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Operator
Operator
Greetings and welcome to the ClearPoint Neuro Inc. second-quarter 2025 financial results conference call. (Operator Instructions)
問候並歡迎參加 ClearPoint Neuro Inc. 2025 年第二季財務績效電話會議。(操作員指示)
As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include without limitation, statements related to anticipated industry trends, the company's plans, prospects, and strategies, both preliminary and projected, the size of total addressable markets, or the market opportunity for the company's products and services.
提醒一下,本次會議正在錄製中。本次電話會議的評論可能包括證券法所定義的前瞻性陳述。這些前瞻性陳述可能包括但不限於與預期的行業趨勢、公司的計劃、前景和策略(包括初步和預測)、整體可尋址市場的規模或公司產品和服務的市場機會有關的陳述。
The company's expectation for future development, regulatory approval, and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies and management's expectations, beliefs, estimates, or projections regarding future revenue, results of operations, or the adequacy of cash and cash equivalent balances to support operations and meet future obligations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for new information or future events.
公司對未來發展、監管部門批准以及細胞和基因療法市場的預期,以及公司產品和服務在基因和細胞療法中的預期應用,以及管理層對未來收入、經營業績或現金和現金等價物餘額是否足以支持經營和履行未來義務的預期、信念、估計或預測。實際結果或趨勢可能有重大差異。本公司不承擔根據新資訊或未來事件修改前瞻性陳述的義務。
For more information, please refer to the company's annual report on Form 10-K for the year ended December 31, 2024 and the company's quarterly report on Form 10-Q for the three months ended March 31, 2025, both of which have been filed with the Securities and Exchange Commission. And the company's quarterly report on Form 10-Q for the three months ended June 30, 2025, which the company intends to file with the Securities and Exchange Commission on or before August 14, 2025. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.
欲了解更多信息,請參閱該公司截至 2024 年 12 月 31 日的年度報告(表 10-K)和截至 2025 年 3 月 31 日的三個月的季度報告(表 10-Q),這兩份報告均已提交給美國證券交易委員會。以及公司截至 2025 年 6 月 30 日的三個月的 10-Q 表季度報告,公司計劃於 2025 年 8 月 14 日或之前向美國證券交易委員會提交該報告。所有公司文件均可向美國證券交易委員會 (SEC) 或公司網站 www.clearpointneuro.com 取得。
It's now my pleasure to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead.
現在我很高興將電話轉給執行長喬·伯內特 (Joe Burnett)。請繼續。
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Thank you, Kevin. And thank you to all of the investors, partners, and analysts joining us on today's call. 2025 is off to a terrific start here at ClearPoint Neuro as we have officially entered the third phase of our company history, a phase we refer to as Fast Forward.
謝謝你,凱文。感謝所有參加今天電話會議的投資者、合作夥伴和分析師。 2025 年對 ClearPoint Neuro 來說是一個好的開端,我們已正式進入公司歷史的第三階段,我們稱之為「快轉」。
As a brief reminder, this new stage at ClearPoint has three primary tenants. First, we will extend our lead in cell and gene therapy by leveraging our complete and unique drug delivery ecosystem including navigation hardware, predictive modeling and monitoring software, cannula-based routes of administration, pre-clinical and clinical drug discovery services, and best in class clinical field personnel. We will use this ecosystem to support our more than 60 active biopharma partners on their path to regulatory approval and commercialization, many of which have already been selected for some form of expedited review by the FDA. This now includes the very first US-based commercial cases for neurocell and gene therapy that have ever been performed as announced just last week.
簡單提醒一下,ClearPoint 的這個新舞台有三個主要租戶。首先,我們將利用我們完整而獨特的藥物輸送生態系統,包括導航硬體、預測模型和監測軟體、基於套管的給藥途徑、臨床前和臨床藥物發現服務以及一流的臨床現場人員,擴大我們在細胞和基因治療領域的領先地位。我們將利用這個生態系統來支持我們 60 多個活躍的生物製藥合作夥伴獲得監管部門的批准和商業化,其中許多合作夥伴已經被 FDA 選中進行某種形式的快速審查。這包括上週剛宣布的美國有史以來首批神經細胞和基因療法商業化案例。
Second, we will evolve our portfolio to focus not only on accuracy and precision, but also on fast, simple, predictable workflows. These new product introductions are designed to increase hospital efficiency and throughput and to create capacity for the significant demand that we believe is coming when patients learn that these new restorative therapies are available and have proven effective. Both our 3.0 ClearPoint ICT navigation software for the operating room and our Prism laser therapy system have been excellent new product introductions and living up to this mantra of fast, simple, and predictable.
其次,我們將改進我們的產品組合,不僅關注準確性和精確度,還專注於快速、簡單、可預測的工作流程。推出這些新產品的目的是提高醫院的效率和吞吐量,並為巨大的需求創造容量,我們相信,當患者了解到這些新的修復療法可用並且已被證明有效時,這種需求就會出現。我們的手術室 3.0 ClearPoint ICT 導航軟體和 Prism 雷射治療系統都是出色的新產品,體現了快速、簡單和可預測的理念。
And third, we will expand our global install base and generate scale to enable more patients around the world access to the ClearPoint ecosystem that will be used for these novel treatments. ClearPoint technology is now available at more than 100 centers around the world and has regulatory clearance in 36 countries and growing.
第三,我們將擴大我們的全球安裝基礎並擴大規模,以使世界各地的更多患者能夠使用這些新療法的 ClearPoint 生態系統。ClearPoint 技術目前已在全球 100 多個中心投入使用,並已在 36 個國家獲得監管部門批准,且這一數字仍在增加。
As previously announced, we have now successfully secured the foundational funding necessary to execute on the strategy for many years to come. This capital in the form of both debt and equity has been provided by our new partner Oberland Capital. Oberland has demonstrated that they very much share our vision of securing ClearPoint as the true gold standard for neuro cell and gene therapy delivery and extending that lead for years to come.
正如先前宣布的那樣,我們現在已經成功獲得了在未來幾年實施該策略所需的基礎資金。此筆債務和股權形式的資本均由我們的新合作夥伴 Oberland Capital 提供。Oberland 已表明他們非常認同我們的願景,確保 ClearPoint 成為神經細胞和基因療法的真正黃金標準,並在未來幾年內延續這一領先地位。
I will now turn the call over to Danilo D'Alessandro, our CFO, to discuss the financial details of the second quarter, after which I will provide additional commentary on our progress in these three Fast Forward initiatives here in the second half of 2025. Danilo?
現在,我將把電話轉給我們的財務長 Danilo D'Alessandro,討論第二季的財務細節,之後我將對我們在 2025 年下半年在這三個 Fast Forward 計劃中取得的進展提供進一步的評論。達尼洛?
Danilo D Alessandro - Chief Financial Officer
Danilo D Alessandro - Chief Financial Officer
Thank you, Joe, and good afternoon, everyone. Looking at the second quarter of 2025 results, total revenue was $9.2 million for the three months ended June 30, 2025, and $7.9 million for the three months ended June 30, 2024, which represents 17% growth versus the second quarter of 2024. As a reminder, our revenue is made up of three components; biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software.
謝謝你,喬,大家下午好。綜觀 2025 年第二季的業績,截至 2025 年 6 月 30 日的三個月總收入為 920 萬美元,截至 2024 年 6 月 30 日的三個月總收入為 790 萬美元,與 2024 年第二季相比增長了 17%。提醒一下,我們的收入由三個部分組成:生物製劑和藥物傳輸、神經外科導航和治療以及資本設備和軟體。
Biologics and drug delivery revenue includes sales of disposable products and services related to customer sponsored pre-clinical and clinical trials utilizing our products. Biologics and drug delivery revenue increased 10% to $4.7 million in the second quarter, up from $4.3 million in 2024. This increase was fueled by a 12% increase in biologics and drug delivery product revenue as multiple pharmaceutical customers progressed in their pre-clinical and clinical development and an 8% increase in service revenue.
生物製劑和藥物傳輸收入包括利用我們的產品進行的客戶贊助的臨床前和臨床試驗相關的一次性產品的銷售和服務。第二季生物製劑和藥物輸送收入成長 10%,達到 470 萬美元,高於 2024 年的 430 萬美元。這一增長得益於多個製藥客戶在臨床前和臨床開發方面取得進展,生物製劑和藥物輸送產品收入增長了 12%,服務收入增長了 8%。
Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the Prism laser system, or SmartFrame OR. This revenue segment increased 33% to $3.4 million for the second quarter of 2025. The revenue growth is primarily attributable to our new product offerings and our new recent additional placements.
神經外科導航收入包括與使用 ClearPoint 系統、Prism 雷射系統或 SmartFrame OR 的病例相關的一次性產品的商業銷售。2025 年第二季度,該部分營收成長 33%,達到 340 萬美元。營收成長主要歸功於我們推出的新產品和近期新增的配售業務。
Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software and of related services increased 11% to $1 million in the quarter. The increase was driven by an increase in service revenue. Gross margin for the second quarter of 2025 was 60% as compared to a gross margin of 63% for the second quarter of 2024. The decrease in gross margin is primarily due to higher excess and obsolete inventory reserves for the three months ended June 30, 2025.
本季度,包括 ClearPoint 可重複使用硬體和軟體銷售及相關服務在內的資本設備和軟體收入成長 11%,達到 100 萬美元。這一增長是由服務收入的增加所推動的。2025 年第二季的毛利率為 60%,而 2024 年第二季的毛利率為 63%。毛利率下降主要是由於截至 2025 年 6 月 30 日的三個月內過剩和過時庫存儲備增加。
In the second quarter of 2025, our operating expenses were $11.2 million compared to $9.7 million for the second quarter of 2024, an increase of 16%. Specifically, research and development costs were $3.8 million for three months ended June 30, 2025 compared to $3.1 million for the same period in 2024, an increase of $0.7 million or 23%. The increase was due primarily to higher product and software development costs as we invest in expanding and upgrading our product offering.
2025 年第二季度,我們的營運費用為 1,120 萬美元,而 2024 年第二季為 970 萬美元,成長了 16%。具體而言,截至 2025 年 6 月 30 日的三個月,研發成本為 380 萬美元,而 2024 年同期為 310 萬美元,增加 70 萬美元,增幅為 23%。成長的主要原因是,我們投資擴大和升級產品供應,導致產品和軟體開發成本增加。
Sales and marketing expenses were $4 million for the second quarter compared to $3.8 million for the same period in 2024, an increase of $0.2 million or 5%. This increase was due primarily to additional personnel costs, including share-based compensation resulting from increases in hand count of $0.4 million partially upset by lower travel costs and other marketing costs of $0.2 million. General and administrative expenses were $3.4 million for the second quarter compared to $2.8 million for the same period in 2024, an increase of $0.6 million or 23%. This increase was due primarily to a higher bad debt expense of $0.4 million and a higher personnel costs, including share-based compensation of $0.2 million.
第二季銷售和行銷費用為 400 萬美元,而 2024 年同期為 380 萬美元,增加 20 萬美元,增幅 5%。這一增長主要是由於額外的人事成本,包括因員工數量增加而產生的 40 萬美元的股權激勵,部分原因是差旅費用和其他行銷費用減少 20 萬美元。第二季的一般及行政費用為 340 萬美元,而 2024 年同期為 280 萬美元,增加 60 萬美元,增幅為 23%。這一成長主要是由於壞帳費用增加 40 萬美元以及人員成本增加(包括 20 萬美元的股權激勵費用)。
At June 30, 2025, the company had cash and cash equivalents totaling $41.5 million as compared to $20.1 million at December 30, 2024. With the increase resulting from the net proceeds of the note payable and stock offerings of $32 million partially offset by the use of $8.7 million in cash for operating activities. Our operational cash burn in Q2 was $2.6 million broadly in line with the operational cash burn of the second quarter of 2024.
截至 2025 年 6 月 30 日,該公司的現金和現金等價物總額為 4,150 萬美元,而 2024 年 12 月 30 日為 2,010 萬美元。應付票據和股票發行淨收益導致的增加為 3,200 萬美元,但部分被用於經營活動的 870 萬美元現金所抵銷。我們第二季的營運現金消耗為 260 萬美元,與 2024 年第二季的營運現金消耗大致相同。
With that, I'd like now to turn the call back to you, Joe.
說完這些,我現在想把電話轉回給你,喬。
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Thank you, Danilo. The team has continued to deliver strong results here in the second quarter, both financially and strategically. From a financial perspective, we achieved record revenue, benefiting from sales contributions across all four of our growth pillars. Strategically, we were able to achieve key milestones that give us confidence that we will see continued growth across our entire portfolio. This is an exciting phase for the company, which again we've called Fast Forward.
謝謝你,達尼洛。該團隊在第二季度繼續在財務和策略方面取得強勁業績。從財務角度來看,我們實現了創紀錄的收入,受益於四大成長支柱的銷售貢獻。從策略上講,我們能夠實現關鍵的里程碑,這使我們有信心看到整個投資組合持續成長。對於公司來說,這是一個令人興奮的階段,我們再次稱之為「快轉」。
It's exciting because we now have multiple growth factors taking shape all at the same time. These various vectors include the expansion into the operating room using both MRI and CT, the expansion into the laser therapy and access market, the expansion of regulatory clearances into new geographies, the addition of multiple new biopharma partners, the addition of new products and services to offer those biopharma partners, the expansion of our site capacity for larger pre-clinical and GOP studies, and the progression of pharma partners into larger Phase 3 clinical trials and eventual commercialization of these new to world cell and gene therapies.
這令人興奮,因為我們現在有多個成長因素同時形成。這些不同的載體包括使用 MRI 和 CT 擴展到手術室、擴展到雷射治療和准入市場、將監管許可擴展到新的地區、增加多個新的生物製藥合作夥伴、增加新產品和服務以提供給這些生物製藥合作夥伴、擴大我們的場地容量以進行更大規模的臨床前和 GOP 研究,以及將製藥合作夥伴開展到更大規模的 3 期藥物和基因化的這些新奇細胞。
All of this is taking place against the backdrop of our strongest cash position in years, and the confidence to use that capital to move each and every one of these growth vectors forward. As always, let's dig a bit deeper into this progress with regard to our four growth pillars. Starting with pillar number 1, biologics and drug delivery. Our strategy once again is to extend our lead in cell and gene therapy delivery.
所有這一切都發生在我們多年來最強勁的現金狀況的背景下,我們有信心利用這些資本來推動每個成長載體向前發展。像往常一樣,讓我們更深入地探討四大成長支柱的進展。從支柱一開始,即生物製劑和藥物傳遞。我們的策略再次是擴大我們在細胞和基因治療領域的領先地位。
Our biologics and drug delivery team continue to support more than 60 active partners in the biopharma space at all phases of development, including pre-clinical testing, clinical trial execution, and even global commercialization. We have successfully entered a long-term lease for our new expanded pre-clinical research facility and began construction late in the second quarter in preparation of adding capacity and offering new capabilities to our network of biopharma partners. We believe that this expanded facility in Torrey Pines, California will be operational here in the second half of 2025.
我們的生物製劑和藥物傳輸團隊繼續為生物製藥領域 60 多個活躍的合作夥伴提供支持,涉及開發的各個階段,包括臨床前測試、臨床試驗執行,甚至全球商業化。我們已成功簽訂了新擴建臨床前研究設施的長期租約,並於第二季末開始建設,為增加產能並為我們的生物製藥合作夥伴網絡提供新功能做準備。我們相信,位於加州托里松樹的擴建工廠將於 2025 年下半年投入營運。
In addition, numerous partners have enrolled patients in global regulatory trials, including those partners who have been accepted into one of the FCA expedited review programs. In the second quarter, we submitted our 510(k) for the SmartFlow cannula for use with the REGENXBIO therapy RGX-121. This submission is once again a cross labeled combination product is being reviewed in parallel with the REGENXBIO BLA, which the company announced was accepted by the FDA for review.
此外,許多合作夥伴已招募患者參與全球監管試驗,其中包括已被納入 FCA 快速審查計劃之一的合作夥伴。在第二季度,我們提交了 SmartFlow 套管的 510(k) 申請,用於 REGENXBIO 療法 RGX-121。此次提交的申請再次是交叉標籤組合產品,正在與 REGENXBIO BLA 同時接受審查,該公司宣布該產品已被 FDA 接受審查。
RGX-121 is intended for use in children with NPS2, also known as Hunter syndrome. The PDUFA date is scheduled for November of this year. Another one of our partners, Solid Bioscience, has also communicated that they have earned expedited review status by the FDA and will begin renewed clinical strategy discussions with the FDA in support of an eventual BLA submission to treat another debilitating disease called Friedreich's Ataxia, which is estimated to impact more than 5,000 patients in the United States alone. This brings the total number of ClearPoint Neuro-related programs that have been accepted to the FDA expedited review up to nine.
RGX-121 適用於 NPS2(也稱為亨特氏症候群)的兒童。PDUFA 日期定於今年 11 月。我們的另一個合作夥伴 Solid Bioscience 也表示,他們已獲得 FDA 的快速審查資格,並將與 FDA 重新開始臨床策略討論,以支持最終提交 BLA 申請,用於治療另一種名為弗里德賴希共濟失調的衰弱性疾病,據估計,僅在美國就有超過 5,000 名患者患有這種疾病。這使得接受 FDA 快速審查的 ClearPoint Neuro 相關項目總數達到九個。
In addition, the ICD-10 coordination and Maintenance Committee has included new neuro infusion specific ICD-10 PCS codes which will be effective October 1, 2025, and will assist in tracking commercial use of the SmartFlow cannula and eventually other device technologies directly to the brain. ClearPoint submitted the application for these new codes earlier this year.
此外,ICD-10 協調和維護委員會已納入新的神經輸注特定 ICD-10 PCS 代碼,該代碼將於 2025 年 10 月 1 日生效,並將協助追蹤 SmartFlow 套管的商業用途以及最終其他直接進入大腦的設備技術。ClearPoint 於今年稍早提交了這些新程式碼的申請。
We also announced a record number of cell and gene therapy infusions in July, performed either commercially or as part of registered clinical trials, including 17 global patients treated across 11 different drug platforms. This demonstrates the continued progression of our more than 60 active partners through the regulatory approval process. We believe that additional cell and gene therapy platforms with significantly underserved patient populations have the potential to be approved within the next two to three years. ClearPoint Neuro has established or is actively collaborating with multiple partners to establish commercial supply agreements to ensure readiness for the launch of these new therapies.
我們還宣布,7 月份細胞和基因治療輸注數量創歷史新高,這些輸注要么是商業化的,要么是作為註冊臨床試驗的一部分進行的,其中包括 17 名全球患者在 11 個不同的藥物平台上接受治療。這表明我們的 60 多個活躍合作夥伴正在透過監管審批流程不斷取得進展。我們相信,未來兩到三年內,針對服務嚴重不足的患者群體的更多細胞和基因治療平台有可能獲得批准。ClearPoint Neuro 已與多個合作夥伴建立或正在積極合作建立商業供應協議,以確保為推出這些新療法做好準備。
Next, let's talk about pillars number 2 and 3, which today represent neurosurgery navigation and laser ablation. Our goal for this segment is to introduce a new products that are not only precise and accurate, but are also fast, simple, and predictable, so that we can help hospitals increase throughput and create capacity for these future drug delivery patients. This segment saw our single use consumables grow 33% in the second quarter, primarily driven by the introduction of our new 3.0 operating room navigation software and gains in laser ablation market share with our Prism laser therapy system.
接下來我們來談談支柱2和支柱3,也就是今天所代表的神經外科導航和雷射消融。我們在這一領域的目標是推出一種不僅精確、準確,而且快速、簡單、可預測的新產品,以便我們能夠幫助醫院提高吞吐量並為未來的藥物輸送患者創造容量。該部門的一次性耗材在第二季度增長了 33%,這主要得益於我們推出新的 3.0 手術室導航軟體以及 Prism 雷射治療系統在雷射消融市場份額的增長。
The 3.0 navigation software has been very well received during the first three months since FDA clearance, and the products moved into full market release here in the second quarter. This has been the fastest technology deployment in our history, and as of today, the 3.0 navigation software is already available in 35 new or existing sites here in the United States. The product is delivering on our promise of fast, simple, predictable procedures, and the early clinical performance is combining accuracy with efficiency as seen in the data collected during our limited market release.
3.0 導航軟體自獲得 FDA 批准後的前三個月內就獲得了廣泛好評,該產品於第二季度全面上市。這是我們歷史上最快的技術部署,截至今天,3.0 導航軟體已經在美國 35 個新建或現有站點投入使用。該產品兌現了我們對快速、簡單、可預測程序的承諾,並且從我們在有限的市場發布期間收集的數據可以看出,早期的臨床表現將準確性與效率結合在一起。
So far we have seen average radial errors less than 1 millimeter and average skin-to-skin procedure times of around two hours, even for bilateral deep brain stimulation procedures. This is all despite the fact that these cases were often the very first experience for these surgeons with our operating room product, and we expect additional time savings with workflow familiarity and optimization. Yet again, this efficiency is being achieved without sacrificing accuracy and precision.
到目前為止,我們已經看到平均徑向誤差小於 1 毫米,平均皮膚對皮膚手術時間約為兩小時,即使是雙側深部腦部刺激手術也是如此。儘管這些病例通常是這些外科醫生第一次使用我們的手術室產品,但我們希望透過熟悉和優化工作流程來節省更多時間。再次強調,這種效率的實現並不犧牲準確性和精確度。
Also impressive was that the cumulative radiation dose of these efficient bilateral procedures was less than that of a single full diagnostic head scan. One of the surgeons even commented that with this level of efficiency and predictability, it would be possible to schedule three surgeries in a single day.
同樣令人印象深刻的是,這些有效的雙側手術的累積輻射劑量小於單次完整的診斷頭部掃描的輻射劑量。一位外科醫生甚至評論說,有了這種效率和可預測性,一天內安排三次手術是可能的。
Another exciting theme was the early release of 3.0 surrounds the clear and unique flexibility of the system to work in both the MRI suite and in the operating room. In the second quarter, we had multiple examples where the pre-planning for the surgery had taken place inside the ClearPoint software. However, the MRI magnet went down with the patient ready for surgery.
另一個令人興奮的主題是 3.0 的早期發布圍繞著系統在 MRI 套件和手術室中工作的清晰而獨特的靈活性。在第二季度,我們有多個案例,其中手術的預先規劃是在 ClearPoint 軟體內部進行的。然而,當病人準備接受手術時,MRI 磁鐵卻掉了下來。
In years past, the patient may have been sent home or treated with another operating room navigation system, meaning ClearPoint would have lost the case. In these examples, the ClearPoint procedures simply pivoted out of the MRI and into the operating room, leveraging all of the pre-planning and preparation that had already taken place. These are cases that ClearPoint does not have to lose anymore when an issue arises with the MRI magnet.
在過去的幾年裡,患者可能已經回家或使用其他手術室導航系統進行治療,這意味著 ClearPoint 可能會輸掉這場官司。在這些例子中,ClearPoint 程序只是從 MRI 轉移到手術室,利用了所有已經進行的預先規劃和準備。當 MRI 磁鐵出現問題時,ClearPoint 不會再輸掉這些案件。
Similarly, our Prism laser therapy system workflow got a boost with the new 3.0 software, making planning and imaging more compatible with both the ClearPoint navigation system and other common workflows like robotics. We have made gains in market share despite being limited to only 3.0 Tesla powered scanners, which we estimate represents about one half of the available market today. We have since submitted the data required by the FDA to achieve compatibility with 1.5 Tesla scanners and expect to have access to the other half of the market sometime in the second half of this year.
同樣,我們的 Prism 雷射治療系統工作流程透過新的 3.0 軟體得到了提升,使規劃和成像與 ClearPoint 導航系統和其他常見工作流程(如機器人)更加相容。儘管僅限於 3.0 特斯拉供電的掃描儀,但我們的市場份額仍然有所增長,我們估計這佔據了目前可用市場的一半左右。我們已經提交了 FDA 所需的數據,以實現與 1.5 特斯拉掃描儀的兼容性,並預計在今年下半年某個時候進入另一半市場。
Our laser therapy case volumes continue to increase, and after one year of full market release, we estimate to have achieved between 5% and 10% of the neuro laser therapy market here in the United States. And finally, moving to our fourth pillar of achieving global scale, we continue to make significant progress expanding our install base and hospital support infrastructure, as well as pursuing global regulatory clearances. In the second quarter we activated two additional new sites.
我們的雷射治療病例數量持續增加,經過一年的全面市場投放,我們估計已經佔據了美國神經雷射治療市場的 5% 至 10%。最後,我們轉向實現全球規模的第四個支柱,我們繼續在擴大安裝基礎和醫院支援基礎設施以及尋求全球監管許可方面取得重大進展。第二季度,我們又啟動了兩個新站點。
As mentioned last quarter, our priorities in the first half of 2025 have been executing the 3.0 and Prism launches at existing accounts where we already have familiarity, specialist coverage, and customer service enabled. In the second half, we plan to once again, accelerate new site activations here in the US. We continue to expect total 2025 activations to be to be between 15 and 20 new sites, which would equate to between 11 and 16 new sites activated here in the second half. For perspective, we have already added two additional sites here in the third quarter and still have seven weeks to go in Q3.
正如上個季度所提到的,我們在 2025 年上半年的首要任務是針對我們已經熟悉、擁有專業覆蓋和客戶服務的現有帳戶執行 3.0 和 Prism 發布。下半年,我們計劃再次加速美國新站點的啟動。我們仍預計 2025 年將有 15 至 20 個新站點啟動,相當於下半年將有 11 至 16 個新站點啟動。從長遠來看,我們已經在第三季增加了兩個站點,而第三季還有七週的時間。
At present we have approximately 30 potential customers in our near term capital funnel, which we believe have a chance to activate before the end of the year, and we estimate that we can activate about half of those targets by by December 31 and the rest in 2026. ClearPoint currently has regulatory clearances supporting 36 countries around the world, and this does not include additional countries where the regulatory approval process has been initiated, including Canada, Japan, and China.
目前,我們的近期資本管道中大約有 30 個潛在客戶,我們相信他們有機會在年底之前激活,我們估計到 12 月 31 日我們可以激活其中大約一半的目標,其餘的可以在 2026 年激活。ClearPoint 目前已獲得支援全球 36 個國家的監管許可,這還不包括已啟動監管審批程序的其他國家,例如加拿大、日本和中國。
The global reach is another significant sales tool that helps ClearPoint extend our lead in drug delivery, as this expansive global product placement is yet another significant barrier to have to replicate. Our operating expense growth in the quarter mirrored our revenue growth, with an operating burn almost identical to Q2 of 2024. As a management team, we will continue to balance scalable financial performance with the appropriate investments required to build a moat around ClearPoint as the gold standard for neurocell and gene therapy delivery. Our plan is to continue to extend our lead and be responsive to our active pharma partners who again are telling us that it's time to get ready.
全球影響力是另一個重要的銷售工具,它可以幫助 ClearPoint 擴大我們在藥物傳輸領域的領先地位,因為這種廣泛的全球產品佈局是另一個需要複製的重大障礙。本季我們的營運費用成長反映了我們的收入成長,營運消耗幾乎與 2024 年第二季相同。作為管理團隊,我們將繼續在可擴展的財務表現與適當的投資之間取得平衡,以圍繞 ClearPoint 建立護城河,使其成為神經細胞和基因治療交付的黃金標準。我們的計劃是繼續擴大領先優勢,並響應我們活躍的製藥合作夥伴的要求,他們再次告訴我們,現在是時候做好準備了。
With that, I would like to open up the call to any questions.
好了,現在我願意開始回答任何問題。
Operator
Operator
(Operator Instructions) Frank Takkinen, Lake Street Capital Markets.
(操作員指示) Frank Takkinen,Lake Street Capital Markets。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
I was hoping maybe I could start with some more color around the biologic partner opportunity. Clearly you're making good progress across the board there. I was hoping you could refresh us more on kind of revenue contribution from Kebilidi and how that may work into the model. And then a second part to that just dots around uniQure, which we would be looking for in the back half of the year. In advance of that, I think it's a Q1 2026 decision date that is expected.
我希望也許我可以更詳細地介紹一下生物合作夥伴的機會。顯然,你們在各方面都取得了良好的進展。我希望您能向我們詳細介紹一下 Kebilidi 的收入貢獻以及它如何融入模型。然後第二部分只是圍繞 uniQure 的點點滴滴,我們將在今年下半年尋找它。在此之前,我認為預計的決策日期是 2026 年第一季。
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
The very -- the first two opportunities that I think we have, one being stability here in the United States and globally for that matter, as well as the REGENXBIO platform which could be approved later this year. Those are still incredibly rare single gene mutation disorders that have very great results when it comes to being treated with this type of therapy but are very small and remote patient populations.
我認為我們擁有的兩個首要機會是,一是美國乃至全球的穩定,二是可能在今年稍後獲得批准的 REGENXBIO 平台。這些仍然是極為罕見的單基因突變疾病,透過這種療法治療可以取得非常好的效果,但患者群體非常小且偏遠。
It's possible that these populations are underdiagnosed, meaning that once awareness is created that there's a treatment out there, that more and more patients may get the blood tests done to confirm if they have one of them. However, from a modeling standpoint, we do not see those as massive revenue drivers in the near term. If anything, they're symbolic and very important milestones to kind of prepare us as we enter hospitals, as we work with pharmacy, as we make sure the pharmacists have the equipment to thaw out these drugs appropriately.
這些人群可能未被充分診斷,這意味著一旦人們意識到有治療方法,越來越多的患者可能會進行血液檢查以確認他們是否患有其中一種疾病。然而,從建模的角度來看,我們並不認為這些在短期內會成為巨大的收入驅動力。無論如何,它們都是具有像徵意義且非常重要的里程碑,可以幫助我們做好準備,以便進入醫院,與藥房合作,確保藥劑師擁有適當解凍這些藥物的設備。
So it's kind of like a dress rehearsal for some of the larger market opportunities to follow, the first of which are an important one of which that you just mentioned being uniQure and their treatment for Huntington's disease. So to put things in perspective, these first two rare disorders, the number of patients are around the world are measured in the tens or maybe the hundreds, compared to something like Huntington's disease, where it's estimated there's 70,000 patients in Europe and sort of Western Europe and the United States alone.
因此,這有點像是為接下來的一些更大的市場機會進行一次彩排,其中第一個很重要的市場機會就是您剛才提到的uniQure及其對亨廷頓舞蹈症的治療。因此,從整體上看,前兩種罕見疾病,全球患者數量只有幾十甚至幾百人,而亨廷頓氏病,據估計僅在歐洲、西歐和美國就有 70,000 名患者。
And these are the patients that are actually in their 30s and 40 years old that have become symptomatic. That's not even accounting the 130,000 estimated patients that are carriers of the Huntington's gene that would still end up being candidates but maybe are not symptomatic yet. So the scale obviously is significantly higher for something like uniQure and their particular disease state.
這些患者實際上年齡在 30 多歲和 40 歲之間,已經出現症狀。這還沒有考慮到大約 13 萬名攜帶亨廷頓基因的患者,他們最終仍會成為候選人,但可能尚未出現症狀。因此,對於 uniQure 之類的疾病及其特定疾病狀態而言,其規模顯然要高得多。
The other thing to to consider when you think about Huntington's disease as being the next large opportunity for us is that it's sort of a race for these patients to get treated as quickly as they can. The two year data that uniQure has presented showed a halt in the progression or a relative halt in the progression, meaning you're not necessarily restoring function that you've lost, but you're kind of stopping it from getting worse. So as a patient, if you hear that, you think to yourself, wow, I don't want to wait six months or a year where the disease continues to progress and then we halt it. I want to get this done as quickly as we possibly can.
當您想到亨廷頓舞蹈症對我們來說是下一個重大機會時,要考慮的另一件事是,這對這些患者來說就像是一場盡快得到治療的競賽。uniQure 提供的兩年數據顯示病情進展停止或相對停止,這意味著您不一定能恢復已經失去的功能,但可以阻止病情惡化。因此,作為一名患者,如果您聽到這個,您會想,哇,我不想等待六個月或一年,讓病情繼續發展,然後我們才能阻止它。我希望我們能盡快完成這件事。
So one of the things that we're working with hospital centers and regional treatment centers right now is to, again, find this extra capacity so we could add 1 to 5,000 additional patients as quickly as we possibly can to be able to kind of open the gates and make this happen. To put that in perspective, it's not a daunting number. You think about 5,000 and what it would take. The math behind that is you'd need 20 hospitals or 20 academic centers that are each capable of having a ClearPoint room that does one procedure a day.
因此,我們目前正在與醫院中心和區域治療中心合作的事情之一就是再次找到這種額外的容量,以便我們能夠盡快增加 1 到 5,000 名患者,從而能夠打開大門並實現這一目標。從這個角度來看,這並不是一個令人畏懼的數字。你想想 5,000 以及需要多少錢。背後的計算是,你需要 20 家醫院或 20 個學術中心,每家醫院或學術中心都能夠擁有一個 ClearPoint 房間,每天可進行一次手術。
So 20 hospitals times one procedure a day gets you to that 5,000 number. So we're not talking about an incredibly heavy lift, but it is time for these hospitals to start thinking about it because it's getting a lot closer. And then as far as some of the other programs that are in expedited review, including Friedreich's Ataxia, frontal temporal lobe dementia, Parkinson's disease, epilepsy, et cetera. Those are all represent significantly larger opportunities and then again these rare childhood disorders that we're working with today.
因此,20 家醫院乘以每天一次的手術,就能達到 5,000 這個數字。因此,我們談論的並不是一個極其繁重的任務,但是這些醫院是時候開始考慮這個問題了,因為它已經越來越近了。至於其他一些正在快速審查的項目,包括弗里德賴希共濟失調、額顳葉失智症、帕金森氏症、癲癇等。這些都代表著更大的機遇,以及我們今天正在研究的這些罕見兒童疾病。
Frank Takkinen - Analyst
Frank Takkinen - Analyst
Got it. That's very helpful. And then, maybe on ClearPoint 3.0, it sounds like you're having strong receptivity to that as well. Where do you stand and maybe rolling it out to the rest of the installed base and maybe any metrics you can provide around the contribution that this has driven to the model and the margin impact of that would be great to understand.
知道了。這非常有幫助。然後,也許對於 ClearPoint 3.0,聽起來您對此也有很強的接受能力。您的立場是什麼?也許您會將其推廣到其餘的已安裝客戶群,也許您可以提供任何指標來說明這對模型的貢獻以及其對利潤的影響,這將非常有助於理解。
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Yeah, so I don't -- as of today, I don't believe there's any margin impact, so it's still a very profitable procedure to us. The capital component is significantly less. So if you think you've got a new hospital that wants to start using ClearPoint for the first time, but maybe historically, they didn't have access to an MRI magnet, the only piece of capital they need is the ClearPoint workstation and the ClearPoint software. You don't have to purchase titanium instruments. You don't need new head coils. You don't need an MRI monitor.
是的,所以我認為截至今天,這不會對利潤產生任何影響,所以對我們來說這仍然是一個非常有利可圖的過程。資本成分明顯較少。因此,如果您認為您有一家新醫院想要首次開始使用 ClearPoint,但也許從歷史上看,他們無法使用 MRI 磁鐵,那麼他們唯一需要的資金就是 ClearPoint 工作站和 ClearPoint 軟體。您不必購買鈦質器械。您不需要新的頭部線圈。您不需要 MRI 監視器。
So the lift to get that in is significantly less, and it allows us to start using the disposables or consumables right away, which again, those margins are very much in line with the MRI ones. In fact, it's the exact same MRI kit that now is labeled with both MRI and CT compatibility. So from an inventory standpoint, a hospital can carry that one product on their shelf and do an MRI case one day and a CT case the next day with that same par of level inventory. So that's been very well received.
因此,獲得這些利潤所需的成本明顯較小,並且使我們能夠立即開始使用一次性用品或消耗品,這些利潤與 MRI 的利潤非常一致。事實上,它是完全相同的 MRI 套件,現在被標記為具有 MRI 和 CT 相容性。因此,從庫存的角度來看,醫院可以在貨架上放置一種產品,並在第一天進行 MRI 檢查,第二天進行 CT 檢查,同時保持相同水準的庫存。因此,這項舉措受到了廣泛好評。
I would say I think we have 35 is what we announced, 35 sites that now have the 3.0 or 3.01 software installed. And of those sites, I believe there's 21 or 22 that have already done procedures. So again, it's our kind of our fastest deployment that we've ever seen. And again, we're also targeting these very high volume academic centers so that we can increase, move -- maybe move some of their DVF procedures out of the MRI and into the operating room with this product so that again we're creating capacity for these clinical trials of drug delivery and eventually the commercial cases as well.
我想說,據我們宣布,目前有 35 個站點安裝了 3.0 或 3.01 軟體。在這些站點中,我相信有 21 或 22 個已經完成了程序。所以,這是我們見過的最快的部署。再次強調,我們也瞄準了這些數量非常大的學術中心,以便我們能夠增加、轉移——也許可以透過該產品將他們的一些 DVF 程序從 MRI 轉移到手術室,這樣我們就可以再次為這些藥物輸送臨床試驗創造能力,並最終為商業案例創造能力。
Operator
Operator
Anderson Schock, B. Riley Security.
安德森‧肖克 (Anderson Schock)、B.萊利安全公司 (B. Riley Security)。
Anderson Schock - Equity Analyst
Anderson Schock - Equity Analyst
So first, on your cell and gene therapy partners, will all these therapies be delivered under live MRI or can they also be delivered in the OR under CT guidance?
那麼首先,對於您的細胞和基因療法合作夥伴,所有這些療法都是在即時 MRI 下進行的嗎?還是也可以在 CT 引導下在手術室中進行?
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Yeah, I would say it depends. So not all of them will be done under live MRI guidance, and it's important to recognize that there's a number of different products in our ecosystem that we're selling into these procedures, right? You've got the cannula itself, so this is the route of the administration which is touching the blood of the patient. It's touching the drug. It has very precise and controlled and studied flow rates, viscosity, et cetera. So all of those things are crucial.
是的,我認為這要視情況而定。因此,並非所有檢查都會在即時 MRI 引導下進行,而且重要的是要認識到,我們的生態系統中有許多不同的產品可供我們銷售,對嗎?你已經有了套管針本身,所以這是接觸病人血液的給藥途徑。它正在接觸藥物。它具有非常精確、可控和研究的流速、黏度等。所以所有這些都至關重要。
What we have seen so far is that the combination devices group at the FDA or other notified bodies have seemed to establish that they plan to approve the drugs and the cannula as combination products. So what I mean by that is if you look across those 60 partners, our expectation is that pretty much all 60 of them would be using ClearPoint technology at least in the form of the cannula, which likely would be approved as a combination device. So that's that's one element of what we provide.
到目前為止,我們看到的是,FDA 或其他公告機構的組合設備組似乎已經確定他們計劃批准藥物和套管作為組合產品。所以我的意思是,如果你看看這 60 個合作夥伴,我們預計幾乎所有 60 個合作夥伴都會使用 ClearPoint 技術,至少以套管的形式,這很可能會被批准為組合設備。這就是我們提供的服務之一。
The others are, I think, a little bit more technology and location dependent. So we have some of those partners who really want to maintain control of the surgical process. I think most pharma companies recognize that one of the biggest risks that we have here is to not only get approval for the drug, but once the drug is approved to make sure that we don't go too fast and too loose here where one or two surgeons that are using a specific technique can potentially cause a disruption for the entire market because they don't get the results and for a drug that could cost hundreds of thousands, maybe even millions, insurance companies are going to ask a lot of questions if they've paid for these procedures and they're not getting the results that they expect.
我認為其他的則更依賴技術和位置。因此,我們的一些合作夥伴確實希望控製手術過程。我認為大多數製藥公司都認識到,我們面臨的最大風險之一不僅是獲得藥物批准,而且在藥物獲得批准後,我們還要確保不會走得太快、太鬆散,一兩個外科醫生使用某種特定技術可能會擾亂整個市場,因為他們沒有得到結果,而對於一種可能花費數十萬甚至數百萬美元的藥物,如果保險公司支付了這些程序的費用,卻沒有得到他們期望的結果。
So there are many of our partners that have said, hey, at launch we want to have as detailed a surgically controlled process as we can. And that comes often with the ClearPoint MRI guidance because you don't only have the consistency of ClearPoint pre-planning and software and hardware during the procedure, but again, you can actually see the drug being infused and it becomes an important part of the quality control process. So that's -- that is one element, and I'd say a good portion, I don't want to put a percentage on it, but it's -- many of our partners at least at this stage are planning to use some form of MRI guidance with ClearPoint.
因此,我們的許多合作夥伴都表示,嘿,我們希望在發佈時擁有盡可能詳細的手術控制流程。這通常伴隨著 ClearPoint MRI 引導,因為您不僅可以在手術過程中獲得 ClearPoint 預先規劃和軟體及硬體的一致性,而且您還可以實際看到藥物的注入,這成為品質控制過程的重要組成部分。所以這是 — — 這是一個因素,我想說是很大一部分,我不想給出具體的百分比,但是 — — 至少在這個階段,我們的許多合作夥伴都計劃使用某種形式的 ClearPoint MRI 引導。
There are, however, additional partners who maybe don't feel that they need the MRI guidance right out of the gate or they want to study the ability to do it within the MRI in one subset and in the operating room with another subset. And most commonly, it's not gene therapy programs, it's cell therapy programs where you're injecting fewer -- a lot less volume, so it's harder to see the infusion on MRI, in which case, if you're not getting as detailed a quality control sort of measurement at the very end of that, then maybe the speed of being able to do it in the operating room is a little bit more appropriate.
然而,其他合作夥伴可能不認為他們一開始就需要 MRI 引導,或者他們想要研究在一個子集中的 MRI 中進行引導,並在手術室中與另一個子集進行引導的能力。最常見的不是基因治療計劃,而是細胞治療計劃,注射的劑量要少得多,因此很難在 MRI 上看到輸液,在這種情況下,如果你在最後沒有得到如此詳細的質量控制測量,那麼也許在手術室中進行的速度更合適一些。
So we really have a mix, but these companies are our partners not just for navigation, they're for the cannula, they're for our clinical support, they're for our pre-clinical research that we do, they're for our GLP capabilities that we're adding, they're for our predictive modeling software. So even if someone chooses not to use the navigation portion of the portfolio, there's still many other products that are certainly certainly being reviewed and could potentially be sources of revenue.
所以我們確實有一個混合體,但這些公司不僅是我們的導航合作夥伴,他們還提供套管針、臨床支援、臨床前研究、我們正在添加的 GLP 功能以及預測模型軟體。因此,即使有人選擇不使用產品組合的導航部分,仍然有許多其他產品肯定會受到審查,並可能成為收入來源。
Anderson Schock - Equity Analyst
Anderson Schock - Equity Analyst
So I guess with the majority -- it sounds like the majority will be using MRI guidance. I guess, how should we think about the bottlenecks of MRI suite availability and how that will impact the launch of these therapies?
所以我猜大多數人——聽起來大多數人都會使用 MRI 引導。我想,我們應該如何看待 MRI 套件可用性的瓶頸以及這將如何影響這些療法的推出?
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Yeah, it's kind of what I was mentioning around Frank's question as well is how do we create the capacity inside of the MRI scanner. So one key approach for us is to do exactly that, to create faster, more efficient procedures in the operating room today that still allow a hospital and a team to be familiar with ClearPoint. So as a quick reminder, if you're using the ClearPoint software in the operating room, it is the same hardware and the same software as you would use in the MRI.
是的,我在回答弗蘭克的問題時也提到了這一點,即我們如何在 MRI 掃描儀內部創造容量。因此,我們的一個關鍵方法是做到這一點,在當今的手術室中創建更快、更有效率的程序,同時仍然讓醫院和團隊熟悉 ClearPoint。因此,快速提醒一下,如果您在手術室中使用 ClearPoint 軟體,它與您在 MRI 中使用的硬體和軟體相同。
So every case that you're doing today in the operating room, if your entire team is practicing for what that procedure is going to be like in the future in the MRI using drug delivery. So it's kind of like a proving ground. It's a way to increase hospital proficiency and to streamline those procedures where, a typical MRI procedure in the past might be three hours. As I mentioned on this call, we're getting it down to two hours here in the operating room. If someone does 100 of those procedures, can we get down to 1 hour or 90 minutes or something like that?
因此,對於您今天在手術室中進行的每一個病例,如果您的整個團隊都在練習該手術將來在 MRI 中使用藥物輸送的情況。所以它有點像一個試驗場。這是一種提高醫院效率和簡化程序的方法,過去典型的 MRI 檢查程序可能需要三個小時。正如我在這次電話中提到的,我們將手術室的時間縮短到兩個小時。如果有人做 100 次這樣的手術,我們能把時間縮短到 1 小時或 90 分鐘左右嗎?
So improving efficiency to not only create more MRI time and operating room time, but also more physician capacity to do the procedures is one key element. Another key element is the expansion of MRI capabilities. I mean there are absolutely more MRIs being installed. Siemens, for example, has a free Mac system which is a half Tesla magnet that is much easier to install in the hospital. There's much a lot less shielding required.
因此,提高效率不僅可以創造更多的 MRI 時間和手術室時間,還可以提高醫生執行手術的能力,這是一個關鍵因素。另一個關鍵因素是 MRI 功能的擴展。我的意思是,肯定有更多的 MRI 被安裝。例如,西門子有一個免費的 Mac 系統,它是一種半特斯拉磁鐵,在醫院安裝起來要容易得多。所需的屏蔽要少得多。
We have done all of our preliminary testing on this kind of next generation lower cost magnet, and it gives us all the confidence that we need that we can perform ClearPoint procedures in that. So in the future if you're building out a new wing of a hospital to do these types of things, it's possible and practical to have these sort of lower power, lower cost magnets that still can perform what we would need them to do. So that's another element where these launches and these kind of big iron companies are sort of listening to this need as well.
我們已經對這種下一代低成本磁鐵完成了所有初步測試,它讓我們有信心能夠在其中執行 ClearPoint 程序。因此,如果將來您要建造醫院的新院區來做這些事情,那麼使用這些功率更低、成本更低且仍能完成我們需要它們做的事情的磁鐵是可能的,也是可行的。因此,這是這些發射和這些大型鋼鐵公司也在傾聽這種需求的另一個因素。
And then the third one is to say, well, how do we make sure that if we treat a patient in the operating room without MRI guidance that we can still give them the best possible chance for success? And this is everything we're doing with our AI platforms including Maestro, including our partnership with New England Scientific and Biophysical Modeling, where we can actually take our predictive model of our software.
第三個問題是,如果我們在手術室中沒有 MRI 導引的情況下治療患者,我們如何確保他們仍然可以獲得最佳的成功機會?這就是我們在包括 Maestro 在內的 AI 平台上所做的一切,包括與新英格蘭科學與生物物理建模公司的合作,我們實際上可以採用我們的軟體的預測模型。
Compare it directly to the actual results of the MRI guided procedures that are used in the clinical trials, and if we can show that the model in fact predicts with a very high correspondence of what the drug did in those first 100 patients as part of the clinical trial, then you can actually say, hey, yes, we can do it in the operating room because we understand where the drug is going to spread, provided we still get that submillimeter accuracy that we do with ClearPoint. So there's kind of three different ways we're working right now to go ahead and expand the capacity and make sure the MRI itself is not a bottleneck.
將其與臨床試驗中使用的 MRI 引導程序的實際結果直接進行比較,如果我們可以證明該模型實際上可以非常準確地預測藥物在臨床試驗的前 100 名患者身上的作用,那麼你就可以說,是的,我們可以在手術室中進行這項手術,因為我們知道藥物會擴散到哪裡,前提是我們仍然能夠獲得 ClearPoint 所達到的毫米精度。因此,我們目前正在採用三種不同的方法來擴大容量並確保 MRI 本身不會成為瓶頸。
Anderson Schock - Equity Analyst
Anderson Schock - Equity Analyst
And then do you have any updates on the timing of GLP compliance at your expanded pre-clinical research facility?
那麼,您對擴大後的臨床前研究設施的 GLP 合規時間有什麼更新嗎?
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
I think we'll have a good sense of that pretty quickly. So I'm not ready to commit to the GLP portion. It's possible that we could do our first GLP study this year, but I think it's going to be kind of close if it happens, December time frame or in Q1 of next year. But what I would say is we've hired the people required and now we are really just getting the facility and getting the quality system for this new facility up and running so that it meets all the necessary accreditations to be doing this kind of preclinical work.
我想我們很快就會對此有一個很好的認識。所以我還沒準備好致力於 GLP 部分。我們有可能在今年進行第一次 GLP 研究,但我認為如果真的進行的話,時間會比較接近,大概是在 12 月或明年第一季。但我想說的是,我們已經僱用了所需的人員,現在我們實際上只是在建立設施並讓這個新設施的品質系統正常運行,以便它滿足開展此類臨床前工作所需的所有必要認證。
Operator
Operator
Thank you. We reached the end of our question in this session. I'd like to turn the floor back over for any further closing comments.
謝謝。本次會議我們的提問已經結束。我想再次請大家發表進一步的結論。
Joseph Burnett - President, Chief Executive Officer, Director
Joseph Burnett - President, Chief Executive Officer, Director
Well, thanks again to everyone for joining today's call. We have spent the last 10 years building a strong foundation, and in 2025 is where we hit the Fast Forward button to get the market ready for this exciting future of cell and gene therapy. We are very excited to be in a position where we can directly impact many patient lives, often being in the room for the very first patient ever treated with these new technologies. Good night and thank you for your attention.
好吧,再次感謝大家參加今天的電話會議。我們花了 10 年時間建立堅實的基礎,並將於 2025 年按下「快轉」按鈕,讓市場為細胞和基因療法這個令人興奮的未來做好準備。我們非常高興能夠直接影響許多患者的生活,並且經常在病房裡接待第一位接受這些新技術治療的患者。晚安,感謝您的關注。
Operator
Operator
Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
謝謝。今天的電話會議和網路直播到此結束。此時您可以斷開線路並享受美好的一天。我們感謝您今天的參與。