使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for third-quarter 2023 financial results. My name is Chris and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. I would now like to introduce your host for today's conference, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.
女士們先生們,謝謝你們的支持。歡迎參加 Gamida Cell 2023 年第三季財務業績電話會議。我叫克里斯,我將擔任今天電話的接線生。請注意,本次通話是應 Gamida Cell 的要求進行錄音的。現在我想介紹一下今天會議的主持人,Gamida Cell Corporate Communications 的 Mike Kuczkowski。麥克,請繼續。
Mike Kuczkowski - Corporate Communications
Mike Kuczkowski - Corporate Communications
Thank you, Chris, 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 third 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.
謝謝你,克里斯,大家早安。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 年第三季度的財務業績。今天早上早些時候,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,您可以在我們的網站 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執行長 Abbey Jenkins;米歇爾‧科爾芬 (Michele Korfin),營運長兼首席商務官; Ronit Simantov,首席醫療官兼首席科學官;以及我們的財務長 Terry Coelho。
Before we 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 potentially life-saving or curative therapeutic potential of Omisirge, omidubicel-onlv; the company's cell therapy candidate, GDA-201; expectations regarding the commercial launch of Omisirge and potential to capture market share and generate revenue; Gamida Cell's plans for commercial or strategic partnerships to support the launch of Omisirge; Gamida Cell's financial runway; Gamida Cell's ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell's Israel operations.
在我們開始之前,我想提醒大家,在這次電話會議中,我們可能會對我們未來的期望和計劃做出前瞻性聲明,包括關於 Omisirge、omidubicel-onlv 的潛在挽救生命或治療潛力;該公司的細胞療法候選產品GDA-201;對 Omisirge 商業推出的期望以及佔領市場份額和創造收入的潛力; Gamida Cell 計劃建立商業或策略合作夥伴關係,以支持 Omisirge 的推出; Gamida Cell的財務跑道; Gamida Cell 維持以色列設施開放的能力、員工狀況以及可能對 Gamida Cell 以色列業務產生不利影響的未來發展。
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 product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around our product 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,以及安全有效的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有重大差異。用作人類治療藥物,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 表格季度報告和我們可能提交的其他文件的風險因素部分中描述的考慮因素SEC 不時。
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,無論是由於新資訊還是未來事件,除非適用法律要求。
Now let me turn the call over to our President and Abbey Jenkins.
現在讓我把電話轉給我們的總統和艾比詹金斯。
Abbey Jenkins - President and CEO
Abbey Jenkins - President and CEO
Thank you, Mike, and everyone joining us today. I want to begin by providing a brief corporate update. We've made strong progress this quarter, which I'll go into detail on in a moment. But I would be remiss if I didn't start this call by first acknowledging the courage and resilience of our Israeli team members, who have shown incredible dedication and commitment to patients as they continue operations to ensure we reliably deliver Omisirge to patients in need while living and working in a war zone. For patients with hematologic malignancies in need of an allogeneic stem cell transplant, Omisirge may represent their last or best hope for a cure, and we are proud to be able to continue to serve our patients under these challenging circumstances.
謝謝邁克和今天加入我們的所有人。首先我想介紹一下公司的最新狀況。本季我們取得了巨大進展,我稍後將詳細介紹。但如果我在這次電話會議開始時沒有首先承認我們以色列團隊成員的勇氣和韌性,那就是我的失職了,他們在繼續運作的過程中表現出了令人難以置信的奉獻精神和對患者的承諾,以確保我們可靠地向有需要的患者提供Omisirge,同時在戰區生活和工作。對於需要同種異體幹細胞移植的血液惡性腫瘤患者來說,Omisirge 可能代表著他們最後或最好的治癒希望,我們很自豪能夠在這些充滿挑戰的情況下繼續為我們的患者提供服務。
Our employees' safety is a key concern, and we are relieved to be able to say everyone remains safe. As you might imagine, the process of getting cells into Israel and delivering Omisirge back to transplant centers in the US could have been impacted when many airlines suspended flight service in Israel. Our team of dedicated employees did not hesitate to put patients first when their own lives were impacted, working diligently to maintain operations and adapting in real time as events unfolded. To see our team members demonstrate such resilience and strength in a challenging environment has been inspiring to witness.
我們員工的安全是一個關鍵問題,我們可以放心地說每個人都安全。正如您可能想像的那樣,當許多航空公司暫停以色列的航班服務時,將細胞運送到以色列並將 Omisirge 運回美國移植中心的過程可能會受到影響。當患者的生活受到影響時,我們的敬業員工團隊會毫不猶豫地將患者放在第一位,勤奮工作以維持運營,並隨著事件的發展實時適應。看到我們的團隊成員在充滿挑戰的環境中表現出如此的韌性和力量,真是令人鼓舞。
Shifting gears and moving on to our corporate update. Our lean launch has continued to exceed our expectations across the two key metrics we defined for launch, transplant center onboarding and market access for patients. As of this morning, we have onboarded 17 transplant centers, exceeding the top end of our projected goal of 10 to 15 transplant centers for the year. Omisirge has confirmed coverage with US payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes confirmed coverage with all of the top 20 US commercial payers. Omisirge has also confirmed coverage and reimbursement with Medicare for the Centers for Medicare and Medicaid Services. This means the vast majority of patients now have coverage in place for Omisirge.
換檔並繼續我們的公司更新。我們的精實推出在我們為推出定義的兩個關鍵指標、移植中心入職和病患市場准入方面繼續超出了我們的預期。截至今天上午,我們已經啟用了 17 個移植中心,超出了我們今年 10 至 15 個移植中心的預期目標的上限。 Omisirge 已確認美國付款人的覆蓋率涵蓋了 90% 以上的商業生活,超過了我們 70% 的全年目標。這包括美國所有前 20 名商業付款人的確認承保範圍。 Omisirge 也確認了醫療保險和醫療補助服務中心的醫療保險承保和報銷。這意味著絕大多數患者現在都有 Omisirge 承保。
The third quarter marks the moment Gamida Cell truly transitioned to a commercial stage company with our first revenue reported. We are so proud to provide Omisirge a potentially life-saving cell therapy for those in need of a transplant donor source. We are reporting revenue from the delivery of two Omisirge unit in the third quarter and are estimating revenue from the delivery of a total of four to six units of Omisirge for the full-year 2023.
第三季標誌著 Gamida Cell 真正轉型為商業階段公司的時刻,並公佈了我們的第一份收入。我們非常自豪能為那些需要移植捐贈者來源的人提供 Omisirge 一種可能挽救生命的細胞療法。我們報告第三季交付兩台 Omisirge 裝置的收入,並估計 2023 年全年交付四到六台 Omisirge 裝置的收入。
The patient volume and Omisirge net ramp are aligned with all our expectations based on a lean launch model, a number of transplant centers onboarded, and consistent with other launches in the cell and gene space. We've received very strong feedback from transplant centers on the onboarding process on Gamida Cell Assist as a tool and resource. And most importantly, on Omisirge ability to fulfill an unmet need. Omisirge is the first and only true pharmaceutical transplant option approved on the basis of a global, randomized Phase 3 trial and transplanters see its value and potential.
患者數量和 Omisirge 淨增長符合我們基於精益啟動模型、多個移植中心的預期,並且與細胞和基因領域的其他啟動一致。我們從移植中心收到了關於 Gamida Cell Assist 作為工具和資源的入職流程的強烈回饋。最重要的是,Omisirge 有能力滿足未滿足的需求。 Omisirge 是第一個也是唯一一個基於全球隨機 3 期試驗批准的真正的藥物移植選擇,移植者看到了它的價值和潛力。
As we end 2023 and prepare to enter 2024, we will continue to maintain our lean launch efforts due to resource constraints as we pursue additional funding. The early launch phase of Omisirge has confirmed our market research insights, there is an unmet need in the market that Omisirge can fulfill. Rapid transplant center onboarding has proven that transplant centers are interested in making Omisirge an option for patients with hematologic malignancies. Considering the need to thoughtfully invest based on our cash position, we will be prioritizing virtually all of our resources moving forward to expand patient access to Omisirge. Assuming our ability to extend our cash runway, we expect to have more than 40 transplant centers onboarded by the end of 2024, including at least half of the top 70 transplant centers in the US.
在 2023 年結束並準備進入 2024 年之際,由於資源限制,我們將在尋求額外資金的同時繼續維持精益推出工作。 Omisirge 的早期推出階段已經證實了我們的市場研究見解,Omisirge 可以滿足市場上未滿足的需求。移植中心的快速入職證明,移植中心有興趣使 Omisirge 成為血液惡性腫瘤患者的選擇。考慮到需要根據我們的現金狀況進行深思熟慮的投資,我們將優先考慮幾乎所有資源,以擴大患者獲得 Omisirge 的機會。假設我們有能力擴展我們的現金跑道,我們預計到 2024 年底將有超過 40 個移植中心加入,其中至少包括美國排名前 70 的移植中心的一半。
To reiterate, we remain committed to our two-pronged corporate strategy announced earlier this year, which involves, first, launching Omisirge in the US with a focus on expanding patient access by onboarding transplant centers and ensuring market access coverage and reimbursement; and second, pursuing a strategic partnership or transaction to fully -- to support fully resourced commercialization of Omisirge.
重申一下,我們仍然致力於今年稍早宣布的雙管齊下的企業策略,其中包括:首先,在美國推出Omisirge,重點是透過引入移植中心來擴大患者的可及性,並確保市場准入覆蓋範圍和報銷;其次,尋求策略夥伴關係或交易,以充分支持 Omisirge 的充分資源商業化。
In terms of our business development activities, our efforts to identify a strategic partner are ongoing. We have received considerable interest from multiple potential partners during the process, which has been supported by the leading global independent investment bank, Moelis & Company, and has resulted in oral and written proposals. However at present, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. It will be critical for us to ensure we have sufficient capital to execute this two-pronged strategy.
在我們的業務發展活動方面,我們正在努力尋找策略夥伴。在此過程中,我們收到了多個潛在合作夥伴的極大興趣,並得到了全球領先的獨立投資銀行 Moelis & Company 的支持,並形成了口頭和書面提案。然而,目前我們尚未確定能夠充分滿足我們戰略需求的合作夥伴關係,併計劃在 2024 年繼續業務發展進程。確保我們有足夠的資本來執行這一雙管齊下的戰略對我們至關重要。
A key step in the process was achieved at our recent annual general meeting of shareholders held in October. At this meeting, a majority of shareholders voted to approve six proposals relating to the company's business, including an increase in Gamida Cell's authorized share capital. This will provide us with the flexibility to continue to finance our operations and enable a potential transaction should one be available to us.
我們最近在 10 月舉行的年度股東大會上實現了這一過程的關鍵一步。在本次會議上,大多數股東投票批准了與公司業務相關的六項提案,包括增加 Gamida Cell 的法定股本。這將為我們提供繼續為我們的營運提供資金的靈活性,並在我們可以進行潛在交易時實現這項交易。
In summary, our lean launch is proceeding ahead of our expectations, and we expect to maintain our lean launch approach to expand the number of onboarded transplant centers and patients receiving Omisirge into 2024. We are proud to report our first Omisirge deliveries and official transition into being a commercial stage revenue reporting company expecting to deliver a total of four to six units for the full-year 2023. We are seeking the necessary funding to support expanded patient access to Omisirge and enable a strategic partnership to fully resource commercialization of Omisirge.
總而言之,我們的精益推出進度超出了我們的預期,我們預計將維持我們的精益推出方法,以在2024 年擴大入職移植中心和接受Omisirge 的患者數量。我們很自豪地報告我們的首次Omisirge 交付和正式過渡到作為一家商業階段收入報告公司,預計在2023 年全年交付總共四到六個單位。我們正在尋求必要的資金來支持擴大患者對Omisirge 的使用,並建立戰略合作夥伴關係,以充分資源將Omisirge 商業化。
I will now turn the call over to Michele for a more in-depth update on the Omisirge launch. Michelle, over to you.
我現在將把電話轉給 Michele,以了解有關 Omisirge 發布的更深入的更新資訊。米歇爾,交給你了。
Michele Korfin - COO and Chief Commercial Officer
Michele Korfin - COO and Chief Commercial Officer
Thank you, Abbey, and good morning, everyone. As Abbey mentioned, Gamida Cell continues to advance efforts and prioritize resources across the organization to execute Omisirge's lean launch and ensure patients in need have access to the therapy. I will be sharing a few updates on how the launch is progressing, as well as a bit of context regarding the process of delivering Omisirge to a transplant center for use of a donor source for a patient in need of an allogeneic stem cell transplant.
謝謝艾比,大家早安。正如 Abbey 所提到的,Gamida Cell 繼續推進工作,並優先考慮整個組織的資源,以執行 Omisirge 的精益啟動,並確保有需要的患者能夠獲得治療。我將分享有關啟動進展的一些最新信息,以及有關將 Omisirge 運送到移植中心以供需要同種異體幹細胞移植的患者使用供體來源的過程的一些背景信息。
The strong interest in Omisirge from transplant centers, including centers that were not part of the Phase 3 trial, has continued to grow since our last update. As of this morning, we have onboarded 17 transplant centers, exceeding our full-year target range of 10 to 15 centers. Overall, we're pleased with how onboarding is proceeding, having already exceeded our expectations for 2023, and considering the limited resources with which we launched.
自我們上次更新以來,移植中心(包括不屬於第三階段試驗的中心)對 Omisirge 的濃厚興趣持續增長。截至今天上午,我們已經設立了 17 個移植中心,超出了我們 10 到 15 個中心的全年目標範圍。總體而言,我們對入職進展感到滿意,已經超出了我們對 2023 年的預期,並且考慮到我們啟動時的資源有限。
In 2024, provided we obtain the necessary resources to support the ongoing commercialization of Omisirge, we anticipate continuing to onboard transplant centers at a robust pace. To support this onboarding, we have expanded our team of account managers since our last call. With our expanded team in place and subject to securing additional financial capital, we anticipate we could onboard more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the US. As a reminder, this is a targeted market, with about 70 of the top transplant centers performing 80% of the allogeneic stem cell transplants on an annual basis.
到 2024 年,如果我們獲得必要的資源來支持 Omisirge 的持續商業化,我們預計將繼續以強勁的速度建立移植中心。為了支援此次入職,自上次通話以來我們擴大了客戶經理團隊。隨著我們擴大的團隊到位並獲得額外的財務資本,我們預計到 2024 年底我們可以建立 40 多個移植中心,其中至少包括美國排名前 70 的移植中心的一半。需要提醒的是,這是一個目標市場,每年約有 70 個頂級移植中心進行 80% 的同種異體幹細胞移植。
Transplant center onboarding is a key step to enable patients to access Omisirge. Our 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. The Gamida team have the ability to be flexible with the timing of our onboarding approach. How quickly a transplant center is onboarded is determined by the needs of each individual transplant center and can include factors like staff availability to participate in the onboarding and the status of patients currently under evaluation who may be good candidates for Omisirge.
移植中心的入職是讓病患能夠存取 Omisirge 的關鍵一步。我們的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訓練、行政政策和程序。 Gamida 團隊能夠靈活調整我們的入職方法的時間表。移植中心的入職速度取決於每個移植中心的需求,並且可能包括參與入職的人員可用性以及目前正在評估的可能是 Omisirge 良好候選人的患者的狀況等因素。
We have been able to onboard centers very quickly who have a patient already identified for Omisirge. Once Omisirge is selected as a donor source by the patient's transplanter and the allogeneic cells are received by Gamida Cell, we are ready to begin manufacturing. We have an experienced team in place and we are ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
我們能夠很快地將已經確定患有 Omisirge 患者的中心納入其中。一旦 Omisirge 被患者的移植者選擇為捐贈者來源並且 Gamida Cell 收到同種異體細胞,我們就準備開始製造。我們擁有一支經驗豐富的團隊,我們準備在製造開始後 30 天內可靠地交付 Omisirge。
In terms of the number of Omisirge deliveries to date, we are tracking as we expected based on the number of transplant centers we anticipated having onboarded at this time and the time it typically takes for a patient to go from being identified as a candidate for transplant to the transplant taking place. Published data have shown that getting to transplant may take four to six months depending on the transplant center's preferred approach and the patient's diagnosis and clinical profile.
就迄今為止 Omisirge 的交付數量而言,我們正在根據我們預計此時已加入的移植中心數量以及患者從被確定為移植候選者通常需要的時間來追蹤我們的預期到移植發生。已發表的數據顯示,進行移植可能需要四到六個月的時間,具體取決於移植中心的首選方法以及患者的診斷和臨床概況。
The evaluation process for a patient considered for Omisirge is consistent with other donor sources and is therefore very familiar to transplant center personnel. This is why it is so critical for us to focus our resources in the first month of launch on accelerating transplant center onboarding. By exceeding our initial target range of 10 to 15 centers, we are in a position to increase the number of patients receiving Omisirge. As more transplant centers are now onboarded, we are seeing an increasing number of patients enrolled in Gamida Cell Assist. Enrolling a patient in Gamida Cell Assist indicates a transplanter intends to use Omisirge as the patient's donor source.
考慮接受 Omisirge 的患者的評估過程與其他捐贈來源一致,因此移植中心人員非常熟悉。這就是為什麼我們在啟動的第一個月將資源集中在加速移植中心的入學上如此重要。透過超出 10 至 15 個中心的初始目標範圍,我們能夠增加接受 Omisirge 治療的患者數量。隨著越來越多的移植中心加入,我們看到越來越多的患者加入 Gamida Cell Assist。將患者納入 Gamida Cell Assist 表明移植者打算使用 Omisirge 作為患者的捐贈來源。
As a result of our progress, in the third quarter, we reached a milestone of delivering Omisirge as a donor source for two patients. I could share that manufacturing is underway for additional units of Omisirge and we project delivering a total of four to six units of Omisirge for the full-year 2023. Given the pace of transplant center onboarding and the variability and time lines for preparing a patient for transplant, these numbers are in line with our expectations, and we are excited about the possibility that Omisirge will capture up to 20% market share peak, provided we are able to secure the necessary funding to support its fully resourced commercialization.
由於我們的進展,在第三季度,我們達到了一個里程碑,為兩名患者提供了 Omisirge 作為捐贈者來源。我可以分享的是,更多Omisirge 裝置的製造正在進行中,我們計劃在2023 年全年交付總共4 到6 個Omisirge 裝置。考慮到移植中心入職的速度以及為患者做好準備的可變性和時間線。移植後,這些數字符合我們的預期,如果我們能夠獲得必要的資金來支持其資源充足的商業化,我們對 Omisirge 可能獲得高達 20% 的市場份額峰值感到興奮。
I also have to note that our Gamida Cell team has gone above and beyond to ensure manufacturing of Omisirge continues at our facility in Kiryat Gat, Israel, making truly heroic efforts to continue operations during the Israel-Hamas war. With the Omisirge launch ongoing and additional patients enrolled in Gamida Cell Assist, one of the foremost concerns for business continuity was ensuring that we could transport Omisirge out of our manufacturing facility and to patients. We were able to adapt and quickly overcome logistical challenges and our facilities remain operational, thanks to the dedication and resilience of our employees.
我還必須指出,我們的 Gamida Cell 團隊竭盡全力確保 Omisirge 在我們位於以色列加特鎮的工廠繼續生產,為在以色列-哈馬斯戰爭期間繼續運作做出了真正英勇的努力。隨著 Omisirge 的持續推出以及更多患者加入 Gamida Cell Assist,業務連續性最重要的問題之一是確保我們能夠將 Omisirge 從我們的製造工廠運送到患者手中。由於我們員工的奉獻精神和適應能力,我們能夠適應並迅速克服後勤挑戰,並且我們的設施保持運作。
With that said, we continue to monitor the situation as it evolves, and we'll adjust our plans as needed. We are incredibly proud of the effort of all of our global employees as they have passionately worked with a lean launch team to ensure patients in need have access to Omisirge. Every team member is honored to play a role and bringing Omisirge to patients in need.
話雖如此,我們將繼續關注事態的發展,並根據需要調整我們的計劃。我們為所有全球員工的努力感到無比自豪,他們與精幹的啟動團隊熱情合作,確保有需要的患者能夠獲得 Omisirge。每個團隊成員都很榮幸能夠發揮作用,將 Omisirge 帶給有需要的患者。
Now I'd like to turn the call over to Ronit Simantov, our Chief Medical and Chief Scientific Officer. Ronit?
現在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?
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Thank you, Michele, and good morning, everyone. Today, I'll be sharing early feedback from transplant centers on Omisirge and some recent data on Omisirge and our NK cell therapy candidate, GDA-201.
謝謝米歇爾,大家早安。今天,我將分享移植中心對 Omisirge 的早期回饋以及 Omisirge 和我們的 NK 細胞候選療法 GDA-201 的一些最新數據。
As Michele stated earlier, we continue to see growing interest in Omisirge from transplant centers. My team and I are engaged in conversations with physicians and staff at transplant centers across the country and the feedback we hear reinforces our confidence in the value of Omisirge. Of note, we know from these discussions that a number of our onboard of transplant centers have identified multiple patients as candidates for Omisirge. The transplant teams we are engaged with be a clear need for an additional donor source option for their patients and are eager to make Omisirge available at their institution.
正如 Michele 之前所說,我們繼續看到移植中心對 Omisirge 越來越感興趣。我和我的團隊正在與全國各地移植中心的醫生和工作人員進行對話,我們聽到的回饋增強了我們對 Omisirge 價值的信心。值得注意的是,我們從這些討論中得知,我們的一些移植中心已確定多位患者為 Omisirge 的候選人。與我們合作的移植團隊明確表示需要為其患者提供額外的捐贈者來源選擇,並渴望在他們的機構中提供 Omisirge。
So far, the patients that have enrolled in Gamida Cell Assist we're seeing some progress Omisirge is the only option and who would otherwise go on transplanted. And some patients where transplanters are considering Omisirge over other options, including haplo.
到目前為止,我們在加入 Gamida Cell Assist 的患者中看到了一些進展,Omisirge 是唯一的選擇,否則他們將繼續進行移植。一些患者的移植者正在考慮使用 Omisirge,而不是其他選擇,包括單倍體。
We recently presented new data at the Society for Immunotherapy of Cancer or SITC Annual Meeting that further advanced our understanding on Omisirge's cellular makeup and potential mechanism of action. The data showed that the application of our NAM technology leads to a unique cellular composition enriched in myeloid populations and dendritic cells, providing a potential mechanism for the rapid engraftment and immune reconstitution observed in patients who were transplanted with Omisirge. This emphasizes how Omisirge is differentiated from other donor source options.
我們最近在癌症免疫治療協會或 SITC 年會上公佈了新數據,進一步加深了我們對 Omisirge 細胞組成和潛在作用機制的理解。數據顯示,我們的 NAM 技術的應用導致了富含骨髓細胞和樹突狀細胞的獨特細胞組成,為在接受 Omisirge 移植的患者中觀察到的快速植入和免疫重建提供了潛在機制。這強調了 Omisirge 與其他捐款來源選擇的差異。
So that you can have the opportunity to hear from a transplant physician directly about his experiences on Omisirge, I'm pleased to share that we'll be holding a virtual fireside chat with Dr. Gary Schiller, professor of hematology/oncology and Director of hematological malignancies and stem cell transplantation at Ronald Reagan UCLA Medical Center. This event will take place on Monday, December 4 at 4:30 PM Eastern Time via webcast and will also be recorded. Dr. Schiller was an investigator in the Phase 3 study of omidubicel and UCLA Health is one of the 17 onboarded transplant centers where patients can access Omisirge. In addition to sharing his experience with Omisirge, Dr. Schiller will talk about the patient journey from diagnosis to transplant and the decision making around donor source selection.
為了讓您有機會直接從移植醫生那裡聽到他在Omisirge 上的經歷,我很高興地告訴大家,我們將與血液學/腫瘤學教授兼移植中心主任加里·席勒(Gary Schiller) 博士進行虛擬爐邊聊天。加州大學洛杉磯分校羅納德·裡根醫學中心的血液惡性腫瘤和幹細胞移植。該活動將於東部時間 12 月 4 日星期一下午 4:30 透過網路直播舉行,並將進行錄製。 Schiller 博士是 omidubicel 3 期研究的研究員,加州大學洛杉磯分校健康中心 (UCLA Health) 是患者可以使用 Omisirge 的 17 個移植中心之一。除了與 Omisirge 分享他的經驗外,席勒博士還將談論患者從診斷到移植的過程以及圍繞捐贈者來源選擇的決策。
I'd now like to take some time to share the recent news about our natural killer cell therapy candidate, GDA-201. We recently reported preliminary data from the ongoing multi-center Phase 1 study of cryopreserved GDA-201, designed to evaluate safety and determine maximum tolerated dose. The preliminary data from 10 patients with CD20 positive non-Hodgkin lymphoma in a Phase 1 study showed no dose-limiting toxicities in patients enrolled in the first three cohorts, treated with doses of up to 100 million cells per kilogram of GDA-201. Enrolled patients had relapsed or refractory lymphoma and were heavily pretreated with a median of six prior lines of therapy, including CAR T cell therapy in six patients and prior hematopoietic stem cell transplant in four patients.
現在我想花一些時間分享有關我們的自然殺手細胞療法候選藥物 GDA-201 的最新消息。我們最近報告了正在進行的冷凍 GDA-201 多中心 1 期研究的初步數據,該研究旨在評估安全性並確定最大耐受劑量。 1 期研究中 10 名 CD20 陽性非何杰金氏淋巴瘤患者的初步數據顯示,前三組患者接受每公斤 1 億個細胞的 GDA-201 治療,沒有出現劑量限制性毒性。入組的患者患有復發性或難治性淋巴瘤,並且接受了平均六種既往治療的嚴格預處理,其中六名患者接受過 CAR T 細胞治療,四名患者接受過造血幹細胞移植。
We saw marked shrinkage of target lesions in 5 of the 10 patients and efficacy evaluation using Lugano criteria demonstrated two patients with complete response, two with partial response, and one with stable disease. Activity appeared to be dose-dependent with two of the three patients in cohort three responding. These results are consistent with previously reported data from the investigator-initiated study on the fresh formulation of GDA-201, which showed complete responses in patients with non-Hodgkin lymphoma. The fourth and final cohort of the current Phase 1 study is enrolling, and we are on track to report full data in the first quarter of 2024.
我們看到 10 名患者中有 5 名的目標病灶明顯縮小,並且使用盧加諾標準進行的療效評估表明,兩名患者完全緩解,兩名患者部分緩解,一名患者疾病穩定。活性似乎與劑量相關,第三組中三名患者中的兩名有反應。這些結果與先前報告的研究者發起的 GDA-201 新鮮製劑研究的數據一致,該研究顯示非何杰金氏淋巴瘤患者完全緩解。目前第一階段研究的第四個也是最後一個隊列正在招募,我們預計在 2024 年第一季報告完整數據。
We're pleased to continue to work with transplant centers and academic institutions to further the availability of Omisirge and to add to the body of scientific evidence about the mechanism and potential of our innovative NAM technology.
我們很高興繼續與移植中心和學術機構合作,進一步提高 Omisirge 的可用性,並增加有關我們創新 NAM 技術的機制和潛力的科學證據。
I will now turn the call over to Terry Coelho, our Chief Financial Officer. Terry?
我現在將電話轉給我們的財務長 Terry Coelho。特里?
Terry Coelho - CFO
Terry Coelho - CFO
Thank you, Ronit, and good morning, everyone. I'm pleased to share that Gamida Cell is reporting revenue for the first time in its history. With the transition to a product revenue generating company, a number of changes have been incorporated into our financial reporting beginning with the third quarter of 2023 and I will point out some of those key changes as we walk through the financial results.
謝謝你,羅尼特,大家早安。我很高興地告訴大家,Gamida Cell 有史以來第一次報告收入。隨著向產品創收公司的轉型,從 2023 年第三季開始,我們的財務報告中發生了一些變化,我將在我們瀏覽財務表現時指出其中一些關鍵變化。
In the third quarter ended September 30, 2023, we are reporting net revenue of $673,000, resulting from the delivery of two units of Omisirge. The gross to net allowances and deductions were particularly low in the third quarter, given the confirmed insurance coverage and transplant status for those patients. Cost of sales, including cost of direct manufacturing and quality in addition to royalty expenses, was $626,000 in the quarter. Over time, we expect the cost of sales and therefore the gross margins to improve measurably as production volumes scale to capacity.
截至 2023 年 9 月 30 日的第三季度,我們報告的淨收入為 673,000 美元,來自交付兩台 Omisirge。考慮到這些患者的已確認的保險範圍和移植狀況,第三季的總淨津貼和扣除額特別低。本季的銷售成本(包括特許權使用費之外的直接製造和品質成本)為 626,000 美元。隨著時間的推移,我們預計隨著產量擴大到產能,銷售成本和毛利率將顯著提高。
Beginning July 1, 2023, reporting of operating expenses has been modified to reflect the company's transition to commercial stage, with all operating expenses being reported as either research and development expenses or selling, general, and administrative or SG&A expenses. For 2022, and the first two quarters of 2023, previously reported commercial and general and administrative costs were combined into SG&A expenses. Additionally, certain expenses previously reported in research and development are now being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
自 2023 年 7 月 1 日起,營運費用的報告已進行修改,以反映公司向商業階段的過渡,所有營運費用均報告為研發費用或銷售、一般和管理或 SG&A 費用。對於 2022 年和 2023 年前兩個季度,先前報告的商業、一般和行政成本已合併到 SG&A 費用中。此外,從 2023 年第三季開始,先前在研發中報告的某些費用現在將在 SG&A 中報告,且不會對前期進行重新分類。
Research and development expenses were $4.2 million in the third quarter of 2023 compared to $9.9 million in the same quarter of 2022. The $5.7 million decrease was primarily due to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the Phase 3 clinical trial. Selling, general, and administrative expenses were $13.8 million in the third quarter of 2023, an increase of $6.6 million compared to $7.2 million in the third quarter of 2022.
2023 年第三季的研發費用為 420 萬美元,而 2022 年第三季為 990 萬美元。減少 570 萬美元主要是由於上述報告過渡,以及與 3 期臨床試驗相關的 omidubicel 臨床支出減少。 2023 年第三季的銷售、一般和管理費用為 1,380 萬美元,比 2022 年第三季的 720 萬美元增加了 660 萬美元。
The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed $4.4 million to the increase in the quarter. Additionally, excess capacity costs of $2.2 million associated with our manufacturing facility were recorded in SG&A in the third quarter.
上述財務報告轉型導致將醫療事務以及某些間接供應鏈和品質保證費用納入 SG&A 報告,為本季的成長貢獻了 440 萬美元。此外,第三季的 SG&A 記錄了與我們的製造工廠相關的 220 萬美元的過剩產能成本。
Selling and marketing expenses increased by $1.3 million compared to the prior year quarter due to commercial launch activities. To further expand upon the excess capacity costs, these costs reflects the labor and manufacturing overhead costs incurred, but not absorbing cost of goods sold in the period, given that our facility is tasked to produce the anticipated demand over the course of the coming year.
由於商業發布活動,銷售和行銷費用與去年同期相比增加了 130 萬美元。為了進一步擴大過剩產能成本,這些成本反映了所產生的勞動力和製造間接成本,但不吸收該期間銷售商品的成本,因為我們的工廠的任務是在來年生產預期的需求。
Financial income and expenses net were $16.5 million of income in the third quarter of 2023 compared to $741,000 in expenses in the same period of 2022. The $17.2 million change in financial income was primarily due to $14 million of income related to the valuation of warrants liability and $3.2 million of income related to the valuation of the company's secured convertible senior notes issued in December 2022.
2023 年第三季的財務收入和支出淨額為1,650 萬美元,而2022 年同期的支出為741,000 美元。財務收入的1,720 萬美元變化主要是由於與認股權證負債估值相關的收入為1,400 萬美元320 萬美元的收入與該公司 2022 年 12 月發行的有擔保可轉換優先票據的估值相關。
Our net loss in the third quarter was $1.5 million compared to a net loss of $17.8 million in the third quarter of 2022, driven primarily by the $17.2 million change in financial income as just discussed. As of September 30, 2023, Gamida Cell has total cash and cash equivalents of $60.4 million compared to $64.7 million as of December 31, 2022. The decrease of $4.3 million is due primarily to $59.2 million in net cash proceeds from financing activities, comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company's underwritten public offering in April 2023 and $39.4 million in net proceeds from the issuance of ordinary shares via the eight PM or at-the-market facility, offset by $1.1 million in principal payments of the company's 2022 convertible senior notes and $62.9 million of net cash used in operating activities.
我們第三季的淨虧損為 150 萬美元,而 2022 年第三季的淨虧損為 1,780 萬美元,這主要是由於剛才討論的財務收入變化 1,720 萬美元造成的。截至2023 年9 月30 日,Gamida Cell 的現金及現金等價物總額為6,040 萬美元,而截至2022 年12 月31 日為6,470 萬美元。減少430 萬美元主要是由於融資活動產生的淨現金收益為5,920萬美元,包括公司於2023 年4 月承銷的公開發行中發行普通股和認股權證的淨收益為2,110 萬美元,透過八點PM 或市場融資發行普通股的淨收益為3,940 萬美元,抵銷了110 萬美元公司 2022 年可轉換優先票據的本金支付和經營活動使用的 6,290 萬美元淨現金。
The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the third 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. The company raised $25.6 million in net proceeds from its ATM facility in the third quarter at an average price of $1.40 per share.
根據Gamida Cell 目前的營運計劃,該公司預計其當前的現金和現金等價物(包括第三季末後籌集的資金)將支持其持續到2024 年第二季的營運活動,並且不包括初始推出之外的商業化活動Omisirge,以及可能進行的任何其他融資活動。該公司第三季從其 ATM 設施籌集了 2,560 萬美元的淨收益,平均價格為每股 1.40 美元。
As of September 30, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $16.7 million, from $25 million as of December 31, 2022, to $8.3 million at the end of the third quarter of 2023. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75 million.
截至2023年9月30日,該公司已將2022年有擔保可轉換票據的本金餘額減少1,670萬美元,從截至2022年12月31日的2,500萬美元減少至2023年第三季末的830萬美元。該公司還持有本金總額為 7,500 萬美元的 2021 年可轉換優先票據。
Earlier in the year, we embarked on a strategic restructuring process to prioritize the vast majority of our resources for the launch of Omisirge. And we have now mostly completed that process, including consolidating operations in Israel to a single location. As Abbey mentioned earlier, shareholders at our recent annual general meeting of shareholders voted to approve an increase in Gamida Cell's authorized share capital to 325 million ordinary shares. We believe this increase in authorized shares will provide us with the increased flexibility necessary to finance our operations.
今年早些時候,我們啟動了策略重組流程,優先將絕大多數資源用於推出 Omisirge。我們現在已經基本完成了這個過程,包括將以色列的業務整合到一個地點。正如 Abbey 之前提到的,在我們最近的年度股東大會上,股東投票批准將 Gamida Cell 的法定股本增加至 3.25 億股普通股。我們相信,授權股份的增加將為我們的營運融資提供更大的靈活性。
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?
Abbey Jenkins - President and CEO
Abbey Jenkins - President and CEO
Thank you, Terry. Before I turn the call over to the operator for questions, I want to bring us back around the beginning of the call and summarize the key points from our discussion today. We continue to make strong progress on the commercial launch of Omisirge, having exceeded our goals across both of the key metrics for launch of transplant center onboarding and market access. Additionally, we have reported revenue for two deliveries of Omisirge in the third quarter and project four to six deliveries of Omisirge units for the full-year 2023, which is in line with our initial launch assumptions based on our lean launch model and the transplant process for patients.
謝謝你,特里。在將電話轉交給接線員詢問問題之前,我想先回顧一下電話的開頭,並總結一下我們今天討論的要點。我們在 Omisirge 的商業推出方面繼續取得強勁進展,在移植中心啟動和市場准入的關鍵指標上都超出了我們的目標。此外,我們還報告了第三季度交付兩架 Omisirge 的收入,並預計 2023 年全年交付四到六架 Omisirge 裝置,這符合我們基於精益發射模型和移植流程的最初發射假設對於患者。
With our expanded launch team in place and the securing of additional capital, we anticipate we could onboard a total of more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the Us. Operations in Israel continue and our team is adapting processes as necessary to ensure patient access to Omisirge continues during the ongoing Israel-Hamas war.
隨著我們擴大的啟動團隊到位並獲得額外資金,我們預計到 2024 年底我們可以總共建立 40 多個移植中心,其中至少包括美國排名前 70 的移植中心的一半。在以色列的業務仍在繼續,我們的團隊正在根據需要調整流程,以確保患者在以色列-哈馬斯戰爭期間繼續獲得 Omisirge 服務。
In terms of business development, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. We share promising preliminary data from the Phase 1 clinical trial for GDA-201 and are on track to share the full data readout in early 2024.
在業務發展方面,我們尚未確定能夠充分滿足我們策略需求的合作夥伴關係,並計劃在 2024 年繼續業務發展流程。我們分享 GDA-201 一期臨床試驗的有希望的初步數據,並有望於2024 年初分享完整的數據讀數。
We are continuing to carefully manage our expenses and prioritizing virtually all of our resources towards the launch of Omisirge. We are thrilled to see increasing demand for Omisirge and are working to ensure that all patients in need have access to our NAM modified cell therapy. We believe our early launch success is a promising sign of Omisirge's long-term potential to increase access and address critical unmet needs in stem cell transplantation.
我們將繼續謹慎管理我們的開支,並將幾乎所有資源優先用於 Omisirge 的推出。我們很高興看到對 Omisirge 的需求不斷增加,並正在努力確保所有有需要的患者都能獲得我們的 NAM 改良細胞療法。我們相信,我們的早期上市成功是一個有希望的跡象,表明 Omisirge 具有增加幹細胞移植的機會並解決未滿足的關鍵需求的長期潛力。
Now let's open the call for questions. Chris?
現在讓我們開始提問。克里斯?
Operator
Operator
(Operator Instructions) Gil Blum, Needham & Co.
(操作員說明)Gil Blum, Needham & Co.
Gil Blum - Analyst
Gil Blum - Analyst
Hi. Good morning. Thank you for taking our questions. Just given the relatively small number of patients in the queue right now, could you give us some color on the individual patient types or anything that you know at this point?
你好。早安.感謝您接受我們的提問。鑑於目前排隊的患者數量相對較少,您能給我們一些關於個別患者類型的信息或您目前所知道的任何信息嗎?
Abbey Jenkins - President and CEO
Abbey Jenkins - President and CEO
Ronit and Michele, do you want to weigh in on this?
Ronit 和 Michele,你們想對此發表意見嗎?
Michele Korfin - COO and Chief Commercial Officer
Michele Korfin - COO and Chief Commercial Officer
Sure, thank you.
當然可以,謝謝。
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
This is Ronit. I'm happy to weigh in and thanks, Gil, for the question. So yeah, there are patients who are enrolled in Gamida Cell Assist and we know some facts about these patients and what we also know is information that we're hearing directly from transplant physicians when we have conversations with them about potential patients. And the kinds of patients are different, depending on what the transplant center is like. Some are patients who really don't have any other transplant options, there are no other graft sources for them, no unrelated donor registry, no other related donor options and Omisirge is really seen as their only choice. And they would otherwise not receive a transplant, which is quite difficult for them.
這是羅尼特。我很高興能參與其中並感謝吉爾提出的問題。所以,是的,有些患者參加了 Gamida Cell Assist,我們知道有關這些患者的一些事實,而且我們也知道,當我們與移植醫生談論潛在患者時,我們直接從他們那裡聽到的信息。而且病人的種類也不同,取決於移植中心的情況。有些患者確實沒有任何其他移植選擇,沒有其他移植來源,沒有不相關的捐贈者登記,沒有其他相關的捐贈者選擇,Omisirge 確實被視為他們唯一的選擇。否則他們就不會接受移植,這對他們來說相當困難。
There are other patients actually, who we've heard from physicians, who have more than one choice. And what physicians do is they really choose the best potential graft source for their patient of the available choices. And so there are some patients who have other choices, either mismatched or haplo or other potential donor sources for whom Omisirge is actually seen as the best choice. And so that's kind of how things are divided up. These are patients who need allogeneic stem cell transplants and may or may not have any other available donor sources.
實際上,我們從醫生那裡聽說,還有其他患者有不只一種選擇。醫生所做的就是從可用的選擇中為患者真正選擇最佳的潛在移植來源。因此,有些患者有其他選擇,要么是不匹配的,要么是單倍體,要么是其他潛在的捐贈者來源,對他們來說,Omisirge 實際上被視為最佳選擇。這就是事情的劃分方式。這些患者需要同種異體幹細胞移植,並且可能有或沒有其他可用的捐贈者來源。
Gil Blum - Analyst
Gil Blum - Analyst
Thank you.
謝謝。
Michele Korfin - COO and Chief Commercial Officer
Michele Korfin - COO and Chief Commercial Officer
Thank you, Roni, and Gil, thank you. I'll just add on just going back to what we spoke about even before launch, we are generally seeing patients that are consistent with what we believe would meet the promise of Omisirge to both increase access and improve outcomes. So on the increasing side, we're seeing patients, as Ronit indicated, where Omisirge is their only donor source option. And that's consistent with the data that we had identified through our market insights that at least 1,700 patients are eligible each year for transplant but unfortunately, were not able to find a donor source before Omisirge approval.
謝謝羅尼和吉爾,謝謝你們。我只想補充一點,回到我們在推出之前所討論的內容,我們通常看到的患者與我們認為符合 Omisirge 增加訪問和改善結果的承諾的患者一致。因此,正如 Ronit 所指出的那樣,我們看到越來越多的患者,其中 Omisirge 是他們唯一的捐贈者來源選擇。這與我們透過市場洞察確定的數據一致,即每年至少有 1,700 名患者有資格接受移植,但不幸的是,在 Omisirge 獲得批准之前無法找到捐贈者來源。
And then on the improving outcome side, as Ronit indicated, we've heard examples where the transplant or has another option, and in one case, the other option was a haploidentical match, but the transplanter is choosing Omisirge for the patient. Although still in an early stage of the launch, we're very encouraged by what we are hearing.
然後,在改善結果方面,正如Ronit 指出的那樣,我們聽說過移植或有另一種選擇的例子,在一種情況下,另一種選擇是單倍體匹配,但移植者為患者選擇了Omisirge。儘管仍處於發布的早期階段,但我們所聽到的消息讓我們深受鼓舞。
Gil Blum - Analyst
Gil Blum - Analyst
All right. Thank you for the answers. Maybe a bit about the dynamic with onboarded centers. Are there examples of where it was a bit of a reverse inquiry where the center reached out to you guys?
好的。謝謝您的回答。也許有一些關於入職中心的動態。有沒有例子說明中心向你們伸出援手,有點反向詢問的狀況?
Michele Korfin - COO and Chief Commercial Officer
Michele Korfin - COO and Chief Commercial Officer
Yes. We have had multiple centers who have reached out to us and some part of the clinical studies, some that were not, that had a patient that was actively being evaluated for transplant and the transplanter felt Omisirge would be the most appropriate option. Certainly, those who were part of the clinical study, we've been in active dialogue with them. But in the case of one particular center who was in the clinical study, they asked if we could expedite the onboarding, which we were able to accommodate to address the patient need.
是的。我們有多個中心與我們聯繫,部分臨床研究(有些沒有),有一名患者正在積極接受移植評估,移植者認為 Omisirge 將是最合適的選擇。當然,對於那些參與臨床研究的人,我們一直在與他們積極對話。但對於參與臨床研究的一個特定中心,他們詢問我們是否可以加快入職速度,我們能夠滿足患者的需求。
Gil Blum - Analyst
Gil Blum - Analyst
Thank you. Very helpful. And maybe a last one. So outreach to physicians, I know you guys have a KOL event in December 4. Are you going to have presence at the upcoming ASH? I didn't see any specific presentation, but a booth for outreach to physicians. Thank you.
謝謝。很有幫助。也許是最後一個。因此,請聯絡醫生,我知道你們將於 12 月 4 日舉辦一場 KOL 活動。你們會參加即將舉行的 ASH 嗎?我沒有看到任何具體的演示,而是看到了一個與醫生聯繫的攤位。謝謝。
Michele Korfin - COO and Chief Commercial Officer
Michele Korfin - COO and Chief Commercial Officer
I'll start and then I'll turn to Ronit. So we will have a presence at ASH. I'll speak about the commercial presence, and then Ronit will talk about the medical, but we'll have our representatives from our launch team at ASH. We will have a commercial booth. So if you're there, please stop by. And we will have the opportunity to attend sessions and understand the dynamics of the scientific developments. But also, just as you alluded to, Gil, you'll have the chance to interact with individuals from the transplant centers that are either onboarded or in the queue to be onboarded. So we're looking forward to San Diego.
我先開始,然後轉向 Ronit。因此,我們將出席 ASH。我將談論商業存在,然後 Ronit 將談論醫療,但我們將有來自 ASH 發布團隊的代表。我們將有一個商業攤位。因此,如果您在那裡,請順便過來。我們將有機會參加會議並了解科學發展的動態。而且,正如您所提到的,吉爾,您將有機會與來自移植中心的已入職或正在排隊入職的人員進行互動。所以我們期待著聖地牙哥。
I'll turn to Ronit to discuss the medical side.
我將請羅尼特討論醫療方面的問題。
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Ronit Simantov - Chief Medical Officer and Chief Scientific Officer
Thanks, Michele. True, we don't have any academic presentations at ASH this year, but we do have a product theater presentation, as well as our medical folks engaging in small group and individual dialogues with physicians at ASH.
謝謝,米歇爾。誠然,我們今年在 ASH 上沒有任何學術演講,但我們確實有一個產品劇院演講,以及我們的醫務人員與 ASH 的醫生進行小組和個人對話。
Operator
Operator
Does that answer your questions, Gil?
這能回答你的問題嗎,吉爾?
Gil Blum - Analyst
Gil Blum - Analyst
Thank you. You've gotten all my questions.
謝謝。你已經回答了我所有的問題。
Operator
Operator
(Operator Instructions) Ladies and gentlemen, we have reached the end of our question-and-answer session and I would like to turn the call back to President and CEO, Abigail Jenkins, for some closing remarks.
(操作員說明)女士們、先生們,我們的問答環節已經結束,我想將電話轉回給總裁兼首席執行官阿比蓋爾·詹金斯 (Abigail Jenkins),讓其做一些結束語。
Abbey Jenkins - President and CEO
Abbey Jenkins - President and CEO
Thank you, Chris. Thank you all for joining us today. To recap, we remain confident in our team's ability to deliver Omisirge to an increasing volume of patients in need of a stem cell transplant in transplant centers across the US. We believe in Omisirge's ability to achieve its market potential and increase patient access to allogeneic stem cell transplant.
謝謝你,克里斯。感謝大家今天加入我們。總而言之,我們仍然相信我們的團隊有能力向美國各地移植中心越來越多需要幹細胞移植的患者提供 Omisirge。我們相信 Omisirge 能夠實現其市場潛力並增加患者接受同種異體幹細胞移植的機會。
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。
Operator
Operator
Thank you very much. Ladies and gentlemen, that concludes today's event and you may now disconnect your lines.
非常感謝。女士們先生們,今天的活動到此結束,現在您可以掛斷電話了。