提供一些關於羅氏可能正在測試的交付類型或方法的相關資訊或軼事？

There have been some presentations at conferences where images of different devices have been provided. I don't know in every case, whether those presentations have been made available to the public online or are they exclusive to the registrants of these conferences. But what I would say as a general matter is that the two big chunky approaches are to deliver transvitreally through the front of the eye or via a suprachoroidal approach, which is going around the eye and accessing the subretinal space from below. They have trade-offs. I won't go through all of the trade-offs right now, but that is just one basic way of looking at delivery to the subretinal space.

在一些會議上，曾有簡報展示了不同設備的圖片。我並不清楚在所有情況下，這些演講是否都已在線向公眾開放，還是僅供這些會議的註冊者觀看。但總的來說，兩種主要的手術方法是經玻璃體腔注射（透過眼睛前部）或經由脈絡膜上腔注射（繞過眼睛，從下方進入視網膜下腔）。它們各有優缺點。我現在不會詳細介紹所有的權衡取捨，但這只是看待向視網膜下空間輸送藥物的一種基本方法。

Within that, there, of course, are more refined approaches regarding the kinds of needles or the methods that one uses. But if you were to pull up or request from us the 2025 CTS desk -- slide deck, I think some examples of some of the technologies that Genentech acquired are available.

當然，其中也有更精細的方法，例如使用哪種針或採用哪種方法。但是，如果您調出或向我們索取 2025 年 CTS 工作台投影片，我認為其中會提供一些 Genentech 收購的技術範例。

But this is an important reminder. This is not -- the study that they're doing is a surgical optimization study. So they're going to be looking at different cohorts of patients and evaluating what works well. So they may try some things that don't go well and abandon those, and that's appropriate. They may find some things that seem to go well and want to push the envelope, and that's also appropriate. In fact, desirable.

但這是一個重要的提醒。這不是——他們正在進行的研究是一項手術優化研究。所以他們將研究不同的患者群體，並評估哪些方法有效。所以他們可能會嘗試一些不太成功的事情，然後放棄這些事情，這是合理的。他們可能會發現一些事情進展順利，並且想要突破常規，這也是合理的。事實上，這是可取的。

But this is not a responder analysis. So there -- it's not some number out of 60 is a success threshold. We know that you get the best results if the cells go to the subretinal space. So of course, it is obvious and appropriate to try and simplify that as much as you can before moving into and committing to larger trials.

但這不是應答者分析。所以，成功並非取決於 60 分中的某個數字。我們知道，如果細胞進入視網膜下腔，就能獲得最佳效果。所以，在進行更大規模的試驗之前，盡可能地簡化試驗是顯而易見且恰當的。

So we're hopeful that everything that has happened is an indication that, that work is going well. I think if that work we're going clearly poorly, they've had abundant time to abandon this initiative, but we also remain confident that our partners know best how to find the right level of risk and reward, moving as quickly as they can while not jeopardizing their leadership position in the space.

所以我們希望，目前發生的一切都表明，這項工作進展順利。我認為，如果這項工作進展明顯不順利，他們有足夠的時間放棄這項計劃，但我們仍然相信我們的合作夥伴最清楚如何找到合適的風險和回報水平，在不危及他們在該領域的領導地位的前提下盡可能快地推進。

Thank you very much, Brian.

非常感謝你，布萊恩。

Thank you, Joe.

謝謝你，喬。

Jack Allen, Baird.

傑克艾倫，貝爾德。

Great, thank you and congrats to the team on all the progress made over the course of 2025. Looking forward to a productive 2026. Just two quick questions from my end. The first one is on the OPC1 program. I was hoping if you could provide some more color on the timing of the functional measures? And anything you can also add as it relates to the baseline characteristics of that first participant in the study there being a chronic participant. I'm curious as it relates to their baseline functionality.

太好了，謝謝，也恭喜團隊在 2025 年取得的所有進展。期待2026年碩果累累。我還有兩個問題想問一下。第一個是關於 OPC1 程序的。希望您能詳細說明一下各項功能性措施的時間安排？您也可以新增任何與研究中第一位參與者（慢性病患者）的基線特徵相關的內容。我很好奇這與它們的基本功能有何關係。

And then secondly, on OpRegen, I know you guys have presented three-year data in the spring of 2025. I'm curious if four-year data could be on the docket as it's been great to see the continued durability response as it relates to OpRegen?

其次，關於 OpRegen，我知道你們將在 2025 年春季公佈三年數據。我很想知道四年的數據是否可以列入議程，因為看到 OpRegen 的持續耐久性表現令人欣喜？

Thank you, Jack. Thank you, Jack. I will ask your second question of our partner. I do not know their plans for four-year data. But obviously, we are excited by the fact that the benefits that we're seeing in year one did continue into year two and year three, which mechanistically makes sense for a transplant that is not rejected. We think that's a great sign, especially because the untreated eye in the same patient continues to lose letters of vision. So the delta, the clinical benefit and the confidence in that benefit only seems to get better with each passing year.

謝謝你，傑克。謝謝你，傑克。我會把你的第二個問題轉達給我們的夥伴。我不知道他們對四年期數據的計劃。但顯然，我們感到興奮的是，我們在第一年看到的益處確實延續到了第二年和第三年，這對於一個沒有被排斥的移植來說，從機制上來說是合理的。我們認為這是一個很好的跡象，尤其是在同一患者未接受治療的眼睛中，視力持續下降。因此，隨著時間的推移，療效差異、臨床獲益以及對該獲益的信心似乎只會越來越好。

With respect to OPC1, we do -- I do want to remind everyone that the OPC1 study is a safety and performance study of a device. So it is not an efficacy design. So we have a more limited set of function measurements that we are collecting.

關於 OPC1，我們確實——我確實想提醒大家，OPC1 研究是一項關於設備的安全性和性能研究。所以這不是以療效為導向的設計。因此，我們收集的功能測量數據比較有限。

But we are collecting things like an ISNCSCI exam and quality of life measures, SCIM is one of the tools that we've -- one of the assessment tools that we've employed in this trial. So we collect baseline data or screening data prior to the cells being administered.

但我們正在收集 ISNCSCI 考試和生活品質指標等信息，SCIM 是我們在此試驗中採用的評估工具之一。因此，我們在進行細胞移植之前收集基線數據或篩選數據。

And then we have some early functional assessments, probably too early to see anything. So these are functional assessments that occur in the first 90 days. They provide some reinforcement or reliability about your baseline measures and ensure that the patient isn't experiencing any decline.

然後我們進行了一些早期功能評估，可能為時過早，還看不出什麼問題。所以這些是在前 90 天內進行的功能性評估。它們可以為你的基線測量結果提供一些佐證或可靠性，並確保患者病情沒有惡化。

And then we wait until a year in most cases because we aren't looking every 30, 60, 90 days at these patients because, again, that's not what the study was designed to do. But when we collect the one-year functional assessments, if we do see some changes, those are things that perhaps would be more meaningful if they're occurring at 12 months versus occurring at three months or even six months.

然後，在大多數情況下，我們會等到一年後再進行觀察，因為我們不會每 30 天、60 天、90 天就對這些患者進行觀察，因為，再說一遍，這項研究的設計目的並非如此。但是，當我們收集一年功能評估數據時，如果我們確實看到一些變化，那麼這些變化如果發生在 12 個月而不是 3 個月甚至 6 個月，可能會更有意義。

There is, quite interestingly, there has been some information. We view this information as coming from a reliable source, but there was some information about the chronic patient having some improvement in certain measures. This is anecdotal. This is not part of our conveyance of clinical data to the public, but people are free to talk about their own experiences on clinical trials.

很有趣的是，已經有一些相關資訊了。我們認為這些資訊來自可靠來源，但也有一些資訊表明，這位慢性病患者在某些指標上有所改善。這只是個例。這並非我們向大眾傳達臨床數據的一部分，但人們可以自由談論自己參與臨床試驗的經驗。

So you may find some evocative information out there. We don't confirm or refute it. We will only be communicating actual data from our trial when it becomes available. But I would add only to your specific question that the patient fits within our specific criteria as being ASIA Impairment A.

所以你可能會在那裡找到一些引人深思的資訊。我們既不證實也不否認。我們將僅在試驗實際數據公佈後才會發布。但我只想針對您的特定問題補充一點，該患者符合我們關於 ASIA A 級損傷的具體標準。

And I guess I could add to that, that we had some difficulty finding the next patient in the stagger. And we recently went through an expansion of the protocol to allow a second impairment level of A for the second patient enrolled in this study. So to the extent that we hadn't enrolled a second patient yet, I can tell you that it was because it was really hard to find the stagger that had been agreed to with FDA.

我還可以補充一點，我們在錯開接診順序時遇到了一些困難，很難找到下一個病人。我們最近擴展了該方案，讓該研究中招募的第二名患者達到第二個 A 級損傷水平。因此，我們尚未招募第二名患者，我可以告訴你，這是因為很難找到與 FDA 商定的交接時間。

So we went through the steps to amend that protocol stagger to broaden it to allow for, another, A, to be treated, and we have someone who has been identified and may get treated here in the coming weeks this month. So I think we're going to be back on track with this trial, but very good and appropriate questions, Jack. Thank you for them.

因此，我們採取了相應步驟來修改該協議的分階段實施方案，以擴大治療範圍，允許另一名患者 A 接受治療。我們已經確定了一名患者，他可能會在本月接下來的幾週內在這裡接受治療。所以我覺得我們這次審判會重回正軌，傑克，你提出的問題非常好，也很恰當。謝謝你們。

Awesome. Thanks for all the color. Maybe if I could just follow up one more on AlloSCOPE. Well, before I do, it's great to hear about the anecdotal progress of the OPC1 program. While it's not necessarily well-vetted clinical data. There's a high unmet need in spinal cord injury, so that's great to hear. There's some enthusiasm there on AlloSCOPE.

驚人的。感謝你們帶來的繽紛色彩。也許我可以在AlloSCOPE上再跟進一次。好的，在此之前，很高興聽到 OPC1 專案的進度。雖然這可能不是經過充分驗證的臨床數據。脊髓損傷領域存在大量未滿足的需求，所以聽到這個消息真是太好了。AlloSCOPE 上有一些熱情。

I just wanted to ask very briefly how you think about ramping expense of that program as you move up from the 0.5 liter bioreactor. I know it could get more expensive as you move into larger reactors. How are you planning to contain cost?

我只是想簡單地問一下，隨著生物反應器從 0.5 升升級，您如何看待該專案成本的增加。我知道隨著反應爐規模的擴大，成本可能會更高。你們打算如何控製成本？

Yeah. It's not too difficult. The cells are eating the media that we feed them, and we have done a lot of batches and the multi-liter batch size, I've spoken frequently about OpRegen already being manufactured at a 3-liter scale.

是的。這並不太難。細胞正在吸收我們餵給它們的培養基，我們已經做了很多批次，批次規模達到多升，我經常談到 OpRegen 已經以 3 公升的規模生產。

So we have abundant experience at that scale. I think where it starts getting really exciting is when you go up one level beyond. I don't want to get ahead of myself at this point. There still are risks and uncertainties associated with this.

因此，我們在該規模上擁有豐富的經驗。我覺得真正精彩的部分是從更高一級開始的。我現在不想操之過急。這其中仍然存在風險和不確定性。

But one of the really powerful attributes of our approach of inverting our development plan and focusing on manufacturing is that we are able to put a relatively modest amount of capital to work to get answers as to the scalability of these lines. If we were doing it the other way, if we were doing expensive animal studies or very expensive human studies, and we were deferring the important questions around scale, we would be spending a tremendous amount of money running studies that others have already shown can be successful and not necessarily proving anything about our viable product candidate in terms of its ability to meet the commercial demand.

但我們反轉發展計畫、專注於製造的方法的一個真正強大的優勢在於，我們能夠投入相對適量的資金來獲得有關這些生產線可擴展性的問題的答案。如果我們反其道而行之，進行昂貴的動物實驗或非常昂貴的人體實驗，卻推遲有關規模的重要問題，那麼我們將花費大量資金進行一些其他人已經證明可以成功進行的研究，而這些研究未必能證明我們的候選產品在滿足商業需求方面具有可行性。

But if instead, you follow the Lineage approach and you say, well, I'm going to answer the question of scale first, then you are looking at the risk profile of your subsequent preclinical and preclinical studies with a little bit of a different view because you already know you can make a lot of your material.

但是，如果你遵循譜系方法，並說，好吧，我要先回答規模問題，那麼你就會以略微不同的視角看待後續臨床前和臨床前研究的風險概況，因為你已經知道你可以生產大量的材料。

So I really like the overall approach. I think it's prudent. I think it's investor friendly. And from our perspective, we have experienced a lot of experience already at a single leader or multi leader scale production. So we have a well-trained team that can fill and finish vials out of that scale in a GMP environment.

所以我很喜歡這種整體方法。我認為這是明智之舉。我認為這對投資者很友好。從我們的角度來看，我們已經在單一領導或多領導規模的生產中累積了豐富的經驗。因此，我們擁有一支訓練有素的團隊，能夠在符合 GMP 標準的環境下大規模填充和完成小瓶包裝。

So we'll have to see. But as Jill said, we're very committed to high returns on our invested research dollars and trying hard to maintain something close to our historic investment of capital on an annual basis.

所以我們拭目以待。但正如吉爾所說，我們非常致力於獲得高額的研發投資回報，並努力維持每年接近我們歷史投資額的水平。

Awesome. Thanks so much for all the color and congrats again on the progress.

驚人的。非常感謝你帶來的繽紛色彩，再次恭喜你所取得的進展。

Thank you.

謝謝。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Yes, good afternoon, team. Thanks for taking our questions and my thoughts also to your company employees and their families in Israel. So Brian, just to piggyback on the last kind of framing you had on this inverted risk framework you have on the scale-up of the manufacturing first for this Islet cell research initiative. Could you maybe just double-click on what have been the learnings to date from the OpRegen work since inception and also as part of specifically the Roche partnership?

是的，下午好，各位。感謝您將我們的問題和我的想法轉達給貴公司在以色列的員工及其家人。所以布萊恩，我想藉用你上次對這種反向風險框架的論述，即先擴大胰島細胞研究計畫的生產規模。您能否簡要介紹一下自 OpRegen 專案啟動以來，特別是與羅氏合作以來，我們取得了哪些經驗教訓？

And maybe also if you could recap what milestones should we be watching for potential candidate being identified here? Or is this being used by a strategic partner since obviously, this would draw a lot of interest?And then I have a follow-up.

另外，您能否簡要概括一下，對於正在篩選出的潛在候選人，我們應該關注哪些里程碑事件？還是這是策略夥伴在利用？因為很明顯，這會引起廣泛關注。然後我還有一個後續問題。

Thank you, Mayank, for that multipart question. Yeah, the inverted risk, I think, as I say, attractive because we're putting what I believe is the least expensive and most challenging step first. And so we're trying to invert the risk profile of Islet cell transplant product initiative or campaign.

謝謝Mayank提出的這個包含多個部分的問題。是的，我認為反向風險很有吸引力，正如我所說，因為我們把我認為成本最低、最具挑戰性的步驟放在了首位。因此，我們正在努力扭轉胰島細胞移植產品計劃或活動的風險狀況。

The specific learnings and lessons from the OpRegen program are coupled with independent learnings and lessons we have because, of course, we have other programs that we've had to solve different problems for whether that's our hearing loss program or our spinal cord program.

OpRegen 計畫的具體經驗和教訓與我們獨立獲得的經驗和教訓相結合，因為我們當然還有其他項目需要解決不同的問題，例如我們的聽力損失項目或脊髓損傷項目。

Altogether, a lot of these have taught us some clever and sometimes patentable material and insights. Overall, I would say that AlloSCOPE is comprised of three components. There are physical or engineering-type components. So these are the physical properties of how we do the manufacturing. There are biological aspects to it, i.e., exactly what we expose the cells to and when. And then you have an engineering component, which is a little bit more of like the know-how.

總而言之，這些都教會了我們一些巧妙的、有時甚至是可申請專利的資料和見解。總的來說，我認為 AlloSCOPE 由三個部分組成。它包含物理組件或工程組件。這些就是我們製造過程中所涉及的物理特性。這其中涉及生物學方面的問題，也就是我們究竟讓細胞接觸什麼、何時接觸。然後還有工程技術部分，更像是專業知識。

So it is not that there's a magical molecule that makes AlloSCOPE work or a special coding of plastic or type of plastic that makes everything click. It is the combination through years, in fact, decades of experience coming together finally being able to show that this capability can legitimately make millions of vials as I said, trillions of cells and then applying it in a very unique way to solve a specific problem in the setting of Islet cells.

所以，並不是某種神奇的分子讓 AlloSCOPE 發揮作用，也不是某種特殊的塑膠編碼或塑膠類型讓一切順利進行。事實上，這是多年，甚至數十年經驗的積累，最終證明這種能力可以合法地製造數百萬個小瓶，正如我所說，數萬億個細胞，然後以一種非常獨特的方式將其應用於解決胰島細胞領域的特定問題。

I don't envision that being a fee-for-service business of our company. I'll never say never because our job here is to create value, it's not necessarily to make medicine. So if we see an opportunity and it makes sense, we may pursue it. But what we would envision with AlloSCOPE in partnerships is always enjoying significant ownership of any program that's going forward.

我不認為這會成為我們公司的收費服務業務。我永遠不會說“絕不”，因為我們在這裡的工作是創造價值，而不一定是製造藥品。所以，如果我們發現機會並且這樣做是合理的，我們可能會去爭取。但我們希望 AlloSCOPE 在合作中始終擁有對任何未來項目的重大所有權。

We are bringing tremendous value to partnerships. We're a healthy company that can carry its own weight in development. And so we want to make sure that we're never viewed as a CDMO, not that there's anything wrong with that business, it's just very hard to price that kind of product when the probability of success is unknown as you go into those alliances.

我們為合作夥伴關係帶來了巨大的價值。我們是一家實力雄厚的公司，在研發方面能夠獨當一面。因此，我們希望確保我們永遠不會被視為 CDMO，並不是說 CDMO 業務有什麼問題，只是在建立這些聯盟時，由於成功機率未知，因此很難為這類產品定價。

And we also have limited GMP space, a very highly trained team. This is not up the shelf skill set that we just grabbed from some recent college grads. So it is something that we have to be very selective where we apply our technology.

而且我們擁有有限的GMP空間，以及一支訓練有素的團隊。這並非我們從應屆大學畢業生直接掌握的現成技能。所以，我們在應用這項技術時必須非常謹慎地選擇應用領域。

But you also asked a very important question in there, which is additional programs, and it occurs to me now in this moment that I have previously said that we had some additional cell types that we are going to talk about and it didn't even make it into my prepared remarks, which gives you a sense of how much exciting stuff is happening here.

但你也問了一個很重要的問題，那就是其他項目。我現在突然想到，我之前說過我們會討論一些其他的細胞類型，但這甚至沒有寫進我的準備稿裡。這讓你感受到這裡正在發生多少令人興奮的事情。

But we do have plans to reveal another new cell type, that could be as early as in the next three to six weeks. It's coming together. It's maturing. I'm very excited about it. but it is as yet undisclosed. But hopefully, that is something that we could have out into -- out for public consumption prior to our next quarterly call.

但我們確實有計劃推出另一種新的細胞類型，最早可能在未來三到六週內推出。事情正在逐步明朗。它正在走向成熟。我對此感到非常興奮，但目前還不能公開。但希望我們能在下次季度電話會議之前，將這些資訊公諸於世。

Yeah. No, that's -- new cells that would be great to learn about them. Thank you for that level of detail. And then on the OpRegen program, if that was to theoretically start a Phase 3 tomorrow -- like what's your capacity for the amount of doses you can provide because these could be like very large trials, at least historically that have been done? And do you have any visibility of regulatory interaction that has occurred beyond the RMAT designation that was secured last year or two years ago?

是的。不，那是──新的細胞，很值得我們去了解它們。感謝您提供如此詳細的資訊。那麼，關於 OpRegen 項目，如果理論上明天就開始第三階段試驗——你們能提供多少劑量？因為這些試驗規模可能非常大，至少從以往的經驗來看是如此。您是否了解在去年或前年獲得的RMAT認證之外，還發生了哪些監管方面的互動？

Thank you for that additional question. Unfortunately, again, that's a question that really can only be answered by Roche and Genentech. I am not a party to regulatory strategy discussions or regulatory interactions that they have regarding OpRegen. So I cannot say because I do not know.

感謝您提出的補充問題。遺憾的是，這個問題只有羅氏和基因泰克才能真正回答。我沒有參與他們就 OpRegen 進行的監管策略討論或監管互動。所以我無法回答，因為我不知道。

Okay. And one last for Jill. In your cash runway, how much of the additional warrants are factored in? If you could just clarify. Thank you team for taking the question.

好的。最後給吉爾一個。在你的現金儲備計畫中，額外認股權證的份額佔多大比例？能否請您解釋一下？感謝團隊回答這個問題。

Yeah. So of the existing runway that we talked through today, it only includes the $5.4 million in warrants that we collected this week on an exercise of the 32 remaining is not factored into our future runway at this point.

是的。因此，在我們今天討論的現有資金儲備中，僅包括我們本週透過行使剩餘 32 份認股權證而獲得的 540 萬美元認股權證，目前尚未計入我們未來的資金儲備。

Mayank, I neglected to answer the remainder of your question. And I'm happy to say that perhaps one of the least of my concerns at this company is being able to manufacture sufficient material. It really speaks to the power of our technology.

Mayank，我忘了回答你問題的剩餘部分。我很高興地說，在這家公司，我最不擔心的問題之一就是能否生產足夠的材料。這充分體現了我們技術的強大力量。

We literally are manufacturing more OpRegen than we can reasonably fill and finish in a day's work. So I do not think that supply of clinical material will be gating because the two-part banking system and then the production vessel scale that we're at, really does generate a very large number of cells on each run that we perform.

我們生產的 OpRegen 數量遠遠超過了我們一天工作所能合理填充和完成的數量。因此，我不認為臨床材料的供應會受到限制，因為我們採用的兩部分庫系統以及生產容器規模，確實可以在我們進行的每次運行中產生大量的細胞。

Albert Lowe, Craig-Hallum.

阿爾伯特·洛，克雷格-哈勒姆。

I was wondering how you'll be applying the hypoimmune cell line that you recently received from the partnership with Factor? And I believe this is an iPSC line. Can you please also speak on some advantages of using induced pluripotent stem cell line?

我想知道您將如何應用您最近從與Factor的合作中獲得的低免疫細胞系？我相信這是一條iPSC線。您能否也談談使用誘導多能幹細胞系的一些優勢？

Hi, Albert. Thank you for that question. The hypoimmune line that we obtained through our Factor alliance is a line that we designed for a neurological indication. That indication is as yet undisclosed. I may or may not -- I think I'll probably just say that I cannot confirm that it is even the same indication that I suggested could be coming out in the next three to six weeks.

你好，阿爾伯特。謝謝你的提問。我們透過與 Factor 的合作而獲得的低免疫細胞系，是我們為治療神經系統疾病而設計的細胞系。該指標尚未公開。我可能不會——我想我大概只能說，我無法確認這是否是我之前提到的可能在未來三到六週內發布的那個跡象。

But you're correct that it is an iPSC line. I don't know if there are advantages of IPS over ES or vice versa. Our view is that it is appropriate to follow the data and the behavior of these lines. I do think that there is an important discussion that occurs about various attributes that may make one or the other more attractive but there simply have not been enough approved agents to be able to definitively say one is superior.

但你說得對，它確實是 iPSC 系。我不知道IPS相比ES是否有優勢，反之亦然。我們認為，遵循這些數據和這些線條的走勢是合適的。我認為，關於哪些特質可能使一種或另一種更具吸引力，確實存在著重要的討論，但目前還沒有足夠多的獲批特質能夠明確地說出哪種特質更勝一籌。

Typically, what one finds is it when you work with one form of a line, that is the line type or source that you defend for us, we are indifferent. We have both types of -- we have both types of pluripotent lines. But in this case, the experience that Factor had with gene editing, with IPS, with hypoimmunity and we also engineered in an additional functional, hopefully, relevant edit into that line, that is about us accessing capabilities that we think are valuable, but that we didn't want to build in-house. And because ourselves are always fully characterized before they go into a patient, we can be confident that there are a number of different editing technologies that could be applied because we can always confirm (technical difficulty) it was designed to be before we utilize it and before we invest in the scale-up of that material.

通常情況下，你會發現，當你使用一種形式的線條，也就是你為我們捍衛的線條類型或來源時，我們卻漠不關心。我們擁有兩種類型的—我們擁有兩種類型的多能幹細胞系。但在這種情況下，Factor 在基因編輯、iPS、低免疫方面的經驗，以及我們也在這個基因係中引入了額外的功能性、希望是相關的編輯，都是為了獲取我們認為有價值的能力，但我們不想在內部建構這些能力。而且，由於我們自身在進入患者體內之前總是會進行充分的特性分析，因此我們可以確信，有許多不同的編輯技術可以應用，因為我們總能在使用它之前以及在投資擴大該材料的規模之前確認（技術難度）它是否是為此設計的。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

This is Yang for Sean. We have one quick question. Could you speak to the process of getting a new OPC1 formulation into the DOSED study? And how much do you think that may shorten the time line versus bridging study? And are you in dialogue with FDA on that front?

這是楊給肖恩的。我們有一個簡短的問題。您能否談談將新的 OPC1 配方引入 DOSED 研究的過程？你認為與銜接研究相比，這能將時間縮短多少？你們是否就此與FDA進行過對話？

Thank you, Yang. Very appropriate question. We elected to separate the new device that we are testing from the new cells that we have manufactured. So we have completed the manufacturer, the new process by which we manufacture those cells.

謝謝你，楊。問得好。我們決定將正在測試的新設備與我們製造的新電池分開。所以我們已經完成了製造這些細胞的新過程。

We have completed the comparability testing including in-life comparability testing and all the other features that go into a meeting package with FDA, but we have not yet presented or delivered that information to FDA to request us to bridge in those studies. We thought it would be prudent to get a little bit of experience with the new device so that then the focus could shift away from the new device and into the new cells.

我們已經完成了可比性測試，包括體內可比性測試以及與 FDA 會議資料包中的所有其他功能，但我們尚未向 FDA 提交或提供該信息，以要求我們在這些研究中進行橋接。我們認為，先對新設備進行一些體驗是明智之舉，這樣就可以將注意力從新設備轉移到新細胞上。

So what we are hopeful for is that the new device will perform as it was designed to be performing in the first four, five, six patients and then proposed to FDA that we would switch over to the lineage new process in the last handful of patients in the DOSED study.

因此，我們希望新設備能夠按照設計預期在前四、五、六名患者中發揮作用，然後向 FDA 提議，在 DOSED 研究的最後幾名患者中改用新的工藝。

If successful with that endeavor, that would save a lot of time. It would prevent us from having to establish and conduct a separate safety cohort with our new cells. So you can imagine that the bioinformatics data, the animal data, all of the analytical work that we have done to propose that switch has been exhaustive in order to give us the best probability of success in accelerating that process because it is correct that in order to run a larger study, our view is that we need to have this superior device deployed and we need to use our higher quality, higher purity, higher scale and better control OPC1 cells. And so that is our plan. And when that is complete, then I believe we would be in a position to run a larger study, either ourselves or in a partnership but a larger study of spinal cord injury patients.

如果這項努力成功，將會節省大量時間。這樣我們就無需為新細胞建立和進行單獨的安全隊列研究。因此，您可以想像，為了提出這一轉變，我們所做的生物資訊數據、動物數據以及所有分析工作都是詳盡的，以便最大限度地提高加速這一進程的成功機率。因為為了進行更大規模的研究，我們認為我們需要部署這種更先進的設備，並且需要使用我們更高品質、更高純度、更大規模和更好控制的 OPC1 細胞。這就是我們的計劃。當這項研究完成後，我相信我們將能夠進行一項更大規模的研究，無論是我們自己開展還是與其他機構合作開展，但這項研究將針對脊髓損傷患者。

No further questions at this time, I will turn the call back over to Brian Colley, CEO for closing remarks.

目前沒有其他問題了，我將把電話轉回給執行長布萊恩·科利，請他作總結發言。

Thanks everyone. I know it was long and complicated, but it's very important and I think also very exciting. So stay tuned. Clearly, we have some exciting stuff coming up not too far away. Thank you for your interest and support of the company and we'll talk again soon.

謝謝大家。我知道過程很長也很複雜，但這非常重要，而且我認為也很令人興奮。敬請期待。顯然，在不久的將來我們會有一些令人興奮的事情發生。感謝您對公司的關注與支持，我們期待盡快再次與您聯繫。

That concludes today's call. Thank you all for joining and you may now disconnect.

今天的電話會議到此結束。感謝各位參與，現在可以斷開連結了。