Plus Therapeutics Inc (PSTV) 2024 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen. Welcome to Plus Therapeutics third quarter 2024 results conference call. Before we begin, we want to advise you that over the course of the call, including any question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position.

女士們、先生們，午安。歡迎參加 Plus Therapeutics 2024 年第三季業績電話會議。在我們開始之前，我們想提醒您，在整個通話過程中，包括任何問答環節，都會出現有關事件、趨勢、業務前景和財務業績的前瞻性陳述，這些陳述可能會影響 Plus Therapeutics 未來的經營業績和財務狀況。

All such statements are subject to risks and uncertainties. and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission from time to time.

所有這些聲明都存在風險和不確定性。和不確定性，包括 Plus Therapeutics 不時向美國證券交易委員會提交的 10-K 表年度報告和 10-Q 表季度報告中「風險因素」部分中所述的風險和不確定性。

Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

Plus Therapeutics 建議您在考慮此類陳述時審查這些風險因素。Plus Therapeutics 不承擔更新或修改任何前瞻性陳述以反映其作出之日後的事件、趨勢或情況的責任。

It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.

現在我很高興將發言權交給Plus Therapeutics總裁兼執行長Marc Hedrick博士。先生，您可以開始啦。

Thank you, Sheri. Good afternoon, everybody, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our third quarter 2024 financial results. Joining me for the call today is Mr. Andrew Sims, our Chief Financial Officer. I'll begin the call by reviewing our recent clinical and corporate progress in the third quarter and then turn the call over to Andrew for review of our financials, and then we'll both come back for Q&A.

謝謝你，雪莉。大家下午好，再次感謝您今天抽出時間加入我們，我們將概述最近的業務亮點並討論我們 2024 年第三季的財務業績。今天與我一起參加電話會議的是我們的財務長安德魯·西姆斯先生。我將在電話會議上首先回顧我們最近在第三季度的臨床和公司進展，然後將電話轉給安德魯審查我們的財務狀況，然後我們倆將回來進行問答。

I'll begin this afternoon with an overview of our leptomeningeal metastases program in which we are investigating our lead radiotherapeutic Rhenium-186Re Obisbemeda in ReSPECT-LM trial. As a note, going forward for this call, I'll refer to Rhenium-186 Obisbemeda as RNL, which is its research name for the sake of brevity.

今天下午我將首先介紹我們的軟腦膜轉移項目，該項目正在 ReSPECT-LM 試驗中研究我們的領先放射治療錸-186Re Obisbemeda。需要注意的是，在本次電話會議中，我將把錸-186 Obisbemeda 稱為 RNL，這是它的研究名稱，以簡潔起見。

Part 1 of our development program our ongoing ReSPECT-LM Phase I single-administration, dose-escalation trial, is perhaps closing in on a maximal cohort 5 in which we administer a very substantial dose of RNL approximately 66 millicuries. Data safety and monitoring Board, the Board recommended proceeding to a modified lesser cohort 6 dose of 75 millicuries, and the first patient has been treated. To date, 21 [indiscernible] including a subset of 3 patients who responded well to the initial dose and have received multiple doses under compassionate use.

我們開發計畫的第 1 部分，即正在進行的 ReSPECT-LM I 期單次給藥劑量遞增試驗，可能即將達到最大第 5 個隊列，其中我們將施用非常大的 RNL 劑量，約為 66 毫居里。資料安全與監測委員會建議對第 6 組進行修改後的較小劑量 75 毫居里，並且已經對第一位患者進行了治療。迄今為止，已有 21 名患者（包括 3 名患者）對初始劑量反應良好，並在同情用藥下接受了多劑量治療。

Part 2 of our integrated development plan is to expand the Phase I ReSPECT-LM trial to a multiple dose administration trial. Relatedly, in Q3, we reached agreement with the FDA to proceed under a multiple dose escalation protocol, and we are currently in site start-up phase for that trial. I'll review that trial design more fully in a moment.

我們的綜合發展計畫的第二部分是將第一階段 ReSPECT-LM 試驗擴展為多劑量給藥試驗。與此相關的是，在第三季度，我們與 FDA 達成協議，按照多劑量遞增方案進行試驗，目前我們正處於該試驗的現場啟動階段。稍後我將更全面地回顧該試驗設計。

In terms of clinical data from the ReSPECT-LM single administration trial, we presented an interim update at the SNO/ASCO conference in August through cohorts 1 through 4. Here are the key highlights from that presentation: doses of RNL up 44 millicuries were found to be safe and well tolerated with no dose-limiting toxicities.

就 ReSPECT-LM 單次給藥試驗的臨床數據而言，我們在 8 月的 SNO/ASCO 會議上展示了第 1 至第 4 組的中期更新結果。以下是該演講的重點：發現高達 44 毫居里的 RNL 劑量是安全的且耐受性良好，且沒有劑量限制性毒性。

Pharmacokinetic data demonstrated a very high therapeutic index, specifically about a 50 to 100 target to off-target ratio. Through cohorts 1 through 3, means circulating tumor cells were reduced on average 53% at day 28 post-treatment. And median overall survival for cohorts 1 through 4 was 12 months which is quite favorable compared to historically reported consensus of approximately four months with treatment in breast and non-small cell lung cancer. The full presentation from that meeting is available on our website.

藥物動力學數據顯示治療指數非常高，具體來說，標靶與脫靶的比例約為50比100。透過第 1 至第 3 組，治療後第 28 天，循環腫瘤細胞平均減少了 53%。第 1 至第 4 組的中位總存活期為 12 個月，與乳癌和非小細胞肺癌治療的歷史報告一致（約 4 個月）相比，此數據相當可觀。該會議的完整簡報可在我們的網站上查看。

Later this month, at the SNO, Society for Neuro-Oncology Annual Meeting, which is going to be November 21, to November 24, in Houston, we will provide a comprehensive update on the Phase I single administration dose escalation trial through cohort 5 with important new data, including PK, PD response and survival data. We will also host a luncheon symposium to discuss the data in greater detail with leading subject matter experts; Dr. Priya Kumthekar, Dr. Jonathan Yang ,and Dr. Andrew Brenner.

本月晚些時候，在 11 月 21 日至 11 月 24 日於休士頓舉行的 SNO（神經腫瘤學會年會）上，我們將透過第 5 組提供有關 I 期單次給藥劑量遞增試驗的全面更新，並提供重要的新數據，包括 PK、PD 反應和生存數據。我們還將舉辦午餐研討會，與領先的主題專家更詳細地討論數據； Priya Kumthekar 博士、Jonathan Yang 博士和 Andrew Brenner 博士。

As I mentioned before, we have reached agreement with the FDA to initiate enrollment in a Phase I trial of multiple dose administrations of RNL for treating patients with LM. Favorable outcomes observed in compassionate use patients receiving multiple doses of RNL from our single administration dose escalation trial, we reinforced the safety and potential value of multiple dose administration regime to obtain long-tail survival in patients with LM.

正如我之前提到的，我們已經與 FDA 達成協議，開始招募 RNL 多劑量給藥治療 LM 患者的 I 期試驗。從我們的單次給藥劑量遞增試驗中觀察到，在接受多劑量 RNL 的同情用藥患者中取得了良好的結果，我們加強了多劑量給藥方案的安全性和潛在價值，以獲得 LM 患者的長尾生存期。

More specifically, the Phase I ReSPECT-LM multiple dose admiration trial is an open-label two-part study aimed at evaluating the safety, dosing intervals and efficacy of administering multiple doses of RNL to patients with LM. Primary objectives are to assess safety and tolerability and to identify both the maximum tolerated and the maximum feasible doses at various dosing intervals and frequencies.

更具體地說，第一階段 ReSPECT-LM 多劑量欽佩試驗是一項開放標籤的兩部分研究，旨在評估對 LM 患者施用多劑量 RNL 的安全性、給藥間隔和有效性。主要目標是評估安全性和耐受性，並確定不同給藥間隔和頻率的最大耐受劑量和最大可行劑量。

The secondary objectives include evaluating response and survival. The first part of the study will treat up to 24 patients administering at minimum three doses of RNL at 13.2 millicuries at progressively shorter intervals, starting at 56 days and then every 28 days and finally, every 14 days and then potentially up to six doses in a subsequent cohort.

次要目標包括評估反應和存活。研究的第一部分將對多達 24 名患者進行治療，這些患者至少接受三劑 13.2 毫居里的 RNL，間隔逐漸縮短，從 56 天開始，然後每 28 天一次，最後每 14 天一次，然後在後續組中可能接受最多六劑。

The trial is expected to begin enrollment in Q1 2025 with the aim to utilize current seven active US trial sites being -- enrolling patients in our ReSPECT-LM Phase I single administration dose escalation trial. We plan to provide further details on the integrated development plan and path to approval for leptomeningeal cancer at the 2024 SNO Annual Conference at Houston.

該試驗預計將於 2025 年第一季開始招募患者，旨在利用目前七個活躍的美國試驗地點——招募患者參加我們的 ReSPECT-LM I 期單次給藥劑量遞增試驗。我們計劃在 2024 年休士頓 SNO 年會上提供有關軟腦膜癌綜合發展計劃和批准途徑的更多詳細資訊。

Now for a discussion around our diagnostic. Increasingly, we are recognizing the importance of our CNSide Cerebrospinal Fluid Assay platform in both the investigation of RNL for LM and the assays commercial value as a stand-alone diagnostics product in the broader group of patients at risk for LM or other CNS malignancies. The CNSide Cerebrospinal Fluid Assay Platform consists of four lab developed tests or LDTs, and may be used by neuro-oncologists, neuro-immunologist, medical oncologist or other petitioners for the diagnosis, treatment selection and monitoring of patients with or at risk for LM as well as other CNS malignancies.

現在討論我們的診斷。我們越來越認識到 CNSide 腦脊髓液檢測平台在 LM RNL 研究中的重要性，以及作為獨立診斷產品在更廣泛的 LM 或其他 CNS 惡性腫瘤風險患者群體中檢測的商業價值。CNSide 腦脊髓液檢測平台由四個實驗室開發的測試或 LDT 組成，可供神經腫瘤學家、神經免疫學家、腫瘤醫學學家或其他請願者用於對患有或有 LM 以及其他 CNS 惡性腫瘤風險的患者進行診斷、治療選擇和監測。

In terms of market access activities related to the planned CNSide launch in January. As you may recall, step one was tech transfer and initiating lab testing, which was completed earlier this year. Step two, at our wholly owned sub-based in Houston, Texas, we obtained a CLIA certificate of registration in Q3, and we intend to obtain a CLIA certificate of compliance in Q1 2025 following inspection by CMS.

就與 1 月計劃推出的 CNSide 相關的市場准入活動而言。您可能還記得，第一步是技術轉移和啟動實驗室測試，這項任務已於今年稍早完成。第二步，在我們位於德州休士頓的全資子公司，我們於第三季獲得了 CLIA 註冊證書，並計劃在 CMS 檢查後於 2025 年第一季度獲得 CLIA 合規證書。

This quarter, we will apply for expanded reimbursement with a Z-Code through the Diagnostics Exchange which helps ensure that both health care providers and payers understand which test is being [billed] and it also allows payers to automate the preauthorization or adjudication of claims.

本季度，我們將透過診斷交換中心使用 Z-Code 申請擴大報銷，這有助於確保醫療保健提供者和付款人都了解正在[計費]哪項測試，並且還允許付款人自動進行索賠的預授權或裁決。

Specifically, Z-Code is required by well-known payers such as Medicare, UnitedHealthcare, Humana, Blue Cross Blue Shield, and so forth. Next quarter, following receipt of the CLIA certificate of compliance, we intend to apply for a CPT Proprietary Laboratory Analysis Code or PLA code with the American Medical Association. This code is required by Medicare and certifies labs for complex testing, ensuring they meet federal standards for quality, accuracy and safety and the PLA code further specifically identifies the test. In parallel to these activities mentioned above, we are negotiating with a number of commercial payers, which previously had agreements in place for the CNSide assay.

具體來說，Medicare、UnitedHealthcare、Humana、Blue Cross Blue Shield 等知名付款人都要求使用 Z-Code。下個季度，在收到 CLIA 合規證書後，我們打算向美國醫學會申請 CPT 專有實驗室分析代碼或 PLA 代碼。此代碼是醫療保險所要求的，用於認證實驗室進行複雜的測試，確保它們符合聯邦品質、準確性和安全性標準，並且 PLA 代碼進一步具體識別了測試。在進行上述活動的同時，我們正在與一些商業付款人進行談判，這些付款人之前已經就 CNSide 檢測達成了協議。

Specifically, we're informing them that we acquired the assets of CNSide from the previous owner and plan to make the test platform commercially available again and new agreements will be put in place. Also, we are focused on payers that cover regions containing the highest number of LM patients. Currently, the CNSide tumor cell and enumeration LDT continues to be used in the ReSPECT-LM clinical trials. We are on track to commercially reintroduce the test as part of a limited market release in the US in January of 2025.

具體來說，我們通知他們，我們從前任所有者手中收購了 CNSide 的資產，並計劃再次讓測試平台投入商業使用，並將製定新的協議。此外，我們將重點放在涵蓋 LM 患者數量最多的地區的付款人。目前，CNSide腫瘤細胞和計數LDT繼續在ReSPECT-LM臨床試驗中使用。我們計劃於 2025 年 1 月在美國有限上市的情況下重新推出該測試。

At the same time, we are expanding the CNSide test menu on a rolling basis to include specific cellular biomarker assays and molecular assays. We'll talk more about that in 2025. Aggregate 2024 investment in the test will remain limited as test costs are offset in a meaningful way by our current CPRIT grant. In 2025, post expanded market access, we will guide more specifically toward forecasted diagnostic growth ramp and related economics.

同時，我們正在滾動擴展 CNSide 測試菜單，以包括特定的細胞生物標記檢測和分子檢測。我們將在 2025 年進一步討論這個問題。由於我們目前的 CPRIT 補助金可以有效地抵消測試成本，因此 2024 年對測試的總投資將保持有限。2025 年，市場進入擴大後，我們將更具體地引導預測的診斷成長坡道和相關經濟。

Now shifting gears to our ReSPECT-GBM trial which evaluates a single dose of RNL in patients with recurrent glioblastoma. Enrollment in the Phase I portion for patients with recurrent glioblastoma tumors greater than [20 mLs] has been completed, and we will be evaluating that data into 2025 and completing the final Phase I clinical study report.

現在轉向我們的 ReSPECT-GBM 試驗，該試驗評估了復發性膠質母細胞瘤患者單劑量 RNL 的效果。復發性膠質母細胞瘤腫瘤大於 [20 mLs] 患者的 I 期臨床試驗招募已經完成，我們將對 2025 年的數據進行評估，並完成 I 期臨床研究的最終報告。

Enrollment continues for the ReSPECT-GBM Phase II trial limited to patients with tumors lesser than or equal to 20 mLs. The last ReSPECT-GBM trial update was at the Congress for Neurological Surgeons Annual Meeting in October of this year. As a reminder, key highlights include a total of 42 patients had been enrolled across three sites at that time.

ReSPECT-GBM 第二階段試驗的招募仍在繼續，僅限於腫瘤小於或等於 20 毫升的患者。ReSPECT-GBM 試驗的最後一次更新是在今年 10 月的神經外科醫師大會年會上。需要提醒的是，主要亮點包括當時共有 42 名患者在三個地點入組。

In Phase II, most adverse events were mild to moderate with over half deemed unrelated to the study drug. Only two of the nine severe adverse events were related to the study drug and systemic radiation exposure remains low. Moreover, the average absorbed radiation dose to tumors in Phase II was 300 gray, well above the 100 gray (technical difficulty) preclinically and in Phase I that is highly correlative with increased overall survival. Furthermore, approximately 90% of patients achieved critical drug delivery parameters also correlating with improved survival.

在第二階段，大多數不良事件都是輕度至中度的，超過一半被認為與研究藥物無關。九起嚴重不良事件中，只有兩起與研究藥物有關，全身放射暴露仍很低。此外，II 期腫瘤平均吸收放射劑量為 300 戈瑞，遠高於臨床前和 I 期的 100 戈瑞（技術難度），這與整體存活率的提高高度相關。此外，約 90% 的患者實現了關鍵的藥物輸送參數，這也與存活率的提高有關。

Finally, objective tumor response analysis using both cerebral blood volume and volumetric analyses showed a statistically significant relationship between tumor control and absorbed dose. Specifically patients receiving doses above 100 gray, showed effective tumor control within the treated areas. The ReSPECT-GBM trial continues to benefit from substantial NIH support, and we are pleased to announce we have added two new large volume clinical trial sites to support Phase II enrollment and potentially a pivotal trial.

最後，使用腦血容量和體積分析的客觀腫瘤反應分析顯示，腫瘤控制和吸收劑量之間存在統計上顯著的關係。具體來說，接受 100 戈瑞以上劑量的患者，治療區域內的腫瘤得到有效控制。ReSPECT-GBM 試驗繼續受益於 NIH 的大力支持，我們很高興地宣布，我們已增加兩個新的大型臨床試驗地點，以支持 II 期招募和潛在的關鍵試驗。

We've added Ohio State University, which provides us coverage in the Upper Midwest and North Shore Hospital, part of the Northwell and Lenox Hill Network in the greater New York metropolitan area. With these two new additional sites activated and screening patients for enrollment, we expect Phase II completion with 34 total patients by midyear 2025 in a data readout in the second half of 2025.

我們增加了俄亥俄州立大學，它為我們提供了中西部北部地區的服務，以及北岸醫院，它是紐約大都會區諾斯韋爾和勒諾克斯山網絡的一部分。隨著這兩個新地點的啟用和對患者的篩選，我們預計 II 期研究將於 2025 年下半年完成，到 2025 年中期將共納入 34 名患者。

Additionally, we would like to announce that we recently entered into a research and collaboration agreement with Brainlab, a software-driven medical technology company, to develop and implement optimized case planning software or convection-enhanced delivery of RNL for brain cancers. Brainlab's software married to their CED Device Ecosystem will enhance treatment planning, procedure execution and more precise drug delivery for GBM patients, anticipated to further improve patient outcomes.

此外，我們想宣布，我們最近與軟體驅動的醫療技術公司 Brainlab 簽訂了一項研究和合作協議，以開發和實施優化的病例規劃軟體或針對腦癌的 RNL 對流增強輸送。Brainlab 的軟體與其 CED 設備生態系統結合，將增強 GBM 患者的治療計劃、程序執行和更精確的藥物輸送，有望進一步改善患者的治療效果。

Now, just a bit about our pediatric brain cancer program. Recall, we previously announced that we have received a US Department of Defense Award of a $3 million grant to substantially support a Phase I trial for children with pediatric high-grade glioma and ependymoma. Approximately $900,000 payment was received in September of 2024 as part of this award. We anticipate obtaining IND approval in the first half of 2025 at Lurie Children's Hospital in Chicago serving the -- as the initial clinical trial site.

現在，簡單介紹一下我們的兒童腦癌計畫。回想一下，我們先前宣布，我們已獲得美國國防部頒發的 300 萬美元資助，以大力支持針對兒童高級別膠質瘤和室管膜瘤的 I 期試驗。作為該獎項的一部分，2024 年 9 月收到了約 90 萬美元的付款。我們預計將於 2025 年上半年在芝加哥 Lurie 兒童醫院獲得 IND 批准，作為初始臨床試驗地點。

And moving on to drug production and manufacturing. We are expanding our GMP manufacturing capabilities and building redundancy in terms of materials and intermediates to support registrational trials and future commercial demand projections. To ensure a reliable level supply of RNL, we recently announced our second GMP manufacturing partnership, this time with SpectronRx.

並轉向藥品生產和製造。我們正在擴大我們的 GMP 製造能力，並在材料和中間體方面建立冗餘，以支援註冊試驗和未來的商業需求預測。為了確保 RNL 的可靠水平供應，我們最近宣布了第二個 GMP 製造合作夥伴關係，這次與 SpectronRx 合作。

Through this partnership, we have completed process qualification to transition from single dose, single batch production to a pilot scale process capable of producing multiple doses per batch with the potential opportunity for scale-up at capacity of approximately 15,000 doses per year around the time of anticipated FDA approval.

透過此次合作，我們已完成製程鑑定，從單劑量、單批次生產過渡到能夠每批生產多劑量的中試規模工藝，並有可能在預計獲得 FDA 批准時將產能擴大至每年約 15,000 劑。

So, Andrew, turn it over to you for a discussion about the financials. Andrew?

所以，安德魯，把財務問題交給你討論。安德魯？

Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the third quarter ended September 2024.

謝謝你，馬克。大家下午好。請參閱我們今天稍早發布的新聞稿，以了解截至 2024 年 9 月第三季的財務業績摘要。

The cash and investments balance was $4.8 million at September '24 compared to $8.6 million at December '23. In addition, we received the first advance from the DoD grant in October '24 of $0.9 million and are on track to receive the next CPRIT advance of $3.9 million within 90 days of today.

24 年 9 月的現金和投資餘額為 480 萬美元，而 23 年 12 月為 860 萬美元。此外，我們於24年10月收到了國防部的第一筆預付款90萬美元，並預計在90天內收到下一筆390萬美元的CPRIT預付款。

The company recognized $4.4 million in grant revenue year-to-date '24 compared to $3.6 million in the same period of '23. This represents CPRIT share of the cost incurred for our RNL development for the treatment of patients with LM. We expect 2024 grant revenue to be in the range of $6 million to $7 million.

該公司 24 年迄今的贈款收入為 440 萬美元，而 23 年同期為 360 萬美元。這代表了 CPRIT 在我們為治療 LM 患者而進行的 RNL 開發中承擔的成本份額。我們預計 2024 年的贈款收入將在 600 萬至 700 萬美元之間。

The total operating loss year-to-date 2024, was $10.8 million compared to $9.5 million in the same period of 2023. The increase is primarily due to increased spend related to the ReSPECT-LM trial. Net loss year-to-date 2024 was $9.1 million or $1.46 per share compared to a net loss of $9.5 million or $3.54 per share for the same period in the prior year.

2024 年迄今的總營業虧損為 1,080 萬美元，而 2023 年同期為 950 萬美元。成長的主要原因是與 ReSPECT-LM 試驗相關的支出增加。2024 年迄今的淨虧損為 910 萬美元或每股 1.46 美元，而去年同期的淨虧損為 950 萬美元或每股 3.54 美元。

I'd also like to provide an update on our runway and cash position based on the previously announced private placement and provide guidance on our grant funding for the remainder of 2024 and into 2025. There are three additional sources of cash that Plus has access to beyond the balance disclosed in cash on hand and liquid investments on our Q3 2024 balance sheet.

我還想根據先前宣布的私募提供我們資金和現金狀況的最新信息，並為我們 2024 年剩餘時間和 2025 年的贈款資金提供指導。除了我們 2024 年第三季資產負債表上揭露的現金和流動投資餘額外，Plus 還可以使用另外三個現金來源。

First, as a reminder, we announced in May that we closed a private placement financing of up to $19.25 million from new health care-focused institutional investors and company insiders with a total of $7.25 million received at closing with up to $12 million remaining available under this financing.

首先，提醒一下，我們在五月宣布，我們已經完成了一筆高達 1,925 萬美元的私募融資，融資來自新的專注於醫療保健的機構投資者和公司內部人士，在完成時共收到 725 萬美元，這筆融資剩餘可用金額高達 1,200 萬美元。

The second source of cash remains our continued funding through now three announced grants. Firstly, the CPRIT grant to support the ReSPECT-LM trial. As reported, we received $3.3 million from CPRIT in Q2, at this time $7.8 million remains due on the grant, and we remain on track to receive the next advance from CPRIT of $3.9 million within the next 90 days from today. An additional $3.9 million is expected from CPRIT in Q3 2025.

第二個現金來源仍然是我們透過現在宣布的三項撥款持續提供的資金。首先，CPRIT 撥款支持 ReSPECT-LM 試驗。據報道，我們在第二季度從 CPRIT 獲得了 330 萬美元，目前仍有 780 萬美元的贈款未支付，並且我們預計從今天起在未來 90 天內從 CPRIT 獲得下一筆 390 萬美元的預付款。預計 2025 年第三季 CPRIT 將額外提供 390 萬美元。

Secondly, as reported on April 22, Plus has received an award recommendation from the United States Department of Defense for $3 million to support the upcoming ReSPECT pediatric brain cancer trial. The first advance was received in October for just under $1 million.

其次，根據4月22日報道，Plus公司已獲得美國國防部300萬美元的獎勵建議，用於支持即將進行的ReSPECT兒童腦癌試驗。首筆預付款於十月收到，金額略低於100萬美元。

Plus also continues to benefit from the NIH grant to support the ReSPECT-GBM Phase I/II trial, although expected to be complete in the next six months, it currently covers approximately 90% of the overall trial costs. We also continue to source other non-dilutive sources of grant capital with a target of applying for at least $10 million per year. We will continue to only report on individual grants when they're awarded. Taking in total, this cash on hand, financing warrants are fully exercised and committed to contractual grant revenue is approximately $27 million.

Plus 也繼續受惠於 NIH 的資助，以支持 ReSPECT-GBM I/II 期試驗，儘管預計將在未來六個月內完成，但目前已涵蓋了整體試驗費用的約 90%。我們也將繼續尋找其他非稀釋性贈款資本來源，目標是每年申請至少 1,000 萬美元。我們將繼續僅在個人資助被授予時進行報道。總的來說，這些庫存現金、融資認股權證已全部行使並承諾的合約贈款收入約為 2,700 萬美元。

And now I'll turn it back to you, Marc.

現在我把話題轉回給你，馬克。

Great. Thank you, Andrew. Appreciate it. Before we move on to Q&A, I'll take a moment to provide a specific summary of guidance for anticipated key events and milestones taking us through the remainder of 2024.

偉大的。謝謝你，安德魯。非常感謝。在我們進入問答環節之前，我將花一點時間為預計在 2024 年剩餘時間內發生的關鍵事件和里程碑提供具體指導摘要。

First in terms of conferences, we'll have a substantial presence at the SNO, its Society for Neuro-Oncology Annual Meeting from November 21 to November 24, this year. There, we will present three abstracts, host an educational symposium on LM and GM, conduct our annual investigator meeting and showcase our CNSide Cerebrospinal Fluid Assay Platform in our booth as we will showcase our investigational drug, RNL for LM, GBM, and pediatric brain cancer.

首先在會議方面，今年我們將積極出席 11 月 21 日至 11 月 24 日舉行的 SNO 神經腫瘤學會年會。在那裡，我們將展示三篇摘要，舉辦關於 LM 和 GM 的教育研討會，召開我們的年度研究者會議，並在我們的展位展示我們的 CNSide 腦脊髓液檢測平台，同時我們將展示我們的研究藥物、用於 LM、GBM 和兒童腦癌的 RNL。

More specifically, in terms of the three abstracts, as mentioned for our LM therapeutic program, we will present data on the safety and feasibility of ReSPECT-LM Phase I single administration dose escalation trial through cohort 5, including important PK/PD response and survival data. We'll also provide an update on our integrated development plan for both single dose and multiple dose ReSPECT-LM programs and linking them to an FDA approval plan and timeline.

更具體地說，就我們的 LM 治療計劃所提到的三個摘要而言，我們將透過第 5 組展示 ReSPECT-LM I 期單次給藥劑量遞增試驗的安全性和可行性數據，包括重要的 PK/PD 反應和存活數據。我們還將提供單劑量和多劑量 ReSPECT-LM 項目的綜合發展計劃的最新信息，並將其與 FDA 批准計劃和時間表聯繫起來。

For our CNSide Assay Platform, we will present data on first, the 4C clinical trial data on CSF tumor cell detection, including its clinical utility and accurately diagnosing LM patients with high sensitivity and specificity compared to the gold standard cytology, and also its clinical utility in enhancing clinical management of patients with LM.

對於我們的 CNSide 檢測平台，我們將首先提供關於 CSF 腫瘤細胞檢測的 4C 臨床試驗數據，包括其臨床實用性以及與金標準細胞學相比以高靈敏度和特異性準確診斷 LM 患者，以及其在加強 LM 患者臨床管理方面的臨床實用性。

Second, we will show the results of a retrospective analysis of CNSide's real-world ability to detect a variety of gene mutations in CSF tumor cells, offering insights in the potential treatment strategies and also ways LM patients may benefit from complementary regional therapies such as RNL and other treatments. As mentioned, the company will host an educational symposium featuring three subject matter experts, Dr. Kumthekar, Dr. Yang and Dr. Brenner, who will provide updates on our LM and GBM programs in our CNSide Platform. Lastly, we will showcase our investigational therapies as well as the CNSide diagnostic at our booth.

其次，我們將展示對 CNSide 在現實世界中檢測 CSF 腫瘤細胞中多種基因突變的能力的回顧性分析結果，為潛在的治療策略提供見解，以及 LM 患者可能從 RNL 和其他治療等補充區域療法中受益的方式。如上所述，該公司將舉辦一場教育研討會，邀請三位主題專家 Kumthekar 博士、Yang 博士和 Brenner 博士參加，他們將在我們的 CNSide 平台上提供有關 LM 和 GBM 計劃的最新資訊。最後，我們將在展位展示我們的研究療法以及 CNSide 診斷。

Later in the year -- in December, we will also attend the San Antonio Breast Cancer Symposium in San Antonio, Texas, where we will present data on the safety, feasibility of the ReSPECT-LM Phase I single administration trial through cohort 5 with a focus on the breast cancer patients and related data. That happens to be the primary cancer with the highest incidence of patients with LM.

今年稍後——12 月，我們還將參加在德克薩斯州聖安東尼奧舉行的聖安東尼奧乳腺癌研討會，在會上我們將透過第 5 組展示 ReSPECT-LM I 期單次給藥試驗的安全性和可行性數據，重點關注乳癌患者和相關數據。這恰好是 LM 患者發生率最高的原發癌症。

In addition to those upcoming events and conferences mentioned above, the company also anticipates completing our ReSPECT-LM single administration dose escalation trial by year-end, initiating enrollment in our ReSPECT-LM multiple administration dose trial in Q1 of 2025 and launching a limited commercial release of our CNSide Platform as an LDT in early 2025.

除了上述即將舉行的活動和會議之外，公司還預計在年底前完成我們的 ReSPECT-LM 單次給藥劑量遞增試驗，在 2025 年第一季度啟動我們的 ReSPECT-LM 多給藥劑量試驗的招募，並在 2025 年初推出我們的 CNSide 平台作為 LDT 的有限商業版本。

We anticipate completing enrollment in our ReSPECT-GBM Phase II trial by mid-2025, and for our pediatric brain cancer trial, obtaining IND acceptance, initiating enrollment for ReSPECT trial for pediatric ependymoma and high-grade glioma in patients in 2025.

我們預計將於 2025 年中期完成 ReSPECT-GBM 第二階段試驗的招募，並於 2025 年獲得兒童腦癌試驗的 IND 批准，啟動針對兒童室管膜瘤和高級別膠質瘤患者的 ReSPECT 試驗的招募。

So, Sheri, with that, I'll turn it back over to you for any questions.

那麼，Sheri，接下來我將把這個問題轉回給你，以便回答你的問題。

(Operator Instructions)

（操作員指令）

Justin Walsh, JonesTrading.

賈斯汀·沃爾什（Justin Walsh），瓊斯貿易（JonesTrading）。

Hi, thanks for taking the question. Congrats on all the progress. I'm wondering how you view the opportunities for CNSide and RNL in LM as complementary products versus on their own?

你好，謝謝你回答這個問題。恭喜你所取得的所有進步。我想知道您如何看待 CNSide 和 RNL 在 LM 中作為互補產品而非獨立產品的機會？

Justin, great question. You know what, we continue to see more and more synergies. And you may recall when we first considered this acquisition, it made sense solely on one factor and that is it could potentially increase the total addressable market for LM by 2 to 4 times just by improving diagnostic sensitivity. But since then, there's more and more data that shows that using circulating tumor cells can be a proxy for survival and for disease monitoring. And there's -- we see more and more papers coming out related to that.

賈斯汀，這個問題問得好。你知道嗎，我們不斷看到越來越多的綜效。您可能還記得，當我們第一次考慮這次收購時，它僅在一個因素上是有意義的，那就是僅通過提高診斷靈敏度，它就有可能將 LM 的總目標市場擴大 2 到 4 倍。但從那時起，越來越多的數據表明，使用循環腫瘤細胞可以作為生存和疾病監測的替代方法。而且，我們看到越來越多與此相關的論文發表。

And then we're now increasingly relying on it as an exploratory endpoint in the Phase I. And we're going to be providing more insight into that data next week. I think it's highly relevant supporting the other signals we've seen in terms of response and efficacy.

我們現在越來越依賴它作為第一階段的探索性終點。我認為它與我們在反應和功效方面看到的其他信號高度相關。

And I think there's a recent publication by actually one of the key opinion-leading doctors in our symposium, Dr. Yang who treated patients with targeted radiation, in that case from proton beam craniospinal irradiation, which showed in that trial targeted radiation therapy. It correlated very highly. The CNSide assay, actually our assay correlated very highly with survival and progression. So I think over time, we'll see more and more reliance on that.

我認為，我們研討會上一位關鍵意見領袖醫生楊醫生最近發表了一篇論文，他使用靶向放射治療患者，該病例採用質子束顱腦脊髓照射，該試驗表明了靶向放射治療。相關性非常高。CNSide 檢測，實際上我們的檢測與存活和進展高度相關。因此我認為隨著時間的推移，我們會看到對此越來越多的依賴。

Is it ready to be used as a primary endpoint in a pivotal trial? I don't think so. But I think as a secondary endpoint, it provides substantial collaborative data to other progression data and survival.

它是否已準備好用作關鍵試驗的主要終點？我不這麼認為。但我認為作為次要終點，它為其他進展數據和生存提供了大量的協作數據。

Great. Thanks for taking the question. Looking forward to the presentation.

偉大的。感謝您回答這個問題。期待演講。

Thanks Justin.

謝謝賈斯汀。

Edward Woo, Ascendiant Capital.

愛德華吳（Edward Woo），Ascendiant Capital。

Yeah, congratulations on the progress. I was just wondering what does the landscape look for grants? Has this changed in terms of the opportunities that are available? And do you anticipate any change with, I guess, the change in the incoming government? Thank you.

是的，祝賀你取得進展。我只是想知道景觀需要什麼樣的補助？就現有的機會而言，這是否發生了變化？您預計新政府換屆後會出現什麼變化嗎？謝謝。

Hi Ed, to answer your latter question, I don't know. It's hard to tell. I think we're in a good -- pretty good spot through the next year as it relates to grants. We think there -- being in Texas insulates us a bit from what's going on at the Federal level. We've been very successful in -- at CPRIT. As I think you know, we have almost $18 million active grant from them and an aggregate $25 million total in active grants.

你好，艾德，回答你的後面一個問題，我不知道。這很難說。我認為，就補助金而言，我們明年的處境會很好——相當不錯。我們認為，在德克薩斯州，我們可以在一定程度上免受聯邦層級發生的事情的影響。我們在 CPRIT 取得了巨大的成功。我想您知道，我們從他們那裡獲得了近 1800 萬美元的活躍贈款，總計 2500 萬美元的活躍贈款。

No guarantees, but what we're hearing from CPRIT is that there -- from time to time, there's additional capital that they can deploy and they're -- they tend to reach out to companies who are executing and we're executing precisely to our proposed and planned timeline. So we're kind of hoping there might be some opportunities there. But also we'll continue, as Andrew said, to talk about grants as they come in, but we think there's continued opportunity in Texas if things change at the federal level.

沒有保證，但我們從 CPRIT 那裡聽說，他們時不時會有額外的資本可以部署，他們往往會聯繫正在執行的公司，而我們正在嚴格按照我們提出和計劃的時間表執行。所以我們希望那裡可能有一些機會。但正如安德魯所說，我們也會繼續討論撥款事宜，但我們認為，如果聯邦層級的情況發生變化，德州仍將有機會。

Great. Well, thanks for answering my questions and I wish you guys good luck. Thank you.

偉大的。好吧，感謝您回答我的問題，祝你們好運。謝謝。

Thank you.

謝謝。

Sean Lee, H.C. Wainwright.

李，H.C.溫賴特。

Hi, good afternoon guys. And thanks for taking my questions. I just have two quick ones. One is -- first is on the LM multi-dose study. So how do you guys come up with the 13 millicuries dose to be used in that study? And how does that compare to what patients have received so far through the compassionate use program?

大家下午好。感謝您回答我的問題。我只有兩個問題。首先是關於 LM 多劑量研究。那麼你們是如何得出在該研究中使用的 13 毫居里的劑量呢？那麼，這與患者迄今為止透過同情用藥計畫獲得的治療相比如何？

Sean, thanks for the question. It's a good one. So as we were -- we're increasingly taking a Bayesian approach to clinical development. We'll talk more about that in our integrated development plan both next week in an ongoing manner. But we found, as we were getting into cohort 4, which is approximately 44 millicuries, that we were seeing excellent safety and also strong response cohort.

肖恩，謝謝你的提問。這是個很好的主意。因此，我們越來越多地採用貝葉斯方法進行臨床開發。我們將在下週的綜合發展計劃中持續討論這個問題。但我們發現，當我們進入第 4 組（約 44 毫居里）時，我們看到了極好的安全性和強烈的反應組。

And so as we began our negotiations with FDA on a multiple dose approach, we felt like we could support taking that cohort 4 dose and then fractionating it. And that follows approaches that FDA is very comfortable with. So we're able to get them to go along with that. And so I think that because of -- based on what we're seeing clinically, that earlier compression of doses will be very important and getting that long tail survival that I mentioned.

因此，當我們開始與 FDA 就多劑量方法進行談判時，我們覺得我們可以支持服用第 4 組劑量然後進行分次給藥。並且這遵循了 FDA 非常滿意的方法。所以，我們能夠讓他們接受這一點。因此我認為，根據我們的臨床觀察，儘早壓縮劑量對於獲得我提到的長尾存活率非常重要。

In terms of the compassionate use, we've had, I think 2 patients that have received three aggregate doses. We're actually giving them the -- whatever dose is currently enrolling. So they're getting actually in the neighborhood of 40 or more higher dose, but their dose frequency is much longer. They're being treated when they come back with symptoms. In other words, patients seem to -- are responding to the initial dose, and then they're doing well for an extended period of time, maybe up to a year or so. They're coming back with symptoms or progression and asking to be retreated. So we treat them with that dose that's available.

在同情用藥方面，我認為我們有 2 名患者總共接受了三劑疫苗。我們實際上正在給他們——無論目前正在招募什麼劑量。因此，他們實際上服用的劑量大約為 40 或更多，但服用頻率要長得多。當他們出現症狀時，正在接受治療。換句話說，患者似乎對初始劑量有反應，並且會在一段較長的時間內（可能長達一年左右）保持良好狀態。他們出現症狀或病情出現進展並要求撤退。因此我們採用可用的劑量來治療他們。

So back to my original point, I think increasingly, we recognize the Bayesian design is appropriate. We're modeling that right now. That's integrated into the multiple dose trial. And then as we'll talk about over time, how do we leverage that and get to approval.

回到我最初的觀點，我認為我們越來越認識到貝葉斯設計是合適的。我們現在正在對此進行建模。這已被納入多劑量試驗。然後，隨著時間的流逝，我們會討論如何利用這一點並獲得批准。

Oh, great, thanks. That's very helpful. My second question is on the CNSide assay. So in the prepared remarks, you mentioned that you needed to get the CLIA compliance followed by a CMS inspection, as well as getting the Z-Code and PLA-Code. So do you have a rough guideline for the approximate timeline for these process?

噢，太好了，謝謝。這非常有幫助。我的第二個問題是關於 CNSide 分析。因此，在準備好的評論中，您提到您需要獲得 CLIA 合規性，然後進行 CMS 檢查，以及取得 Z-Code 和 PLA-Code。那麼您對這些過程的大致時間表有什麼粗略的指導嗎？

I'm sorry, Sean, just to clarify, what's the timeline for getting additional reimbursement?

抱歉，肖恩，我只是想澄清一下，獲得額外報銷的時間表是什麼時候？

Yeah, getting the inspection done as well as having -- getting the reimbursements online. So like when can we expect CNSide to start selling commercially and getting reimbursed?

是的，完成檢查並在線獲得報銷。那麼我們什麼時候可以預期 CNSide 開始商業銷售並獲得報銷？

Yeah. So I think we're on track to being able to commercialize the test in Q4 of this year. I think the issue is going to be that we need to -- we're more likely to get imbursed if we have a CNSide CLIA compliance and that inspection is -- it's not been scheduled, but it's going to be Q1 and we're pushing to make that as early in Q1 as possible because we want to try to accelerate that timeline.

是的。因此我認為我們預計在今年第四季實現該測試的商業化。我認為問題在於我們需要——如果我們符合 CNSide CLIA 合規性，我們更有可能獲得報銷，並且該檢查——尚未安排，但將在第一季度進行，我們正在努力儘早在第一季度完成檢查，因為我們想嘗試加快這個時間表。

And then number two, I think some of these -- some of the laboratory services agreements, which were -- I think they were approximately 10. Is that right, Andrew? 10 in place with Biocept. We've hired market access team that is actively negotiating with those 10 institutions on a regionally focused basis based on my comments, where are the patients and where the highest level of reimbursements? So we're prioritizing those areas just sort of being practical, obviously.

然後第二，我認為其中一些——一些實驗室服務協議——我認為大約有 10 個。是嗎，安德魯？10 與 Biocept 一起到位。我們已經聘請了市場准入團隊，該團隊正在根據我的意見，以區域為重點，積極與這 10 家機構進行談判，患者在哪裡，最高報銷水平在哪裡？因此，我們優先考慮這些領域顯然是出於實際考慮。

I think we're going to have some more things to talk about in Q1 as it relates to reimbursement. And I think once those reimbursement dominoes fall, then I think we'll feel more comfortable talking about pricing ramp, margins and so forth. And I think right now, it's just a bit premature until we get those things in place.

我認為我們將在第一季討論更多與報銷有關的事情。我認為，一旦這些報銷骨牌倒下，我們就會更願意談論價格上漲、利潤率等問題。我認為現在就將這些事情落實到位還為時過早。

We want to be really cautious in terms of guiding in the early phases until we get comfortable that we can stand behind that guidance. I can tell you that with the time that Biocept quit offering the test, they had 200 unique customers. They were growing at about 30% per year CAGR. And that was with no data, no NCCN guidelines, no specific reimbursement, no foresee clinical trial data.

我們希望在早期階段的指導方面非常謹慎，直到我們確信我們能夠支持該指導。我可以告訴你，當 Biocept 停止提供測試時，他們已經有 200 名獨立客戶了。它們每年的複合年增長率約為 30%。而且沒有數據、沒有 NCCN 指引、沒有特定的報銷、沒有預見的臨床試驗數據。

So we have all those elements behind us at this point today, and that's only going to grow. There are only more papers coming out and so forth. So I think the environment continues to look really positive for that as a stand-alone product.

所以今天我們已經擁有了所有這些要素，而且這些要素還會繼續成長。只會有更多的論文問世等等。因此我認為，作為獨立產品，其環境仍然非常積極。

Got it. Thank you for that. It makes it a lot more clear. That's all the questions I have.

知道了。謝謝你。這使其變得更加清晰。這就是我所有的問題。

Thanks a lot, Sean. Appreciate it.

非常感謝，肖恩。非常感謝。

I'm showing no further questions in the queue at this time. I would now like to turn the call over to Mr. Andrew Sims.

顯示隊列中目前沒有其他問題。現在我想將電話轉給安德魯·西姆斯先生。

Thanks, Sheri. We have two written questions. So the first is, can you elaborate on the therapeutic ratio you are seeing in your trials and safety data profile?

謝謝，雪莉。我們有兩個書面問題。那麼首先，您能詳細說明您在試驗和安全數據資料中看到的治療比率嗎？

Yes. So that's a good question. We'll talk probably more in detail. We will talk more in detail about that at next week at SNO. But I think it's a key point that the therapeutic ratio that we're seeing going out to cohort 4 is very high. In particular, for LM, we're seeing about -- a ratio of about 50-plus in cohort 4 in terms of therapeutic to target versus off target.

是的。這是個好問題。我們可能會討論得更詳細。我們將在下週的 SNO 上更詳細地討論這個問題。但我認為關鍵點在於，我們看到的第 4 組的治療率非常高。特別是對於 LM，我們看到第 4 組中標靶治療與脫靶治療的比例約為 50 多。

I can give you a preview of cohort 5. I think we're seeing that as greater than 100:1 ratio. So we're continuing to see a linear dose -- as we dose escalate a higher and higher absorbed dose in the spinal subarachnoid space and really relatively flat absorption in the key critical organs.

我可以為您提供第 5 組的預覽。我認為我們看到的比例大於 100:1。因此，我們繼續看到線性劑量 - 隨著劑量的增加，脊髓蛛網膜下腔的吸收劑量越來越高，而關鍵器官的吸收量實際上相對平穩。

Bone marrow is starting to tick up a bit in cohort 5, and we'll talk about that, and that was part of the rationale for the DSMB to cut back the cohort 6 dose. And I think we're increasingly becoming more comfortable that the cohort 4 dose will be the recommended Phase II dose, and the maximum tolerated dose will be cohort 5. But the FDA has been very consistent about us continuing to dose escalate to failure, hence, the cohort 6 dose.

第 5 組的骨髓開始略有增加，我們將討論這一點，這也是 DSMB 減少第 6 組劑量的部分原因。我認為，我們越來越確信第 4 組的劑量將成為建議的 II 期劑量，而最大耐受劑量將是第 5 組的劑量。但 FDA 一直堅持讓我們繼續增加劑量直至失敗，因此才增加第 6 組的劑量。

In terms of GBM, I think the therapeutic ratio is really hard to calculate because we're seeing essentially very minimal systemic absorption and very high delivery of radiation to the region of interest, tumor in the infiltrated margin. So yeah, I think we're seeing -- what we're seeing is very favorable, much higher than other companies are reporting with their systemically delivered technology. So I think that's really strong part of the technology.

就膠質母細胞瘤 (GBM) 而言，我認為治療比率很難計算，因為我們看到全身吸收基本上非常小，而對感興趣區域（浸潤邊緣的腫瘤）的輻射輸送非常高。是的，我認為我們看到的是非常有利的，比其他公司報告的系統交付技術要高得多。所以我認為這是該技術真正強大的部分。

And the second question is, can you provide details on your integrated development plan for LM?

第二個問題是，您能否詳細介紹一下 LM 的綜合發展計畫？

Yes, I think I've mentioned some of the details, and I think we'll present more at SNO and roll that out over the first part of 2025. I think -- right now, I think there is -- based on the data we're seeing in single dose, there is clearly activity and there's a strong potential for advancing to single dose in an expansion cohort for -- specifically on breast and lung cancer, non-small cell lung cancer, that data continues to look strong. We can use that data to help derisk a pivotal Phase II/III trial thereafter. And I anticipate getting that into the clinic pretty soon next year, but we'll talk more about that.

是的，我想我已經提到了一些細節，我認為我們將在 SNO 上展示更多內容，並在 2025 年上半年推出。我認為——現在，我認為——基於我們在單劑量中看到的數據，顯然存在活性，並且在擴展隊列中推進到單劑量的潛力很大——特別是對於乳腺癌和肺癌，非小細胞肺癌，這些數據看起來仍然很強勁。我們可以利用這些數據來幫助降低隨後關鍵的 II/III 期試驗的風險。我預計明年很快就能投入臨床，我們以後還會進一步討論這個問題。

In terms of multiple dose, I think we could follow a similar pattern where we pick as we complete each cohort, a promising dose, cohort expand it, confirm that there's an efficacy signal there as well as safety signal and then move that forward. And I could potentially see taking two different doses to market, a high single dose and a lesser multiple dose regime. And then -- so more on that next week and then first half of next year.

在多劑量方面，我認為我們可以遵循類似的模式，即在完成每個隊列時選擇一個有希望的劑量，然後擴大隊列，確認存在功效信號和安全性信號，然後繼續推進。我可能會看到兩種不同的劑量推向市場，一種是高單劑量，另一種是低多劑量方案。然後——下周和明年上半年將會有更多消息。

Are there any other questions? That's okay. Thank you, Andrew.

還有其他問題嗎？沒關係。謝謝你，安德魯。

Well, just to conclude, thank you, Sheri, and thank you, everyone. I appreciate you being on the call. On behalf of the Board, I'd just like to thank our employees and team members and the physicians we work with and very much thank you to the patients who continually trust us to enter into these trials. Thank you for your participation. Have a good evening.

好吧，總而言之，謝謝你，Sheri，也謝謝大家。感謝您接聽我的電話。我謹代表董事會感謝我們的員工、團隊成員和與我們合作的醫生，並非常感謝一直信任我們參加這些試驗的患者。感謝您的參與。祝你晚上愉快。

This concludes today's program. Thank you all for participating. You may now disconnect.

今天的節目到此結束。感謝大家的參與。您現在可以斷開連線。