Gamida Cell Ltd (GMDA) 2023 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cell's conference call for second quarter of 2023 finance results. My name is Michelle, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gamida Cell's requests.

女士們先生們，感謝你們的支持。歡迎參加 Gamida Cell 2023 年第二季度財務業績電話會議。我叫米歇爾，我將擔任您今天通話的接線員。請注意，本次通話是應 Gamida Cell 的要求進行錄音的。

And now, I would like to introduce your host for today's call, Mike Kuczkowski of Gamida Cell's corporate communications. Mike, please go ahead.

現在，我想介紹一下今天電話會議的主持人，Gamida Cell 企業傳播部的 Mike Kuczkowski。邁克，請繼續。

Thank you and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the second quarter of 2023. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.gamidacell.com.

謝謝大家，早上好。歡迎參加今天的電話會議，在此期間我們將提供公司的最新情況並審查2023 年第二季度的財務業績。今天上午早些時候，我們發布了一份新聞稿，總結了我們的財務業績並提供了業務更新，可在我們的網站為 www.gamidacell.com。

Here with me on our call today are Abbey Jenkins, President and Chief Executive Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; Ronit Simantov, Chief Medical Officer and Chief Scientific Officer; and Terry Coelho, our Chief Financial Officer.

今天與我一起參加電話會議的還有總裁兼首席執行官 Abbey Jenkins；米歇爾·科爾芬 (Michele Korfin)，首席運營官兼首席商務官； Ronit Simantov，首席醫療官兼首席科學官；以及我們的首席財務官 Terry Coelho。

Before I begin, I want to remind everyone that during this call, we may make forward-looking statements about our future expectations and plans, including with respect to the product and product candidates, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell's product Omisirge, expectations regarding the commercial launch of Omisirge, and its potential to capture market share, the company's plans for commercial or strategic partnerships to support the launch of Omisirge, and the company's anticipated financial runway.

在開始之前，我想提醒大家，在這次電話會議中，我們可能會就我們未來的期望和計劃做出前瞻性聲明，包括關於產品和產品候選者、潛在的挽救生命或治療和商業潛力的聲明。 Gamida Cell 的產品 Omisirge、對 Omisirge 商業推出的期望及其奪取市場份額的潛力、公司為支持 Omisirge 推出而建立商業或戰略合作夥伴關係的計劃，以及公司預期的財務跑道。

Our actual results may differ materially from what we project today due to a number of important factors, including those related to clinical, scientific, regulatory, and technical developments, and those inherent in the process of developing and commercializing products and product candidates that are safe and effective for human use as human therapeutics, and in the endeavor of building a business around our products and product candidate, as well as those considerations described in the risk factors section of our most recent quarterly report on Form 10-Q and other filings that we may make with the SEC from time to time.

由於許多重要因素，包括與臨床、科學、監管和技術發展相關的因素，以及安全產品和候選產品的開發和商業化過程中固有的因素，我們的實際結果可能與我們今天的預測存在重大差異並作為人類療法有效地用於人類，並努力圍繞我們的產品和候選產品建立業務，以及我們最近的10-Q 表格季度報告和其他文件的風險因素部分中描述的考慮因素我們可能會不時與SEC 協商。

These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information or future events except as required by applicable law.

這些前瞻性陳述僅代表我們今天的觀點，我們提醒您，我們將來可能不會更新這些陳述，無論是由於新信息還是未來事件，除非適用法律要求。

Now I will turn the call over to our President and CEO, Abbey Jenkins. Abbey?

現在我將把電話轉給我們的總裁兼首席執行官 Abbey Jenkins。修道院？

Thank you, Mike, and everyone joining us today. I'll begin by providing a brief corporate update.

謝謝邁克和今天加入我們的所有人。我將首先提供簡短的公司最新情況。

I know many of you are wondering how our launch is progressing. Well, we've made remarkable progress since the FDA approval of Omisirge in April. We are seeing a very high level of interest and engagement from transplant centers and are exceeding expectations with transplant center onboarding as Michele will discuss in more detail shortly.

我知道你們很多人都想知道我們的發布進展如何。自 4 月份 FDA 批准 Omisirge 以來，我們已經取得了顯著的進展。我們看到移植中心的興趣和參與度非常高，並且移植中心的入職超出了預期，米歇爾將很快對此進行更詳細的討論。

As of this morning, we have onboarded 12 transplant centers and have 8 additional transplant centers currently in the onboarding process against the goal of 10 to 15 for the year. That is tremendous progress for our first four months of launch. We've confirmed coverage with US payers that cover more than 85% of commercial lives. This includes confirmed national coverage with 9 out of the top 10 payers.

截至今天上午，我們已入駐 12 個移植中心，目前還有 8 個移植中心正在入駐過程中，今年的目標是 10 至 15 個。這是我們推出後前四個月的巨大進步。我們已向美國付款人確認其承保範圍涵蓋超過 85% 的商業生活。這包括已確認的全國覆蓋範圍，前 10 名付款人中有 9 家。

In June, we confirmed coverage and reimbursement for Omisirge with Medicare. This means the vast majority of patients now have coverage in place for Omisirge. We are thrilled with the progress we are making on the launch of Omisirge. This demonstrates that there is significant interest from transplanters to have Omisirge available as a donor source option for patients. And it signals that the real-world potential of Omisirge is consistent with the market research we conducted prior to and just after approval.

6 月，我們確認了 Medicare 對 Omisirge 的承保和報銷。這意味著絕大多數患者現在都有 Omisirge 承保。我們對 Omisirge 的推出所取得的進展感到非常興奮。這表明移植者對 Omisirge 作為患者的供體來源選擇非常感興趣。這表明 Omisirge 的現實潛力與我們在批准之前和批准後不久進行的市場研究是一致的。

In fact, based on this progress, we plan to hire four account managers and two additional medical science liaisons or MSLs to join the existing team of four account directors and four medical science liaisons to further support the demand for Omisirge.

事實上，基於這一進展，我們計劃聘請四名客戶經理和兩名額外的醫學科學聯絡員或MSL，加入現有的四名客戶總監和四名醫學科學聯絡員團隊，以進一步支持對Omisirge 的需求。

As many of you know, we hosted an Investor Day on June 29th to discuss the unmet need in stem cell transplantation and the role Omisirge may play in addressing those needs. We were joined by two thought leaders in stem cell transplantation, Dr. Stephen Devine, Chief Medical Officer at the National Marrow Donor Program/Be The Match and Senior Scientific Director at the CIBMTR, The Center for International Blood and Marrow Transplant Research; and Dr. Usama Gergis, Professor of Oncology and Director of Transplant and Cellular Therapy at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia.

正如你們許多人所知，我們於 6 月 29 日舉辦了投資者日活動，討論幹細胞移植方面未滿足的需求以及 Omisirge 在滿足這些需求方面可能發揮的作用。兩位幹細胞移植領域的思想領袖加入了我們的行列，史蒂芬·迪瓦恩(Stephen Devine) 博士是國家骨髓捐贈計劃/Be The Match 的首席醫療官，也是國際血液和骨髓移植研究中心CIBMTR 的高級科學總監；以及費城托馬斯杰斐遜大學悉尼金梅爾癌症中心腫瘤學教授兼移植和細胞治療主任 Usama Gergis 博士。

Dr. Devine addressed the unmet need regarding access to stem cell transplant. You explain that while approximately 20,000 people are eligible each year for transplants, only about half of these patients actually receive one. He outlined a variety of barriers, including highlighting the inequities and access for patients who are racially or ethnically diverse and Omisirge's potential to help expand access and address those health disparities.

Devine 博士解決了有關幹細胞移植的未滿足的需求。您解釋說，雖然每年大約有 20,000 人有資格接受移植，但其中只有大約一半的患者真正接受了移植。他概述了各種障礙，包括強調種族或民族多元化患者的不平等和就診機會，以及 Omisirge 幫助擴大就診範圍和解決這些健康差異的潛力。

Our Phase 3 study had over 40% of patients who are racially and ethnically diverse, which demonstrates both the unmet need and also Omisirge's ability to be a viable donor source for these patients. Dr. Devine concluded that today, no patient should go without a potentially curative transplant because they can't find a match.

我們的 3 期研究中有超過 40% 的患者是不同種族和民族的，這表明了未滿足的需求，也表明了 Omisirge 有能力成為這些患者的可行的捐贈來源。迪瓦恩博士得出的結論是，今天，任何患者都不應該因為找不到匹配的移植而放棄潛在的治愈性移植手術。

Dr. Gergis' presentation was especially poignant. He shared the story of his patient who was eligible for stem cell transplant a year-and-a-half ago, but struggled to find the donor, illustrating the need for Omisirge as a new donor source. This person was a young Black patient who could not find a match from a family member. Unfortunately, the only options available to this patient were mismatched unrelated donors.

Gergis 博士的演講尤其令人心酸。他分享了一位患者的故事，該患者一年半前有資格接受干細胞移植，但很難找到捐贈者，這說明了 Omisirge 作為新捐贈來源的必要性。這個人是一位年輕的黑人患者，他無法從家庭成員那裡找到匹配的人。不幸的是，該患者唯一可用的選擇是不匹配的無關捐贈者。

Throughout this talk, Dr. Gergis explained that timing is key with transplants as the patient could potentially relapse and become ineligible for transplant or become too weak to withstand the transplantation process. He said that if he was treating this patient today, he likely would have chosen Omisirge as the donor source and highlighted the 30-day turnaround for Omisirge as a positive benefit.

在整個演講中，傑吉斯博士解釋說，時機對於移植來說至關重要，因為患者可能會復發並變得不適合移植，或者變得太虛弱而無法承受移植過程。他說，如果他今天治療這名患者，他可能會選擇 Omisirge 作為捐贈者來源，並強調 Omisirge 的 30 天周轉是一個積極的好處。

Dr. Gergis also discussed a decision tree research model developed in partnership with Gamida Cell, evaluating outcomes in patients undergoing transplant. The research showed that availability of Omisirge at a 20% peak market share may increase transplant access, particularly for patients who are racially and ethnically diverse, demonstrating a 25% overall increase in allogeneic stem cell transplant rates with the degree of benefit largest for Black patients and those of Asian, Hispanic, and multi-racial backgrounds.

Gergis 博士還討論了與 Gamida Cell 合作開發的決策樹研究模型，用於評估接受移植的患者的結果。研究表明，Omisirge 的可用性達到20% 的峰值市場份額可能會增加移植的機會，特別是對於種族和民族多樣化的患者，這表明同種異體幹細胞移植率總體增加了25%，其中黑人患者受益程度最大以及亞洲人、西班牙人和多種族背景的人。

This makes us very optimistic about the potential role Omisirge may have in addressing what we estimate to be about 1,700 patients who are eligible for stem cell transplant annually, but for who are unable to find a donor. That's in addition to the transplanters potentially choosing Omisirge instead of other donor sources.

這讓我們對 Omisirge 可能發揮的潛在作用非常樂觀，我們估計每年約有 1,700 名符合幹細胞移植資格但無法找到捐贈者的患者。除此之外，移植者可能會選擇 Omisirge 而不是其他捐贈來源。

As we heard from both Dr. Gergis and Dr. Devine, there is a clear need for Omisirge, which we believe is reflected in the launch progress we're seeing. We remain committed to our two-pronged corporate strategy announced at the end of March, which involves first, launching Omisirge in the US with the goal of onboarding 10 to 15 transplant centers by the end of 2023, a goal we now expect to meet or exceed.

正如我們從 Gergis 博士和 Devine 博士那裡聽到的那樣，對 Omisirge 的需求是明顯的，我們相信這反映在我們所看到的發布進度中。我們仍然致力於 3 月底宣布的雙管齊下的企業戰略，其中首先是在美國推出 Omisirge，目標是到 2023 年底建立 10 至 15 個移植中心，我們現在預計能夠實現或實現這一目標。超過。

And secondly, pursuing a strategic partnership or transaction with a biopharmaceutical company to expand transplant center onboarding and accelerate patient access to Omisirge.

其次，尋求與生物製藥公司建立戰略合作夥伴關係或交易，以擴大移植中心的入職範圍並加快患者獲得 Omisirge 的機會。

On the second part of that strategy, we are continuing conversations with potential strategic partners. We believe our early launch success is a promising sign of Omisirge's long-term potential.

在該戰略的第二部分，我們正在繼續與潛在的戰略合作夥伴進行對話。我們相信，我們早期發布的成功是 Omisirge 長期潛力的一個有希望的跡象。

On board to help with these efforts is our recently appointed Chief Financial Officer, Terry Coelho, who joined the team in May. Terry is a seasoned finance executive with over 35 years of experience across all areas of finance and business development at both emerging growth and established global companies. She was most recently Executive Vice President, CFO, and Chief Business Development Officer at CinCor Pharma, Inc., where she led the company's successful initial public offering and follow-on financing in 2022.

我們最近任命的首席財務官 Terry Coelho 將於 5 月加入該團隊，為這些工作提供幫助。 Terry 是一位經驗豐富的財務主管，在新興成長型企業和成熟的跨國公司的財務和業務開發各個領域擁有超過 35 年的經驗。她最近擔任 CinCor Pharma, Inc. 的執行副總裁、首席財務官兼首席業務開發官，領導該公司在 2022 年成功進行首次公開​​募股和後續融資。

She's also held senior financial and executive roles at several other companies, including Novartis Pharmaceuticals, where for close to eight years, she held roles of increasing responsibility, including as finance lead for the oncology hematology franchise, and later led the global oncology development finance function. We are thrilled to have Terry on board to support Gamida Cell's ongoing transition into a commercial stage company and help drive our strategic partnership efforts.

她還在諾華製藥等其他幾家公司擔任過高級財務和行政職務，在近八年的時間裡，她擔任的職務越來越大，包括擔任腫瘤血液學特許經營權的財務負責人，後來領導了全球腫瘤開發財務職能。我們很高興 Terry 加入，支持 Gamida Cell 向商業階段公司的持續轉型，並幫助推動我們的戰略合作夥伴關係。

In addition, the Gamida Cell Board of Directors appointed Jeremy Blank, Founding Partner and Chief Investment Officer of Community Fund to the Board. Community Fund is a significant shareholder in Gamida Cell. Jeremy has a deep experience as an investment adviser for both companies and investors, and we believe he is well positioned to help the Board support our execution of Gamida Cell's corporate strategy to identify the right partner to fully resource the launch of Omisirge. Jeremy believe strongly in our two-pronged corporate strategy.

此外，Gamida Cell董事會任命社區基金創始合夥人兼首席投資官Jeremy Blank為董事會成員。社區基金是 Gamida Cell 的重要股東。 Jeremy 作為公司和投資者的投資顧問擁有豐富的經驗，我們相信他有能力幫助董事會支持我們執行 Gamida Cell 的企業戰略，以確定合適的合作夥伴，為 Omisirge 的推出提供充分的資源。傑里米堅信我們的雙管齊下的企業戰略。

In terms of our current financial position, we are pleased to share that we have strengthened our balance sheet significantly in the past quarter, enabling us to effectively drive our launch effort while also extending our cash runway into Q2 of 2024. You'll hear more details on our financials from Terry in just a moment.

就我們當前的財務狀況而言，我們很高興地告訴大家，我們在過去一個季度顯著增強了資產負債表，使我們能夠有效推動我們的發布工作，同時還將我們的現金跑道延長到2024 年第二季度。您會聽到更多特里稍後會詳細介紹我們的財務狀況。

So to summarize, we have made significant progress on the commercial launch of Omisirge exceeding expectations in terms of both securing payer coverage and onboarding transplant centers. We heard inspiring testimony from external thought leaders about Omisirge's potential to increase access and address barriers to care for patients in need of a stem cell transplant at our recent Investor Day. And it's delightful to say that we have heard similarly positive feedback from transplant centers during our onboarding process.

總而言之，我們在 Omisirge 的商業推出方面取得了重大進展，在確保付款人覆蓋和入職移植中心方面超出了預期。在我們最近的投資者日上，我們聽到了外部思想領袖關於 Omisirge 的潛力的鼓舞人心的證言，該潛力可以增加需要幹細胞移植的患者的獲取機會並解決護理障礙。令人高興的是，我們在入職過程中從移植中心聽到了類似的積極反饋。

We continue to progress our discussions to secure a business development transaction, and we are thrilled to have Terry on board as our new CFO. We are confident in our team's ability to deliver Omisirge to patients and its potential to save lives.

我們將繼續推進討論以確保業務發展交易，我們很高興特里擔任我們的新首席財務官。我們對我們的團隊向患者提供 Omisirge 的能力及其拯救生命的潛力充滿信心。

I'll now turn the call over to Michele for a more in-depth update on our commercial launch. Michele, over to you.

現在，我將把電話轉給米歇爾，以獲取有關我們商業發布的更深入的更新信息。米歇爾，交給你了。

Thank you, Abbey, and good morning, everyone.

謝謝艾比，大家早上好。

Gamida Cell continues to advance efforts and prioritize resources across the organization to execute Omisirge's launch and ensure patients in need can have access to Omisirge. We are pleased to share that the launch is off to a great start. Our real-world launch experience is consistent with both our pre- and post-approval market insights, both in terms of unmet needs with existing donor sources and the interest in Omisirge from transplanters and the multidisciplinary teams at their centers.

Gamida Cell 繼續推進工作並優先安排整個組織的資源來執行 Omisirge 的啟動，並確保有需要的患者能夠獲得 Omisirge。我們很高興地告訴大家，此次發布有了一個良好的開端。我們的實際啟動經驗與我們在批准前和批准後的市場洞察是一致的，無論是在現有捐助來源未滿足的需求方面，還是在移植者及其中心的多學科團隊對 Omisirge 的興趣方面。

As you may recall, Gamida Cell conducted a total of five independent blinded market insight studies with healthcare providers and payers, both pre and post approval. That showed Omisirge has the potential to capture approximately 20% market share at peak, which we estimate could occur by 2028.

您可能還記得，Gamida Cell 在批准前和批准後與醫療保健提供者和付款人總共進行了五次獨立的盲法市場洞察研究。這表明 Omisirge 有潛力在高峰期佔據約 20% 的市場份額，我們估計這可能會在 2028 年實現。

The insights were consistent that the market share capture for Omisirge could come from transplanters using Omisirge instead of other donor sources as well as transplanters using Omisirge for those approximately 1,700 patients who are eligible for transplant each year and could not find an appropriate donor. Although we previously estimated this number to be about 1,200, we now have independent data that show it is more likely about 1,700 patients each year who cannot find an appropriate donor.

一致認為，Omisirge 的市場份額佔領可能來自使用 Omisirge 而不是其他供體來源的移植者，以及使用 Omisirge 為每年大約 1,700 名符合移植資格但無法找到合適供體的患者使用 Omisirge 的移植者。儘管我們之前估計這個數字約為 1,200 人，但我們現在有獨立數據顯示，每年更有可能有約 1,700 名患者找不到合適的捐贈者。

As a reminder, a patient with a hematologic malignancy goes to transplant since that may be their only potential remaining treatment option. For those approximately 1,700 patients who cannot find a donor, they will most likely succumb to their disease.

提醒一下，患有血液惡性腫瘤的患者會接受移植，因為這可能是他們唯一可能的剩餘治療選擇。對於那些找不到捐贈者的大約 1,700 名患者來說，他們很可能會死於疾病。

We are passionate at Gamida about making sure transplant centers have access to Omisirge as a potential option for their patients. Today and in the past few months since approval, we have seen very strong interest in Omisirge from transplant centers, including centers that were not part of the Phase 3 trial. As of this morning, 12 transplant centers have been onboarded including centers such as Duke University Medical Center, Jefferson Health in Philadelphia, the Ohio State, and UCLA Health; and eight additional transplant centers are actively in the onboarding process.

Gamida 熱衷於確保移植中心能夠將 Omisirge 作為患者的潛在選擇。今天以及自批准以來的過去幾個月，我們看到移植中心對 Omisirge 表現出濃厚的興趣，包括不參與第三階段試驗的中心。截至今天上午，已有 12 個移植中心加入，其中包括杜克大學醫學中心、費城杰斐遜健康中心、俄亥俄州立大學和加州大學洛杉磯分校健康中心等中心；另外八個移植中心正在積極參與入職過程。

We are engaged with virtually all of the top 70 centers, which conduct about 80% of the transplants in the US.

我們與幾乎所有排名前 70 的中心都有合作，這些中心承擔了美國約 80% 的移植手術。

I'm very excited to say that Gamida Cell remains on track to possibly exceed our goal of onboarding 10 to 15 transplant centers by the end of 2023, and that we have exceeded our expectations with regard to the number of centers onboarded to date.

我很高興地說，Gamida Cell 仍有望超越我們到 2023 年底建立 10 至 15 個移植中心的目標，並且迄今為止我們已經超出了我們對建立的中心數量的預期。

Our transplant center onboarding team works closely with transplant center personnel on the clinical training and administrative policies and procedures required to begin using Omisirge as a donor source. How quickly a transplant center onboarded is determined by the needs of each individual transplant center. This includes doctors on staff availability to participate in the onboarding and the status of patients currently under evaluation that may be good candidates from research.

我們的移植中心入職團隊與移植中心人員密切合作，制定開始使用 Omisirge 作為捐贈者來源所需的臨床培訓、行政政策和程序。移植中心成立的速度取決於每個移植中心的需求。這包括醫生是否有工作人員參與入職，以及目前正在接受評估的患者的狀況，這些患者可能是研究中的良好候選者。

Our team is nimble and customizes onboarding timelines to meet individual transplant center and patient needs. The clinical approach and policies and procedures needed for Omisirge are consistent with other donor sources and are therefore very familiar to transplant center personnel. So ultimately, the onboarding process can be completed very quickly, typically more quickly than for other cell therapies.

我們的團隊非常靈活，可以定制入職時間表，以滿足各個移植中心和患者的需求。 Omisirge 所需的臨床方法、政策和程序與其他供體來源一致，因此移植中心人員非常熟悉。因此最終，啟動過程可以非常快地完成，通常比其他細胞療法更快。

We have also been focused on ensuring payer coverage for Omisirge. We have confirmed coverage for the vast majority of patients in the US. In fact, more than 85% of commercial lives have confirmed coverage. This includes national coverage with 9 out of the top 10 payers, and we are in ongoing discussions with additional commercial payers to further expand coverage.

我們還致力於確保 Omisirge 的付款人承保。我們已經確認了美國絕大多數患者的承保範圍。事實上，超過85%的商業生活已得到確認覆蓋。這包括前 10 個付款人中有 9 個的全國覆蓋範圍，我們正在與其他商業付款人進行持續討論，以進一步擴大覆蓋範圍。

Last year, we secured our Omisirge specific ICD-10 codes. And in June, we announced that we now also have confirmed CMS coverage and reimbursement for patients covered by Medicare. We also have all the required documentation in place for patients who are covered under Medicaid, the Department of Defense, and the Department of Veteran Affairs.

去年，我們獲得了 Omisirge 特定的 ICD-10 代碼。 6 月份，我們宣布現在還確認了 CMS 承保範圍以及對 Medicare 承保患者的報銷。我們還為醫療補助、國防部和退伍軍人事務部承保的患者準備了所有必需的文件。

We know from our clinical trials and working in transplant that it takes time to evaluate patients and get them ready for transplant. This is true for all donor sources and the specific timeline and approach for preparing a patient for transplant can vary by transplant center based on each center's policies and procedures.

我們從臨床試驗和移植工作中知道，評估患者並讓他們為移植做好準備需要時間。對於所有捐贈者來源都是如此，並且根據每個中心的政策和程序，準備患者進行移植的具體時間表和方法可能會因移植中心而異。

I am excited to share that patients are enrolled in the Gamida Cell Assist program, which was created to ensure healthcare providers and patients could access therapy and have a personalized positive experience.

我很高興地告訴大家，患者已加入 Gamida Cell Assist 計劃，該計劃的創建是為了確保醫療保健提供者和患者能夠獲得治療並獲得個性化的積極體驗。

When a transplant physician enrolls a patient in Gamida Cell Assist, it signals that they intend to use Omisirge as the patient's donor source. The transplant centers enroll patients to Gamida Cell Assist, select Omisirge, and schedule their manufacturing date; and could also work with Gamida Cell Assist for patient assistance, including benefit verification, patient support programs, and copay or coinsurance assistance. This is a significant step for the patient in terms of their journey to transplantation.

當移植醫生將患者納入 Gamida Cell Assist 時，這表明他們打算使用 Omisirge 作為患者的供體來源。移植中心將患者納入 Gamida Cell Assist，選擇 Omisirge，並安排其生產日期；還可以與 Gamida Cell Assist 合作提供患者援助，包括福利驗證、患者支持計劃以及共付額或共同保險援助。對於患者的移植之旅來說，這是重要的一步。

Once the Omisirge donor source is selected by the patient's transplanter and the core blood unit is received by Gamida Cell, we are ready to begin manufacturing.

一旦患者的移植者選擇了 Omisirge 供體來源並且 Gamida Cell 收到了核心血液單位，我們就準備開始製造。

As a reminder, we have been successfully manufacturing clinical batches in our facilities for over a year. We have an experienced team in place and we are ready to reliably deliver on the surge within 30 days from the start of manufacturing.

提醒一下，我們已經在我們的設施中成功生產臨床批次一年多了。我們擁有一支經驗豐富的團隊，準備在生產開始後 30 天內可靠地交付激增的產品。

To continue the rapid expansion of our commercial launch and support the demand for Omisirge, we have plans to hire four account managers and two additional medical science liaisons to support the current team of four regional account directors and four MSLs. We feel this is an appropriate investment to capitalize on the momentum and interest we are seeing from transplant centers.

為了繼續快速擴大我們的商業發布並支持對 Omisirge 的需求，我們計劃聘請四名客戶經理和兩名額外的醫學聯絡員來支持當前由四名區域客戶總監和四名 MSL 組成的團隊。我們認為這是一項適當的投資，可以利用我們從移植中心看到的勢頭和興趣。

Going back to our mission, Gamida Cell was built to deliver potentially curative therapies for patients with blood cancers. Omisirge is a core element in delivering on that mission based on its potential to increase access and address critical unmet needs in stem cell transplantation. We are prioritizing every resource possible to support this launch, knowing the meaningful impact Omisirge can potentially have on patients' lives.

回到我們的使命，Gamida Cell 旨在為血癌患者提供潛在的治療方法。 Omisirge 是實現這一使命的核心要素，因為它具有增加干細胞移植的機會並解決未滿足的關鍵需求的潛力。我們正在優先考慮一切可能的資源來支持此次發布，因為我們知道 Omisirge 可能對患者的生活產生有意義的影響。

The interest and enthusiasm from transplant centers are both gratifying and supportive of the prelaunch market insights. Our team at Gamida Cell has been working hard to meet transplant center demand and ensure that every patient in need of a stem cell transplant has access to Omisirge.

移植中心的興趣和熱情既令人欣慰，又支持了上市前的市場洞察。我們 Gamida Cell 的團隊一直在努力滿足移植中心的需求，並確保每位需要幹細胞移植的患者都能獲得 Omisirge。

With that, I'd like to turn the call over to Ronit Simantov, our Chief Medical and Chief Scientific Officer. Ronit?

我想將電話轉給我們的首席醫療兼首席科學官羅尼特·西曼托夫 (Ronit Simantov)。羅尼特？

Thank you, Michele, and good morning, everyone. Thank you for joining us today.

謝謝米歇爾，大家早上好。感謝您今天加入我們。

My team and I have been speaking with physicians across the country and the feedback we hear on Omisirge echoes what Michele has shared. We see a clear need for transplant options for their patients and are eager to make Omisirge available at their institutions.

我和我的團隊一直在與全國各地的醫生進行交談，我們在 Omisirge 上聽到的反饋與 Michele 分享的內容相呼應。我們看到他們的患者顯然需要移植選擇，並渴望在他們的機構提供 Omisirge。

Today, I will provide a few updates on recent data for Omisirge and for our NK cell therapy candidate, GDA-201. First, results in the prospective substudy of the Phase 3 Omisirge trial were recently published in the journal, Transplantation and Cellular Therapy.

今天，我將提供 Omisirge 和我們的 NK 細胞療法候選藥物 GDA-201 的最新數據的一些更新。首先，第三階段 Omisirge 試驗的前瞻性子研究結果最近發表在《移植與細胞治療》雜誌上。

Our Phase 3 study, which over 40% of patients were members of ethnic and racial minority groups, demonstrated rapid neutrophil engraftment, a key early marker of transplant success; and lower rates of serious infections in patients transplanted with Omisirge compared to cord blood. Using real-world data from CIBMTR, we also showed that transplantation with Omisirge led to faster hematopoietic recovery than other donor sources.

我們的 3 期研究表明，超過 40% 的患者是少數族裔和少數族裔群體的成員，該研究表明中性粒細胞快速植入，這是移植成功的關鍵早期標誌；與臍帶血移植相比，接受 Omisirge 移植的患者嚴重感染率較低。使用來自 CIBMTR 的真實數據，我們還表明，與其他供體來源相比，Omisirge 移植導致造血恢復更快。

A potential mechanism for these observations was elucidated in a substudy of 37 patients from the Phase 3 trial, which showed prompt and robust recovery of immune cells after transplant with Omisirge, with up to a 70-fold advantage in median cell counts across most cell populations, including NKT and B cells. The authors concluded that the faster recruitment and development of immune cells may account for the reduced rate of bacterial, fungal, and viral infections observed after transplantation with Omisirge versus cord blood.

對 37 名患者進行的 3 期試驗的亞組研究闡明了這些觀察結果的潛在機制，該研究表明，移植 Omisirge 後免疫細胞迅速而強勁地恢復，大多數細胞群的中位細胞計數優勢高達 70 倍，包括NKT 和B 細胞。作者得出的結論是，與臍帶血移植相比，Omisirge 移植後觀察到的細菌、真菌和病毒感染率降低，免疫細胞的更快募集和發育可能是其原因。

We continue to present and publish data that add to the scientific and clinical understanding of Omisirge and provide insights to the transplant community.

我們將繼續提供和發布數據，以增加對 Omisirge 的科學和臨床理解，並為移植界提供見解。

I'll now turn to GDA-201, our allogeneic NK cell therapy candidate derived from adult donors and manufactured using our proprietary nicotinamide or NAM technology. We presented data at the International Society for Cell and Gene Therapy or ISCT 2023 Annual Meeting in June, demonstrating the robustness of cryopreserved GDA-201.

現在我將談談 GDA-201，這是我們的同種異體 NK 細胞療法候選藥物，源自成人捐贈者，並使用我們專有的煙酰胺或 NAM 技術製造。我們在 6 月份的國際細胞和基因治療學會或 ISCT 2023 年會上展示了數據，證明了冷凍保存的 GDA-201 的穩健性。

We showed that NAM expansion of NK cells led to the expression of lymphoid homing marker CD62 ligand and decreased levels of lineage exhaustion markers, CD57 and CD161, providing further phenotypic characterization of GDA-201.

我們發現，NK 細胞的 NAM 擴增導致淋巴歸巢標記物 CD62 配體的表達，並降低譜系耗竭標記物 CD57 和 CD161 的水平，從而提供了 GDA-201 的進一步表型特徵。

In addition, data from the investigator-led study at the University of Minnesota using the fresh formulation of GDA-201 were published in the July 19th edition of Science Translational Medicine. The publication included preclinical, clinical, and translational data. The preclinical data demonstrated that our NAM technology increased metabolic fitness, energy charge, and glucose flux in NK cells.

此外，由研究者主導的明尼蘇達大學使用 GDA-201 新鮮配方的研究的數據發表在 7 月 19 日版《科學轉化醫學》上。該出版物包括臨床前、臨床和轉化數據。臨床前數據表明，我們的 NAM 技術提高了 NK 細胞的代謝適應性、能量消耗和葡萄糖通量。

The implications of these findings are significant given recent research showing the importance of metabolic fitness in cellular therapies. The clinical data shows 74% overall response rate and 57% complete response rate in heavily pretreated patients with non-Hodgkin lymphoma treated with GDA-201. And translational data in biopsy specimens showed that tumor regression was associated with then host T cell infiltration into lymph node tissue after GDA-201 treatment suggesting that GDA-201 generated an adaptive immune response in patients.

鑑於最近的研究表明代謝健康在細胞療法中的重要性，這些發現的意義非常重大。臨床數據顯示，接受 GDA-201 治療的經過深度治療的非霍奇金淋巴瘤患者的總體緩解率為 74%，完全緩解率為 57%。活檢標本的轉化數據顯示，GDA-201 治療後，腫瘤消退與宿主 T 細胞浸潤到淋巴結組織相關，這表明 GDA-201 在患者中產生了適應性免疫反應。

These data provide further evidence that GDA-201 NK cells, which originate from human donors and our expanded using our NAM technology, can overcome the historic limitations of NK cells as a viable therapeutic.

這些數據進一步證明 GDA-201 NK 細胞（源自人類捐贈者並使用我們的 NAM 技術進行擴增）可以克服 NK 細胞作為可行療法的歷史局限性。

We are excited about these new insights on metabolic fitness, cytotoxicity, and engagement of the adaptive immune system as we proceed with our Phase 1 dose escalation study of GDA-201. We are enrolling patients with non-Hodgkin lymphoma at six US sites and expect to report data in the first quarter of 2024.

當我們繼續進行 GDA-201 的 1 期劑量遞增研究時，我們對這些關於代謝適應性、細胞毒性和適應性免疫系統參與的新見解感到興奮。我們正在美國六個地點招募非霍奇金淋巴瘤患者，預計在 2024 年第一季度報告數據。

I will now turn the call over to Terry Coelho, our Chief Financial Officer. Terry?

我現在將把電話轉給我們的首席財務官 Terry Coelho。特里？

Thank you, Ronit, and good morning, everyone.

謝謝你，羅尼特，大家早上好。

As Abbey mentioned earlier, I'm pleased to share that the company has strengthened its balance sheet in the second quarter. We ended the second quarter with $54.1 million in cash as a result of combined net proceeds of $34.7 million from both the April equity offering and funds raised using the at the market or ATM facility in the quarter.

正如艾比之前提到的，我很高興地告訴大家，該公司在第二季度加強了資產負債表。第二季度結束時，我們的現金為 5,410 萬美元，四月份的股票發行和本季度使用市場或 ATM 設施籌集的資金合計淨收益為 3,470 萬美元。

In addition, the outstanding principal balance of our 2022 $25 million convertible term loan was $10 million as of June 30, 2023, a reduction of $9 million as compared to the balance of $19 million at the end of the first quarter. The $9 million reduction reflects primarily voluntary share exchanges by the lender in addition to the payment of a monthly installment and shares. The combined principal balance of the 2022 note and the $75 million senior convertible note is $85 million as of June 30th, down from $94 million at the end of the first quarter.

此外，截至2023年6月30日，我們的2022年2500萬美元可轉換定期貸款的未償還本金餘額為1000萬美元，比第一季度末的1900萬美元餘額減少900萬美元。 900 萬美元的減少主要反映了貸款人除了支付每月分期付款和股票之外的自願股票交換。截至 6 月 30 日，2022 年票據和 7500 萬美元高級可轉換票據的本金餘額合計為 8500 萬美元，低於第一季度末的 9400 萬美元。

Research and development expenses were $8.7 million in the second quarter of 2023 compared to $10.6 million in the same quarter in 2022, the decrease of $1.9 million was primarily due to a $1.6 million reduction associated with the discontinuation of development of our engineered NK cell therapy pipeline and $700,000 in lower Omisirge Phase 3 spend, including a decrease in payments for manufacturing services, partially offset by a decrease of $400,000 in Israeli Innovation Authority income.

2023 年第二季度的研發費用為870 萬美元，而2022 年同一季度的研發費用為1060 萬美元，減少190 萬美元主要是由於與我們的工程NK 細胞治療管道的開發停止相關的減少了160 萬美元Omisirge 第三階段支出減少 70 萬美元，包括製造服務付款的減少，但部分被以色列創新局收入減少 40 萬美元所抵消。

Commercial expenses were $3.9 million in the second quarter of 2023 compared to $3.2 million in the second quarter of 2022. The increase of $700,000 was attributable to an increase in launch readiness activities.

2023 年第二季度的商業費用為 390 萬美元，而 2022 年第二季度的商業費用為 320 萬美元。增加 70 萬美元是由於發射準備活動的增加。

General and administrative expenses were $6.3 million in the second quarter of 2023 compared to $4.3 million in the same period in 2022. The increase of $2 million was associated with higher professional services expenses of $1 million in part due to the April follow-on offering and business development activities.

2023 年第二季度的一般和行政費用為 630 萬美元，而 2022 年同期為 430 萬美元。增加 200 萬美元與專業服務費用增加 100 萬美元有關，部分原因是 4 月份的後續發行和業務發展活動。

Financial expenses were $12.9 million net in the second quarter of 2023 compared to $500,000 in the same period of 2022. The increase of $12.4 million was primarily due to non-cash expenses totaling approximately $10.4 million, including the fair value impact on our warrant liability of $4.9 million, the fair value impact on the 2022 convertible note of $4.3 million, and a decrease in capitalization of finance cost to fixed assets of $600,000.

2023 年第二季度的財務費用淨額為1,290 萬美元，而2022 年同期為50 萬美元。增加1,240 萬美元主要是由於非現金費用總計約1,040 萬美元，包括對我們認股權證負債的公允價值影響490 萬美元，對 2022 年可轉換票據的公允價值影響為 430 萬美元，固定資產融資成本資本化減少 60 萬美元。

In addition, the increase was due to higher cash expenses of $2 million, including $1.7 million in issuance costs from our April 2023 underwritten public offering and an increase of $1 million in interest expenses associated with the 2022 convertible note, partially offset by increased interest income of $500,000. Our net loss was $31.7 million in the second quarter of 2023 compared to a net loss of $18.6 million in the second quarter of 2022, driven primarily by the increase in financial expenses of $12.4 million.

此外，增加的原因是現金支出增加了200 萬美元，其中包括我們2023 年4 月承銷的公開發行的170 萬美元發行成本，以及與2022 年可轉換票據相關的利息支出增加了100 萬美元，部分被利息收入增加所抵消500,000 美元。 2023 年第二季度的淨虧損為 3170 萬美元，而 2022 年第二季度的淨虧損為 1860 萬美元，主要是由於財務費用增加 1240 萬美元。

As I mentioned before, as of June 30, 2023, Gamida Cell had total cash and cash equivalents of $54.1 million compared to $64.7 million as of December 31, 2022. The decrease of $10.4 million is due primarily to net cash used in operating activities of $44.3 million, partially offset by $34.7 million in net cash proceeds from the issuance of shares and warrants in our underwritten public offering, along with the issuance of shares via the ATM facility.

正如我之前提到的，截至2023 年6 月30 日，Gamida Cell 的現金和現金等價物總額為5,410 萬美元，而截至2022 年12 月31 日為6,470 萬美元。減少1,040 萬美元主要是由於運營活動中使用的現金淨額4,430 萬美元，部分被我們承銷的公開發行中發行股票和認股權證以及通過 ATM 設施發行股票所產生的 3,470 萬美元淨現金收益所抵消。

Subsequent to the quarter close and through August 9th, the company raised an additional $14 million in net proceeds via the ATM facility. The company expects its current cash and cash equivalents, including the funds raised via the ATM subsequent to the close of the second quarter to support its ongoing operating activities into the second quarter of 2024 based on Gamida Cell's current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken.

本季度結束後直至 8 月 9 日，該公司通過 ATM 融資額外籌集了 1,400 萬美元的淨收益。根據Gamida Cell 目前的運營計劃，該公司預計其當前的現金和現金等價物（包括第二季度末通過ATM 籌集的資金）將支持其持續到2024 年第二季度的運營活動，並且不包括超出預期的商業化活動。 Omisirge 的首次啟動，以及可能進行的任何其他融資活動。

We believe that this cash runway will enable us to effectively support the launch of Omisirge while pursuing strategic alternatives.

我們相信，這條現金跑道將使我們能夠有效支持 Omisirge 的推出，同時尋求戰略替代方案。

With that, I'll turn the call back over to Abbey for some concluding remarks. Abbey?

至此，我會將電話轉回 Abbey 進行一些總結性發言。修道院？

Thank you, Terry.

謝謝你，特里。

Before I turn the call over to the operator for questions, I want to bring us back around to the beginning of the call and summarize the key points from our discussion today. We've made great progress on the commercial launch of Omisirge. We are on track to possibly exceed our goal of onboarding 10 to 15 transplant centers this year, which is the first prong of our two-pronged strategy. And we have confirmed coverage from payers that cover more than 85% of commercial live, along with securing Medicare coverage and reimbursement.

在我將電話轉交給接線員詢問問題之前，我想讓我們回到電話的開頭並總結我們今天討論的要點。我們在 Omisirge 的商業發布方面取得了巨大進展。我們有望超越今年設立 10 至 15 個移植中心的目標，這是我們雙管齊下戰略的第一步。我們已經確認付款人的承保覆蓋了超過 85% 的商業生活，同時還確保了 Medicare 承保和報銷。

We are also continuing to execute on the second prong of our strategy to pursue a strategic partnership or transaction in order to expand transplant center onboarding and accelerate patient access to Omisirge. Conversations with potential strategic partners are ongoing. The Phase 1 clinical trials for GDA-201 is proceeding as expected, and we look forward to the data readout in early 2024. We have strengthened our balance sheet significantly enabling us to effectively drive these efforts and extending our cash runway into Q2 of 2024.

我們還將繼續執行戰略的第二個方面，以尋求戰略合作夥伴關係或交易，以擴大移植中心的入職範圍並加快患者獲得 Omisirge 的機會。與潛在戰略合作夥伴的對話正在進行中。 GDA-201 的1 期臨床試驗正在按預期進行，我們期待在2024 年初讀出數據。我們已經顯著增強了我們的資產負債表，使我們能夠有效推動這些努力，並將我們的現金跑道延長到2024 年第二季度。

Most importantly, we are thrilled that patients now have access to a new stem cell donor source. We believe our early launch success a promising sign of Omisirge long-term potential to increase access and address critical unmet needs in stem cell transplantation.

最重要的是，我們很高興患者現在可以獲得新的干細胞供體來源。我們相信，我們早期的成功推出是 Omisirge 在增加干細胞移植的機會和解決未滿足的關鍵需求方面的長期潛力的一個有希望的跡象。

Now let's open the call for questions. Operator?

現在讓我們開始提問。操作員？

(Operator Instructions) Jason Butler, JMP Securities.

（操作員指令）Jason Butler，JMP 證券。

Hi. Thanks for taking my questions and congrats on all the progress. Just wondering if more color on the patients that are already in the Gamida Cell Asist program. Where along the process towards treatment are they and what would need to happen between now and then actually getting treated or for between now and you actually starting the manufacturing process for these patients? Thanks.

你好。感謝您提出我的問題並祝賀所有的進展。只是想知道是否對已經參加 Gamida 細胞輔助計劃的患者有更多的了解。他們在治療過程中處於什麼位置？從現在到實際接受治療，或者從現在到您實際開始為這些患者製造過程之間需要發生什麼？謝謝。

Good morning, Jason. It's Michele and thank you for the question. So we do have patients enrolled in Gamida Cell Assist so hence, the commercial manufacturing process is now underway. From the standpoint of just a reminder, we have successfully manufactured Omisirge for value here at this facility for both our EAP and clinical trials. So the team is excited to now have the commercial manufacturing process started too.

早上好，傑森。我是米歇爾，謝謝你的提問。因此，我們確實有患者註冊了 Gamida Cell Assist，因此商業製造過程正在進行中。謹在此提醒您，我們已在該工廠成功製造了 Omisirge，用於我們的 EAP 和臨床試驗。因此，該團隊很高興現在也開始商業製造過程。

Jason, let me pause there and see if I fully addressed your question.

傑森，讓我暫停一下，看看我是否完全回答了你的問題。

Yeah. I guess just to clarify, does that mean that you already have reimbursement approval for these patients? And then if you can, can you give us a sense of the patients in Gamida Assist now? Are they more heavily weighted towards commercial plans or Medicare? Thanks.

是的。我想澄清一下，這是否意味著您已經獲得了這些患者的報銷批准？如果可以的話，您能給我們介紹一下 Gamida Assist 中的患者嗎？他們更傾向於商業計劃還是醫療保險？謝謝。

Excellent questions. So let's start with coverage and reimbursement, and then we'll talk about the patient mix. So from the standpoint of coverage and reimbursement. We're very encouraged with where we stand on both the commercial side and the CMS side.

很好的問題。因此，讓我們從承保和報銷開始，然後我們將討論患者組合。所以從承保和報銷的角度來看。我們對我們在商業方面和 CMS 方面的立場感到非常鼓舞。

So let me start with commercial. We have confirmed coverage for commercial payers who cover over 85% of the commercial lives. So that's the coverage. From a reimbursement standpoint, what we're hearing so far from the centers is they're generally working with their respective payers, utilizing single case agreements, those that have gone through already have gone through very smoothly and consistent with expectations from both the payer side and the center side. So that's the reimbursement side on the commercial side.

那麼讓我從商業廣告開始。我們已經確認商業付款人的覆蓋範圍覆蓋了超過 85% 的商業生活。這就是覆蓋範圍。從報銷的角度來看，到目前為止，我們從這些中心聽到的是，他們通常與各自的付款人合作，利用單一案例協議，那些已經完成的協議進展得非常順利，並且符合付款人雙方的期望側和中心側。這就是商業方面的報銷方面。

Coverage and reimbursement for CMS or Medicare specifically, we did receive our ICD-10 codes last year and coverage was map to DRG 40, which is where we'd expect it to be for an allogeneic stem cell transplant. And in June, we received confirmation from CMS that reimbursement will be covered under the legislation that led to section 108, and that covers donor sources as a pass through. So from the standpoint of Medicare, we have both the confirmed coverage and reimbursement.

特別是 CMS 或 Medicare 的承保範圍和報銷，我們去年確實收到了 ICD-10 代碼，承保範圍映射到 DRG 40，這是我們期望同種異體幹細胞移植的範圍。 6 月份，我們收到 CMS 的確認，報銷將涵蓋在導致第 108 條的立法範圍內，並且涵蓋了作為傳遞的捐助來源。所以從醫療保險的角度來看，我們既有確認的承保範圍，也有報銷。

You asked about the patients that are in Gamida Cell Assist, we've seen a mixture of commercial and CMS patients. And yeah, as I mentioned, we're very encouraged by both the confirmed coverage and also the reimbursement process to date on both the commercial and the Medicare side.

您詢問了 Gamida Cell Assist 中的患者，我們看到了商業患者和 CMS 患者的混合體。是的，正如我所提到的，我們對商業和醫療保險方面已確認的承保範圍以及迄今為止的報銷流程感到非常鼓舞。

Great. And then just last one for me. If you hit the target of onboarding centers this year, do you have the resources to continue to onboard centers above that initial target? Thanks.

偉大的。然後是我的最後一個。如果您今年達到了入職中心的目標，您是否有資源繼續在高於初始目標的情況下入職中心？謝謝。

And so as we mentioned in our prepared remarks, we are adding additional account managers. So four commercial account managers and Ronit and her team are adding additional MSLs. And your question is very astute. We do need to make sure that as that level of interest from centers continues to grow, which we're very encouraged by that we have the appropriate resources, so hence the additional resources that we'll be adding on both the account manager and MSL side.

正如我們在準備好的發言中提到的，我們正在增加更多的客戶經理。因此，四位商業客戶經理和 Ronit 及其團隊正在添加額外的 MSL。而且你的問題很精明。我們確實需要確保，隨著中心的興趣水平持續增長，我們對我們擁有適當的資源感到非常鼓舞，因此我們將在客戶經理和 MSL 上添加額外的資源邊。

Hi. This is [Ethan on for Gil]. Thank you for taking our question. I was just wondering if you could tell us based on the 12 centers onboarded so far, how many of those are previously involved in clinical studies versus those not? Because I know that was a previous point at Analyst Day.

你好。這是[伊森替吉爾]。感謝您提出我們的問題。我只是想知道您能否告訴我們，根據迄今為止已加入的 12 個中心，其中有多少是之前參與過臨床研究的，哪些沒有參與過？因為我知道這是分析師日的前一點。

And then the second question is during the analyst event, I believe you guided that first commercial manufacturing might initiate in the third quarter. So wondering if you're still on track for that or if that's changed? Thank you.

第二個問題是在分析師活動期間，我相信您指導第一個商業製造可能會在第三季度啟動。那麼想知道您是否仍在朝著這個目標前進，或者情況是否發生了變化？謝謝。

This is Michele and thank you for the question. So I'll take the first one in regards to clinical -- the 12 centers onboarded and clinical study participation, the vast majority of the centers onboard and were not in the clinical study. So we're very encouraged by the fact that we have the strong level of interest from centers who were not part of the clinical studies, and our medical team has worked very closely with them as have our commercial team for onboarding.

我是米歇爾，謝謝你的提問。因此，我將選擇第一個關於臨床的問題——12 個中心已加入並參與臨床研究，絕大多數中心已加入但未參與臨床研究。因此，令我們深受鼓舞的是，未參與臨床研究的中心對我們表現出濃厚的興趣，我們的醫療團隊與他們密切合作，我們的商業團隊也與他們密切合作。

So that's the first question. The second question, we do have patients enrolled in Gamida Cell Assist. So hence once they are enrolled in Gamida Cell Assist, the commercial manufacturing process still initiate.

這是第一個問題。第二個問題，我們確實有患者參加了 Gamida Cell Assist。因此，一旦他們加入 Gamida Cell Assist，商業製造過程仍然會啟動。

(Operator Instructions) There are no further questions. I'd like to turn the call back over to Abbey Jenkins, President and CEO, for closing remarks.

（操作員說明）沒有其他問題。我想將電話轉回給總裁兼首席執行官 Abbey Jenkins，讓其致閉幕詞。

Thank you all again for joining us. To recap, just a few months after FDA approval of Omisirge, Gamida Cell is well positioned to bring Omisirge to patients with hematologic malignancies in need of a stem cell transplant in transplant centers across the country. Our team at Gamida Cell is working hard to meet the significant interest we are seeing from transplant centers, and we are so excited at the prospect of bringing Omisirge to patients.

再次感謝大家加入我們。回顧一下，在 FDA 批准 Omisirge 幾個月後，Gamida Cell 已做好準備，將 Omisirge 帶給全國各地移植中心需要幹細胞移植的血液惡性腫瘤患者。我們 Gamida Cell 的團隊正在努力滿足移植中心的濃厚興趣，我們對將 Omisirge 帶給患者的前景感到非常興奮。

Thank you, everyone, for joining us on today's call, and we look forward to providing further updates on future calls. Thank you.

感謝大家參加今天的電話會議，我們期待在未來的電話會議上提供進一步的更新。謝謝。