Orgenesis Inc (ORGS) 2023 Q2 法說會逐字稿

Greetings. And welcome to the Orgenesis' Second Quarter 2023 Business Update Call. (Operator Instructions) A question and answer session will follow the formal presentation. (Operator Instructions) Please note this conference is being recorded. I will now turn the conference over to your host, David Waldman, Investor Relations. You may begin.

問候。歡迎參加 Orgenesis 2023 年第二季度業務更新電話會議。 （操作員說明）正式演示之後將進行問答環節。 （操作員說明）請注意，本次會議正在錄製中。現在我將會議交給東道主投資者關係部門的大衛·沃爾德曼 (David Waldman)。你可以開始了。

Thank you, and good morning, everyone, and welcome to the Orgenesis' Second Quarter 2023 Business Update Conference Call. On the call with us this morning are Vered Caplan, Chief Executive Officer; and Neil Reithinger, Chief Financial Officer. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at 212 671-1020. This conference call contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 as amended and Section 21E of the Securities Exchange Act of 1934 as amended.

謝謝大家，大家早上好，歡迎參加 Orgenesis 2023 年第二季度業務更新電話會議。今天早上與我們通話的是首席執行官 Vered Caplan；首席財務官尼爾·雷辛格 (Neil Reithinger)。如果您在通話後有任何疑問或想了解有關該公司的任何其他信息，請致電 212 671-1020 聯繫 Crescendo Communications。本次電話會議包含前瞻性陳述，這些陳述是根據經修訂的 1933 年證券法第 27A 條和經修訂的 1934 年證券交易法第 21E 條的安全港條款作出的。

These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this conference call. We caution listeners that forward-looking statements are predictions based on our current expectations about future events.

這些前瞻性陳述涉及重大的不確定性和風險，基於我們當前的預期、估計和預測，並反映了我們基於本次電話會議之日掌握的信息的信念和假設。我們提醒聽眾，前瞻性陳述是基於我們當前對未來事件的預期的預測。

These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties discussed under the heading Risk Factors in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 2022, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statements for any reason.

這些前瞻性陳述不是對未來業績的保證，並且受到難以預測的風險、不確定性和假設的影響。由於多種因素的影響，我們的實際結果、業績或成就可能與前瞻性陳述中明示或暗示的結果、業績或成就存在重大差異，這些因素包括但不限於在《前瞻性聲明》第1A 項中的“風險因素”標題下討論的風險和不確定性。我們截至 2022 年 12 月 31 日的財政年度的 10-K 表格年度報告以及我們向美國證券交易委員會提交的其他文件中。我們不承擔以任何理由修改或更新任何前瞻性陳述的義務。

I'd now like to turn the call over to our Orgenesis' CEO, Ms. Vered Caplan. Please go ahead, Vered.

現在我想將電話轉給我們 Orgenesis 的首席執行官 Vered Caplan 女士。請繼續，維雷德。

Thank you, David, and thanks to everyone for joining us on our call today. We reported revenue of approximately $7 million in the second quarter of 2023, which reflects the continued activity of our point-of-care strategy. Most recently, we rebranded the point-of-care services business for Orgenesis to Okta mail, which reflects our focus on providing standardized decentralized, cost-effective development and production of advanced cell and gene therapies. The ongoing expansion of our point-of-care strategy has been enabled in part by the recent investments for Metalmark Capital. This capital allows us to increase our capacity and expand our activity as well as the rollout of our point-of-care centers and deployment of our OMPULs in the U.S.

謝謝大衛，也感謝大家今天加入我們的電話會議。我們報告 2023 年第二季度的收入約為 700 萬美元，這反映了我們的即時護理戰略的持續活動。最近，我們將 Orgenesis 的護理點服務業務更名為 Okta mail，這反映了我們專注於提供標準化、分散式、經濟高效的先進細胞和基因療法的開發和生產。我們的即時護理策略的持續擴展在一定程度上得益於 Metalmark Capital 最近的投資。這筆資金使我們能夠提高產能並擴大我們的活動，以及在美國推出我們的護理中心和部署我們的 OMPUL。

The reason our point-of-care business is resonating well in the industry. And among those familiar with the industry is quite simple. Our point-of-care platform addresses many of the key challenges facing the industry, including capacity constraints and excessive cost. Despite the fact that the autologous cell therapy market is valued at $13 billion and growing, the centralized production approach is not a sustainable business model as illustrated by supply shortages, high prices of products and limited availability of coverage.

這就是我們的現場護理業務在業界引起良好反響的原因。而且對於熟悉這個行業的人來說是相當簡單的。我們的護理點平台解決了行業面臨的許多關鍵挑戰，包括容量限制和成本過高。儘管自體細胞治療市場價值達 130 億美元，並且還在不斷增長，但集中生產方式並不是一種可持續的商業模式，供應短缺、產品價格高昂和覆蓋範圍有限就說明了這一點。

And because of our experience in this business for the past 10 years, we recognize the stats in fact, before the rest of the industry. When announcing the industry acknowledged the urgent need to shift production away from a centralized to a decentralized model and towards point-of-care, hospital and health systems can't afford to produce cell and gene therapies in a centralized manner.

由於我們過去 10 年在該行業的經驗，我們實際上比業內其他公司更早認識到這些統計數據。當該行業宣布迫切需要將生產從集中式模式轉變為分散式模式並轉向即時護理時，醫院和衛生系統無力以集中式方式生產細胞和基因療法。

This is a fact. And Octomera, our rebranded service activity is the only service provider that can offer solutions today. We are also seeing growing recognition and support for decentralized production of cell and gene therapies amongst the regulators including the FDA, which addressed decentralized manufacturing for the first time in the [BAS] guidance document, consideration for the development of chimeric antigen receptor, the CAR-T cell products, which we believe comes as a response to the industry search for solutions in this space.

這是事實。我們重新命名的服務活動 Octomera 是當今唯一能夠提供解決方案的服務提供商。我們還看到包括 FDA 在內的監管機構對細胞和基因療法分散化生產的日益認可和支持，FDA 首次在 [BAS] 指導文件中解決了分散化生產問題，考慮開發嵌合抗原受體、CAR -T 細胞產品，我們相信這是對行業在該領域尋找解決方案的回應。

In fact, the recent article in Labiotech noted that over 9,900 cell therapy trials are currently recruiting. They go on to point out that even if 5% to 10% are successful, a significant number of cell therapies will be approved in the near future. This is extraordinary, considering the average number of drugs approved over the last 10 years is around 40.

事實上，Labiotech 最近的一篇文章指出，目前正在招募超過 9,900 項細胞治療試驗。他們接著指出，即使 5% 到 10% 成功，大量細胞療法也將在不久的將來獲得批准。考慮到過去 10 年批准的藥物平均數量約為 40 種，這是非同尋常的。

They go on to note that a traditional centralized CDMO model is a capital-intensive approach, essentially a dead end and I quote, "economically, it doesn't work. The cost of centralized manual processes will keep therapies out of reach for patients and peers. " They point out a recent example which was Bluebird's (inaudible) of Zynteglo as gene therapy for rare blood disorders from the German market because it could not agree on a price with the health authorities.

他們接著指出，傳統的集中式CDMO 模式是一種資本密集型方法，本質上是一個死胡同，我引用的話，“從經濟角度來看，這是行不通的。集中式手動流程的成本將使患者無法獲得治療，並且他們指出了最近的一個例子，即 Bluebird（聽不清）將 Zynteglo 作為德國市場上罕見血液疾病的基因療法，因為它無法與衛生當局就價格達成一致。

They conclude by saying the centralized approach also doesn't work from a clinical perspective because of the complicated logistics, time lags and failed batches. In context, we are poised to capitalize on this growing underserved market and have shown our process work in a decentralized manner within the field of cell and gene therapy, our processes apply to regenerative medicine and immuno-oncology as well as other genetically modified cells.

他們最後表示，從臨床角度來看，由於復雜的物流、時間滯後和批次失敗，集中式方法也行不通。在這方面，我們準備利用這個不斷增長的服務不足的市場，並在細胞和基因治療領域以分散的方式展示我們的工藝工作，我們的工藝適用於再生醫學和免疫腫瘤學以及其他轉基因細胞。

We are now expanding to new customers and moving to more advanced clinical stages among existing ones. As a result, we believe our model based on standardization of the production environment is uniquely positioned to address industry challenges to a highly innovative decentralized model, which lower costs, streamlined logistics and expands capacity.

我們現在正在擴展到新客戶，並在現有客戶中進入更高級的臨床階段。因此，我們相信，我們基於生產環境標準化的模式具有獨特的優勢，能夠解決行業對高度創新的分散模式的挑戰，從而降低成本、簡化物流並擴大產能。

In addition, we designed a scalable modular format so we can add capacity as the needs of the hospital biotech companies expand. This process is exactly the same regardless of where the product is still used. We have a GMP team with significant practical experiences overseeing the centers and OMPULs and working to implement advanced quality management and IT solutions.

此外，我們還設計了可擴展的模塊化格式，以便我們可以隨著醫院生物技術公司需求的擴大而增加容量。無論產品在哪裡使用，這個過程都是完全相同的。我們擁有一支具有豐富實踐經驗的 GMP 團隊，負責監督中心和 OMPUL，並致力於實施先進的質量管理和 IT 解決方案。

We are also be enrolling our new GMP service -- rolling out our new GMP services in the U.S. in the coming quarters. In addition, OMPULs can be deployed and operational and fleet of 6 months with an existing structure or an available outdoor space. And production capacity can be easily scaled via the additional units. OMPULs are fully integrated, all-in-one bio prospecting production units that can be rapidly implemented as a standardized industrial cleaning alternative at the point-of-care, [ample] shorten the implementation time of new capacity from 24 months to 3 to 6 months, the interior can be purpose-built to include GMP-compliant production space with options for quality control labs and warehouse spaces.

我們還將註冊新的 GMP 服務——未來幾個季度在美國推出新的 GMP 服務。此外，OMPUL 可以在現有結構或可用的室外空間中進行部署和運行，且使用壽命為 6 個月。並且可以通過額外的單元輕鬆擴展生產能力。 OMPUL 是完全集成、一體化的生物勘探生產單元，可以作為護理點的標準化工業清潔替代方案快速實施，[充分]將新產能的實施時間從 24 個月縮短到 3 至 6 個月幾個月後，內部可以專門建造，包括符合GMP 的生產空間，並可選擇質量控制實驗室和倉庫空間。

We believe our strategy of decentralizing and harmonizing the supplier for cell and gene therapies will ultimately become the solution for this industry, lowering costs, streamlining logistics and accelerating development of therapies through on-site processing. Through these steps, we are clearly executing all our strategy to make cell and gene therapy products and services more accessible, affordable and available to patients than traditional centralized models of production.

我們相信，我們分散和協調細胞和基因療法供應商的戰略最終將成為該行業的解決方案，降低成本，簡化物流並通過現場處理加速療法的開發。通過這些步驟，我們正在明確執行我們的所有戰略，以使細胞和基因治療產品和服務比傳統的集中生產模式更容易獲得、負擔得起並為患者提供。

In terms of expenses, our goal over time is to reduce the cost of these therapies to tens of thousands versus hundreds of thousand dollars. On a related note, it is important to point out that some of the growing pains we went through to get where we are today. When we started out our point-of-care strategy over 3 years ago, decentralized production was a topic discussed as a distant option at industry events with various bioreactor companies taking initial steps to provide systems for use in hospital cleanings.

在費用方面，我們的目標是隨著時間的推移將這些療法的成本降低到數万美元而不是數十萬美元。與此相關的是，必須指出的是，我們經歷了一些成長的痛苦才取得今天的成就。三年前，當我們開始製定護理點戰略時，分散式生產是行業活動中作為一個遙遠的選擇而討論的話題，各種生物反應器公司採取了初步措施，提供用於醫院清潔的系統。

We had already tried this approach and realized that though this was important. This was not the full solution the industry needed. Our first clients were smaller, earlier-stage companies. It couldn't even access production capacity due to supply constraints within the market. For this reason, they were willing to take a risk with us while this was still an early-stage concept and recognize the value proposition we would be able to offer in terms of more rapid lower-cost production if and when successful.

我們已經嘗試過這種方法並意識到這很重要。這不是行業所需的完整解決方案。我們的第一批客戶是規模較小、處於早期階段的公司。由於市場供應限制，它甚至無法獲得生產能力。出於這個原因，他們願意在這仍然是一個早期概念時與我們一起冒險，並認識到如果成功的話，我們將能夠在更快速、更低成本的生產方面提供價值主張。

But because many of these smaller companies who are early stage and undercapitalized, we were also willing to provide greater flexibility in payment terms and mutual support and work [reason]. They [were and are] our partners, and we appreciate the support while we were still in the development stages.

但由於許多規模較小的公司還處於早期階段且資本不足，我們也願意在付款條件以及相互支持和工作方面提供更大的靈活性[原因]。他們過去和現在都是我們的合作夥伴，我們感謝在我們仍處於開發階段時所提供的支持。

This approach has impacted our accounts receivable, but we believe that we have achieved our goals and hopefully, as these companies mature, we hope to continue providing the products in more advanced clinical phase. We have also advanced and matured and have validated our approach across several product types and can now work with companies in this industry sustainable levels.

這種方法影響了我們的應收賬款，但我們相信我們已經實現了我們的目標，並且希望隨著這些公司的成熟，我們希望繼續提供處於更高級臨床階段的產品。我們還取得了進步和成熟，並在多種產品類型中驗證了我們的方法，現在可以與該行業可持續水平的公司合作。

With the deconsolidation of OMPULs, we believe our decentralized service platform can now function as an independent entity as it continues to expand the reach globally. It has been rebranded as Octomera, with the name Octomera expressing the unique characteristics of the Octopus, its capability to adapt and integrate to a wide range of spaces.

隨著 OMPUL 的拆分，我們相信我們的去中心化服務平台現在可以作為一個獨立的實體發揮作用，並繼續擴大全球範圍。它已更名為 Octomera，Octomera 這個名稱表達了 Octopus 的獨特特徵，以及其適應和融入各種空間的能力。

It's decentralized intelligence. Octopus arm's can actually think independently of the central brain. The ability to regenerate the limbs and the ability to reach out in all directions. The [main] part of the names come from the word Chimera, which signifies our ability to genetically modify cells.

這是分散的情報。章魚手臂實際上可以獨立於中樞大腦思考。四肢再生的能力，以及向各個方向伸出的能力。名稱的[主要]部分來自單詞Chimera，它表示我們對細胞進行基因改造的能力。

Because of the head start, this has given us in the market, we have now proven our model and Octomera is positioned as a clear leader in terms of providing decentralized services. The industry itself is also maturing and cell and gene autologous therapies once considered almost a science fiction are now becoming a viable approach for therapeutic treatment with more and more therapeutic areas targeted.

由於領先優勢，這讓我們進入了市場，我們現在已經證明了我們的模式，Octomera 在提供去中心化服務方面處於明顯的領先地位。該行業本身也在日趨成熟，曾經被認為幾乎是科幻小說的細胞和基因自體療法現在正成為一種可行的治療方法，並針對越來越多的治療領域。

A good example is the CAR or chimeric antigen receptor approach, which the patient's immune cells are genetically modified, we may target a specific target. CAR was first used only to treat blood cancer, making history by enabling unheard of clinical results in extremely ill patients and have now expanded to multiple modalities, including autoimmune diseases and even cardiac disease.

一個很好的例子是CAR或嵌合抗原受體方法，它對患者的免疫細胞進行基因改造，我們可以針對特定的目標。 CAR 最初僅用於治療血癌，在病情危重的患者中取得了聞所未聞的臨床結果，創造了歷史，現在已擴展到多種治療方式，包括自身免疫性疾病甚至心髒病。

As the number of therapies goes, and more and more patients acquire these treatments, it has become obvious that the industry must find solutions to reduce costs and enable capacity. And we believe Octomera will play a significant role in providing this solution. Also, once these customers start working with us, as I have discussed in the past, we become central to their entire production process and regulatory approval.

隨著治療方法數量的增加，以及越來越多的患者接受這些治療，很明顯，該行業必須找到降低成本和提高產能的解決方案。我們相信 Octomera 將在提供這一解決方案方面發揮重要作用。此外，一旦這些客戶開始與我們合作，正如我過去所討論的那樣，我們就成為他們整個生產流程和監管審批的核心。

This leads to a long-term collaborative relationship and interdependency. As it progresses to various stages of clinical trials, so do we and ultimately into commercialization together. Our strong process development capabilities, coupled with our going GMP capacity enables us to decentralize the supply of cell and gene therapies in various regions.

這導致了長期的合作關係和相互依賴。隨著它進入臨床試驗的各個階段，我們也一起進入商業化階段。我們強大的工藝開發能力，加上我們正在進行的 GMP 能力，使我們能夠將細胞和基因療法的供應分散到各個地區。

By initially developing a robust production process programmed into our proprietary agnostic and flexible [options], the production can be efficiently scaled and transferred to various locations in the network. We have our initial locations, which have operated directly by us, but we have also identified regional partners at which we can work that can support the expansion of the network to meet local demand.

通過最初開發一個強大的生產流程，並將其編程到我們專有的不可知論和靈活的[選項]中，生產可以有效地擴展並轉移到網絡中的各個位置。我們的初始地點由我們直接運營，但我們也確定了可以合作的區域合作夥伴，以支持網絡的擴展以滿足當地需求。

This allows us to reduce regional overhead and expand our reach and providing decentralized services. It is also part of our strategy of providing a standard for the industry and utilizing available resource and integrating innovative technologies into the platform. We have successfully implemented a certified academic program to support additional recruitment and are performing multiple Tech transfer to additional sites for production stage products supplied at existing sites.

這使我們能夠減少區域開銷並擴大我們的覆蓋範圍並提供分散的服務。這也是我們為行業提供標準、利用可用資源並將創新技術集成到平台中的戰略的一部分。我們已經成功實施了經過認證的學術計劃來支持額外的招聘，並且正在向其他地點進行多項技術轉讓，以在現有地點提供生產階段的產品。

We continue to support the growth of our network, which now spans North America, Europe and Asia and the Middle East, compromised with both point-of-care centers, which serve as hub for the entire region. In Europe and Asia and the Middle East, Octomera is already providing production services.

我們繼續支持我們網絡的發展，該網絡現已遍布北美、歐洲、亞洲和中東，並與作為整個地區樞紐的兩個護理中心相結合。 Octomera 已經在歐洲、亞洲和中東提供製作服務。

It is still setting up point-of-care centers and strategic hubs in the U.S., implementing procedures in GMP in the international hubs. In order to maintain Octomera's value as an industry leader, it must not rush at the cost of not complying with its (inaudible) quality requirements. There can be no compromise on this issue as this both legal and an ethical beauty. Octomera recently reached an important milestone and its collaborated...

該公司仍在美國設立護理中心和戰略中心，並在國際中心實施 GMP 程序。為了保持 Octomera 作為行業領導者的價值，它絕不能以不遵守（聽不清）質量要求為代價而倉促行事。在這個問題上不能有任何妥協，因為這既是合法的，也是道德的。 Octomera 最近達到了一個重要的里程碑，其合作...

(technical difficulty)

（技術難度）

Vered Caplan has rejoined. Vered Please proceed.

維里德·卡普蘭重新加入。維雷德 請繼續。

Sorry for being disconnected. Octomera recently reached an important milestone in its collaboration with the University of California. Specifically signed a partnership agreement to deploy OMPULs, [QC] data and other healthcare universities within the state of California. They are now setting up the first hub, which we expect will expand over time.

抱歉斷線了。 Octomera 最近與加州大學的合作達到了一個重要的里程碑。具體簽署了一項合作協議，在加利福尼亞州部署 OMPUL、[QC] 數據和其他醫療保健大學。他們現在正在建立第一個中心，我們預計該中心將隨著時間的推移而擴大。

We believe that having UCD university, UC Davis University as a partner is also strong validation and is likely to enhance the sales process with other institutions as Octomera expand it's services across America. This agreement sets out the stages approach which Octomera will install and operate OMPULs, enable the point-of-care platform to produce therapies with hospitals throughout California, empaneling on-site production for clinical trials like cell and gene therapies in development at UC Davis' Health Alpha Stem Cell Clinic as well as marketed products for patients of the hospital.

我們相信，擁有都柏林大學、加州大學戴維斯分校作為合作夥伴也是強有力的驗證，並且隨著 Octomera 在美國擴展其服務，可能會加強與其他機構的銷售流程。該協議規定了Octomera 將安裝和運營OMPUL 的分階段方法，使該護理點平台能夠與加州各地的醫院一起生產療法，並為加州大學戴維斯分校正在開發的細胞和基因療法等臨床試驗提供現場生產。 Health Alpha 幹細胞診所以及為醫院患者銷售的產品。

Orgenesis has also developed additional assets that are positioned to be integrated into a decentralized model. One unique asset has been developed by MiNA Biotech, our wholly owned subsidiary under the support of a prestigious EU grant. We've seen an explosion in the market in terms of new therapies utilizing induced pluripotent stem cells known as iPSCs.

Orgenesis 還開發了其他資產，這些資產可以集成到去中心化模型中。我們的全資子公司 MiNA Biotech 在一項著名的歐盟撥款的支持下開發了一項獨特的資產。我們已經看到利用誘導性多能幹細胞（iPSC）的新療法市場出現爆炸式增長。

MiNA has developed a unique technology and capabilities to support production of autologous iPSC therapies, including using microfluidic technologies and Artificial Intelligence. This project is advancing rapidly and is already being integrated into areas such as neurological conditions, diabetes and oncology.

MiNA 開發了獨特的技術和能力來支持自體 iPSC 療法的生產，包括使用微流體技術和人工智能。該項目進展迅速，已經融入神經系統疾病、糖尿病和腫瘤學等領域。

We are working in collaboration with several companies to integrate this for decentralized production. We believe that this will further propel and sustain our position as an innovative leader in the market. We also have other innovations in therapeutic technologies that state-of-the-art vectors and delivery technologies that have developed low-cost capital -- and have developed a low-cost, capital-efficient business model to bring these technologies to market.

我們正在與多家公司合作，將其整合到分散生產中。我們相信，這將進一步推動和維持我們作為市場創新領導者的地位。我們在治療技術方面還有其他創新，包括最先進的載體和遞送技術，這些技術開發了低成本資本，並開發了低成本、資本效率高的商業模式，將這些技術推向市場。

These technologies target a broader lay of indication for immuno-oncology, antiviral, to metabolic and autoimmune disease, tissue generation and more. We are leveraging government grants and other sources of non-dilutive funding from regional partners in order to advance this.

這些技術針對免疫腫瘤學、抗病毒、代謝和自身免疫性疾病、組織生成等更廣泛的適應症。我們正在利用政府撥款和區域合作夥伴提供的其他非稀釋性資金來源來推動這一進程。

More broadly, our strategy involves in-licensing technologies from leading research centers, hospitals and biotech companies industrializing them so they can be utilized in a decentralized approach and out-licensing them to development partners, benefiting from co-development related payments. By designing these technologies to be integrated into a decentralized point-of-care model, we believe these therapies and technologies can be advanced through clinical trials at a lower cost than traditional ones by leveraging our network of academic institute and health care systems around the world.

更廣泛地說，我們的戰略包括引進來自領先研究中心、醫院和生物技術公司的技術，將其工業化，以便可以以分散的方式使用它們，並將其授權給開發合作夥伴，並從共同開發相關的付款中受益。通過設計將這些技術集成到分散的護理點模型中，我們相信，利用我們在世界各地的學術機構和醫療保健系統網絡，這些療法和技術可以通過臨床試驗以比傳統療法更低的成本得到推進。

Through this network, we are establishing key strategic partnership and licensing arrangements for several of these assets. And while our partners are responsible for funding development and clinical trials, we get paid for supporting the development efforts.

通過這個網絡，我們正在為其中一些資產建立重要的戰略合作夥伴關係和許可安排。雖然我們的合作夥伴負責資助開發和臨床試驗，但我們卻因支持開發工作而獲得報酬。

As these program progress, we expect to increasingly benefit from revenue sharing of [dividends] with our partners as we seek to advance with respective therapy through commercialization. Our subsidiary Koligo therapeutics continues to supply Kyslecel to Medical Institute for total pancreatectomy with islet autotransplant cases. As previously announced, Koligo passed an FDA inspection for the site as a registered tissue production establishment. Following this confirmation of the infrastructure design and production protocols and building on increasing demand, we are now aiming to expand capacity in the U.S. and internationally.

隨著這些計劃的進展，我們希望通過與合作夥伴的[股息]收入分享來不斷受益，因為我們尋求通過商業化推進各自的治療。我們的子公司 Koligo Therapeutics 繼續向醫學研究所提供 Kyslecel，用於全胰腺切除術和胰島自體移植病例。正如之前宣布的，Koligo 作為註冊衛生紙生產企業通過了 FDA 的檢查。在確認基礎設施設計和生產協議並滿足不斷增長的需求之後，我們現在的目標是擴大美國和國際產能。

In the EU, Koligo is utilizing the expertise of Orgenesis to enable regional production capacity and leverage [gas] to drive clinical development. We also aim to expand into type 1 diabetes market valued at over $7 billion. So to wrap up, we continue to progress toward our goal of winning life-changing cell and genes therapy treatments to large number of patients that reduce cost under a decentralized strategy.

在歐盟，Koligo 正在利用 Orgenesis 的專業知識來提高區域生產能力並利用 [gas] 來推動臨床開發。我們還計劃進軍價值超過 70 億美元的 1 型糖尿病市場。總而言之，我們將繼續朝著我們的目標前進，即為大量患者贏得改變生命的細胞和基因療法，並在分散的策略下降低成本。

Following the successful sale of Masthercell, we invested in the technology and methodology required for setting up a decentralized platform. We also invested in building out capacity for providing services in the EU, U.S. and the Middle East, which has generated revenue in the range of $35 million annually over the past 2 years. We have now built up an independent service company, Octomera, that following the investment from Metalmark is now expanding in the U.S. market.

成功出售 Masthercell 後，我們投資了建立去中心化平台所需的技術和方法。我們還投資建設在歐盟、美國和中東提供服務的能力，在過去兩年中每年創造了 3500 萬美元的收入。我們現在已經建立了一家獨立的服務公司 Octomera，在獲得 Metalmark 的投資後，該公司目前正在美國市場擴張。

We have developed a pipeline of products into diabetes field with Koligo leading the way with Kyslecel, currently provided and reimbursed at leading entities in the U.S. With the goal of expanding its services under a decentralized approach both to additional regions and additional therapeutic modalities. We have developed a unique capabilities in the iPSC field being integrated into therapeutic modalities.

我們已經在糖尿病領域開發了一系列產品，Koligo 在 Kyslecel 的引領下，目前在美國的領先實體提供和報銷，目標是通過分散的方法將其服務擴展到更多地區和更多治療方式。我們在 iPSC 領域開發了獨特的能力，並將其整合到治療方式中。

We have developed and in-licensed multiple technologies integrated into a point-of-care therapeutic target and developed on the partnerships and licenses. We believe that by partnering and bringing in financial support at the subsidiary level, we are optimizing shareholder value. Importantly, we are still in the first inning and building value in the biotech market, either as a service or as a solution or technology provider.

我們開發並許可了多種技術，將其集成到即時治療目標中，並在合作夥伴關係和許可的基礎上進行開發。我們相信，通過在子公司層面開展合作並引入財務支持，我們正在優化股東價值。重要的是，我們仍處於生物技術市場的第一局並正在創造價值，無論是作為服務還是作為解決方案或技術提供商。

And that value of a solution and technology provider cannot be measured in months or quarter, nor achieved in a year or 2. We believe we have a deep understanding of this industry through our relationship with industry groups, technology provider, a leading research institute we are always one step ahead in understanding what are the industry needs and have developed solutions and services that target such requirements like Masthercell whose value was not obvious to non-industry parties, it may take time for the 2 value activities are fully realized.

解決方案和技術提供商的價值無法用幾個月或一個季度來衡量，也不能用一年或兩年來實現。我們相信，通過我們與行業團體、技術提供商、領先研究機構的關係，我們對這個行業有了深刻的了解。總是先一步了解行業需求，並開發出針對此類需求的解決方案和服務，例如Masthercell，其價值對於非行業各方來說並不明顯，這2個價值活動的完全實現可能需要時間。

Orgenesis is a company that has a goal of implementing amazing scientific achievements of the last decade into an industrial approach, enabling the patients who need these breakthroughs to benefit from them. We believe that tremendous economic value in advancing this capability, both as a service and as a technology provider, and we have spilled no efforts to achieve these goals as quickly as possible in the last 3 years despite extremely challenging economic conditions.

Orgenesis 是一家公司，其目標是將過去十年的驚人科學成就轉化為工業方法，使需要這些突破的患者從中受益。我們相信，無論是作為服務提供商還是作為技術提供商，推進這種能力都具有巨大的經濟價值，儘管經濟條件極具挑戰性，但在過去 3 年裡，我們仍不遺餘力地盡快實現這些目標。

I am proud of our mission and of our team's achievement. We are providing this industry a strong foundation in which to go and believe we will be among the first benefits from these goals. Octomera is the only company with full service capabilities to support cell and gene decentralized production. In this regard, we have positioned Octomera at the forefront of this industry.

我為我們的使命和我們團隊的成就感到自豪。我們正在為這個行業提供堅實的基礎，並相信我們將成為這些目標的首批受益者之一。 Octomera是唯一一家具備支持細胞和基因去中心化生產全方位服務能力的公司。在這方面，我們將 Octomera 定位在這個行業的前沿。

There are other companies, some of them quite large that is developing technology for decentralized production, but these are devices, not solutions, which makes Octomera very unique. These companies announcing the shift in the market and need a decentralized service platform on which to integrate through equipment. And ours is the only platform that has already been incorporated into production and clinical.

還有其他公司（其中一些規模相當大）正在開發分散式生產技術，但這些只是設備，而不是解決方案，這使得 Octomera 非常獨特。這些公司宣布市場發生轉變，需要一個去中心化的服務平台，通過設備進行整合。我們的平台是唯一已經投入生產和臨床的平台。

All that said, our first and foremost considerations have always bring life-saving therapies to market while driving value for our shareholders. Importantly, we've built a scalable reoccurring revenue business model that will support the growth of the industry and the growing capacity requirements of our partners and customers.

話雖如此，我們首要考慮的始終是將挽救生命的療法推向市場，同時為股東創造價值。重要的是，我們建立了一個可擴展的經常性收入業務模型，該模型將支持行業的增長以及我們的合作夥伴和客戶不斷增長的容量需求。

We hope to benefit from growth in high margins, recurring revenue streams based on future royalties and long-term agreements contracts for industrializing and supplying these cell and gene therapies. One final note I'd like to welcome Elliot Maltz, who is recently appointed CFO for Orgenesis effective September 1. Elliot brings 16 years of accounting and corporate finance experience working with public and private companies specializing in the biotechnology, medical device and manufacturing industries.

我們希望受益於高利潤的增長、基於未來特許權使用費的經常性收入流以及工業化和供應這些細胞和基因療法的長期協議合同。最後一點，我想對Elliot Maltz 表示歡迎，他最近被任命為Orgenesis 首席財務官，將於9 月1 日生效。Elliot 擁有16 年的會計和企業財務經驗，曾與專門從事生物技術、醫療器械和製造行業的上市和私營公司合作。

We believe his strategic insight and experience will be invaluable as we enter our next phase of goals. I would like also to personally thank and express our sincere gratitude to Neil Reithinger for his significant contributions following years of dedicated service. We are always appreciative of the support of our shareholders and investors and hope they appreciate the endless efforts we invest in making Orgenesis a best-in-class company.

我們相信，當我們進入下一階段的目標時，他的戰略洞察力和經驗將非常寶貴。我還要親自感謝尼爾·雷辛格 (Neil Reithinger)，他多年來的竭誠服務為我們做出了重大貢獻。我們始終感謝股東和投資者的支持，並希望他們感謝我們為使 Orgenesis 成為一流公司而付出的不懈努力。

We look forward to sharing more developments to be announced in the weeks and months ahead. On that note, I'd like now to turn the call over to Neil Reithinger, our Chief Financial Officer.

我們期待在未來幾周和幾個月內分享更多即將宣布的進展。就此而言，我現在想將電話轉給我們的首席財務官 Neil Reithinger。

Thank you, Vered. Revenue for the 3 months ended June 30, 2023, was $7 million compared to $7.2 million for the 3 months ended June 30, 2022. We recorded an increase in POC cell processing revenue in the amount of $375,000 as a result of new signed cell processing contracts in the Octomera segment, and an increase in cell process development services revenue in the amount of $5.7 million, offset by a decline in the POC development services revenue of $6.3 million, mainly in the Octomera segment.

謝謝你，維雷德。截至2023 年6 月30 日止3 個月的收入為700 萬美元，而截至2022 年6 月30 日止3 個月的收入為720 萬美元。由於新簽署的單元處理，我們的POC 單元處理收入增加了375,000 美元Octomera 部門的合同，以及電池工藝開發服務收入增加 570 萬美元，但被 POC 開發服務收入下降 630 萬美元（主要是在 Octomera 部門）所抵消。

Cost of revenues for the 3 months ended June 30, 2023, were $3.2 million as compared to $1.1 million for the 3 months ended June 30, 2022, representing an increase of 204%. The increase was due to increased cost in the Octomera segment, including additional salaries, professional fees, raw materials and depreciation expenses incurred mainly related to higher cost of revenues, of process development and POC cell processing, the revenues of which increase.

截至2023年6月30日止三個月的收入成本為320萬美元，而截至2022年6月30日止三個月的收入成本為110萬美元，增長了204%。這一增長是由於 Octomera 部門的成本增加，包括額外工資、專業費用、原材料和折舊費用，這些費用主要與工藝開發和 POC 電池加工的收入成本增加有關，而工藝開發和 POC 電池加工的收入增加。

Selling, General and Administrative expenses for the 3 months ended June 30, 2023, were $3.3 million compared to $2.8 million for the same period last year representing an increase of 19%. The increase in Selling, General and Administrative expenses in the 3 months ended June 30, '22 compared to the 3 months ended June 30, '21 is primarily attributed to an increase in salaries related to expenses, professional fees and other General and Administrative expenses in the Octomera segment due to the ramp-up activity, offset by a decline in accounting and legal fees.

截至 2023 年 6 月 30 日止三個月的銷售、一般和管理費用為 330 萬美元，而去年同期為 280 萬美元，增長了 19%。與截至21 年6 月30 日止的3 個月相比，截至22 年6 月30 日止的3 個月銷售、一般和管理費用增加，主要歸因於與費用、專業費用和其他一般和管理費用相關的工資增加Octomera 業務的增長歸因於活動的增加，但被會計和法律費用的下降所抵消。

Operating loss for the 3 months ended June 30, '23 was $3.3 million compared to $4.7 million for the same period last year. Net loss for the 3 months ended June 30, '23 was 3.7%, a decrease of 33% compared to $5.5 million for the same period last year. Comprehensive loss attributed to Orgenesis for 3 months ended June 30 was $3.8 million, which included the translation adjustment due to deconsolidation of Octomera of $384,000 and comprehensive income attributed to noncontrolling interest of $466,000.

截至2023年6月30日止三個月的運營虧損為330萬美元，而去年同期為470萬美元。截至2023年6月30日的三個月淨虧損為3.7%，與去年同期的550萬美元相比下降了33%。截至 6 月 30 日止的 3 個月，Orgenesis 的綜合虧損為 380 萬美元，其中包括因 Octomera 取消合併而產生的折算調整 384,000 美元，以及非控股權益的綜合收入 466,000 美元。

We recorded a decrease of 35% in comprehensive loss attributed to Orgenesis Inc. compared to $5.7 million for the same period last year. In terms of liquidity, we ended the quarter with cash, cash equivalents and restricted cash of approximately $1.2 million. This does not reflect the most recent funding from Metalmark into Octomera. That was received subsequent to the end of the quarter. We look forward to benefiting from this recent investment and advancing our collaboration with them to expand POCare services.

與去年同期的 570 萬美元相比，Orgenesis Inc. 的綜合虧損減少了 35%。在流動性方面，本季度末我們的現金、現金等價物和限制性現金約為 120 萬美元。這並不反映 Metalmark 向 Octomera 提供的最新資金。這是在季度末後收到的。我們期待從最近的投資中受益，並推進與他們的合作以擴展 POCare 服務。

It is important to note that while we still have significant influence over Octomera and still on approximately 75% following a deconsolidation, the assets and liabilities of Octomera did not show up on our balance sheet. Finally, we remain focused on carefully managing expenses for our POCare therapies through cost-effective international partnering and licensing strategy and nondilutive grant funding. Operator, we'll now open the call to questions.

值得注意的是，雖然我們仍然對 Octomera 具有重大影響力，並且在分拆後仍具有約 75% 的影響力，但 Octomera 的資產和負債並未顯示在我們的資產負債表上。最後，我們仍然致力於通過具有成本效益的國際合作和許可策略以及非稀釋性贈款資金來謹慎管理 POCare 療法的費用。接線員，我們現在開始提問。

(Operator Instructions)

（操作員說明）

And our first question this morning is coming from Bruce Jackson from The Benchmark Company.

今天早上我們的第一個問題來自基準公司的布魯斯·傑克遜。

With regard to the University of California agreement, it looks like you expanded during the quarter. So the first site was at UC Davis, and I just wanted to check and make sure I heard this correctly that there were 2 other sites that you were now working with. And then do you have a rough idea of how many sites in total you could expand to?

關於加州大學的協議，看起來你們在本季度有所擴大。所以第一個站點是在加州大學戴維斯分校，我只是想檢查並確保我正確地聽到了您現在正在使用的其他兩個站點。然後您是否大致了解總共可以擴展到多少個站點？

So we have other site but not in California, okay? And that's -- at the moment, we'll just focus on one site in California because we -- it's better to validate that site and then expand. I think in general, we were talking about 5, but again, let me just explain again that when you talk about a site, okay, a site can serve multiple hospitals, okay, multiple it can manage multiple OMPULs or multiple indications. So one hub can host 1 OMPUL, 10 OMPULs depending on how much. So it's really about regional reach, you want these service to get to the location a few hours away, right? So don't think of a site as just one OMPUL to a hospital. Let's confirm this misconception.

所以我們還有其他站點，但不在加利福尼亞州，好嗎？目前，我們將只關注加利福尼亞州的一個站點，因為我們最好驗證該站點，然後進行擴展。我認為一般來說，我們談論的是5 個，但是，讓我再次解釋一下，當你談論一個站點時，好吧，一個站點可以為多家醫院提供服務，好吧，多個它可以管理多個OMPUL 或多種適應症。因此，一個集線器可以託管 1 個 OMPUL、10 個 OMPUL，具體取決於數量。所以這實際上與區域覆蓋範圍有關，您希望這些服務能夠在幾個小時之外到達該地點，對吧？因此，不要將站點視為醫院的一個 OMPUL。讓我們確認一下這個錯誤的想法。

Okay. So the sites can have different capabilities and they're not directly comparable is what you're getting at?

好的。因此，這些網站可以具有不同的功能，並且它們不能直接比較，這就是您所得到的？

Yes. Yes, they can -- each site can increase capacity. I mean, for instance, our [greek] site have several OMPULs targeting different indications, okay? I'm just giving a example. But it's not one site the hospital, it doesn't work that way. One site can offer anything in the vicinity of a couple of hours away.

是的。是的，他們可以——每個站點都可以增加容量。我的意思是，例如，我們的[希臘語]網站有幾個針對不同適應症的 OMPUL，好嗎？我只是舉個例子。但這不是醫院的一個站點，它不是這樣運作的。一個站點可以提供附近幾小時路程內的任何信息。

Okay. And then with Koligo, on a past call, you discussed that you might be able to take some of that capability to international markets. Is that still the -- is that -- are you thinking about that?

好的。然後，在過去的一次電話會議中，您與 Koligo 討論過，您也許能夠將其中一些功能推向國際市場。那仍然是——是嗎——你在想那個嗎？

Yes. Yes. But we'd like to have that funding supported. We do have that. Kyslecel is actually included in Belgium grant at the moment. So we hope to utilize that to expand the European -- to the European market.

是的。是的。但我們希望得到這筆資金的支持。我們確實有。 Kyslecel 目前實際上已包含在比利時補助金中。因此，我們希望利用這一點來拓展歐洲市場。

Okay. And then just last question about the cell process development services, it's been ramping. While the other -- the POCare business has been kind of been peeling off. And actually, it's been kind of -- I guess the question here is with the mix between those 2 businesses, should we expect that the cell process development services are going to continue to ramp?

好的。關於細胞工藝開發服務的最後一個問題，它一直在增加。而另一個——POCare 業務卻在逐漸萎縮。實際上，我想這裡的問題是這兩個業務之間的混合，我們是否應該期望細胞工藝開發服務將繼續增長？

So let me explain this, okay. So that's why -- and I've explained this. I think I've mentioned this in another call, it's very difficult to, I'd say, kind of partition this revenue and our business by quarters. And we used to have the same issues with Masthercell? Because what happens is, I mean, for the past quarter, when you have a new customer, you basically focus a lot on PD. Now you finished, let's say, some -- a certain phase or a certain production phase. And now you're waiting for an existing customer for the next one. So it really actually reflects the fact that we've moved to a few several new customers more than anything else, okay? And it's just a timing issue in terms of this quarter happened to be this, next quarter, maybe something else.

那麼讓我解釋一下，好吧。這就是原因——我已經對此進行了解釋。我想我在另一次電話會議中提到過這一點，我想說，很難將收入和我們的業務按季度劃分。我們以前在 Masthercell 上也遇到過同樣的問題嗎？因為我的意思是，在過去的一個季度，當你有了新客戶時，你基本上會非常關注 PD。現在你已經完成了，比如說，一些——某個階段或某個生產階段。現在您正在等待現有客戶的下一位客戶。所以這確實反映了這樣一個事實：我們已經轉向了一些新客戶，這比其他任何事情都重要，好嗎？這只是一個時間問題，本季度恰好是這個，下個季度，也許是其他事情。

So -- but yes, in general, in concept, we want to maintain a strong process development capability. Why? Because that each time builds up the pipeline for new production capacities, but they're very interconnected. And even the line of what is actual production and what is considered post development is not that clear cut.

所以，但是，是的，總的來說，從概念上來說，我們希望保持強大的工藝開發能力。為什麼？因為每次都會建立新的生產能力的管道，但它們之間的聯繫非常緊密。甚至什麼是實際生產和什麼是後期開發的界限也不是那麼明確。

You may be producing batches, but for development reasons or other reasons. So it really reflects the fact in this last quarter of bringing in new customers that initially need post development.

您可能會批量生產，但出於開發原因或其他原因。因此，這確實反映了最後一個季度引入最初需要後期開發的新客戶的事實。

(Operator Instructions) And there are no further questions in queue at this time. I would now like to turn the floor back to management for closing remarks.

（操作員說明） 目前隊列中沒有其他問題。我現在想請管理層發表結束語。

I'd like to thank everyone for participating on our Second Quarter 2023 Business Update Conference Call. We are excited about the outlook for the business and appreciate the support of our shareholders. We look forward to providing the updates as we advance our therapeutic targeting technology pipeline, expanding our point-of-care platform and deploying our onto worldwide. Thank you very much.

我要感謝大家參加我們的 2023 年第二季度業務更新電話會議。我們對業務前景感到興奮，並感謝股東的支持。我們期待在推進我們的治療靶向技術管道、擴展我們的護理點平台並將其部署到全球範圍內時提供更新。非常感謝。

Thank you. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開電話線，度過美好的一天。感謝您的參與。