Lineage Cell Therapeutics Inc (LCTX) 2025 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Welcome to the Lineage Cell Therapeutics third quarter 2025 conference call. (Operator Instruction). I would now like to introduce your host for today's call, Iona Hoh, Head of Investor Relations of Lineage. Miss Hoh, please go ahead.

    歡迎參加 Lineage Cell Therapeutics 2025 年第三季電話會議。(操作說明)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 Iona Hoh。霍小姐,請繼續。

  • Iona Hoh - Head of Investor Relation

    Iona Hoh - Head of Investor Relation

  • Thank you, Angela. Good afternoon and thank you for joining us. A press release reporting our third quarter 2025 financial results was issued earlier today, November 6, 2025, 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,安吉拉。下午好,感謝各位的參與。我們於今天(2025 年 11 月 6 日)早些時候發布了 2025 年第三季財務業績的新聞稿,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 facts 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. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statement sections in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-k and in subsequent SEC filings. 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. I'll now hand the call over to Brian.

    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。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,包括其最新的 10-k 表格年度報告和後續的美國證券交易委員會文件。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。今天和我們在一起的是我們的執行長布萊恩·庫利和我們的財務長吉爾·豪。現在我將把電話交給布萊恩。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Iona and good afternoon, everyone. We appreciate you taking the time to join us on the call today.

    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。

  • I'll begin with an update on our lead program OpRegen, then review our progress against the five strategic goals which I outlined for you last quarter. In addition, I'll provide some insights on our pipeline strategy before concluding with some information on our islet cell project. Then I'll hand the call to Jill for a review of our financials before taking questions from our analysts.

    首先,我將報告我們的主要項目 OpRegen 的最新進展,然後回顧一下我們在上個季度我向大家概述的五個戰略目標方面取得的進展。此外,我將介紹我們的研發管線策略,最後再介紹一下我們的胰島細胞專案。然後我會把電話交給吉爾,讓她先審查我們的財務狀況,然後再回答分析師們的問題。

  • I want to begin with an update on Orogen because there have been some very exciting advancements in the ongoing phase 2a GAlette study. We're pleased to update you that Genentech is continuing to expand the retinal community's exposure and experience with OpRegen.

    我想先報告 Orogen 的最新進展,因為正在進行的 2a 期 GAlette 研究取得了一些非常令人興奮的進展。我們很高興地通知大家,基因泰克正在繼續擴大視網膜領域對 OpRegen 的了解和體驗。

  • In particular, Genentech opened two new clinical sites last month, and five new clinical sites were opened during the prior quarter. Overall, eight clinical sites have Genentech opened in just the past six months, bringing us to a total of 15 unique locations. In comparison, Genentech opened only one new site in all of 2024, so we take this site expansion to be a positive sign.

    具體來說,基因泰克上個月開設了兩個新的臨床試驗中心,而上一季則開設了五個新的臨床試驗中心。總體而言,基因泰克在過去六個月內開設了八個臨床中心,使其臨床中心總數達到 15 個。相較之下,基因泰克在 2024 年全年只開設了一個新站點,因此我們認為這次站點擴張是一個正面的訊號。

  • As a reminder, we don't have full visibility into the Gillette study enrollment or its findings, but the study has been running for more than two years, and it is an open label trial for which all primary and secondary outcome measures are captured at 90 days. Given that there has been abundant time for Genentech to collect outcomes data in year one and they more than doubled the number of sites in year two, we interpret this acceleration of their clinical efforts to be a positive signal for the future of this program.

    提醒一下,我們目前還無法完全了解吉列研究的入組情況或研究結果,但該研究已經進行了兩年多,這是一項開放標籤試驗,所有主要和次要結果指標均在 90 天時收集。鑑於基因泰克公司在第一年有充足的時間收集結果數據,並且在第二年將試驗點數量增加了一倍多,我們認為他們加快臨床工作的步伐,對該計畫的未來來說是一個積極的信號。

  • The rising number of clinical sites is of course just one element contributing to our belief that things are going well for OpRegen. There is a growing body of additional publicly available information which in the aggregate provides further evidence that OpRegen could be advanced into a controlled clinical trial, possibly in parallel with continued efforts at surgical optimization of this new technology.

    臨床試驗點數量的增加當然只是我們相信 OpRegen 發展順利的因素之一。越來越多的公開資訊綜合起來進一步證明,OpRegen 可以推進到受控臨床試驗階段,並可能與持續努力優化這項新技術的手術方法並行。

  • For example, Since the GAlette study began, Genentech reported its own 24-month and 36-month analyses from the lineage phase 1/2a trial.

    例如,自 GAlette 研究開始以來,基因泰克公司報告了其自身在譜系 1/2a 期試驗中的 24 個月和 36 個月分析結果。

  • That data showed that as a group, patients who received a one-time dose of OpRegen RPE cells across large areas of their GA enjoyed improvements in retinal structure, consistent and durable increases in visual acuity, and an acceptable safety profile. These are remarkable clinical findings because patients with GA don't self-heal.

    數據顯示,接受一次性 OpRegen RPE 細胞治療的患者群體,其大面積 GA 視網膜結構得到改善,視力持續且持久提高,且安全性良好。這些是意義非凡的臨床發現,因為患有 GA 的患者無法自癒。

  • And earlier this year, these outcomes were independently validated by similar reports coming from three other groups, each using their own version of an RPE suspension. One of those competing entities is a multinational pharmaceutical company which we believe further supports the commercial potential of our cell transplant approach.

    今年早些時候,其他三個小組也分別使用各自版本的 RPE 懸浮液,獨立驗證了這些結果。其中一家競爭對手是一家跨國製藥公司,我們相信這進一步支持了我們細胞移植方法的商業潛力。

  • As a further reminder, about a year ago, Roche was streamlining its pipeline and eliminated a set of development programs to focus on those with best-in-class potential. Some investors had asked about how these pipeline cuts could affect the OpRegen program, but OpRegen was not affected. And a few months later, we actually entered into an additional and expanded services agreement with Genentech to further support OpRegen development.

    再次提醒大家,大約一年前,羅氏精簡了其研發管線,取消了一系列研發項目,以便專注於那些具有一流潛力的項目。一些投資人曾詢問這些管線削減會對 OpRegen 專案產生怎樣的影響,但 OpRegen 並未受到影響。幾個月後,我們與基因泰克公司簽訂了額外的擴展服務協議,以進一步支持 OpRegen 的開發。

  • Around the same time, Roche elected to seek and successfully received Aratt designation for ergen. And more recently, Genentech shared that they would be evaluating two next generation delivery devices acquired specifically for the OpRegen program and which have the potential to not only improve the safety and success of the cell transplant procedure but may also offer a significant competitive advantage over companies that lack both this specialized equipment and the extensive delivery experience of our partner Roche.

    大約在同一時間,羅氏公司選擇申請並成功獲得了ergen的Aratt認證。最近,基因泰克公司透露,他們將評估專門為 OpRegen 專案購買的兩款新一代輸送設備,這些設備不僅有可能提高細胞移植手術的安全性和成功率,而且可能比那些既缺乏這種專用設備又缺乏我們合作夥伴羅氏公司廣泛輸送經驗的公司具有顯著的競爭優勢。

  • When you aggregate all of these publicly available actions, and I did not list all of them today, but I hope you will appreciate why we are bullish on the future of OpRegen to treat GA patients and why we are taking steps to try to repeat the success with other cell types.

    當你把所有這些公開可用的措施匯總起來(我今天並沒有全部列出來),但我希望你能理解為什麼我們對 OpRegen 治療 GA 患者的未來充滿信心,以及為什麼我們正在採取措施嘗試在其他細胞類型中複製成功。

  • So given what appears to be a steadily growing list of asymmetrically positive indicators for the successful advancement of OpRegen into a controlled clinical trial, and while still noting the ultimate decision to advance the program is solely with our partners Roche and Genentech, we have increasingly been thinking about how we can create value from the clinical, technical, and financial success that we're anticipating from OpRegen.

    鑑於 OpRegen 成功推進到受控臨床試驗的各項不對稱積極指標似乎都在穩步增長,雖然我們仍然注意到,推進該項目的最終決定權完全在於我們的合作夥伴羅氏和基因泰克,但我們一直在思考如何從我們預期 OpRegen 的臨床、技術和財務成功中創造價值。

  • With that in mind, I will turn next to some statements I made on our prior quarterly call to get a scorecard on how we've been doing.

    有鑑於此,接下來我將回顧我在上一次季度電話會議上發表的一些言論,以便對我們過去的工作表現進行評估。

  • Last quarter I outlined five areas of focus through the end of this year, and I'm pleased to report that we have already successfully delivered on several of those strategic initiatives and we still have nearly two months to go.

    上個季度我概述了今年年底前的五個重點領域,我很高興地報告說,我們已經成功實現了其中幾項戰略舉措,而且我們還有近兩個月的時間。

  • Our first goal was to enter into deals which partly or completely fund existing product candidates. We accomplished this goal through the partnership we announced with William DuMont Investor WDI, which is expected to fund up to $12 million in research and collaboration costs for all planned pre-clinical development of resonance, our first internally developed cell transplant program for the treatment of hearing loss.

    我們的首要目標是達成協議,為現有候選產品提供部分或全部資金。我們透過與威廉杜蒙特投資公司 (WDI) 宣布的合作關係實現了這一目標,預計該合作關係將為共振療法(我們首個自主研發的用於治療聽力損失的細胞移植項目)的所有計劃臨床前開發提供高達 1200 萬美元的研究和合作費用。

  • Resonance was an important test for our business model because it showed that we could conceive of and successfully manufacture a new cell-based product candidate. Generate new intellectual property and advance it into initial preclinical testing in approximately one year and with a modest initial investment.

    Resonance 對我們的商業模式來說是一項重要的考驗,因為它表明我們可以構思並成功製造出一種新的基於細胞的候選產品。創造新的智慧財產權,並在大約一年內以適度的初始投資將其推進到初步臨床前試驗階段。

  • Soon thereafter we signed a collaboration agreement with WDI, which is a world leading hearing healthcare company, securing external funding, leading to an IMD or CTA if the data supports it. And also provides access to technology expertise and a network of hearing health leaders.

    此後不久,我們與世界領先的聽力保健公司 WDI 簽署了合作協議,獲得了外部資金,如果數據支持,我們將進行 IMD 或 CTA 測試。它還提供技術專長和聽力健康領域領導者網路。

  • We and WDI also have preserved the right to enter into a future clinical and or commercial deal with a pharma partner if such an opportunity does arise. I believe this collaboration was an important demonstration of the speed, efficiency, and return on investment that the lineage platform can provide and provides evidence to support our strategy of replicating our OpRegen success with other cell transplant programs.

    我們和WDI也保留了在未來有機會時與製藥合作夥伴達成臨床和/或商業協議的權利。我認為這次合作充分展現了譜系平台的速度、效率和投資回報率,並為我們複製 OpRegen 成功經驗到其他細胞移植專案的策略提供了證據支持。

  • In addition to funding existing assets, our second goal was creating new assets which could attract external funding or collaborations. And while we have not yet said anything publicly about what we're doing in this category, I can share this year we conducted initial wet lab work on multiple target cell types, and if that work continues to go well, our expectation is that we would then disclose our next intended indication before our next quarterly call.

    除了為現有資產提供資金外,我們的第二個目標是創造能夠吸引外部資金或合作的新資產。雖然我們尚未公開談論我們在這一領域所做的工作,但我可以透露,今年我們對多種目標細胞類型進行了初步的濕實驗室研究,如果這項工作繼續進展順利,我們預計在下一次季度電話會議之前,我們將公佈我們下一個擬定的適應症。

  • Our third goal was to capitalize on our unique manufacturing capability, which we believe could solve issues which impede others' programs from success. Our new initiative in islet cell production is an example of how we're trying to meet this goal. Specifically, we're looking to tackle the major limitations in production scale, which must be solved in order to have a commercially viable cell therapy product for Type 1 diabetes.

    我們的第三個目標是充分利用我們獨特的製造能力,我們相信這可以解決阻礙其他專案成功的問題。我們在胰島細胞生產方面的新舉措,正是我們努力實現這一目標的例證。具體來說,我們正在努力解決生產規模的主要限制,這是開發出具有商業可行性的 1 型糖尿病細胞療法產品所必須解決的問題。

  • If we are successful with this initiative, our innovations could be applicable to other programs. Potentially opening the door to conditions previously thought to be too big and too expensive to address with cell therapy. At scale affordability is in fact the entire point of allogeneic off the shelf product development, so achieving this goal would mark a crucial moment for the field.

    如果這項計劃取得成功,我們的創新成果可以應用於其他專案。這可能為以前被認為規模太大、成本太高而無法用細胞療法治療的疾病打開一扇門。規模化生產中,價格可負擔性實際上是同種異體現成產品開發的全部意義所在,因此實現這一目標將標誌著該領域的一個重要時刻。

  • Our fourth goal was to obtain a CIRM CLIN grant, which we applied for earlier this year. CIRM has employed a new review process, and our understanding of that process is that only seven applications were advanced out of an initial larger pool of candidates. We were among those seven finalists.

    我們的第四個目標是獲得 CIRM CLIN 撥款,我們已在今年稍早申請了該撥款。CIRM採用了新的審查流程,據我們了解,流程是從最初較多的申請者中篩選出7份申請。我們是那七支入圍決賽的隊伍之一。

  • Since that selection to the final seven, we have answered a series of questions from the grants working group, but we have not received a grant score or any indication of whether we ultimately will receive a grant or not.

    自從入選最終七強以來,我們已經回答了撥款工作組的一系列問題,但我們還沒有收到撥款評分,也沒有任何跡象表明我們最終是否會獲得撥款。

  • However, we believe the finalists will be voted on at the next CIRM ICOC meeting on December 11th. Therefore, assuming CIRM maintains its plans timing and we have interpreted their plans correctly, we should know our status toward meeting our fourth goal in about four or five weeks. And by the way, if we do receive CE funding, it would provide a very nice non-dilutive offset of up to approximately $7 million from the ongoing dose study of OPC-1 for spinal cord injury.

    不過,我們相信最終入圍者將在 12 月 11 日舉行的下一次 CIRM ICOC 會議上進行投票表決。因此,假設 CIRM 保持其計劃進度,並且我們對他們的計劃理解正確,那麼我們應該在大約四到五週內知道我們實現第四個目標的進展。順便說一句,如果我們確實獲得了 CE 的資助,那麼正在進行的 OPC-1 治療脊髓損傷的劑量研究將獲得高達約 700 萬美元的非常不錯的非稀釋性抵消資金。

  • The last of the five goals I outlined for the quarter was to complete activities leading to milestone revenues from our partnership with Roche and Genentech. As you already know, I cannot speak to our milestones or their amounts until such time as they are met, but it remains an important activity. It is a top priority, and I am pleased with our progress related to this effort.

    我為本季設定的五個目標中的最後一個是完成與羅氏和基因泰克合作的各項活動,從而實現里程碑式的收入目標。如您所知,在各項里程碑達成之前,我無法談論它們的具體目標或數量,但這仍然是一項重要的活動。這是頭等大事,我對我們在這方面取得的進展感到滿意。

  • As a final point, most of the goals we have focused on are tied in some way to an expansion of our business, for example, expanding the scope of the OPC-1 study via CIRM grant or expanding the output of new assets from our in-house manufacturing platform. These are intentional moves by us. Because they reflect the convergence of three key factors. One, the reduction to practice of our high scale GMP banking system, which we announced a few months ago.

    最後一點,我們所關注的大多數目標都與我們業務的擴張在某種程度上有關,例如,透過 CIRM 撥款擴大 OPC-1 研究的範圍,或擴大我們內部製造平台新資產的產量。這些都是我們有意為之的舉措。因為它們反映了三個關鍵因素的匯合。第一,將我們幾個月前宣布的大規模GMP銀行系統付諸實踐。

  • Two, the emergence of a more favorable biotech market which has improved the cost of capital from which we can fund judicious and stepwise expansion.

    第二,生技市場環境更有利,資本成本降低,我們可以從中獲得資金,從而進行審慎而循序漸進的擴張。

  • And three, the belief that the OpRegen program will continue to advance under our Roche and Genentech Alliance and provide us with the credibility, confidence, and capital to take our platform further than where it is today. We have been eagerly awaiting a time when this accumulation of factors would align and permit us to elevate lineage's growth trajectory. We believe this momentum began in the second half of this year and expect it to continue during 2026.

    第三,我們相信 OpRegen 計畫將在羅氏和基因泰克聯盟的支持下繼續推進,並為我們提供信譽、信心和資金,使我們的平台比現在走得更遠。我們一直熱切期盼著各種因素能夠匯聚在一起,進而提升家族的發展軌跡。我們認為這一勢頭始於今年下半年,並預計將持續到 2026 年。

  • I should add at this point that while we aim in time to create a basket of cell therapy assets, some of which we might choose to develop internally and some of which we might partner, I have been asked on occasion how we as a small company, which has long demonstrated such fiscal discipline, how would we manage a larger portfolio. The answer is clear. Our core technology, our platform, generates assets which share essential traits in common.

    在此,我應該補充一點,雖然我們的目標是最終建立一個細胞療法資產組合,其中一些我們可能會選擇內部開發,一些我們可能會選擇合作開發,但我偶爾會被問到,作為一家長期以來表現出如此嚴謹財務紀律的小公司,我們將如何管理更大的資產組合。答案顯而易見。我們的核心技術,我們的平台,能夠產生具有共同基本特徵的資產。

  • Those traits occur early enough in a project that they're not dependent on us having a huge body of disease-specific expertise.

    這些特性在專案早期就已出現,因此並不依賴我們擁有大量的疾病特定專業知識。

  • Our technology is based foremost on the directed differentiation of pluripotent cells into discrete and scalable cell types of the human body. And while each product candidate is of course intended for a different condition and each cell line behaves in a unique manner, the early and necessary steps of process development, control, scale, and purity are largely common features in the way we apply them.

    我們的技術主要基於將多能幹細胞定向分化為人體內離散且可擴展的細胞類型。當然,每個候選產品都是針對不同的情況而設計的,每個細胞系的表現也各不相同,但工藝開發、控制、規模化和純度等早期必要步驟在我們應用這些步驟的方式上,很大程度上是共同的特徵。

  • Which allows us to expand the scope of our pipeline without losing the focus necessary to succeed or without requiring an excessive amount of capital investment.

    這使我們能夠在不失去成功所需重點或無需過多資本投資的情況下,擴大我們的產品線範圍。

  • And by adapting or initiating each program on the same process development modality, we are generating more shots on goal per dollar invested. So, with platform expansion as a convenient transition point, I'll turn lastly to an explanation of our recently revealed islet cell initiative.

    透過採用相同的流程開發模式來調整或啟動每個項目,我們每投入一美元就能獲得更多成功機會。因此,以平台擴展為一個便利的過渡點,我最後將解釋我們最近公佈的胰島細胞計劃。

  • 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 new product candidates. When we were nearly 100% focused on OpRegen, this selection process was largely running in the background.

    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到新產品候選藥物方面有很多選擇。當我們幾乎 100% 專注於 OpRegen 時,這個篩選過程基本上是在背景進行的。

  • Our initial pilot effort from the strategy was our program in auditory neurons because we knew auditory neurons represented a high-quality opportunity and based on our recent collaboration with WDI that has proven to be true. But there are many other cell types we could tackle, and as OpRegen's future brightened, we have increasingly emphasized and acted on our plans to repeat our OpRegen's success.

    我們最初的試點計畫是聽覺神經元計劃,因為我們知道聽覺神經元代表著一個高品質的機會,而我們最近與 WDI 的合作也證明了這一點。但我們還可以研究其他許多細胞類型,隨著 OpRegen 的未來越來越光明,我們越來越重視並採取行動,以複製 OpRegen 的成功。

  • To that end, we hired a former venture capitalist who built for us a proprietary opportunity tracker. The basic idea for that tracker is matrix each of your product opportunities against dozens of product characteristics such as the addressable market, the quality of translational models, and many other aspects, including, of course, our proprietary manufacturing insights. And from the thousands of data points which are generated, we can identify our best potential returns on investments.

    為此,我們聘請了一位前創投家,為我們開發了一款專有的機會追蹤器。這款追蹤器的基本想法是將您的每個產品機會與數十個產品特性進行矩陣式比較,例如目標市場、轉換模型的品質以及許多其他方面,當然也包括我們專有的製造洞察。透過產生的數千個數據點,我們可以確定最佳的潛在投資回報。

  • One of the top outputs from this proprietary process was the opportunity for us to enter the Type 1 Diabetes space. Our work identified three main obstacles preventing cell transplantation from providing a commercially feasible functional cure for Type 1 Diabetes patients.

    這個專有流程的最大成果之一是讓我們有機會進入第 1 型糖尿病領域。我們的研究發現了阻礙細胞移植為第 1 型糖尿病患者提供商業上可行的功能性治癒的三大主要障礙。

  • The first of these was the mechanism, but multiple companies have since shown that indeed an islet cell transplant can achieve insulin independence for patients. The second obstacle is the need for lifetime immunosuppression, which is not a commercially feasible solution for the vast majority of patients.

    第一個問題是機制,但此後多家公司已經證明,胰島細胞移植確實可以幫助患者實現胰島素非依賴性。第二個障礙是需要終身免疫抑制,這對絕大多數患者來說在商業上是不可行的解決方案。

  • Several attempts to eliminate the need for immunosuppression have been explored, such as capsules or droplets, but we find the recent evidence from genetically edited hypo immune cells to be the most attractive approach, one which has created a line of sight on breaching that second obstacle.

    人們已經探索了多種消除免疫抑制需求的方法,例如膠囊或滴劑,但我們發現,最近來自基因編輯的低免疫細胞的證據是最有吸引力的方法,這種方法為突破第二個障礙開闢了一條道路。

  • That leaves only the third major hurdle, which is production scale. Cadavers are not a sustainable or stable source of islet cells, but pluripotent cells are self-renewing, so they can solve those deficiencies. However, while a single pluripotent cell can give rise to thousands of RPE cells in our system, you can only get a dozen or so islet cells from each pluripotent cell that you start with.

    這樣就只剩下第三個主要障礙,那就是生產規模。屍體不是胰島細胞的可持續或穩定來源,但多能幹細胞具有自我更新能力,因此可以彌補這些不足。然而,雖然在我們的系統中,一個多能幹細胞可以產生數千個 RPE 細胞,但你從每個多能幹細胞開始只能得到十幾個胰島細胞。

  • And because the anticipated dose levels are as high as a billion cells per patient, you're not really a commercially viable product until and unless you can overcome the biological feeling imposed by the generally accepted differentiation processes that exist today. I obviously cannot go into detail for competitive reasons, but the gist of the matter is that we have conducted some early work that suggests we may be able to increase our already large-scale production process by many thousandfold.

    由於預期劑量水平高達每位患者十億個細胞,因此,除非你能克服目前普遍接受的分化過程所帶來的生物學限制,否則你的產品在商業上是不可行的。出於競爭原因,我顯然不能透露細節,但事情的要點是,我們已經進行了一些初步工作,結果表明我們或許能夠將我們現有的大規模生產流程擴大數千倍。

  • If we are successful, this could increase our relevance in the race to develop a functional cure for Type 1 Diabetes. Our initial goal for this program is to demonstrate our capability with one of our proprietary and best behaving cell lines. This initial work is ongoing and intended to lead to a go-no-go decision on further development which we will expect to occur next quarter.

    如果我們成功了,這可能會提高我們在研發1型糖尿病功能性療法競賽中的地位。該計畫的初步目標是利用我們專有的、性能最佳的細胞系之一來展示我們的能力。這項初步工作正在進行中,旨在最終決定是否繼續推進後續開發,我們預計下個季度將做出決定。

  • If the initial work with an internal cell line is successful, we believe it could accelerate partnership conversations for this program. And in parallel with any such talks, we would also seek to demonstrate system compatibility with a hypo immune cell line, either internally or externally sourced, which would be a more suitable line from which to support a clinical campaign.

    如果利用內部細胞系進行的初步研究取得成功,我們相信這將加快該計畫的合作洽談進程。同時,在進行此類討論的同時,我們也會尋求證明該系統與低免疫細胞系(無論是內部來源還是外部來源)的兼容性,這將是一種更適合支持臨床試驗的細胞系。

  • And depending of course on the results and feedback we collect along the way, we may elect to do this work for a partner or retain the product internally for a longer period.

    當然,根據我們在過程中收集到的結果和回饋,我們可能會選擇將這項工作交給合作夥伴,或將產品保留在內部更長時間。

  • So, to summarize, We believe we can reach an initial feasibility decision on this T1D initiative with a modest investment and just a few more months of work. And even if our overall goal isn't met, we might still discover some things which we can apply to improve the efficiency of our existing programs.

    綜上所述,我們相信只需少量投資和幾個月的努力,就能就這項 1 型糖尿病計畫做出初步可行性決定。即使我們的整體目標沒有實現,我們仍然可能會發現一些可以應用於提高現有專案效率的方法。

  • So, with that, I'll turn things over to Jill for a review of our financials.

    那麼,接下來我將把財務審查工作交給吉爾。

  • Jill Howe - Chief Financial Officer

    Jill Howe - Chief Financial Officer

  • Thanks, Brian, and good afternoon, everyone.

    謝謝你,布萊恩,大家下午好。

  • As of September 30, 2025, our overall cash position was $40.5 million. This amount is expected to support our planned operations into Q2 of 2027, which is one quarter longer than we guided to on our last call. The biggest contributor to the longer runway we are reporting today is cash we have already received from our new alliance with WDI.

    截至 2025 年 9 月 30 日,我們的現金總額為 4,050 萬美元。預計這筆資金將支持我們計劃營運至 2027 年第二季度,比我們上次電話會議中預測的時間長一個季度。我們今天公佈的較長資金儲備的最大貢獻因素是我們已經從與 WDI 的新聯盟中獲得的資金。

  • This we also continue to pursue other sources of funding like TORM grants. To support the dose study and milestone payments we are eligible for under the Roche Genentech collaboration Agreement, as well as any additional partnerships which we may elect to enter into in the future.

    為此,我們將繼續尋求其他資金來源,例如 TORM 撥款。為了支持劑量研究和我們根據與羅氏基因泰克的合作協議有資格獲得的里程碑付款,以及我們未來可能選擇達成的任何其他合作關係。

  • Separately, a large additional source of potential cash is the approximately $37 million of warrant capital we may receive if Roche and Genentech publicly disclose their intent to advance OpRegen into a clinical trial with the comparator arm and our investors exercise their warrants in cash.

    此外,如果羅氏和基因泰克公開披露將 OpRegen 推進到與對照組進行臨床試驗的意圖,並且我們的投資者以現金行使認股權證,我們可能會收到約 3700 萬美元的認股權證資本,這將是潛在的額外現金來源。

  • Now let me review our third quarter results. Our revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues were $3.7 million a decrease of approximately $0.1 million as compared to $3.8 million for the same period in 2024. The decrease was primarily driven by lower royalty revenue and other service revenues recognized at $0.3 million, partially offset by more collaboration revenues of $0.2 million.

    現在讓我來回顧一下我們第三季的業績。我們的收入主要來自合作收入、版稅和其他收入。總收入為 370 萬美元,比 2024 年同期的 380 萬美元減少了約 10 萬美元。下降的主要原因是版稅收入和其他服務收入減少 0.3 億美元,部分被合作收入增加 0.2 億美元所抵銷。

  • Our operating expenses are primarily comprised of R&D and G& ex expenses. Total operating expenses for the third quarter were $7.5 million a decrease of $0.1 million as compared to $7.6 million for the same period in 2024. Our R&D expenses were $3.3 million an increase of $0.1 million as compared to $3.2 million for the same period in 2024. The net increase was primarily driven by $0.2 million for our OPC-1 program, $0.4 million for our pre-clinical programs, and other undisclosed programs partially offset by $0.5 million for our OpRegen program.

    我們的營運費用主要包括研發費用及一般及商品費用。第三季總營運支出為 750 萬美元,比 2024 年同期的 760 萬美元減少了 10 萬美元。我們的研發費用為 330 萬美元,比 2024 年同期的 320 萬美元增加了 10 萬美元。淨成長主要得益於 OPC-1 項目 20 萬美元、臨床前項目 40 萬美元以及其他未公開項目,部分被 OpRegen 項目 50 萬美元所抵銷。

  • Our G&A expenses were $4.2 million a decrease of $0.2 million as compared to $4.4 million for the same period in 2024. This decrease is primarily attributable to stock-based compensation expenses and services provided by third parties. Loss from operations was 3.8 million, which was in line with the comparative prior period loss. Other income expenses reflected other expenses of $26 million compared to other income of $0.8 million for the same period in 2024. The change was largely attributable to the non-cash quarterly faire value remeasurement of the warrant liabilities of 26.6 million compared primarily due to change in our share prices compared to the prior year and $0.2 million for exchange rate fluctuations related to lineage's international subsidiaries.

    我們的一般及行政費用為 420 萬美元,比 2024 年同期的 440 萬美元減少了 20 萬美元。這一下降主要歸因於股票選擇權激勵費用和第三方提供的服務。營業虧損為 380 萬,與去年同期虧損基本持平。其他收入支出反映了其他支出 2,600 萬美元,而 2024 年同期其他收入為 80 萬美元。這項變動主要歸因於認股權證負債的非現金季度公允價值重估,金額為 2,660 萬美元,這主要是由於我們的股價與上一年相比發生了變化;此外,還有 20 萬美元是由於 Lineage 的國際子公司匯率波動造成的。

  • The net loss was $29.8 million, or $0.13 per share, compared to a net loss of $3 million or $0.02 per share for the same period in 2024. The change was primarily driven by the aforementioned warrant liability. 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.

    淨虧損為 2,980 萬美元,即每股虧損 0.13 美元,而 2024 年同期淨虧損為 300 萬美元,即每股虧損 0.02 美元。這項變更主要是由上述認股權證責任所驅動的。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。

  • So with that, I'll hand the call back to Brian.

    那麼,我就把電話交還給布萊恩了。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

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

    謝謝你,吉爾。因此,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 推動積極的臨床結果和乾性 AMD 的潛力充滿信心,而我們的合作夥伴對該計畫的承諾也令我們感到鼓舞。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 via funded partnerships or independently.

    其次,我們正在為未來成功做準備,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, and with that operator, we are ready 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和信任,有了您的支持,我們已準備好回答分析師的問題。

  • Operator

    Operator

  • Thank you. We will now begin the question-and-answer session. (Operator Instruction)

    謝謝。現在開始問答環節。(操作說明)

  • And your first question comes from the line of Mayank Mamtani with B. Riley Securities. Your line is now open.

    你的第一個問題來自 B. Riley Securities 的 Mayank Mamtani。您的線路已開通。

  • Unidentified Participant - Analyst

    Unidentified Participant - Analyst

  • Hi, yes, thanks. Sorry for the pause there. This is William on for Mayank.

    你好,是的,謝謝。剛才停頓了一下,抱歉。這是威廉為馬揚克作客。

  • Congratulations on a very nice quarter. A couple from us if we may just kinda curious, in terms of your, the considerations for your, islet cell program. You mentioned that there was sort of, a go-no-go decision in the works, and I was, curious what the internal considerations are incorporated into that for, on how to move forward. And then, I'm just also kind of curious in terms of partnerships you obviously mentioned the William Demant collaboration. How should we think, how should we be thinking about an additional partnership? Are you still looking to extend additional collaborations or, sort of what's the ballpark or the goalpost, internal goal that you're looking for, to complete and whether it's based on sort of capital or capacity wise?

    恭喜你本季表現出色。我們幾個朋友想問一下,就你們的胰島細胞計畫而言,你們有哪些考慮因素?你提到當時正在醞釀一個是否繼續前進的決定,我很好奇,在決定如何前進的過程中,內部考慮了哪些因素。另外,關於合作關係,我也挺好奇的,你剛才提到了與 William Demant 的合作。我們該如何看待,應該如何考慮建立新的合作關係?您是否仍在尋求擴大合作?或者,您希望達成的內部目標是什麼?這個目標是基於資金還是能力方面?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, William. Great question. So, with respect to the islet cell program, Due to the biological ceiling which exists in differentiation protocols today. The opportunity to really step function change the process by which you differentiate is probably fairly limited and probably not a solution that would lead to the kind of scale that we're talking about.

    謝謝你,威廉。問得好。因此,就胰島細胞培養計畫而言,由於目前分化方案中存在的生物學上限。真正實現差異化流程的階躍式改變的機會可能相當有限,而且可能也不是能夠達到我們所談論的那種規模的解決方案。

  • But if you can start with a much larger number of cells. That biological ceiling becomes less relevant, so our efforts are aimed at some of the earliest steps.

    但如果你能從數量更多的細胞開始就好了。生物學上的限制變得不那麼重要了,因此我們的努力方向是著眼於一些最早的步驟。

  • So that by the time you get to the later steps, which are, let's say capped, you're already on track for the kinds of output that you need to get. So, it, at the end of the day, it's a mathematical formula where you start with, let's say 100 trillion cells per year and you need to work backwards through various size of vessels, how long does it take to turn around. Found a batch of product and ultimately all the way back to the earliest steps. And if you do not maximize the earliest steps sufficiently, you will never reach the kind of output that is required to have a commercially viable product. You would perhaps create an interesting niche product, but that's not really our objective here.

    這樣,當你進入後面的步驟(比如說,已經達到上限的步驟)時,你已經走上了獲得所需輸出的正軌。所以,歸根究底,這是一個數學公式,假設你從每年 100 兆個細胞開始,你需要反向推算不同大小的血管,計算出血管週轉需要多長時間。找到了一批產品,最終追溯到了最初的步驟。如果你沒有充分發揮早期步驟的優勢,你將永遠無法達到生產具有商業可行性的產品所需的產量。你或許能創造出一個有趣的利基產品,但這並不是我們真正的目標。

  • So, we have a lot of experience with this part of the process development activity and so we are working on some fairly straightforward efforts and if we can knock down the barriers in the earliest steps, we think that that provides a credible line of sight. To conduct the same activities with some other cell lines that potential partners could have or be able to do it with our own cell line and be able to just continue on the process, obviously we are not saying that we can or need to in the initial days.

    因此,我們在流程開發活動的這一部分有很多經驗,所以我們正在進行一些相當直接的工作,如果我們能在早期階段就掃清障礙,我們認為這將提供一個可靠的方向。為了用其他細胞系進行同樣的活動,潛在的合作夥伴可能擁有或能夠用我們自己的細胞系開展同樣的活動,並能夠繼續進行該過程,顯然我們並不是說在最初幾天我們可以或需要這樣做。

  • Show someone that we can make 100 trillion cells, but rather we want to show the modality, the platform has that capability, and then of course there's risk inherent in actually reducing that fully to practice, but that is partnered all the time in this industry. People partner pre-clinical programs or phase one programs, not knowing if they will ever generate revenues.

    我們不會向別人展示我們可以製造 100 兆個細胞,而是想展示這種模式,這個平台具備這種能力。當然,將這種能力完全應用於實踐中存在固有的風險,但這在這個行業中一直都是合作解決的問題。人們參與臨床前項目或一期項目,卻不知道這些項目是否最終會產生利益。

  • So, it's analogous to that, it just happens to have an emphasis in the early-stage scale. The second question you asked was regarding partnerships. So, I'm very proud of the team for identifying Dumont as a bit of an atypical partner for us. However, they're ideal for us because of their hearing expertise. We don't have an a priori objective to find atypical partnerships, nor do we oppose them. They must be fit for purpose because we lack hearing loss expertise. William DuMont Invest is a terrific choice for us, and we reserve the right with them if we want to partner with some traditional pharma later, we can still do that. But you asked about our vision for partnerships and future partnerships. Ultimately, because our platform is capable of generating multiple assets, multiple product candidates, we envision having a basket of assets, some of which are partnered and some of which are retained for longer.

    所以,它與此類似,只是剛好更專注於早期階段。你提出的第二個問題是關於合作關係的。因此,我為團隊感到非常自豪,因為他們認定杜蒙是與我們不太尋常的合作夥伴。然而,由於他們擁有聽力方面的專業知識,他們對我們來說是理想的選擇。我們事先並沒有尋找非典型合作關係的目標,也不反對這段合作關係。它們必須符合用途,因為我們缺乏聽力損失的專業知識。威廉杜蒙投資公司對我們來說是一個絕佳的選擇,我們保留與他們合作的權利,如果以後我們想與一些傳統製藥公司合作,我們仍然可以這樣做。但您問的是我們對合作關係和未來合作關係的願景。最終,由於我們的平台能夠產生多個資產、多個候選產品,我們設想擁有一系列資產,其中一些是合作開發的,而另一些則會長期保留。

  • The specific question as to whether an asset gets partnered or not has many inputs. One of those inputs certainly is what is the cost and what is the risk and when would it would be appreciated by the investment community versus being appreciated by a partner. That's not a question that we can really answer because it depends in large part on our cost of capital. So if we have an unattractive share price, it makes sense to rely on partners to advance programs. If we have a more reasonable share. Price we have the lovely opportunity to hold on to things a little bit longer, create more value, so it really comes back ultimately to the business of value creation and value creation per share. So there are other factors I can, I won't go into them, but ultimately all of the factors come together and we then make an assessment of whether now is the right time to do a partnership and with whom.

    一項資產是否能獲得合作機會,這個具體問題涉及許多因素。其中一個考慮因素當然是成本和風險,以及投資界何時會欣賞它,而合作夥伴何時會欣賞它。這個問題我們無法真正回答,因為它很大程度上取決於我們的資金成本。因此,如果我們的股價沒有吸引力,依靠合作夥伴來推進專案就顯得合理了。如果我們能擁有更合理的份額。價格方面,我們有很好的機會持有股票更長時間,創造更多價值,所以最終還是要回到價值創造和每股價值創造的業務。所以還有其他一些因素,我就不一一贅述了,但最終所有因素都會綜合起來,我們會評估現在是否是建立合作關係的合適時機,以及與誰合作。

  • Unidentified Participant - Analyst

    Unidentified Participant - Analyst

  • Got it. That's very helpful.

    知道了。那很有幫助。

  • Thank you, Brian. One more, if I may, just briefly on OPC1, congratulations on the, on your first, SBI patient being dosed. I was just curious, based on sort of, if the patient, is affected, say, in this case from T1 to T10, I believe originally. At least pre-clinically, OPC1, or OPCs in general could migrate approximately about 5 centimeters. And so just thinking about the span of injury there, even if it's, originally at a single site, is there a potential here for OPC1 to be administered, or dosed at multiple sites to, achieve greater coverage along the spinal cord?

    謝謝你,布萊恩。如果可以的話,我再簡單提一下關於 OPC1 的事,祝賀你們的第一位 SBI 患者接受了給藥。我只是好奇,基於某種程度上,如果患者受到影響,比如說,在這種情況下,從 T1 到 T10,我相信最初是這樣。至少在臨床前研究中,OPC1 或一般的 OPC 可以遷移約 5 公分。因此,即使最初損傷部位只有一個,考慮到損傷的範圍,是否有可能在多個部位施用 OPC1,從而更好地覆蓋脊髓?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Yeah, the question, your question is correct. The first patient was a thoracic injury patient. We have in prior cases. Had patients who received cells in two separate locations during the same surgery, so I would describe it as saying approximately half the dose was administered on one side of the lesion and the other, the remainder of the dose was delivered on the other side of the lesion. So you're asking a very interesting question. Can you deliver multiple doses, multiple locations? The short answer is yes. Is there a benefit from re-dosing down the road? We don't know the answer to that yet.

    是的,你的問題問得對。第一位患者是胸部受傷的患者。我們在之前的案例中有過這樣的經驗。我曾經遇過在同一次手術中於兩個不同部位接受細胞治療的患者,所以我可以這樣描述:大約一半的劑量被注射到病灶的一側,而剩餘的劑量則注射到病灶的另一側。你問了一個非常有趣的問題。你們可以多次在多個地點接種疫苗嗎?簡而言之,答案是肯定的。以後再給藥有好處嗎?我們目前還不知道答案。

  • But we have what we consider to be a very strong safety profile for OPC1, so it would be something that we would like to investigate, and we know of no reason why one could not receive, multiple doses of the of the product even at the even at the full dose of 20 million cells.

    但我們認為 OPC1 具有非常強的安全性,因此我們想對此進行研究,而且我們認為沒有任何理由不能接受多次注射該產品,即使是 2000 萬個細胞的全劑量。

  • Unidentified Participant - Analyst

    Unidentified Participant - Analyst

  • Got it. Thanks, Brian. Congratulations again and we'll hop back to the queue.

    知道了。謝謝你,布萊恩。再次恭喜,我們這就回到隊列裡去。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, William.

    謝謝你,威廉。

  • Operator

    Operator

  • Your next question comes from the line of Joseph Pantginis with HC Wainwright. Your line is now open.

    你的下一個問題源自 Joseph Pantginis 與 HC Wainwright 的淵源。您的線路已開通。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • Hey everybody, good afternoon. Thanks for taking the questions. So, Brian, first, I want to go to your comments around the potential for the CIRM grant, whether it's 7 million or what have you. I wanted to simply ask, based on your commentary, how you feel the additional funding might expand or accelerate the program?

    大家好,下午好。謝謝您回答問題。布萊恩,首先,我想談談你對 CIRM 撥款可能性的看法,不管是 700 萬美元還是其他什麼金額。我想問的是,根據您的評論,您認為額外的資金可能會如何擴大或加速該專案?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thanks, Joe. So yeah, we don't know if we will get, we don't know a final amount because the way that the funding works is there's a bit of a bring down exercise where they, check on your budget to make sure it aligns with your original application, nothing significant has changed, but in the ideal case for us, we would be somewhere, maybe just a little north of 7 million, this would accomplish multiple things for us.

    謝謝,喬。是的,我們不知道能否獲得資助,也不知道最終金額是多少,因為資助流程中會有一個審核環節,他們會檢查你的預算,確保它與你最初的申請一致。目前還沒有什麼重大變化,但對我們來說,理想情況下,我們可以拿到700萬美元左右,這筆錢可以幫我們實現很多目標。

  • The first is that we would feel, emboldened to expand the number of sites and be more aggressive about recruiting patients, because we have both acute and chronic injury patients that will be enrolled. Acute injury patients are harder to find because you have a window where they are, eligible for your trial. So, it's good to cast a wide net.

    首先,我們會更有信心擴大試驗點數量,更積極地招募患者,因為我們既有急性損傷患者也有慢性損傷患者需要招募。急性損傷患者更難找到,因為你只有一段時間才能找到符合試驗條件的患者。所以,廣撒網是好事。

  • But we also have had the first utilization of the new device and so that has had some level of de-risking. So just as we are now more comfortable having more patients come on the study, we've learned what we needed to learn, we also are meeting. Hopefully with a successful outcome from the CIRM grant that'll help fund that and that's the second part of the answer is the funding is that we have in our budget in our plans for our business, a meaningful number of millions of dollars that will fund this trial. If in fact we are offsetting approximately 50% of this study, that frees up cash that we would otherwise plan to spend on this trial, so it's a very nice pick up, but just to be clear, if anyone who's listening is not certain about this. Does not hand you a check for the full amount. It is essentially a reimbursement, so there's a delay and a stagger, but you are, if you conduct all the activities and the program continues, you are likely to collect the full amount of the grant over the multi-year period.

    但我們也已經首次使用了這種新設備,因此在一定程度上降低了風險。所以,正如我們現在更願意讓更多患者參與研究一樣,我們已經了解了我們需要了解的內容,我們也正在開會討論。希望 CIRM 的撥款能夠成功,從而幫助資助這項研究。答案的第二部分是資金問題,我們公司預算和計劃中已經撥出數百萬美元用於資助這項試驗。如果這筆資金確實抵消了這項研究約 50% 的費用,那麼就能騰出原本計劃用於這項試驗的資金,所以這是一個非常好的收穫。但為了避免誤解,如果有人對此仍有疑問,我在此澄清一下。不會給你全額支票。這本質上是一種補償,所以會有延遲和分期付款,但是,如果你開展所有活動並且項目繼續進行,你很可能在多年期間收到全部撥款。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • That's very helpful.

    那很有幫助。

  • Thank you for that.

    謝謝。

  • Next question, a bit of housekeeping, probably a little rhetorical, for Jill, with regard to your cash runway, are any of the Roche milestones or beyond included in that runway, or it's basically, you'll update when they happen?

    下一個問題,一些瑣碎的事情,可能有點反問意味,吉爾,關於你的現金儲備,羅氏的任何里程碑或後續目標是否包含在你的現金儲備中,還是基本上,你會在這些里程碑實現時更新?

  • Jill Howe - Chief Financial Officer

    Jill Howe - Chief Financial Officer

  • Yeah, that's right. Just so it's not included, and we do plan to update when we are able to achieve those milestones and they get added into our forward runway, excuse me.

    是的,沒錯。抱歉,目前還沒有包含這些內容,我們計劃在實現這些里程碑並將其添加到我們的未來計劃中時進行更新。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • Perfect. And then Brian, my last question is really about your longer-term business model. You obviously have a foundational platform with all of the different, sell directions you can take here. So looking deep into the future, and I know this is, difficult, can you tell us how or, why or why not lineage could become a tool or self-services company as part of its approach?

    完美的。布萊恩,我的最後一個問題其實是關於你的長期商業模式。顯然,您已經擁有一個基礎平台,可以朝著各種不同的銷售方向發展。展望未來,我知道這很困難,您能否告訴我們,作為其發展策略的一部分,Lineage 如何、為什麼或為什麼不可能成為工具或自助服務公司?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • I hope we never do, is my answer. The problem is that I think, it remains difficult to do the work that we do. We have a lovely advantage of having been around and involved in this technology for over 20 years, so I think we've gotten quite good at it, but nevertheless, it's difficult to price. The development of the recipe by which you develop a cell because you don't know how long it's going to take. So it's not a easily, it's not a widget that you can easily price.

    我的回答是:我希望我們永遠不會那麼做。我認為,問題在於,我們所做的工作仍然很難進行。我們在這項技術領域已經耕耘了 20 多年,這是我們的一大優勢,所以我認為我們在這方面已經相當熟練了,但即便如此,定價仍然很困難。制定培養細胞的配方,因為你不知道需要多長時間。所以它不是一個容易定價的小部件。

  • The other factor with respect to sort of behaving like a CDMO is that, those margins tend to be unattractive to me. I want through our partnerships to have significant ownership in the upside. We're not particularly interested in doing fee for service work. We do have an exquisitely well trained team, but we also have a small facility, so we don't really have the capacity to do that. There are some scenarios that I think are worth considering which are whether we have some intellectual property or some other technology that perhaps an alliance with one of those CDMOs would make sense, especially in areas that we have deemed not to be of interest to us because there are plenty of people who are working on cell therapy programs that we wouldn't touch. But the fact that they have raised capital and perhaps some of that capital could find its way to flow back to lineage would be fantastic.

    另一個與扮演 CDMO 角色相關的因素是,這些利潤率對我來說往往沒有吸引力。我希望透過我們的合作關係,在收益成長中獲得相當大的份額。我們對按服務收費的工作沒有特別的興趣。我們確實擁有一支訓練有素的團隊,但我們的設施也很小,所以我們真的沒有能力做到這一點。我認為有一些情況值得考慮,例如我們是否擁有一些智慧財產權或其他技術,與CDMO公司結盟或許是有意義的,尤其是在我們認為不感興趣的領域,因為有很多公司在從事我們不會涉足的細胞療法計畫。但他們已經籌集到了資金,而且其中一部分資金或許能夠回流到家族中,這將是件非常棒的事情。

  • So, do we have formulation technology or storage technology or process technology, and could that be utilized by others in sort of a multi-handed deal? I think that's a really interesting idea, but it is not our ambition to be Become a two-sided business where we're developing products for ourselves on one side and we're doing fee for service. To the extent that fee for service does bring in capital that you can use for innovation, I would rather do that by separating, by getting a big return on investment, i.e. separating the amount of money required to launch a new program from the amount of money we get. From a partnership and I think that both the Roche Agreement and the WDI agreements are really good examples of that. Our upfront or our reimbursed amount is greater than the amount that we put in to invent these things. So, I think if we can continue to find those opportunities, we will be less reliant on the capital markets than perhaps we would if we did not conduct those, strategies.

    那麼,我們是否擁有配方技術、儲存技術或製程技術,而其他人能否在某種多方合作的交易中利用這些技術呢?我認為這是一個非常有趣的想法,但我們的目標並不是成為雙邊企業,一方面開發自己的產品,另一方面提供收費服務。如果按服務收費確實能帶來可用於創新的資金,我寧願透過分離來獲得高額投資回報,也就是說,將啟動新專案所需的資金與我們獲得的資金分開。從夥伴關係的角度來看,我認為羅氏協議和世界發展研究所協議都是這方面的很好的例子。我們預付的款項或報銷的金額大於我們為發明這些東西所投入的金額。所以,我認為如果我們能夠繼續找到這些機會,我們對資本市場的依賴程度就會比我們不採取這些策略時還要低。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • Great, really appreciate that, answer as well as all the others. Thanks a lot.

    太好了,非常感謝,你的回答和其他人的回答一樣好。多謝。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Jill.

    謝謝你,吉爾。

  • Operator

    Operator

  • Your next question comes from the line of Jack Allen from BAIRD.

    你的下一個問題來自 BAIRD 的 Jack Allen 的一條線。

  • You mean your line is now open.

    你的意思是說你的線路現在開通了。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • Hi, this is Charlie on for Jack.

    大家好,我是查理,替傑克報道。

  • Thank you for taking our questions. So, just to start with the dose study, could you remind us of any inpatient stagger requirements there, how quickly you could dose patients, and what sort of data set you envision collecting, before announcing initial data, as well as, with this first chronic patient, could you let us know when they were dosed and how we should think about the stability of their motor function prior to dosing? Thanks, and then I have a follow-up afterward.

    感謝您回答我們的問題。那麼,首先來說說劑量研究,您能否提醒我們一下住院患者在給藥方面是否有任何交錯要求,您能以多快的速度給患者給藥,以及在公佈初步數據之前,您設想收集什麼樣的數據集?另外,對於第一位慢性患者,您能否告訴我們他們的給藥時間,以及在給藥之前我們應該如何考慮他們的運動功能穩定性?謝謝,之後我還有一個後續問題。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you. A lot to unpack there. So, the dose study does have a stagger. The first patient was a thoracic age A, and the next patient will be a thoracic age B, and then the third patient will be thoracic A or B, and then we can do our first cervical patient. And those steps that I outlined can be either chronic or subacute, at that point. We then go into open enrollment for an additional two to six patients.

    謝謝。這裡面有很多資訊需要分析。所以,劑量研究確實採用了分階段進行的方式。第一位患者是胸椎年齡 A,下一位患者是胸椎年齡 B,然後第三位患者是胸椎 A 或 B,然後我們就可以進行第一位頸椎患者的手術了。而我概述的那些步驟,在那時可能是慢性的,也可能是亞急性的。然後我們再招募兩到六名患者。

  • The data set, we have already provided initial data. We have shared that the new device had performed and delivered the cells in its intended way, and that is the primary objective of the study. Was to assess the safety and performance. However, I recognize that the investment community is, more intrigued by the possibility of seeing some functional improvement in patients, especially chronic patients, and I think that's the right thing to be excited about.

    我們已經提供了初始資料集。我們已經分享過,新設備已經按照預期的方式完成了細胞輸送,這也是這項研究的主要目標。目的是評估安全性和性能。不過,我意識到投資界更感興趣的是看到患者(尤其是慢性病患者)的功能有所改善,我認為這才是真正值得興奮的事情。

  • The the status of the patient, the stability of the patient is not known to me, but in any case, the patient was dosed on July 30th, so approximately. Two months ago, so we would assume that that would be too soon to report on any sort of functional changes that they might be experiencing if they are experiencing any at all, and that is because there can be some variability even among chronic injury patients and we would not want to get ahead of the story.

    我不知道病人的狀況和穩定性,但無論如何,病人大約在 7 月 30 日接受了治療。兩個月前,所以我們認為現在報告他們可能經歷的任何功能變化(如果他們確實經歷了任何變化)都為時過早,因為即使是慢性損傷患者也可能存在一些差異,我們不想操之過急。

  • And I would point no further than the OpRegen program. When we first identified retinal restoration, we didn't go public for nine months because it was such an extraordinary claim. Frankly, we needed to make sure we had a lot of independent and blinded reviews of that data before we went out to speak about it, and by doing so we were able to speak quite credibly about it. We would imagine the same approach with respect to the dose study, so we will continue to watch this patient. There is a stagger the patients go approximately a month and they have to pull together your DSMB, and then they go through the review before you get cleared, so what I really can only. Say about the patient at this point is that there have been no significant safety events and that's through the first 60 days following the treatment so that's great and the device seemed to work the way it was intended so that's great and we will continue and you know I think it's really more of a 2026 story for this trial.

    我最推薦的就是 OpRegen 計畫。當我們首次發現視網膜修復技術時,由於這是一項非常了不起的發現,所以我們九個月後才對外公佈。坦白說,在對外發表意見之前,我們需要確保對這些數據進行大量的獨立和盲審,透過這樣做,我們才能相當有說服力地談論此事。我們預計劑量研究也將採取相同的方法,因此我們將繼續觀察這位患者。患者大約需要一個月的時間才能完成治療,他們需要召集你的資料安全監察委員會 (DSMB),然後進行審查,之後你才能獲得批准,所以我只能說這麼多。就目前而言,關於這位患者的情況是,在治療後的前 60 天內沒有發生任何重大安全事件,這很好。該設備似乎也按預期發揮了作用,這很好。我們將繼續進行試驗。我認為這項試驗的最終結果要到 2026 年才能揭曉。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • Wonderful.

    精彩的。

  • Thank you for the color there and helping to unpack that multifaceted question. For the follow-up, just curious on the OpRegen, program, has Roche given you a sense for the degree of follow-up they'd like to see from patients treated in the Gillette study prior to moving into a pivotal trial? And is there any kind of description of a data package they're working toward that we should keep in mind? And that'll do it for us.

    感謝您提供的豐富信息,並幫助我們理清這個複雜的問題。關於後續問題,我很好奇 OpRegen 項目,羅氏是否向您說明,在進入關鍵性試驗之前,他們希望從吉列研究中接受治療的患者那裡獲得多大程度的隨訪?他們正在開發的資料包是否有任何描述,我們應該記住嗎?這就結束了。

  • Thank you.

    謝謝。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Charlie. The degree of follow-up is known. The primary and secondary assessments are through 90 days. So the two primaries and the secondary assessment occur within 90 days. So, now that that is not inclusive of. Of, longer-term functional data so those data of course do get collected those patients are on study for for years, but the initial questions that should be framing decisions occur very rapidly. So that's in part why we're so encouraged by seeing the expansion and the continuation of this of this program is that. If it were a disaster, presumably that would be quite easy to know.

    謝謝你,查理。後續跟進程度是已知的。初次和二次評估持續 90 天。因此,兩次初試和二次評估將在 90 天內完成。所以,現在這並不包括。當然,長期功能數據會被收集起來,因為這些患者會接受多年的研究,但最初決定決策的問題出現得非常快。所以,部分原因在於,我們看到這個計畫的擴展和延續,感到非常鼓舞。如果是一場災難,想必很容易就知道。

  • But we do not know what the plans are for the data package and it's probably worth reminding everyone that this is not a conventional phase two study. There is no pre-specified endpoint. It is not a responder's analysis the way that we often see phase two responders analysis. This is surgical optimization.

    但我們不知道資料包的計畫是什麼,而且或許值得提醒大家,這不是一項常規的二期研究。沒有預先設定的終點。這不是我們通常看到的二期臨床試驗應答者分析。這是手術優化。

  • A large number of patients could have very bad outcomes, but if enough of them using one particular set of criteria are encouraging, then presumably Roche would follow that set of criteria as they consider moving into a subsequent trial. But the truth of the matter is that we do not have that information. We are not part of that discussion, and we do not know what that plan will be or when it will occur.

    大量患者可能會出現非常糟糕的結果,但如果足夠多的患者按照某一特定標準得出的結果令人鼓舞,那麼羅氏公司在考慮進行後續試驗時,很可能會遵循該標準。但事實是我們並沒有這些資訊。我們沒有參與那次討論,也不知道那項計畫是什麼,也不知道它何時實施。

  • We just know that it's an end point that is difficult to miss. It occurs very rapidly. And there seemed to be a lot of activities which I outlined on the call today that would suggest that things are going well, so we're hopeful that we're correct in interpreting these events and that, at some point in the future we will all learn the very specific answer to your question.

    我們只知道這是一個很難錯過的終點。它發生得非常迅速。今天我在電話會議上概述了很多活動,這些活動似乎表明事情進展順利,所以我們希望我們對這些事件的解釋是正確的,並且在未來某個時候,我們都會知道你問題的具體答案。

  • I would add to that that this is a new technology, optimization, surgical optimization presumably could continue for many years. That would not be unusual to me in any way.

    我還要補充一點,這是一項新技術,優化,特別是手術優化,可能會持續很多年。對我來說,這完全不足為奇。

  • But at some point, saying that you feel comfortable enough to continue development because there's a clock ticking. Of course, there are some competitors and there are hopes for v revenues out there. So, I think that there is tension between optimizing to perfection, which is an unrealistic goal in the short-term, and moving forward into, aggressive development, and I trust that our partners who have been so profoundly successful in ophthalmology product development. Know exactly what they're doing, and I have no problem saying they surely know better about how to do this than we do.

    但到了某個時候,你會覺得時間緊迫,可以繼續開發了。當然,也有一些競爭對手,而且對收入也有很高的期望。所以,我認為存在著一種矛盾:一方面是追求完美,這在短期內是不切實際的目標;另一方面是積極進取,不斷發展。我相信,我們在眼科產品開發領域取得巨大成功的合作夥伴們能夠做到這一點。他們非常清楚自己在做什麼,我可以毫不猶豫地說,他們肯定比我們更懂得如何做好這件事。

  • So, we believe the asset is in the very best and most capable hands possible and if through their work they are ultimately increasing the future peak sales of this product, if they are increasing the probability of success of this product, then we are quite comfortable waiting for their timelines to hit so that we can all enjoy success.

    因此,我們相信這項資產掌握在最優秀、最有能力的人手中,如果他們的工作最終能夠提高該產品未來的銷售峰值,提高該產品成功的機率,那麼我們很樂意等待他們的計劃實現,以便我們都能享受成功。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • Wonderful. Makes a lot of sense. Thanks so much for the thorough answer, Brian.

    精彩的。很有道理。布萊恩,非常感謝你詳盡的解答。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Charlie.

    謝謝你,查理。

  • Operator

    Operator

  • Your next question comes from the line of Boris Speaker with Python Partners. Your line is now open.

    你的下一個問題來自 Boris Speaker 與 Python Partners 的對話。您的線路已開通。

  • Boris Speaker - Analyst

    Boris Speaker - Analyst

  • Great, thanks for squeezing me. Just, quickly on OpRegen, are there any conferences where you think the next data update could be presented, or have you spoken to Genentech Roche on their intention of presenting more data?

    太好了,謝謝你擠壓我。關於 OpRegen,您認為有哪些會議可以發布下一次數據更新?還是您與 Genentech Roche 談過他們發布更多數據的意圖?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • We speak with them very frequently, perhaps surprisingly frequently, and from time to time we do have discussions about upcoming presentations and, we share content at some point, before, but with respect to what I believe you're really aiming at, which is, a disclosure of fulsome galeite data or at least some form of galeite data, we do not know their plans and so we just like you look at the calendar and we just imagine different events and forums where that could occur, but we don't know, it could be something that spontaneously comes out ad hoc, a pharma day, an ophthalmology day, a random day, Monday, like we just don't know.

    我們與他們溝通非常頻繁,或許頻繁得令人驚訝。我們時不時會討論即將進行的演講,也會在某個時候分享一些內容。但就我認為你真正想要的,也就是揭露完整的伽利特數據,或至少是某種形式的伽利特數據而言,我們並不了解他們的計畫。所以我們和你一樣,只能看看日曆,想像一下可能會出現這種情況的不同活動和論壇。但我們並不知道,這可能是臨時性的,例如在醫藥日、眼科日,或是任何一個隨機的日子,例如星期一,我們真的不知道。

  • Boris Speaker - Analyst

    Boris Speaker - Analyst

  • Got it. And maybe on the CIRM grant.

    知道了。或許還能獲得CIRM的資助。

  • I guess what happens if you don't get CIRM funding? How does that impact your program?

    我想問,如果拿不到CIRM的資助會怎麼樣?這會對你的專案產生什麼影響?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • It's a few tears shed in the beer for the hard work of the team to go through the effort to put together a really fantastic application.

    這是對團隊辛勤付出、努力打造出如此出色申請材料的感慨,我們忍不住在啤酒裡流下了幾滴眼淚。

  • It's probably a phone call to really TRY to understand why, because we feel like the fit for this program is right in the center of the bull's eye for CIRM's mission. But ultimately it changes very little. The program will continue. We will continue to find and identify patients. We need to demonstrate that this new device is adequate and sufficient to support a larger trial. We need to bridge in the new cells that we have. Prepared and tested and all of that work will continue we would just regret that we were not successful in securing some external and and very good cause of capital support for the program in the way that we've envisioned it for so long.

    可能需要打個電話才能真正了解原因,因為我們覺得這個計畫與 CIRM 的使命非常契合。但歸根結底,它幾乎不會改變什麼。該項目將繼續進行。我們將繼續尋找和識別患者。我們需要證明這種新設備足以支援更大規模的試驗。我們需要將新細胞連接起來。準備和測試工作已經完成,所有這些工作都將繼續進行,我們只是遺憾未能成功地為該項目爭取到一些外部的、非常好的資金支持,以按照我們長期以來設想的方式開展。

  • The runway, by the way that we described does not include any SER dollars so potentially there would be a pickup depending on how close to the edges we are on a on a quarter there.

    順便一提,我們描述的跑道不包括任何SER美元,因此可能會增加,這取決於我們距離邊緣有多近,以及我們在一個季度中的位置。

  • Boris Speaker - Analyst

    Boris Speaker - Analyst

  • Great, thank you very much for taking my questions.

    太好了,非常感謝您回答我的問題。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Boris.

    謝謝你,鮑里斯。

  • Operator

    Operator

  • Your next question comes from the line of Sean Mccutcheon with Raymond James. Your line is now open.

    你的下一個問題來自 Sean McCutcheon 與 Raymond James 的合作系列。您的線路已開通。

  • Sean Mccutcheon - Analyst

    Sean Mccutcheon - Analyst

  • Hi, guys. Thanks for the questions. Brian, I think you helped bridge into my first one. Can you speak to the process of potentially getting the new OPC formulation into the D study? How much that could truncate the timeline versus a separate bridging study and whether or not you're in dialogue with FDA on that front? And then there's a second question, could you provide a sightline to getting, more patients treated in the dose study, maybe remind us of the safety waiting period and the progress you're making in terms of identifying patients, to be treated. Thanks.

    嗨,大家好。謝謝大家的提問。布萊恩,我覺得你幫我搭建了通往第一個夢想的橋。您能否談談將新的 OPC 配方納入 D 研究的潛在流程?與單獨的橋接研究相比,這能將時間表縮短多少?你們是否就此與FDA進行過對話?第二個問題是,您能否提供一些關於如何讓更多患者參與劑量研究的展望,或許可以提醒我們一下安全等待期以及您在確定待治療患者方面取得的進展。謝謝。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thanks, Sean. Yeah, the idea that we have was that we could accelerate things by, not having the new cells be a separate study. So our strategy is to have the cells introduced, more or less at the end of the dose study. Does that mean that the dose study gets larger? Not necessarily. It depends on the next part of your question, which is the FDA dialogue.

    謝謝你,肖恩。是的,我們的想法是,我們可以透過不將新細胞作為單獨的研究來加快研究進程。因此,我們的策略是在劑量研究的最後階段引入細胞。那是否意味著劑量研究的規模會擴大?未必。這取決於你問題的下一部分,也就是關於FDA的對話。

  • So, we have been preparing. Package to take all of that information to FDA so that we could find out what it, what exactly the path will need to be, so potentially the agency would say you can introduce these cells into the dose study in the last, four or five patients, last one or two patients, maybe they'll ask us to add four or five patients at the end, but we're trying to accelerate and compressed timelines by not doing it as a separate campaign.

    所以,我們一直在做準備。我們會將所有這些資訊提交給 FDA,以便我們能夠了解具體需要採取的路徑,因此 FDA 可能會說,我們可以將這些細胞引入劑量研究的最後四五名患者,或者最後一兩名患者,他們可能會要求我們在最後增加四五名患者,但我們正在努力加快進度,縮短時間,而不是將其作為單獨的活動來開展。

  • With respect to the gating of patients in the waiting period, I think I mentioned before, it's about a month, but then you've got this sort of You know practical reality of assembling, you're collecting your data, preparing your data, assembling it for your data safety monitoring board, getting them to discuss and say everything is okay, and then going back to your sites and saying it's okay to go. I mean on average it's hard for me to estimate because we don't have a lot of experience running spinal cord trials. The prior data was collected by others, but I would estimate that the turnaround time would.

    關於患者在等待期內的准入限制,我想我之前提到過,大約是一個月的時間,但之後你就會遇到這種實際問題,比如收集數據、準備數據、將其匯總提交給數據安全監測委員會,讓他們討論並確認一切正常,然後回到你的站點,告訴他們一切可以開始了。我的意思是,平均而言,我很難估計,因為我們沒有太多進行脊髓損傷試驗的經驗。先前的數據是由其他人收集的,但我估計週轉時間會是…

  • The quarterly because you've got the explicit stagger and then you've got the implied stagger, but it also will be a function of additional sites so you know one of the convenient, nuances of what we've done here is we wanted to start slowly because we wanted to make sure that the new device was going well and we also had to start slowly because we had a. Stagger, but conveniently we've been waiting for a CIRM output, so SERM's not funding any of this currently. So, just at the time that we would hope to be getting out of a stagger and opening more sites, we may be having partial reimbursement from CIRM, so that it all sort of is, coming together in the most economically feasible way.

    季度性的,因為你既有明確的錯開時間,也有隱含的錯開時間,但它也將取決於額外的站點,所以你知道,我們在這裡所做的一個方便的細微差別是,我們希望慢慢開始,因為我們想確保新設備運行良好,我們也必須慢慢開始,因為我們有一個。雖然進展緩慢,但巧合的是,我們一直在等待 CIRM 的成果,所以 SERM 目前沒有為這些計畫提供任何資金。所以,正當我們希望擺脫錯峰狀態並開放更多站點的時候,我們可能會從 CIRM 獲得部分補償,這樣一來,所有事情就以最經濟可行的方式結合起來了。

  • And I think that that makes sense for for where we are as a business and as I said before around around our our cost of capital so you can expect to see more activity with the study you can expect us to see having that FDA engagement and you can expect to hear more detail from us on timing as we secure that timing and information from FDA.

    我認為這對我們公司目前的業務狀況來說是合理的,正如我之前所說,這與我們的資本成本差不多,所以你們可以期待看到這項研究有更多進展,你們可以期待看到我們與FDA的溝通,你們也可以期待在我們確定FDA的時間安排和信息後,聽到更多關於時間安排的細節。

  • Understood, thanks, Brian. Awesome, thank you, Sean.

    明白了,謝謝你,布萊恩。太棒了,謝謝你,肖恩。

  • Operator

    Operator

  • Your next question comes from the line of Albert Lowe. Your line is now open.

    你的下一個問題出自艾伯特·洛的詩句。您的線路已開通。

  • Albert Lowe - Analyst

    Albert Lowe - Analyst

  • Hi. I noticed that Roche highlighted the OpRegen program in an investor event they held in September and discussed these new devices that they acquired for the procedure.

    你好。我注意到羅氏在9月份舉辦的投資者活動中重點介紹了OpRegen項目,並討論了他們為該手術收購的這些新設備。

  • Can you just give us some more color around the capability of these Devices?

    能否詳細介紹一下這些設備的功能?

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thanks, Albert. I'd be happy to. There are two basic ways to access the subretinal space, and everyone should be reminded that you must deliver the OpRegen cells to the subretinal space. These cells are not working at big distances. They are a transplant, so they have to go where the RPE cells belong.

    謝謝你,阿爾伯特。我很樂意。進入視網膜下腔有兩種基本方法,每個人都應該記住,必須將 OpRegen 細胞輸送到視網膜下腔。這些電池在遠距離工作時效果不佳。它們是移植的,所以必須移植到 RPE 細胞原本所在的位置。

  • And you can go through the front of the eye, which is transvitrial, or there's a newer technology or newer method, which is super coroidal, which goes around and accesses the subretinal space from the back of the eye, so front door or back door. Each of those devices that, Roche described on their recent, Pharma Day or ophthalmology Day, I don't recall which, each of those is a next generation. Version.

    你可以透過眼睛的前部進行手術,也就是經玻璃體入路;或者有一種更新的技術或方法,即超視網膜入路,它可以繞到眼睛後部進入視網膜下腔,所以可以是前門入路,也可以是後門入路。羅氏在最近的醫藥日或眼科日(我不記得是哪個了)上介紹的每款設備都是下一代產品。版本。

  • So, the trans vitriol is an improved version of what is off the shelf, and the suprachoroidal is also an improved version of the technology that we first demonstrated in these patients in our phase one study that we acquired a license to Gyroscope that was then acquired by Novartis. So, they have trade-offs. The front of the eye and the back of the eye are just different. Different, we do not know, and I don't know if Roche and Genentech have decided, but we do not know as lineage which of the two is superior. One is very straightforward. You can see everything you're doing. It's very off the shelf. The other requires some specialized training and some specialized tools, but it may have some advantages. Ultimately we're going to have to wait and see what kind of information from these devices comes from it.

    因此,透皮硫酸鹽是市售產品的改良版,脈絡膜上腔注射液也是我們首次在一期研究中向這些患者展示的技術的改良版,我們獲得了 Gyroscope 公司的許可,該公司後來被諾華公司收購。所以,它們之間需要權衡取捨。眼睛的前部和後部是不同的。不同之處我們不得而知,我也不知道羅氏和基因泰克是否已經做出決定,但我們身為業內人士,並不知道哪一種更勝一籌。一個非常簡單明了。你可以看到你所做的一切。它非常現成。另一種方法需要一些專門的培訓和工具,但可能有一些優勢。最終,我們只能拭目以待,看看這些設備會提供什麼樣的資訊。

  • And I do want to caution everyone that there's no guarantee that our partners are going to tell us all what they found. When I look at some of the competitor data, I feel that they are advantaged in a way because we at Lineage showed them where to put the cells. So, if you go around telling everyone every piece of data that you discover in a way you can be enabling your competitors, so, It is very important because the warrant, the $37 million of warrant capital that Jill described was intentionally designed with milestone language that did not, that was uncoupled from specific devices or data presentations. It simply and solely required our partners to. Disclose their intent to run a controlled or comparative arm study. So, it's somewhat of a lower bar, but it was intentionally written that way to capture the possibility that they might say that they're going forward and not tell everyone why, but that's okay.

    我還要提醒大家,我們無法保證合作夥伴會告訴我們他們所發現的一切。當我查看一些競爭對手的數據時,我覺得他們在某種程度上具有優勢,因為 Lineage 向他們展示瞭如何放置細胞。所以,如果你到處告訴所有人你發現的每一個數據,你就是在幫助你的競爭對手。因此,這一點非常重要,因為吉爾描述的3700萬美元認股權證資本是特意設計成帶有里程碑條款的,這些條款與特定的設備或數據展示無關。這僅僅且僅要求我們的合作夥伴這樣做。揭露他們進行對照或對照研究的意圖。所以,標準稍微低了一些,但故意這樣寫的是為了考慮到他們可能會說他們要繼續推進,但不會告訴大家原因,但沒關係。

  • We still would stand to interpret that as a very big positive. But of course, we're hopeful that they will, be comfortable sharing everything that they like, and I think given that at one of those conferences, the global franchise had said that they wanted to pioneer innovation in vision restoration, in the context of words talking about going beyond compliment. I think that they're going to find some interesting things. I think they're going to be proud. I think they're going to want to show off, and I think that'll be great for us and our shareholders.

    我們仍然會將其解讀為一個非常積極的信號。當然,我們希望他們能夠自在地分享他們喜歡的一切,而且我認為,鑑於在一次會議上,全球特許經營權曾表示,他們希望在視力恢復領域引領創新,這番話也超越了讚美的範疇。我認為他們會發現一些有趣的東西。我想他們會感到自豪的。我認為他們會想要炫耀一番,這對我們和我們的股東來說都是好事。

  • Albert Lowe - Analyst

    Albert Lowe - Analyst

  • Great. Thank you.

    偉大的。謝謝。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Thank you, Albert.

    謝謝你,阿爾伯特。

  • Operator

    Operator

  • If there are no further questions, I will now turn the call back over to Mr. Brian Cully for closing remarks.

    如果沒有其他問題,我現在將把電話轉回給布萊恩·卡利先生,請他作總結發言。

  • Brian Culley - Chief Executive Officer, Director

    Brian Culley - Chief Executive Officer, Director

  • Well, thank you so much. Everybody, I've been reading the headlines, I think it's a bit misfortune, a bit of misfortune that there's a lot of, discouraging news around cell and gene therapy, we've all seen the news from Tacada and Galapagos and Novo. I think it's important to keep in mind that, lineage is not doing autologous CAT.

    非常感謝。各位,我一直在看新聞標題,我覺得有點不幸,細胞和基因療法領域有很多令人沮喪的新聞,我們都看到了來自 Tacada、Galapagos 和 Novo 的新聞。我認為需要記住的是,譜系分析並不涉及自體 CAT。

  • What we are doing is quite different and the criticisms that may be levied against certain kinds of cell therapy may not be entirely applicable to what we're doing. So I invite everyone to go deeper and really consider how we are distinguishing ourselves through manufacturing and our basic approach of developing allogeneic off the shelf cell transplants, and then, please contact us if you have any questions. We're really happy about how things are going. Thanks for your attention.

    我們所做的事情截然不同,針對某些細胞療法的批評可能並不完全適用於我們正在做的事情。因此,我邀請大家深入了解,認真思考我們如何透過生產製造以及我們開發同種異體現成細胞移植的基本方法來脫穎而出,然後,如果您有任何疑問,請與我們聯繫。我們對目前的發展狀況非常滿意。謝謝您的關注。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's call.

    女士們、先生們,今天的電話會議到此結束。

  • Thank you all for joining. You may now disconnect.

    感謝各位的參與。您現在可以斷開連線了。